TechNation Magazine October 2020

1technation.com

Vol. 11

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

OCTOBER 2020

Collaborative Approach WHAT IS THE FUTURE OF HTM REGULATION? PAGE 54

14 Association of the Month

The Michigan Society for Clinical Engineering

22 Colorado HTM Mixer 2020

HTM Mixer Rocks the Rockies

48 Roundtable

AI/Machine Learning

49 Scrapbook MSCE

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CONTENTS

FEATURED

48

HE ROUNDTABLE: AI/MACHINE T LEARNING TechNation reached out to industry leaders to find out the latest regarding AI and machine learning for the monthly roundtable article.

Next month’s Roundtable article: Radiography

54

COLLABORATIVE APPROACH: WHAT IS THE FUTURE OF HTM REGULATION? With the broader impact of regulation on health care as an industry, the question of regulations that impact HTM have been highlighted the past couple of years. How does government intervention impact the future of the HTM community, the safe practice of medical equipment servicing and patient safety? ext month’s Feature article: N Team Concept: Bridge communication gaps between hospital departments

TechNation (Vol. 11, Issue #10) October 2020 is published monthly by MD Publishing, 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290.

POSTMASTER: Send address changes to TechNation at 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290.

TechNation magazine is dedicated to providing medical equipment service professionals with comprehensive, reliable, information concerning medical equipment, parts, service and supplies. It is published monthly by MD Publishing, Inc. Subscriptions are available free of charge to qualified individuals within the United States. Publisher reserves the right to determine qualification for a free subscriptions. Every precaution is taken to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher. ©2020

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

OCTOBER 2020

TECHNATION

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Proud supporters of

P.12 SPOTLIGHT p.12 Professional of the Month: Lisandro D. Olivares, CBET p.14 Association of the Month: The Michigan Society for Clinical Engineering (MSCE) p.18 Department of the Month: FirstHealth of the Carolinas Biomedical Services Department P.22 INDUSTRY UPDATES p.22 HTM Mixer Rocks the Rockies p.24 News and Notes: Updates

from the HTM Industry p.32 Ribbon Cutting: Contrast Injector Tools p.34 AAMI Update p.36 ECRI Update p.38 Welcome to TechNation P.40 p.40 p.43 p.44 p.47

THE BENCH Biomed 101 Tools of the Trade Webinar Wednesday Shop Talk

P.60 EXPERT ADVICE p.60 Career Center p.62 20/20 Imaging Insights, sponsored by Innovatus Imaging p.64 View on Value p.66 Think Inside the Box to Maximize Resources, sponsored by TKA p.69 The Future p.70 Cybersecurity p.72 Tips for Maximizing the Performance of Infusion Pumps at Your Facility, sponsored by Avante p.75 The Other Side p.76 Clinical Network Visibility – Health Care’s New Currency, sponsored by Medigate p.79 Roman Review P.82 BREAKROOM p.82 Did You Know? p.84 The Vault p.85 Scrapbook: MCSE p.87 Scrapbook: HTM Mixer Colorado p.88 MedWrench: Where in the World is Ben C.? p.96 Flashback p.92 Service Index p.95 Alphabetical Index Like us on Facebook, www.facebook.com/TechNationMag

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SPOTLIGHT

PROFESSIONAL OF THE MONTH Lisandro D. Olivares, CBET Absorbing Knowledge

BY K. RICHARD DOUGLAS

A

s a biomed, it can be advantageous to be surrounded by a large team of colleagues with different skill sets. There is always something to learn and someone with the knowledge to share useful tips.

That is the case at Baylor Scott & White Health, the largest not-for-profit health care system in Texas, which has an equally large and impressive HTM department. The 52-hospital system has been around for more than 100 years serving patients throughout Texas.

One of those biomeds, who has benefited from the large HTM contingent servicing Baylor Scott & White facilities, is Lisandro D. Olivares, CBET, BMET II. Olivares always liked the idea of helping other people and that led to discovering the HTM field.

“The goal of my profession has always been to help other people – directly or indirectly. At first, I was aiming for the medical field, but since I’m not much of a people person, I needed to find a way to do this through another path,” he says.

“In my third year of high school, I learned about this profession, started to do some research on it and from my point of view, it perfectly matched my goal and my skills,” Olivares says.

Olivares used his bachelor’s degree as a strong foundation on which to build an HTM career.

“I have a B.S. in biomedical engi-

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Lisandro D. Olivares, CBET, BMET II, enjoys being able to help people as an HTM professional. neering from Universidad La Salle Laguna back in Mexico, where I used to live. No training other than a six-month internship prior to graduating. Everything else has pretty much been on-the-job training,” he says.

Olivares says that after getting his degree, he moved to Dallas and started his biomed career as a dialysis tech for a home dialysis company.

“Worked with them for two years taking care of the dialysis machines and portable reverse osmosis (RO) systems that we installed in patient’s homes – by doing PMs, corrective maintenance, disinfecting and water testing on all units,” he says.

“Then I got the opportunity to interview for a BMET I position at Baylor Scott and White back in February 2019; a month later I received a job offer and accepted it,” Olivares says.

He has since earned his CBET

certification and been promoted to BMET II. He works on many types of devices.

“I feel like it’s too early in my career to pick an area of specialty since there are a lot of options,” Olivares says. “I’d rather learn and get hands-on experience on as many devices as possible so that later on, if needed, I’ll be able to make a decision that fits what I like and feel comfortable doing.”

PITCHING IN WITH A POSITIVE ATTITUDE As with any biomed, the more routine daily tasks often morph into special projects and challenges. Olivares says that as experience pushes a biomed to learn more, the ability to rely on colleagues helps mitigate many challenges.

“Since I don’t have a lot of experience in this field, there have been a lot of challenges and a lot of new stuff to learn. Luckily, we have a pretty big

WWW.1TECHNATION.COM

SPOTLIGHT

team of biomeds which are always ready to help you out and answer any questions you might have,” he says.

He says that of the most memorable, fun and difficult projects that he has been involved with include the opening of the second-floor of a new tower which holds the NICU, nursery and post-partum departments just a month after he started working for Baylor Scott & White.

He helped to tag, inventory and perform initial inspections on all the new equipment.

“This was a challenge since I was brand new to the organization and all the tools used here, including the database. Overall, it was an excellent learning experience and gave me a lot of insight on how the database works,” Olivares says.

He says two other challenging projects were an EPIC integration and the COVID-19 surge.

“Another interesting project was the EPIC integration to the hospital. We had to be present at the hospital a couple of hours after midnight because that was the chosen time to switch servers. We had to install the new configuration to all the EKG carts and make sure the information was transferring over correctly. After we were done with the hospital, we had to go to the off-sites and do the same with their EKG carts. It was a fun night since we had been preparing for it for a week. It all actually went pretty smoothly. All the hard work paid off,” Olivares says.

One big challenge for biomeds everywhere has been the preparation of their facilities for a pandemic.

Olivares says that ramping up and preparing for a surge of patients involved everyone working together.

“It involved a lot of teamwork through all of our hospitals. We also had to rent, perform incoming inspections and tag a lot of equipment. It was very fast paced but a lot of people stood out by their ideas or actions to help others,” he says.

When not hustling to help clinicians prepare for COVID patients, Olivares finds more relaxing things to do in his off-hours.

“Music has always been something I like to spend time on. I’ve learned to play, over the years, a couple of instruments on my own as a hobby – bass, guitar, piano,” he says.

“And recently, since I built my gaming PC, I’ve been spending quite a bit of time playing video games in my free time,” he adds.

Olivares describes his guiding principle as a biomed as “I’ll be glad to help you out if you ever need help.”

The patients and clinicians at Baylor Scott & White can’t ask for more than that from a dedicated HTM professional.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Lisandro D. Olivares says he does not yet have a type of equipment he specializes in at Baylor Scott & White.

FAVORITE ARTIST/MUSICIAN: Hans Zimmer

FAVORITE MOVIE: “Interstellar”

FAVORITE FOOD: Sushi

HIDDEN TALENT:

I meal prep for the week.

FAVORITE PART OF BEING A BIOMED:

“The satisfaction of knowing that I get to help others, and all the amazing people you get to know.”

WHAT’S ON MY BENCH? • • • • • •

Cellphone Earbuds Face mask (because of COVID-19) Laptop Notebook Post-it notes

OCTOBER 2020

TECHNATION

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SPOTLIGHT The Michigan Society for Clinical Engineering (MSCE) offers an annual golf outing for members to compete and network.

ASSOCIATION OF THE MONTH The Michigan Society for Clinical Engineering (MSCE)

BY K. RICHARD DOUGLAS

M

ichigan was once known as the Water-Winter Wonderland and the motto could be found on every license plate during the mid-1960s up until 1968.

The Great Lakes State is a water winter wonderland with its five great lakes and many ski resorts in the northern portions of the state. Best known as the home of domestic automakers and the Motown sound, Michigan was also the home of Thomas Edison and Henry Ford.

The state is also known for apples, Mackinac Island, boating and pizza.

While HTM professionals in Michigan can partake in these local rewards, they also have a source for networking and education.

The Michigan Society for Clinical Engineering (MSCE) has existed since the late 1970s and has achieved a number of accomplishments through the decades.

The group’s leadership includes President Thomas Brown, Board Member At-large William Fox, Vice

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OCTOBER 2020

President Lawrence Barton, Secretary Stan Gordan and Treasurer John S. Crissman III. The fledgling group recognized the need for interaction among local biomed professionals in February of 1977. “[The] initial focus group meeting was held in Lansing at the Michigan Hospital Association. It was proposed and accepted that a steering committee be established to consider how best to interact,” Thomas says.

Two months later, the first meeting of the new steering committee took place.

The meeting was held at the home of Pat Pollard. Participants were Tom Bauld (Sinai Hospital, Detroit), Alex Berman (Grand Rapids Hospital Council Clinical Engineering), Jim Freeman (University of Detroit), Frank Hosner (Mercy Hospital Detroit), Chuck Jones (MIS), Don Lee (Veterans Administration Hospital, Allen Park), Pat O’Brian (BioSentry), Bryanne Patail (Detroit Osteopathic Hospital Corporation), Dale Petty (Beaumont Hospital-Royal Oak), Jay Hall (MIS) and Pat Pollard (PJ Pollard, Assoc). Objectives identified included service to other

groups, sharing technical data, promotion of the profession and social contacts.

Through the remainder of the decade, the group developed bylaws and a formal organizational structure.

Thomas says that the bylaws were officially approved in September of 1978.

He says that members were required to hold a degree in engineering, life or physical sciences and be employed in the health care field, including research and education. The bylaws also outlined that active (voting) membership is determined by attendance at a minimum of four of nine meetings.

The society’s first officers included President Tom Bauld, Vice President Chuck Jones and Secretary Dale Petty.

By 1984, the young biomed society amended its bylaws to allow active membership to anyone actively employed in the field, regardless of educational background. Leadership also made a name change from the Michigan Society for Clinical Engineers to the Michigan Society for Clinical Engineering.

Two years later, the bylaws were amended to increase opportunities for

WWW.1TECHNATION.COM

SPOTLIGHT

(Above) The Michigan Society for Clinical Engineering held its January 2019 meeting at Schoolcraft College. The meeting included a GE imaging simulator presentation.

(Right) Continuing education is one goal of the MSCE.

maintaining active membership through committee participation, publication of articles relating to field and more.

In the 1970s and into the early 1980s, the group achieved several accomplishments.

In the spring of 1979, the first workshop sponsored by MSCE was held with a focus on computerized patient monitoring.

The next decade saw the first MSCE-sponsored CBET review course with 70 participants. The society was becoming well established and by the end of 1982, leadership had filed incorporation papers with the state of Michigan and was officially recognized as a non-profit society.

The following years saw many new firsts, including the first AAMI/MSCE midyear meeting held at the Westin Hotel (the former Detroit Renaissance Center) in Detroit.

In 1988, it hosted an AAMI/MSCE anesthesia workshop in Romulus, Michigan. A couple of years later, it held an AAMI/MSCE Midyear Meeting at the Dearborn Inn in Dearborn.

Many more accomplishments followed in the 1990s, including the Michigan governor responding to the group’s request to proclaim February 14-20 “Clinical Engineering and Biomedical Equipment Technology Week” in conjunction with National

Engineers Week.

There was also the first meeting of the proposed West Michigan Chapter of MSCE and the launch of the group’s website in 1999.

AN EXPERIENCED HTM ORGANIZATION Today, the society is well-established and, like most biomed groups, it is negotiating the pandemic and juggling its schedule to accommodate that reality.

“MSCE is a chapter affiliate of the Engineering Society of Detroit,” Thomas says.

“The mission of MSCE is to promote the professional development of the membership, advance the development of excellence in patient care in hospitals and related health care facilities and provide a forum for the exchange of information among the members and to/ with other organizations,” Thomas adds.

He says that MSCE supports the right to repair movement that would require manufacturers to supply service manuals and affordable replacement parts.

It is an active organization with an annual MSCE Golf Outing in July.

Thomas says that meetings are held monthly; September through June with the golf event in July. Upcoming events will be set up on Zoom.

MSCE supports the Larry Sharmen

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Scholarship at Schoolcraft College.

Larry Scharmen was a beloved Schoolcraft College faculty member. He was a biomedical engineering technology professor, emeritus and served the college from 1985-2000. One of his former students, began the process to establish this scholarship to benefit Scholarcraft College students enrolled in the biomedical program. To be considered, students must be enrolled in the biomedical technology program and have a minimum grade point average of 3.0.

“We have a relationship with the Schoolcraft College Biomedical Engineering Technology Program, which is run by Chris Peters. We have held events at Schoolcraft College in the past,” Thomas says.

The pandemic has required some changes to the group’s remaining 2020 schedule and they plan on mostly holding meetings on Zoom for the rest of the year. Details will be posted online at michbmet.com.

To help fill open positions in the state created by retiring biomeds, the group makes announcements during meetings and posts jobs on its website.

In the state shaped like a mitten, HTM professionals have an experienced organization where they can network, play golf and keep up with the profession.

OCTOBER 2020

TECHNATION

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SPOTLIGHT Members of the FirstHealth of the Carolinas Biomedical Services Department include (front row from left) Keith Gilliam, Matt Dunn, Helen Cheong, Keith Wright, Jared Deal, Nick Batten, (back row from left) Jeremy Spencer, Lewis Beeman, Matt Hunsucker, Greg Curtis and Larry Riley. Not pictured are Brian Lefler, Donna Caviness, Greg Williams, Jason Lucas and Austin McKenzie.

DEPARTMENT OF THE MONTH FirstHealth of the Carolinas Biomedical Services Department

BY K. RICHARD DOUGLAS

O

ne of the premier health care systems in the Southeast is FirstHealth of the Carolinas, a private, not-for-profit health care network headquartered in Pinehurst, North Carolina.

It serves patients from 15 counties in the mid-Carolinas.

The system’s medical equipment is managed by its Biomedical Services Department.

The 16-member department includes Director Brian Lefler, MBA, CHTM; Office Coordinator Donna Caviness; Biomedical Supervisor Helen Cheong, CCE, PMP; and Biomedical Systems Analyst Larry Riley, CBET. The team also includes BMET IIIs Matt Dunn and Matt Hunsucker as well as BMET IIs Keith Gilliam, CBET, Greg Curtis and Jason Lucas, CBET. BMET Is on the team include Jared Deal, Nick Batten, Austin McKenzie and Keith Wright.

The team also has three imaging engineers in Greg Williams, Jeremy Spencer and Lewis Beeman.

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The biomedical services team provides coverage to several hospitals and other facilities. These include FirstHealth Moore Regional Hospital – 402-bed hospital, which is the main campus in Pinehurst, North Carolina. The Richmond Campus – a 99-bed community hospital in Rockingham, North Carolina, the Hoke Campus – the system’s newest hospital campus in Raeford, North Carolina and Montgomery Memorial Hospital – a 25-bed critical access hospital in Troy, North Carolina.

In addition to the hospital facilities, the team provides HTM coverage to eight Convenient Care (urgent care) centers as well as more than 85 clinics and health and fitness centers, a regional EMS/critical care transport system and five non-affiliated clients, where they serve as an independent service organization.

“Most biomedical staff report to the supervisor, which is a new position.

Helen is also new to our organization. It has been an adjustment with her coming from outside the organization but she

brings a new perspective that has been helpful,” Lefler says.

“The supervisor, imaging engineers, biomedical systems analyst and office coordinator report to me,” he adds, highlighting the team’s reporting structure.

Lefler says that all staff members are based at the main campus, except Greg Curtis, who is based at the Richmond campus because it is large enough to require a full-time technician.

“In general, the technicians are split into four teams with assigned areas of responsibility. There is also cross team assistance on the biomed side. This is necessary because there is only one biomed technician on call at any given time – along with one imaging engineer – for the system,” Lefler says.

The group judiciously manages service contracts.

“Biomedical Services has full responsibility for managing and budgeting for service agreements. By pooling risk across the entire system, we’re able to reduce the number and scope of service agreements.

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SPOTLIGHT For equipment not serviced in-house, we use a diverse mixture of OEM and ISO contracts and T&M arrangements,” Lefler says.

The department utilizes a CMMS with customer access for work requests.

“There is no requirement to submit work orders online, we accept phone calls directly to the department. We utilize network discovery tools and vulnerability scanners to aid in management of equipment connected to the network,” Lefler says.

He says that they also make use of online customer service surveys, which are conducted periodically.

The group also lends its expertise in capital purchase decisions. Lefler says they take an active role in capital equipment planning.

“Each technician is expected to provide input on recommending equipment replacement. Equipment is often moved around the various facilities to maximize the utilization of the assets,” he says.

Lefler says that the department participates as a member of the capital equipment procurement team along with the finance and supply chain departments.

Together, the departments negotiate the purchase of medical technology and assist with value analysis.

HELPING CLINICIANS ACROSS THE SPECTRUM The biomedical services department has been involved in a number of projects that showcase its diverse skills and capabilities.

One of those projects was an EMR replacement project. The department led the selection of a middleware vendor (Capsule) and planned the various phases for biomedical device integration. It has also been involved in infusion pump evaluation as well as vendor selection and ventilator evaluation and vendor selection.

Lefler says that the team has even been a part of extensive renovation projects that required the house-wide telemetry system to remain in place and operational.

Other projects have included contingency planning for downtime with PACs and the establishment of multiple send-to destinations with as many imaging modalities as possible as well as contingency planning for downtime with imaging equipment.

The department has also been active in the creation of a centralized telemetry war room.

“In order to provide the same standard of care for all telemetry patients across all our hospitals, we worked to establish central monitoring in a single location for all four hospitals. This involved working with IT, our patient monitoring vendor and clinical staff at each facility,” Lefler says.

Another project saw the team’s imaging engineers improve efficiencies for clinicians.

“Most of our fleet of C-arms were not purchased with wireless capabilities.

Normal IT security practices require deactivation of unused network connections/wall jacks. In order to allow clinical

Greg Curtis (right) reviews servicing procedures of a BiPAP unit with Jared Deal.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

staff to transmit images to PACs (and not have to spend time searching for an active wall jack), our imaging engineers installed and configured wireless routers on the C-arms and verified,” Lefler says.

The team has also helped during the COVID-19 pandemic, and with the challenge of PPE availability, and brought Sterrad service in-house for cost reduction and increased uptime. The plasma sterilizers have been instrumental in reprocessing N95 masks during COVID-19.

The group has been a valuable asset to other clinical colleagues as well.

“Biomed has worked very closely with the dialysis service line and is very much a partner in patient care. We serve on the Dialysis Quality Team and are very much involved with all issues related to equipment availability. We have worked to get to the bottom of water pressure and quality issues, intermittent/random leaks and have maximized equipment uptime. They are a high-volume, high-need customer and we strive to provide excellent service for them,” Lefler says.

Away from work, members of the group remain active in the HTM community.

Lefler is the outgoing president of the North Carolina Biomedical Association (NCBA).

“All are members of NCBA and attend the annual symposium,” he says.

“Larry and I are members of North Carolina Healthcare Information and Communications Alliance (NCHICA) that is traditionally made up of IT professionals. Larry is an active member of the NCHICA Biomedical Device Security Task Force,” Lefler adds.

“We try to attend the HTMA-SC annual meeting, which is a one-day event that we have found to be very useful,” Lefler says.

He says that they try to send three staff members to this meeting. The department members also have an AAMI membership.

An experienced and involved biomedical department is a valuable asset to clinical staff and patients alike. The biomed team at FirstHealth of the Carolinas embodies the talent and willingness needed to tackle any project while maintaining and repairing the system’s many assets.

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HTM MIXER ROCKS THE ROCKIES “We’re back!”

T

he healthcare technology management (HTM) community gave the first HTM Mixer a warm welcome and an abundance of support in Colorado. The new “safe and clean” model for a smaller MD Expo-like event was extremely successful, with 40 companies exhibiting and about 150 attendees.

The turnout was near the maximum for a “safe event during a pandemic.”

MD Publishing, parent company of TechNation magazine, hosted the HTM Mixer along with support from the Colorado Association of Biomedical Equipment Technicians (CABMET).

MD Publishing Founder and President John Krieg admitted that there was some nervousness ahead of the first-ever HTM Mixer.

“2020 has been unquestionably one of the most challenging times anyone, or any business, has ever had to face.

Blindsided might be the most fitting word to use. We certainly were at MD Publishing and have had our fair share of challenges, particularly when dealing with face-to-face meetings and our conferences,” Krieg shared in an email.

“So when we descended upon Denver for the HTM Mixer CO (our first live meeting since this craziness began) I was a bit nervous. Would people show?

How would they react to the new restrictions and safety guidelines?”

“Well, to say it exceeded all our

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expectations is a gross understatement.

Upon arriving, it was like a heartfelt family reunion, so many warm and genuinely happy people,” he added.

MD Publishing Vice President Kristin Leavoy was also impressed by the event’s success.

“As one of the event organizers for the HTM Mixer in Colorado, it was so rewarding to see attendees and vendors reconnect after such a long hiatus,” Leavoy shared. “Several in attendance made the effort to express their appreciation that we were willing to take the first step in bringing meetings back to the industry and that made all the hard work and uncertainty worthwhile.”

Attendees and exhibitors shared positive feedback regarding the mixer.

CABMET President Leticia Reynolds was pleased with the event.

“It was an awesome event and we had a pretty decent turnout even in spite of COVID. I have never been to an MD Expo, but this makes me want to go,” Reynolds said. “It was great to be able to socialize and see other biomeds. This year has been so crazy and, really, we haven’t had a CABMET since January, so unless you work in the same shop you haven’t seen other people. It was great to catch up and see what is going on in everyone’s life.

Knowing all the precautions were in place to ensure everyone was safe made it less concerning.”

She said the safe and clean plan

worked great.

“I think the organizers and the hotel did a great job keeping everyone safe.

They ensured people were wearing a mask, had plenty of hand sanitizer and provided bottled waters and other individually packaged meals or snacks.

One thing the hotel did to help was the option to skip the room service, but they encouraged it by offering a meal to Feeding America. Great way to help a community,” Reynolds said.

Dave Francoeur from TKA felt energized after being able to interact with HTM peers at the event.

“I was thoroughly impressed with how well the entire meeting went off,” Francoeur said. “There was a significant number of attendees and a wonderful representation of vendors.”

Francoeur said it was obvious that work was being done to provide a clean and safe environment throughout the entire mixer.

“The MD Publishing team was extremely conscientious and carried themselves without question regarding safety measures related to COVID-19 concerns,” he added. “The hosting facility did a phenomenal job at ensuring a very high level of COVID-19 safety. The meeting space was laid out very well, ensuring appropriate social distancing between each person. Masks were worn by everyone in all appropriate areas.”

“I felt very safe at all times. Everyone

WWW.1TECHNATION.COM

INDUSTRY UPDATES

LEFT: A great perk to in-person meetings is the ability to network with speakers and other attendees between educational sessions. RIGHT: Attendees were able to earn valuable CE credits via a variety of insightful educational sessions. was very conscientious of their surroundings and other people’s safety,” Francoeur added.

He attended because he was giving a presentation. However, the opportunity to interact with peers was a priority.

“I attended because I was a speaker and wanted to provide individuals within our industry a just-in-time update regarding the Medical Device Serving Community activities. In addition, I was excited to have industry conversations and hang out with industry professionals,” Francoeur said.

“I absolutely accomplished those activities.”

Sydney Humes, director of business development and strategic sourcing at ZRG Medical, said the opportunity to attend a conference in a “safe setting” was one of the reasons her company decided to exhibit.

“Really having that face-to-face interaction is important for us,” Humes said. “We love that we can be here in a safe setting and still social distance and be here with our colleagues and our peers.”

Brian Wilson from Trimedx echoed some of those sentiments.

“I think it was a great opportunity to get out. You know, we have all been kind of hunkered down with the

pandemic and all of that,” Wilson said.

He added that colleague Dave Scott recommended the HTM Mixer based on positive experiences at previous MD Publishing events.

“I thought it was worth it to get out and network and talk with the other people and vendors,” Wilson added.

“It’s been great. I really appreciate you guys hosting it and letting us come out.

It has been a great show.”

John Nalley, executive vice president of equipment service operations at TTG Imaging Solutions, explained that his company decided to attend its first-ever MD Publishing event to grow the parts segment of its business.

“We want to get ourselves in here with you guys at this expo so we can start building that business, reach out to different biomeds and providers and start that network out for our company,” Nalley said.

He added that the event was a success for his company with lots of traffic in the exhibit area.

Cecil Hitzges from Rose Medical Center enjoyed the chance to connect with peers.

“I really enjoyed the HTM Mixer today,” he shared. “I had a lot of fun meeting a lot of people and doing a lot of networking.”

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

He added that he was able to talk with several companies and that he walked away with cost-saving tips to implement at his facility.

Dave Scott a biomed tech at Children’s Hospital Colorado has attended many MD Publishing events. He said the first-ever HTM Mixer was great because it was held at about the same time that the CABMET symposium would have been held. He said the mixer was well planned and that he felt safe amid the pandemic. He encouraged his HTM peers to attend an HTM Mixer if they are lucky enough to have one in their city or region.

Reynolds also encourages HTM professionals to attend future HTM Mixers.

“While it may be shorter and smaller in size than other events, you will not be disappointed by the classes,” she explained. “It is a great opportunity to learn something new, as well as socialize and relax a little. Everyone should consider going if possible.”

The next HTM Mixer is scheduled to be held at the Hyatt Regency Milwaukee in Milwaukee, Wisconsin, October 1-2.

For more information, visit HTMMixer.com.

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INDUSTRY UPDATES

NEWS & NOTES

Updates from the HTM Industry MD EXPO SETS SAIL FOR TAMPA Tampa is the X on the treasure map for healthcare technology management (HTM) professionals in 2020. Home to historic cigar factories and an annual pirate-themed celebration, Tampa will be the site for this fall’s MD Expo.

The signature, must-attend event for HTM professionals begins on November 8 with new safe and clean protocols in place amid the COVID-19 pandemic. Expectations are cautiously optimistic following two smaller, regional HTM Mixers held in Denver, Colorado and Milwaukee, Wisconsin.

MD Expo strives to provide HTM professionals with a unique, intimate and rewarding conference. For two eventful days, clinical engineers, biomedical technicians, directors and managers, procurement/asset managers and others

responsible for medical technology will gather in a one-of-akind welcoming environment to network with peers while they learn about the latest technologies and advances.

MD Expo Tampa includes industry-leading speakers covering the hottest topics in HTM, compliance, IT, cybersecurity, management and equipment service. The conference also regularly hosts the industry’s most unique networking events to connect and share best practices with other leading HTM professionals. In addition, attendees can expect a world-class exhibit hall with the latest technology, products and services. • For more information, visit MDExpoShow.com.

ECRI HELPS REDUCE COSTS AMID PANDEMIC ECRI recently released an enhanced value analysis workflow solution that drives team transparency, clinical engagement and improves efficiency of the medical product decision-making process. ECRI’s Value Analysis Workflow empowers supply chain leaders, value analysis teams and clinicians to reach consensus on complex technology purchasing decisions based on sound clinical evidence.

“The COVID-19 pandemic is tightening financial pressures on an already strained health care system,” says Marcus Schabacker, MD, PhD, president and CEO, ECRI. “Our new value analysis workflow adds much-needed transparency, safety and clinical evidence assurance that leaders can rely on to stretch scarce resources when selecting new patient-care technologies.”

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ECRI’s Value Analysis Workflow integrates pricing and utilization analytics, evidence-based assessments and comparative product evaluations to reduce clinical spend and enhance patient outcomes.

The cloud-based project management tool includes three major enhancements: 1. Visual workflow; increases efficiency by providing organization-level transparency on the status of any project under consideration.

2. Mobile notifications; makes it easy for clinicians and value analysis members to review, research and approve project tasks directly from mobile devices.

3. Automated decision logic; automatically routes supporting financial, technical or clinical evidence to the correct person for approval ensuring the right people are making the best decisions.

The workflow application adds efficiency by integrating clinicians and all members of the value analysis team into the process, streamlining decisions.

Hospital Sisters Health System, a multi-institutional health care system in Illinois and Wisconsin, shortened request turn-around times by 76 percent, reducing the time to completion to approximately 14 to 18 days.

“Unlike other workflow solutions, ECRI embeds trusted, unbiased clinical evidence analysis and guidance into our services to inform clinical decisions and improve patient outcomes,” says Karen Schoelles, MD, vice president, clinical excellence and safety, ECRI. • For more information about ECRI’s Value Analysis Workflow or to request a demo, contact ECRI at 610-825-6000 or clientservices@ecri.org.

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INDUSTRY UPDATES

THE WORLD MOVES FAST. WE MOVE FASTER.™

626 ACQUIRES PHIGEM PARTS On August 17, 626 Holdings LLC announced its acquisition of PhiGEM Parts.

“626 has always been service first. When Michael Fischer and I started the business, we always felt we would need to be able to control the quality of our product. The one area of the service event where it was difficult to control 100 percent of the quality, was with the parts needed to repair the system. Now we can. With this investment, we are now united with the highest quality parts company in the business. When we looked for the team we wanted to partner with it was simple; PhiGEM Parts has the highest success rate of all third-party parts companies in the marketplace. Josh Glas has built an incredible family atmosphere and business. We look forward to the expertise he and his team brings to 626. Our 85-plus engineers in the field just got a whole lot stronger. Out of all of our deals so far, this improves our quality the most. Look out world, we just got a whole lot faster,” commented Phil Revien, CEO of 626.

“Due to the COVID-19 pandemic, there is perhaps no other time in our country’s history where the expediency and quality of radiology imaging service delivery is at such a critical level,” said Michael Fischer, president of 626 Holdings. “With the acquisition of PhiGEM Parts, 626 will be even more efficient with our operations, allowing us to streamline our process for image system repairs.”

Glas will join 626 as president of the parts division.

“Under the leadership of Josh, PhiGEM has become best in class in providing the highest-quality, field-tested diagnostic imaging parts,” said Fischer. “His commitment to customer care aligns perfectly with the corporate culture at 626 where customers and the patients they serve is our top priority. We welcome the employees of PhiGEM Parts to the 626 family as we continue to take a team approach to meeting the increasing needs of our health care partners.”

Glas added, “I am beyond excited to start working with Phil, Michael and the team. I met Phil and Michael early on in 626’s life and we all clicked immediately. The culture among both of our organizations is very similar and together we are going to bring our combined customer-centric approach to ensure those that have come to rely on us, and those that will, enjoy maximized value and satisfaction. Together we are going to do amazing things!”

In business since 2010, PhiGEM Parts has a long history of quality and innovation as it consistently grew its market share and customer base by supplying multi-modality, multi-manufacturer, high-quality parts at a value as an original equipment manufacturer alternative, according to a news release.

626’s purchase of Walsh Imaging three years ago followed its approach to base acquisitions on what matters most to them; family, according to a news release. This method was repeated with the purchase of ISS, the leading third-party injector service and support supplier in the HTM space, Innovatus’ DR-CR service business earlier this summer and now the PhiGEM Parts business, the release states. •

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NUVOLO’S HEIDI HORN ELECTED CHAIR OF AAMI’S TECHNOLOGY MANAGEMENT COUNCIL Heidi Horn, vice president of global enablement-healthcare at Nuvolo, has been elected as chair of the Association for the Advancement of Medical Instrumentation’s (AAMI) Technology Management Council (TMC). Horn is currently on the AAMI Board of Directors and received AAMI’s 2019 HTM Leadership Award. She is also an inaugural AAMI Fellow and active in many national healthcare initiatives.

“One of the many things that differentiates Nuvolo as a company is its active participation in initiatives that impact the healthcare industry,” says Tom Stanford, CEO of Nuvolo.

“We’re not just a company that operates on the periphery.

We are actively involved in the industries we support, and we encourage our team to participate in industry associations and

projects to ensure they fully understand factors affecting our clients which enables us to better define how we can help.”

Founded in 2004, the TMC is an advisory committee of healthcare technology management (HTM) thought leaders who work with AAMI to advance and support the field. It represents the interests of biomedical equipment technicians (BMETs), clinical engineers, and other HTM professionals.

Priorities for the TMC include strengthening the HTM field by finding creative ways to promote HTM careers, developing materials to highlight HTM as a desirable profession to students and young professionals, creating education programs to develop the existing workforce, and producing resources to promote best practices. •

RENOVO SOLUTIONS INTEGRATES ASIMILY INTO MANAGED SECURITY SERVICE PROGRAM Renovo Solutions has partnered with Asimily to integrate Asimly Insight into Renovo Solutions’ ISM Program.

“Asimily’s detailed networked medical device information, vulnerability management, anomaly detection and alerting, and risk profiling use cases provided by Asimily’s network monitoring platform creates a strategic and tactical fit into Renovo Solutions’ Cybersecurity Managed Services.

Converging the technical competence of Asimily and Renovo Solutions creates the best-of-breed HTM lifecycle and risk management portfolio,” according to a news release.

From the inception of its asset management/health technology management (HTM) program offerings in 2009, Renovo Solutions recognized that the HTM programs of the future must include a focused and disciplined framework to effectively manage the risks associated with networked medical devices, the release adds.

At that time, Renovo Solutions was the first independent HTM service

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organization to author a whitepaper addressing this subject. Integrating best practices from the NIST, CIS and the information technology industry with traditional HTM asset management principles, Renovo Solutions developed and introduced a redefined and innovative medical equipment management framework called Integrated Systems Management (ISM).

In 2013, Renovo Solutions and Methodist Hospital in Arcadia, California received the ECRI Health Devices Achievement Award, recognizing excellence and innovation enabling health care organizations to improve patient care. In 2018 Renovo Solutions and Beebe Healthcare in Lewes, Delaware were presented the AAMI Foundation & Institute for Technology in Health Care’s Clinical Solutions Award. This award honors healthcare technology professionals who have applied innovative clinical engineering practices to solve a significant patient care problem facing a patient population or community. •

MARYLAND AREA COLLEGE OFFERS NEW BMET APPRENTICESHIP PROGRAM Employers of biomedical engineering technologists were recently invited to join the Howard Community College (HCC) apprenticeship team in a virtual networking event to learn about the college’s biomedical engineering technology (BMET) apprenticeship program. The event included a presentation that provided an overview of the program and how it can benefit businesses. Additionally, a representative from the Maryland Department of Labor was present to answer questions regarding incentives and tax benefits.

Students completing the threeyear apprenticeship program will earn 46 credits and an A.A.S. degree. The curriculum includes lecture, lab and 2,000 hours of on-the-job training per year. • For more information, visit https://bit. ly/2Q77bqH.

WWW.1TECHNATION.COM

INDUSTRY UPDATES

ELITE BIOMEDICAL NAMES NEW CFO Elite Biomedical Solutions has named Susan McClure its chief financial officer.

In this role, McClure will lead the financial team, provide strategic recommendations to the co-owners, and serve as a member on the executive leadership team, reporting directly to CEO Jeff Smith.

McClure and her team will manage the day-to-day financial operations, as well as ensure alignment with the core business expansion strategies. McClure will be involved immediately with expanding Elite’s in-house manufacturing capabilities and offerings. will MED-Ad-cables.pdf 1 She 25/08/2020

also run the human resources department and be involved with Elite’s banking and insurance partnerships.

McClure has over 29 years of financial accountSusan McClure ing experience. She started her career as an auditor for Price Waterhouse, its official name at that time. After which, she spent several years in the industry and in 2000 went 18:30

back into public accounting, where she stayed until she made the move to Elite Biomedical Solutions two years ago.

During her years in public accounting she helped many businesses, including several big home builders and manufacturing companies in the Greater Cincinnati area, with their financial, auditing and tax needs.

“Her impressive experience in both large accounting firms and industry experience brings a wealth of knowledge and talent to the Elite Biomedical Solutions’ team,” according to a press release. •

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INDUSTRY UPDATES

VIZZIA TECHNOLOGIES ACHIEVES INC. 5000 FOR THIRD CONSECUTIVE YEAR Vizzia Technologies, a leading software and managed service provider of real-time location systems (RTLS) for health care organizations, was recognized on the 2020 Inc. 5000 list of fastest-growing private companies in America.

This is Vizzia’s third consecutive appearance on the Inc. 5000 list, due to

the company’s three-year revenue growth of 98 percent. According to Inc. magazine, only 1 in 10 companies have made the list three times.

“We are honored to join the elite 10% of companies to achieve three appearances on the coveted Inc. 5000,” said Andrew L. Halasz, founder and CEO of Vizzia Technologies. “The

Vizzia team has consistently delivered excellent products and support to our growing list of health care customers nationwide.”

Vizzia is also one of only 123 health technology companies to make the Inc. 5000, according to a news release. •

Krieg said. “If hospitals can’t come to us, we will go to them.”

Webinar Week, which was held July 27-30, averaged more than 100 attendees per session and each presentation is available on-demand at WebinarWednesday.Live.

Attendees praised Webinar Week saying it was “a refreshing way to earn continuing education credits” and “like looking through a catalog of neat stuff you want to add to your Christmas wish list.”

One popular session offered during Webinar Week was “Straight Talk on COVID-19’s Effect on the HTM Industry.” The panel discussion provided insights and a forum where biomeds could share best practices.

Another presentation was “A Collaborative Approach to Downtime Planning for Critical Medical Device Systems” presented by Izabella Gieras, director, clinical technology, Hunting-

ton Hospital.

“Strategic Technology Planning – Process, Leading Practices & Pandemics” was also a part of Webinar Week.

Carol Davis-Smith, president of Carol Davis-Smith & Associates LLC explored how the COVID-19 pandemic has or could impact strategic technology planning going forward. She clarified what strategic technology planning is and is not, then reviewed the process steps and leading practices so HTM professionals can initiate or enhance the strategic technology planning process within their organization.

Also, Biomed Security Administrator David Yaeger and ProHealth Care Director HTM and Biomedical Engineering Rob Bundick presented “Maintaining an In-House Medical Device Cybersecurity Program.” •

For more information, visit VizziaTech.com.

Week WEBINAR WEEK EXCEEDS EXPECTATIONS Amid the COVID-19 pandemic, TechNation remains committed to delivering quality educational opportunities for HTM professionals. This commitment resulted in the first-ever Webinar Week. The bonus is that the webinars are eligible for 1 credit from the AAMI Credentials Institute (ACI).

ACI awards certification credentials to professionals in healthcare technology management and the sterilization industry.

Webinar Week became a reality when the MD Expo scheduled for earlier this year had to be modified after the venue closed amid the COVID-19 pandemic. The result was a series of HTM Mixers and Webinar Week.

“We understand that participants may be hesitant or unable to travel so by providing local, regional conferences, we will be able to provide the education and networking that they need,” MD Publishing President and Founder John

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For more information, visit 1technation.com/ webinarweek.

WWW.1TECHNATION.COM

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ACCRUENT ENHANCES ASSET MANAGEMENT PRODUCTS Accruent has enhanced two of its core health care asset management products, Connectiv and Accruent Data Insights. These enhancements add additional tools to Accruent’s health care platform to help organizations manage the complete asset life cycle, from pre-assessment and acquisition to support and final disposition. Accruent software helps hospitals manage purchasing decisions, optimize asset maintenance and service contracts, improve support services and reduce the total cost of ownership of medical equipment.

Accruent Data Insights is a web application that provides hospital executives information to assist them in making equipment planning, purchasing, maintenance and labor decisions for their biomedical equipment. Based on the documented ownership experiences of U.S. hospitals, Accruent Data Insights aggregates millions of data points and delivers valuable metrics in easy to consume visualizations to guide asset decisions.

Connectiv is Accruent’s computerized maintenance management system (CMMS) designed exclusively for the health care industry. Connectiv helps health care organizations consolidate facilities management, technology and device management and information technology into a single user experience. Built on the ServiceNow platform, Connectiv supports health care organizations in their quest to transform the patient experience, gain real-time visibility into asset performance, optimize work productivity and ensure compliance with changing policies, laws and regulations.

New enhancements to the Accruent health care portfolio include: • Peer and institutional benchmarking functionality in Accruent Data Insights, allowing hospitals to

compare their asset life cycle management outcomes to other hospitals and locate opportunities to improve capital life cycle decisions • Automated request management workflows in Connectiv to optimize equipment and service request experience, leverage situational context and eliminate fulfillment delays • Automated contracting workflows in Connectiv to improve customer contract management, and increase obligation and pricing transparency These enhancements to the Accruent health care portfolio will help hospitals manage their resources most efficiently during critical times such as the response to COVID-19, assisting with such goals as: • Increasing staff productivity by improving service quality and request fulfillment response times (SLAs) • Improving margins by reducing capital spend and overbuying while improving equipment life cycle decisions • Optimizing equipment management and elevating performance with accurate, comprehensive data • Increasing equipment availability, utilization and uptime • Efficiently managing customers and contractual obligations on an account level In other news, Attainia Inc. announced the integration of its flagship planning software with Accruent Data Insights. This new feature will allow health care organizations working in Attainia’s PLAN-IT suite of products to optimize their purchasing decisions and control capital asset costs by viewing reliability and total cost of ownership (TCO) data during the equipment planning process. • For more information, visit accruent.com.

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TRIMEDX PARTNERS WITH MEDIGATE Healthcare technology company TRIMEDX recently announced a strategic partnership with Medigate to meet the unique demands of clinical asset management (CAM) and medical device safety and security for health care systems.

This coincides with TRIMEDX’s launch of its new CAM Advanced and CYBER Advanced product offerings, which makes it uniquely able to offer comprehensive, real-time data along with enhanced visibility to guide providers in improving their overall performance – improving financial health, reducing risk and improving patient/clinician satisfaction.

Through this partnership, TRIMEDX and Medigate deliver an integrated solution that merges the TRIMEDX CAM Advanced and CYBER Advanced solutions with Medigate’s real-time visibility, utilization data and threat/ vulnerability detection.

“Leveraging the power of cybersecurity monitoring, the depth and breadth of device-level data, analytics, and the skills and expertise of our field associates and leadership, TRIMEDX delivers a best-in-class portfolio designed to manage the full lifecycle of a hospital or health system’s clinical assets,” says TRIMEDX CEO Henry Hummel.

The Medigate platform discovers and precisely identifies every connected device on a clinical network, automatically doing so, in real-time, through proprietary algorithms specifically built to identify devices and communication protocols.

“The foundation of our work together is around leveraging the strengths of both organizations,” says Jonathan Langer, CEO and co-founder of Medigate. “The combined value of TRIMEDX’s clinical engineering expertise with Medigate’s deep technology specific to health care cybersecurity will fuel the TRIMEDX operation with even greater actionable and accurate data in providing high-value service and information.”

Through this partnership, Medigate and TRIMEDX address device safety and security monitoring, threat detection and remediation in a closed-loop system, marrying best-in-class industry expertise in technology and people.

Medigate’s platform continuously reviews network activity, quickly identifying anomalies that are escalated for review, while a dedicated team of TRIMEDX clinical engineering

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cyber specialists proactively searches for known vulnerabilities, monitors supplier response to known risks, and applies approved patches. In addition, recognizing the unique expertise required to manage the cyber risk of medical devices, all members of the TRIMEDX Cybersecurity Team receive approximately 200 hours of dedicated training through the TRIMEDX CYBER Academy. All data is tracked through the TRIMEDX proprietary work order system to keep clients continually apprised on the status of remediation.

WWW.1TECHNATION.COM

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effrey Wojnovich’s contrast injector experience began in 1998 when he spent several years on a team that developed the software for the MEDRAD Stellant and Solaris injectors. He was also a member of a coalition of imaging companies that developed the current standards for interfacing scanners to injectors. After leaving that company, Wojnovich worked with several other service companies to develop tools that aid in the service of these devices.

“In May of 2019 I started Contrast Injector Tools, primarily to provide tools and information to biomedical engineers focused on a self-service model,” said Wojnovich. “As we progressed, we had the time to develop a full line of parts, services and tools that allow us to provide any level of service required.”

TechNation learned more about Contrast Injector Tools in a question-and-answer interview.

Q: WHAT IS THE MAIN FOCUS OF CONTRAST INJECTOR TOOLS? A: The main focus is to provide our customers with the right information, parts and tools at the right time.

Whether it is a routine PM or an emergency, we want to be available to bring the equipment back to manufacturer’s specifications in the most efficient manner. We realize the importance of

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the device and are committed to keeping it in top working order. We use the latest technology to bring predictability and fixed cost service to the injector market.

Q: WHAT ARE SOME OF THE SERVICES CONTRAST INJECTOR TOOLS OFFERS? A: We are a full-service injector company and offer everything including parts, PMs, on-site service, depot service, remote monitoring and virtual service calls. Since we opened last year, we have worked with Global Light Company, a tremendous third-party parts manufacturer. Our partnership has produced very high-quality replacement parts for several of the injector models.

Since the outbreak of COVID-19, we have also worked with a few manufacturers of ventilators to provide comprehensive service to this fast-growing market. In addition to contrast injector service, we also offer reverse and software engineering, PCB/electronic repair and design, remote monitoring (IoT solutions), test device development and more.

Q: HOW DOES CONTRAST INJECTOR TOOLS STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: We are leveraging technology to provide a comprehensive service offering to our customers. We offer a threemonth warranty with our PMs or service calls. There is not another company that can match that. Our PMs

provide us historical and current data to make the proper part and service decisions before the unit breaks.

We are also preparing to do virtual service calls, so a technician can connect to an experienced service agent who will walk them through a service event. With our downloadable tools, we can receive the same information from the injector as if we were there. Afterwards, a comprehensive service report is emailed to the user.

Our unique ability to reverse engineer medical devices allows us to provide product service at a superior level, even compared to what the OEM can provide.

Q: DO YOU HAVE ANY SPECIFIC GOALS THAT YOU WANT CONTRAST INJECTOR TOOLS TO ACHIEVE IN THE NEAR FUTURE? A: We plan on revolutionizing the contrast injector service business. Using our technology, knowledge and staff, we will bring down the cost of ownership for hospitals and clinics. We wish to partner with other service organizations that manage injectors and provide them with a cost-effective and high-quality service offering.

We will continue to work with ventilators and other medical device manufacturers to provide guidance, tools, service and parts from product development to end of life.

For more information, visit www.contrastinjectors.com.

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INDUSTRY UPDATES

AAMI UPDATE

BY AAMI

AAMI INTRODUCES NEW HTM CERTIFICATION FOR NEXT-GEN WORKFORCE AAMI has developed the Certified Associate in Biomedical Technology (CABT), a new kind of certification aimed at professionals considering or just starting a career in healthcare technology management (HTM). By passing the certification exam, candidates can demonstrate that they possess the fundamental skill set to meet the growing demands of the HTM field while ensuring a high level of competency.

It’s no secret that the HTM field is expecting a glut of open positions. The U.S. Bureau of Labor Statistics projects that 2,000 new medical equipment repairer positions will be created by 2028, while clinical lab and industry technician positions are facing even more substantial growth, creating an additional 35,100 new jobs across science and medical sectors. However, what’s worrying managers is that an estimated 50% of the current clinical engineering workforce is over the age of 50. As this group retires, and the number of senior professionals available to coach new hires dwindles, the demand for new hires will only increase.

“AAMI is working hard not only to provide a solution for this anticipated deficit of HTM professionals, but to help promising professionals start their HTM careers right,” said MJ McLaughlin, director of education programming at AAMI. “Extensive work went into developing the CABT to help address these concerns and ensure a bright future for HTM.” Starting this autumn, entry-level HTM professionals already working in the field may apply for CABT certification to demonstrate mastery of basic competencies, a commitment to professional development and position one’s self for accelerated career advancement. There are no minimum work experience requirements for CABT applicants.

For more information, visit www.aami.org/aci.

AAMI TO LEVERAGE COGNITIVE SCIENCE TO DELIVER ONLINE TRAINING Over the last two years, AAMI has been transforming and modernizing to better serve members and stakeholders. Now, the organization is announcing a new strategic partnership, one aimed at delivering revolutionary online training.

“We’ve invested heavily in upgrading our education offerings – overhauling core components of our curriculum, investing in new courses and certifications, and launching our state-of-the-art AAMI Center for Excellence to support classroom-based and live-streamed training,” noted Rob Jensen, president and CEO of AAMI. “Now, we’re turning our attention to transforming the delivery of online education.

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To that end, we are delighted to announce a strategic partnership with Amplifire, the leader in leveraging cognitive science to radically improve training outcomes.”

The platform was developed by neuroscientists and cognitive experts from Harvard and four other leading academic institutions. Amplifire’s strategy of using memory “triggers” to promote rapid learning and long-term retention will now be harnessed for crucial industry training.

As a part of the strategic partnership, AAMI will become a member of the Amplifire Healthcare Alliance, leveraging AAMI expertise to add medical device and health technology courses to the Alliance network. In addition, AAMI will work directly with medical device manufacturers, independent service organizations and healthcare delivery organizations to develop custom solutions utilizing the Amplifire platform.

NEW COLLABORATION BETWEEN AAMI, ARCHIMEDES CENTER PROMISES GREATER INNOVATION IN MEDICAL DEVICE SECURITY AAMI and the Archimedes Center for Medical Device Security have announced a new collaboration to advance medical device cybersecurity practices across the entire medical device lifecycle. The two organizations will work together to connect their networks of medical device and health technology professionals across the country.

“Cybersecurity is a major area of concern for medical device safety, and it’s an area where AAMI has been active and will be even more active in the future,” says Robert Burroughs, AAMI senior vice president of education. “Our collaboration with Archimedes will expand the reach of some of the world’s leading experts in the area of cybersecurity and lead to new education offerings and resources that will drive patient safety. We welcome them as members to the AAMI community.”

Housed at the University of Michigan’s Computer Science and Engineering Department, Archimedes is funded by 17 institutional members to support graduate students and train health care professionals to better integrate security engineering into medical device design, procurement and operation.

The center is led by UM professor Kevin Fu, who previously co-chaired the AAMI Working Group on Medical Device Security, which developed technical information report AAMI TIR57:2016, which outlines core principles for medical device security and risk management.

LOOKING FOR A JOB OR A CANDIDATE? AAMI CAREER CENTER CAN HELP In these unprecedented times, searching for a job can be more overwhelming and stressful than ever. The AAMI Career

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INDUSTRY UPDATES Center is a valuable resource to help health technology professionals navigate your next career move or find the ideal candidate for your organization. Whether you graduated this year in a virtual ceremony, are adapting your skills in this constantly changing environment, or are hiring to cover a surging need in your hospital, we are here to support you throughout your search.

The Career Center provides 24-hour access to HTM job openings, attracting thousands of professionals every week and new postings daily, as well as a wealth of helpful resources for AAMI members. The Career Center allows you to upload your résumé, or you can create one online. There are a number of articles and tips on résumé writing, from things you may have forgotten to include to how to make your writing sound more professional.

Additionally, make sure to increase your confidence in your résumé by taking advantage of our service to receive expert review and feedback on this important document.

Once you’ve perfected it, you can include your résumé anonymously in our bank for companies to review.

The Career Center allows you to create custom job alerts tailored to what you are looking for. You can easily set up alerts on your account to be notified when positions are posted that match your criteria. This is a helpful tool to use when you don’t have time to check the job boards every day, and instead the best matched postings are sent straight to you at a frequency of your choosing.

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INDUSTRY UPDATES

ECRI UPDATE

Cybersecurity: Getting the Most Out of the MDS2 Form

C

ybersecurity needs ever-increasing attention as the networking and connectivity of medical devices expand. One way to better ensure the cybersecurity of health care equipment is the Manufacturer Disclosure Statement for Medical Device Security, commonly nicknamed the MDS2. It’s a standardized form filled out by medical device manufacturers to communicate information about their devices’ security and privacy characteristics – that is, the devices’ security profile. This information is intended for current device owners and potential buyers, typically healthcare delivery organizations (HDO).

Notes Chad Waters, senior project officer in ECRI’s Device Evaluation group, “The MDS2 provides an understanding of how a device handles sensitive information and interacts with a health care environment. This can be a helpful tool in procurement and be an aid in the secure implementation of a device.”

ABOUT THE FORM The MDS2 was developed by the Healthcare Information and Management Systems Society (HIMSS) and the Medical Imaging and Technology Alliance (MITA), the medical device division of the National Electrical Manufacturers Association (NEMA). It is available for free from NEMA’s website.

A manufacturer’s answers to the questions in MDS2 forms can be used to conduct a high-level assessment of a product’s security profile. This can aid in a side-by-side comparison of different models (i.e., identifying high-level

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differentiators) during procurement. It can also serve as a tool for risk assessment, or to feed a governance, risk and compliance (GRC) system for further analysis. And it can be beneficial in assessing both newly purchased devices and legacy equipment for which an MDS2 form may not have been originally requested.

Currently, most manufacturers provide the form upon request. The form, introduced in 2004, was updated in 2013 and again in 2019. ECRI considers the 2019 version to be a substantial improvement, providing a lot more information. But earlier versions of the MDS2 are still in circulation. For many products, manufacturers are just now starting to complete the 2019 form. For other products, manufacturers may decide not to complete the new form at all, particularly for devices that are no longer being actively marketed.

“Medical device manufacturers encourage health delivery organizations to ask for and utilize the MDS2 ,” says Zack Hornberger, director of cybersecurity and informatics at MITA. “The 2019 document is the result of a years-long collaboration between device manufacturers, health delivery organizations, health IT professionals and other industry stakeholders to provide a comprehensive tool that helps everyone work together and improve health care cybersecurity.”

FIRST STEPS IN USING THE FORM • Request an MDS2 form for each medical device. This should be done for every device in the current inventory and on an ongoing basis during prepurchasing – for example, in a request for information (RFI) or

•

•

•

•

•

request for proposal (RFP) – or at the time of purchase in a purchase order and/or contract.

Develop a clear policy for analyzing the form’s contents. IT and risk management should review the form to identify potential high-level differentiators that might influence a final purchasing decision. Keep in mind that all answers may not be applicable to each specific device, and risk should be assessed accordingly.

When a form is received, verify that it is the most up-to-date version. If an outdated form is received, request that the manufacturer provide you with a filled-out form based on the 2019 version. The manufacturer should update MDS2 forms for each of its devices as new software versions are released.

Check that the device software version matches the version described on the MDS2. Software versions in the MDS2 should correspond to the “to be shipped” version.

If different versions of a device’s software are in use in the facility, an MDS2 should be provided for each version.

Identify whether the unit stores, generates and/or transmits protected health information. The form will let you do this quickly. The form will also help you understand how much protected data is stored on the device (e.g., last patient only versus all history), the type of data, and whether it is permanent or temporary. If data is permanent, the manufacturer should provide instructions on how it can be purged.

Determine whether the device’s security profile meets your facility’s requirements. Document whether the

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INDUSTRY UPDATES

system meets your requirements as is, can be brought into compliance with compensating controls, or cannot meet your requirements even with compensating controls and thus should not be placed on the network.

The majority of the questions are formatted to be answered with a response of “yes,” “no,” or “not applicable”; however, the instructions for some of the questions require technical details to be provided in the notes field, so scrutinize these fields closely. In addition, you should request any supplemental documentation available, including network diagrams, security documentation and Software Bills of Materials (SBoMs).

• Check that the manufacturer has filled the form out properly. Among the things to look for are repeated answers of “N/A,” or multiple instances of notes that are vague or conflicting or that contain no explanation. If insufficient information is provided in the MDS2 form, request that the manufacturer appropriately answer all questions, and/or request a conference call with the manufacturer’s technical team for clarifications.

NEXT STEPS If you are already successfully obtaining and analyzing MDS2 forms as a part of your purchasing process, there are further steps you can consider.

• Plan to include the 2019 form in your procurement process. Note that manufacturers are transitioning to this new form; while you can encourage them to adopt the 2019 version, we expect it to be a long process.

• If possible, include MDS2 forms, or a

link to them, with the assets in your asset management database, CMMS or GRC system. This may facilitate future risk management efforts. It may also help in identifying affected units during ongoing security threats (e.g., ransomware attacks). ECRI is aware of these capabilities being offered by some computerized maintenance management system (CMMS) and GRC vendors. The 2019 form requires the information to be in spreadsheet format, which should enable the data to be imported into a CMMS or GRC system.

• Provide all parties involved (clinical engineering, IT, security) with access to MDS2 and supplemental documentation gathered.

• Periodically check for updated MDS2 forms to guide your ongoing risk management efforts. Additional software tools are available from CMMS vendors and third-party security vendors that can use MDS2 information in the creation of a risk profile or a risk score for a particular device. The MDS2 form is also harmonized with the requirements outlined in IEC 80001-2-2 to aid facilities that are currently in the process of or considering implementation of the IEC 80001-1 standard.

This article is adapted from material on ECRI’s website designed to help health care personnel cope with the growing number of cybersecurity threats. That article and many additional health-IT-related resources are available through membership in various ECRI programs, including its Capital Guide and Device Evaluation services.

To learn more about ECRI’s technology decision support solutions, visit https://www.ecri.org/ solutions/technology-decision-support, or contact ECRI at 610-825-6000, ext. 5891, or by email at clientservices@ecri.org.

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BY NIKHIL KANAMALA

T

he area of clinical engineering in hospitals is dynamic and must always be changing to meet technological advances. Clinical engineering departments in hospitals must strive to perform preventive maintenance and repairs to ensure safe medical equipment for patients. They must also be aware of the advances in health care, the growing population of patients, nurses and physicians who are becoming more technologically “savvy” and the dynamic economic forces that influence hospital administrative decision making. As a result, the area of clinical engineering in hospitals must shift away from the normal paradigm of being a technical service department toward becoming more integrated with the clinical staff on the floor. Clinical engineering must understand patient needs and work toward meeting the clinical requirements.

The advances in medical device interconnectivity and e-health means that clinical engineering departments must understand the importance of how medical devices interact, transfer patient data (which can be vital for diagnosis) and how medical devices work together as a system. For example, a patient monitor may only be useful for taking the vital signs of the patient. However, the interconnectivity of the patient monitor with the hospital central database and the monitor central server means that all the patient data across all the departments can be stored for diagnostic purposes. Solving an issue, therefore, moves away from just fixing the patient monitor but rather finding the problem in the over arching system.

This also means that clinical engineer-

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ing departments must train staff regarding basic IT skills so that they can establish close working relationships with IT. It is also essential, for the sake of patient safety, that the clinical engineering staff must always be aware of the latest advances in technology and regulations affecting health care. Staff must always be aware of unsafe equipment parts such as batteries that are overdue for replacement or equipment that has been recalled by a manufacturer. Staff must then work together with regulatory bodies such as Health Canada or ECRI to address malpractice by vendors and to ensure that patients are being diagnosed with the safest possible equipment that has passed all regulatory standards.

Clinical engineering departments must also be aware of the economic forces affecting health care. After all, being a department in a hospital, clinical engineers must know how to work hand in glove with the finance department to manage medical equipment that is cost effective for the hospital. This means that it is important for clinical engineers to understand the return on investment (ROI), the total ownership cost and the cost benefit analysis. For example, if an expensive piece of equipment such as an X-ray has reached the end of its life cycle, but it works perfectly well and passes all safety and functional tests, it may be more practical to prolong the life of the X-ray rather than replace it.

On the other hand, an inexpensive pulse oximeter that has reached the end of the life cycle can be disposed of and replaced as the cost of ownership is very low. Another example is to understand that when equipment is

Nikhil Kanamala, BMET

Northern Health, Bulkley Valley Health District

newly purchased, clinical engineering departments must prepare themselves financially to deal with a high ownership cost during the initial quarter of the lifecycle due to frequent repairs and recalls. However, as the product matures, clinical engineering departments can expect a lower ownership cost as the repairs and recalls would decline due to better education of the clinical staff using the equipment and manufacturers fixing the recalls.

One of the critical steps toward advancing the area of clinical engineering in hospitals is to build relationships with key stakeholders – that is the clinical staff on the floor by educating them on safely using the equipment, information technology by gaining IT skills for better communication, finance, risk management by consulting with them regarding any safety issues regarding equipment and the risk classification and materials management.

While the points stated above are important in advancing the area of clinical engineering, it can never be overemphasized that the vision of clinical engineers must align with the vision and purpose of the hospital where they are located. In most cases, it must be to promote service of equipment, quality of patient care and innovation.

Nikhil Kanamala, BMET, works in biomedical engineering at Northern Health, Bulkley Valley Health District.

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WEBINAR WEDNESDAY STAFF REPORT

T

he 2020 Webinar Wednesday series continues to deliver valuable information and credits from the ACI. Attendance is nearing the 10,000 mark for the year with an average of 171 attendees for each live presentation. The most recent webinars have covered a range of topics from a hydrogen peroxide sterilization system to high-tech test equipment and more.

STERRAD HYDROGEN PEROXIDE SYSTEM The August 19 Webinar Wednesday presentation “Introduction to Servicing the Sterrad NX Hydrogen Peroxide Sterilization System” was presented by Neil Blagman and sponsored by RPI. It was eligible for 1 credit from the ACI. The live presentation drew 163 attendees.

The attendees received an overview of the operation of the Sterrad hydrogen peroxide system. It provided knowledge of how the machine functions, and a close look at the key parts and assemblies of the unit. In addition, attendees were able to learn how to reduce downtime through planned maintenance routines, troubleshooting techniques and service tips. The presentation offered biomedical equipment technicians the opportunity to learn the idiosyncrasies of the Sterrad hydrogen peroxide system.

Centering on both the extensive knowledge base of the presenter and his hands-on experience with this unit, this course was intended for all levels of biomedical equipment technicians.

Beginning with an overview of how the

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system functions then leading into planned maintenance routines, troubleshooting techniques and service tips, the webinar had a natural progression that allowed even the most experienced biomedical equipment technicians to benefit from the course. During a Q&A session, attendees were able to hear from others in the industry regarding what they experience with these units and learn from the presenter regarding the best action to pursue in order to keep the unit up and running at its best performance.

In a post-webinar survey, attendees were asked, “What did you like most about today’s webinar?”

“Neil really knew that machine very well. And he explained it efficiently – enough info for what you need, and then kept it moving along,” said B. Treichler, BMET III. “Very precise and easy to follow,” is how Biomedical Supervisor S. Schafer explained the webinar.

A recording of the webinar is available online for on-demand viewing.

NEW TECHNOLOGY Julio Castro presented the Webinar Wednesday session “Harnessing New Technology – Wirelessly Control Test Equipment and Capture Results for Service and PMs with Your Smart Device.” It was eligible for 1 credit from the ACI. The webinar was available free thanks to a Pronk Technologies sponsorship.

Castro, sales director at Pronk Technologies, discussed how biomeds can use new technology to control test equipment from a smart device to

increase accuracy and efficiency in performing PMs and service on medical devices. He also shared how it can automatically collect test results as one works, including tests performed, notes and images. It can also generate a complete electronic report and grow the device library with hundreds of custom medical device types.

The webinar drew 140 attendees for the live presentation and even more have viewed a recording of the webinar online at WebinarWednesday.Live. A survey sent to attendees gathered positive feedback including a 3.9 rating on a 5-point scale with 5 being the best possible score.

Attendees were asked, “What did you like most about today’s webinar?”

Some of their responses are below.

“Very informative and answered all good questions on the new technology.

Looking forward to upgrading our test equipment,” said D. Reyes, Biomedical Engineering Technician 2.

“The webinar was very specific about product capabilities and the presenter seemed to be very knowledgeable about data capturing and time constraints that we experience as biomedical engineers every day,” Imaging Specialist R. Juarez said.

RTLS Webinar Wednesday delivered real-time locating service (RTLS) information in August. The Zulafly-sponsored webinar “RTLS for Multiple Industries and Contact Tracing” was eligible for 1 credit from the ACI. This 60-minute webinar featured Stephanie Andersen, managing partner

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THE BENCH

at ZulaFly, and Alan Tangen, head of RTLS business development and sales at Cooper Lighting. They focused on providing a working knowledge of how RTLS applications can be beneficial in multiple industries and understanding of the hardware offering the value add of RTLS applications. They also explained how RTLS can play a role in contact tracing and social distancing.

The live webinar presentation drew 100 attendees with even more viewing the webinar on-demand.

Attendees shared feedback via a survey that included the question, “How did today’s webinar meet your expectations?”

“Better understanding of alternative implementation methods,” said C. Nieland, CE manager.

“It was very educational on the different ways and devices used to complete a RTLS and work with it,” said R. Akin, biomedical manager.

“Covered the material well,” shared S. Ross, CREST IV. TEE PROBE CARE AND REPAIRS Innovatus Imaging sponsored the Webinar Wednesday presentation “Avoiding Big Failures Without Big Expenses with 4 Easy Steps” that was eligible for 1 credit from the ACI. The July 22 session was presented by Matt Tomory, vice president of sales and marketing at Innovatus Imaging.

When it comes to imaging devices, little things go a long way. And not always in the right direction. A little slip of the hand could cause trauma to a TEE probe, and according to years of data from first-hand experience and researching common failures, trauma is one of the leading reasons for costly repair services. In this session, attendees were able to learn how to identify the little changes to daily routines of cross-functional teams that can have a big impact on lowering costs associated with downtime and repairs. Tomory helped them identify opportunities for improvement, establishing goals, metrics, checkpoints and how to work

with end-users to take routine processes to a new level.

Attendees provided feedback via a post-webinar survey that included the question, “Give us three words to describe today’s webinar?”

“Precise, informative, simple,” Director of Clinical Engineering S. Cruz said.

“Organized, informative and planned well,” Manager O. Dillard said.

“I found it very interesting. Some very good advice and examples of tools for managing one’s time and tasks,” D. Cormier, instructor.

“Really enjoyed Matt’s thorough review of the process and tips for reducing cost of repairs,” said System Director M. Philpott.

“Guilty as charged! In my biomed department, I have been given the duty to have the TEE probes repaired. I was going about this task blindly. But Matt opened my eyes to an even greater issue, our staff is mishandling our probes. I will be calling Matt for his assistance,” said J. Clark, Biomed II. “Matt always does a great job. Good combo of technical and customer experience to make it beneficial,” said M. Lubliner, sales representative.

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EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

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Real-World Management of Medical Devices -

ON-DEMAND PODCASTS: SERIES 1 EPISODE 1 In this episode Summit Imaging’s CEO, Larry Nguyen sits down with Randy Snelling, Chief Physical Environment Officer at DNV Healthcare, to discuss Hospital Standards and how ISO, Vendor QMS and Engineers play a roll in the future of accreditation to increase the quality of care and reduce total cost of ownership.

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SERIES 1 EPISODE 2 In this episode Al Gresch, VP of Healthcare Strategy, Accruent and Mike Zimmer, Senior Solutions Engineer Accruent, sit down with Jason Tessari, Senior Client Success Manager at Accruent, to discuss how automating the Request Management process transforms risk management, safety management and the delivery of care.

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THE BENCH

SHOP TALK POWERED BY

FISHER AND PAYKEL HEALTHCARE AIRVO 2

Q: A:

Does anyone have a PM procedure and what is the frequency of PM? Or, are you risking out or doing AEM?

A:

Check the couch vertical encoder string and horizontal photodiode sensors. But, I also recommend checking KGTP’s power board. And since you replaced the GTS board and the battery make sure the “Zero Adjustment” was done properly.

I took a look at their website but could not find a service manual. The closest thing I could find to maintenance requirements is this: • Controlled oxygen delivery (when required) • Oxygen from a concentrator or cylinder can be added. An in-built ultrasonic analyzer requires no calibration, service or replacement.

If it were me, I would contact the vendor and ask about preventive maintenance.

Q: A:

A:

A:

Per the technical manual, “Arivo 2 humidifiers do NOT require routine servicing or calibration.” There is a performance check option, however; there’s no manufacturer requirement to carry out these checks on a routine basis as stated in the technical manual. This was also confirmed via email with F&P’s quality and regulatory specialist and we have that correspondence on file in case the no-service/PM strategy is questioned by surveyors. You may wish to do the same. In the meantime, I’ll send the technical manual to MedWrench’s admin for posting.

A:

The manuals may be found online at bit.ly/3fAoXNt.

TOSHIBA AQUILION 64

Q:

I started off with a gantry rotation error which led me to changing the rotation servo amp. After changing this, the gantry panel greyed out the bed in and out positions and would only go down just below 0 to 005 and not any lower. I did all couch calibrations on GTSA and that did not fix it. Does anyone have an idea of what could cause this issue?

A:

I would check the KGTSP power board. There are a few relays on that board that can go bad. I’ve always replaced the board but you can try cleaning the relays.

IRIS INTERNATIONAL STATSPIN EXPRESS 4 The service light is on.

The service light on indicates the drive system has reached a predetermined number of cycles and the drive should be replaced before it completely fails. Contact Ozark Biomedical, if I’m correct they will do rebuilds on these for a flat fee.

Yeah, there is a timer chip on the main board. Once it reaches the limit, the service light turns on. The motor replacement kit comes with a new chip. It’s not that expensive and it’s easy to replace. Having the motor rebuilt won’t get rid of the light; that chip needs to be replaced as well.

A:

My name is David and I work for Ozark Biomedical. I would be happy to assist you in this issue.

It is important to emphasize that the cycle count limit is to require customers to inspect their drive assembly and replace their rotor assembly after a set number of runs. This limit was determined by the OEM, based upon the relative lifespan of the average StatSpin Express 4 rotor. Iris found the rotor for the Express 4 could develop stress cracks in the center plate or other components, resulting in vibrations and eventual complete failure during operation. I have personally worked on several StatSpin Express 4 units that have had their rotors fail during operation and can attest to the damage. I highly recommend customers consider the condition of their rotor before resetting the cycle limit.

To reset the cycle limit: Press and hold the “3 & 5” minute buttons simultaneously while powering on the unit, continuing to hold them for approximately 6-10 seconds. While doing this, the unit will produce multiple audible beeps. After awaiting the defined time, release the buttons and power cycle the unit. The cycle limit will have been reset.

Let me know if I can assist you further.

SHOP TALK

is compiled from MedWrench.com. Go to MedWrench.com community threads to find out how you can join and be part of the discussion.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

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ROUNDTABLE

ROUNDTABLE AI/Machine Learning

T

echNation reached out to industry leaders to find out the latest regarding AI and machine learning for the monthly roundtable article.

Sharing their knowledge about AI and machine learning are TINC CMMS co-founder and CEO Luis E. Fernández, Medigate Vice President of Systems Engineering Stephan Goldberg, Asimily Director of Business Development Michael Nielsen and Nuvolo Chief Product Officer Asim Rizvi.

Q: HOW CAN HTM PROFESSIONALS BEST USE AI OR MACHINE LEARNING (ML)?

FERNÁNDEZ: Learning from medical equipment experiences and also recording them is of huge importance, since health care establishments can have rotations in their staff. AI/ML can help build predictive models for medical equipment failure and also help newly incorporated clinical engineers learn

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questions but also guide the clinical engineering department on how to prevent/anticipate future problems.

Luis E. Fernández TINC CMMS from previous experiences to reduce medical equipment downtime and increase their availability. Just ask yourself … How many times have we solved this problem? Was this problem solved before? If so, how was it solved?

AI/ML can not only answer these

GOLDBERG: HTM professionals can leverage AI and machine learning for several specific applications, most notably predictive analytics for strategic modalities failure and offline time. In turn, this allows for better project management planning, as well as enabling critical functions like spare part procurement and maintenance activity. By utilizing these technologies to achieve critical functions, HTM professionals can help to create a more collaborative, forward-driven health care ecosystem that is based on data-validated insights and streamlined processes.

NIELSEN: AI or machine learning can be used in a variety of ways, including: • Maintenance: AI can help HTM professionals better manage their

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own equipment with detailed asset management parameters • Capacity management: HTM professionals need to plan for how many devices are needed and in what department or location. By using a variety of parameters, AI or machine learning can provide insights into asset utilization, how, when, where, and how it is used and permit better capital planning and resource allocation as well as clear understanding of TCO and ROI. • Cybersecurity: As cybersecurity vulnerabilities threats continue to increase, AI or machine learning can assist HTM professionals in discovering, managing, and mitigating vulnerabilities and threats impacting their devices.

• Clinical diagnosis: AI has developed to help doctors with simple and, in some cases, even complicated diagnosis which could improve patient care and reduce costs. HTM professionals could offer such technologies to the clinical team.

RIZVI: HTM has significant challenges across several areas of the business that can benefit tremendously from AI and machine learning. In an environment of disparate legacy client server solutions where data structures are not well architected for conformity, structure and analytics, it can be very difficult to even consolidate the processes and data that drive the engine of HTM. This preverbal gold mine of data is locked behind ancient systems and paper reports. AI and machine learning can transform this landscape by normalizing this data for consolidation to new cloud platforms, providing new insights from unstructured data and helping reduce cybersecurity risk for equipment by identifying vulnerabilities and orchestrated automated action.

a future failure. By achieving these insights, HTM professionals can then minimize the allocation of redundant PM efforts and eliminate device downtime altogether.

Stephan Goldberg Medigate

Q: HOW CAN AI ASSIST WITH PROPER MAINTENANCE OF MEDICAL EQUIPMENT? FERNÁNDEZ: AI/ML represent the capability of machines and systems to learn, bringing great benefits for numerous sectors. Clinical engineers around the globe are working everyday repairing and practicing preventive maintenance on a diversity of devices. If their operations are not only registered but also introduced as data to be modeled by a system, key information can be produced to showcase clinical engineers and medical equipment performance. It can also enhance decision making by showing which devices are more feasible than others, allowing health care institutions to base their decisions on trends of their current operations.

GOLDBERG: AI is immensely useful for not only understanding the current state of medical equipment, but predicting their behavior and maintenance needs. For example, calculating the maximum-likelihood-estimate for the time frame that devices will actually break or malfunction (per device model) or using a predictive (online) model to alert about

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

NIELSEN: When considering medical equipment maintenance, many aspects need to be looked at, which include deciding how long to use a device, when to service the devices, what level of servicing is required and others. All of this requires looking through a lot of information like age of the device, utilization and many other parameters including any events happening on the device. AI or machine learning can combine all this information and help HTM professionals make decisions on when and how to maintain their equipment.

RIZVI: Maintenance of medical equipment is a complex and scientific process that requires planning and deliberate strategies. The key drivers are compliance, patient outcomes, security, cost reduction and equipment life extension.

It is very difficult for HTM teams to deliver results without insights into the service history, asset performance and utilization of equipment. AI and machine learning solve this by providing these insights against traditionally unstructured data to help set more efficient equipment maintenance schedules, address vulnerabilities as they are detected not just for one device but similar devices across the whole asset base as well as base maintenance schedules on utilization in an orchestrated and automated fashion versus traditional costly calendar based schedules. Predictive maintenance can change this landscape but cannot be accomplished without the use of machine learning to arrive at the right maintenance plan for the assets.

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Q: WHAT BENEFITS CAN AI PROVIDE FROM A CYBERSECURITY STANDPOINT? FERNÁNDEZ: Since AI/ML produce information regarding usual device and clinical engineering staff operations, by using AI/ML an organization can detect abnormal activity based on their registered data. With this information at hand, it’s much easier and faster to detect cybersecurity threats. Comparing the current analysis that is based on human intelligence, these disciplines and technologies can be more efficient as they’re mostly available on a 24/7 basis, can analyze huge quantities of data, and have the capabilities on running a vast diversity of algorithms to alert of any unusual activity.

GOLDBERG: AI for cybersecurity – and particularly healthcare IoT cybersecurity – is essential to ensuring visibility and eliminating the knowledge gaps that plague hospital networks. By this I mean the thousands of devices connected to a network , all of which must be discovered, maintained and protected from malicious threats. Notably, AI can generalize device profiling for initial discovery (for devices not seen previously) and before DPI efforts. Once this is achieved, HTM professionals can better create policies and more robust, validated baselines, which allows for enhanced alerts on anomalies and other suspicious behavior.

NIELSEN: Cybersecurity has many aspects to it: • Inventory: Getting all aspects about a device on the network • Security Threat Detection and Mitigation: Analyzing anomalies and threats and acting on them • Vulnerability Management: Prioritizing and mitigating the most

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critical vulnerabilities • Forensic Analysis: Analyzing root cause of a problem RIZVI: Cybersecurity is a key concern for all HTM teams today. Twenty to 30 percent of the fleet is connected and this number keeps rising every day. However, these OT assets are typically a blind spot for cybersecurity tools. AI solutions identify vulnerabilities and security events from a monitoring perspective but that is not enough. Once a vulnerability is identified against a MAC address, how do we address the vulnerability, which device is it anyway.

This is where OT cybersecurity combined with AI is so powerful. Machine learning algorithms monitor and identify, automated orchestration takes it to the next level and identifies the asset and all of its attributes to kick off workflow to address. While this is happening machine learning finds matches in the asset base for all other assets that share the same vulnerability and derive workflow and visibility of threat that was never possible before.

This is a transformational in solving

Michael Nielsen Asimily

traditionally paper and manual methods for addressing cybersecurity concerns.

Q: HOW CAN AI ASSIST WITH A HEALTH CARE FACILITY’S EQUIPMENT PLANNING? FERNÁNDEZ: Trend analysis and modeling can play a huge role when building a procurement or maintenance plan for healthcare technology, as most clinical engineering departments rely on limited information that is available on systems that are not designed exclusively for an HTM manager. If medical equipment activity is registered on paper, spreadsheets, ERPs or any CMMS that has not been designed for the clinical engineering department, the organization is leaving big money on the table. Every data input should be used for either identifying a device/activity and/or to produce a metric or indicator that can help the clinical engineering department make a decision. If we have key information at hand about risk, performance, and finance of every piece of equipment, and we can study/ compare it over a period of time, we can surely enhance not only patient safety, but also the organization’s feasibility in medical equipment related topics.

GOLDBERG: Similar to its other applications within a health care ecosystem, AI for equipment planning provides an avenue to better understand and anticipate the best ways to maintain and deploy these devices. Recently, AI has become an increasingly useful tool for device procurement, especially in the age of COVID-19. By understanding and analyzing key usage trends, you can then strategically deploy these devices to not only achieve cost savings, but improve clinical care. For example, hospitals that have a low usage rate for ventilators could conceivably recognize

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this and move the devices to a sister site within the greater health system, helping to prepare for an influx of patients or otherwise bolster a clinical staff under great demand. AI provides these types of actionable insights that allow us to truly understand and be proactive in our planning, rather than reactive and slow to respond.

NIELSEN: HTM professionals need to plan for how many devices they need and in which facility. Several parameters come into play here like utilization, number of devices as well as many of the parameters around maintenance and cybersecurity along with others. AI or machine learning can help with analyzing across all the information and provide the HTM department with information on equipment planning

solutions, this data is all captured but machine learning can help with automated routing and scheduling while considering all of these factors as rules to the model. Planning is a tedious task that can be automated with the help of AI to reduce errors. Further inclusion of utilization and metric-based predictive maintenance planning takes it to the next level to prevent corrective maintenance scenarios that are extremely costly to the organization and disruptive to the core mission of patient outcomes and patient safety.

Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT PURCHASING AND USING AN ASSET TRACKING SYSTEM?

Asim Rizvi Nuvolo

FERNÁNDEZ: Before any clinical engineering professional acquires a CMMS, they must first set the questions that need to be answered with the help of this tool in order to benefit the organization’s strategy. A CMMS is much more than just an asset tracking tool, it’s a very powerful tool that can help guide clinical engineering departments into accomplishing their main goal: keeping every piece of technology available, safe, accurate and feasible during its lifecycle. I believe that choosing a CMMS should not be based on the experience of others; the organization needs to assess their current processes, stakeholder expectations and organizational goals so that this can drive their market research. What doesn’t get measured simply won’t ever be improved.

RIZVI: Health care equipment facility planning is a complex task with so many asset types, models and procedures. The planning has to consider skill sets, manufacturer procedures, tool needs, part needs and technician availability. In progressive cloud

GOLDBERG: AI is a great algorithmic architecture and works best with unstructured big data. For structured data such as device communications, DPI is essential to extract relevant attributes from the device’s communications and logs, enabling users to better identify, profile and properly analyze the devices’

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

behavior. It’s important to note that AI is only a piece of the puzzle, not a silver bullet that solves all our problems from a cybersecurity, health care or device perspective. Rather, the technology’s applications to ensure greater device familiarity is essential for contextual decision making and, in turn, better management and clinical care.

NIELSEN: Considering the evolving needs and market, an asset tracking system should handle a wide variety of devices and be flexible and configurable. The vendor’s roadmap is also important since technology is rapidly evolving.

Other aspects include whether the system integrates with other systems, though for this if the asset tracking system uses APIs, then this should be easily achievable. Finally cost and scope of the asset tracking system should be scalable so that the system does not become prohibitively expensive as the utility of the system is scaled up.

RIZVI: Asset tracking and performance management systems traditionally have been client server based with disparate databases and unstructured data. There is a tremendous lack of flexibility in these legacy systems. A few important aspects that are necessary for taking the HTM process and outcomes to the next level are process and workflow flexibility, secure cloud access to ensure availability not just in one site but everywhere work is done, cutting edge automation to reduce tedious planning, mobile experiences to reduce paper and data entry errors as well as focus on cybersecurity to prepare for the next age of assets that are connected. Without the above considerations, a database with a UI only will never be able to meet the challenges of the new and demanding remit of HTM.

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Collaborative Approach WHAT IS THE FUTURE OF HTM REGULATION?

BY K. RICHARD DOUGLAS

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M

uch has been made in modern-day politics about the burden or significance of regulations. One political party has always supported more regulation and the other seeks less. Is the U.S. over-regulated? Does regulation do more harm than good? What is the trade-off between regulations and public safety and economics, household income, economic expansion or economic contraction?

The petroleum, electric, nuclear power, banking, insurance, brokerage, legal, real estate and coal industries are heavily regulated; and these regulations protect consumers, workers and investors.

The term “garbage in, garbage out,” was popularized during the early days of computer science, indicating that flawed input data can result in faulty output.

The same can be said for regulations.

During the rulemaking process, Congress needs to be working with accurate data before a member proposes a bill and before it becomes a law. A law must be based upon good data, including any negative impact it might have, before it goes to regulators for enforcement.

It is very important to those subject to regulations that both the lawmakers and the regulators are fully informed during the entire process by sources with reliable data.

Health care is also one of the most regulated industries. Just as compliance officers are important in financial services, they are an important part of health care.

Health care facilities are regulated by the Department of Health and Human Services (HHS), which has oversight over the Centers for Medicare and Medicaid Services (CMS) as well as regulation by state agencies in every state. Additional federal agencies with regulatory oversight over health care

include the Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA).

These agencies publish and enforce the regulations that impact all those who work in health care and ultimately; patients.

Sometimes regulations can be as burdensome to clinical staff as they are beneficial to patients. These clinicians spend so much time pursuing regulatory compliance that it can take them away from patient care. It can be a two-edged sword.

With the broader impact of regulation on health care as an industry, the question of regulations that impact HTM have been highlighted the past couple of years.

How does government intervention impact the future of the HTM community, the safe practice of medical equipment servicing and patient safety?

Are decisions made in a vacuum, using reasonable advice or consultation or just purely bureaucratic?

Do biomeds who are not affiliated with an OEM provide a standard of maintenance that is up to the task? That was the impetus for the creation of the FDA-supported Medical Device Servicing Collaborative Communities (MDSCC).

When regulations impact the HTM community, it is important that the bills passed by Congress, that are the basis for the regulations, are sound and based on accurate data.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

THE CREATION OF A COLLABORATIVE COMMUNITY The evolution and formation of the Medical Device Servicing Community (MDSC) grew out of the Medical Device Servicing Collaborate Community (MDSCC).

The MDSC has continued its work, breaking areas of focus into four subgroups. Some background on the formation of the MDSCC in 2018 and its focus then and now follows.

“The MDSCC was formed over the course of two years. Efforts started when the Medical Imaging Technology Alliance (MITA) approached Congress and stated individuals servicing medical devices that are not employed by, and/or trained/sanctioned by the original equipment manufacturer (OEM) are delivering low-quality, unsafe maintenance on medical equipment,” says Dave Francoeur, senior vice president of marketing and sales, TKA. Francoeur says that the non-OEM individuals consist of independent service organizations (ISOs) and healthcare delivery organizations (HDOs) in-house groups.

“When Congress was approached to look into, vote on whether MITA’s claim was valid, fortunately IAMERS organization had sent their legal council representative to the hearing of Congress where the vote was to take place stating non-OEM servicing individuals would no longer be able to provide service on medical equipment as they

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“ The team has landed on several key performance indicators that they believe represent measurements that demonstrate service/maintenance being performed on medical equipment by any entity will provide evidence of quality and safety.

These are to be presented to the MDSC for consideration.”

– Dave Francoeur have in the past. Robert J. Kerwin, IAMERS legal counsel was able to stop Congress from passing the bill,” Francoeur says.

Congress then asked the FDA to look into MITA’s claims.

“FDA put out a formal request for information (RFI) where they asked the industry for data and input so they could make a determination as to if there was any validity to MITA’s claim.

After many organizations and individuals responded to the RFI as well as a two-day forum for discussions and presentations on this topic, the FDA responded with an official notice, while there does not seem to be evidence that non-OEM servicing entities deliver less quality or less safe maintenance of medical device servicing, there also was not enough evidence to say they do not deliver less quality and less safe servicing of medical devices,” Francoeur adds.

Francoeur says that after a meeting set by the FDA in December of 2018, individuals representing OEMs, ISOs, HDOs, industry associations and regulatory bodies participated in exercises that provided a platform to work together in an attempt to bring unity to the profession and help establish good working practices.

He says that from this effort, the MDSCC was established and the basis for its formation and structure were developed.

It was determined that the group would have a steering committee and that it would consist of representation across all impacted parties throughout the profession.

“Today that has been decided to be 25 or so individuals; approximately five per group – regulatory/associations,

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OEMs, ISOs, HDOs, patients,” Francoeur says.

The group has met in person or via the phone for just over a year.

Francoeur says that there were three areas during the year that the group could not seem to reach consensus on.

Those areas were antitrust activities, a charter and a voting process.

MITA, AdvaMed and Philips decided to remove themselves from the MDSCC. “Ironically, they stated it was because of the lack of progress being made by the group. Yet the lack in progress was created because they objected to everything the group wanted to do in regards to the areas on non-consensus (antitrust activities, charter, voting process),” Francoeur says.

MDSC: CURRENT INITIATIVES At the time of this writing, none of the work done by the subgroups has been reviewed or approved by the steering team, so the recommendations listed are proposals.

The subgroup that Francoeur chairs, is the standardize benchmarking, data collection and analytics (BDCA) group.

Its focus is to establish a framework for assessing quality of medical equipment servicing and establish a baseline to assess the effectiveness of improvements to quality and patient safety.

The BDCA subgroup’s objectives include the establishment of industry KPIs and benchmarks for those KPIs, with the resulting benefits being the continuous improvement of the quality and safety of medical equipment maintenance. One goal is the standardization of quality and safety metrics.

The group’s assumptions are outlined as: All parties have a vested interest in

validating quality and safety baselines; all parties want to improve/ensure quality and safety of medical equipment maintenance.

Constraints include: Any stakeholder segments unable/unwilling to participate may limit the outcomes. Money to implement program. Differences in data, data gathering, data manipulation and nomenclature among stakeholder groups.

“The team has landed on several key performance indicators that they believe represent measurements that demonstrate service/maintenance being performed on medical equipment by any entity will provide evidence of quality and safety. These are to be presented to the MDSC for consideration,” Francoeur says.

He says that today, the group has listed the KPIs that would represent quality and safety, defined the numerator and denominator of each KPI and clearly detailed components for each numerator and denominator.

The chair of the cross-stakeholder education group is Samantha Jacques, Ph.D., FACHE, vice president of McLaren Clinical Engineering Services (MCES) at McLaren Health.

The focus of the subgroup is to establish a base understanding of each industry involved in the servicing community such as HDOs, OEMs, ISOs, regulatory bodies and accrediting organizations.

“Each subgroup has been directed to develop a slide deck to inform the other subgroups related to the regulations and processes in place related to servicing and how they ensure quality and safety in medical devices,” she says.

“Presentations from the HDO and associations representing the industry (AAMI, DNV and FDA) have been presented to the subgroup. The ISO group is slated to present its slides the first week of September. The group is still looking for additional OEM representatives who would participate and develop their education slides,” Jacques adds.

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Kerwin chairs the best practices for servicer training subgroup. The focus of the group is to develop high-level training best practices to establish industry-wide expectations for servicing personnel.

The fourth subgroup is the best practices for quality management systems. It seeks to establish quality management system principles specific to medical device servicing. Presently, a chair for this group is being sought.

Once all presentations are complete, the subgroups are tasked with identifying a method to disseminate the education to the larger MDSC. TRADE ASSOCIATIONS SEEK OTHER REGULATORY FRAMEWORKS The members who left the group continued their work while representing their stakeholders. Both AdvaMed and MITA offered follow-up statements indicating their current focus, as well as their stance; post-MDSCC. “Patient safety is the medical technology industry’s number one priority, which is why the proper servicing of complex, life-saving and life-sustaining medical devices is so vital. We are concerned that unregulated third-party servicers continue to be allowed to work on these highly sophisticated medical devices without having to follow the strict patient safety regulations FDA requires of OEMs and their authorized servicers,” says a spokesperson from the Advanced Medical Technology Association (AdvaMed).

“This has clearly harmed patients: The FDA itself estimated in May 2018

that there were up to 21,000 companies servicing medical devices, and reported that more than 4,300 negative incidents involving medical devices, including 40 deaths and 294 serious patient or device user injuries, had occurred – all the result of unregulated third-party servicers attempting and failing to repair complex medical devices,” the spokesperson adds.

MITA also stated its position.

“The challenges presented by the COVID-19 pandemic have been a major area of attention for MITA as it seeks to guarantee ongoing patient access to safe and effective medical imaging technologies. We have been working with FDA, CMS, Congress and others to implement policies that ensure expedient delivery of our technologies, help patients return to care, and secure the ongoing viability of radiology practices and departments across the country,” says Peter Weems, MITA senior director of strategic operations and policy.

He says that early in the pandemic, they decided that the nascent and ineffective Medical Device Servicing Collaborative Community (MDSCC) was not an area where they could dedicate concerted attention given its lack of governance and progress toward shared goals.

“We are open to considering new approaches to ensuring patient safety and device performance in the future,” Weems says.

“It is outrageous, however, that unregulated independent servicing businesses have decided to exploit the pandemic for their own business

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

interests by championing self-serving and irresponsible ‘smash and grab’ legislation such as the Critical Medical Infrastructure Right-to-Repair Act of 2020. This, while they continue to avoid any responsibility for quality controls, FDA registration or filing Medical Device Reports (MDRs) – especially considering the lack of any evidence that medical imaging technologies have gone un-serviced during the public health emergency,” Weems adds.

“One must wonder what these organizations wish to hide if they will not even make themselves known to the FDA. Instead they have resorted to expansive demands for their competitors’ proprietary information without committing to taking any responsibility for putting necessary quality control systems in place. Are these third-party servicing businesses afraid that they won’t stand up to even basic scrutiny?”

Weems asks.

MORE TO FOLLOW While the pandemic has thrown a wrench in many ongoing endeavors, the work being done by the MDSCC or MDSC will continue. While there are competing interests and varying viewpoints, the resulting product of the various stakeholders will impact the future of HTM and future regulations.

Decisions that result from good data and historic evidence will play an important role in the process.

“There’s a lot more that could be communicated to the industry and the industry should be aware of what’s going on that will have an impact on them,” Francoeur says.

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CAREER CENTER

Advancing Your Career During a Pandemic

BY JENIFER BROWN

S

ome of you may have been personally affected employment-wise due to COVID-19 either by a cutback in hours or salary or even a downsizing layoff. Perhaps you just want to continue to advance in your career but are unsure how to do so in these uncertain times!

Now, it is even more crucial to network on social media and career websites.

During this COVID-19 pandemic, many of the 2020 conferences and meetings have been cancelled or postponed until next year limiting in-person networking opportunities.

Note that MD Publishing is hosting regional HTM Mixers and MD Expo in Tampa this November. You can find out more at HTMMixer.com and MDExpoShow.com. However, because of the limited in-person events, now is the time to make sure you are “profiled” on sites like LinkedIn, the AAMI Career website, regional biomed association websites and career websites like Indeed.com and Glassdoor.com. No matter what site your “profile/resume” is on (though I suggest using all of them) be sure to add a photo, correct and updated work history along with contact information including a cellphone number and email address.

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Once you have your “completed profile” on these sites, you need to go a step further. You need to be proactive in networking and reaching out to members. Don’t assume that just because you are on there, that employers and opportunities will come to you!

For example, on LinkedIn you can join various biomed groups and/or your specialty area and then participate in the virtual discussions to get noticed.

On the Association of the Advancement of Medical Instrumentation (AAMI) website at www.aami.org, become a member and read up on the latest news and trends. Then, check out the organization’s career web page and post your resume. For the regional biomed associations, do a search for which ones are in your state or geographical area and become a member!

The AAMI website has a list of biomed associations. Click on the tab “Who We Serve” and then click on “HTM Associations” to view regional organizations.

For career websites, you need to make sure that your resume has current and correct work history with dates and complete contact information. To be proactive on those sites, you need to check job postings on a regular basis and apply directly rather than wait

Jenifer Brown Health Tech Talent Management LLC until employers reach out to you! Most importantly, if contacted you need to respond in a timely professional manner. Most employers/hiring managers have the “three strikes and you’re out” rule of thumb. If they reached out to you three times with no response back, they will move on to the next candidate and an opportunity that may have been perfect for you is lost!

Lastly, because of COVID-19 most employers have replaced the in-person interview stage of their process with a video interview. Video interviews need to be treated just as professionally as one done in person. In a video interview, like an in-person interview, your appearance, attire and body language are being assessed as much as your communication skills. Prior to a scheduled video interview, be sure to set up and test the software on your computer or tablet to prevent technical difficulties!

The views expressed here are those of the authors and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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SPONSORED CONTENT

20/20 IMAGING INSIGHTS Are You Fixing to Grow or Just Survive?

The Answers Lie in your Management Mindset

BY MATT TOMORY

I

n uncertain times, it’s easy to hunker down and hold tightly to what you have. After all, there is nothing we can do about current and future circumstances which are completely out of our control. Right?

The above is a classic example of a fixed mindset, one that does not believe in a company’s ability to control their own future vs. take what comes. During past recessions, companies with this mentality are quite often those that actually didn’t survive. Harvard Business Review, March 2010, in an article called “Roaring Out of Recession,” analyzed companies that survived the recessions of 1980, 1990 and 2000 to see what they did differently than those that failed to survive or even to thrive.

What they found is very telling.

Only 9% survived and actually outperformed competitors as the recession recovered. The 9% that survived and actually thrived to reach

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the top of their industry had a key management characteristic that set them apart from those that did not. This distinction was not having more money for building inventory, expanding operations or marketing but having a growth vs. a fixed mindset. Here’s why this matters.

• Companies with a fixed mindset start cutting staff, investments, even core competencies to create a bottom line that gives them a sense of security.

• Companies with a growth mindset focus on fine-tuning efficiencies, investing in the future and gearing up for growth.

Which mindset governs a business or a department matters for the now and the future. A good example given by Harvard Business Review is that of Staples vs. Office Depot as the two developed and executed plans for surviving the 2000 recession. Office Depot hunkered down, cut 6% of its staff and focused on its current bottom

Matt Tomory Innovatus Imaging line. Staples hired more staff as they restructured their operations and sought ways to work more efficiently and serve customers better. Post-recession, Staples emerged with more than $1 billion in sales than Office Depot.

Following Staples’ growth mindset lead is critical for health care facilities, clinical engineering departments and imaging departments as we move forward, blindly into the new normal.

When the world settles back into the routine of serving patients’ imaging needs beyond those demanded by a pandemic, whomever is best poised to fill the immediate need will win. Not just for the short term, but likely a very solid long-term.

A growth mindset aligns with the following actions: • Streamlining operational efficiencies: Finding ways to reduce error that results in damaged or destroyed probes and coils. Preventing damage from drops, fluids, improper cleaning can be managed effectively

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through ongoing training.

• Maintenance Priorities: Growth is often dependent on managing what you have so your budget goes toward expansion more than maintaining the status quo.

Like people, imaging devices need regular checkups. You should invest in maintenance that prevents breakdowns by finding little issues throughout a device’s lifecycle that can be addressed before they become catastrophic.

• Strategic Partnerships Built on Technology: The right partner for maintenance and repairs delivers more than great customer service and low price. They deliver sustainability by using sophisticated and proven technology for testing and repair methodologies.

Short-term repairs are detrimental to serving patients, operating efficiency and budgets. Before choosing a vendor based upon service or price, dig deep into the technology, technical processes and parts used in your repairs. Choosing a partner who offers expanded repair capabilities, sustainable repairs, longevity and ROI means the fewer repairs you have to make and the more you can focus on your bottom line, operating efficiencies and overall growth.

Regardless of what is happening in your current market with COVID-19, economic fluctuations, and more, you can overcome and set your team and your facility up to thrive while others are still trying to figure out how to survive. It’s just a matter of mindset.

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MATT TOMORY is the Vice President of Ultrasound Center of Excellence for Innovatus Imaging. Contact Matt directly at matt.tomory@innovatusimaging.com for more information. The views expressed here are those of the authors and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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EXPERT ADVICE

VIEW ON VALUE The MITA Touch

BY PATRICK FLAHERTY AND JOSEPH HADUCH

M

any of you have seen references in some of our more recent articles to two organizations that represent the interests of many major clinical equipment OEMs. They are Advanced Medical Technology Association (AdvaMed) and Medical Imaging and Technology Alliance (MITA), which is a part of National Electrical Manufacturers Association (NEMA). Some of you have asked, “Why, as HTM leaders and representatives, should I have any concern about either of the organizations and the messages they are delivering to Congress and the public at large?” Allow us to provide some easily verifiable background information and you can decide for yourself what, if any, concern is warranted from our industry.

AdvaMed is a global trade association that advocates the interests of over 400 technology companies ranging in size from global-market companies to small clinical equipment and device startups.

Some of the common organizations that participate in either or both of these organizations that you might recognize include GE Healthcare, Philips, Fuji, J&J, Siemens, Medtronic and Cardinal.

AdvaMed actively engages policy makers in Washington, D.C. to advance the interests of its members through legislation and public policy.

MITA, as part of NEMA, represents companies that make up over 90 percent of the global market for imaging technologies. The participants include medical imaging equipment and radiopharmaceutical manufacturers. I’ll spare

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MITA’s position, as a representative for the majority of imaging OEMS, is for the FDA to implement “regulatory requirements for everyone who services a medical device, including requiring all servicers to register with the FDA, file medical device reports and implement a quality management system.” you the list of members but, as you can imagine, given MITA is representing over 90 percent of the industry, pretty much any imaging company you’re working with belongs to MITA. Both organizations have recently gained notice within our industry because of their positions on right to repair, publication of service documentation through public platforms and their withdrawal from the FDA’s Collaborative Community, known as the Medical Device Servicing Collaborative Community (MDSCC). Unlike MITA, who only represents OEMs, the MDSCC is a diverse group of service professionals that includes hospital service groups, ISOs and OEMs. For the purpose of this column we will concentrate on MITA primarily because, based on their web page, their number one strategic priority is to adopt uniform standards for imaging service providers. In the interest of context, their number two strategic priority is patient access to imaging. How they reconcile this with their stated mission “to reduce regulatory barriers” is beyond the scope of this article. If you believe

or if you’re being told that MITA’s position only affects third-party ISOs or equipment remanufacturers you are being actively misled. MITA’s position, as a representative for the majority of imaging OEMS, is for the FDA to implement “regulatory requirements for everyone who services a medical device, including requiring all servicers to register with the FDA, file medical device reports and implement a quality management system.” Please take special note of the focus on the quality management system (QMS) implementation as, in addition to being expensive, a QMS is more commonly associated with a manufacturer, not an exclusively service-focused department or business.

Adding a QMS to an in-house solution adds no additional quality control over an effective CMMS and it would only increase costs for the provider … hardly a recipe for increased patient access.

One of the speaking tracks of OEMs is that in-house service organizations are not the point of the MITA message. Do you see a carve out for in-house organizations in the quoted MITA statement above?

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For those of you unfamiliar with MITA’s history, allow us to provide some background. MITA developed a servicing standard NEMA/MITA 2-201x. Although this is a NEMA adopted standard, keep in mind MITA is part of NEMA, so this “standard” has an innate bias toward OEMs, a bias that was highlighted when it failed to gain acceptance through ANSI, a much more diverse standards organization.

After failing to gain ANSI acceptance, MITA attempted to use this as the basis for driving additional regulatory standards through the FDA. In 2018, after much hype and months of public input, the FDA issued a report on the quality, safety and effectiveness of servicing medical devices. It found the following: • T he currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third-party servicers, of medical devices that would justify imposing additional/different, burdensome regulatory requirements at this time; • Rather, the objective evidence indicates that many OEMs and third-party entities provide high quality, safe and effective servicing of medical devices.

• A majority of comments, complaints and adverse event reports alleging that inadequate “servicing” caused or contributed to clinical adverse events and deaths actually pertain to “remanufactur-

MITA, as part of NEMA, represents companies that make up over 90 percent of the global market for imaging technologies. ing” and not “servicing”; and • T he continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.

Insufficient evidence to implement burdensome regulatory requirements; the conclusion from the objective evidence available was that both OEMs and third-party organizations provide a high level of service and third-party entities are “critical” to the U.S. health care systems. In addition, the FDA believed there would be value in creating a collaborative community forum to “address the challenges associated with … effective servicing of medical devices.” The FDA also agreed to facilitate the creation of this community if there was sufficient interest, hence the MDSCC. In May MITA and AdvaMed decided to remove themselves from the Collaborative Community citing they “did not feel the group made sufficient progress” and that “progress is unlikely any time soon.”

Other reports claim that “AdvaMed, supported by MITA, would only accept

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100% unanimity” on voting and ratifying positions. Essentially, they wanted the ability to veto any policy or position this group would take. Hardly collaborative and inclusive of a provider’s needs and thoughts but entirely consistent with each organization’s commitment to unilateral behavior.

Everything you have just read is easily verified and cannot be objectively disputed. The point and the impact for HTM is that your OEMs, through government lobbying groups, are looking to create burdensome regulation that will directly impact in-house service organizations, increase service costs and limit patient access to imaging by increasing costs to providers. Unlike ISOs HTM groups are uniquely qualified to hold OEMs responsible for their political position as HTM organizations are not seeking highly margined revenue streams. Ask for data that supports their position, but do not hold your breath waiting for their response. Inform your administration of the impact the OEM will have on you and your organization.

Hospitals have lobbying groups, too. It’s cliché, but call your congressman. Get involved, before your OEM dangerously stretches their oligopoly powers further into equipment service.

PATRICK FLAHERTY is the vice president of operations for UPMC BioTronics. JOSEPH HADUCH, MBA, MS, is the senior director of clinical engineering for UPMC BioTronics. The views expressed here are those of the authors and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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SPONSORED CONTENT

THINK INSIDE THE BOX TO MAXIMIZE RESOURCES

BY JEFF NIEDERHAUSEN

I

n most cases, when organizations are challenged to find new opportunities, the rallying cry is generally to “think outside the box.”

But what if you ask your HTM team to “think inside the box” instead? When organizations skip this step, they miss great insights and learnings that can be just as innovative and impactful.

The goal is to take what you already have and improve, which is a critical tactic when managing the tightest budgets. Taking time for an internal brainstorming session can unlock untapped capabilities that can improve productivity and your bottom line.

I can think of several examples where those internal analyses have delivered game-changing innovation.

Consider the razor. For years, companies produced shaving devices with a single tool. Almost a quarter-century ago, Gillette reinvented that product with the twin-blade Trac II, followed by another industry-shifting invention, the Mach 3 – with, you guessed it, a trio of blades. Still looking at its basic core offering, the company has pushed now into five-blade razors, all with a

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mission to create a product for the smoothest shave possible.

Sometimes, the best solutions are already right in front of us. But we need to retrain our minds to consider how we can maximize the resources we’ve already invested.

TAKING A DIFFERENT PERSPECTIVE I’ve been on the accounting side of the HTM business for decades, but I’m not your typical kind of chief financial officer. I don’t look at the world through numbers and cost centers.

Rather, I’ve seen the full picture of what makes programs work, both financially and operationally. While accounting might always be in black and white, our industry operates with color gradients that allow us to look for the best answers in changing situations, while always keeping patient safety as our priority.

What does this mean for clinical engineering? By looking at common practices and tools used by your biomeds, you can find several opportunities to “think inside the box.”

Here are a few scenarios: • Maintenance Systems: Build an interface that connects your computer-

Jeff Niederhausen Tech Knowledge Associates (TKA)

ized maintenance management system (CMMS) with your accounting software. When those systems stand in silos, your clinical technology team doesn’t have line-of-sight to monitor spend and make solid financial decisions for their customers (your hospital and providers). This approach ensures departmental managers understand how every action comes with a financial impact, and they’re always prepared when the CFO catches them in the elevator and asks how the monthly budget is going. And let’s not overlook the great benefit of an audit trail since all costs are tied back to your patient equipment. When the time comes to decide whether to repair, buy or retire equipment, you have accurate histories on every device right at your fingertips.

• Maintenance Agreements: Once again, look to integrate your service agreements – which should always be under the management of your HTM program – with your CMMS. This connects all parts of your HTM operation into one powerful tool for making the best-informed decisions.

By linking more capabilities to your

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you’re

CMMS, it becomes more than a database; it becomes a comprehensive resource capable of illustrating the complete financial picture of your HTM program. As a stepping stone to building a contract module in your CMMS, consider creating an Excel worksheet that helps you review contract terms, allowing you to capture the return on investment (ROI) as you weigh whether it makes sense to increase or slowly ramp down service levels.

• Budget Uptraining: Tap into your biomeds’ technical thinking and help them develop strategic and financial thinking to apply in making your HTM profitable. While most don’t automatically gravitate to finance, biomeds are proven problem-solvers.

You have an opportunity to tap into that specialty skill set as a means to drive new thinking. As you coach them on the finance front, teach them that – just like at home – they need to live within their means, in this case it’s for the HTM program they’re overseeing. You can find ample professional development resources to help, and this goes a long way in deepening your biomeds’ accountability. Does it work? Certainly. We have one TKA director who sees the budget process as a whole-year exercise. He develops issue files, builds business cases for tech training, and constantly reviews and dissects monthly financial data. When budget time comes, he’s prepared; if there’s a hiccup or variance, he can easily explain why.

While that’s a destination for every director, you might start with an Excel budget pack that goes through each account in the HTM profit and loss statement.

• Training to Close Service Gaps: This is a simple ROI exercise on whether to train your biomeds to handle service covered by an external contract. When does it make financial

sense to eliminate a contract and will the hospital leaders agree to your philosophy and reasoning? Managers need to look at the machines’ life cycle when making a contract decision, as many factors come into play to capture total spend. That might include the volume of that kind of equipment or whether your existing contract covers parts. Determine if that training makes sense in dollars and cents. For example, let’s say a training expense will take four years to recoup, you need to gauge whether that equipment will still be in use at that point. Managers with insight into finance and tools at their fingers can make the smartest choices.

Our bottom line is: don’t handcuff your clinical technology departments.

Give them opportunities to rise up and be the heroes that we want and expect them to be. By empowering them with expanded tools, including financial insights, you’ll gain a loyal advocate who will make strategic advances that deliver on your mission for high-quality patient care – at the most efficient cost.

At TKA, our commitment to our partners starts with ensuring safe, clean and available medical equipment, but we also take our responsibility on the financial side just as seriously. In working with numerous hospitals, we have walked the razor’s edge on financial margins, and we can step up to the challenge.

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JEFF NIEDERHAUSEN is the CFO at Tech Knowledge Associates (TKA). The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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THE FUTURE The Picture is Still Foggy

BY ROGER A. BOWLES

T

he last time I wrote, we were just getting started in this “new normal.” Pardon the term, I really hate it also, but it is clear that this stuff will be around for quite some time. Our classes resumed on campus for the summer semester on June 1 with modifications. As much “lecture” as possible is done online and labs are done face-to-face with protective gear. This approach has required some modifications. The state likes to divide us into neat little lecture/lab bundles: two hours of lecture and four hours of lab. For us, it has been something we have accommodated but not always followed to a “T.” In our classes, we have equipment in the room so lecture and lab are usually happening at the same time. We explain some theory, demonstrate and facilitate.

The administration is requiring all lecture be online with limited labs. It is hard to convince people that do not have a technician background that everything cannot be divided up so neatly. Texas State Technical College (TSTC) has always been somewhat different in that we are technicians training technicians. Every instructor in our department (and most other departments) worked as a technician before becoming an instructor. The instructor training process is a long one and not everyone succeeds. In fact, many decide instructing is not for them and move back to the field. Some, like

me, make a career out of it. Still, sometimes I miss those days I spent as a technician.

The summer semester for us was abbreviated as we had a late start. So, 12 weeks instead of 15 weeks. This, along with the online lecturing for some classes, had some students feeling like they were drinking from a fire hose.

Most students have been very understanding and have put their best effort toward accommodating the new arrangement.

As I write this in August, the fall semester is in question. So far, we have seen a significant drop in enrollment of new students. That may change during August. Right now, we have approximately 40 new students coming in for the fall semester. A normal incoming fall group is around 60 students. We do face some challenges in limiting class size for the labs to 10 students. This is, of course, good for the students but it will tax our instructor resources.

Another problem we are facing is self-quarantines for exposure. We have an elaborate reporting system and several students have reported exposure and are out for a minimum of 10 days.

We do our best to catch them up when they return. The same happens to instructors. As I’m writing this, I am in self-quarantine for the next 10 days as my wife tested positive for the virus last week. Some material will not be covered as much as I would have liked.

On the bright side, we are hearing rumors about grant money that might

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Roger A. Bowles MS, EdD, CBET

be available soon. This money will be used for additional equipment and resources to keep lab groups small and students separated as much as possible.

Some internships are starting to open back up to students. Hopefully your company or hospital participates in internships. Our students require an internship to graduate and the shutdown created a bit of a bottleneck in students completing the program. If students have completed all of their other coursework, and the company/ hospital is willing, the first four months of their employment can count as their internship.

The future is still a bit foggy. One thing is for sure, it has forced us to re-evaluate everything. Each course has had to be revised, and in most cases, this is a good thing. Some courses tend to go stale if they are not revised. We will continue to meet employers’ expectations in providing quality graduates and rely on their feedback/guidance in making necessary changes.

The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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EXPERT ADVICE

CYBERSECURITY Inventory Tracking, CNL and HIPAA

BY JOSEPH FISHEL

I

nventory loss is occurring with more frequency. This is because of theft, hoarding and the improper documentation of equipment when it is disposed of or traded in. This has impact in several ways such as clinical assets no longer being available to support patient care. This can create a need to rent additional equipment to meet a facility’s needs. Also, HTM teams can use up valuable time trying to locate equipment for maintenance. When maintenance isn’t performed in the prescribed time frame, the equipment is no longer in compliance for use.

Let’s look at several factors that help address this issue. There are networked and non-networked devices as well as devices with PHI and those that don’t contain PHI. So, what do they all have in common? Each of them should be included in your Medical Equipment Maintenance Plan (MEMP). They should be in your inventory and they should have been evaluated for a PM frequency or risked into an AEM program.

Have you updated your Can Not Locate (CNL) policy or are you still waiting three PM cycles to declare a device lost, missing or stolen? Years ago, when devices were not networked, we performed monthly, bimonthly and quarterly PMs. When we could not locate a device, it went two more PM cycles before we declared it missing/lost or stolen and

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retired it from the inventory. Back then, the maximum amount of time was 9 months before a resolution was determined. Since then, the time between scheduled PMs has increased.

Devices could go a year or two before a scheduled PM, and if they are on an AEM program they may not be inspected at all.

With devices now being networked and having PI/PHI information on them this has significantly changed the urgency to locate. When a device containing PI/PHI can’t be found it needs to be reported to outside agencies within a short period of time.

We no longer have the time to wait three PM cycles. We have less than 30 days with today’s HIPAA laws for devices with PI and PHI on them. Also with the price of equipment going up and budgets getting tighter, you need more control or visibility of equipment leaving the premises.

I know of one facility that had 30% of their IV pumps stolen in a migration type of manner over a period of time. When PM time came, the missing ones were put on the CNL list. After three PM cycles (totaling 3 years) they were retired. The total amount lost was around $2 million in equipment. While they didn’t have PI or PHI, they were networked and could be seen, or in this case not seen, as they disappeared from the network.

Because there was no immediate follow up, the hospital ended up having to rent additional pumps

Joseph Fishel, CBET, MBA Healthcare IT Leaders LLC

because the clinical staff assumed that the clinical need had them in use.

So, what can be done for networked devices? There are reactive measures such as searching for them using an Internet of Things (IoT) application to see if the device is still on the network and where on the network. A more proactive approach would be to implement or create settings on an IoT tool to monitor networked devices so that if they go offline for a certain period of time the IoT tool will notify you of the loss of connectivity. Once notified, you can verify why it is not connecting to the network.

What about devices that aren’t networked? You can have devices such as point-of-care ultrasounds that have PHI and PI on them, but they aren’t networked. How can you track them?

This is where an RTLS/RFID system comes into play. By attaching a tag that can be seen on the network you can create filters similar to network devices that notify you when the device isn’t seen by the network or leaves the building. I would also suggest attaching the tag inside the device so it can’t be easily removed.

CNL is becoming more prominent in resolving where did it go or where is it than before. Like I said before, if it

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has PHI on it the loss needs to be identified and an investigation needs to start immediately. I would suggest that you start involving your facilities security department as well.

This should also start being reported as part of the environment of care (EOC) meetings because it could put the facility at risk. This risk needs to be elevated so that leadership is aware and provides support. Department heads need to be involved as well. It’s their equipment, so they should know where it is. Getting EOC buy-in on the importance of this (both from the PHI and financial standpoints) can assist when you have to go to department managers with your CNL list because you don’t have the tools and apps to locate equipment.

JOSEPH FISHEL, CBET, MBA, is a Nuvolo Business Process Consultant, Healthcare IT Leaders LLC. The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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TIPS FOR MAXIMIZING THE PERFORMANCE OF INFUSION PUMPS AT YOUR FACILITY

BY DREW DENNIS AND DORIAN J. DAVIS

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he infusion pump is a ubiquitous device in the patient care process.

They can be found in almost any care setting and deliver crucial medications when they’re needed most.

Care facilities often maintain a large fleet of infusion pumps, a considerable undertaking for busy technicians and hospital staff. In order to maximize the efficiency of the infusion pumps at their facilities, clinicians can employ some key strategies when it comes to purchasing and maintenance.

GET COST SAVINGS WITH PROFESSIONALLY REFURBISHED INFUSION PUMPS The most obvious advantage to choosing refurbished infusion pumps is the price. Even professionally refurbished, late-model infusion pumps are available at a fraction of the cost of brand-new units. A properly refurbished device will function just as well and have a similar service life cycle of a new unit, but without the hefty price tag. With the extra budget refurbished units provide, facilities can plan for larger, more strategic purchases.

Purchasing refurbished infusion pumps is not only a cost-saving tactic, but professionally refurbished equipment can also provide facilities with other unique benefits. Upgrading to a late-model pump often reduces staff training time. Instead of taking valuable hours to familiarize staff with unfamil-

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Drew Dennis Avante Health Solutions

iar technology on the latest model, facilities can keep using platforms they already know, allowing them to return to what they do best – providing quality care to their patients.

As an equipment refurbishing partner with years of industry experience, Avante Health Solutions provides facilities with one of the widest selections of professionally refurbished infusion pumps in the market today.

SIMPLIFY THE INFUSION PUMP REPAIR PROCESS While opting for refurbished equipment can save facilities money, choosing a reliable equipment repair partner can cut down on costly equipment downtime. Facilities can simplify the process for repairing their infusion pumps by

working with one reputable company that offers comprehensive services for all common makes and models of pumps.

Independent equipment repair companies should be able to handle most common infusion pumps currently used in hospitals and other facilities, including the Medfusion 3500, the Sigma Spectrum and Infus OR from Baxter and more. Repair technicians should have the skills and knowledge to undertake a variety of repairs from preventive maintenance, calibrations, corrupted software, component-level repairs and everything in between.

Avante Health Solutions offers comprehensive repair solutions and leads the industry in terms of response times and equipment turnaround.

Avante handles all infusion-pump related repairs, in addition to patient monitors, fetal monitors, modules, telemetry and more. Technicians use certified, specialized processes to make sure equipment is repaired quickly and efficiently, with loaner and exchange programs available to help cover facilities while equipment is being serviced.

INCREASE FLEXIBILITY WITH RENTAL OPTIONS While a tremendous amount of planning goes into the management of equipment inventory, seasonal demands can quickly change the needs of any

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Dorian J. Davis Avante Health Solutions

medical facility. As medical facilities continue to cope with unexpected viral outbreaks, whether the current COVID-19 pandemic or yearly influenza spikes, more facilities are turning to medical equipment rental to help maintain the availability of infusion pumps and other critical equipment.

Equipment rental services can give facilities quick access to critical equipment with same-day shipments or onsite delivery.

Instead of waiting on equipment manufacturers or completing purchase orders, rental companies can expediently get ready-to-use equipment into the hands of hospital staff.

Facilities can also make the most of their budget dollars by opting for rented equipment. Rental costs are usually allocated to operating budgets, leaving valuable space in capital equipment budgets. Instead of investing in a fleet of medical equipment and being solely responsible for costly upgrades, working with a rental partner also offers increased flexibility to trade out equipment as needed.

Avante’s rental division offers both long- and short-term rental services on infusion pumps and a variety of other equipment options. Our long-term rental plans also usually include annual biomedical service, which can also save facilities money on upkeep.

Avante Health Solutions has years of experience providing medical facilities with comprehensive infusion pump solutions including access to an inventory of professionally refurbished infusion pumps, infusion pump repair and infusion pump rental.

DREW DENNIS is the Division Manager of Rental Services for Avante Heath Solutions. DORIAN J. DAVIS, BMETII, is the Lead Technician Pumps Department for Avante Health Solutions Center of Excellence in San Clemente, Calif. The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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THE OTHER SIDE Biomeds Are Resilient, Patient-Focused Professionals

BY JIM FEDELE

I

n my opinion, biomed techs endure a lot of change throughout their careers from regulation to their reporting structure.

For me, there has never been a time where change wasn’t occurring. Recently, in one of my volunteer roles, I had the opportunity to hire a new CEO for our credit union. The experience made me realize how special biomeds are in fulfilling their duties in the face of ever-changing conditions. I would like to share that experience with you to illustrate the dedication we all have for our customers and patients.

I am the president of the board of directors for one of our local credit unions. I needed to hire a new CEO because the previous one decided to move on to a bigger credit union to expand her career. It was a move that I was a little disappointed with but, ultimately, I understood. It was a great growth opportunity for her. We posted the job and sifted through numerous applications. We found two applicants we felt would fit our organization.

The first interviewed candidate was professional and met our requirements.

The second candidate was very impressive. He was enthusiastic, had experience doing all the things we wanted to do and was very successful in his present position. So much so, I was worried he was too good to be true. I asked him why he wanted to leave given all he had accomplished at his present company. He looked at me squarely in the eyes and said, “Culture.” He explained how the leadership at his company had abandoned customer service due to financial pressures and thus made decisions that would ultimately hurt the organization in the long term. He told me that they were already losing customers and he had lost

his trust and loyalty to the company. He was sad about that fact and knew it was best for him to move on. We offered him the job that day.

This experience made me think about how resilient biomed techs are at dealing with change, specifically culture and leadership. My observation has been that biomed departments report to many different leaders in their facilities, from the facilities director to the CIO and everyone in between. They also endure company changes. Sometimes a facility decides to go from an in-house program to an ISO (or vice versa) or from one ISO to another ISO. Even the biomeds that work for the OEM get passed around to different vice presidents in the company. If you have spent any time in the industry, there is a good chance you have been passed around to different leaders and companies like a hot potato. Often, decisions about the biomed program are made by people who have very little understanding of what we do and are disconnected from the positive and negative impact of that decision. The biomed techs are the faceless victims of someone’s better way to run the program.

All this changing would make one think the turnover ratio in our industry is very high. It is not. Many techs I know have been at their hospitals 15-30 years.

I think what makes the biomed so special is, no matter who they report to or work for, their core values of ensuring medical equipment works correctly and safely does not change. In the face of leadership instability and organizational culture change, the biomed manages to ensure that the patients being treated at their facilities do not suffer the consequences. Health care always seems to be under great financial pressure – although

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Jim Fedele, CBET UPMC and BioTronics

it feels like it is worse today. This triggers leaders to try anything to improve the bottom line. I feel the decisions that affect biomeds directly are never negatively transferred to patient care. As biomeds effectively insulate our most vulnerable from being victims of a solely financial decision or poor company morale.

I am not saying that all changes are negative; some changes are good and necessary. An inefficiently run program or a greedy OEM/ISO program needs to be changed to keep the hospital operating. My point is that the instability in leadership that many biomeds endure is never a factor in the product that gets to the patient. That can’t be said about many other industries.

Even during a global pandemic, biomeds continue to shine by creating solutions to assist clinicians in caring for the sick. The stories are numerous, and every one of them makes me proud to be a biomed.

JIM FEDELE, CBET, is the senior director of clinical engineering for UPMC. He manages six Susquehanna Health hospitals. He has 30 years of HTM experience and has worked for multiple service organizations. The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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EXPERT ADVICE

SPONSORED CONTENT

CLINICAL NETWORK VISIBILITY – HEALTH CARE’S NEW CURRENCY

BY JONATHAN LANGER

T

he Internet of Medical Things (IoMT) is revolutionizing the process and practice of patient care.

Also known as “connected medical devices,” they generate, collect, analyze and transmit patient data. Whether they’re stationary or mobile, internally or externally deployed, connecting to home, public WiFi or cellular networks, the problem for health systems is at some point they’re connecting to enterprise networks.

Furthermore, as these devices frequently enter and exit the landscape at different intersections, each presents its own dynamic set of risks. Not only were traditional network security protocols

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not designed to address them, but managing each device’s whereabouts, let alone its effective operation, maintenance and security, has become an overwhelming challenge. The increasing interconnectivity of IoMT-enabled devices collecting and sharing patient data hasn’t just dramatically increased points of patient data security failure, but have also exposed numerous systemic deficits, including vulnerabilities directly related to the provisioning of timely patient care.

MarketsandMarkets has projected the global IoT medical devices market to reach $63.43 billion by 2023. That represents growth from $20.59 billion in 2018, at a compound annual growth rate of 25.2% over the period. Those

aren’t just impressive growth statistics.

They reflect a revolution in care.

Meanwhile, health care’s attack surface remains the most vulnerable and lucrative target for bad actors across industry. What’s notable is that the threats are now accepted as real and the potential danger to patients is no longer the subject of debate. That recognition has led most every related problem-facing regulatory authority to converge around a practical, common-sense precept: care providers must know the assets connected to their networks and take deliberate steps to secure them. To be fair, although these same regulators appreciate that cybersecurity threats cannot be eliminated, they are still making it clear that cross-functional teams

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EXPERT ADVICE

must collaborate and adopt a proactive approach to managing the risks.

If the goal of connected medicine is to further develop our understanding of the patient, then the need for health care technology management (HTM) professionals to develop a contextualized and actionable understanding of the devices critical to their care is self-evident. This pursuit requires far more enlightened expressions of clinical network visibility.

We can no longer limit our thinking to device discovery and superficial identification. Although many health systems would be thrilled to know that much, the point is, it is not near enough detail to address today’s challenge-set.

HTM professionals must take a step back, recalibrate and adopt a no-compromise approach to clinical visibility.

Modern day clinical visibility should mean a real-time line of sight to every connected asset, because a continuously refreshed, fully profiled and dynamic, risk scored inventory is what’s required. Beyond make, model and IP address, we’ve got to know everything about the device including, where it is, network status, its firmware-specifics and the underlying details of its security posture.

From a risk assessment perspective, we must have the ability to instantly correlate device-specific vulnerabilities and threats, put our hands on accurate remediation instruction-sets, have insights into patient and operational impacts if the device is compromised and/or decommissioned, and an audit trail detailing our efforts. Also, we must know the operating requirements and authorized workflows of each device including internal/external connections, content flows, how the device is being utilized, when it is being used and who is using it. And if we can’t fix a problem even when we understand it, then at a minimum, we must have the ability to apply compensating controls with prioritized precision.

Although we don’t always regard them as such, this data is health care’s new currency. Maintaining a connected medical device ecosystem hinges on technologies that can support the kind of visibility just described. Only then can we confidently identify which assets are secure, available and providing the data-driven interoperability that lowers costs and improves patient care. Furthermore, if we don’t have these data, then we can’t share them when necessary – in times of crisis. As stated, a continuous, device-specific monitoring capability is needed, along with threat modeling analysis, mitigation and remediation practices that are proactive and collaborative. It’s a visibility-fueled security design that appropriately views every connected asset as the weakest link in the system.

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JONATHAN LANGER is the CEO and co-founder of Medigate. The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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ROMAN REVIEW Amor Fati

BY MANNY ROMAN

L

ast month, I wrote about how our expectations can be unrealistic and about the pain caused when they are not met. In this column, I will continue the discussion of expectations and how attitude and reframing can help deal with life’s unwelcome issues.

We all want to have only good things happen and to receive all the things we desire. Life disagrees. Our expectations are not often met and that is why I wrote last month’s column. Daily life seems to be full of what I will now call issues, some expected and others not so much. Our minds spend much time in anticipation of what is to come and in fear of the future because it is not in our control. Our minds naturally float toward what might happen since we desire a particular outcome. How much time do you spend each day stressing over what might happen in the unknowable future?

On the other hand, how much time do you spend each day searching through your past looking for “if only” items that would have made your present situation better? If only I had done this, if only that had not happened, if only I were rich, beautiful, athletic and charismatic like Manny Roman, etc. How much time, energy and anxiety do you expend on regrets, remorse and repentance?

Amor fati is a philosophy in which fate is regarded with appreciation and even with love. To love one’s fate is total acceptance of what has happened in our lives and even in the entire history of the world. This is a belief that what happened was meant to happen and what will happen is unavoidable. We are what we are and we cannot have regrets about any of our experiences. What we experienced was beyond our control and necessary so love it. You can no longer alter the past so

why hate it? Amor fati eliminates resentment for the past, fear of the future and allows for a happier present.

Ancient philosopher Epictetus said, “Seek not for events to happen as you wish but rather wish for events to happen as they do and your life will go smoothly.”

So, how do we implement amor fati?

We do this with attitude and framing.

I am confident that you have heard the phrase, “Attitude determines altitude.”

This means that how we choose to view things, our attitude, greatly influences what we can achieve. In the morning we choose what to wear and attitude should be part of our wardrobe. Will we choose to have a great and happy day or wander through the day looking to be offended?

With the former attitude, we might still run into situations that could offend however our attitude gives us the ability to respond how we choose.

Make your daily attitude one where you are not going to be driven by regrets, remorse and repentance. Be happy in being alive. Be happy for the opportunity to face the challenges of the day. Accept that a life without challenges would be a very boring existence.

Prepare to decide what you have control over and what is beyond your control.

Accept, and love, that there are things that are fundamental to your existence that will happen no matter what you do.

Exert your efforts toward influencing that which you can control.

What all this is about is framing things in a different perspective, different from the normal point of view. Framing is a technique where we view and present a situation from a particular perspective.

We all use framing whenever we think and talk. We present a situation to ourselves and to others from a very specific point of view. For example, as I write this I have a particular point I want

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Manny Roman, CRES AMSP Business Operation Manager to make. I think of multiple words in a particular order with particular definitions. I then imagine you reading them and deciphering my meaning. Seriously, I think of a few actual individuals that I know and think about how they will perceive my presentations. I often change the framing of the presentation to better fit the two of you who read this stuff.

If you want to implement amor fati, or portions of it, you must frame the past and the future in a different way. You must change how you present your past, and future, to yourself. Rather than dwell on regrets, remorse and repentance, view the past as an inevitable series of events that happened and that cannot ever be altered. Were they bad? Maybe. Were they good? Maybe. Could you have changed some outcomes? Maybe. Could some good have come from the bad? Maybe, explore that. Could some bad have come from the good? Maybe, ignore that.

No matter what, the past cannot be changed and the future cannot be predicted. What cannot be changed must be accepted. Therefore, love the present.

Someone once told me, “Tomorrow, today will be yesterday, so why worry about the past.” Wise words indeed!

The views expressed here are those of the author and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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he Michigan Society of Clinical Engineering hosted its annual golf outing July 25 at the Hartland Glen Golf Course in Hartland, Michigan. The event included 18 holes of scramble format golf with a power cart and lunch at the turn. The annual event is a signature networking event for area biomeds. Everyone enjoyed great weather and a fun times with some winning prizes at the event.

1. MSCE Vendor Ambassador ReneÊ Myers and MSCE President Tom Brown welcome participants to the group’s annual golf outing.

2. Bill Fox with St. Joseph Mercy Ann Arbor is past president of MSCE. His golf team was made up of himself, his daughter, her husband and father-in-law.

3 & 4. Sponsors were recognized with signs at the registration desk.

5. ATC Paragon Owner/President Jeff Ross and team members pose for a group photo.

7. Golfers who participated in the outing include (from left to right) Mike Billings with St. Mary Mercy Livonia, Thomas Brown with ACT-Paragon and Stan Gordan with St. Joseph Mercy Ann Arbor.

6. Biomed Greg Chappel took home the TechNation prize pack after a fun round of golf.

8. St. Joseph Mercy Ann Arbor was represented by (from left to right) Greg Michael, Dale Lewis and Ted Lybeck.

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he healthcare technology management (HTM) community supported the first HTM Mixer in Colorado. The “safe and clean” event included 40 vendors with exhibits and 150 companies. Everyone benefited from signature networking events, educational offerings and the sharing of ideas.

1. M ultiMedical Systems takes a fun selfie with their masks during the event.

2. The MD Publishing team was excited to get back to live, in-person events!

3. Vendors who were not able to travel had the opportunity to virtually represent their company so attendees could become acquainted with its products and services.

4. The outdoor exhibit hall was one of the first of its kind in the HTM industry and provided a safer, more spacious environment.

5. Several precautions and safety measures were taken before, during and after the event to ensure a clean and safe environment for everyone.

presented the popular two-part educational session “Using Standardized CMMS Data to Make Smarter HTM Decisions.”

7. A saxophone player entertains attendees during the welcome reception.

8. Julio Castro and Paul Wessler of Pronk Technologies traveled from California to exhibit at the Colorado HTM Mixer.

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FilAMed

www.FilAMedllc.com • 833-FILAMED

Health Tech Talent Management, Inc. www.HealthTechTM.com • 757-563-0448

InterMed Group

www.intermed1.com • 386-462-5220

Master Medical Equipment

MMEMed.com • 866-468-9558

Medical Equipment Doctor, INC.

www.medicalequipdoc.com • 800-285-9918

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

oneSOURCE

oneSOURCEdocs.com • 1-800-701-3560

Sodexo CTM

www.sodexousa.com • 1-888-Sodexo7

83

TTG

100

Contrast Media Injectors

P P 85 P 73 P P 71 P 58 P 78

P P P 61 P P 27, 61 P P 38 P 74

Rigel Medical, Seaward Group

www.seaward-groupusa.com • 813-886-2775

www.jetmedical.com • 714-937-0809

OCTOBER 2020

Injector Support and Service

www.injectorsupport.com • 888-667-1062

Maull Biomedical Training

www.maullbiomedicaltraining.com • 440-724-7511

Biomedical Support Systems

www.biomedicalsupportsystems.com • 1-800-290-1345

FilAMed

www.FilAMedllc.com • 833-FILAMED

Master Medical Equipment

MMEMed.com • 866-468-9558

Diagnostic Imaging International X-Ray Brokers

internationalxraybrokers.com/ •

Biomedical Support Systems

www.biomedicalsupportsystems.com • 1-800-290-1345

Cadmet

www.cadmet.com • 800-543-7282

Healthmark Industries

www.multimedicalsystems.com • 888-532-8056

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

52

P P P

63

83

P P P P P

52

P P

88

21

P

P 58 P 61 P P 85

63

85 85

www.brcsrepair.com • 844-656-9418

P

P

6 38

P

38

P

Gas Monitors Biomedical Repair & Consulting Services, Inc.

P P

59

Fetal Monitoring Multimedical Systems

63

42

Endoscopy

77

3

39

Defibrillator

HMARK.COM • 800-521-6224

Cardiac Monitoring Jet Medical Electronics Inc

www.ttgimagingsolutions.com • 866-NUC-MED1

74

Calibration

P P P P

Computed Tomography

www.triimaging.com • 855-401-4888

78

53

CMMS

Tri-Imaging Solutions

ALCO Sales & Service Co.

TECHNATION

sebiomedical.com/ • 828-396-6010

www.allpartsmedical.com • 866-507-4793

Biomedical

94

Southeastern Biomedical, Inc

www.swbiomed.com/ • 800-880-7231

2

P P

Cardiology

Southwestern Biomedical Electronics, Inc. 97

61

TRAINING

MMEMed.com • 866-468-9558

SERVICE

Master Medical Equipment

A.M. Bickford

PARTS

Anesthesia

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

78

P P

WWW.1TECHNATION.COM

SERVICE INDEX salesmakercarts.com • 800-821-4140

Monitors/CRTs 83 29

Imaging Health Tech Talent Management, Inc. www.HealthTechTM.com • 757-563-0448

ZRG Medical

www.zrgmedical.com • 760-438-8835

HMARK.COM • 800-521-6224

78 35

aiv-inc.com • 888-656-0755

Biomedical Support Systems

www.biomedicalsupportsystems.com • 1-800-290-1345

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

FilAMed

www.FilAMedllc.com • 833-FILAMED

Infusion Pump Repair

www.infusionpumprepair.com • 855-477-8866

Master Medical Equipment

MMEMed.com • 866-468-9558

Multimedical Systems

www.multimedicalsystems.com • 888-532-8056

Infusion Therapy AIV

aiv-inc.com • 888-656-0755

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6702

Infusion Pump Repair

www.infusionpumprepair.com • 855-477-8866

Select BioMedical

www.selectpos.com • 866-559-3500

USOC Bio-Medical Services

www.usocmedical.com • 855-888-8762

6

www.ozarkbiomedical.com • 800-457-7576

P P 85 P 68 P P 58 P 16

86

P P 38 P 61

www.ampronix.com • 800-400-7972

International X-Ray Brokers

internationalxraybrokers.com/ •

16 68

P P P P

86

P P P

31 7

www.selectpos.com • 866-559-3500

Innovatus Imaging

www.innovatusimaging.com • 844-687-5100

41

P P

InterMed Group

8

74

TTG

www.ttgimagingsolutions.com • 866-NUC-MED1

HTM Jobs

83

P P

63

MedWrench

80

www.MedWrench.com • 866-989-7057

oneSOURCE

oneSOURCEdocs.com • 1-800-701-3560

Webinar Wednesday

www.1technation.com/webinars • 800-906-3373

74 46, 81

Patient Monitoring AIV

16

aiv-inc.com • 888-656-0755

Ampronix, Inc.

4

www.ampronix.com • 800-400-7972

BETA Biomed Services

20

Biomedical Repair & Consulting Services, Inc. www.brcsrepair.com • 844-656-9418

Biomedical Support Systems

www.biomedicalsupportsystems.com • 1-800-290-1345

Jet Medical Electronics Inc

Southeastern Biomedical, Inc

53

sebiomedical.com/ • 828-396-6010

Southwestern Biomedical Electronics, Inc.

www.usocmedical.com • 855-888-8762

39 7

Patient Monitors www.FilAMedllc.com • 833-FILAMED

www.interpower.com • 800-662-2290

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

P

Ampronix, Inc.

www.ampronix.com • 800-400-7972

P P P P

58

Power System Components Interpower

P P P P

85 63

www.jetmedical.com • 714-937-0809

www.swbiomed.com/ • 800-880-7231

78

P

P P P P P P P P P P

99

P

4

P P

Radiology 31

P P P P P

93

www.htmjobs.com

FilAMed 4

P P P P

Nuclear Medicine

USOC Bio-Medical Services

Monitors Select BioMedical

7

www.usocmedical.com • 855-888-8762

www.betabiomed.com/ • 800-315-7551

Mammography Ampronix, Inc.

USOC Bio-Medical Services

Online Resource

Labratory Ozark Biomedical

4

www.ampronix.com • 800-400-7972

www.intermed1.com • 386-462-5220

Infusion Pumps AIV

Ampronix, Inc.

MRI

Infection Control Healthmark Industries

TRAINING

SalesMaker Carts

SERVICE

www.alcosales.com • 800-323-4282

PARTS

ALCO Sales & Service Co.

Company Info

AD PAGE

General

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

OCTOBER 2020

TECHNATION

95

SERVICE INDEX Sodexo CTM

www.sodexousa.com • 1-888-Sodexo7

Stephens International Recruiting Inc. www.bmets-usa.com/ • 870-431-5485

78

Southwestern Biomedical Electronics, Inc.

77

USOC Bio-Medical Services

35

Test Equipment

Refurbish

www.swbiomed.com/ • 800-880-7231

www.usocmedical.com • 855-888-8762

A.M. Bickford

www.ambickford.com • 800-795-3062

AIV

aiv-inc.com • 888-656-0755

16

Rental/Leasing Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6703

BC Group International, Inc

www.BCGroupStore.com • 314-638-3800

Pronk Technologies, Inc. 68

Repair

P

www.pronktech.com • 800-609-9802

Radcal Corporation

www.radcal.com • 800-423-7169

ALCO Sales & Service Co.

www.alcosales.com • 800-323-4282

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

Jet Medical Electronics Inc

www.jetmedical.com • 714-937-0809

83 68 63

Replacement Parts Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

Engineering Services, KCS Inc

www.eng-services.com • 888-364-7782x11

ZRG Medical

www.zrgmedical.com • 760-438-8835

P P P P

Rigel Medical, Seaward Group

www.seaward-groupusa.com • 813-886-2775

Southeastern Biomedical, Inc

sebiomedical.com/ • 828-396-6010

www.cbet.edu • 866-866-9027

68 17

P P P

35

Respiratory

ECRI Institute

www.ecri.org • 1-610-825-6000.

Tri-Imaging Solutions

www.triimaging.com • 855-401-4888

www.ambickford.com • 800-795-3062

FilAMed

www.FilAMedllc.com • 833-FILAMED

Software

P 58 P 41

Cadmet

Tri-Imaging Solutions

www.triimaging.com • 855-401-4888

www.medigate.io

Nuvolo

nuvolo.com • 844-468-8656

TruAsset, LLC

www.truasset.com • 214-276-1280

AllParts Medical

33

Ampronix, Inc.

42

CIRS, Inc.

25

Innovatus Imaging

Surgical Healthmark Industries

HMARK.COM • 800-521-6224

www.ampronix.com • 800-400-7972 www.cirsinc.com • admin@cirsinc.com www.innovatusimaging.com • 844-687-5100

6

AllParts Medical

www.allpartsmedical.com • 866-507-4793

Engineering Services, KCS Inc

aiv-inc.com • 888-656-0755

Biomedical Repair & Consulting Services, Inc. www.brcsrepair.com • 844-656-9418

Elite Biomedical Solutions

elitebiomedicalsolutions.com • 855-291-6701

FilAMed

www.FilAMedllc.com • 833-FILAMED

P P 78 P P 68 P P 58 P 16

www.eng-services.com • 888-364-7782x11

Innovatus Imaging

www.innovatusimaging.com • 844-687-5100

InterMed Group

www.intermed1.com • 386-462-5220

International X-Ray Brokers internationalxraybrokers.com/

Tri-Imaging Solutions

www.triimaging.com • 855-401-4888 96

TECHNATION

OCTOBER 2020

41 100

P P

5 31 3 53

P P

11 92 88

85 88

P P P

P P P

P P 4 P P 71 P 59

8

X-Ray

Telemetry AIV

7

Ultrasound www.allpartsmedical.com • 866-507-4793

Medigate

39

Tubes/Bulbs www.cadmet.com • 800-543-7282

A.M. Bickford

P P P P P

38

Training College of Biomedical Equipment Technology

TRAINING

www.HealthTechTM.com • 757-563-0448

www.multimedicalsystems.com • 888-532-8056

SERVICE

Multimedical Systems

Health Tech Talent Management, Inc.

PARTS

Recruiting

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

59 17

P P P

8 74

P P P

63 88

P P P

WWW.1TECHNATION.COM

ALPHABETICAL INDEX A.M. Bickford………………………… 41 AIV…………………………………… 16 ALCO Sales & Service Co.…………… 83 AllParts Medical……………………… 59 Ampronix, Inc.…………………………… 4 Asset Services………………………… 97 BC Group International, Inc………… 100 BETA Biomed Services……………… 20 Biomedical Repair & Consulting Services, Inc.…………… 78 Biomedical Support Systems………… 85 Cadmet……………………………… 85 CIRS, Inc.…………………………… 71 College of Biomedical Equipment Technology……………… 11 Crothall Healthcare Technology Solutions………………… 73 D.A. Surgical………………………… 71 ECRI Institute………………………… 92 Elite Biomedical Solutions…………… 68

Engineering Services, KCS Inc……… 17 FilAMed……………………………… 58 Health Tech Talent Management, Inc.…………………… 78 Healthmark Industries………………… 6 HTM Jobs…………………………… 93 Infusion Pump Repair………………… 86 Injector Support and Service………… 52 Innovatus Imaging……………………… 8 InterMed Group……………………… 74 International X-Ray Brokers………… 63 Interpower…………………………… 99 Jet Medical Electronics Inc………… 63 Master Medical Equipment………… 61 Maull Biomedical Training…………… 21 Medical Equipment Doctor, INC.…… 27, 61 Medical Equipment Solutions………… 2 Medigate……………………………… 33 MedWrench………………………… 80 Multimedical Systems……………… 38

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Nuvolo………………………………… 42 oneSOURCE………………………… 74 Ozark Biomedical…………………… 41 Pronk Technologies, Inc. ……………… 5 Radcal Corporation…………………… 31 Rigel Medical, Seaward Group………… 3 SalesMaker Carts…………………… 29 Select BioMedical…………………… 31 Sodexo CTM………………………… 77 Southeastern Biomedical, Inc……… 53 Southwestern Biomedical Electronics, Inc.……………………… 39 Stephens International Recruiting Inc.………………………… 35 Tri-Imaging Solutions………………… 88 TruAsset, LLC………………………… 25 TTG…………………………………… 83 USOC Bio-Medical Services…………… 7 Webinar Wednesday……………… 46, 81 ZRG Medical………………………… 35

OCTOBER 2020

TECHNATION

97

BREAKROOM

FLASHBACK Fall 2014 marked the 3rd anniversary of MD Expo teaming up with the Florida Biomedical Society (FBS) and it resulted in success once again!

T he U

S OC Medic featur a l bo o ed To th m ‘ Tin Liste r y’ Jr. ak a Dee bo .

s S e r vic e of Trac e y sk d v n u lo a Ultra so Jay C hv n A xess a h it w s pe a k s ntative . re prese

D r. Bin se ng Wang presen ts to a pack session on ed house on “How to C during a omply w ith M an agem en the Revised t st an dard s E quipm ent issued by C M S an d T JC ”

sure to represent the Tri- Imaging Solution s was held in Orl ando.

Mouse sinc e the event was

98

TECHNATION

OCTOBER 2020

r of Nafzige atthe w M d ring n u a d an t prize S por tsm H o t S po a t A m be r n se re rs. aging p hall hou M W Im exhibit

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