ACCE News
Newsletter of the American College of Clinical Engineering
President ’ s Message
It was both my privilege and pleasure to present recognition awards to our Clinical Engineering colleagues at the 34th Annual Members reception at AAMI eXchange24 in Phoenix in June. It was truly a great experience to meet and connect with all of the award winners and our members who attended this ACCE sponsored event.
Most of our Board of Directors are returning for the second term of their mandate now that voting is complete. (see election results on page 17) I want to personally thank the members of the ACCE Board of Directors and all of the Committees for their continued dedicated service to the College and to the entire Clinical Engineering profession. This dedication makes a difference in the success of the College and ultimately of our profession.
As we look forward to the start of our new operating year, the leadership and committees of the ACCE are hard at work. Some of the work on our ‘to do’ list includes: planning upcoming educational programs and conference symposiums, advocating for our profession, preparing for our upcoming Body of Knowledge survey, and updating parts of our Advocacy Awards program. Work also continues to improve organizational effectiveness and transparency between the ACCE, HTCC, and the two Boards of Examiners through the work of the CCE Audit Task Force. Steady progress is being made under the strong leadership of task force chair Katherine Navarro.
As you may have noticed, work is continuing on our website redesign project which is planned to be completed by the end of fall. Our project team of Michele Manzoli, Bhaskar Iduri, and Suly Chi have been leading the revision work of our contracted web designer. Special thanks to this team of volunteers for their extra effort on this important project. I am sure everyone will be pleased with the final product later this year!
Finally, I want to mention that next year is the 35th anniversary of the ACCE. The Board of Directors will be looking for ways to celebrate this important milestone in June 2025. If you have any suggestions on how we might recognize this special anniversary, please reach out to any one of the members of our Board of Directors. Summer is now upon us, and I hope everyone can set some time aside and enjoy the weather with your loved ones. Have a great summer and take the time to recharge before we start into the busy months in the fall.
Kim
CCE Prep: Sample questions
In this column we are providing sample questions and information regarding preparation for the CCE exam. The sample questions are based on topics from the ACCE Body of Knowledge survey and the CCE Study Guide, version 12. Note that the instructors for the ACCE CCE Prep courses, and the writers of this column, do NOT have any affiliation with the CCE Board of Examiners and have no access to the actual exam questions. If you have specific topics you would like us to cover, please contact the ACCE Body of Knowledge (BoK) Committee chair at jennie_nichols@yahoo.com.
Section 5.1.C-Project Management
1. Which of the following is not an element of a Project Management Plan?
A. Work Breakdown Structure
B. Project Monitoring
C. Resource Plan
D. Risk Analysis
The correct answer is ‘B’. Project Monitoring is a major function of Project Management and not one of the elements of a Project Management Plan.
Section 5.1.J Device Integration Planning
Interfacing medical devices to Electronic Medical Records (EMR), and Clinical Decision Support (CDS) systems has become an integral component of the Clinical Engineer’s responsibilities.
2. Which of the following elements would not be a consideration for integrating a medical device to an Electronic Medical Record (EMR)?
A. The format of the data being exchanged, (i.e., FHIR or HL7 2.X).
B. The connection between the medical device and the network that transmits the data to the EMR system.
C. The latency of the data transfers.
D. The leakage current of the medical device.
The correct answer is ‘D’ as the leakage current, while an important component of a device’s electrical safety is not a
ACCE News
ACCE News is the official newsletter of the American College of Clinical Engineering (ACCE).
Managing Editor
Ted Cohen tedcohen@pacbell.net
Co-Editor
Sonja Markez editor@accenet.org
Circulation & Address Corrections
Suly Chi, ACCE Secretariat secretariat@accenet.org
consideration for device integration. All of the other answers are important factors that need to be taken into consideration.
Section 5.1.O Return on Investment (ROI) Analysis
3. What is the formula for Return on Investment (ROI)=?
A. ROI = (Gain from Investment –Cost of Investment) / Cost of Investment
B. ROI=(Cost of Investment-Gain from Investment)/Cost of Investment
C. ROI=(Cost of Investment + Gain from Investment)/Cost of Investment
D. ROI= (Gain from Investment + Cost of Investment) / Cost of Investment
The correct answer is ‘A’ ROI= Gain from the Investment minus the Cost of the Investment divided by the Cost of the Investment.
Chris Riha cdriha@crihaconsulting.com
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ACCE News is a benefit of ACCE membership; nonmembers may subscribe for $75 per year. To subscribe e-mail secretariat@accenet.org Copyright © 2024 by ACCE
ACCE at AAMI eXchange 2024
ACCE was very well represented at the recent AAMI Exchange 2024 in Phoenix with a board meeting (in-person for a change); a Symposium on “Navigating Homecare and Virtual/TeleHealth Technologies – Adapting to Shifting Patient Care and Tech Support Challenges at Home”; a booth at the exhibit hall; a members meeting/awards reception; and an educational session on “Going Through Mergers and Acquisitions”. (See photos on pages 3, 4, and 5).
For the Symposium, ACCE President Kim Greenwood introduced Ashley O’Mara, moderator for Part 1, where each panelist described his/her current experience and near-future plans at their organization. Priyanka Shah, ECRI, shared the trend towards home care – leading to Medical Devices used in the home. Then Praneetha Elugunti introduced Mayo Clinic’s Virtual Care Solutions Across the Continuum. After that, Michael Brilling shared the Dartmouth-Hitchcock’s Hope Grows at Home Program. Next, Nadia ElKaissi, shared the Veterans Health Administration’s Telehealth Technologies and Virtual Care program. Part 1 closed with Dr. Jamie Brennan from Masimo discussing “Masimo within the Continuum of Care” and their telehealth solution overview.
The symposium’s Part II was a panel discussion on Homecare-Virtual/TeleHealth Considerations moderated by Erin Sparnon, from ICA Inc. Erin posed questions directly to the panelists, and on behalf of the audience, to delve into key questions about homecare technologies, connectivity and cybersecurity considerations, and their impact on Clinical Engineers.
If you missed the CE Symposium, the presentation slides are available for download on the ACCE website. ACCE looks forward to continuing its coverage of Homecare/Virtual – TeleHealth Technologies through our upcoming educational webinars.
The Mergers and Acquisition session covered how it is crucial to the success of HDOs to align with the new organization’s principles to provide safe and effective access to medical technology.
ACCE thanks all its members who attended AAMI Exchange 24; the sessions organizers, speakers and participants; and Suly Chi, ACCE Secretariat, for all her hard work to organize the booth, the members meeting and award ceremony, and many of the other ACCE activities.
Bhaskar Iduri, Qusai Shikari.
ACCE at AAMI exchange 2024
Several ACCE Past Presidents attended the 34th Members meeting (L-R): Steve Grimes, Tom Bauld, Arif Subhan,
Hitchcock; Priyanka Shah, ECRI; Nadia ElKaissi, VA; and Erin Sparnon, ICA
Jenn Nichols, receiving the 2024 Tom O’Dea Advocacy Award from ACCE President Kim Greenwood
Carolyn Mahoney, receiving the 2024 ACCE Professional Achievement in Management/Managerial Excellence Award
ACCE Fellow Members at the 34th Members meeting & Reception. (L-R): Jennifer Jackson, Ted Cohen, Erin Sparnon, Steve Grimes, Tom Bauld, Arif Subhan, Frank Painter, Samantha Jacques, Matt Baretich, Izabella Gieras, Kim Greenwood, Hank Stankiewicz, Mark Brody, Larry Fennigkoh & Binseng Wang
Thomas Bauld, PhD, receiving the 2024 ACCE Lifetime Achievement Award from ACCE President Kim Greenwood
Antonio Carlos Moreno, receiving the 2024 International Undergraduate Student Paper award from Kim Greenwood
ACCE at AAMI eXchange 2024
Enjoying the last moments of the 34th ACCE party (L-R): Jennifer Jackson, Samantha Jacques, Kevin Kreitzman, Erin Sparnon, Michael Brilling, Justin Marquadt, Julia Salemo, and Elizabeth Sayles.
Old fashioned face-to-face networking at the ACCE members meeting and awards ceremony (L-R): Larry Fennigkoh, Tom Bauld, Gary Barkov, Steve Grimes, Mark Brody, Binseng Wang.
Samantha Jacques receives her ACCE Fellow certificate from Kim Greenwood, ACCE President.
Erin Sparnon receives her ACCE Fellow certificate from Kim Greenwood, ACCE President.
Women in Clinical Engineering: 3rd in a Series
In this issue, we highlight the journey of three female members from various ACCE Committees. These committee chairs lead their respective committees to support and promote the profession of Clinical Engineering.
Amy Klemm, MS, CCE: I work as a Clinical Engineering Area Director for TRIMEDX and have been in the CE/ HTM field for over 14 years.
Helen Cheong, MS, PMP, CCE: I am a Sr. Project Manager at Baxter, focusing on integration and process improvement. Prior to joining Baxter, I held positions as biomedical service supervisor at Firsthealth of the Carolinas, clinical engineer at Brigham and Women’s Hospital, and clinical integration analyst at Yale New Haven Health System. I have a Master of Science in Biomedical Engineering from University of Connecticut, and am a Certified Clinical Engineer and Project Management Professional.
Jennifer Nichols, MS, CCE, CHTM: I graduated from Cal Poly San Luis Obispo with a BS in Industrial Engineering and an MS in Engineering with a specialization in Integrated Technology Management. Upon graduation
from Cal Poly, I worked for UPS as an Industrial Engineer responsible for time studies, projects, volume projections, delivery efficiencies, and operations improvements; and later as an Industrial Engineering Transportation Manager responsible for planning and executing consolidation plans for outbound packages.
My career took an unexpected turn when a mentor called to ask if I was ready for a new challenge: applying my Industrial Engineering skills to Clinical Engineering. After shadowing a Clinical Engineering manager for a week, I decided to launch my new career.
Currently I work as the General Manager of Clinical Engineering for the West Operations, TRIMEDX. I lead a team responsible for clinical engineering operations, associate engagement, customer experience, and growth for over 30 hospital systems.
In addition to my primary role at TRIMEDX, I contribute in other ways including Executive Sponsor of the Women Empowered Associate Resource Group. I also serve as a mentor through the TRIMEDX MentorXchange program. Besides the formal mentoring
program at TRIMEDX, I also mentor up to four women engineering students a year through Cal Poly’s Women’s Engineering Mentorship Program.
How long have you been involved with ACCE?
Klemm: I joined ACCE in 2010, and started serving on the Membership Committee in 2016 and took over as the Membership Committee Chair in 2023.
Cheong: I joined ACCE in 2010, while a graduate student at UCONN’s Clinical Engineering Program. I joined the Advocacy Committee in 2017, and have served as Chair since 2022.
Nichols: When I first transitioned to Clinical Engineering in 2011, I was searching for ways to expand my field knowledge through education and certifications. That’s when I learned about ACCE and the CCE certification. Though new to the field, I set my sights on obtaining my CCE. In 2021, I received my CCE. In 2020, I joined the Body of Knowledge (BoK) committee, and in 2021, became the chair of BoK. My work on the committee includes teach-
(Continued
Helen Cheong, MS, CCE, PMP
Amy Klemm, MS, CCE
Women in Clinical Engineering
(Continued from page 7)
ing in the CCE Prep series for the written and oral exams, authoring multiple sections of the Body of Knowledge manual, co-presenting webinars on how the CCE process works, and on how to prepare for the written and oral exams. I also wrote a comprehensive report summarizing the results from the Clinical Engineering Knowledge survey. I was recently honored by ACCE as the 2024 recipient of the Thomas O’Dea Advocacy Award.
What do you think of being female in engineering?
Klemm: We are seeing a sizable increase of women studying and working in engineering professions. When I was at Vanderbilt University in their Biomedical Engineering (BME) program, the BME class was about 50% female. I work for an organization [TRIMEDX] that has several women in senior leadership roles including our C-Suite. I feel fortunate to be part of this influx of women in engineering roles and I feel grateful to be able to learn from such incredible female role models.
Cheong: When I was studying biomedical engineering in university, about 1/3 of the students were female. I understood that some engineering majors were male dominant, but it never occurred to me that biomedical engineering was one of them. However, when I started in a biomed department where I was the only female, and most of my undergraduate female classmates left this field, I saw the field was male dominant. I have seen growing number of females in the field which I take as solid progress.
Nichols: Being a female in engineering is rewarding; however, we have all had
challenging moments. Whether in college, as part of the 13% of women who graduated from Cal Poly in 2003, or in the ever-growing Clinical Engineering field, I have leaned on my determination and continuous education to succeed. As a female, there are instances where you must prove your value and gain the trust of your team or other leaders because of your career choice or career path as a female in engineering. I enjoy the challenge of creatively solving a different problem every day, collaborating to identify new solutions, improving operations or processes, and creating a path to excellence.
As women, we must bring our authentic selves to our roles and avoid trying to fill the shoes of someone we think we should be. Multiple studies show that having women in the decision-making team provides more diverse and successful solutions. We should all strive for the day when women practicing engineering reaches 50%.
Who was your greatest influence/ advocate for choosing clinical engineering?
Klemm: I was greatly influenced by my grandfather and uncle growing up. My grandfather was an engineer, and my uncle was an anesthesiologist. Both encouraged me to find a profession that challenged me. I found that studying Biomedical Engineering and becoming a Certified Clinical Engineer blended my aptitude for engineering and my passion for healthcare.
Cheong: My grandfather was a mechanical engineer; I think it runs in our blood that I like to know how a machine works. When I grew up, I
developed a desire to help patients, however facing life/ death situations remained a challenge for me. I thank my dad for choosing biomedical engineering for me, a combination of engineering and healthcare which is what I wanted. My influencer to remain in the field is the department supervisor of a hospital in Hangzhou, China where I had my first undergraduate internship. She had run the department well for a decade in a traditional male dominated industry and society.
Nichols: My parents were my biggest champions in guiding me into engineering as I entered college. Along the way, I have met and been inspired by so many. I feel lucky to have found a way to apply my Industrial Engineering degree in healthcare and enhance my knowledge of the industry by returning to school at the University of Vermont (thanks, Tobey Clark) to obtain a certificate and then my CHTM and CCE. My first biomed team at Glendale Memorial was a huge inspiration for me and that helped a lot in my future success.
What surprises you in clinical engineering?
Klemm: We are asked to take on a lot and come up with solutions for challenging issues and I am so proud of my team, and I am continually im-
(Continued on page 10)
AAMI Update: Medical Device Service Regulation Debate Continues
To Regulate or Not to Regulate Medical Device Servicing? eXchange Speakers Debate
Day three of the 2024 AAMI eXchange featured an open forum on whether medical device servicing should be subject to additional regulations. This debate comes hot on the heels of the “Final Guidance to Clarify ‘Remanufacturing’ of Devices that Need Maintenance or Repair,” issued by the U.S. FDA this past May, 2024.
While AAMI does not take a stance on hotly contested issues of policy, the association provides a neutral forum for conversations among members. The session featured Dr. Binseng Wang, Vice President of Program Management for Healthcare Technology Management at Sodexo and G. Wayne Moore, founding partner at Acertara Acoustic Laboratories. Larry Hertzler, Chief Operating Officer at The InterMed Group, moderated the event.
Moore took the floor first, stating a preference for regulations that accommodate different employment situations. "My position is that third party servicers … should be regulated, actively regulated, by FDA." That said, he would prefer “that HTM professionals in hospitals have more autonomy as regards remanufacturing.”
Dr. Wang strongly disagreed, stating that given FDA’s statutory authority to regulate, “everyone under the sun should be regulated equally.”
Hertzler then pressed on, presenting the pair with a number of questions:
If the Right to Repair legislation forces the OEMs to release service materials, would this require OEMs to reveal trade secrets and intellectual property (IP)?
According to Moore, “not necessarily.” State and federal right to repair legislation has stated that OEMs will not have to give up trade secrets or intellectual property. Right to repair legislation is likely to result in OEMs compartmentalizing service-related software and moving away from the integrated software approach. But if the right to repair were made retrospective, it could create vulnerabilities to cyberattacks.
Wang concurred, stating “the answer is definitely no.” Trade secrets will remain safe, and there are plenty of legal remedies to protect intellectual property, such as non-disclosure agreements (NDAs). Further, international manufacturers have not faced this issue and software compartmentalization is a valid option.
If the third parties are not regulated by the FDA, how can one be sure that they are not exceeding servicing limits and venturing into remanufacturing?
According to Wang, “if medical device servicers are punished for taking actions that are not clearly defined as remanufacturing, it is comparable to a local government issuing speeding tickets without posting speed limits. Also, the EU has explicit requirements for manufacturers to provide information, and America should do the same.”
But Moore thinks that existing guidance is sufficiently clear as to what HTM professionals are allowed to do. “I don’t believe in unintentional manufacturing.” HTM workers have a responsibility to look up available regulations and OEM specifications before they take certain actions. “Go look up the information or don’t do it.”
What are the pros and cons of registration with the FDA for all nonmanufacturers?
Per Moore, the fact that OEMs are required to be registered and third-party services are not, creates a “blind spot” for FDA of between 15-20 thousand non-registered entities. Registration requirements for third party services would create welcome clarity. Further, FDA registration would apply only to third party ISO and OEM servicers, rather than hospital-employed HTM workers. Notably, Moore did not see any major concerns that he would place in the ‘con’ category.
Wang, however, was concerned with how in-house hospital employees and federal employees are unregulated. Good patient care should be the north star, and Wang noted that OEMs were more cooperative during the pandemic as opposed to during its aftermath. Even minor delays from OEMs can accumulate and result in harm to patients. Wang also expressed skepticism that FDA intervention would be effective, noting that there are still challenges for medical device manufacturers that current regulatory intervention does not always solve.
Should servicing information from OEMs be available to anyone who wants it?
“The short answer is ‘no,’” said Wang. He elaborated, suggesting that the U.S. should follow the EU’s example, and have manufacturers release information to buyers or owners of equipment.
Moore kept his remarks even more brief. “I agree.”
(Continued on page 10)
AAMI Update: Service debate
(Continued from page 9)
In its final version of the remanufacturing guidance, the FDA stated that “Consistent with promoting and protecting the public health, FDA encourages OEMs, as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices.” Wouldn’t this statement preempt the need for a new regulation or right to repair law?
Moore noted that FDA encouragements are not legal requirements. If FDA established requirements this would create clarity, but the agency uses language such as “routine,” that is open to interpretation. He suggested that panel attendees check out an FDA training held on June 27th related to the issue.
Wang, however, reiterated his point about the speed limit. Without the right information, device servicers cannot know the right course of ac-
tion. Wang would prefer equal treatment for hospital employees and third-party services alike. After all, they are “under the same pressure” and a distinction based on which entity disburses paychecks is “really absurd.”
What’s your take on the optimal way to move the right to repair issue forward to a “final” conclusion?
In addition to his previous point about the need for clear guidance and the equal application of existing remanufacturing rules, Wang noted that a 2018 FDA report on medical device servicing did not indicate that additional regulations for medical device servicing were needed. The report found no major public health concerns. Further, while Wang is in favor of equal enforcement of existing rules across the board, he believes that FDA does not have the resources to equally enforce new inspection regulations. In Wang’s words, these new regulations would
amount to “solving a cockroach problem with a nuclear missile." Instead, memoranda of understanding among OEMs and servicers are the best possible outcome.
Moore concurred that he would rather have third party services and manufacturers solve this issue among themselves. But he believes that having third party services registered with FDA would give the agency vital information. While FDA did not find evidence of a public health risk, “the absence of evidence isn’t the evidence of its absence.”
Remanufacturing and the future
The debate over this key issue is far from over, and longtime AAMI members will recognize the arguments and personalities on both sides. As this issue further evolves AAMI will periodically publish updates on future developments.
Daniel Visnovsky AAMI dvisnovsky@aami.org
Women in Clinical Engineering continued
(Continued
pressed by their creativity, ingenuity, and ability to effectively problem solve.
Cheong: Soft skills are as important as engineering knowledge.
Nichols: I have been surprised and excited by the constant innovation in the field to find better solutions for hospitals.
What would you tell other women when considering engineering?
Klemm: I would tell them that engi-
neering is about creativity, problemsolving, and making a difference in the world. That their perspective and contributions as a woman in this field are invaluable. And I would encourage them to pursue their goals with determination and passion.
Cheong: If you want to be an engineer, do not let naysayers discourage you. Even if one does not stay in a traditional engineering field, the path is wide open and options are endless. The foundation built from an engineering course will prepare one for the modern digital world.
Nichols: Engineering provides many opportunities for collaboration, creating new solutions, and unlimited career paths. The foundational learnings from engineering, such as critical thinking, problem-solving, and adaptability, are transferrable to many industries. Engineering is challenging; however, more women are needed in the field to bring more comprehensive discussions and solutions. Be confident in yourself and your abilities! The hard work will be rewarding!
Helen Cheong helen_cheong@baxter.com
From the Managing Editor’s Desk: A Personal Commentary on Home Health Technology
Each time I have “retired” from Clinical Engineering (CE) I have soon gone back to work in CE, albeit at a slower pace and with a modified perspective. I mention this to highlight how I viewed my trip to the AAMI conference and ACCE Symposium in Phoenix last month. My latest perspective includes sadness, as well as hope that I can use my experiences over the recent past to further advance the CE profession that has given me such great satisfaction over my 50+ year engineering career.
The sadness is because on December 31, 2023 my wife of 44 years, Diane, died from complications of Parkinson’s Disease. My comments here on the need to improve home healthcare technology support are based on my role as the primary caregiver for Diane over the last 5 years and particularly her last 6 months. What does that have to do with CE and this year’s AAMI eXchange? One focus of the AAMI conference, including one of the keynote sessions and the ACCE Symposium, was technology and CE in the home health and hospital-at-home realm.
Diane wished to remain at home as long as possible. She fell seriously ill in July 2023 and required major abdominal surgery. As she got weaker and weaker, she was subsequently rehospitalized several times, eventually being placed in home hospice. Each time she came back home from being hospitalized, more and more equipment was needed to take care of her. As the panelists and presenters at AAMI mentioned, this increase in quantity and complexity of technology at home is becoming more prevalent as healthcare systems move more patients into the home care setting.
For Diane, from a technology standpoint, we started with the basics (e.g., sit-to-stand lift, specialty wheelchair, hospital bed) then had to move to more
equipment including pressure relief air mattresses, a “Hoyer” lift, specialized speech therapy equipment, oxygen concentrator, and more. Most of this equipment is similar to equipment at a skilled nursing facility and not the type of equipment that most hospital-based CE departments normally support. But it is the reality for many patients at home.
So, what is the point of this article? Diane received excellent care from all the various RNs, speech therapists, caregivers, and others who came to our home. However, we noticed a big disconnect between the support and funding for hospital-based technology and the home. A few examples from our experience: A speech therapist from hospital system “A” orders a very sophisticated speech assistance device. The device is shipped to our house and we start to use a few of its simpler features (e.g., I created a touch screen-based food selection menu). However, later when Diane could no longer use the touch feature, we tried the “gaze” feature but couldn’t get it calibrated to her gaze. The speech therapist that normally came to our house had no clue about the device. She was from a different healthcare company than the ordering speech therapist and had never seen this device or anything similar. I called the company rep.
A second example was inoperable bed rails on the hospital bed at home. The bed was provided by one DME and the air mattress by a different DME. It took at least 5 different on-site calls with the “tech” (more like a delivery truck driver) before they were able to complete the repair. Fortunately, Diane had me, a BME husband, who could at least temporarily resolve many of these technology problems. And these were relatively low-tech systems compared to some of the technology now being
placed in the home.
The purpose of this commentary is not to complain but to raise awareness that healthcare organizations, and their CE/HTM departments, will need to manage the technology, and/or the contracted providers of the technology, so it can be safe and effective at home. There is no doubt that being able to manage many more patients at home is best for the patient and, overall potentially much more cost effective. Based on our experience, much more needs to be done to get better technology support, training and improved communication with DME vendors, home health organizations, and equipment suppliers. As home technology gets more and more sophisticated these problems will greatly increase unless this improvement in the overall system takes place.
What is CE’s role in home health? For healthcare systems that are moving into more sophisticated technology at home, the CE’s role may include: Equipment repair and maintenance in the home; Providing training on the equipment to the patient, family, caregivers, or DME company staff and others involved in delivering equipment or providing patient care in the home; Home assessments: Is the home infrastructure ready for the equipment; and Incident follow-up.
There is a great need for much better communication amongst all the various groups involved to make this technology at home successful. All parties will need access to information (e.g., EHR data) so that there are fewer gaps and surprises. And I did not even get into the requirements for IT connectivity, electrical utility, including backup batteries, and other infrastructure requirements as this technology gets more sophisticated and widespread.
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From the Education Committee Desk
The Education Committee thanks our speakers and panelists from the 2023-2024 Educational Webinars for another very successful series. We had distinguished speakers from all over the country, representing manufacturers, hospital staff, clinical engineers, IT professionals, managers, directors, and administrators. We would like to thank all of them for taking time out of their busy schedules to share with us their knowledge, help us advance the Clinical Engineering profession, and support ACCE through the Webinar Series.
From all of us on the Education Committee – THANK YOU!
The 2023-2024 Educational Webinar series was delivered complimentary to all ACCE members with the support of the following sponsors:
From the Education Committee Desk
The 2024-2025 ACCE Education Webinar series will kick off on Thursday, September 12th with “Navigating Homecare Technologies”. This session will share the Mass General Brigham’s Healthcare at Home model – from concept to creation project.
The remainder of the 2024-2025 series is under development and will be published soon.
This education series is provided free of charge to members thanks to our generous sponsors. If you would like to support the 2024-2025 series, please contact secretariat@accenet.org .
Also, If you are interested in volunteering to be on the ACCE Education Committee, or its Symposium Task Force, please complete this volunteer form.
Juuso Leinonen & Mike Powers Education Committee co-chairs
Suly Chi Webinar coordinator Secretariat@accenet.org ACCE members Click here to register for this session (FREE for members)
CCE Prep Course Revamped
Based on feedback from previous attendees, the CCE study course format has been updated to a study group environment. The topics covered will remain the same. However, it will be a more collaborative environment. The attendees will be asked to watch the previously-recorded sessions and submit questions two weeks before the instructor leads the study group. The instructor will review all questions submitted and prepare material to discuss during the study groups. The instructors look forward to the new format and welcome all feedback for improvements. Join us for the CCE Study Course!
Welcome New ACCE Members
Welcome to our newest members, approved by the Membership Committee, and supported by the Board of Directors:
Kelvin Knight, CHTM, MHA Associate Director, Biomedical Engineering Children’s of Alabama AL/USA
Hilarion Amedzekoir, MSc Associate Recent graduate Job Candidate OH/USA
Gregory Foggleman, CCE Institutional Individual Senior Clinical Systems Engineer Department of Veterans Affairs FL/USA
Ammar Ali, MS Individual Clinical EngineerMedical Equipment Planner NYU Langone Healh NY/USA
Selina Lam In-Yan, MS Individual Assistant Biomedical Engineer Hospital Authority – Pamela Youde Nethersole Eastern Hospital Hong Kong SAR China
Jason Walewski Corporate/Associate Senior Site Manager TRIMEDX IN/USA
Jaspinder S. Ratth, MS Institutional/ Associate Clinical Engineer II Cedars Sinai CA/USA
Please join us in congratulating new 2024 ACCE Fellow Member: Jonathan A. Gaev, MS, CCE, FACCE
Amy Klemm, MS, CCE Membership Committee Chair Amy.s.klemm@gmail.com
HELP WANTED ACCE News Co-Editor
The ACCE News co-editor is responsible for editing three newsletters each year and performing several other tasks including the following:
• Notifying regular article contributors of the upcoming issue’s submission deadlines
• Editing submitted articles
• Editing photos and graphics
• Editing and formatting newsletter pages
• Writing headlines and subheadings
• Submitting draft Newsletter for further editing
• Completing final editing for submission for publishing
• Occasionally writing, or rewriting, an article
• Assisting the other editor(s), reviewing and editing articles, and responsible for compiling three Newsletter issues per year
• Currently, the software used for this process is Microsoft Publisher.
It takes approximately 10-20 hours per issue to complete the above-mentioned editor tasks. If interested, please contact editor@accenet.org.
ECRI Update: Harnessing AI for Better Health: Managing Risks to Maximize Benefits
Artificial Intelligence (AI) is revolutionizing healthcare. The potential to improve clinical outcomes, reduce costs, and minimize healthcare inequities is immense; but so too is the potential for preventable harm.
AI systems are only as good as the model generated from the data on which they are trained, and the working clinical environment in which they are implemented. Shortcomings in any area can lead to an inappropriate AI response that degrades patient care or worsens health inequities.
Download ECRI’s Artificial Intelligence (AI) Position Paper, which includes a seven-point plan for healthcare organizations striving to use AI safely and responsibly.
In addition to specific recommendations to mitigate risk, ECRI’s AI position paper answers some of the most pressing questions related to AI in healthcare:
• How is AI currently being used in healthcare?
• What are the risks and how can they be managed?
• What assurance should regulatory clearance provide?
• How can AI functionality be assessed?
• How can AI performance be monitored?
• How should healthcare organizations proceed?
ECRI Now
If you have not done so already, please check out the ECRI Now podcast series which provides unique insights on pressing healthcare issues. In each episode, ECRI’s subject matter experts share their experience in
relationship to the latest healthcare news.
Topics range from ethical issues in healthcare, patient safety, infection control, healthcare IT, and spend management across the continuum of care from health systems to non-acute care settings.
Keep in touch and let us know your thoughts on how ECRI can better help our clinical engineering community.
Ismael Cordero Senior Project Engineer Device Safety, ECRI icordero@ecri.org
Student Paper Winner
Maryam Sangargir is awarded the 2024 Student Paper Competition, Master Division, winner by ACCE President Kim Greenwood, at the CMBES annual conference in Toronto, Canada for her paper: Safety Verification Procedure in the Implementation of Alternative Equipment Maintenance at The Ottawa Hospital.
IFMBE — CED Update
The Role of Clinical Engineers in AI-Based Healthcare Technology Management
Incorporating artificial intelligence (AI) has catalyzed a transformative shift in the ever-evolving healthcare landscape. AI-driven innovations are revolutionizing medical diagnoses, treatments, and patient care. Clinical engineers are at the forefront of this transformation; their blend of technical expertise and in-depth healthcare domain knowledge makes them indispensable. Here, we will explore the crucial role of clinical engineers in utilizing AI to enhance healthcare technology management.
Clinical engineers function as a bridge between AI developers and healthcare providers. Their role involves facilitating the integration of AI algorithms into medical devices and hospital systems. Their technical proficiency ensures that AI algorithms align with clinical workflows and contribute to better patient outcomes and more efficient healthcare delivery. They are also responsible for ensuring the rigorous testing and validation of AI algorithms to guarantee their accuracy and safety within a clinical setting.
Clinical engineers collaborate with data scientists and clinicians to help validate AI models using real-world patient data. This validation process is essential in enhancing diagnostic precision and refining treatment recommendations. The profession of clinical engineering is responsible for continuously monitoring AI-based healthcare technologies to detect any anomalies or malfunctions.
Clinical engineers also develop preventive maintenance strategies, leveraging AI-based predictive analytics to minimize downtime and ensure uninterrupted patient care. This proactive approach to maintenance ensures that AI
systems remain reliable and effective.
With the increasing connectivity of AIpowered devices, clinical engineers lead efforts to safeguard patient data and ensure cybersecurity. They implement robust security protocols and collaborate closely with IT departments to protect against data breaches, unauthorized access, and potential vulnerabilities associated with AI technology.
Reporting the AI algorithms’ performance in medical devices is essential to appreciate the impact on patient outcomes and make adjustments if necessary. AI integration and expansion will depend on informed decisions made by policymakers and administrators based on data-driven insights.
Clinical engineers are a key factor in educating healthcare professionals on the proper use of AI-based technologies. They develop and facilitate training programs to ensure clinicians can effectively leverage AI tools to improve patient care, and their role in knowledge transfer is vital to successfully adopting AI in healthcare settings. Likewise, understanding the regulatory requirements and standards governing AI in healthcare is a challenge that clinical engineers can face. They ensure that AI-based technologies adhere to compliance standards such as HIPAA, FDA regulations, and ISO certifications. Compliance is a critical aspect of guaranteeing patient safety and data integrity.
The multifaceted role of clinical engineers in integrating and managing AIbased healthcare technologies cannot be overstated. Their expertise ensures that AI enhances patient care, improves diagnostic accuracy, and opti-
mizes clinical workflows. The impact of AI on the healthcare industry is becoming increasingly evident and continues to shape its future. Clinical engineers will remain at the forefront, driving innovation and ensuring that AIdriven advancements benefit healthcare providers and, most importantly, patients. Their pivotal role in AI technology management is integral to the ongoing transformation of healthcare delivery.
Fabiola
Martinez, MS, PhD Chair, IFMBE/CED boardchair@ced.ifmbe.org
Editor’s Desk
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In conclusion, moving more ill patients with their supportive technology to the home should help patients, and potentially reduce costs, and make more hospital beds available for the most-ill patients. However, it will also create many new support challenges as the technology gets more widespread and more sophisticated. CE/HTM departments will need to continue to evolve to meet this new demand.
Ted Cohen
Managing Editor, ACCE News tedcohen@pacbell.net
2024 ACCE Officer and Board Election
Thank you for participating in the 2024 ACCE Officer and Board Election and casting your important vote. The election for ACCE’s new Board for the year 2024 has been finalized and the Board has approved the results. The election ballot was emailed to 300 eligible members, including Individual, Fellow, and Emeritus members in good standing. Institutional/Corporate Fellow and Individual members are also able to participate in elections. Of the 321 members, 87 votes were received between July 8 and July 22, 2024.
The new Board of Directors will take office as the governance body for ACCE on August 16, 2024. We are pleased to announce the 2024-2025 team and, as always, we look forward to serving you and your needs.
In addition, Bhaskar Iduri will continue in his second year, and second term as Treasurer, and Ilir Kullolli will remain as Immediate Past President when the President takes office for his second term.
Michele Manzoli ACCE
Michele.Manzoli@cshs.org
Journal of Clinical Engineering Subscriptions for ACCE Members
The Journal of Clinical Engineering is a compilation of articles, papers, and extensive manuscripts relevant to clinical/biomedical engineering or biomedical technology. Subject matter directly relates to the engineering or technology involved in patient care and treatment or technology in the broad field of health care delivery.
ACCE members receive a discounted subscription to the Journal of Clinical Engineering for only $99! (Originally $351). You must login to the ACCE website to view the code. Then visit LWW.com to enter code.
The
Board and Committee Chairs
Study Group Session 2: Service Delivery Management 2
28 August 2024 2024 CCE Exam Instructor-led Study Group Session 3: Service Delivery Management 1 04 September 2024 2024 CCE Exam Instructor-led Study Group Session 4: Technology Management 2 11 September 2024 2024 CCE Exam
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October
MD Expo -Fall 2024 _Mohegan Sun, New England Location: 1 Mohegan Sun Blvd, Uncasville, CT 06382 Register here: (Free Admission if employed by a hospital, health care facility, or are active military/students.)