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contents

ICE FEATURES

May 2018 “ No one’s got a clear conscience and clean hands. All these different factions have an axe to grind and a cross to bear, and they say the data doesn’t show they have to be

FDA DEADLINE

regulated. The point is we should all have this discussion.”

SERVICE REGULATION REPORT DUE SOON

30 FDA Deadline

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rofessional P Spotlight

We look at what people in the industry are saying ahead of this month’s

Adam Byrd serves as one of the

deadline for the release of the FDA’s report on the maintenance and repair of

VA Portland Health Care System’s

medical devices as mandated by the FDA Reauthorization Act of 2017.

imaging professionals. Byrd has worked at the VA medical center for over a decade including the last five years as an imaging special-

Department

The five-member imaging service team at Gundersen Health System handles a wide range of devices including X-ray, fluoroscopy, portables, mammography, bone density, ultrasound, interventional systems, CT, PET and nuclear medicine.

ist. He is also supports his peers by serving as an officer in the OBA.

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ADVANCING THE IMAGING PROFESSIONAL

contents

ICE DEPARTMENTS

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19

25

May 2018

35

news

people

products

insight

8 Imaging News

18 Professional Spotlight

35 Imaging Matters

14 People on the Move

20 Department Spotlight

23 Surgical Imaging Product Spotlight

16 Webinar Wednesday

24 Surgical Imaging Gallery 29 Tools of the Trade

37 Imaging Service 101 39 Career Advice 40 Daniel Bobinski 42 Index

MD Publishing 18 Eastbrook Bend Peachtree City, GA 30269 Phone: 800-906-3373 Fax: 770-632-9090

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Art Department Jonathan Riley Karlee Gower Kathryn Keur

Account Executives Jayme McKelvey Lisa Gosser Megan Cabot

Contributors

K. Richard Douglas Matthew N. Skoufalos Jim Carr Cindy Stephens John Garrett Daniel Bobinski Jenifer Brown

Accounting Kim Callahan

Circulation

Lisa Cover Melissa Brand

Digital Department Cindy Galindo Travis Saylor Jena Mattison

Webinar

Linda Hasluem

ICE Magazine (Vol. 2, Issue #5) May 2018 is published by MD Publishing, 18 Eastbrook Bend, Peachtree City, GA 30269-1530. POSTMASTER: Send address changes to ICE Magazine at 18 Eastbrook Bend, Peachtree City, GA 30269-1530.

For subscription information visit www.imagingigloo.com. The information and opinions expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher.

Reproduction in whole or in part without written permission is prohibited. Š 2018

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news

IMAGING NEWS A LOOK AT WHAT’S CHANGING IN THE IMAGING INDUSTRY

Merry X-Ray Expands with Another Acquisition Merry X-Ray Corporation has announced the purchase of Premier Imaging Inc., a diagnostic imaging equipment re-conditioning, sales and service company.

Premier has been a long-term partner to hospitals, clinics, outpatient imaging centers, outpatient emergency rooms and private practice physicians throughout Texas since 1994.

Premier Imaging is a recognized medical imaging system reconditioning enti-

ty with more than 60 years of combined service experience. With capabilities to recondition virtually any piece of diagnostic X-ray equipment, including multi-slice computed tomography (CT) systems, portables and radiographic rooms, Premier helps customers extend the useful life of diagnostic imaging equipment.

“Adding Premier’s capabilities to our recent acquisitions further broadens Merry X-Ray’s offerings to the diagnostic im-

aging market and takes another strategic step forward on our mission of being the largest medical imaging sales and service network in the United States,” Merry X-Ray President Ted Sloan stated. “With 2018 being our 60th anniversary, we are accelerating our investment in the future of Merry X-Ray by actively looking to make additional acquisitions to further expand our portfolio of offerings to the market.” •

Accruent Acquires Connectiv Accruent, a provider of physical resource management solutions, has acquired California-based Connectiv, enhancing Accruent’s ability to meet the needs of clients in health care. This marks Accruent’s seventh company acquisition in the past 24 months as it strives to help clients have control and visibility across asset management solutions.

Connectiv is a cloud-based, mobile-enabled software company that allows biomedical and clinical engineering groups to manage and control all aspects of their medical devices and equipment. Connectiv software helps health care organizations fulfill their mission by mitigating risk, ensuring regulatory compliance and maximizing utilization. Connectiv is a ServiceNow Technology Partner automating the management of medical applications, devices and facilities.

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“With 67 percent of medical device manufacturers and 56 percent of health care providers believing an attack on their devices is likely to occur within a year, we saw the urgency to provide a solution for managing biomedical assets,” said Accruent CEO John Borgerding. “We are acquiring Connectiv because their software, co-created with clinical engineers in national health care organizations, enables management of medical devices across the lifecycle, including automatic security monitoring that identifies threats in minutes. Connectiv’s biomedical asset management solution has the feature set and the flexibility to address changing health care needs, new technologies and regulatory demands.”

With hospitals and clinical providers looking for the user-friendliness and control of a master IT platform, Connectiv

leverages the Now Platform from ServiceNow Inc., enabling automated management across clinical applications and medical assets.

The acquired solution set and its planned enhancements will continue serving existing Connectiv customers, and will be offered as a complement to Accruent’s existing suite of health care solutions in asset and maintenance management, lease accounting and capital planning.

The acquisition, effective immediately, includes the continuation of existing Connectiv product development, support and sales resources. •

ADVANCING THE IMAGING PROFESSIONAL

news Probo Medical Inc., MedCorp, LLC Announce Merger Probo Medical is partnering with MedCorp LLC. With the merger, Probo Medical will have an ultrasound system resell and repair business to complement its ultrasound probe sales and repair departments.

Probo Medical was established in 2014 and is a reseller of refurbished ultrasound equipment. With 55 employees and two probe repair facilities in Oklahoma, Probo Medical offers comprehensive probe repair and resale for all 2D, 3D/4D and transesophageal ultrasound probes.

MedCorp, established in 1999, is a full-service resource for ultrasound system, equipment and ongoing maintenance with 18 employees at its Tampa, Florida location.

“We are excited about the union of these two great companies,” said David Trogden, who will be president of the combined companies. “MedCorp’s extensive ultrasound system experience, coupled

with Probo Medical’s ultrasound probe focus, will create the unquestioned market leader in stocking ultrasound systems and probes.”

Probo Medical and MedCorp will continue to operate under their current names. MedCorp partners Michael Asmer, Mike Dilick and Chris Munyon will remain officers of the combined businesses.

“This merger will result in one of the most experienced teams in our industry,” said Trogden. “We are in a dynamic environment and believe our united companies will be a platform for continued growth and expansion for years to come.” •

Canon Devices Receive FDA Clearance Health care professionals seeking a cost-effective imaging solution without compromising image quality can now leverage the newly FDA-cleared Aplio i600 from Canon Medical Systems USA Inc. Combined with a full host of easy-to-use workflow tools and performance features, the Aplio i600 improves diagnostic confidence and enables clinicians to deliver quick, reliable exams.

The Aplio i600 provides intuitive ergonomics to help boost productivity during routine and complex exams thanks to its small and light iSense design which makes it easy for clinicians to adjust the console to virtually any scanning position.

The newly FDA-cleared system also offers an image-guided user interface to visually guide the clinician through the exam, simplifying system operation and helping improve efficiency. To help health care providers give more confident diagnoses, this premium performance system features iPerformance imaging technology which reduces clutter, strengthens signal and improves visualization. The Aplio i600 uses the same transducers from the current Aplio Platinum Series, making migration to this new system easier.

Also, Canon Medical Systems’ Vantage Galan 3T XGO Edition with Saturn X Gradient recently received FDA clearance. OutWWW.IMAGINGIGLOO.COM

fitted with the all-new Saturn X Gradient, the system can provide up to 30 percent improved signal-to-noise ratio (SNR) for brain diffusion weighted imaging (DWI), resulting in even higher resolution neuro images than previously offered. The newly FDA-cleared system enables sequences for quantitative analysis and allows cardiac exams to be completed with fewer breath

holds and improved patient comfort.

The Galan 3T XGO Edition offers the ability to conduct quick, comfortable and high-quality neuro imaging exams, and allows for faster sampling and higher resolution images, thanks to PURERF and Saturn technologies. This, combined with the ability to stack protocol sequences, results in quick neuro exams, enabling health care providers to produce higher resolution images for myriad neuro exams in under five minutes. New software that comes with the system also offers MultiBand SPEEDER technology, which allows for multiple slices to be acquired at the same time, reducing diffusion weighted imaging scan times by up to two times.

The Galan 3T XGO Edition also delivers enhanced cardiac capabilities, including T1 mapping that utilizes MOdified Look-Locker Inversion recovery (MOLLI) sequence and allows providers to acquire a more quantitative characterization of myocardial tissue within a single breath hold. The system’s Phase Sensitive Inversion Recovery (PSIR) in the heart provides improved contrast in late-enhanced imaging and eliminates the need for inversion time (TI) calibration scan, allowing cardiac exams to be completed with fewer breath holds and greater patient comfort. • ICEMAGAZINE

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news

Siemens Healthineers Launch New Products at ACC At the American College of Cardiology’s Scientific Session and Expo, Siemens Healthineers launched its new portable cardiovascular ultrasound solution, the ACUSON Bonsai. According to a recent study, 34 million echo exams were performed in the U.S. in 2017.

The ACUSON Bonsai addresses the challenge of these increased clinician workloads by providing a portable and quick system, while maintaining high-quality imaging and diagnostic confidence through user-friendly applications. Together with Mindray Medical

International Limited, Siemens Healthineers created a cardiovascular-dedicated, maneuverable system to transform the care delivery of routine echo exams.

Siemens Healthineers also has launched the next generation of syngo Dynamics, a cardiovascular imaging and information solution. The newest version of the software emphasizes enhanced security, widespread access, enterprise consistency and structured reporting.

Siemens Healthineers developed the next generation of syngo Dynamics with enhanced security features and improved

workflow capabilities that enable fast and secure readings from any location. Now HTML 5 enabled, syngo Dynamics can be accessed remotely with a common worklist on a variety of platforms, allowing users to access images across imaging modalities on any device. This single point of access ensures that all data is included in one place and available to users at a glance. • For more information, visit the Siemens Healthineers website.

CS Medical Announces New Product CS Medical has announced the release of a new enzymatic product specially designed for endocavity ultrasound probes in NUZYME sponges. NUZYME sponges are a single-use pre-saturated enzymatic applicator designed for endocavity ultrasound probes.

NUZYME has a neutral pH, multi-tiered enzymatic detergent, specifically formulated to remove gross contaminants while targeting insoluble polysaccharides

that encase biofilm, exposing them to the high-level disinfectant.

NUZYME sponges are individually packaged for easy single-use application.

The enzymatic sponges have been treated with a preservative to inhibit and protect the product from mold and fungus and to preserve against bacteria growth. • For more information, visit www.csmedicalllc.com.

Dicom Systems Installs First Enterprise Imaging Platform in Kilimanjaro Dicom Systems Inc., a health IT company specializing in enterprise imaging interoperability and workflows, has deployed its flagship Workflow Unifier platform at the foot of Mount Kilimanjaro in Moshi, Tanzania. The project was funded by the nonprofit East Africa Medical Assistance Foundation (EAMAF) which chose the Kili-

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ICEMAGAZINE | MAY 2018

manjaro Christian Medical Centre (KCMC), a 630-bed referral hospital and medical school, as the recipient site.

“We are proud that our first customer in Africa is KCMC, a leading health care institution in Tanzania,” said Dmitriy Tochilnik, president and CTO of Dicom Systems.

“Our early teleradiology installations took

place in rural health environments where technology has not traditionally flourished.

It’s our privilege that the Workflow Unifier will serve as ground zero for teleradiology workflows and archiving as KCMC executes their vision for enterprise imaging.” • For more information, visit dcmsys.com.

ADVANCING THE IMAGING PROFESSIONAL

news FDA Approves Hologic Mammography Innovations Hologic Inc. has announced that Clarity HD high-resolution 3D imaging and Intelligent 2D imaging technology have received PMA approval from the FDA and are now available on the 3Dimensions breast tomosynthesis system. With these innovations, the system now provides higher resolution 3D images for radiologists, enhanced workflow for technologists, and a more comfortable mammography experience, with low-dose options, for patients.

The new Clarity HD high-resolution 3D imaging technology provides one of the industry’s fastest, highest resolution 3D images to accelerate screening and analysis, and is designed to clearly reveal subtle lesions and fine calcifications to help pinpoint cancers early. Clarity HD technology’s advanced detector and innovative 3D imaging algorithm work together to deliver exceptional 3D images, regardless of breast size or density.

Intelligent 2D imaging technology works with Clarity HD technology to deliver superior overall image quality, and unprecedented clarity, contrast and detail at a lower dose.

“Our experience as a leader in breast cancer screening has taught us that radiologists and technologists value accuracy above all else,” added Hologic’s Tracy Accardi. “We developed the 3Dimensions system with that in mind, while adding two features that have great potential to improve patient satisfaction.”

One of these features, the SmartCurve breast stabilization system, is clinically proven to deliver a more comfortable mammogram without compromising image quality, workflow or dose. The SmartCurve system features a curved compression surface that mirrors the shape of a woman’s breast to reduce pinching and allow uniform compression over the entire breast.

In addition, Quantra 2.2 Breast Density Assessment Software, also available on the 3Dimensions system, enables clinicians to provide women with consistent breast density assessments during routine breast cancer screenings. Through a proprietary algorithm powered by machine learning, Quantra software analyzes mammography images for

distribution and texture of breast tissue, delivering clinicians accurate breast density assessment. Quantra software categorizes breasts into four density categories, in alignment with the ACR BI-RADS Atlas 5th Edition. • For more information, visit 3DimensionsSystem.com.

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news FDA Clears MAMMOMAT Revelation Mammography System The FDA has cleared MAMMOMAT Revelation, a mammography platform from Siemens Healthineers with the new InSpect integrated specimen imaging tool and the new HD Breast Biopsy solution for oneclick targeting of suspicious areas. These and other features are designed to expand precision medicine and improve the patient experience.

MAMMOMAT Revelation’s InSpect integrated specimen imaging tool permits imaging and real-time review of biopsy samples at the workstation. This tool improves biopsy workflow, shortens compression time and reduces patient discomfort.

HD Breast Tomosynthesis offers the widest image acquisition angle available at 50 degrees. The wide angle delivers the industry’s highest depth resolution for better separation of overlapping breast tissue, providing high-quality 3D images for improved diagnostic confidence and earlier lesion detection. This technology is the basis for MAMMOMAT Revelation’s HD

Breast Biopsy solution, which enables one-click targeting of suspicious areas with a +/- 1mm accuracy.

MAMMOMAT Revelation offers automated breast density measurement during the mammogram for immediate, personalized risk stratification, and more personalized care.

MAMMOMAT Revelation’s Personalized Soft Compression adjusts the level of breast compression automatically to suit each patient’s anatomy. Coupled with ergonomic SoftComp Paddles, Personalized Soft Compression enables improved breast positioning, more consistent image quality, and less discomfort and anxiety.

And for inconclusive cases, MAMMOMAT Revelation offers titanium contrast-enhanced mammography as a cost-effective alternative to magnetic resonance imaging (MRI), reducing scheduling conflicts and reassuring the patient. •

MR Solutions Launches Gradient Coil Upgrade Service for MRI Systems MR Solutions, subsidiary MRS Magnetics, is launching a gradient coil upgrade service for coil replacement within preclinical MRI imaging systems. This will significantly improve the magnet capability and system performance of older MRI systems including Bruker, Agilent, Varian and Magnex.

MR Solutions can also install smaller high-strength removable gradient coils within a larger gradient coil for research which requires higher gradient strength.

As part of the upgrade service the temperature sensor type and interface configura-

tion would be upgraded to match the gradient being replaced.

MR Solutions has for many years provided upgraded spectrometers – the electronic brains of the system. Their latest model, the EVO2+ spectrometer, is provided with comprehensive development software and an extensive sequence library optimized for multiple applications and has an unlimited number of TX and RX channels and can operate MRI systems up to 11.7T. •

Samsung Unveils Ultrasound System Samsung NeuroLogica, a subsidiary of Samsung Electronics Co. Ltd., announced that the Samsung RS85A ultrasound system has received FDA 510(k) clearance. The RS85A is the latest expansion of Samsung’s ultrasound portfolio.

“We are pleased to launch the RS85A, a new premium general imaging ultrasound system with superior image quality and usability based on Samsung’s advanced ul12

ICEMAGAZINE | MAY 2018

trasound and radiology technologies,” said Philip Sullivan, president and CEO of Samsung NeuroLogica. “The RS85A embodies Samsung’s commitment to providing leading technologies to health care providers by combining our key values of access, accuracy and efficiency.”

The RS85A features an array of improvements, including MV-Flow, S-Shearwave Imaging, CEUS+ and S-Fusion.

The RS85A was also developed to help decrease user-fatigue and repetitive motions with an enhanced monitor arm and increased range of motion and tilt. These improvements allow users to position the monitor for optimal viewing and control. Additionally, multi-step actions have been combined into a single step to help reduce keystrokes and repetitive user interface interactions. • ADVANCING THE IMAGING PROFESSIONAL

news FUJIFILM Debuts New Multimodality Mammography Workstation FUJIFILM Medical Systems U.S.A. Inc. unveiled the ASPIRE Bellus II mammography diagnostic workstation at the National Consortium of Breast Centers (NCoBC) conference.

“With early detection as the leading defense against breast cancer it is crucial that radiologists are armed with the right technology to inform diagnoses,” said FUJIFILM’s Rob Fabrizio. “The ASPIRE Bellus II, a one-stop workstation solution de-

signed specifically for mammographic diagnosis, aims to streamline workflow and optimize image displays enabling radiologists to make a more precise diagnosis.”

The ASPIRE Bellus II smart mammography workstation offers a multimodality view for radiologists in an a high-resolution display and also offers 2D and tomosynthesis comparisons. While supporting a range of DICOM formats, the system is designed around the unique require-

ments of mammography. The ASPIRE Bellus II incorporates diagnostic features such as current and prior image comparison, quadrant view, tomosynthesis support and invert. To optimize workflow the ASPIRE Bellus II enables customization for reading protocols and personalized configuration. It received 510(k) clearance from the FDA in September 2017 and will begin shipping to customers in spring 2018. •

Philips Announces Integrated Tele-Ultrasound Solution Royal Philips has announced an integrated tele-ultrasound solution based on Philips’ Lumify portable ultrasound system and powered by IIT’s Reacts collaborative platform. This connects clinicians around the globe in real time by turning a compatible smart device into an integrated tele-ultrasound solution, combining two-way audio-visual calls with live ultrasound streaming. This innovation in point-of-care ultrasound brings endless possibilities to users inside and outside hospital walls.

With this intuitive, easy-to-use integrated system, clinicians can begin their

Reacts session with a face-to-face conversation on their Lumify ultrasound system.

Users can switch to the front-facing camera on their smart device to show the position of the probe. They can then share the Lumify ultrasound stream, so both parties are simultaneously viewing the live ultrasound image and probe positioning, while discussing and interacting at the same time. In addition to clinicians seeking virtual guidance, Philips Lumify with Reacts is a tool for teaching institutions, medical students and residents, emergency medical service providers, disaster relief providers and hospitals with satellite clinics.

“By combining exceptional mobility and reliability, Philips Lumify with Reacts will open up new doors for the way clinicians collaborate, educate and train,” said Randy Hamlin, pointof-care business leader, Philips. “This all-in-one tele-ultrasound solution will enhance care delivery by bringing even more confidence to ultrasound clinicians and removing longstanding barriers in education, support and training.” • For more information, visit www.philips.com/lumifywithreacts.

Varian Eclipse Customers Earn Honors Varian has announced customers using Varian Eclipse treatment planning software placed the highest in the overall category in the first-ever World Championships of Treatment Planning, hosted by ProKnow. In addition to the top four and six of the top 10 positions in the overall category, Eclipse customers also had the top three scoring VMAT plans.

WWW.IMAGINGIGLOO.COM

The objective of the World Championships of Treatment Planning is to determine which planner and planning system can produce the highest quality plan in a rigorous and limited timeframe. Professionals from over 30 countries all competed at the same time and were given four hours to create treatment plans, score them online, and submit their best effort. A description of the body

site, physician prescription and the plan scoring algorithm were provided to participants in advance, and plan scoring was unbiased and objective, powered by the cloud-based ProKnow system. • For more information on competition and the top scoring plans, visit www. proknowsystems.com.

ICEMAGAZINE

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PEOPLE ON THE MOVE

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By Matt Skoufalos

Find weekly installments at imagingigloo.com

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After 14 years of service, AHRA: The Association for Medical Imaging Management CEO Edward J. Cronin Jr. has announced his plans to retire from the association at the end of 2018. Under his leadership, AHRA has become widely known as the premier association for radiology management, with recognizable expertise and a leadership position in disciplines across the medical imaging industry. Over the next few months, the board of directors will be conducting a search to find the new CEO of AHRA.

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Innovatus Imaging of Pittsburgh, Pennsylvania has named Xueli Wang its CFO. Wang has been head of business analytics at Bayer Medical Care Multi Vendor Service and has a Carnegie Mellon MBA.

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associate member, breast medicine service, department of medicine, MSKCC and associate professor of medicine, Weill Cornell Medical College, New York. Dickler is a clinical researcher on the breast medicine service at MSKCC.

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The National Association of Locum Tenens Organizations’ (NALTO) of Norcross, Georgia has named Anne Anderson executive vice president of its board of directors; Anderson was NALTO president from 2011-13, served on its board from 2006-14, and is currently serving a second term on its board, begun in 2016.

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Greater Newport Physicians (GNP) of Los Angeles, California has selected MemorialCare Medical Foundation (MMF) CEO Mark Schafer to replace retiring CEO Diane Laird. Laird founded GNP in 1985 and led its merger with MMF in 2012. Schafer will also continue as CEO of MMF.

The Morristown, New Jersey-based Morristown Medical Center named James C. Wittig chair of its department of orthopedics and medical director of orthopedic oncology at Atlantic Health System. Wittig was previously vice chairman of orthopedic surgery, chief of orthopedic oncology and sarcoma surgery, and director of the skin and sarcoma division at Hackensack University Medical Center.

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Frenesius Medical Care North America of Waltham, Massachusetts has named Angela McClure its chief experience officer (CXO). McClure was most recently senior vice president of human resources for Fresenius Kidney Care, Azura, Physician Practice Services and Spectra Laboratories.

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Valley Presbyterian Hospital of Van Nuys, California has added Clyde Wesp as its new chief medical officer. Wesp is a board-certified pediatrician and USC adjunct professor at the Sol Price School of Public Policy.

Athenahealth of Watertown, Massachusetts has named former GE Chairman and CEO Jeff Immelt to chairman of its board of directors. Immelt becomes the 11th director of the company board, and will purchase $1 million in Athenahealth common stock on the open market. He was the GE chairman and CEO for 16 years, and holds a bachelor’s degree in applied mathematics from Dartmouth and a Harvard MBA.

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The Pancreatic Cancer Action Network (PanCAN) of Manhattan Beach, California, named Sudheer Doss its chief data officer. Doss spent a decade at Pricewaterhouse Coopers (PwC) and served as director of its precision medicine practice.

ConcertoHealth of Aliso Viejo, California promoted Regional Medical Director Christopher Dodd to chief care transformation officer.

Dodd has been with the company since 2016 and also works as a physician at the ConcertoHealth Lakewood Care Center. Dodd is a founding member and current president of the board of directors of Maravilla Health, and serves as a faculty member in the Department of Global Health at the University of Washington

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Eli Lilly and Company of Indianapolis, Indiana named Maura Dickler its vice president of late phase development, effective May 7, 2018.

Dickler is currently the section head, endocrine therapy clinical research program at Memorial Sloan Kettering Cancer Center (MSKCC) and an 14

ICEMAGAZINE | MAY 2018

Cook Medical of Bloomington, Indiana has added Mark Breedlove as vice president of its vascular division and DJ Sirota as vice president of its med/surg division.

ADVANCING THE IMAGING PROFESSIONAL

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news

WEBINAR WEDNESDAY Sessions Deliver ACI-approved Credit

T

he Webinar Wednesday program continues to provide quality educational opportunities to HTM professionals around the world.

One recent Webinar Wednesday presentation – “Why a Nuclear Medicine Camera Evaluation is Vital to Ensure SPECT Camera Performance and Longevity” sponsored by Universal Medical – was among those eligible for 1 CE credit from the ACI. The 60-minute webinar featured Chad Watson, evaluation program director, Universal Medical, and Ann Hamilton, radiology director, Texas County Memorial Hospital. The presenters discussed the evaluation experience from the perspective of the company conducting the evaluation and the owner of the SPECT camera.

Their presentation featured insightful information, including: • Why it is important to have your SPECT camera(s) evaluated periodically.

• Actions you can make after receiving the results of your evaluation to improve performance and useful life of your nuclear medicine camera(s).

• An overview of what must be included in evaluation and how you can use the information.

• A radiology director’s firsthand experience before, during and after an evaluation was performed on their SPECT camera.

Webinar attendees were impressed by the presentation based on a post-webinar survey.

“There is always something new to learn when viewing Wednesday webinars.

Each vendor has helped find answers to problems that you might face in your daily 16

ICEMAGAZINE | MAY 2018

job. The tips to improve my job and per- effortless mobile experience. formance are appreciated,” said H. Martin, The webinar received outstanding reCBET. views in a post-webinar survey sent to at“This is an excellent way to stay sharp tendees. and keep current in the field! Outstanding,” “Great information! Good to know Biomed L. Countee added. there’s someone out there thinking like “Webinar Wednesday is a great way to someone on the front lines,” shared stay in touch with our industry,” said Imag- Biomed L. Smith. ing Specialist T. Jasensky.

“This was an extremely useful presen“Excellent and concise information re- tation. I enjoyed that a demonstration was garding nuclear camera evaluation,” Imag- added into the middle of the presentation ing Equipment Specialist K. Revallo wrote. instead of everything just being slides,” More than 200 people attended the we- said Metrology Professional S. Strzalkowbinar “How a CMMS Upgrade Can Empow- ski. er HTM and Clinical Engineering Teams” “Ben did a great job presenting; good sponsored by Nuvolo. Participation in the speed, transitions and made time to anpresentation was eligible for 1 CE credit swer questions throughout the presentafrom the ACI. tion, thank you,” said B. Kara, Jump Team In the 60-minute webinar Ben Person, Operations Manager. senior director for solution consulting at Nuvolo, discussed how innovative health care providers are advancing HTM programs by replacing their legacy CMMS. He shared how these thought leaders are upgrading with Nuvolo Clinical – S. Orrin, Biomed Technician EAM – a modern, cloud-based CMMS alternative designed to improve patient care, cut costs and boost “Wow, from what I saw today, this compliance. would greatly increase our productivity,” In his presentation, Person shared said S. Orrin, Biomed Technician. how Nuvolo can help a department “This webinar was fantastically well put make data-driven decisions with re- together. The information range that was al-time reporting and analytics de- provided and detail were exceptional givsigned for health care providers as well en only 60-minute time frame. I wish our as eliminate expensive and lengthy cus- system would have waited/or knew about tomization. He also shared how the pro- Nuvolo and implemented it instead of the cess can empower technicians with an Maintenance Connection software we are

“Wow, from what I saw

today, this would greatly

increase our productivity.”

ADVANCING THE IMAGING PROFESSIONAL

now utilizing,” said B. Judah, Biomed Technician.

The webinar series also received compliments from attendees.

“I love the webinars. Quality speakers and the most relevant materials,” said D. Townson, Clinical Engineering Supervisor.

“Webinar Wednesdays provide a consistent opportunity to learn more about hot-button topics in our industry,” said B. Shearer, Executive Assistant.

“Webinar Wednesdays are great! I really enjoy them and they are very helpful. I always look forward to the next webinar and always try to attend,” said G. Havens, Site Coordinator. ICE For more information, visit WebinarWednesday.live.

MEDICA 2018 Inter national Trade Fair

www.mdna.com/trade-shows/details/medica

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people

By K. Richard Douglas

PROFESSIONAL SPOTLIGHT Connecting with Colleagues: Adam Byrd

I

n Portland, Oregon and surrounding areas, veterans of the United States Armed Forces are served by the VA Portland Health Care System and the medical center there. The health care system serves 95,000 veterans in Oregon and Southwest Washington.

The first structure on the campus of the present day hospital was dedicated in 1929. The current medical center was opened in 1988. There is another campus in Vancouver, Washington and 10 outpatient centers.

One of the facility’s imaging professionals is Adam Byrd. He also serves as treasurer of the Oregon Biomedical Association. Byrd has worked at the VA medical center as a biomed for 10 years and has spent the last five years as an imaging specialist.

“While working in the hospital in 2005 I met a person who worked in biomed and I went down to the biomed shop and was immediately interested in the field. There was an opportunity to get hired on as an imaging technician after years of interning, I had the good fortune of being hired,” Byrd remembers.

Like many in the industry, Byrd’s initial training came by way of the military.

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“I was an electro-optics ordnance repairman in the Marine Corps for five years,” he says. “I also attended Portland Community College in the EET program and attended three imaging service training courses at DITEC as well as vendor-specific radiographic and ultrasound training.”

He also earned a bachelor’s degree in psychology.

Since entering the field, Byrd has been a biomed intern, medical equipment repairman and a biomedical equipment support specialist-imaging.

Applying Soft Skills In the challenges and projects department, Byrd says that a PACS upgrade and juggling several balls at once can challenge even the most experienced imaging specialist.

“As the field evolves to encompass more high-level networking, I have had to adapt and develop my skill set to accommodate. I have been managing a few major facility and regional projects, one of which involves adding new servers as part of an upgrade to our current cardiology PACS system. I have been handling the documentation, the instal-

lation, the IT integration and implementation including port configurations, ACL design, core switch connection, HL7 assembly, etcetera,” he explains.

Byrd says that it has been a challenge to learn new processes and complete all of the tasks while being responsible for

“I pride myself on being a good communicator and being able to adapt to any situation regardless of the stress level or urgency. “ all other areas, including imaging equipment repairs, networking, PACS administration, server maintenance and PMs. “Part of being good is being able to multitask and prioritize work; which can be very difficult at times especially in imaging, where everything is an emergency,” Byrd adds.

Byrd was elected as the treasurer of ADVANCING THE IMAGING PROFESSIONAL

Favorite part of being an imaging professional?

“The daily challenges.”

GET TO KNOW THE PRO Favorite book: I really fell in love with “The Hitchhiker’s Guide to the Galaxy,” that got me reading for pleasure in the military Favorite movie: “Die Hard” Favorite food: TV dinners – bachelor mode engage Hidden talent: Impressions – I’m always getting myself in trouble What’s in your van?

• Electric drill with a bit set • Network testing kit • Multimeter • Tablet

Adam Byrd Imaging Professional

the Oregon Biomedical Association in April as part of a two-year voluntary appointment. This gives him a chance to connect with the local imaging and biomedical community and “offer my experience and energy to increase awareness of our field, emphasis and improve accreditation, and educate them on new or existing equipment,” he says.

When asked what ICE readers should know about him, Byrd points out his foWWW.IMAGINGIGLOO.COM

cus on the importance of “soft skills.”

“I try my best to connect with my customers and really cultivate a positive relationship with all the people I can in the areas I support. It is all about helping people and communicating effectively. In my opinion, technical skills can be acquired easily, but the intangibles are hard to come by,” he says.

“I pride myself on being a good communicator and being able to adapt to any situation regardless of the stress level or urgency. I have been involved with the local biomed community for years, recently becoming the treasurer of the Oregon Biomedical Association. I truly love talking to my fellow biomeds about their careers, the

• A sound effects board to mess with vendors – endless entertainment equipment they work on, and the direction this field is going,” Byrd adds.

“I find biomedical engineering fascinating and I want to share my passion and inquisitive nature with like-minded people.

All biomeds share a common bond, as my mentor Keith Momberg used to say; ‘Them boys ain’t right.’ ” Byrd still lives relatively close to his family. His two sisters, mother and father all live in the northwest. In his off time, he enjoys snowboarding, basketball, playing music, hiking and fishing.

Byrd is bringing his commitment to the field to the Portland area imaging community in an effort to connect with colleagues as well as customers. ICE ICEMAGAZINE

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people

By K. Richard Douglas

DEPARTMENT SPOTLIGHT Gundersen Health System Imaging Team

T

he Gundersen Health System (GHS), based in La Crosse, Wisconsin, serves patients located throughout western Wisconsin, northeastern Iowa and southeastern Minnesota. The health care system has regional centers in West Union, Iowa; Whitehall, Wisconsin; Hillsboro, Wisconsin; Friendship, Wisconsin and Boscobel, Wisconsin along with 25 other locations.

Healthgrades chose Gundersen as one of “America’s 50 Best Hospitals” in 2017.

The main hospital is also a teaching hospital and is designated as the Western Academic Campus for the University of Wisconsin School of Medicine and Public Health.

Behind the public-facing presence of this health system is a group of imaging professionals who maintain the equipment that helps Gundersen clinicians diagnose patients.

“The Gundersen Health System Clinical Engineering Department consists of 18 staff and one manager. Our department is specific to a Clinical Engineering scope, however we are part of the Information Systems (IS) division of GHS, specifically in the customer and technical service subdivision,” says Ryan Motl, manager of IS Clinical Engineering at Gundersen Health System.

“Of these 18 staff, five are dedicated to imaging and therapy modalities specifically, and although they have specific job titles, they are a full part of the CE program,” 20

ICEMAGAZINE | MAY 2018

he says.

The imaging team handles a wide range of equipment, which they are the primary servicers on.

“This includes X-ray, fluoro, portables, mammography and bone density; CR & DR acquisition systems; ultrasounds; interventional systems; CT, PET, and SPECT/NM; and LINACs and ancillary software, hardware and workstations,” Motl says.

When it comes to ongoing training, Motl says that helping staff develop mastery of their work is an ongoing challenge.

“As you may find in many in-house departments, the ‘full-array’ of options are used at GHS to maintain skills. We use a variety of educational sources including OEM, non-OEM (both on-site and off-site), internal cross training, and on-the-job training,” he says.

Maintaining a good reputation as a leading health care provider in the midwest is made easier when all the imaging equipment is ready to serve patients.

“Service methods and options are usually determined as part of the cost of ownership analysis when a device is being considered for purchase, and if we choose to

service in-house, training costs are rolled into that analysis. This helps make sure that when purchasing decisions are made, training (both service and end-user) it is not an afterthought to be worked out later,” Motl adds.

Motl says that the imaging team has oversight of, or direct responsibility for, three MRI, six CTs, seven interventional labs, three LINACs, three SPECT, one PET, 10 DR systems, six DR mammo, several portables, C-arms, ultrasounds and other equipment at the main La Crosse/Onalaska campuses.

“In addition to that, members are often on the road supporting our 20 regional family practice clinics that have basic imaging — rad rooms, CR, ultrasound and occasional mammo. GHS also provides mobile mammo and bone dens to these regional sites that don’t have their own services. As we have grown, new critical access hospitals have joined the GHS family, and each bring an imaging center for which we provide differing types of support,” Motl says.

Finding a Solution Problem solving and specialized knowledge are traits of the imaging group’s team members.

“As a growing health system, GHS is engaged in new facility construction and renovation quite frequently. Most of the install/de-install ‘project’ work for the imaging group stems from this, or replacement ADVANCING THE IMAGING PROFESSIONAL

The members of the GHS imaging service team include (from left to right) Dave Houge, Todd Frederick, Matt Miller, Mike Starch and Alan Engstler.

cycle activity. Case in point; we are just beginning the months-long process of replacing an older LINAC with a new system,” Motl says.

“In this process, Alan Engstler has been working hand-in-hand with the department leaders, physicists, construction engineering and Varian. He is a central figure in the process of making sure that all of these stakeholders are aligned to the needs of a successful medical equipment implementation,” Motl adds.

He says that there are other projects that are not directly related to install/ de-install.

“Matt Miller has been our primary imaging resource for a medical device security project currently underway, assisting with port, IP and destination mapping for firewall activities. Mike Starch has recently finished a long project partnering with diagnostic radiology to help automate the capture of re-take data from our dozens of Fuji CR workstations scattered throughout the tri-state region,” Motl says.

Motl says that the imaging staff are familiar faces in the departments that they work with, and are often asked to be the WWW.IMAGINGIGLOO.COM

problem solvers of first and last resort, and are key resources for planning activities. If no one else can figure it out, they often can, even if it is not related to imaging equipment per se.

“Dave Houge is a veteran of the imaging realm, and able to take on just about any piece of complex equipment, but when advice is needed about the straight truck hauling around the mobile mammo, he is the first call they make,” Motl says.

“It’s a long way from troubleshooting issues with the SPECT/CT, but really just as necessary. This group is very customer

focused, and the culture of the group does not subscribe to the notion that ‘it’s not my job.’ ” “Todd Frederick is our newest member of the group, recently promoted from the biomed team. He too shares this spirit, diving in on day two of his new job – scrounging local resources to find a power supply for a PC in a mini-C that another team member was working on. The customer was really needing this system back, and parts delivery would be the next day. He had ideas and resources from his previous position that led to a parts solution in less than a couple of hours. This type of teamwork and problem solving is par for the course, and as a result, they are often asked to help find solutions that our customers need, beyond equipment maintenance activities,” Motl adds.

Maintaining a good reputation as a leading health care provider in the Midwest is made easier when all the imaging equipment is ready to serve patients. The Gundersen Health System imaging team does its part to keep that reputation intact. ICE

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products

PRODUCT SPOTLIGHT Reports: Surgical Imaging Market Growing

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he global surgical imaging market is expected to meet new heights in the near future. Various market research reports predict continued growth fueled by a variety of factors, including new technology and an aging population.

“The global surgical imaging market is projected to reach $1.63 billion by 2022 from an estimated value of $1.25 billion in 2017,

“Global surgical imaging market is expected to witness an exponential growth over the coming seven years, owing to increasing geriatric population base globally coupled with adoption of imaging devices by hospitals especially in developed economies.”

- Grand View Research at a compound annual growth rate of 5.5 percent,” according to MarketsandMarkets.

“The key factors driving the growth of this market are growing popularity of Flat Panel Detector C-arms (FPD C-arms) owing to advantages of FPDs over image intensifiers, reimbursement cuts on analog radiWWW.IMAGINGIGLOO.COM

ography systems, and increasing demand for minimally invasive procedures. The growing demand for data integrated imaging systems and high growth in emerging markets like Asia Pacific is an opportunity for the market to grow. However, the high cost of these instruments is restraining the growth of the global market.”

“North America is expected to account for the largest share of the surgical imaging market in 2017, followed by Europe, Asia Pacific (APAC), and the Rest of the World,” MarketsandMarkets added. “The large share of this region can be attributed to a rising number of overuse sports injuries, and rising prevalence of CVD, along with the increasing number of cardiac arrest cases, and increase in the number of minimally invasive procedures performed in Canada. However, Asia Pacific is expected to register the highest compound annual growth rate of 7.1 percent during the forecast period, owing to the rapid growth in geriatric population in Japan, health care reforms in China, improving health care infrastructure in India, and rising number of orthopedic and CVD procedures in Australia.”

Grand View Research also predicts a bright future for the surgical imaging market.

“Global surgical imaging market is expected to witness an exponential growth over the coming seven years, owing to increasing geriatric population base globally coupled with adoption of imaging devices by hospitals especially

in developed economies,” according to Grand View Research.

The report from Grand View Research also said that surgical imaging equipment is instrumental in providing greater accuracy and efficiency while performing surgeries.

The report also pointed out that an increase in funding via public and private sectors pertaining to research and development of surgical imaging equipment should boost growth of this market.

“The overall global surgical imaging market is broadly classified on the basis of product and application. On the basis of products, it is divided into two types such as mobile C-arms and mini C-arms. Mobile C-arm is expected to gain popularity in near future owing to its increasing usage in cardiovascular, orthopedic and trauma, neurosurgery, and gastroenterology surgeries and its ability to provide higher resolution and manipulation free clear images,” Grand View Research adds.

“As of 2014, North America held the largest market share in surgical imaging market due to increasing sports injuries in the U.S., advanced health care infrastructure supporting adoption of surgical imaging devices, and supportive government policies pertaining to reimbursement and purchase of the same,” according to Grand View Research. “The European market is also expected to grow at a stable rate due to increasing geriatric population base and preference for minimally invasive surgical procedures.” ICE ICEMAGAZINE

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products

Canon Medical Systems USA Inc. Infinix-i Sky + Offering clinicians flexibility to perform a wide array of procedures in the interventional radiology lab, Canon Medical Systems USA Inc. offers the Infinix-i Sky + system. The ceiling mounted system* features a double sliding C-arm that can be positioned in more ways to help clinicians increase coverage, speed and patient access. The Infinix-i Sky + can deliver 3D imaging anywhere for highquality exams with 210 degrees of anatomical coverage on both sides of the patient and a high-speed 3D rotation of 80 degrees per second. The system also includes an extensive set of automated and user-selectable dose management tools designed to help minimize X-ray exposure to patients and clinicians. • *The Infinix-i Sky + is the INFX-8000C (930A C-arm)

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ADVANCING THE IMAGING PROFESSIONAL

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Carestream DRX-Revolution Mobile X-ray System Carestream’s DRX-Revolution Mobile X-ray System is an ideal choice for mobile imaging in surgical suites. This system’s powerful 32 kilowatt generator produces rapid, high-quality images and its optional tube and line visualization software instantly verifies placement of tubes and peripherally inserted central catheter lines. Consistent, precise images can help reduce retakes and support fast and accurate imaging of surgical patients. Carestream offers comprehensive training classes in which imaging service professionals sit side-by-side with our service engineers as they learn to maximize the performance and life of DRX systems. •

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products

GE Healthcare OEC Elite CFD The OEC Elite CFD is the first premium mobile C-arm offering both a 31 cm and 21cm CMOS flat panel detector, which is designed to produce high image quality at a low dose. It produces crisp and clean images, enabling better imaging confidence by allowing surgeons to see greater differentiation between a patient’s anatomy, such as bone, organs and skin and exceptional vessel detail in even the toughest vascular procedures. The streamlined design of the C-arm is intended to provide the surgeon with more control and maneuverability in the OR with an easy-to-use workstation, an intuitive user interface and an entirely new ergonomically designed C-arm called Ergo C. The new OEC Elite CFD premium C-arm portfolio provides high-quality images during a variety of surgical procedures, including vascular, spinal, orthopedic, urological, general surgery and pain management. •

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ICEMAGAZINE | MAY 2018

ADVANCING THE IMAGING PROFESSIONAL

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Siemens Healthineers ARTIS pheno The ARTIS pheno robotic C-arm angiography system from Siemens Healthineers provides versatility in movement and has a wide C-arm design, which facilitates 360-degree patient access. The system’s expanded weight capacity and heightened flexibility in patient positioning allow clinicians to broaden their spectrum of patient cases and interventional procedures. With tools dedicated to improving 2D/3D visualization and streamlining workflow, the system supports minimally invasive patient procedures. The absence of ceiling components enables uninterrupted sterile airflow, and sealed, antimicrobial surfaces help maintain infection control and simplify system cleaning. •

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ICEMAGAZINE

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FDA DEADLINE

By Matt Skoufalos

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ICEMAGAZINE | MAY 2018

SERVICE REGULATION REPORT DUE SOON

ADVANCING THE IMAGING PROFESSIONAL

In Congressional testimony before the House Committee of Energy and Commerce last May, Joseph Robinson, senior vice president of health systems solutions at Philips Healthcare and vicechair of the board of directors at the Medical Imaging & Technology Alliance (MITA), stumped for a new law that would hold independent service organizations (ISOs) to the same FDA standards for medical device repair as original equipment manufacturers (OEMs).

The bill in question is “HR-2118: The Medical Device Servicing Safety and Accountability Act,” which Robinson testified “takes an important first step toward the accomplishment of this [patient safety] goal by requiring that all ISOs step out of the dark and register with the FDA, file adverse event reports, and maintain a complaint handling system.”

“Service activities performed by an independent, third-party service organization do not have the same oversight or quality, safety and regulatory requirements [as those performed by an OEM],” Robinson said. “Third parties are not even required to register with the FDA … creating an enormous blind spot.”

“These are minimum requirements which would give the agency information on how many businesses are engaging in servicing medical equipment and, we hope, will help get a better handle on adverse events to ensure that they never happen again,” he said.

Robinson went on to allege that, “unfortunately, unregulated third parties have caused a number of patient safety issues in their attempts to repair medical devices,” a familiar

WWW.IMAGINGIGLOO.COM

refrain among OEMs lobbying for the passage of the bill.

In follow-up testimony, Robert Kerwin, general counsel for the International Association of Medical Equipment Resellers and Servicers (IAMERS), told the body that HR-2118 “is a solution for which there has been no evidence of a problem.”

“If this was such a significant problem, why have we not heard the hospitals clamoring for this?” Kerwin said.

Kerwin continued by noting that OEMs and ISOs already collaborate on multivendor service agreements, that ISOs comprise many professionals who built their careers at OEMs, and that there’s a difference in scale when some of the largest companies in the world are asked to absorb policy changes that the smallest cannot.

“With the extra paperwork comes significant cost to be shouldered,” Kerwin said. “The complaint management system, the staffing, the training, the assessment costs, the outside auditors … This section basically requires every repair that’s done to be catalogued, documented and processed. In an era of smart regulation, this

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FDA DEADLINE

SERVICE REGULATION REPORT DUE SOON

seems to be at odds.”

It’s a conflict that has emerged in an ever-consolidating health care industry, where hospital margins are razor-thin and the largest players in the business drive closer to vertical integration through channel partnerships, mergers and acquisitions, and recapturing business in secondary markets. But if there’s a patient safety problem, and not a regulatory policy one, it isn’t playing out like that in the marketplace. And as outlined in the FDA Reauthorization Act of 2017 a Congressionally mandated report will be posted on the FDA website in May 2018 regarding the continued quality, safety, and effectiveness of devices with respect to servicing. (See more at 1technation.com/fda-2017update.)

One of the only people to analyze the FDA data on instances of device safety is Mark Bruley, vice-president emeritus of accident and forensic investigation for the ECRI Institute.

to servicing or manufacturing concerns, Bruley said. In 2016, the group updated its search of the database – which in the time since had climbed to 4 million reports, some 2.4 million of which involve the servicing of capital equipment – and found that the adverse event rate had fallen by two orders of magnitude, to 0.005 percent.

“If there’s any inkling in that report that the accident was due to ineffective repair, calibration, or servicing, don’t you think the manufacturer would jump right on there and comment to that effect?” Bruley said. “I think there’s every incentive for a manufacturer to comment on whether a servicing problem was the cause of an adverse event. I said, ‘Do your analysis. Let’s see your data.’ Here we are 18 months later, and I’ve seen nothing.”

“No one has done any evidencebased analysis of whether there are any problems or not except me and my colleagues,” Bruley said. “The only

“ Manufacturers who wish to make more money doing their own service are pushing it as a cause celebre absent any evidence that it’s an issue.” – Bruley

About 20 years ago, Bruley led a team from ECRI that reviewed the FDA MAUDE (Manufacturer and User Facility Device Experience) database, which hosts medical device reports submitted to the agency by mandatory reporters (manufacturers, importers and device user facilities) and voluntary reporters (health care professionals, patients and consumers).

In 1996, they found that 0.2 percent, or some 240 adverse events out of about 900,000 clinical equipment reports, could have been attributable

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thing anyone else gave were anecdotes.

Anecdotes are not data. Sometimes the legislation is based not on data, but anecdotes.”

Bruley said that ECRI published its data in June 2016 comments to the FDA along with its search methodologies; the group concluded that there wasn’t any statistically significant correlation among adverse effects and improper servicing.

“Manufacturers who wish to make more money doing their own service are pushing it as a cause celebre absent

any evidence that it’s an issue,” Bruley said. “I challenged anyone when I gave testimony in October 2016 – where is your evidence that there is a problem?

There are anecdotes. Where is your data from a cogent analysis? They never challenged my data. To date, no one has done the research.”

To Jim Spearman, president of Consensys Imaging, understanding the problem of regulation means recognizing the factionalism that drives most of the arguments.

“No one’s got a clear conscience and clean hands,” Spearman said. “All these different factions have an axe to grind and a cross to bear, and they say the data doesn’t show they have to be regulated. The point is we should all have this discussion.”

Spearman finds faulty the logic that FDA regulations on service and repair currently obligate medical device manufacturers to warranty their equipment until no longer in patient use. He believes that as medical devices are regulated equipment, their servicers – OEM, third-party or otherwise – must prove objectively that they are maintaining the equipment to a standard.

“What are you doing to ensure that they are being maintained to their regulatory compliant status?” Spearman said.

“You should have no problem with any independent body coming in and checking them. All OEMs are mandated by the FDA to keep those records. If a third-party provider is servicing a piece of equipment, they are largely unaccountable to the FDA until an adverse event happens.”

“We come back to this fundamental question of why are we skirting the regulations?” Spearman said. “Doctors are regulated and so are airline pilots.”

Spearman also objected to the argument that regulatory processes need necessarily be financially onerous and complicated in order to be effective.

Consensys has held to the ISO 13485 standard since 2010, with annual audits and a three-year recertification process.

The 2016 version of the same standard

ADVANCING THE IMAGING PROFESSIONAL

includes mandatory regulatory reporting; thanks to it, “We have objective evidence that we’re regulatory-compliant,” Spearman said.

But even in instances where third-party servicers would be motivated to report their findings to the agency, sometimes it’s not in their best interests to do so, he noted.

“We took over a site in Texas, and there were 30 to 40 ultrasound transvaginal probes that had been illegally modified by a previous servicer,” Spearman said. “We locked them down and said they were not fit for service. I asked, ‘Do I have to notify the OEM, and do I have to notify the FDA?’” Perhaps counter-intuitively, the answer from Spearman’s legal counsel was to not voluntarily report, so as to avoid potential liability for a problem his business did not create. He was instead advised to allow his attorneys to report it to the agencies involved to maintain his privilege of anonymity. If even such relatively benign events are at all commonplace, Spearman doesn’t hold out much hope for a regulatory solution that moves toward a higher standard of equipment and patient safety without encumbering one or more of the parties involved.

“The FDA knows this is the third rail on a subway, and they’re going to get zapped if they touch this thing,” he said. “It comes down to lobby money and funding. If you [aggravate] Congress, what are your chances of getting funding?”

Spearman also noted the break in the logic of FDA only looking to enforce the standards of service and maintenance in limited instances.

“You’re going to look the other way when the warranty expires, until a patient gets injured, and then you’re going to lock the thing down when you investigate because it’s a regulated medical device?”

Spearman said. “You have regulations in law, but you are intentionally not looking to enforce them?”

More than likely, Spearman believes the FDA will pass on issuing any new WWW.IMAGINGIGLOO.COM

“ No one’s got a clear conscience and clean hands. All these different factions have an axe to grind and a cross to bear, and they say the data doesn’t show they have to be regulated. The point is we should all have this discussion.” – Spearman

enforcement of medical device repair and allow Congressional attitudes to shape the future of the law. He thinks that unless the agency sees an overwhelming amount of data that there is a legitimate health crisis related to the improper servicing of medical devices, it won’t move to regulate servicing any more than it has. Pressed to guess where the agency might lean, the 2016 ISO 13485 standard is a fitting benchmark (and one that an FDA spokesperson cited at the March 2018 International Conference on Medical Device Standards and Regulations), Spearman said. Absent any other regulatory moves, he believes the agency is likely to direct ISOs and OEMs to work together more closely for access to service manuals, training and preventive maintenance tools.

Yet Spearman noted, “we have more fundamental disconnects to this issue,” including the enforcement of existing statutes, which he pointed out is scattershot at best.

“I don’t know what to anticipate because half the stuff they say they’re going to do never happens,” agreed Sarah Lee, COO of Medical Imaging Technologies Inc. (MIT). “XR-29 was two years ago, and none of my customers are actually getting money taken away from reimbursement.

We just wait to see if it’s going to happen.”

The difficulty of distinction between enforcement and compliance isn’t something that only affects regulators; rather, there’s a pass-through effect that organizations operating in the health care space feel as they await word from on high that something is changing.

“I don’t think it’s a bad thing to have ISOs have to report problems,” Lee said, citing the existence of “one-man fly-bynights” that ISOs and OEMs alike criticize as unscrupulous and dangerous in comparison with the structured operations of more established companies.

“I think it’s the big companies against us,” Lee said. “They sit on the boards to make these rules; they’re out to help themselves.”

She said she would feel less threatened by the notion of additional regulation if there hadn’t been such longstanding efforts by larger manufacturers to discredit, in broad strokes, independent vendors and their operations.

“There are third parties that are good, and others that aren’t so good,” Lee said.

“At the same time, I’ve never heard of anybody getting injured patient-wise that wasn’t something a tech did. I’ve never heard of any system error or anybody in the service industry making something harmful happen.”

One antidote to instances of adverse events is training, said MIT owner Rick Player.

“We do a lot of it internally, but we send staff off to third-party schools like RSTI (Radiologic Services Training Institute) or parts providers, and sometimes the OEMs,” Player said. “All this equipment has to be inspected on a yearly basis, and if it’s not in compliance, once you get too big, they have to look at who’s doing the service.”

“As far as what’s coming out of Washington, we can’t control any of that,” he said. “There’s no teeth. It’s just irritating.

Ain’t a lot you can do.”

Player said smaller operators in the medical device field haven’t been afforded the same access to legislative remedies that larger businesses with lobbying agencies have. He marks it as a battle of “anti-business sentiment” and described “having been in business for 31 years of being hated by our government.”

“If you’re a small business in this country, it’s a fight,” Player said.

If you’re a big business in this country, it seems it’s still a fight, albeit one played out on Capitol Hill. ICE

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ICEMAGAZINE | MAY 2018

ADVANCING THE IMAGING PROFESSIONAL

insight

IMAGING MATTERS Preventive Maintenance

P

reventive Maintenance (PM) is an ingrained term. PMs have been around for so very long in our industry no one stops to consider them or how they are developed or what they really mean within the industry. The PM has to be done, so there is a schedule to ensure they are performed when they are required per the manufacturer. There is a procedure that the manufacturer has created that is followed and the work is recorded. This allows everyone a sense of security and it protects the hospital or imaging center in case of an audit by licensing, insurance or legal parties. But what is a PM really?

The PM is maintenance that is designed to prevent premature failure and ensure safety.

There is no argument that PMs have value.

From a purely legal point of view they provide a valid service in protecting from unwarranted litigation. The question is, “Are preventive maintenance procedures really designed to prevent premature failure and ensure safety?”

Preventing premature failure is questionable. There are a number of checks and tests on various machines made by all of the major manufacturers that seem to put more wear on the equipment without any measurable benefit of preventing an early failure. These typically come from one of two origins. A manufacturer builds a CT. They start their PM procedures with all of the basic tests that they have done on all of the CT models they have ever built. There is no consideration from the ground up if the new model needs a specific test. This may be that there simply isn’t enough performance data to result in a true indication of what the highest failure points on the system will be. This leads to the mindset of doing it the way it has always been WWW.IMAGINGIGLOO.COM

done being the safe way to go. The people that might have to review the procedure are used to seeing that test on a CT and will ask why it is not there. In a legal contest a lawyer may portray that test as an industry standard, or point out that it has existed on previous models and attempt to make points in a court room. Even if the test isn’t warranted, because of these reasons it may be required.

An example of such a test might be a balance test on a CT unit. If the balance is monitored real time on the unit as a constant, a balance test or a balance calibration being required is simply stress on the CT without any real benefit in performance or safety. Checking the logs and verifying proper balance can serve the same purpose. If the logs report a need for calibration, then the stress of a calibration would be warranted.

Typically, the answer to the safety question is, “yes.” The safeguards, collision sensors and movement limit tests are part of preventive maintenance. However, this can get out of control. In the last 10 years a nuclear medicine camera had a head fall off and crush a patient.

Unfortunately, the patient did not survive.

What followed was controlled by politics and media spin instead of science and logic. The manufacturer handled it the only way they could. A massive recall and turning a semi-annual 6-8 hour PM into a semi-annual 12-16 hour PM. They now require that all of the bolts that support the detector heads be checked for proper torque.

The reality of the situation was that if proper monthly checks of the center of rotation had been done, there would have been a continual drift. This should have alerted the team that there was a problem in advance. The visual inspections that were to be done semi-an-

Written by John Garrett Director, Clinical Engineering at Baylor St. Luke’s Medical Center

nually would have produced the same results.

As a result of people that do not understand that there was an individual or group that did not ensure that proper PMs were completed, and that individual or group not being held responsible the manufacturer had to do something. The result is that the manufacturer had to incur a huge expense over the incident, including marketing damage to the brand, and a PM that does not increase safety and increases the cost to maintain the equipment What considerations should manufacturers make when creating PMs? If you have ideas of what should and should not be in the PMs, use the feedback mechanisms with the manufacturer. That will have limited impact, but it is still a good place to start. More importantly, become part of your local HTM association. Be active and participate and create a voice that can be heard by the industry. Remember, the laws that are being put into place are done so by elected officials that do not understand medical imaging or medical imaging service.

Currently, they rely on the manufacturer for information. To change that, people in the industry will have to participate in creating a group of professionals who can help lawmakers understand the realities of the industry. ICE John Garrett has 20 years experience in imaging service including general radiation, mammography, CT and nuclear medicine. He has worked for third-party service companies, manufacturers, sales companies and in-house imaging teams.

ICEMAGAZINE

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IMAGING SERVICE 101 Networking Among Peers Pays Off

E

ven before the use of Ethernet cables and PACS, all of us in the imaging world have needed to know about networking. In the past few columns I have explored the importance of reputation and communication with customers and fellow employees.

Networking with people is another type of communication that is important to your career, will help you in your daily job, expands your knowledge and horizons, and helps to build your personal brand. Communication outside of your regular network of customers and coworkers is important in life for personal and business reasons. Our social networks can provide information and support when we need it, and provide an opportunity for us to help and give back to others. Business networking also does those things, and is critical to maintaining or advancing our careers.

We’ve all heard the adage, “It’s not what you know, it’s who you know!” Many of us technical engineering types are a little put off by that, since it is somewhat important how much we know when it comes to repairing a scanner!

We understand that business networking is important to entrepreneurs who need to find and develop new customers. But “who you know” is also important and valuable in our job as imaging techs. Business networking can help us obtain information, build our reputation in the community by sharing information and further our careers through expanded opportunities.

And critically, networking is generally regarded as the single most important factor in finding a job. I have found that to be especially true in the imaging service business, which is a relatively small and tight-knit community. Many career advisors say you should do something every day to expand your business network, WWW.IMAGINGIGLOO.COM

so that you are ready when you need to find a job. For us, since we sometimes have long days that must be spent on our top priority (such as fixing a down scanner), “every day” probably translates to making sure we spend 30 minutes to an hour every week building our network.

The methods and opportunities for networking are numerous, and the best ways to do it depend on your objectives and the available resources. If you want to connect with people and companies (and see the latest scanners on the convention floor), the RSNA annual meeting held every November is a huge gathering of companies and clinicians in radiology, with tens of thousands of people and over 600 exhibitors.

You are reading a column in ICE magazine, and ICE has archives of “Webinar Wednesday” seminars, searchable issues of past articles, and a job board at imagingigloo.com. The ICE conferences such as the one in Tampa in February 2019 provide opportunities for education and interaction with others in the industry.

Social media such as LinkedIn and Facebook can be useful for business development and career enhancement, and MedWrench and DOTmed are great tools for the exchange of information. LinkedIn has Groups that are aimed at specific interests, such as the American College of Clinical Engineering, the AAMI community, Diagnostic Imaging and the Medical Imaging Network.

The American Association for Medical Instrumentation (AAMI) is an organization that supports the safe use of technology in health care and all professionals working in healthcare technology. They have established a certification for radiology equipment specialists (CRES), and their annual conference and expo

Written by Jim Carr Director of Services and International Operations for AUE

is attended by around 3,000 folks. Members get access to an online job board and regular publications that include research papers and industry news. AAMI has technical committees working on industry standards that are comprised of volunteers, a great networking opportunity.

Other industry organizations and associations that you might consider include the IEEE Engineering in Medicine and Biology Society (EMBS) and the association for medical imaging management, AHRA. Each has publications and meetings that can improve your knowledge as well as your career.

There are many regional healthcare technology management (HTM) organizations around the USA and Canada that provide business networking and help support the technical people in our industry. Most have regular meetings and some have annual symposiums with educational and networking opportunities. You can find a list of HTM associations in the USA with hyperlinks to the association websites on the AAMI website, www.aami.org.

Over the next couple of weeks, when you are dedicating time to developing your network, think about what networking you do now and if it is meeting your needs. Do more investigation into one or two new networking opportunities. Try some that can help you learn from others, open your horizons, support other imaging professionals and the medical community as well as advance your career. ICE

ICEMAGAZINE

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ADVANCING THE IMAGING PROFESSIONAL

insight

CAREER ADVICE Successful Time Management

I

n today’s fast-paced health care environment, it is easy to feel overwhelmed and stressed by the significant tasks needed to be accomplished on a daily basis. It is easy to lose sight of what is important to achieve in a day. Goals, organizational skills and effective time management can improve productivity and ensure career success.

Since we only have 24 hours in a day, we need to plan our day and life accordingly.

Managing our time helps to ensure we make conscious choices to allow us to spend more time doing the most important things. Time management allows us to plan and organize a schedule which results in increased productivity and effectiveness. The key to managing time successfully begins with setting realistic goals, then organizing yourself and your schedule to ensure you can achieve those goals. Clutter and disorganization create stress in our lives, and sometimes we spend too much time looking for important information in the chaos. You will accomplish more in a day by utilizing a planning system to assist with maintaining your calendar, whether it is a Day-Timer, MS Outlook or technology (phone, iPad, etc.). Along with managing your daily schedule, it is important to maintain a to-do list. Again, choose a system that works for you – electronic or paper. Your to-do list should support your overall goals and successful completion of duties to meet your specific goals. Begin by listing everything you need to accomplish, then prioritize tasks by importance and urgency.

Be sure your to-do list and schedule are realistic and achievable in the time frame allotted for each task. Regularly review your list and revise it to meet the specific demands and requirements for that day or week. Priorities change so you need to allow time at the end of the day to plan and prioritize your schedWWW.IMAGINGIGLOO.COM

ule and to-do list. It is wise to review your list each morning to allow for revisions as needed.

At the end of the week, review what you have accomplished. Then, set your schedule and priorities for the following week. Continual review of your schedule and to-do list will ensure you stay on top of priorities and move less important activities to allow time for achieving the more important tasks.

Block out time to work on important projects when you know you are freshest. Save the less important tasks for periods that do not require a lot of concentration. For large projects, schedule timeframes into manageable segments and allow breaks to maximize your concentration period.

Electronic messages can be important to what we need to do in a day, but they can also be a hinderance in what we accomplish. It is important to manage your time spent on reading email and text messages. Decide what is important, and don’t waste time on personal or frivolous messages. Recognize what is critical to your job and take care of it immediately.

Set aside two or three times a day to read email so that you are not continually interrupted. You can quickly respond to important messages, but delay responses to personal messages until non-work hours. Reading emails on a phone or other portable devices can also be a challenge if they are long or include attachments that require further attention. Delay reading those messages until you have access to a computer.

Do not waste time at work on non-productive activities. Make a list of your time “bandits” – those people and interruptions that drain your energy and time – and do something about them. Personal interruptions can drain your time, focus and energy. If you find yourself taking personal calls and texts from family and friends during the work day, make an effort to

Written by Cindy Stephens Stephens International Recruiting, Inc.

ignore them until your lunch breaks or after work hours. Co-workers can become time bandits as well, conversing about their personal issues or complaining about irrelevant issues that decrease productivity. Although management should take care of repeated time wasters, it is important that you ignore them and continue to work diligently on the important tasks at hand. It may not be easy, but avoid involvement in these types of distractions.

Today’s technology allows non-work-related distractions for many employees who use work hours for personal online shopping, games, social media, etc. Do not fall into this trap and avoid it at all costs. Using work time and resources to access the Internet for personal purposes interferes with the overall productivity and effectiveness of the employees and many people have been fired over it.

It is important to balance your personal life and work. Taking time for family, friends and outside interests helps us to maintain our sanity and a well-balanced lifestyle. However, a healthy life includes some downtime and that includes turning off electronic devices to ensure you are relaxing, not allowing electronic interruption of your personal time off.

Remain committed to your goals, your time management schedule and your prioritized todo list. Continually tweak your plan as needed.

You can accomplish more in less time by appropriately managing your time. Be sure to implement a time management plan that will ensure high productivity and still maintain a healthy quality of life. ICE ICEMAGAZINE

39

insight

CULTURE CHANGE REQUIRES A PLAN – AND MORE P

erhaps you’ve seen something like the following: A group of employees attend an inspirational workshop and they’re motivated to make improvements in their team’s operations.

But several weeks later, their motivation has dissipated, and they fall back into the status quo.

This dilemma also happens in the C-suite. A CEO reads a book that inspires him to make changes in his organization.

He’s excited, so he gets his entire leadership team to read the book. But six months later, nothing has changed.

The problem in these two scenarios is not that people don’t want the improvements. The problem is they fail to follow through. To address these all-too-common scenarios, we need to consider several basic root causes.

• Lack of a plan • Lack of a cheerleader Let’s start with planning. According to the Wharton School at the University of Pennsylvania, culture change needs a structure and a process that’s thought out. In other words, specific action items need to be identified. According to the Wharton School, culture change is more likely to occur when organizations look at changing things that affect the culture instead of focusing on the culture itself.

Larry Hrebiniak, author of “Making Strategy Work: Leading Effective Execution and Change” and an Emeritus Professor at the Wharton School’s Department of Management, is quoted as saying, “Appealing to managers to change behaviors, thinking, values, and 40

ICEMAGAZINE | MAY 2018

beliefs rarely works.” As a certified behavior analyst and certified values analyst, I heartily agree. People’s behavioral styles are hardwired from birth, and although people can adapt away from their core styles, it can’t happen too much or too often because of the stress involved.

And getting people to change their values is like pushing pudding uphill by blowing through a straw. Our values are established in our earliest years, and they change only in the face of significant emotional events.

Therefore, the best way to engage a culture change is to make small, incremental changes on things that affect culture, and to do so using a clarified process. This means setting goals, and being consistent in tracking them.

The opening paragraph’s examples of the excited employees and the inspired CEO serve merely as catalysts. They’re the spark. If you want to get a fire going, you need the spark, but the spark has to be fanned into a flame. The sparks in the opening examples burned out because people didn’t know how to fan the flame.

What follows is an outline of the steps needed.

Part I of a good culture change plan involves: • Identifying “what is” • Identifying “where we want to be” • Gaining leadership’s commitment to make it happen The first two steps usual revolve around results and performance issues.

Questions might include, “What results are we getting now?” And, “What differ-

Written by Daniel Bobinski Workplace Consultant

ent results do we want in the future?”

A second set of questions need to be, “What behaviors are getting our current results?” And, “What different behaviors will get us the results that we want?”

None of these answers can be glossed over lightly – nor quickly. The more time spent considering the various angles surrounding these questions, the clearer your answers will be. This is important, because your answers to these questions set the stage for everything else that follows.

Once you have answers for the first set of questions, you’re ready to move to Part II: • Identify what will get measured • Identify which actions will build buy-in and momentum • Identify realistic timelines for when you’d like to see certain things • Identify a popular cheerleader to keep the project moving forward ADVANCING THE IMAGING PROFESSIONAL

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Therefore, the best way to engage a culture change is to make small, incremental changes on things that affect culture, and to do so using a clarified process.

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TRIM 4.5”

Please note that the “cheerleader” is the key to the plan’s success.

Whoever gets chosen must have strong emotional intelligence and have a deep commitment to building teams and generating enthusiasm in others. Another skill your cheerleader must have is the ability to delegate.

The “by when” aspect associated with goal setting helps the organization move forward on the projected path and in keeping with the desired timelines.

GE • TOSHIBA Remember I said that people’s behavioral style and their individual SIEMENS • PHILIPS values are established from early in life, and not something you want to change? The key here, as I explain in my book “Creating Passion-Driven Give us a call at 213-276-8209 Teams,” is connecting people’s individual preferences with the desired vi(844-PMIM-MRI) sion of the organization. A person who can help employees see how their or visit www.pmimagingmgmt.com natural styles and preferences can connect to an organization’s bigger picture is a person who can bring out the passion to succeed. This is part of the skillset needed by your cheerleader.

In contrast, a person who drives others through intimidation or browbeating may get results in the short term, but only the short term. Those results will not last.

Part III of your culture change plan is implementation. It might take Call KEI Med PARTS! on different appearances in different organizations, but the basic plan is: AD SIZE PUBLICATION • Put the action items you identified in Part II on the calendar 1/6 Page Vertical MEDICAL DEALER TECHNATION Parts areORTODAY housed, tested, and shipped from KEI’s facility • Paint the desired big picture in broad strokes and talk about it often GUIDE • Have at least one person ensure the calendaredBUYERS action items stay OTHER NOTES Med on the agenda MONTH One way the CEO in our opening paragraph could have implemented the changes he wanted could have started with a “book club” meeting, where J emerged F M at that A M J A S O N D his team discussed the book. As thoughts and ideas meet-J ing, he could have asked two people on his team to take ownership DESIGNER: JL of making things happen. They would need to desire the changes too, plus have ical Techn ort the skills to oversee the project.

Supp ed Provid These C-suite leaders may identify another cheerleader who works on ironing out the details in Parts I and II, but they will serve as the leadership We have system parts and upgrades for: catalysts. They will help create the word picture that they talk about reguAchieva, Intera, NT, Panorama 0.6T, larly throughout the organization, and they will make sure that the action Symphony, Sonata, Harmony, Infinion, Eclipse, items in this plan stay on the calendar.

Polaris, MX8000 and all Brilliance CTs Bottom line, if you’re trying to make improvements on the status quo, a KEIMed PARTS specializes in plan like this can get you the changes you want. ICE

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42

ICEMAGAZINE | MAY 2018

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