ACCE News, May/June 2025, Vol 35 Issue 3

ACCE News Newsletter of the American College of Clinical Engineering

May—June 2025

President’s Message

In this issue

CCE Exam Prep

2

ACCE at AAMI eXchange 2025

3-5

Robert L. Morris Humanitarian Award

5

AAMI Update

6

ECRI Update

7

Women in CE

8-9

Mario Castañada Scholarship Winner

9

2025 Student Paper Competition Winners

10

Welcome New ACCE Members

11

IFMBE-CED Update

12

Device Interoperability Technology Management

Volume 35 Issue 3

13-14

UCONN CE Update

15

From the Education Committee

17-18

Clinical Engineering Hall of Fame

19

Congratulations to 2025 Fellow Member

20

Healthcare Technology Management (HTM) week (May 18th - 24th) has just passed us by and I hope you were able to celebrate all of your team’s accomplishments throughout the last 12 months. This juncture is also a good time to reflect on what it is you might want to tackle next to improve service delivery in your healthcare community. We at ACCE celebrated 2025 HTM Week with a complimentary webinar on May 22 nd, covering the topic “Why SBOMs Matter: Securing Medical Devices and Reducing Exposure”, sponsored by Ordr. On behalf of the ACCE Board of Directors, I would like to say thank you to our members for their continuing efforts this last year to improve healthcare through the provision of reliable, innovative, and safe healthcare technology.

In line with ACCE’s commitment to professional continuing education, we are offering a webinar titled “What Kim Greenwood, President, ACCE Does ‘Clinical’ Mean to You in Clinical Engineering?” on June 12th. This webinar examines Clinical Engineering’s role in today’s complex healthcare environment. Please remember to register in advance for this session. This webinar, like the entire series, is complimentary to ACCE members thanks to the support of our co-sponsors.

Work continues as we prepare for our participation in the upcoming AAMI eXchange 2025 in New Orleans, Louisiana, and as in previous years, ACCE is an official conference contributor.

One of the best ways to keep updated with the latest conference changes and news to is to check both the AAMI and ACCE websites. If you have not registered yet, I encourage you to do so and use this registration form to qualify for the ACCE member’s discounted rate. Please visit us in the vendor exhibits area at Booth #2943. We will be hosting the Saturday morning conference Clinical Engineering Symposium that investigates the “Impact of AI on Health Technology Management: An Evolving Landscape”.

Also, we will be holding our 35th Members Meeting/Awards Reception during the AAMI conference on Sunday June 22nd from 6:30 to 8:30 pm. This event is open to all ACCE members but you must RSVP to attend. It is our opportunity to acknowledge the accomplishments and contributions of our peers to the profession with the presentation of the 2025 ACCE Advocacy Awards, Student Awards, 2025 Fellows Awards, and to induct the new members of the Clinical Engineering Hall of Fame for 2025. I hope to see most of you at this year’s AAMI eXchange where we can keep up to date on the latest trends in our profession.

If your CCE certification is expiring in June 2025, please remember that the deadline for submitting your CCE renewal is fast approaching on June 30 th. Don’t forget to action this task and please submit your renewal application to avoid late fees or cancellation of your certification.

Finally, on behalf of the ACCE Board of Directors, I hope all of you had a happy HTM week and thank you for your commitment to our mission and shared values in the healthcare community.

Kim Greenwood President, ACCE greenwood@cheo.on.ca

CCE Exam Prep: Sample Review Questions This column provides example questions and information regarding preparation for the CCE exam. The questions are based on topics from the ACCE Body of Knowledge survey and the CCE Study Guide, Version 13. Note that the instructors for the ACCE CCE Prep courses, and the writers for 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 editor@accenet.org.

outright and will last 10 years. You will need to replace the brushes four times during the lifecycle at $500 each time. You estimate it will cost $20/year in utilities to run the centrifuge. It will also cost you $1,000 per year in consumables if you purchase the centrifuge. However, if you lease the centrifuge, the consumables and brush replacement are included. The lease cost is $25,000, what should you do?

1) CMS drives the AEM requirements and requires specific medical equipment to always follow the manufacturer’s PM schedule regardless of whether a hospital runs an AEM program and are outlined in the reference in the MEMP requirements. What groups of equipment does this apply to? (Single answer)

a. Purchase New b. Lease

a.

Medical Lasers, Imaging/Radiology, New Equipment without maintenance history b. Laboratory, Medical Lasers, Linear Accelerators c. Laboratory, Imaging/Radiology, New Equipment without maintenance history d. Medical Lasers, Imaging/Radiology, and Sterilizers e. None of the Above 2) What is CLIA? (Single answer) a. b. c. d.

Country Laboratory Investment Agreement Code of Legal Instrumentation Advancements Clinical Laboratory Improvement Amendments None of the Above

3) You’ve been asked to determine if it’s more cost effective to lease or rent a new centrifuge. The centrifuge you are replacing cost $10,000 when it was purchased 5 years ago. The new centrifuge is $15,000 if purchased

4) Many laboratory analyzers in the hospital are not purchased outright, why is that? a.

Typically, the initial purchase price is too low to warrant inclusion in the hospital’s capital purchasing plan. b. The analyzers are complex machines that require specific knowledge for troubleshooting and having a service agreement in place increases downtime of the device as facilities have to wait for the leaser to get in contact. c. Lab technologies change very slowly, so purchasing the equipment outright means high cost of ownership as the technology will be at the hospital for a very long time. d. Leases can include a “cost per test” which includes the cost of the instrument, service, reagents, and consumables for the term of the agreement, making it easier to budget as the cost are spread across the term of the agreement.

(Answers on page 16)

ACCE News ACCE News is the official newsletter of the American College of Clinical Engineering (ACCE).

Managing Editor Ted Cohen tedcohen@pacbell.net

ACCE News is a benefit of ACCE membership; nonmembers may subscribe for $100 per year.

To subscribe e-mail: secretariat@accenet.org

Co-Editors Sonja Markez Jason Launders editor@accenet.org Circulation & Address Corrections Suly Chi, ACCE Secretariat secretariat@accenet.org Advertising Dave Smith advertising@accenet.org

ACCE News

Copyright © 2025 by ACCE

Volume 35 Issue 3: May — June 2025

2

Join ACCE at AAMI eXchange 2025: New Orleans

ACCE is a Contributing Organization for

Stop by the ACCE booth at the Exhibition!

Ernest N. Morial Convention Center 900 Convention Center Blvd Halls D-E Booth# 2943

AAMI eXchange 2025.

ACCE members are eligible to register for the conference at AAMI members discounted rate.

Just download and complete the pdf registration form from AAMI website.

Plan your travel. Click here for an overview of the hotels.

Map of hotels

eXchange25 Schedule at a Glance

ACCE News

• • • • • •

Learn about new webinar series Learn about the Certification in Clinical Engineering (CCE) Learn about the membership programs Learn about volunteering opportunities Connect with old and new friends Check/update your membership status

Volume 35 Issue 3: May — June 2025

3

Time

Event

7:15AM Light refreshments, sponsored by Asimily 7:30 8:00

Artificial Intelligence: An Overview and Clinical Engineering’s Role | Peter Dziedzic, MS, Assistant Professor, Director, Center of mHealth and Innovations, Johns Hopkins University School of Medicine

8:00 – 8:30

Building a Sustainable AI Support Model | Nathan Licht, RN, MSN, Principal Data Analyst, Enterprise Data Intelligence, Cedars-Sinai

8:30 – 9:00

Building Smarter Hospitals: Artificial Intelligence Applications for the Decade Ahead | Dr. Thomas H. McCoy, Clinical Investigator, Associate Professor, Mass General Research Institute. Assistant Professor of Medicine, Harvard Medical School.

9:15 10:15

AI Panel Discussion | Panelists: Peter H. Dziedzic, Nathan Licht, Tom McCoy, Mike Powers, Priyanka U. Sollinger | Moderator: Erin Sparnon

ACCE News

Volume 35 Issue 3: May — June 2025

4

35th ACCE Members Meeting/Award Reception Date/Time: Sunday, June 22, 2025, 6:30PM – 8:30PM Location: Hilton New Orleans Riverside, 2 Poydras Street, New Orleans, LA 70130 Join us for an evening of networking with your peers and to congratulate the 2025 Advocacy Awards recipients, the 2025 ACCE Fellows, and the 2025 & 2024 Clinical Engineering Hall of Fame inductees. You are invited!

AAMI Foundation-ACCE Robert L. Morris Humanitarian Award This award—honoring the late humanitarian Bob Morris—recognizes individuals or organizations whose humanitarian efforts have applied healthcare technology to improving global human conditions.

This year’s recipient is Elliot Sloane, MSEE, PhD, CCE, FACCE, FAIMBE, FHIMSS, co-founder for Digital Health and Equity; President/Executive Director & Founder/Foundation for Living, Wellness and Health; Adjunct Professor/Villanova PA (Computing Sciences & Center for Excellence in Tech).

“Elliot Sloane has been a driving force for positive change in our field for many years.

He co-founded the Pul Alliance that encourages effective collaboration to foster safer healthcare in underserved communities and has for many years led the Foundation for Living, Wellness and Health which supports the improvement of patient care through effective use of health informatics. He has been a true visionary in our field for many years. This, coupled with his volunteering service to the clinical engineering community, inspired by Bob Morris, makes him well deserving of the Robert L. Morris Humanitarian Award.” Kim Greenwood, President, ACCE. From one of his nominators: “During the pandemic, Elliot led a global initiative ... to provide weekday updates with useful and relevant professional information and multiple social network hubs to accelerate critical global knowledge-sharing and collaboration (#HackingCoronavirus). This was completely a volunteer effort. Lastly, one of the most deserving actions by Elliot was his leadership and philanthropic role in setting up the Robert Morris Humanitarian Award. He was instrumental in starting the award in 2001 at ACCE.” Link to article on the AAMI website.

ACCE News

Volume 35 Issue 3: May — June 2025

5

AAMI Update AI & Medical Imaging: Considering Opportunities and Challenges Guest authors for AAMI’s Troubleshoot It series share how hospital systems and HTM service providers can tackle some of the industry’s most frustrating problems. Guest author AAMI member Melissa Lyder is a Graduate Student in Clinical Engineering at the University of Connecticut. Opinions and advice are her own.

ability to detect more subtle abnormalities with the potential for early diagnosis), which is sometimes higher than human reading. But does this sensitivity directly translate to clinical use and safety?

Traversing the gap between what an AI model predicts, and what the optimal diagnosis, intervention and treatment is, is Nothing grabs today’s media quite like Artificial Intelligence one of the most prominent challenges with using AI in med(AI) and its myriad of applications. When it comes to medi- icine. cal imaging, there are real productivity improvements to be Use of these models is often projected to reduce radiologists’ increasing workload and address staffing issues. Furseen from emerging AI capabilities in medical devices and software. There are also unique risks from integrating these thermore, their high sensitivity implies more early detecfeatures into medical imaging systems and the clinical envi- tions of disease or conditions, and combined with timely interventions, this can save lives. This could be the height of ronment at large. So, what does this paradigm say for the AI’s positive influence in healthcare. future of medical imaging? What does a tech-savvy IT or Healthcare Technology Management (HTM) But by the nature of machine learning, even the most techleader need to know when discussing the adoption of this nically complex and intentionally designed algorithms are technology with clinicians? only as intelligent as the data fed to it. Concerns are arising as to the accuracy of the data used to train these rapidly For medical imaging, artificial intelligence integration can mean rapid reading and analysis of medical images. AI fea- emerging tools. There is also cause for questioning the size tures of devices currently on the market receive a patient’s of the datasets used, their breadth, and depth. Do they account for all cases of disease? Do they account for how disscan and run it through a deep learning algorithm using a eases may manifest differently in different patient demultilayer convolutional neural network. These algorithms extract characteristic features that define anatomical struc- mographics? If not, can any algorithm really confidently adtures and potential abnormalities. Each feature is extracted vise a diagnosis? at a different layer in the network. Based on these characteristics, the system then classifies the image as affected or unaffected by the specified condition. Along with this classification, many systems provide heat maps of affected areas, and the probability of the results.

Generative Adversarial Networks (GANs) are a class of machine learning models that generate new, synthetic data based on their training data. That is, they create synthetic medical images. GANs may be used by researchers for training data when there is limited applicable data available.

In other words, medical imaging AI features may now be Processing X-Ray images, CT scans, or MRI scans with a machine learning (ML) or AI algorithm for detection of spec- developed based on synthetic medical images. ified abnormalities in the image, saves technologists and Training data validation is another major challenge that is radiologists an abundance of time compared to manually raising concern when considering the accuracy and safety of reading each image. But just how trustworthy are the deusing AI in clinical applications. tecting capabilities of these systems? Validation for AI mod- Image classification is just one application of ML technology els in medical imaging yields high sensitivity (meaning the in the clinical environment and yet these models are quickly gaining popularity in the market. The FDA has approved thousands of medical devices leveraging AI. However, these systems only use locked algorithms, meaning the training of the algorithm takes place prior to implementation and stays the same until a new version is released. The FDA continues to enforce safety in AI-enabled medical devices.

As AI classification models continue to reach the clinical environment, the need for specified standards becomes greater. AAMI TIR34971:2023 is the first document to address risk management of medical devices with Artificial Intelligence and Machine Learning components. The guidance essentially describes how to apply ISO 14971 to (Continued on page 11)

ACCE News

Volume 35 Issue 3: May — June 2025

6

ECRI Update ECRI Examines Reliability of Pulse Oximeters on People with Varying Skin Pigmentation Darker skin pigmentation can adversely influence pulse oximeter readings, leading to missed or delayed diagnoses and treatment. This health disparity has caused the U.S. Food and Drug Administration (FDA) to issue draft guidance on pulse oximeters, which are used to estimate the amount of oxygen in the blood, and are able to detect conditions such as sleep apnea and heart disease.

ECRI’s recent evidence analysis on pulse oximeters found that readings for individuals with darker skin might overestimate hemoglobin’s light absorption, showing normal oxygenation levels despite hypoxemia. This inaccuracy raises the risk of undetected hypoxemia and adverse outcomes in hospitalized patients with darker skin pigmentation.

ECRI has a long history of evaluating medical devices and issued its first report on pulse oximeters in 1989. At an FDA advisory panel meeting earlier this year, Dr. Scott Lucas, ECRI’s Vice President of Device Safety, explained the “significant health equity issue” associated with pulse oximeters. “The color of a patient’s skin should never degrade the quality or the effectiveness of tools that healthcare providers use to give lifesaving care,” Lucas said.

Studies Illustrate Health Disparities

•

Several recently published studies have also confirmed that these sensors are more inaccurate on darker skin tones.

Among these studies was a New England Journal of Medicine report that showed darker skin tones receive more inaccurate readings than lighter ones. In Black patients, 11.7% of apparently normal readings were incorrect compared with 3.6% of readings in White patients.

This health technology issue also prompted more than 20 state attorneys general to send a letter to FDA in late 2023 urging for updated guidelines to include warnings that address pulse oximetry’s inaccuracy on darker skin. “It is unconscionable in a multi-racial, multi-ethnic nation with populations spanning the color, age, and medical vulnerability spectra that sub-optimal and potentially harmful diagnostic technology such as the pulse oximeter is not calibrated to adjust for skin color,” the letter states.

ECRI’s Recommendations ECRI outlined three main recommendations for FDA to improve the quality of premarket studies and associated methods used to evaluate the performance of pulse oximeters.

• Pilot test the proposed Monk Skin Tone (MST) protocol to assess skin tone and skin variations across many patients. Train users on the tool, and evaluate whether they can use it consistently. Assess whether different users can get the same reading on the same patient, then address discrepancies through cognitive interviewing. Update relevant training programs.

ACCE News

•

MST is typically performed by looking at the skin pigment on a patient’s forehead, but pulse oximeters are primarily placed on the finger. For many people, skin pigment differs between the face and hands. Identify MST at the pulse oximeter sensor location, the finger (which is consistent with FDA’s proposal for quantification of skin tone).

For calculating Individual Typology Angle, choose colorimetry devices validated for reliable and consistent use across diverse users. Some device vendors may have completed testing that shows they can produce consistent readings. Without that validation data, conduct a pre-study validation trial to assess whether individuals use the colorimeters consistently, such as at the same angle and same pressure against the skin and whether different users get the same readings on a single patient.

ECRI’s evidence analysis concluded that, based on the published clinical studies, pulse oximeter readings from individuals with darker skin may overestimate the light absorption from hemoglobin and report normal peripheral oxygen saturation (SpO2) when the individuals are actually hypoxemic.

Less accurate SpO2 measurements in hospitalized patients with darker skin pigmentation increases the risk of undetected (occult) hypoxemia and adverse clinical outcomes.

ECRI members may access this Clinical Evidence Assessment through ECRI’s web portal. Non-members may learn more about Clinical Evidence Assessment and request additional information.

Keep in touch and let us know your thoughts on this and other topics. We would love to hear about your experiences and suggestions.

Ismael Cordero Senior Project Engineer, Device Safety, ECRI icordero@ecri.org

Volume 35 Issue 3: May — June 2025

7

Women in Clinical Engineering In this issue, we will highlight the journey of two legendary Clinical Engineers who have served in various capacities with ACCE and also volunteer with many task forces. of AAMI Equipment committee, HTCC, ACCE Education committee and was the recipient of the AAMI 2024 Young Professional of the Year award.

My journey to become a clinical engineer was inspired by a graduate of my college who spoke highly of the profession and how it integrates medicine and engineering. I wanted to study neuroHow long have you been involved surgery; however, my penchant for with ACCE? electronics and physics took over durI have been involved with the ACCE Education Committee for several years; ing high school and that led me to pursue engineering. Upon learning about since 2014. I joined HTCC in 2017. I have been able to provide feedback on medical electronics as an option, I was fascinated from day one about how enprofessional development tracks. gineering and technology facilitated What do you think of being female in medicine with ease to diagnose, treat, engineering? and monitor disease conditions.

Historically, the engineering field has I completed my undergraduate degree been male-dominated, which can Arleen Thukral in medical electronics and biomedical sometimes lead to biases or a lack of VISN 2 Healthcare Technology Manengineering in India and moved to the representation. However, there is a ager, VHA United States to pursue graduate studgrowing emphasis on diversity and inI have over 10 years of experience in ies in Biomedical Engineering. Whilst clusion, with many initiatives aimed at the development and management of doing so, my curiosity to understand complex, professional, highly technical supporting women in engineering. This post market management of these shift is creating more opportunities and healthcare technology management medical devices peaked. I had worked fostering environments where women programs that meet or exceed Joint for several years at GE and Philips in Commission, NFPA, OIG, FDA and other can thrive. Being a female in engineer- their engineering research programs ing is rewarding. applicable healthcare regulatory reand I had gained experience in reWho/what was your greatest influquirements in New York and New Jersearch, design, & development. When encer/advocate for choosing clinical sey VA Medical Centers. I lead a team an internship opportunity opened up at engineering? of dedicated HTM professionals (over Stanford, I knew that was the perfect While not an individual, ACCE is a lead- segue to learn about how these medi130 service line staff) supporting 9 ing organization in clinical engineering cal devices were operating in true clinimedical centers and transitioning to a and is a great resource for providing new CMMS (Nuvolo). The program is cal environments. education and advocacy for profession- My voluntary internship (a fancier name responsible for over $543M dollars of medical technology and provides safe, als in the field. for unpaid internship) started off in the reliably maintained medical equipment What surprises you in CE? central distribution areas where I for the delivery of quality health care in I am surprised by the variability in oplearned maintenance and repair on low a cost-efficient manner ($54M cost erations in the field. As the advancerisk devices. Over time, I quickly prosaving/avoidance). ment of medical technology increases gressed to high-risk areas where more Previously, I worked on VA’s $16B 10 year EHR modernization project in V20 VA NorthWest Health Network and oversaw a full range of supervisory and managerial functions at Seattle and Fresno VAMCs. I began my tenure with the Department of Veteran Affairs through the Technical Career Field (TCF) program and became Chief Biomedical Engineer in 2014 at Fresno, CA, VA Hospital. I am a past president of the California Medical Instrumentation Association, San Joaquin Valley Chapter. I have been an active member ACCE News

its pace, it is even more important that the management of that healthcare technology standardizes to best practices. New standards are helpful in reducing variability.

complex devices were managed. This internship opened up a full-time job for me that allowed me to explore all areas of maintenance and repair, eventually leading me to quality, compliance, and cybersecurity management. That was What would you tell other females almost 2 decades ago. I’ve had wonconsidering engineering?

There are many career growth opportu- derful mentors and leaders guide me through the years and I’ve had the opnities in engineering. As healthcare evolves to incorporate AI and cyberse- portunity to do the same for young procurity challenges, clinical engineers will fessionals, guiding them to pursue this extremely satisfying profession. be at the forefront of discussions with the implementation of medical devices.

(Continued on page 9) It is exciting times ahead!

Volume 35 Issue 3: May — June 2025

8

Women in Clinical Engineering (Continued) • • • • • • •

2016-2017: Member, Education Committee 2017-2018: ACCE Member-atLarge 2018-2019: ACCE Secretary 2019-2021: President-Elect 2021-04/2023: President 2021-2023: Cybersecurity Response Task Force 2020 Student Paper Competition, Doctorate Division winner.

Paper: Bed Control Process Standardization at a County Hospital

What do you think of being female in engineering?

Priyanka Upendra Sollinger, MS, CHTM, AAMIF Vice President of Cybersecurity Services, Asimily

How long have you been involved with ACCE? •

Member since 2016

ACCE News

It’s like anyone else being in engineering. There is a lot of preconceived bias around females/women in engineering.

Without dwelling on gender disparities, I think people need to focus on the outcomes achieved and the execution that gets us to the outcomes.

Volume 35 Issue 3: May — June 2025

Who/what was your greatest influencer/advocate for choosing clinical engineering?

Dr. Purna Prasad at Stanford Health Care, Dr. Guna Selvaduray at San Jose State University and Dr. Paul Yock at Stanford University School of Medicine.

What surprises you in Clinical Engineering?

It is still a male-dominated field with not many sponsoring the advancement of women. There is plenty of mentoring but not enough sponsoring.

What would you tell other females who are considering engineering?

Don’t hold back on your own potential because of biases and what’s perceived as norms. Go out, challenge them, and make your path.

9

Congratulations to the 2025 Student Paper Competition Winners US/Canada Master Division, Hamidreza Hatami, Graduate Student at University of Ottawa, Canada.

Winning Paper: “Medical Device Service Contract Comparative Analysis” This paper presents a structured approach to evaluating service contracts for medical equipment using a Total Cost of Ownership (TCO) framework. The study compares Full-Service, Shared-Service, and Parts-Only contracts, analyzing their financial and operational implications to aid hospitals in making informed decisions. Based on predefined criteria, an internal model was developed to capture and normalize costs, initially in Excel and later redeveloped in HTML for improved functionality and reliability.

International Undergraduate Division, Ana Cristina Aldana Palomino, Undergraduate student at Pontificia Universidad Católica del Peru.

Winning Paper: “Integrating Clinical Engineering into Hospital Design: A Multidisciplinary Approach to Optimizing Healthcare Infrastructure” The study “Integrating Clinical Engineering into Hospital Design: A Multidisciplinary Approach to Optimizing Healthcare Infrastructure” explores the challenges and limitations in hospital infrastructure development within Peru's health system. It emphasizes the critical role of clinical engineers in bridging the gap between clinical needs, technological innovation, and architectural design. The paper highlights the importance of adopting Building Information Modeling (BIM) technology for efficient hospital design, operation, and maintenance.

ACCE News

Volume 35 Issue 3: May — June 2025

10

Welcome New ACCE Members Name

Class

Job Title

Organization

State/ Country

Greg Barker

Inst/Associate

Manager, HTM-Biomedical Engineering

UF Health Shands

FL/USA

Fadi Alakhras

Individual

Project Manager

Advanced Technology Company K.S.C.P.

Kuwait

Waqas Mehmood

Individual

Senior Biomedical Engineer

Shaukat Khanum Memorial Cancer Hospital & Research Centre

Lahore/ Pakistan

Welcome to our newest Institutional member: https://ufhealth.org/

Amy Klemm, MS, CCE Membership Committee Chair Amy.s.klemm@gmail.com

AAMI Update (Continued) (Continued from page 6)

devices with AI and ML features. ISO 14971 more generally defines risk management of medical devices, including software and cybersecurity risks.

ISO/IEC 5259-2:2024 outlines a framework for managing the quality of the data used to train data supported decisionmaking models, notably AI and ML models. However, it does not specifically inform medical devices or the use of AI in the clinical environment.

Overall, AI’s potential to enhance diagnostic accuracy, alleviate workloads, and increase early disease detection is groundbreaking. Still, its dependence on training data and lack of full clinical feasibility raises critical concerns about safety, reliability, and ethical implications. Because of these concerns, the future of AI in medical imaging will not be determined solely by its capabilities, but by the ethical and technical safeguards put in place to ensure it serves patients and staff safely and effectively. With all of this in mind, professionals must strike a unique balance between progress and caution.

Sources: Artificial intelligence in medical imaging: switching from radiographic pathological data to clinically meaningful endpoints How Artificial Intelligence Is Shaping Medical Imaging Technology: A Survey of Innovations and Applications ISO 14971:2019 ISO/IEC 5259-2:2024 ISO/IEC 25024:2015 Ethical Considerations for Artificial Intelligence in Medical Imaging AI/ML in Medical Devices: Regulatory Perspectives AI Medical Device Standards Daniel Visnovsky, Manager, Media Relations AAMI dvisnovsky@aami.org ACCE News

Volume 35 Issue 3: May — June 2025

11

IFMBE-CED Update The Trends and Opportunities for Wearable Medical Devices Wearable medical devices have proven to be innovative healthcare resources that have transformed the way individuals monitor and manage their health. They are worn on the body and equipped with sensors that collect physiological and biometric data, providing insights into a person’s health status. These devices are reshaping healthcare delivery by offering real-time and personalized solutions that include fitness tracking and chronic disease management.

Current trends in this kind of medical device include aspects like the focus on preventive care, the integration with Artificial Intelligence, the possibility of remote patient monitoring, the increase in chronic disease management, and the comfort achieved by miniaturization. Wearable devices are able to keep track of physiological parameters such as heart rate, blood pressure, oxygen levels, and sleep patterns, which are all indicators of a person’s health state. Thus, this feature not only promotes health consciousness but also gives doctors information about patients’ conditions. AI transforms wearable health devices through its predictive and high-end data analysis capabilities. AI algorithms review copious amounts of data produced by wearables to identify patterns, predict health risks, and recommend interventions. For example, AIfortable. Companies are prioritizing ergonomic designs to powered wearables can detect abnormal heart rhythms, such as atrial fibrillation, and alert users to seek medical at- enhance user compliance, particularly for devices that are worn for extended periods. tention. Wearables are increasingly being utilized in remote patient monitoring, enabling healthcare practitioners to monitor patients’ health remotely. This trend increased, especially during the COVID-19 pandemic when treatment from a distance was critical.

The future of wearable medical devices is promising; their contribution to the management of people’s health is still under development, with the aim of a preventive care scheme for individuals. Some of the future directions in this field include personalized care that will use the integration of Remote ECG monitors and smart blood pressure cuffs are among the technologies facilitating doctors to remotely mon- different kinds of data to customize insights and make recommendations tailored to the patient, the extended use of itor chronic conditions without requiring frequent physical energy harvesting to potentialize the device’s usability, the check-ups. An increasing number of wearable devices are being used to manage chronic diseases. These wearable de- development of advanced biosensors that detect biomarkers and expand the monitoring capabilities for early diagnosis, vices have functions that measure and evaluate critical facthe integration with IoT and medical systems to provide an tors, allowing doctors to optimize treatment plans. Recent advancements in technology have led to the development of integrated platform for the health ecosystem and the application in mental health by using the provided data to assess wearable devices that are smaller, lighter, and more comstress, anxiety, or depression from variables like heart rate variability or sleep patterns. As wearables continue to evolve, prioritizing data security and adhering to regulatory requirements will be essential. Future initiatives will aim to implement strong privacy protections and guarantee that wearable devices comply with rigorous safety and effectiveness standards.

Fabiola Martinez, MS, PhD Chair, IFMBE/CED ced.chair22@gmail.com ACCE News

Volume 35 Issue 3: May — June 2025

12

Clinical Engineers Engaging in Next Generation of Device Interoperability Technology Management In the weeks before the recent HIMSS’25 conference in Las Vegas, a group of Notified Bodies in Germany, who are charged with reviewing medical devices for conformance to European Directives and awarding “CE” marks, issued a “Questionnaire Interoperability of Medical Devices – Version 1”1, also known as the “SDC Checklist”. In this context, “SDC” references the ISO/IEEE 11073 Service-oriented Device Connectivity standards for acute care device-todevice, plug-and-trust interoperability2. A notified body auditor will use this checklist as their basis for inspecting the medical device submission information and determining compliance, including a particular focus on safety and implement 80001 has been identified, it is met with deep risk management. skepticism: “clinical engineers will never implement this kind of risk management even if the value is clearly recogFor those who say, “We’ve been hearing about vendor innized and there are few, if any, alternatives.” dependent medical device interoperability for years … it will never happen!”, products that are 11073 SDC-enabled are coming to the commercial market in Europe in 2025. In fact, the Philips booth at HIMSS’25 included a demonstration of alert delegation and “Silent ICU” where systems from B. Braun, Dräger, and Philips connected using SDC to annunciate alerts on a central station and other mobile devices, while keeping the bedside … silent!

Is your hospital ready to work with your technology suppliers on the application of 80001-based risk management when implementing and managing interoperable SDCenabled medical devices?

And what about the FDA? Though the Notified Bodies are focused on Europe, the same systems are actively being considered for the U.S. market requiring FDA review and Great! So what does that have to do with clinical engineers? clearance. The FDA has already recognized the published ISO/IEEE 11073 SDC standards, and are actively particiThe surprise was reviewing the SDC Checklist and seeing pating in standards meetings and device interoperability some questions that directly pointed to hospitals (healthcare delivery organizations, HDOs) and clinical engi- programs such as the joint HL7-IHE Gemini device interoperability program that focuses on SDC implementation and neers: testing, leveraging the now 20+ year success of the IHE • Are contractual agreements with HDO’s and Service Patient Care Devices (PCD) integration profiles. ACCE has a Providers / Consumers of Interoperable Products in long history of support of the IHE devices community, place as specified in ISO TR 80001-2-63? providing Technical Program Managers for the testing and • Has the HDO performed an integration analysis accordHIMSS “Interoperability Showcase” demonstrations, ing to ISO 80001 standard series? though in recent years there has been little to no active • Remark: Guidance on the integration at HDO-level can participation in the work. be found in ISO 80001 – Application of risk manageOpportunity for Clinical Engineering Engagement ment for IT-networks incorporating medical devices4.

The good news is that there are major revisions being conFor those clinical engineers who have been around for a sidered for the 80001-1 standard and the numerous guidwhile, they will remember the excitement of the original ance “technical report” documents, 80001-2-x, that have publication of the 2010 edition of the 80001 standard, but either been withdrawn or need to be updated. This reprethen they will also say that though it was helpful for medisents an opportunity for CE / HTM to participate in these cal device manufacturers, HDOs and especially clinical endiscussions, either directly in the standards teams or in gineering were essentially left with an “unfunded mandate” focused workshops that provide the perspectives and con– little expertise, few resources, and a long list of new actent that will be needed to ensure that the next generation tivities and deliverables. of these standards reflects the needs of the HDOs and are For those who have only been in the field for the last 10-15 truly implementable. years, it is likely that there is no or very little recognition ISO/TC 215 and IEC/SC 62A, the two international standeven of the standards, let alone any understanding of the ards groups that work jointly to create and manage these substance of their content. risk management standards, met in London, 28 May 2025, In fact, in recent industry discussions when the need to (Continued on page 14)

ACCE News

Volume 35 Issue 3: May — June 2025

13

CEs Engaging in Next Generation of Device Interoperability Technology Management (Cont’d) (Continued from page 13)

to discuss the best path forward for revising and refactoring this family of standards. These discussions will result in a multiyear effort that will aim at providing what is needed to support the entire ecosystem – vendors, hospitals, regulators, and integrators – to realize vendor-independent, safe, effective and secure, plug-and-trust interoperable medical devices.

Additionally, a new HL7 devices accelerator program 5 is being created to establish an implementation community that will steward the Gemini program forward and identify additional work that needs to be done. Hospitals, including CE/HTM stakeholders, need to be represented in this new group.

Clinical engineers need to step up and actively engage in the discussion, if they are to receive the support they need.

For more information on how to participate in this discussion, contact Todd Cooper at todd.cooper@devices.HL7.org.

Endnotes 1. IG-NB Veröffentlichungen (accessed: 2025.05.09) 2. For example, ISO/IEEE 11073-10700:2024 (accessed: 2025.05.09) 3. See ISO/IEC 80001-2-6:2014 (accessed: 2025.05.09) 4. See ISO/IEC 80001-1:2021 (accessed: 2025.05.09); note, this is the 2nd 2021 edition; in Germany, the 2010 edition is often referenced.

5. See For more information about the accelerator and participation as a founding member (accessed: 2025.05.09)

We are Hiring!

American College of Clinical Engineering (ACCE) - Secretariat About the Role The ACCE Secretariat is a critical position that serves as the backbone of the organization’s daily operations. You will wear many hats, providing comprehensive administrative and logistical support across various departments. This role offers a dynamic and fast-paced environment where you can contribute significantly to the success of ACCE. Responsibilities • Membership Management • Support Board and Committees • Coordinate Educational Webinars and ACCE News • Manage collaborations & Social Media • Support webmaster with website content, ensuring accuracy and functionality Qualifications: • Bachelor’s degree in relevant field (e.g., Business Administration, Communications) or equivalent experience preferred • Proficiency in MS Office Suite, Intuit, Acrobat, Zoom • Working knowledge of accounting software (QuickBooks preferred) • Ability to work independently with minimal supervision, demonstrating initiative and problem-solving skills • If you are interested, or know someone that would be willing to help the ACCE, please contact Bhaskar Iduri at: contact@accenet.org

ACCE News

Volume 35 Issue 3: May — June 2025

14

Update from the UCONN Clinical Engineering Internship Program: Spring 2025 CE Week cises made us rely on only on our verbal communication skills.

The spring semester Clinical Engineering Week lands squarely in the winter season, but there is always a warm “welcome home” waiting for us on the UCONN Storrs campus.

Professional Communication We kicked off a jam-packed CE week with a 3-day professional communication skills workshop with Alex Bridgemohan, a PhD candidate in UCONN’s Department of Communications. Alex began our experiential learning by pairing the interns before CE Week so they could introduce each other on Day 1. He followed up with a demonstration of Ikigai – the intersections of what you love, what you’re good at, and what the world needs – to introduce the afternoon’s visual storytelling exercise.

We re-engaged with Alex on Day 3 to explore the topics of influence and persuasion. Our first exercise was a familiar ice-breaker activity – Two Truths and a Lie. The second exercise was a small group activity. One person from each group looked at the image of a completed Tangram Puzzle, then attempted to verbally tell the rest of the team how to arrange the Tangram puzzle pieces. The “viewer” was not allowed to touch any puzzle pieces. Every group had the same puzzle pieces and attempted to duplicate the same images at the same time. It was a race of sorts! Whereas the colleague introductions and Ikigai presentations used verbal and visual components, these exerACCE News

We wrapped up our 3-day workshop with Alex on Day 4 of CE Week by playing a modified game of Traitor – i.e., a reality show on the Peacock streaming service. This exercise leveraged our verbal influence and persuasion skills, but also required us to test our ability to discern which of our small group teammates were a Faithful and which were a Traitor. We experienced a number of unexpected, but interesting, twists as the game played out.

A big “Thank You” to Alexander Bridgemohan for sharing his insights, experience, and passion with us. If you are interested in developing your team’s professional communication skills, reach out to Alex directly to design your own workshop. You won’t be disappointed.

Perspectives in Clinical Engineering We dedicated Day 2 of CE Week to guest speakers and a mini-workshop to evaluate project management tools.

Gabby Rosales – one of our 2nd year interns – who was looking for best practices and tools to streamline her work at Brigham & Women’s Hospital. Using a hypothetical, but realistic, operating room renovation project, we broke into small groups to “document” with the project management tools used by the members of each group. A member of each small group presented the tool to the larger group and together we identified pros, cons, and use cases for each tool.

While our spring 2025 CE Week was intense, we managed to squeeze in a bit of fun too.

My colleague, Michelle Leatherwood, CPA, shared the purpose and function of Internal Audit in healthcare along with how she has collaborated with healthcare technology management (HTM) and clinical engineering (CE) teams.

We also heard from our VA HTM colleagues - Arleen Thukral MS, CCE, CHTM (VISN 2 Chief Biomedical Engineer), Clarice M.L. Holden (VISN 17 Chief Biomedical Engineer), Arif Subhan (Chief Biomedical Engineer, Greater Los Angeles Medical Center), Ann Valliyakalayil (VISN 5 Chief Biomedical Engineer), and Sara Ostrowski (VISN 17 Biomedical Engineer) – about their respective teams and the VA job application process. Each of our VA colleagues shared tips for optimizing resumes as well as the online application to improve the odds of being accepted into the interview process.

2nd Year Interns – Our Graduates!

We have 14 fabulous interns graduating in May! Each of them has grown considerably in their clinical engineering knowledge. Perhaps more importantly, they are more confident in themselves and their ability to, not just contribute, but to lead. Join me in congratulating them on their accomplishments and bright futures!

As always, a huge “Thank You” to our host hospitals and health systems for providing the real-world experience so valuable to our interns.

Our mini-workshop was requested by

(Continued on page 16)

Volume 35 Issue 3: May — June 2025

15

Update from the UCONN CE Program (Cont’d) (Continued from page 15)

I would love to hear from you if you’re interested in learning more about the UCONN Clinical Engineering Internship program or if you would like to hire one of our talented students!

Carol Davis-Smith, MS, CCE, FACCE, AAMIF Program Director – UCONN BME Clinical Engineering Internship Program UCONN EMAIL: Carol.Davis-Smith@uconn.edu

CCE Exam Prep (Continued): Answers (Continued from page 2)

Answers Question 1 Correct answer: A Explanation: a. These categories require hospitals/ISOs to follow the manufacturer’s PM Schedule. b. Linear Accelerators is not one of the categories. In addition, laboratories have separate accreditations, which are not included in the AEM language, nor the MEMP requirements. CMS drives the AEM requirements and they do not mention laboratory equipment. However, the laboratory will have other standards to comply with, including CAP (College of American Pathologists), CLIA, and other TJC Laboratory Standards. c. Laboratories have separate accreditations, which are not included in the AEM language, nor the MEMP requirements. CMS drives the AEM requirements and they do not mention laboratory equipment. However, the labora-

ACCE News

tory will have other standards to comply with, including CAP (College of American Pathologists), CLIA, and other TJC Laboratory Standards.. d. Sterilizers is not one of the categories. e. Incorrect as answer a) is correct.

Notes: CMS = Center for Medicare and Medicaid Services AEM = Alternative Equipment Maintenance MEMP = Medical Equipment Maintenance Plan From TJC Website: “AEM is not allowed for the following, and maintenance activities and frequencies must follow manufacturers’ recommendations: • Equipment subject to federal or state law or Medicare Conditions of Participation • Imaging and radiologic equipment (diagnostic or therapeutic) • Medical LASER devices • New medical equipment with insufficient maintenance history to support the use of an AEM strategy”

Volume 35 Issue 3: May — June 2025

(Continued on page 18)

16

From the Education Committee: In ACCE’s 2024-2025 Educational webinar Session 8 held on April 10th, 2025, and titled “From Early Career to Expert: Empowering the Upcoming Generation of CE/HTM Professionals,” four distinguished panelists—Michelle Baquie (VA), Charles Wickens (Mayo Clinic), Carol Park (Providence Health Care), and Anna C. Samik (Kaiser Permanente)—shared thoughtful insights into the evolving needs of the CE/HTM profession.

The discussion addressed key skill gaps among early-career professionals, including communication, troubleshooting, and regulatory awareness. Strategies to bridge these gaps focused on mentorship, hands-on learning, and interdisciplinary collaboration. Panelists highlighted the importance of networking, clinical shadowing, and professional involvement as critical tools for career development.

The future of CE/HTM was explored through the lens of emerging technologies such as AI, robotics, and telehealth, along with evolving challenges around equipment servicing and the “right to repair” movement. Finally, panelists emphasized how CE/HTM professionals can leverage their technical expertise to influence executive-level decisions and drive organizational improvements.

A sincere thank you to all who attended this engaging and forward-thinking session!

Maryam Samiee, Session Moderator, and Education Committee member.

May’s ACCE Webinar Series, “AI / ML in Healthcare: Mayo Clinic’s Journey and Experiences + AI/ML Based Tools: Evaluation & Implementation Criteria” was, ACCE’s 2024-2025 Educational webinar Session 9, by panelists, Praneetha Elugunti from Mayo Clinic and Francisco Rodriguez-Campos from ECRI. This session brought forth considerations and use cases regarding the implementation, governance, policies, and leverage of AI and ML technologies and processes in healthcare.

Charles Wickens, Session Moderator and Education Committee member In case you missed the live sessions, you may review the presentation material on ACCE website by logging in to your member account.

2024-2025 Educational Webinar Series The 2024-2025 Educational webinar series is scheduled to close with Session 10 on June 12 th covering the topic, “What does ‘clinical’ mean to you in Clinical Engineering?” Pre-register today and join the panel discussion with Izabella Gieras and Jennifer McFarlane to learn from our expert presenters about the special collaboration between Clinical Engineering and end users, focusing on the practical aspects of medical equipment management.

Essential Skills: Understand the key competencies required to support the continued success of these partnerships and its ongoing evolution.

Real-World Applications: Dive into compelling case studies that showcase the cross pollination of “clinical” expertise into the healthcare technology.

We are excited to present this opportunity to enhance your knowledge and contribute to the future success of our field.

The Education committee will be busy working over the summer to prepare for the 2025-2026 Educational Webinar series. Your feedback on what you would like to learn in the 2025-2026 series, will be essential. Please complete this survey by June 11th.

(Continued on page 18)

ACCE News

Volume 35 Issue 3: May — June 2025

17

From the Education Committee: (Continued) (Continued from page 17)

If you are interested in volunteering with the Education Committee, please contact us at secretariat@accenet.org or complete this volunteering form.

Happy summer to all.

Juuso Leinonen & Mike Powers, Education Committee co-chairs Suly Chi, Webinar Coordinator

CCE Exam Prep (Continued): Answers (Continued from page 16)

c.

Question 2 Correct answer: C Explanation: a. Incorrect. Not an actual entity. b. Incorrect. Not an actual entity.

CMS regulates all laboratory testing (except research) performed on humans in the US through CLIA. The objective of the CLIA program is to ensure quality laboratory testing. All clinical laboratories must be properly certified to receive Medicare or Medicaid payments. d. Incorrect as answer c is correct.

(Continued on page 19)

ACCE News

Volume 35 Issue 3: May — June 2025

18

Congratulations to the Clinical Engineering Hall of Fame Inductees!

CCE Exam Prep (Continued): Answers b. Many biomed shops do not maintain the knowledge it would take to a. If Purchased New: troubleshoot high $15,000 for the centrifuge -end lab equip$500 x 4 = $2,000 for brushes ment. Purely from $1,000 x 10 years = $10,000 for consumables a cost standpoint, Total Life Cycle Cost = $27,000 the hospital would have to b. If Leased: extend a lot of $25,000 for the lease funds to maintain $0 for the brushes the biomed’s $0 for the consumables knowledge of the Total Life Cycle Cost = $25,000 device. c. Laboratory devicNote: The purchase cost of the old centrifuge is not relevant; es are one of the most quickly evolving technologies in the utilities would be the same no matter if you purchased medicine. or leased the centrifuge so they are not relevant. d. Cost per test allows the cost of each test to be spread across a pre-determined period of time.

Question 4 Correct answer: D Questions written by the ACCE CCE Written Exam Study Group Instructors.

Explanation: Jenn Nichols, MSE, CCE, CHTM a. Actually, the initial purchase of lab analyzers is quite BOK Committee Chair high. jennie_nichols@yahoo.com (Continued from page 18)

Question 3 Correct answer: B Explanation:

ACCE News

Volume 35 Issue 3: May — June 2025

19

On May 22nd, ACCE celebrated 2025 HTM week with a complimentary webinar for the CE/HTM community, covering the topic: “Why SBOMs Matter: Securing Medical Devices and Reducing Exposure.” The presenters were Ben Stock, Director of Healthcare Product Management at Ordr, and Tola Amusan, Principal Security Analyst at Mayo Clinic.

If you missed the live session, you may register to view the On-Demand recording. The presentation material is available from ACCE website.

ACCE News

Volume 35 Issue 3: May — June 2025

20

Journal of Clinical Engineering Subscriptions for ECRI Update (Continued) 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 $378). You must login to the ACCE website to view the code. Then visit LWW.com to enter code.

ACCE CALENDAR https://accenet.org/NewsEvents/Pages/Calendar.aspx 12 June 2025 12:00 PM 1:00 PM

2024-2025 Educational Webinar Series Session #10: What does “clinical” mean to you in Clinical Engineering?

Location: Zoom ACCE members: click here to register

20 June 2025 23 June 2025

AAMI eXchange 25 - New Orleans Registration and Housing are now OPEN! ACCE Members, register with the PDF form to receive the Member rate discount.

Location: Ernest N. Morial Convention Center, Halls D-E, New Orleans, LA Click here to register.

21 June 2025 7:30 AM 10:15 AM

ACCE CE Symposium - eXchange25: Impact of AI on HTM: An Evolving Landscape Location: New Orleans Convention Center, Lobby E, Room# E-2

22 June 2025 6:30 PM-8:30 PM

35th ACCE Members meeting/awards reception (6:30—8:30pm CT) Location: Hilton New Orleans Riverside Downtown Two Poydras Street, New Orleans, LA 70130 Click here to RSVP.

30 June 2025

30 June 2025

Last day to complete the 2025 Body of Knowledge Survey Click here to complete the BOK Survey Last day to renew you 2025 CCE (regular renewal deadline) Check your CCE expiration date here.

Click here for more information 2025 ACCE Officers Election

29 Sept 2025 04 Oct 2025

2025 IUPESM World Congress on Medical Physics and Biomedical Engineering 2025 Location: Adelaide Convention Centre, Australia Click here for more information.

ACCE News

President ........................................................... Kim Greenwood President Elect ................................................ Katherine Navarro Vice President ......................................................... Qusai Shikari Secretary ........................................................... Michele Manzoli Treasurer .............................................................. Bhaskar Iduri Member-at-Large......................................................Jim Panella Member-at-Large.............................................. Kevin Kreitzman Member-at-Large.................................................... Erin Sparnon Member-at-Large ................................................ Ashley O’Mara Immediate Past President ......................................... Arif Subhan Advocacy Committee Chair .............. Francisco Rodriguez-Campos

07 July 2025 25 July 2025

30 Sept 2025 5pm

The ACCE Board and Committee Chairs

CE Body of Knowledge/CCE Promo Chair .......... Jennifer Nichols

Last day to renew your 2025 CCE (with late fee) After this date, will result in loss of certification Click here for detail information and to renew

Education Committee Co-Chairs ..................... Juuso Leinonen & Mike Powers Membership Committee Chair ................................. Amy Klemm Nominations Committee Chair ................................... Arif Subhan CE-HOF Nominations Review Committee Chair ..... Matthew Baretich Secretariat ................................................................... Suly Chi

Volume 35 Issue 3: May — June 2025

21