TechNation February 2024 by MD Publishing

1technation.com

Vol. 15

FEBRUARY 2024

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

ROUNDTABLE

RIGHT to REPAIR PAGE 40

P.14 | PROFESSIONAL OF THE MONTH: Earl Morris Jr. P.20 | NEXT GEN: Terrence Hum

P.46 | COVER STORY

Legislative & Regulatory Changes in HTM

P.66 | NETWORKING NOTES:

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CONTENTS P.12 SPOTLIGHT p.12 Association of the Month: The New England Society of Clinical Engineering (NESCE) p.14 Professional of the Month: Earl Morris Jr., BMET p.18 Department of the Month: The VIKAND Biomedical Operations Department p.20 Next Gen: Terrence Hum P.22 INDUSTRY UPDATES p.22 News & Notes p.26 Welcome to TechNation p.28 Ribbon Cutting: Equiptrack p.30 AAMI Update p.32 ECRI Update P.34 THE BENCH p.34 Biomed 101 p.37 Tools of the Trade p.39 Webinar Wednesday

46 P. 40 FEATURE ARTICLES p.40 Roundtable: Right to Repair p.46 Cover Story: Legislative & Regulatory Changes in HTM: Some Change, But Not Enough P.50 EXPERT ADVICE p.50 Career Center p.52 SPONSORED: Innovatus Imaging p.54 Right to Repair p.56 SPONSORED: Avante Health Solutions p.58 The Future P.60 CONNECTED p.60 Cybersecurity p.62 HIMSS p.64 Health-ISAC p.66 Networking Notes

TechNation (Vol. 15, Issue #2) February 2024 is published monthly by MD Publishing, 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290. TechNation magazine is dedicated to providing medical equipment service professionals with comprehensive, reliable, information concerning medical equipment, parts, service and supplies. It is published monthly by MD Publishing, Inc. Subscriptions are available free of charge to qualified individuals within the United States. Publisher reserves the right to determine qualification for a free subscriptions. Every precaution is taken to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher. ©2024

February 2024 | TechNation 9

PUBLISHER

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VICE PRESIDENT

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EDITORIAL

John Wallace

CONTRIBUTORS

Roger Bowles K. Richard Douglas Jim Fedele Joie Marhefka Manny Roman Steven J. Yelton

ACCOUNT EXECUTIVES

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ART DEPARTMENT

Karlee Gower Taylor Hayes Kameryn Johnson

DIGITAL SERVICES

Cindy Galindo Kennedy Krieg Haley Wells

EVENTS

Kristin Leavoy

WEBINARS

Linda Hasluem

HTMJOBS.COM

Kristen Register Sydney Krieg

ACCOUNTING

Diane Costea

CIRCULATION

Joanna Manjarrez

EDITORIAL BOARD Rob Bundick, Director HTM & Biomedical Engineering, ProHealth Care Carol Davis-Smith, CCE, FACCE, AAMIF, Owner/ President of Carol Davis-Smith & Associates, LLC Jim Fedele, CBET, Senior Director of Clinical Engineering, UPMC Bryant Hawkins Sr., Site Manager, Children’s Hospital of New Orleans

72 P.69 BREAKROOM p.69 Biomed Brainbuster p.70 TechNation Poll p.71 [Contest] What’s on Your Bench? p.72 #ShowUsYourShop p.73 Bulletin Board Sponsored by MedWrench p.78 Service Index p.81 Alphabetical Index

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SPOTLIGHT

The New England Society of Clinical Engineering (NESCE) President Ashley O'Mara (third from left) is seen with board members.

ASSOCIATION OF THE MONTH

The New England Society of Clinical Engineering (NESCE)

BY K. RICHARD DOUGLAS iomed associations and societies can look at their recent history in terms of pre-pandemic and post-pandemic. The pandemic threw a wrench into the operations of most groups and forced changes. One or two groups did not survive.

This isn’t necessarily new. Some local and regional biomed groups have materialized and then dissolved in the past without the challenge of a pandemic. One regional biomed group that has survived is the New England Society of Clinical Engineering (NESCE). “NESCE was one of four regional CE organizations in the northeast. The others were the Medical Device Society (MDS) in Massachusetts, the Northern New England Society of Biomedical Technology (NNSBET) in Maine, Vermont and 12 TechNation | February 2024

New Hampshire and the Iroquois Biomedical Society (IBS) in eastern upstate New York. These four societies were formed at about the same time as clinical engineering was growing. The societies worked together to hold an annual conference which was hosted by each group on a rotating basis. NESCE is the only remaining active regional CE organization in the Northeast,” says Ashley O’Mara, the group’s president. O’Mara says that a group of clinical engineering directors from the Hartford, Connecticut area was instrumental in the group’s creation. “Mark English, director of CE at Hartford Hospital, and Ernie Gignon, director of CE at UCONN Health Center, were two of the founders,” she says. The society covers biomeds in an expansive area of the Northeastern United States. The New England region of the country is comprised of the states of Maine, Vermont, New Hampshire, Massachusetts, Connecticut and Rhode Island. It is anchored by the city of Boston and has significant historical relevance to

New England • October 8-10, 2024

NESC is a strong clinical engineering society that is supporting the fall MD Expo at the Mohegan Sun Casino in Connecticut.

the U.S. going back to colonial times. NESCE was founded on December 10, 1975. The society’s history has included a big focus on education and student participation is a key pillar of the group. The region that the society covers also includes some of the country’s leading educational institutions. The group not only survived the pandemic, but adopted procedures to keep members connected. “NESCE continues to adapt to the changing times and the work/life balance, the HTM community continues to try and find. We offer both virtual and in-person quarterly meetings,” O’Mara says. REGIONAL EVENT AND EDUCATION In the past, the group has hosted a symposium every three years. The society has also traditionally hosted quarterly membership meetings. As mentioned earlier, the pandemic had an influence on the operations of many biomed groups. “As COVID has changed the HTM community, NESCE has adapted by offering both virtual and in-person quarterly meeting formats,” O’Mara says. NESCE has its 2024 regional meeting and event on the calendar, as well as an event scheduled for 2025. “We will be partnering with MD Expo for the fall 2024 Expo being held October 8-10 at the Mohegan Sun Casino. Our next NESCE Symposium will be held in October of 2025, with a location to be determined. Both events will feature keynote speakers, education sessions, vendor expo halls and networking activities for the New England HTM community,” O’Mara says. Next year will also see a new program added to the society’s offerings. “We are planning to launch a NESCE student scholar-

ship program at our 2025 NESCE symposium,” O’Mara says. The group will also begin initiative to help create a pipeline for new biomeds entering the profession and coordinating with local programs. “The NESCE Executive Committee has recently launched an HTM outreach subcommittee. This group will be building relationships with local biomed technical schools/community colleges as well as reaching out to local high schools,” O’ Mara says. The goal is to supplement current efforts to help replenish the talent-drain from the HTM profession caused by retirements. “The association works closely with the UCONN clinical engineering master’s degree program and subsidizes their attendance at select quarterly membership meetings to allow the students to interact with HTM professionals throughout New England that may be recruiting,” O’Mara says. She says that NESCE also has an active membership development subcommittee that meets routinely to look for new ways to recruit members, including free membership drives, social media membership campaigns and more. “HTM leaders in New England continue to look for entry-level technician training partnership programs and NESCE is working on how to best assist the HTM community in these efforts,” O’Mara says. As a biomed society that survived the early days in the region, NESCE has grown and brought together the HTM community in the Northeast and survived the challenges of the COVID-19 pandemic. It now is doing its part in connecting with new biomeds and helping the field replace a dwindling workforce. February 2024 | TechNation 13

SPOTLIGHT

PROFESSIONAL OF THE MONTH

Biomed and Deputy Coroner

Earl Morris Jr., BMET

BY K. RICHARD DOUGLAS iomeds spend a lot of time around patients who are being treated by clinical staff to make them healthy again or to keep them alive. One biomed in Indiana lives in this world, but also has the responsibility of assisting with those who aren’t so fortunate.

Earl Morris Jr., BMET, is a one-man biomed shop for Harrison County Hospital in Corydon, Indiana, and the deputy coroner for the county coroner’s office. Morris had his interest sparked in the biomed profession from an early age. “I have always wanted to help. I remember when I was in the hospital when I was in the second grade, [and] while there, the biomed techs came by and did preventative maintenance on the machines in the room and I talked to them and they answered all of my questions, and I thought, I want to be like these guys,” he remembers. Morris obtained an associate degree from the College of Biomedical Equipment Technology. He also had two years of on-the-job training while he was in school. While he has retained the same title as a biomed, he has held other positions. Morris worked in the IT field before entering biomed. “Since I have been in the biomedical world, I have only had one title and that is BMET. During my working career, I have held the title of Deputy Coroner, MDI (Medicolegal Death Investigator) certified. During my information technology career, I have been a Systems Administrator, Level 2 Support and Desktop Support,” Morris says. WEARING TWO HATS Morris faces some unique challenges as a one-man 14 TechNation | February 2024

biomed shop and a deputy coroner. “I think the challenges that I have encountered have been diagnosing equipment; most of the time I receive equipment with a note that says ‘broken’ or ‘doesn’t work.’ I also found that time management can be a big challenge as you have to prioritize what is the most important to what is just important; as everything is important. I have been assigned some special projects which include security cameras and maintenance/service contracts in the hospital,” he says. Beside repairing and maintaining medical equipment, Morris has the difficult job in the coroner’s office. “I am also one of the county coroners; my official title is Deputy Coroner. I am also MDI certified, which stands for medicolegal death investigator. Some of the challenges with this job are controlling your emotions as you are handling very sensitive issues, as this is the most important thing that can happen to any one person. I am very fortunate that the hospital that I work for also allows me to take calls during the day when the coroner is in a meeting and or on vacation,” Morris says. Morris adds that his coroner career has helped him in many ways, as these people are strangers and he is coming in at their time of need and asking the tough questions about the individual who has died. “If I can do that, I can surely be able to talk to the admin team at my hospital, which I believe makes the biomed portion operate a lot smoother, as you have great communication,” he says. He says that as a one-man biomed shop, his routine is somewhat unique, as he is able to diversify what he wants to do each day. “I am not tied to one type of equipment that I have to work on, as some of my fellow biomed techs have told me that they have specific people for specific types of

Earl Morris is seen with Detective Jason White of the Tulsa Police Department’s Homicide Division while at the Dr. David Avolt Memorial Training Conference, in Indianapolis.

Earl Morris Jr., BMET

BIOMETRICS Earl Morris is seen with Harrison County Hospital Plant Manager Steve Etienne.

equipment. The only challenging portion of being solo is the conversation about how you think or someone else may go about to tackle a bed or any other type of equipment. I mean it’s the way I figure it out to be, but on the other hand, I have found out a lot of ways not to do something, and the next time, it will be easier on myself to complete certain tasks,” Morris says. He says that before biomed, he was in the IT world for 15 years and then decided to try his hand at biomed, which is what he had studied in school many years earlier. “I am learning something new every day at everything I do, whether it be the biomed world or the coroner world, it all can have lessons that can be applied to each aspect and make you a better person,” Morris says. Away from his two jobs, Morris spends time with family and hobbies. “I have a domestic partner. We have two children; one boy and one girl. Also, we have one dog, three cats and one hamster. I like to collect Funko Pops even though my collection is rather small; one day it may be large. I also like retro video games; I have an NES with over 60 games,” he says. Morris is also an Assistant Cubmaster for the Boy Scouts of America. Morris was recognized as one of TechNation’s 40 Under 40 for 2023. He also won a gold medal from Skills USA for his soldering ability. It may be safe to assume that Morris is the only deputy coroner/biomed technician in the country. Working in these two professions requires broad-based knowledge and skills. He is serving his community well.

FAVORITE BOOK: “To Kill a Mockingbird”

FAVORITE MOVIE:

“The Shawshank Redemption”

HIDDEN TALENT:

A hidden talent I have would be my ability to smoke food on the smoker. I am getting better every time I smoke something.

FAVORITE FOOD: Japanese

FAVORITE PART OF BEING A BIOMED? My favorite part of being a biomed is helping the patients. I know I am not directly involved but we do make sure that any piece of equipment that is connected to a patient is working properly and safely. I also like being able to go around and talk to the nurses and doctors about how the equipment is working. It is very important to have a great rapport with the clinical staff.

WHAT’S ON MY BENCH?

I have a set of screwdrivers, nut drivers, electrical tester, red bull sugar free, and jawbreakers.

February 2024 | TechNation 15

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SPOTLIGHT

DEPARTMENT OF THE MONTH The VIKAND Biomedical Operations Department

BY K. RICHARD DOUGLAS

magine being a mobile biomed, but instead of traveling between hospitals or clinics, you instead travel between ships? Repairing a device, or providing a PM, and then announcing that things are now “ship-shape” may have greater significance for these biomeds.

This is one of the services provided by VIKAND Medical Solutions. According to the company’s website: “VIKAND provides proactive total health care solutions for the commercial shipping, cruise, yachting and offshore industries.” Operating out of Dania Beach, Florida, the company’s Biomedical Operations Department oversees medical equipment management for seagoing devices. “The department team members are composed of by a team of four account managers, five biomedical field service technicians, two remote technical support biomedical technicians, one in-house biomedical technician, four CMMS administrators (TMS Online) which handle the software infrastructure as well as data management, three administrative assistants, which assist with recall management, reporting, parts management and financial records,” says Robert Wentworth, vice president of biomedical operations. He says that the department is also supported by a travel coordinator who, although not organic to the biomedical operations department, spends much of their time directly supporting the biomed department by coordinating and arranging travel. Although this biomed department is unique compared with most, Wentworth says that it is also unique because most team members are trained across a variety of modalities. “Most of our technicians are trained on lab equipment, 18 TechNation | February 2024

ventilators, portable X-ray including digital radiography and computed radiography, as well as various other types of equipment. As VIKAND continues to grow, we have begun creating a new diagnostic imaging division in which we will expand our capabilities of providing support for X-ray, ultrasound and PACS,” he says. Wentworth says that the department supports roughly 225 cruise ships. “Medical facilities on these vessels range from a single treatment room on smaller ships to centers that have an ER/treatment room, up to three ICUs, laboratory and multiple patient wards. They also have secondary medical centers, which can contain medical equipment that can be used in the event the main medical center is unusable/ reachable, as well as medical equipment such as AEDs and oxygen concentrators around the ship,” he says. STARTING WITH DESIGN While the department has projects that are more aligned with traditional biomeds, there are many unique challenges that face HTM professionals working with ships or fleets of ships. “VIKAND has participated in the design of medical centers, [and the] outfitting and installation of medical equipment for those medical centers located on cruise ships. Most recently we began installing patient monitoring systems on the larger ships,” Wentworth says. He says that the biomedical operations department plays a crucial role in the ship building and launching of new ships. “When new ships are being built, the owners must design a medical center and outfit it with appropriate medical equipment. This requires collaboration between the biomedical operations, medical operations and supply

Charlie Ruttenberg, VIKAND Biomedical Equipment Technician, is testing out the calibrated ventilator with the shipboard medical team.

Charlie Ruttenberg, VIKAND Biomedical Equipment Technician, is performing an annual detail calibration on a ventilator onboard a cruise ship.

chain departments. Through a unique process, we are able to “From time to time, there are ships that sail in very analyze equipment requirements, ensure that the shipyards are remote locations which makes traditional methods of designing the medical center to accommodate the equipment providing biomedical support impossible. During the such as power requirements, networking, spacing and so forth. pandemic we faced periods where international travel was It also allows for proper planning of equipment type, brands banned. Our department created relationships with and models,” Wentworth says. biomedical organizations and expanded our relationships He says that not all medical equipment is suitable for such with manufacturers around the world. We worked with environments, which can contain higher levels of humidity and these other organizations to develop strategic support particles in the air, vibration, power fluctuaagreements, provided them resources tions and so forth. and training, which allowed us to “We work with different manufacturers to continue to support our clients,” The VIKAND biomed thoroughly evaluate each new type of deWentworth says. vice being brought to market before we recTeam members also stay active team must be one of ommend or distribute those products to our away from their many work locations. the most unique HTM clients. We look at things such as operating “We are involved in internal and storage environments, service requirediscussions, which from time to time, departments anywhere. ments, maintenance reports and history, rehave an impact on [the] American call activity, support capabilities of that manTheir special skill sets College of Emergency Physicians ufacturer, initial cost of product, cost of (ACEP) and Cruise Line International facilitate the health of Association (CLIA) guidelines for cruise ownership over time, and availability of parts, consumables and accessories, and so sea-going people and ship medicine. All of our U.S.-based forth,” Wentworth says. techs are members of local biomedical He says that since VIKAND has performed societies. We aim to attend the Florida medical equipment many of these projects over the years, they Biomedical Society Symposium, MD around the globe. have been able to help standardize the medExpo, and AAMI conferences each ical equipment across fleets. year to engage in training opportuni“This has enabled our biomedical technities. Additionally, we aim to attend cians to become experts by reducing the number of various other events such as FIME, Seatrade, and both the Fort brands and models of a particular equipment type, such as deLauderdale and Miami international boat shows,” fibrillators. It has also allowed for the medical staff to become Wentworth says. more familiar with the equipment, resulting in reduced work orThe VIKAND biomed team must be one of the most ders related to operator error,” Wentworth adds. unique HTM departments anywhere. Their special skill There are also logistical challenges that face biomeds assigned to sets facilitate the health of sea-going people and medical working on ships that the VIKAND team has contended with. equipment around the globe. February 2024 | TechNation 19

SPOTLIGHT

NEXT GEN POWERED BY YP AT MD

Terrence Hum

uke University Health System Biomedical Technician Terrence Hum earned a Bachelor of Science in Biomedical Engineering from the University of North Texas. TechNation recently quizzed this member of the Next Gen of HTM to find out more about his training and his vision for the future.

Q: WHERE DID YOU GROW UP? A: Malaysia Q: WHERE DID YOU RECEIVE YOUR HTM TRAINING/ EDUCATION? A: My HTM education started at University of North Texas from the biomedical engineering program. I also receive on-the-job training at Duke University Health System. Q: HOW DID YOU FIRST DISCOVER HTM? A: After graduating from high school, I was deciding

between biomedical engineering and aerospace engineering. I decided to go with biomedical engineering and started my 4-year biomedical engineering program at the University of North Texas. Q: HOW DID YOU CHOOSE TO GET INTO THIS FIELD? A: I chose this field because this field aligns with my personal interests and qualities. I like to solve real-world challenges using logical and critical thinking. I also want to make a positive impact on health technology in the future.

Q: WHAT INTERESTS YOU THE MOST ABOUT HTM? A: HTM offers diverse career opportunities for individuals interested in both health care and technology. It is also a fast-growing field, providing ongoing opportunities for professional development and continuous learning. Q: WHAT HAS BEEN YOUR GREATEST ACCOMPLISHMENT IN YOUR FIELD THUS FAR? A: One of my greatest accomplishment lies in the recognition and appreciation I receive from my colleagues for the dedicated efforts, which serves as a motivating factor for me to continue to strive for greatness. Q: WHAT GOALS DO YOU HAVE FOR YOURSELF IN THE NEXT 5 YEARS? A: In the next 5 years, I want to enhance my technical proficiency in the rapidly evolving field of biomedical technology, and aim to deepen my expertise in specific areas such as patient monitoring system and medical imaging equipment. I also want to improve my leadership and communication skills, fostering effective teamwork and collaboration.

FUN FACTS FAVORITE HOBBY:

Watching all kinds of sports (basketball, baseball, football, soccer)

FAVORITE SHOW OR MOVIE: “Jurassic Park”

FAVORITE MEAL: Thai food

WHAT WOULD YOUR SUPERPOWER BE? Teleportation

Q: WHAT DO YOU LIKE MOST ABOUT YOUR POSITION? A: I enjoy what I do because I get to learn to work on a variety of medical equipment and how they interact with patients to improve the quality of life. I also enjoy working with health care professionals as we work towards the same goal of improving health care. 20 TechNation | February 2024

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INDUSTRY UPDATES

NEWS & NOTES Updates from the HTM Industry DON’T MISS MD EXPO LAS VEGAS MD Expo Las Vegas is set for April 7-9. Registration is open and free for hospital employees, active military and students! MD Expo always delivers HTM professionals with a unique and rewarding conference second to none. It is packed with quality educational sessions, entertaining networking events and a must-see exhibit hall. Clinical engineers, biomedical technicians, directors, managers, asset managers and others responsible for medical technology are afforded the opportunity to network with peers and learn about the latest technologies. Find out what everyone has been talking about;

this is one event you can’t afford to miss! “It’s always great to come to an MD Expo,” Chief Biomedical Engineer for VA CT Michael Huesser said after a previous MD Expo. Find out more and register today at MDExpoShow.com.

STUDY RATES TRIMEDX TOP CLINICAL ENGINEERING PROVIDER TRIMEDX was recently rated the top provider of services to health care providers in equipment maintenance, clinical and biomedical engineering outsourcing through a Black Book Research study. Nearly 16,000 client users of independent providers responded to polls on customer satisfaction and experience in several outsourced functional areas. This includes responses from small hospitals, community hospitals, health systems and other inpatient providers. The survey period ranged between Q4 FY22 and Q3 FY23. “I am extremely pleased to learn of this independently published study and to see how TRIMEDX and the service our associates provide clients are being recognized as first class,” says CEO Henry Hummel. TRIMEDX earned 13-of-18 total number one criteria ratings within the category results (with the next highest provider earning two). These are: strategic alignment of client goals; innovation; client relationship and cultural fit; trust, transparency, accountability, ethics; breadth of offerings, client types, delivery excellence; deployment and implementation; customization; scalability, client adaptability, flexible pricing; compensation and employee performance; brand image and marketing communications; marginal value-adds; support and customer care; and best of breed technology and process improvement. “As hospitals and health systems continue to look for 22 TechNation | February 2024

efficiencies while delivering patient care, it appears we will see a major shift to those utilizing independent service providers for clinical engineering services,” says Doug Brown, president of Black Book Research. “People, process and technology are crucial to delivering these services, and TRIMEDX excels in serving clients and also meeting their capital needs.” Of the 18 criteria ratings, TRIMEDX’s results all ranged between 9.2 and 9.92 with a mean of 9.72; all of which fall within the top 10%, scoring better than 90% of providers, receiving the highest client satisfaction scores under the feedback responses of: “overwhelming satisfaction,” “exceeds expectations,” and “highly recommended vendor.” “It’s reaffirming to see highly performing numbers across the board,” says Chief Operating Officer Kristi McDermott. “And when reviewing the areas we’ve achieved number one ratings, we can truly attribute the results to the work each associate contributes daily, from all areas of the business.” The study, that surveyed nearly 16,000 hospital and physician organizations across 40 categories of service, also revealed that over the next five years, health care will see an increase in independent service providers partnering with health systems because of a lack of in-house expertise, the need to keep up with accelerated pace of technology implementation while facing reduced capital, and the risk of not supporting existing technology.

ADVAMED ANNOUNCES MEDICAL IMAGING DIVISION AdvaMed, the Medtech Association, has announced the establishment of a new Medical Imaging Technology division focused on advocating on behalf of large and small companies for the essential role of medical imaging technology, radiopharmaceuticals, contrast media and focused ultrasound devices in the nation’s health care system. Leading medical imaging companies – such as Bayer, Fujifilm Sonosite, GE HealthCare, Hologic, Philips, and Siemens Healthineers – have formally established AdvaMed as a new home for advocacy on behalf of medical imaging companies. AdvaMed President and CEO Scott Whitaker said, “This new division is a big step forward not merely for the medical imaging sector, but for AdvaMed and the entire medtech industry. Never before have medical technologies been so connected and interdependent as they are today – and it’s really only the beginning. From traditional medical devices to digital health tech to AI and medical imaging, the opportunity to unify the industry and advance policy solutions for the health care system has never been better. No trade organization is better prepared than AdvaMed to represent the entire medtech industry and take on these advocacy challenges so that our members can continue focusing on what they do best – meeting the needs of the patients they serve.” “Finally, the timing of Peter Arduini’s election as our new chair couldn’t be better. His leadership of GE HealthCare, a global leader in medical imaging, pharmaceutical diagnostics

and digital solutions, will provide strategic insight and direction to AdvaMed as we work to ensure an aligned and inclusive focus across companies in every sector of medtech,” he added. Patrick Hope served as executive director of MITA since 2015 and will now serve as executive director of the new Medical Imaging Technology division at AdvaMed. As is the case with AdvaMed’s Accel, Dx, and Digital Health Tech divisions, AdvaMed’s new Medical Imaging Technology division will be led by a board of directors comprised of executives from its imaging company members. The new division will be led within AdvaMed by Patrick Hope, former executive director of the Medical Imaging Technology Alliance (MITA). Hope and Peter Weems, who led MITA’s government affairs and policy strategy, as well as other staff, will round out the division’s staffing needs at AdvaMed going forward. This division’s creation comes on the heels of AdvaMed’s announcement last month that it had established a Digital Health division. The recent creation of these two divisions “further demonstrates that AdvaMed is well positioned to lead the entire medtech industry on the advocacy front,” Whitaker said. In January, AdvaMed released a refreshed version of its “Medical Innovation Agenda for the 118th Congress,” a list of policy and legislative priorities critical to patient care that will include a new set of priorities for the medical imaging sector.

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INDUSTRY UPDATES

LAWMAKERS QUESTION FDA’S RECALL EFFORTS U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Richard Blumenthal (D-CT) recently sent a letter to the Government Accountability Office (GAO) calling on the agency to update its 2011 report entitled “Medical Devices: FDA Should Enhance Its Oversight of Recalls” by conducting a review of the Food and Drug Administration’s (FDA) oversight of medical device recalls. The Senators sent the letter following reporting on Philips Respironics’ failure to submit timely and comprehensive adverse event reports, or recall faulty CPAP machines for more than a decade, despite the company’s knowledge that patients could be experiencing severe health consequences from using the medical devices. “From contact lenses and catheters to prosthetics and pacemakers, medical devices improve and save lives. Health care providers use them to diagnose and treat illnesses and injuries. Tens of millions of patients have implanted medical devices or use them in their homes to live healthier, more productive lives. But, there can be major risks. Due to unforeseen safety or manufacturing issues, medical devices can cause harm to patients, which can lead to a recall,” Durbin and Blumenthal began their letter. The letter goes on to note that in Fiscal Year (FY) 2022, FDA oversaw 898 medical device recalls, impacting tens of millions of medical devices. This figure represents a 125 percent increase compared to FY 2012, when there were 399 medical device recalls. It also includes 70 Class I recalls – FDA’s highest recall classification – a 15-year high. In FY 2012, FDA also received 486,986 adverse event reports, but it received 2,946,889 adverse event reports in FY 2022 – a 505 percent increase. The Senators continued their letter, explaining the harm caused by Philips’ failure to report its faulty CPAP machines despite the first adverse event report being issued in 2010. More than a decade later, Philips finally recalled millions of CPAP, BiPAPs, and mechanical ventilators, which patients with sleep apnea, COPD, and other respiratory conditions use to help them breathe. The machines contained a sound abatement foam that frequently deteriorated and was being inhaled by patients. As a result, patients could experience headaches, vomiting, allergic reactions, and “toxic or cancer-causing” effects. More than a decade passed, in which Philips knew of the issue, before a recall was initiated. “According to the Pittsburgh Post-Gazette and ProPublica, Philips Respironics received an adverse event report about this issue in 2010. Rather than reporting the

24 TechNation | February 2024

adverse event report to FDA or initiating a recall, it waited and withheld thousands of additional adverse event reports for more than a decade. Even when Philips Respironics conducted an internal health hazard evaluation, which confirmed that inhaling the chemicals from the sound abatement foam could cause ‘permanent impairment,’ it did nothing, while patients suffered. That is unacceptable,” the Senators wrote. FDA also missed several opportunities to mitigate harm done to millions of patients who used Philips’ faulty medical devices. “FDA reportedly also received at least 30 adverse event reports related to degradation of the sound abatement foam significantly prior to the initiation of the recall. FDA has stated that it ‘reviews all reports of adverse events associated with medical devices.’ However, it is not clear whether or not FDA took action to inform hospitals, health care providers and patients about the potential risks,” the Senators wrote. “Further, the Pittsburgh Post-Gazette and ProPublica’s reporting suggests that FDA knew Philips had a history of withholding adverse event reports from the agency, but still allowed it – and other medical device manufacturers – to submit late adverse event reports without appropriate enforcement for such violations,” the Senators’ letter continued. In concluding the letter, Durbin and Blumenthal emphasized that GAO must update its report on medical device recalls to ensure that FDA is adequately fulfilling its duty to ensure that medical device recalls are initiated in a timely manner. The Senators attached an extensive list of questions to the letter, to understand what additional steps must be taken to improve FDA’s oversight of medical devices. The letter came after Durbin’s introduction of the bicameral Medical Device Recall Improvement Act. The legislation would require FDA to establish an electronic format for medical device recall notifications to streamline communication between medical device manufacturers, FDA, hospitals and health care professionals. It would also require manufacturers to include in recall notices information about how the recall could affect patients with medical devices and instruct hospitals and health care professionals to provide that information to patients. The legislation was inspired by Illinois constituents who had shared their personal stories about medical harms and other concerns related to recalled medical devices.

ESTAR AVAILABLE FOR CERTAIN PMS SUBMISSIONS On December 6, the U.S. Food and Drug Administration (FDA) announced that eSTAR is now available for voluntary use for certain PMA Submissions. eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. eSTAR is intended to enhance the incoming quality of submissions for a wide range of medical devices by helping to ensure submitters provide quality, comprehensive data for premarket review.

The updated eSTAR template includes a guide that follows the recommendations noted in the final guidance: “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.” The recommendations are intended to promote consistency, facilitate efficient premarket review, and help ensure that marketed medical devices are sufficiently resilient to cybersecurity threats.

MEDICAL DEVICE STANDARDS DEVELOPMENT PLATFORM LAUNCHED AAMI’s improved Standards Monitoring Platform (StMP) has officially launched. A first wave of 81 working groups, representing more than 700 active standards development volunteers from regulatory bodies and the health care industry, have been invited to start using the platform. For a list of all committees that have moved over to StMP, visit the Find My Committee page on the AAMI website. “StMP is not just a platform, but a finely honed tool designed to optimize workflow and supercharge efficiency,” AAMI Vice President of Standards Matt Williams said. “The entire AAMI Standards Team has been hard at work preparing for this transition and we are looking forward to this new chapter.” “The feedback from members during an initial testing phase was overwhelmingly positive,” added Anna Leggett, standards program specialist, AAMI. She noted, however, that AAMI staff

is treating this first phase of transitions as a single stride toward refining AAMI standards development. “We plan to continually improve the platform and will consider participant feedback in this process.” For more than 50 years, AAMI has been at the forefront in developing voluntary consensus standards, technical information reports and other technical documents. These standards, developed through the coordination of volunteers from around the world, are used throughout the health care field to ensure the safe and effective production, distribution and use of health technology. The subject matter experts who voluntarily participate in AAMI standards development serve more than 200 committees and working groups in all, making the first wave of StMP participants only a portion of the overall community.

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February 2024 | TechNation 25

INDUSTRY UPDATES

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INDUSTRY UPDATES

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echNation recently reached out to Equiptrack CEO and Founder Mark Mayeux to find out more about how its services help healthcare technology management professionals.

Q: WHAT ARE SOME OF THE SERVICES AND PRODUCTS YOU OFFER? A: We offer several new and innovative services and products including: • Equiptrack Reports: Like CarFax but designed for the medical equipment industry, these reports provide comprehensive insights into recalls based on serial numbers and reported maintenance history. • U.S.-market Medical Equipment Recall API Service: Integrates with CMMS partners, enabling the generation of Medical Equipment Recall Work Orders for ISOs and in-house biomed departments. • Commerce Components Shopify App: Sellers can elevate their medical equipment selling experience with our Shopify app. It incorporates our exclusive No Recall Guarantee, Equipscores, and a direct link to obtain Equiptrack Reports for each relevant product listing. The app is free for sellers, with the cost of reports covered by equipment buyers. • Recall Sentry Service: Our latest subscription service has been designed for both small and large medical supply chain companies. The service syncs their products with our platform, automatically cross-referencing their inventory with newly classified recalls. The intuitive dashboard highlights affected recalled inventory, providing detailed information down to product lot 28 TechNation | February 2024

codes and expiration dates. This proactive approach significantly reduces the workload for supply chain organizations, mitigating risks and effectively managing recalls across all OEMs and warehouse inventory locations. Q: HOW DOES YOUR COMPANY STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: Our platform helps partners expand their revenue streams by introducing new equipment information and leveraging it for increased profitability. For instance, by installing our Commerce Components app, the platform can identify equipment without recalls which enhances the value of those units. With the ability to systematically identify recall-free units on a large scale, partners can strategically re-price these items, capturing additional revenue. Q: WHAT IS ON THE HORIZON FOR YOUR COMPANY? A: Looking forward, we aim to bring on board 5-10 significant new partners and 15-20 additional medical supply chain companies within the next 6-12 months. As part of our strategy, we’ll be hosting regular online marketing and training sessions each month to spotlight new revenue streams and the risk management capabilities our technology facilitates. Q: IS THERE ANYTHING ELSE YOU WOULD LIKE TECHNATION READERS TO KNOW? A: To bring our platform to as many medical equipment and medical supply chain companies as possible, we’re set to introduce our app-related services, Commerce Components and Recall Sentry, on platforms like BigCommerce and WooCommerce in the coming months. Stay tuned for updates on these significant developments. For more information, visit equiptrack.com.

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INDUSTRY UPDATES

AAMI UPDATE

AAMI Publishes Best Practices Guide for HTM Employee Retention

AMI has taken the next step in its ongoing assessment of the healthcare technology management (HTM) field, producing a comprehensive report on HTM employee retention.

In 2022, AAMI surveyed HTM professionals and reported back on their concerns and various employee retention issues. This timely survey coincided with ongoing job market turbulence and the fact that a large proportion of HTM professionals are expected to age out of the workforce in the coming decades. Then, in 2023, AAMI staff produced an in-depth report assessing the primary concerns of the HTM workforce, with a focus on factors that threaten employee retention. This report was built on the free text comments from participants in the 2022 survey. The report identifies what issues are top of mind for HTM staff and makes clear recommendations related to employee retention. The primary issue areas addressed in the free text survey comments include pay and benefits, communication, leadership, and advancement and training. 1. EMPLOYEE BENEFITS The survey indicated that pay and benefits are vital to HTM staff retention. Employees are not only concerned with monetary compensation, but also their ability to take advantage of other benefits like vacation days and paid time off. “Once structure, job descriptions, and promotion paths are developed, HTM leaders should work with their HR departments to ensure equitable salaries for the defined positions,” the report reads. 2. COMMUNICATION Communication is vital to employee retention and wellbeing. It is important for leadership and management to set expecta30 TechNation | February 2024

tions, maintain consistency, and to listen and engage with employees in a transparent fashion. The report provides a list of 10 essential characteristics that employers should consider. This includes suggestions for setting expectations and goals. 3. LEADERSHIP Culture is key, and management needs to provide employees with a voice. Issues such as quality and safety concerns, what procedures work well, ideas for improvement, and ideas related to staff recognition are outlined in detail for management in the report. AAMI’s report finds that establishing an employee advisory committee is one way to effectively collect this information. 4. ADVANCEMENT AND TRAINING A robust training regimen is a must-have for employers interested in improving employee retention. As medical devices become more common and complex, HTM will continue to evolve rapidly. Every organization needs continuous training and a succession plan. The report finds that “HTM leaders must be creative and flexible when determining the training needed and finding where opportunities exist for their team, including AAMI, OEM courses, third-party providers, formal education, online training, or on-site apprenticeship programs.” Managers and employers looking to learn more can download the report at AAMI’s HTM resources page. Access is free for AAMI members. NEXT STEPS What’s next for AAMI’s ongoing assessment of the HTM workforce? AAMI recently initiated a survey related to how HTM professionals interact with home healthcare. Does your department make house calls or work in patients’ homes? Either way, we want to know! The survey can be found here. If you have questions about the HTM workforce survey results, the methodology, or accessing the full report, please contact AAMI staff at htm@aami.org.

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AAMI Publishes Leadership Development Guide for HTM Professionals As the healthcare technology management (HTM) field faces record staffing shortages and an ever-increasing demand for new skills and specializations, promoting a department’s best and brightest remains one of the most effective ways to ensure a health system or service provider is ready for tomorrow. That’s why AAMI is pleased to announce the publication of a practical guide for HTM professionals who are interested in advancing their careers into leadership roles and for supervisors looking to develop the next generation of leaders. The Leadership Development Guide: A Resource for Healthcare Technology Management Professionals provides comprehensive tips, best practices, and exercises for HTM staff seeking professional advancement and supervisors seeking to train employees for leadership roles. The document was produced by the AAMI’s Technology Management Council (TMC). Danielle McGeary, AAMI vice president of HTM said, “This guide was created to give HTM professionals a roadmap for career advancement. It provides guidance for those looking to move into leadership roles.” The guide features various sections, including: • Getting Started – A step-by-step guide to creating your own career plan . • Toolkit – A career progressions graphic and leadership progression grid for HTM professionals, alongside planning worksheets on advancement and corporate structure. • Career Planning Opportunities – Sources on development opportunities for each of the skill and knowledge domains on the HTM leadership progression grid. These include leadership, equipment expertise, financial management, and much more. • Communicating Your Plans – A ‘how to’ for working with your HR department and organizational leadership, including meeting guidelines and sample agendas for communicating your career goals and plans. • Interviewing for Leadership Positions – Tips and techniques for senior level interviewing, including key dos and don’ts. • FAQs – Answers to the most frequently asked questions about career planning, taking on leadership roles, continuing education, and more! In short, the new Leadership Development Guide is an excellent resource for HTM professionals looking to move into the next stage of their career and for professionals who are uncertain but would like more information. AAMI’s new guide has you covered and can set you up for success. The document is free for AAMI members but can be purchased a la carte in the AAMI store. Questions? Reach out to htm@aami.org.

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February 2024 | TechNation 31

INDUSTRY UPDATES

ECRI UPDATE

Medical Errors and Health IT: What Does the Data Say? ealth information technology (IT) is a powerful tool for documenting and sharing information about patients’ health and helping providers to make well-informed decisions about patient care. However, problems relating to health IT, including both system and user issues, are also sometimes cited as factors in causing or contributing to patient harm – and even lawsuits.

PATIENT SAFETY Problems related to health IT can cause patient harm, including serious harm or death. A 2017 systematic review of health IT problems and their effect on patient outcomes and care delivery found that health IT problems were associated with patient harm and death in 53% of the studies reviewed. Use errors and poor user interfaces impeded the receipt of information and led to errors of commission in decision-making. Problems with system functionality (including poor user interfaces and fragmented displays), system access, system configuration and software updates caused delays in care delivery. Several studies characterized medication errors related to health IT problems in more detail.

32 TechNation | February 2024

In 2012, ECRI’s Patient Safety Organization (PSO) published “Deep Dive: Health Information Technology,” which reviewed 171 health IT-related events submitted by PSO member health care facilities during a nine-week period. Of the 124 events for which a harm score was entered, 8 events (6.4%) resulted in patient harm: 3 events may have caused or contributed to the patient’s death, 1 event required life-sustaining intervention, 1 required hospitalization and 3 resulted in harm requiring other types of intervention. An additional 24 events (19%) required monitoring to confirm that there was no harm or need for intervention. The most commonly involved systems were: • Computerized provider order entry system (25%) • Clinical documentation system (17%) • Electronic medication administration record (15%) • Laboratory information system (13%) • Pharmacy system (11%) • Human interface device (e.g., computer not functioning) (9%) • Radiology or diagnostic imaging system (8%) The most common problem types were: • Data transfer: System interface issue (16%) • Data input: Wrong input (14%) • General technical: System configuration software issue (13%) • Data output: Wrong record retrieved (11%) Health IT-related medication errors continue to receive particular attention. In an analysis of patient safety event reports from more than 595 health care facilities entered

between 2013 and 2018, researchers identified 1,508 event reports describing medication errors associated with health IT use, 50% of which reached the patient. Wrong dose errors were by far the most common medication error type (81%). Nearly all reports (97%) described a usability issue, most commonly problems with data entry (43%), workflow support (30%), alerting (16%), and system automation and defaults (6%). LAWSUITS AND INSURANCE CLAIMS Issues relating to health IT are increasingly cited as contributing factors in lawsuits and claims. A Doctors Company claims analysis published in 2019 found that the percentage of claims alleging that EHRs contributed to patient injury generally increased from 2010 to 2018, from a low of 0.35% in 2010 to a peak of 1.62% in 2016. Usually, EHRs were contributing factors, not the primary cause of the claim. The most prevalent injuries were death (25%) and adverse reaction to a medication (23%). The most common allegations were diagnosis-related (31%). The most common specific system technology and design issues were: • Electronic systems or technology failure of the EHR (12%) • Lack or failure of EHR alert or alarm (7%) • Fragmented record (6%) The most common user-related issues were: • Incorrect information (13%) • Prepopulation or copy and paste (13%)

• Hybrid health record or EHR conversion issue (13%) • User error (other) (12%) • Training and/or education (7%) A 2019 study of CRICO claims coded from 2012 through 2014 analyzed 248 cases identified as having one or more EHR-related contributing factors. For the years 2013 and 2014, 0.84% of all cases coded during that period were identified as having one or more EHR-related contributing factors. These issues more often occurred in ambulatory settings (59%) than inpatient (31%) or emergency (10%) settings. The most common system-related issues were: • System and software design (15%) • Routing of electronic data (9%) • System dysfunction or malfunction (8%) The most common user-related issues were: • Miscellaneous user error (17%) • Hybrid health record or EHR conversion issue (14%) • Incorrect information (13%) • Prepopulation or copy and paste (8%) The most common allegations related to medications (31%), diagnosis (28%), medical treatment (14%) and surgical treatment (13%). The severity of harm was higher in inpatient and emergency settings than in ambulatory settings. Learn how ECRI can help you address health IT and technology related risks. Visit www.ECRI.org/device-evaluations.

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February 2024 | TechNation 33

THE BENCH

BIOMED 101

Difference Between a Biomedical Engineer and a Biomedical Equipment Technician

BY BRYANT K. HAWKINS SR.

will be answering a question that a lot of new technicians that come into the HTM industry have. It’s a very important question to answer. The hot topic question is, “What is the difference between a biomedical engineer and a biomedical equipment technician?” We know the most obvious difference is the education route. A BMET can obtain a certificate, join an apprenticeship program or an associate degree to enter the HTM industry. To be a biomedical engineer you need to obtain at least a bachelor’s degree.

Before we can compare, lets first explain in detail what it takes to become a biomedical engineer. The biomedical engineer is an evolving discipline in the engineering field that works directly with engineers, physicians and scientists to provide interdisciplinary insight into medical and biological problems. Take, for example, the biomedical engineering programs at Columbia University. They prepare students to apply engineering and applied science to problems in biology, medicine, and the understanding of living systems and their behavior to develop biomedical devices. Modern engineering encompasses sophisticated approaches to measurement, data acquisition and analysis, simulation, and system identification. These approaches are useful in the study of individual cells, organs, entire organisms and populations of organisms. That’s an example of the education’s programs. You also have biomedical engineering companies that leverage technology to create pharmaceutical drugs, surgical robots, micro implants and other cutting-edge products designed to improve human health. Their employees focus on solving medical problems and promoting innovation in health care. In the medical industry: The role of a biomedical engineer includes designing biomedical equipment and

34 TechNation | February 2024

devices to aid the recovery or improve the health of individuals. This can include internal devices, such as stents or artificial organs, or external devices, such as braces and supports. It can also include creating and adapting medical equipment. It’s a role that requires excellent knowledge of computing, biology and engineering, an inventive nature and good problem-solving skills. When COVID-19 was at its worst peak, biomedical engineers from a range of different industry backgrounds had to put their normal tasks to one side to build ventilators and personal protection equipment (PPE) to help the NHS care for the increasing numbers of patients in intensive care units with COVID-19. They were using their ingenuity to make the items that were so desperately needed. Many were using reverse engineering techniques to help them to deconstruct items and their parts to help them better understand the make-up of the equipment and the optimum methods needed to recreate them. This process would normally take many months, but because of the COVID-19 threat to humankind, the challenge was shortening this time frame as much as possible. Items were needed within days or weeks, so they were working to safely speed up the production and testing process, to ensure that equipment is distributed quickly, while still meeting high health and safety requirements such as sterilization measures set out by the Medicines and Healthcare Products Regulatory Agency (MHRA). Biomedical engineers were taking advantage of the processes used in manufacturing like 3D printing. This was a useful tool for engineers, as it allowed them to make copies of precise items several times over. In response to the COVID-19 outbreak, many small companies or individuals with access to 3D printers were doing their part to produce additional face masks and visors for health care workers, and those working near other people. Then, we had big name companies like Airbus, Apple, Babcock, Dyson, Mercedes Formula 1 and Tesla that helped

bridge the gap in supply, and some are following specifications provided by the government to make the process as efficient as possible. The pandemic has helped to highlight the impact that biomedical engineering can have on people’s lives. I will share a quote from Ian Chell (a medical device electrical safety expert) from the UK. “The recent COVID-19 events will change the face of biomedical engineering. Now, when you tell people you are learning about biomedical engineering, everybody will be able to relate to what you do as you fix the life-saving ventilators. Biomedical engineering has suddenly become the most important engineering discipline in the world,” Chell said. Biomedical engineers focus on advances in technology and medicine to develop new devices and equipment for improving human health. To simplify it, they will design or create software to run medical equipment or simulate computers to test new drug therapies. A biomedical engineer can work in various industries, but I will just speak on biomedical engineers in the medical field in relation to biomedical equipment technicians. A biomedical equipment technician has some of the same training as a biomedical engineer, but their main responsibil-

ities are to install and service medical equipment. On the other hand, a biomedical engineer often helps to design and manufacture the equipment that biomed equipment technicians service. Biomedical engineers also have more advanced training, and they typically need a minimum of a bachelor’s degree. They also collaborate with other scientists, engineers and designers to create many of the protocols and specifications that dictate the biomedical equipment technician job. Hopefully this gives you some insight to the difference between a biomedical engineer and a biomedical equipment technician. As always, I must leave you with a quote. “Scientists study the world as it is; engineers create the world that has never been.” - Theodore von Karman, Hungarian-American mathematician, aerospace engineer, and physicist.

Bryant K. Hawkins is a senior site manager at Children’s Hospital, Trimedx.

February 2024 | TechNation 35

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36 TechNation | February 2024

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Tools of the Trade Demo: SmartTank

lifesparkmed.com

The recent TechNation Tools of the Trade Demo explored how to properly test CO2 modules and anesthesia gas monitors with the SmartTank. Brent Weight of Life Spark Medical discussed the SmartTank. During the demo attendees were able to learn how the SmartTank facilitates proper testing of CO2 modules and gas monitors while saving time and gas. The SmartTank is an all-in-one testing device for CO2 gas modules and anesthesia monitors (like GE E modules E-sCO/E-sCAiOV, Philips 3015A/B, Philips 1026A, LoFlow, Capnostat, Zoll, Draeger and many others). The SmartTank automates the testing of these devices providing better testing in less time, using less gas – all documented in detailed test reports. Weight also fielded questions from attendees during his presentation. Attendees provided feedback via a survey that included the question, “What was your single biggest takeaway from today’s product demo?” •

“The SmartTank is useable for all kinds of capnography devices, allowing it to be used easily for all sorts of situations.” – Dixon Shapiro HTMT

“The Top 10 RTLS Questions Biomeds Should Ask in 2024”

kontakt.io

Kontakt.io Senior Director of Professional Services Matt Cannell presented the webinar “The Top 10 RTLS Questions Biomeds Should Ask in 2024.” What are the important questions for biomeds to ask regarding RTLS in 2024? As the technology evolves to meet more and more use cases, it’s absolutely critical to get answers regarding selection, implementation and value. Cannell walked attendees through the important questions (and answers) that will shape RTLS for biomeds in 2024 and beyond. Attendees provided feedback via a survey that included the question, “Why did you attend today’s webinar?” •

“To learn more about RTLS and how to integrate it.”

– Franciscan Health Dyer HTM Manager Ronald Richardson.

“MRI Introduction – A Brief History, MRI Safety and System Functionality”

allpartsmedical.com

Ed Mireles, Service Innovation Manager MV MRI at AllParts Medical, provided information about the development of MRI, how to work around it safely, and how images are generated. He also introduced the various subsystems used in MRI. The session had 90 attendees for the live presentation and is available for on-demand viewing at WebinarWednesday.live. Attendees provided feedback via a survey that asked, “What was your single biggest takeaway from today’s webinar? •

“The complexity of MRI.” – Henry Stankiewicz Jr., CE, Sigma VA.

Tools of the Trade Demo: Pressure MAX PM-1 Digital Pressure Meter

pronktech.com

In the Tools of the Trade Demo from TechNation, attendees were able to learn about a biomedical test equipment first! The Pressure MAX PM-1 Digital Pressure Meter from Pronk Technologies is the smallest, most versatile and accurate multi-channel pressure meter designed with the range and accuracy to test virtually any type of medical device. Capable of positive and negative pressure measurements for gas and fluids, providing extreme performance and accuracy. The palm-sized Pressure MAX fits in a shirt pocket and operates on batteries. It is the only pressure meter verified to operate after 50 drops from 3 feet and is backed by Pronk’s industry-leading 4-year warranty. The session also included an informative Q&A with presenter Julio Castro, a Regional Sales Director for Pronk Technologies. Castro travels to biomedical associations nationwide presenting technical and educational information to the biomedical engineering community. Attendees provided feedback via a survey that included the question, “What was your single biggest takeaway from today’s product demo?” •

“The compact size and versatility of the Pressure MAX and its implications for productivity.” – Ryan Thomas, a biomed student at Jefferson State Community College. February 2024 | TechNation 39

ROUNDTABLE

Right to Repair

ight to Repair continues to be a hot topic in healthcare technology management. TechNation recently contacted key stakeholders within the medical device repair industry to gather their insights on the Right to Repair. Participants in this roundtable article are College of Biomedical Equipment Technology President Dr. Richard L. “Monty” Gonzales; MultiMedical Systems LLC Vice President of Operation Nicole Palmer; U.S. PIRG Campaign for the Right to Repair Senior Director Nathan Proctor; Elite Biomedical Solutions CEO and Co-Founder Jeff Smith; Innovatus Imaging Vice President of Sales and Marketing Matt Tomory; and Renovo Solutions Chief Operating Officer Andrew Ulvenes. Q: WHY IS RIGHT TO REPAIR IMPORTANT FOR HEALTH CARE FACILITIES? GONZALES: To better address the question of why health care organizations should be concerned about the Right to Repair, we should emphasize that financial stewardship 40 TechNation | February 2024

plays a crucial role in health care facilities. I have read many arguments for and against Right to Repair, but it is undeniable that the issue primarily revolves around financial aspects. By limiting health care organizations’ ability to make informed decisions about maintaining their medical devices, arbitrary restrictions can hinder their ability to exercise prudent financial judgment. The same professionals entrusted to make life and death decisions about patients, should be granted control over the maintenance and repair of their medical equipment. PALMER: We believe when you own equipment you should have the right to access manuals, equipment, parts, tools and diagnostic equipment. This is especially critical in health care when support could be delayed days or weeks. Critical hours can pass while trying to reach tech support and booking an OEM tech to respond. The loss of revenue when some devices are not operable is affecting health care’s bottom line, patient care and patient safety. PROCTOR: Right to Repair is about empowering choice. Not just the ability to choose a repair option that might involve less downtime, or less cost. It’s also about

choosing the method of repair that has the best quality. Manufacturers would like us to believe that they offer the best service automatically, but that’s just not true. Sometimes, manufacturers have bought another company, and their servicing quality has taken a hit, but they still charge five times what a local ISO charges, who also does the repair in hours instead of weeks. Meanwhile, the devices fail more often when serviced by this over-stretched OEM. Facing a loss of service revenue, some OEMs would take this opportunity to lock down their service manuals, PM kits, service keys and triple the cost for their trainings – all of which would be aimed at pushing the health care facility to renew a bad service contract. Why shouldn’t the hospital be able to hire the best, fastest, safest option? Sometimes manufacturers do offer the safest service, and for some equipment a health care facility would never choose any other option given the market options right now. But even in those cases, Right to Repair is a benefit. It keeps the OEM honest, forces them to maintain that quality if they want to keep winning those contracts. This is about creating a system with good incentives. SMITH: Medical devices are integral to a health care facility’s ability to provide patient care. Unfortunately, there is shortage of repair technicians in the health care industry, and so hospitals often must outsource device repairs. One significant concern for hospitals focuses on how the Right to Repair fight will impact their ability to repair devices in a timely manner, as OEMs may not be able to repair equipment fast enough or have sufficient available parts. Based on analysis of millions of complaints, a 2018 FDA report concluded that, “the objective evidence indicates that many OEMs and third-party entities provide high quality, safe and effective servicing of medical devices,” and that “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.” Given the importance of medical devices to patient care, we, as a community, must work together for our country. TOMORY: The migration to in-house service has been going on for many years and has accelerated due to rising support costs and the increase in competency of HTM staff. With many organizations performing their own service and maintenance, it is critical they have the proper tools and documentation to comprehensively support the equipment they own and operate as well as ensure it is performing as the OEM intends. ULVENES: Hospitals need very responsive, high-quality and cost-effective solutions for maintaining their medical equipment. They purchase and own their assets and they should have the choice in how they manage their life cycle. Right to Repair creates healthy options for health

care facilities that allows them to provide the best patient care and experience to those they care for. Q: HOW CAN HTM PROFESSIONALS HELP THE RIGHT TO REPAIR CAUSE? GONZALES: The most important thing that HTM professionals can contribute to the Right to Repair movement is to be well-informed and engaged. Being well-informed includes understanding the fundamental tenants of the argument, the legislative initiatives shaping the fight, and other trends influencing the national debate. Actively participating in trade shows, HTM associations and other professional forums is also important. Lastly, active involvement in the political process, contacting your representatives and engaging in both public and private discourse on the topic. PALMER: Ask your local HTM management professionals and follow those working for health care on social media, such as www.prig.org. MMS has worked on initiatives with US PIRG, and many others to raise awareness on this important issue. Write or leave a voice message for your senator or representative. Provide examples of why or how the right to repair affects you and your team and, most importantly, those whom we serve – the patient. We, together as an HTM community, can be a powerful voice! PROCTOR: I think there are two ways we need more biomeds and HTMs to help. Number 1 is we need your voice. We live in a democracy, where decisions are made by speaking up, and finding others who agree with you. You should join groups like the Medical Device Servicing Community, which aims at fostering a dialog and collaborative community around these topics and other important issues facing HTMs. You can sign our letter and join the more than 500 other biomeds active on this issue. Number 2 is data and facts. I know hospitals track which device servicers are more effective, faster and how much they charge. Lawmakers need to understand this data to make informed decisions. We are working hard to collect data, but we need more people who can share some of their insights with us without violating patient privacy. The FDA 2018 report is the closest we have, but it doesn’t consider downtime, price or how long a repaired device kept working before failing again. I know people track this, and this data tells a very compelling story about why Right to Repair would be common sense. SMITH: HTM professionals should demand access to the proper manuals/training/parts needed to safely repair and maintain medical equipment, and OEMs should be made to provide that information. Additionally, consumers should reach out to the Federal Trade Commission (FTC) to inform the agency of any concerning practices or February 2024 | TechNation 41

ROUNDTABLE

Richard L. “Monty” Gonzales College of Biomedical Equipment (CBET)

Nicole Palmer MultiMedical Systems LLC

Nathan Proctor U.S. PIRG Campaign for the Right to Repair

statements OEMs may be utilizing, including unsupported statements regarding the safety of third-party parts or when OEMs characterize third-party parts as “counterfeit” parts or “gray market” parts. The FTC has focused on Right to Repair restrictions generally, and the Senate Judiciary Committee’s Subcommittee on Antitrust emphasized the FTC’s continued work combating repair restrictions that allegedly harm consumers, explaining that the FTC is “prioritizing action against business practices that unlawfully restrict consumers’ ability to repair their products, costing them more over the long term.” TOMORY: The HTM team should be involved in all equipment purchasing processes (in my humble opinion) to provide a post-warranty support perspective. During the purchasing process, critical items such as manuals, software (keys), proprietary test equipment, etc. should be negotiated so the health care provider may partially or fully support after the OEM warranty expires. ULVENES: There are several things HTM professionals can and are doing to help the cause. One of those is making sure our teams have proper training and skills to repair and support medical devices. In addition, many service providers are ISO (13485 or 9001) certified ensuring that they have quality standards in place. Q: CAN YOU SHARE AN EXAMPLE OF A TIME WHEN YOU HAD AN ISSUE WITH A DEVICE THAT RIGHT TO REPAIR COULD PREVENT? GONZALES: I have a slightly different perspective in my current role as the president of the college and can only speak as an authority to that which I am directly responsible. Nevertheless, it is hardly likely that most technicians within the HTM industry would assert their unfamiliarity with the potential pitfalls that could have been averted had they been granted the Right to Repair a device. PALMER: It is hard to choose just one. As a national company, MMS works with clients ranging from clinics to hospitals. We see how the Right to Repair affects our clients, especially the critical/rural access hospitals. As well as the smaller, independent health care facilities. Due to the geographical areas, they are delayed much longer than their acute care counterparts. Third-party organizations are restricted even further. Owners not only 42 TechNation | February 2024

Jeff Smith Elite Biomedical Solutions

Matt Tomory Innovatus Imaging

Andrew Ulvenes Renovo Solutions

should have access to the necessary tools and diagnostic equipment, but they should be able to transfer access to their qualified and skilled third-party partners. SMITH: As a third-party service provider, I can think of multiple examples, but most recently we have learned that our customers have received letters from the OEM informing them that if they utilized third-party parts on the OEM’s devices, the OEM would not repair or upgrade the device unless the customer paid an exorbitant amount of money to remove the third-party parts. I am both dismayed and disappointed in our community of health care professionals that, instead of working together to serve our country’s patient population, they choose to make false accusations and charge significant monetary amounts that may potentially disrupt health care priorities. TOMORY: As an independent service organization, we engineer solutions to repair OEM MRI coils and ultrasound probes daily so we may serve health care providers, asset management organizations and even several OEMs. We are essentially the forefront of Right to Repair as we partner with these organizations as an OEM supplement or alternative. ULVENES: In my years I have seen many issues where Right to Repair has unequivocally benefited health care facilities. Supply chain resiliency is one where having multiple sources/options have proved to have better quality and faster turnaround time. In addition, service responsiveness has been lacking where in-house or third-party service providers have provided instant response because we are onsite allowing continuous operations for health care providers. Q: HOW CAN RIGHT TO REPAIR LEGISLATION PROMOTE PATIENT SAFETY? GONZALES: Right to Repair legislation offers tremendous potential to promote patient safety by fostering collaboration and knowledge sharing among key stakeholders, including original equipment manufacturers (OEMs), healthcare delivery organizations (HDOs), independent service organizations (ISOs) and others. By working together on a more evenly defined playing field, these stakeholders can clarify standards, establish uniform practices, and provide the necessary education and

training required to ensure the safe and effective servicing of medical equipment and, ultimately, patient safety. PALMER: The old saying “Time has a way of showing us what really matters.” Giving the device owner’s control would give them freedom to choose what is right for their facility or health care system. This would also give them the right to choose a qualified vendor who best suits their needs. Delay in service equals time lost. Time lost equals compromised care. Reducing inefficiencies in health care would be a win for all. PROCTOR: First, I believe that the health care delivery organization has the best and most complete view of patient safety. Right to Repair ensures they have the ability to make choices to repair equipment faster and have more in-house capacity to keep critical devices running. We found that most hospital-based biomeds have had to delay patient procedures because of equipment downtime, downtime they say would be alleviated through Right to Repair. Secondly, there are a set of important safety issues which are caught in an impasse because they involve a false choice between repair access and safety. Manufacturers want to end device alteration, but are pushing for rules which do that by increasing their control on who does repairs. That’s just not going to work. We have a similar fear in the world of cybersecurity which clearly negatively impacts all of us. We need a solution, but one that doesn’t create more control for manufacturers over devices. Once we strike the right balance, we can move forward on all these fronts. SMITH: The momentum continues to build for the Right to Repair cause. It is my opinion that it is one of the most critical fights for patient safety. As a registered FDA company, Elite consciously chooses to certify to ISO 13485 and ISO 9001, and closely follow the FDA’s 21 CFR Part 820 guidelines. I am absolutely in favor of requirements that demand all OEMs and third-party servicers adhere to the same standards. TOMORY: HTM staff are already successfully and safely repairing and maintaining their own equipment using a variety of resources. Imagine the increase in efficiency if they are provided the same tools and documentation as the OEM. ULVENES: Legislation must create an even playing field for medical device service/support in order for health care facilities to deliver consistent patient care. The right equipment, at the right time, for the right patient care is critical for patient safety. Data and evidence exists that shows how delays in care create increased mortality and morbidity. Less choices and options will create patient care delays that increase risks to patients.

Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT RIGHT TO REPAIR? GONZALES: Ensuring the Right to Repair issue does not become overly polarizing is crucial for fostering positive and necessary change in the health care industry. By allowing individuals and health care providers access to repair, modify, or customize medical devices and equipment, we can enhance patient care, reduce costs, and expand innovation. It is essential to strike a balance between protecting proprietary information for security reasons and empowering stakeholders with the necessary tools to maintain and repair critical medical technologies. By adopting a collaborative and inclusive approach, we can address concerns from all sides and drive progress that benefits patients, health care providers and the industry. PALMER: The Right to Repair could enhance not only patient care and patient safety but promote sustainability. Right to Repair could help reduce electronic waste and replacement costs. Legislation could provide cost savings, which is critical in today’s economy. It is especially critical to help our rural hospitals from shuttering. Skilled technicians can be easily trained to maintain and repair these devices just as the OEM techs have been trained. We should never forget that someone’s loved one is counting on this equipment to be working and ready to go 24/7 and 365! PROCTOR: Right to Repair has passed in six different states for a range of devices ... but so far, not medical devices. If we want that to happen, we need more people to raise their voices. SMITH: Right to Repair is everyone’s responsibility. It is imperative that we all be accountable and strive for the highest of level of patient safety. That’s why all of us chose this field. TOMORY: There is always a place for the OEM when developing and supporting a successful in-house program. I believe the best path forward for Right to Repair is cooperation between manufacturers and HTM teams to ensure safe, effective and economical equipment repair and maintenance. ULVENES: Everyone’s voice is important, and each person can make an impact. I encourage all to get involved and help make sure the Right to Repair effort is supported. We all have the common goal: providing safe and available medical devices for the best patient care. Let’s rally together and make sure we continue to advance this together. February 2024 | TechNation 43

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COVER STORY

Legislative & Regulatory Changes in HTM Some Change, But Not Enough By K. Richard Douglas

46 TechNation | February 2024

he DIY movement could be said to have expanded and contracted simultaneously. The expansion can be found in the sheer numbers of resources available to DIY’ers in terms of information found on the Internet and video content created for that population. The contraction has come by way of the decreasing number of people interested in working with their hands, using tools and learning the trades. Thankfully, there is still a faction of people who enjoy fixing things and completing home improvement projects by working with their hands. They keep companies that sell tools, calibration equipment and raw materials in business. Many in the DIY community also like to repair and maintain items they own to extend a device’s usable lifespan, or to simply repair something that has stopped working. Often, information to achieve this end can be found online in content that other DIY’ers or professionals in the trades have posted as written content or as videos. These home-fixit DIY’ers, along with technicians in repair shops and biomedical technicians all believe that they have a right to repair, with access from the manufacturer to the information and parts needed to achieve that end. Manufacturers have often argued that the parts and repair information for their products, such as farm equipment, cellphones, tablets and other products is proprietary. The only way to compel manufacturers to share the information and parts needed to do many repairs is

through legislation. Lawmakers are working throughout the year in state legislatures and at the federal level to craft new laws and review regulations. Lawmakers can also address the growing threat of cyberattacks and craft laws that address the many needs of cybersecurity and codify cybersecurity practices into health care practices and everywhere else that feels the impact of cybercriminals. Other regulations and policies are either enacted, sunsetted, revised or proposed. Some of these may impact biomeds and many don’t go through the legislative process, but result from actions by government agencies. SOME SUCCESSES Those who have been actively lobbying legislators on behalf of the Right to Repair movement have seen some victories result from their efforts in the past year. “Right to Repair had a banner year,” says Nathan Proctor, senior director, U.S. PIRG Campaign for the Right to Repair, referring to 2023. He says that 30 states had active legislation and five states enacted new laws. “First a consumer electronics Right to Repair bill was signed in New York, followed by a farm equipment law in Colorado. Minnesota then passed the broadest consumer and commercial equipment law to date. Next, California passed the strongest consumer device Right to Repair law we’ve seen so far. Next, voters in Maine decided, by a margin of 84 to 16 percent, to require car makers to allow access to repair data transmitted wirelessly,” Proctor says. Although the trend bodes well for right to repair in the general sense, Proctor says that so far, medical devices have not been included, other than a measure concerning power wheelchairs in Colorado. “But as more and more people

become comfortable with the idea of right to repair, it has opened opportunities for us to make the case around medical devices,” he adds. MEDICAL DEVICE RIGHT TO REPAIR STALLED Many biomeds have experienced that moment in their careers where there is a sense of frustration as they are handcuffed figuratively by restrictions on access to parts or schematics/ diagrams and the phrase “right to repair” becomes very real. Just like the frustration of the DIY enthusiast, who just wants to repair something themselves, or the electronics technician who relies on information or parts from the manufacturer to make repairs, the biomed may just need to get a repair done quickly and outside forces hamper their best efforts. The only solution is legislation that would compel the manufacturer to change their policies and recognize those in the after-market or repair industry with support to facilitate repairs. While there hasn’t been much movement in legislation that directly benefits biomeds, there have been important developments within the Right to Repair movement, and as the old saying goes, “a rising tide lifts all boats.” The momentum gained in some areas improves the chances for favorable results in others. Yet, those who go to bat for the entire Right to Repair movement have been disappointed that more focus hasn’t been put on medical device repair and maintenance. With the recent victories in car repair and farm equipment repair, the focus for legislators needs to be on the smaller, yet equally important, medical device repair and maintenance industry. “Although it varies by state, momentum has been building at a federal level regarding the Right to Repair, pertaining to medical devices.

February 2024 | TechNation 47

COVER STORY Manufacturers use copyright laws to protect service information so users may not have access to important service information. Some states may have a Right to Repair law that may or may not include medical equipment. However, many states may not have enough leverage to induce manufacturers to comply,” says Barry Kohler, senior project officer in device evaluation at ECRI. He says, for example, ECRI is aware that California and New York opted to not include medical devices in their right to repair laws. “The Federal Trade Commission solicits input on renewing the Digital Copyright Act every three years. There is a window open for comments until December 22, 2023. The current administration seems more amenable to Right to Repair issues than previous ones. An exception to the digital copyright act for medical devices may reduce barriers to obtaining manuals and passwords required to properly service medical equipment,” Kohler says. (He was interviewed in early December for print deadline purposes.) But, while the environment is becoming more favorable for the Right to Repair movement at the federal level, many states continue to exclude medical devices. “Medical Right to Repair remains stubbornly elusive. We had a comprehensive bill which included medical equipment filed in Delaware by the Minority Leader (Republican), but the Speaker (Democrat) refused to move to a vote for purely political reasons. Bills in North Carolina and California for medical failed to advance. AdvaMed has been a very aggressive opponent and has really dominated in lobbying. More comprehensive bills which may be able to retain medical equipment are possible, but we doubt they will survive the first set of lobbying where legislators will be told that consumers will do their own pacemaker repair. Not joking,” says Gay Gordon-Byrne, executive director of The Repair 48 TechNation | February 2024

Association. Apart from state legislatures, the federal government hands down rules and regulations that impact HTM. Proctor says that the impacts of a potential rule from the FDA on remanufacturing or cyber are significant. “The remanufacturing rule would outline the conditions under which a device repair crosses the line and involves alteration. Because alteration might result in a device being unsafe or unpredictable, it would then be subjected to the standards the FDA puts on new devices (which also includes paying FDA device manufacturer fees),” he says. Proctor says that the idea that people shouldn’t be deploying unpredictable and untested medical devices is not controversial, but there is controversy in this rule. “It stems from the fact that the FDA doesn’t direct manufacturers to share enough technical information to biomeds to know exactly what might alter the device – and the draft rule gives manufacturers the ability to tattle on biomeds who they feel are in violation. This creates a terrible incentive for manufacturers to restrict critical information, retaliate against competitors by accusing them of altering devices when the biomeds servicing them don’t even have the information to perform service work exactly as the manufacturers would recommend,” he says. “I, and other Right to Repair advocates, feel the only responsible path forward is to require manufacturers to share all the necessary service documentation with biomeds, so they have clear information about what the intended service is supposed to look like. Then, if the biomeds have that information and still make changes to the device, the FDA could step in and stop that,” Proctor adds. RECENT LEGISLATION A breakout of the initiatives voted on by state legislatures, and the more limited laws added to the books, finds that many include a narrow interpreta-

tion of what the consumer can do or which market the law applies to. Also, it appears that some politics have crept into the process. “Colorado has statute now covering ag (agriculture) and a separate law for powered wheelchairs,” Byrne says. She says that New York has a law unclearly limited to consumer electronics. “It is unclear because the law that was passed by the legislature included electronics used by business, industry, government, education, etc. but the governor wouldn’t sign it unless B2B and B2G products were exempted. The dilemma is obvious – if I buy a business-class laptop for my LLC consulting business – is that product covered by statute? What about a doctor, lawyer, baker or deli,” Byrne says. Byrne says that Minnesota has the broadest statute of all – including most everything in high-tech used by consumers and business under the logic that the buyer of the equipment is entitled to fix their owned equipment. “For purely political reasons, the statute does not include agricultural equipment, medical equipment, fire alarm equipment and a few other oddities,” she says. Byrne says that California passed a law covering mostly consumer products, including CE and home appliances. “Several of the largest of the Silicon Valley OEMs changed their marketing to support legislation, in exchange for some not so wonderful concessions. We won’t know how these concessions will function in the real world. Two of the largest loopholes were pushed by Apple – one to allow Apple to continue to require they control ‘parts pairing’ and the other to set the start date back to July of 2021 – which only makes sense of requiring access to spare parts in the context of late-model equipment,” Byrne says. She adds that there are several bills that were partially passed in

“ I, and other Right to Repair advocates, feel the only responsible path forward is to require manufacturers to share all the necessary service documentation with biomeds, so they have clear information about what the intended service is supposed to look like. Then, if the biomeds have that information and still make changes to the device, the FDA could step in and stop that.” – Nathan Proctor, senior director, U.S. PIRG Campaign for the Right to Repair

2023 and expect to finish up in 2024. “Both Vermont and West Virginia are halfway done with bills to restore repair options for agricultural equipment. Most states are in the ‘short’ session of a two-year legislature – so relatively few new bills will be filed although we will see several filings that have been underway for a while,” Byrne says. NEW RULES AND CYBERSECURITY CONSIDERATIONS Beyond Right to Repair legislation, other rules, regulations and policies may impact HTM professionals or point to best practices. “Section 3305 of the 2023 Omnibus spending bill placed new requirements on medical device manufacturers, mostly as it pertains to approval for new or significantly updated devices. One change to be aware of is the FDA now requires a Software Bill of Materials (SBOM) from medical device manufacturers,” Kohler says. He says that the SBOMs are lists of the software components within a device. “Collecting this may aid in the risk assessment of medical devices. End users may be able to obtain them from their device manufacturers,” Kohler says. On the topic of cybersecurity, he says that the Cybersecurity & Infrastructure Security Agency (CISA) maintains a list of cybersecurity

vulnerabilities. These vulnerabilities are often tied to software components which can be used in medical devices. “When CISA reports a known vulnerability, it can be difficult to identify the devices impacted. Often there is a delay while that information trickles from the discovery of the zero-day exploit, to the device manufacturer, to the end user. The SBOMs may allow faster notification to the manufacturers and allow end users to link devices to software components to known vulnerabilities in a more timely manner,” Kohler says. He says that the new requirements apply to new device approvals. “It would be easier for manufacturers to simply apply the same policies for cybersecurity to all their devices. So SBOMs may be submitted for legacy devices, as well as new submissions. Currently it is not well understood how the gathering of SBOMs will be implemented in a way that disperses actionable intelligence. ECRI has received reports that some manufacturers are providing SBOMs to customers,” Kohler adds. Adding to what he has already stated about manufacturers providing biomeds with service documents, Proctor says that the risks on the cybersecurity guidance are very similar, but there are some key differences. “If we set up a cybersecurity best practice that allows the manufacturer

to control who accesses the equipment, say through a proprietary service key, that increases their ability to monopolize service. True cybersecurity best practices involve all hands-on deck – a hospital might be more able to manage cyber risk than the manufacturer – they certainly have more incentive,” Proctor says. He says that it’s the hospitals and other health delivery organizations that are targeted in the attacks. “We see manufacturers in the marketplace with a clear business plan to capture as much connected service revenue as possible, and in order to ensure a healthy marketplace, we can’t let cybersecurity become an excuse for manufacturers to monopolize access to devices. This model, known by security experts as ‘security through obscurity’ is both a bad business practice, and a bad security practice,” Proctor says. On the Right to Repair front, hope can remain that a rising tide is set to benefit the HTM community, so it can join farmers and home mechanics. Cybersecurity will remain a growing concern and will evolve into the need for a growing body of knowledge. Some of that information will be the topic of the March TechNation cover story. In both Right to Repair and cybersecurity, there are experts working tirelessly to move the needle forward.

February 2024 | TechNation 49

EXPERT ADVICE

CAREER CENTER

When the Team Feels Overshadowed by Manager

W BY KATHLEEN FURORE

orking on a team project has pros and cons – one con being that a team leader can often take charge in such a way that others on the team don’t get the opportunity to shine. How can someone who feels they aren’t being given the chance to contribute handle the situation?

According to Jeff Mains, CEO of Champion Leadership Group LLC, a company that specializes in cultivating leadership skills and fostering collaborative environments, it isn’t an unusual situation to find yourself in. “I’ve often seen that it’s common for a leader to inadvertently overshadow others, limiting their chance to shine,” Mains says. “This makes it more difficult for others to show off their abilities.” That doesn’t mean the situation can’t be remedied. As Mains says, “There are several useful strategies to deal with this team imbalance in these kinds of situations.” What are some of those strategies? Here, experts share some tips. Demonstrate expertise and show initiative. Mains calls this a crucial step in mitigating the problem. “This could involve volunteering for tasks that align with one’s strengths or taking the initiative in specific areas where contributions haven’t been explored,” he explains. “Showing initiative can earn the trust of the team leader and the team, gradually carving out a more prominent role.” Communicate openly with the team leader. This goes hand-in-hand with demonstrating expertise and showing initiative, and it is an essential step for anyone who wants to address the feeling of being undervalued, according to 50 TechNation | February 2024

Jonathan Rosenfeld, founder and managing attorney at Chicago-based Rosenfeld Injury Lawyers. “Express your interest in making a more significant contribution and inquire about specific tasks or responsibilities that align with your skills and expertise,” Rosenfeld suggests. “By voicing your desire to actively participate, you demonstrate your commitment to the team’s success and your eagerness to contribute meaningfully.” Seek feedback. This is one way to discover valuable insights into expectations the team leader has, as well as areas where improvement may be needed, Rosenfeld explains. “Understanding the leader’s perspective allows you to tailor your efforts more effectively and align them with the overall goals of the project,” he says. Leverage the team leader’s strengths to enhance your own contributions. “By aligning personal strengths with the leader’s expertise, individuals can propose collaborative approaches that capitalize on everyone’s abilities,” Mains says. “This not only ensures a more inclusive project but also showcases the value of a collective effort, reinforcing the team’s overall success.” Collaborate with your peers. Building strong connections with your team members is essential, Rosenfeld says. “Actively engage with your peers, offer to collaborate on tasks and contribute to group discussions,” he advises. “Collaboration not only enhances the overall team dynamic, but also provides opportunities for you to shine in a collective setting.” Kathleen Furore is a Chicago-based writer and editor who has covered personal finance and other business-related topics for a variety of trade and consumer publications. You can email her your career questions at kfurore@yahoo.com.

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February 2024 | TechNation 51

EXPERT ADVICE

20/20 IMAGING INSIGHTS What’s That Noise, Part 2

BY TED LUCIDI, CBET

ast month, we presented information on a commonly encountered image quality issue in the clinical environment. Whether you prefer the term EMI, RFI, or environmental noise, the manners in which Radio Frequency Interference can affect image quality can cause clinicians great frustration. As a former in-house service engineer supporting diagnostic ultrasound, I found these issues to be the most time-consuming and most-frustrating, but the most-rewarding when solved.

Since 2000, Innovatus has successfully repaired over 185,000 ultrasound probes. As part of our data-driven repair processes, we track and trend data such as reported problem, modes of failure, root cause, corrective action, and when the failures occurred in the probe’s life cycle. I thought that it would provide some relevance and credibility if I shared just how common this issue is. Since the writing of last month’s column (less than 30-days ago), Innovatus has evaluated hundreds of ultrasound probes. Over 60 probes, in 1-months’ time, had a reported problem of “noise artifacts.” With a high degree of confidence, we can say that less than 5% of probes sent in, with a reported problem of noise artifacts, actually have a hard, internal failure affecting noise sensitivity. Of the fractionally small segment which were probe-related, failures to the shielding were the primary root cause. Examples are: • Assemblies designed to secure braided shielding have loosened over-time.

52 TechNation | February 2024

• Set screws, securing shielding within the handle of a TEE probe have loosened. • Accidental cable pulls have broken braided shielding from an internal ground plane within the connector electronics or scanhead electronics. • Cable roll-over damage has compromised the integrity of the braided shielding within the wiring harness. • Trauma to the scan head has broken solder joints of copper shielding surrounding the scanhead electronics and acoustic array. Based on our data, greater than 95% of the reported noise artifact issues would be non-probe-related factors. Following are some real-world scenarios and first-hand experiences that my colleagues and I have experienced in our 30-some years in the ultrasound industry. Scenario 1: 1-month of troubleshooting, numerous probes swapped/replaced, scanner hardware replaced, and noise artifact persisted when using a single probe model until someone disconnected the ethernet cable from the rear of the scanner. Findings: A faulty network cable was acting as an antenna and created a pathway for excessive RF noise to enter the scanner. Solution: Replacing the network cable resolved the problem. Scenario 2: Every time scans were performed in a certain area, noise artifact was present when using a select few probe models. When used in this area, the system was connected to an external monitor via an external video cable (often common in OB/GYN settings). Findings: Visual inspection of the video cable revealed roll-over damage which damaged the braided shielding. Solution: Replacing the cable (or disconnecting the video cable from the scanner) resolved the problem. Scenario 3: 1-month of troubleshooting, numerous probes swapped/replaced, different scanners swapped into the same location and still, noise artifact appeared sporadically through-

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February 2024 | TechNation 57

EXPERT ADVICE

THE FUTURE

Use Your Industrial Advisory Committee

BY STEVEN J. YELTON, P.E., AAMIF

s I write this column for the February 2024 issue, we are beginning our holiday break for 2023. When we return to school in winter for what we call our spring semester, we will also begin preparation for our new 2024 school year which begins in September of 2024. The reason I mention this is that I fell it’s a good time to revisit the need and the benefits of the Industrial Advisory Committee (Advisory Committee). I have mentioned that our program remains relatively small but solid for the past 30-plus years. In order to make the program more efficient, it was made a major off of the electronics program. We do still maintain an HTM specific advisory committee. This committee has been instrumental to the success of our program. Without the support of our advisory committee not only their time but also donations of equipment, hiring of students and graduates and donation of supplies, we would not have survived over the years. As I read Joie’s December 2023 column “HTM Hot Topics Going into 2024,” it just reinforced the need for industrial advisory committees. She mentioned topics such as: Artificial Intelligence, Cybersecurity, AR/VR, Right to Repair and staffing struggles. I believe she is right on track. As I read these, I realize that we are going to have to train the next generation of HTM technicians to meet these challenges. From the standpoint of the college and the employers, we need to work together to adequately get this information out. I rarely have a conversation with my advisors without most of these topics being mentioned. As a side item, many of the advisors and

58 TechNation | February 2024

I meet on a monthly basis. These are informal except for a couple of times a year when we have “official” meetings. These meetings allow us to bounce ideas off of each other. This isn’t always college related. It gives the rest of the group time to share ideas and concerns with each other from their workplaces. The advisory committee meetings are beneficial to the advisors as well as the college for many reasons. These reasons include, but aren’t limited to, idea exchange and staffing help. I rely on advisors and employers to help teach many of these emerging hot topics. We often meet at a local hospital where HTM professionals volunteer their time to meet with our students and talk about these items. They make equipment and expertise available to us. We have had a cybersecurity program and courses at the college for many years, however there are only a limited amount of HTM related topics available in these classes. The use of the committee members is paramount in importance for the HTM students. Some of our local hospitals have hired HTM cybersecurity technicians. These technicians have had extensive training and experience in related cybersecurity topics and are willing to share this experience with our students. Unfortunately, the amount of cybersecurity training is limited in the standard HTM courses. I would like to mention the benefits that the Industrial Advisory Committee members tell me that they realize. These members find our meetings to be a forum for them to discuss issues and solutions with members from other hospitals as well as related businesses. We are a tight knit group in Cincinnati, and this group helps each other in many ways. We feel that we provide an advisory committee of sorts for the HTM managers in the area. I find it very enlightening to listen to the conversations that occur in our meetings.

In working on the development of the educational standard within AAMI, it was decided by members of the working group that an advisory committee should be utilized by all HTM programs no matter their level. It is also required of programs that are interested in attaining accreditation from the Technology Accreditation Commission for the Accreditation Board for Engineering and Technology (TAC-ABET). When a program is being reviewed for accreditation, they must show minutes from their industrial advisory committee meetings. They must also show where they have used the input from their committee in the development of their courses as well as their curriculum. It is also advised that when the program evaluator from TAC-ABET visits the program, a meeting is scheduled for the evaluator to meet with advisors usually without program personnel present. This is all done to make sure that the advisors are utilized properly. In conclusion, it is not a secret that I am a big fan of advisory committees of all types and they have enhanced my career. Many of my advisors have become close friends over the years. Steven J. Yelton, P.E., AAMIF; is a senior HTM engineer for a large health network in Cincinnati, Ohio and is a professor emeritus at Cincinnati State Technical and Community College where he teaches biomedical instrumentation (HTM) courses.

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diagnostic-solutions.com February 2024 | TechNation 59

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CYBERSECURITY

YOUR MEDICAL DEVICE HAS AN AI - AI, AI, UH-OH!

BY STEVEN HUGHES

dvances in Artificial Intelligence (AI) and Machine Learning (ML) have drastically improved the speed, scale and automation of many tasks not only in medical devices, but also in many aspects of technology. Currently in medical devices AI/ML has been in use for years in diagnosing arrythmias by utilizing algorithms based on known data sets, EKG analysis, medical transcription and providing initial readings and findings in cardiology, dermatology, laboratory medicine, oncology, pathology and radiology. All of which require confirmation of the analysis by a clinician. These solutions are currently hard coded, but newer iterations will soon hit the market working on updated data sets, increased automation of processes and may even adapt and learn from real-world use and evolve over time from its original intended use. To ensure the integrity of the analysis and data used there are some great guidelines recently made available.

FDA Currently any AI/ML-based software that is intended to treat, diagnose, cure, or prevent disease or other conditions are considered a “Software as a Medical Device” (SaMD) under the Food, Drug and Cosmetics Act. The U.S. Food and Drug Administration (FDA) has authority to regulate SaMDs and has implemented several policies intended to guide the industry in safe practices for the development and use of SaMDs in the U.S. The FDA has also recently issued guidance specific to AI/ ML in medical devices. The FDA, in cooperation with Health Canada and United Kingdom’s Medicines and Healthcare products Regulatory Agency, released “Guiding Principles” for the use of AI/ML in medical devices on Oct. 27, 2021. The Guiding Principles are not regulations, but guidelines for the safety and efficacy in medical devices that employ AI/ML and provide a starting point for the health care industry to work together to promote Good Machine Learning Practices. To date, the FDA has cleared ~700 AI/ML-based SaMDs with most devices in Radiology (77%), Cardiology (10%), Neurology (3%) and Hematology (2%) with more being added every month (see QR code 1). 60 TechNation | February 2024

In January 2021, the FDA released the Artificial Intelligence/Machine Learning (AI/ ML)-Based Software as a Medical Device (SaMD) Action Plan (see QR code 2) that includes a framework for “Algorithm Change Protocol” to implement changes in a controlled manner that manages risks posed to patients focusing on SaMD which is also relevant to QR Code #1 Software in a Medical Device (SiMD). AI/ML functionality and development has exponentially increased in recent months because of the development of large language models (LLMs). LLMs are AI models that are trained on very large datasets, enabling them to sift, recognize, summarize, translate, predict and generate content on. Some familiar LLM platforms are ChatGPT, Claude, Llama, PaLM, etc. Currently, QR Code #2 no device that uses generative AI or artificial general intelligence (AGI) or is powered by LLM has been approved. EXECUTIVE ORDER President Joe Biden on Oct. 30, 2023, signed an executive order (EO) called the Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence (see QR code 3) to establish the first set of standards for using AI in health care and other industries. Just like how advances in technology and use of the Internet have dramatically changed the landscape of health care, the use of AI and ML are destined to do the same. The EO seeks to find that balance between managing potential risks of AI while encouraging innovation that can benefit consumers and the EO’s many directives depend heavily on agencies and companies that have been called to assist with their development and rollout. The EO uses the definition of AI as “a machine-based system that can, for a given set of human-defined objectives, make predictions, recommendations or decisions influencing real or virtual environments.” The scope of the EO is not just limited to generative AI or ML technologies instead, the EO has the potential to QR Code #3 affect any machine-based system that can make decisions, recommendations or predictions based on data. The EO outlines principles that agencies must follow when

designing, developing, acquiring, securing and using AI in the federal government. HSCC The Health Sector Coordinating Council (HSCC) published a 35-page white paper: “Health Industry Cybersecurity-Artificial Intelligence Machine Learning (HIC-AIM)” which provides an overview and discussion of 9 specific cybersecurity considerations for the implementation of AI /ML. Covering cybersecurity signal detection, continuous monitoring, evaluation, patching, disposition and considerations when implementing an AI/ML system in a health care environment while ensuring that the system has an Explainable Artificial Intelligence (XAI), an understanding of how it works for its developers and users and QR Code #4 validating quality data to confirm correct results (see QR code 4). GOVERNING AI There are also several privacy and security related concerns that need to be considered that fall under Health Insurance Portability and Accountability Act (HIPAA) regulations, the U.S. Federal Trade Commission’s (FTC) and HHS health breach notification regulations, the EU’s General Data Protection Regulation (GDPR) and various state laws and regulations that require heightened privacy and security mechanisms for certain classes of information like genetic information. The FDA oversees AI/ML in health care, but there are additional laws, regulations and guidance to be considered that can set off a chain of reaction to any changes of intended use. When a variation of a software product is used for diagnosis or treatment, the process of reimbursement will also need to be reviewed by a Medicare Administrative Contractor (MAC). If a new product is “similar” to another product already on the market an analysis of Current Procedural Terminology (CPT) and Healthcare Common Procedure Coding System (HCPCS) codes like IDC-10 will provide potential reimbursements and an analysis of Local and National Coverage Determinations will need to be performed. Medical Device Manufacturers (MDM) must consider the totality of these laws and regulations for their SaMD and build their software with the relevant privacy and security protections. The NIST GAI Public Working Group was launched in June 2023 to help address the opportunities and challenges associated with AI that can generate content, such as code, text, images, videos and music. The public working group will also assist NIST develop key guidance to help organizations address the special risks associated with generative AI technologies and the potential to revolutionize many industries and society working with the National Artificial Intelligence Advisory Committee more information on their work can be found at https://ai.gov/naiac/.

SECURITY CONCERNS & DATA POISONING The promise of AI/ML introduces vulnerability to intentional attacks that involve data poisoning, model replication, evasion and exploitation of traditional software flaws designed to alter, deceive, manipulate, compromise and render them ineffective. Organizations adopting AI/ML systems need to be aware of these potential vulnerabilities before implementing. AI/ML also presents other challenges including potential bias based on the algorithms used that are introduced by utilizing very large data sets and the difficulty of evaluating the safety of AI-driven products and services while maintaining privacy and security of the data involved. These must be continuously evaluated and assessed to ensure the safety and integrity of AI/ML driven products and services. SaMD utilization for diagnosis and treatment may also require the access, storage, and use of personal identifiable data, depending upon the organization creating the data, from which country the data is collected, how it is regulated, and what U.S. federal and state laws, and international laws and regulations may also come into play. It is imperative that medical device manufacturers and software development consider the totality of these laws and regulations for their SaMD and build AI/ML software with relevant privacy and security protections and be transparent with their customers. FUTURE USE OF AI AI/ML promises to efficiently assist clinicians in their day-today activities to compile, review and analyze data gathered on their patients, provide workflow analysis, and make educated inferences as to what that data means to the patient and thus how to treat the patient or cure the disease. The applications of AI/ML in healthcare technology are potentially endless but with this potential, there is also risk. In managing this risk involves a full understanding and proper implementation of the broad array of laws, regulations and guidelines that govern these new technologies to provide safe secure equitable efficient health care with full transparency to end users and patients. AI/ML has the potential to access multiple sources of compiled data to reveal known patterns in disease and provide a proper assessment and treatment as well predict an individual’s potential risk of future diseases and provide a preventative care plan all while analyzing and optimizing workflows to maintain safety, privacy and security, reducing costs, reducing wait times, reducing turnaround times of treatment, and improving overall health care delivery. The advancement of AI/ML in health care is inevitable and it is our responsibility to shape its future and proper use.

Steven Hughes, FAC-COR, FACP/PM, VHA-CM, is a VISN 21 biomedical engineer with the VA Sierra Pacific Network. February 2024 | TechNation 61

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HIMSS

ONC Publishes HTI-1 Certification Final Rule

he Office of the National Coordinator for Health Information Technology (ONC) published the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule on Dec. 13. The new rule requires new and updated standards, implementation specifications and certification criteria for electronic health records and health information technology modules for certification through the ONC certification program.

Most notably, the final rule mandated that certified Health IT must adopt version 3 of the United States Core Data for Interoperability (USCDI v3) no later than Jan. 1, 2026. The USCDI v3 standard, which consists of health data classes and constituent data elements required to facilitate interoperable health information exchange, is currently available and can be implemented sooner than the deadline by health IT developers and their customers. HIMSS recommended a Jan. 1, 2026, deadline to allow for time to successfully complete the extensive work required to implement and test the new and revised criteria across the health care ecosystem in a manner ensuring that quality, safety and patient privacy would not be compromised; and that health care delivery sites caring for underserved communities were not left behind. The implementation of new standards and certification criteria associated with USCDI v3 were also delayed. “HIMSS applauds ONC on the release of today’s HTI-1 final rule, which takes a realistic path to achieving greater information sharing to aid patient safety and accelerates digital health transformation in the U.S.,” said Tom Leary, senior vice president and head of government relations at HIMSS. “We

62 TechNation | February 2024

appreciate ONC listening to stakeholders to establish a timeline to successfully complete the extensive work required to implement the new and revised criteria in a manner ensuring that quality, safety and patient privacy are not compromised; and that health care delivery sites caring for underserved communities aren’t left behind.” The rule also establishes: • Certification criteria establishing requirements for providing the source attribution for predictive algorithms called “decision support interventions” that are part of or interact with health IT and health IT modules seeking certification. These requirements include mechanisms to allow end-users to provide feedback through a web-based tool. These new requirements will need to be implemented no later than Jan. 1, 2025. • The establishment of the “Insights Condition” EHR reporting program, which includes measures and reporting periods for health IT developers looking to maintain certification for their health IT and health IT modules. • Modifications to the Information Blocking requirements for the developers of certified health IT, including modifications to the Feasibility Exception (requiring the uncontrolled event to be directly responsible for information blocking activity to meet the exception) and the Content and Manner Exception, which will allow actors to provide requested information using TEFCA even if that isn’t the manner requested by the party seeking the requested information. ONC will host a series of listening sessions to go over the provisions of the HTI-1 final rule. In addition, HIMSS will publish a series of resources to help the community understand the provisions of the HTI-1 final rule on the HIMSS 21st Century Cures Act resource page in the coming weeks. For more information, visit himss.org/global-conference.

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I stretche rs. When repair beds and PMs on “I was hired to I started doing ine on beds, ing my 1/6/23 wasn’t working U.S. Navy submar manual s, expand 9:08 AM 15,000 reading tech ons. equipm ent and can load up with ent and its operati at the biomed equipm time in the knowle dge of pounds of food dge during my knowle deploybiomed a Also, I gained beginning of he says. ion the submar ine,” l cans, such a firm foundat U.S. Navy on ment. Aeroso nce provide d ant or His military experie as spray deodor does today. not training in for the work he hair spray, are 19 years of military be brought “I did have my as well as my authorized to was very helpful, to life of a electronics, which onboard. The gave me the ability a submar iner, is unique in succeed as a experie nce as submariners to tion id informa absorb the require many ways. Submar It Sanlin says. our shifts. SPO biomed tech,” operate in eight-h ay, TL IGHT ners, when underw AND OFF nity. ON THE JOB is a tight commu PROJECTS – led to his current experie nce that ing as part of The accumu lated ibility for oversee lot of knowle dge in the respons also take on a That Submar iners to learn and compre position resulted his health system. ine. This ability g campuses at four includin at s ions; life on a submar biomed profess . es well to other several projects telemon hend translat has include d es [to] Philips upgrad out major two system biomed . “I manage d 1996. After getting dge of the Philips U.S. Navy until biomed “I served the systems . My knowle Banner Baywoo d helped working as a itor job a for I looked upgrad e at of of the U.S. Navy, during the last r I ended up taking time and ahead Chicago, howeve upgrad e in record resolve d 2002,” says technician in complete the technician in needed to be d issues that a field service ng d and Heart another job as schedu le. I identifie Also, at this time, I am managi III, Banner Baywoo e. three Larry Sanlin, BMET Arizona . to finish the upgrad call systems at Health in Mesa, ment of the nurse s. laid off from the Hospita l, Banner a total replace Goldfie ld) facilitie in 2009, he was job as od, Heart and Sanlin says that applied for a nurse call system, hospita ls (Baywo ian job and he om to ASCOM he technic West-C a BD day, ted from service g next field The Changin I just comple ance technician. dollar project. him to of Alaris a facility mainten director asking which is a millionto 2,600 pieces e biomed the upgrad e BY K. from says. d a call receive as a maintenance Alaris major firmwar with medium staff,” Sanlin RICHA w for a position on time RDintervie d Sanlin to step come in to DOUG LVP and PCU el also require and LAS technician. A change in personn I am a Tech III 11 years later, ge. “I was hired and manage r in a s,” he says. up to the challen s at four facilitie director and shop shop dge from his managi ng biomed “After losing my and manage the ed biomed knowle I had to step up study to get Sanlin has combin iding 30-day period, job training and a mo withcaon-thetorcyc military days n be le today. unne to where he is ers do rving in traffic n’t se when ine go e ing ov the biker. drivab le hour se llin er 20 Imag on 1/6/23 9:08 AM ge g 0 a 2023 him miles t lic mo requir | February 14 TechNation per es ne torcycle. 20 11. en se d sh on e of his quick rves That ort ly of reacti aft er bikes an “I alw on tim steel an d on a ay s d fro m Su zu he lpe d es. 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training options In addition available to the departme to managin the large nt’s tech g equipme biomed nicians. nt at team and spor ts medicine also serves more the eight hosp itals, tional thera locations than 20 orthoped py acro offering ss the physical ic They are and occu also resp Greater Houston paPhysician area. Group with onsible for equi pment at Primary Care Grou 848 physician the Spe s at 191 cialty p with 169 The hosp loca tions physician ital is affili and the NewYork s at 42 ated with -Presbyt Weill Corn locations. erian Hos Conferen ell Med pital ce icine, Methodis of the United Meth and the Texas Annual t Academic odist Chu education Institute, rch. The institute, Houston which is tialed rese has a facu a research archers. lty of 742, and with 2,110 creden-

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CONNECTED

HEALTH-ISAC

Principles and Practices for the Cybersecurity of Legacy Medical Devices

BY PHIL ENGLERT n May 2022, the International Medical Devie Regulators Forum (IMDRF) published the “Principles and Practices for the Cybersecurity of Legacy Medical Devices.” This document is cataloged as IMDRF/CYBER WG/N70. The goal was to lay out framework guidance that both medical device manufacturers and health care delivery practitioners could use as a foundation for not only identifying which life cycle phase a medical device may be in but also the responsibilities each party may have in managing the cyber-related risks for those devices.

This column will focus on the health care delivery responsibilities identified in the IMDRF paper during the support life cycle stage and provide some contextual examples so health care providers (HCP) may more consistently implement the recommendations. Before we begin the discussion, let’s start with some definitions so we are on the same page. We’ll begin with the definition of legacy devices. One definition of a legacy device is timebound. A device that is still in use after its expected useful life is exceeded. The American Hospital Association publishes an “Estimated Useful Lives of Depreciable Hospital Assets” to provide health care organizations with estimates for the productive period before assets become technically or commercially obsolete. Another definition may be technology-oriented, referring to outdated software or hardware components contained within still-active systems. Yet another approach is life cycle based. A device or technology that is outdated, unsupported, no longer in production and in need of replacement. For this paper, we will rely on the IMDRF definition of a legacy medical device as one “that cannot be reasonably protected against current cybersecurity

64 TechNation | February 2024

threats. Note that by this definition, a device or system can become a ‘Legacy’ device at any time. Whenever a new tactic, technique or procedure used by threat actors to carry out attacks emerges from which the device cannot be protected, can change a device to legacy status. The IMDRF N70 document describes four life cycle phases or stages, Development, Support, Limited Support, and EOS. This article concentrates on the Stage 2 or Support phase. Before discussing the health care provider’s responsibilities, let’s review the four phases. Stage 1 or the Development phase is a pre-market stage where the medical device manufacturers (MDM) are expected to incorporate security by design principles. These include risk assessments, threat identification, security testing, and risk mitigation to ensure devices can operate safely and securely. Health care providers have little responsibilities at this stage but may be called upon to provide input. In Stage 2 or the Support Phase, the device transitions from development to the market and is used for delivering patient care. The health care provider begins to assume some responsibilities in the support phase such as procurement, configuration, monitoring and – in some cases – patching and updating. Developing good communication practices between the HCP and MDM is essential for maintaining the most secure posture possible. Stage 3 or the Limited Support phase begins when the manufacturer declares end of life (EOL) for the product and no longer markets or sells it. During this phase, the HCP may continue to operate the device, and the device can be reasonably protected against current cybersecurity threats. When devices fall into the End of Support phase

or Stage 4, they can no longer be reasonably protected as they could in Stage 3. MDMs should communicate transitions at each stage well ahead of time and communications should identify potential risks the HCP may inherit as well as mitigation strategies and upgrade opportunities. At each stage, the HCPs and MDMs have certain responsibilities for establishing and maintaining the security posture of the devices. The N70 document contains recommendations for three responsibility areas; Communications, Risk Management, and Transfer of Responsibility, and makes clear how the responsibilities shift from MDM to HCP as the product life cycle progresses. Let’s look at the health care provider for the three responsibility areas. I encourage you to read the IMDRF N70 document to gain a solid understanding of the HCP and MDM responsibilities at each phase to better maintain a robust risk management program at every stage during the equipment life cycle. Communications between the HCP and MDM in Stage 2 can establish the flow of information habits and practices that can keep devices working safely and securely throughout it’s productive life. Just as HCPs plan for periodic and on-demand maintenance activities, they should also identify what information is needed to maintain the cyber posture of the device. Identifying the information needed for equipment already in place can help keep it operational and make cyber readiness more

efficient and cost-effective. Finding out if a device will receive updates, how often, and for how long can help you make appropriate operational, maintenance, and capital investment decisions. Use an established checklist when considering new equipment. In addition to the security questionnaire, obtain security operations information as well such as EOL/EOS dates, patch and update cycles, and update strategies for software components such as the operating systems and third-party components. Ask for the MDS2 and SBOM. Obtain secure configuration settings necessary ports, firewall rules, security scanning capabilities, security logging capabilities, and backup and restore procedures. Establishing an open and regular exchange of security information early in Stage 2 can help maximize the value while maintaining secure operations of essential patient care equipment. In the next installment, we’ll continue this discussion with a review of Risk Management and Transfer of Responsibility as presented in the IMDRF Principles and Practices for the Cybersecurity of Legacy Medical Devices.

Phil Englert is the director of medical device security for Health-ISAC.

February 2024 | TechNation 65

CONNECTED

NETWORKING NOTES Enterprise Risk Assessment for Medical Devices

W BY TONY PHAM

ithin the clinical industry, medical equipment and systems are constantly being redesigned and innovated. One main byproduct of all these designs is the increase in how many medical devices connect to a hospital’s network. Most medical equipment now either requires a network connection or at least recommend one to perform their intended functions. Couple in the growing importance of interoperability (the ability for one system to communicate with other systems) along with vendor remote support, it is easy to imagine how much traffic flows through and across each hospital’s network.

With so many machines that manage or have access to sensitive patient information on the same network, the hospital environment becomes a prized target for hackers. Since each networked device introduces vulnerabilities to other networked devices, cybersecurity measures must be enacted to mitigate any threats and vulnerabilities. At the Department of Veteran Affairs, the Office of Healthcare Technology Management (HTM) administers a Medical Device Protection Program (MDPP), in collaboration with the Office of Information Security (OIS). In short, the MDPP is a comprehensive cybersecurity initiative geared toward monitoring, mitigating, and remediating cybersecurity threats and vulnerabilities related to medical devices and systems. One of the centerpieces of the MDPP is what is known as the Enterprise Risk Assessment (ERA) that essentially determines how any networked device or system, medical and non-medical, connects to and communicates with the VA network. To clarify the importance of the ERA, any medical device that connects to the VA network must first undergo a formal investigation by the Specialized Device Cyber-

66 TechNation | February 2024

security Department (SDCD), which is a part of the OIS. It will investigate the impact of the device with support of an HTM (or biomed) team and the original equipment manufacturer (OEM). The purpose of the ERA is to document what can and cannot be done by the device on the network. As a formal process, an ERA is normally initiated by a local HTM (or biomed) before the procurement of new medical equipment. Within the scope of cybersecurity, even if an approved ERA already exists for a device, it will be considered a completely different system if it either uses another operating system (OS) version (i.e., Windows 7 vs Windows 10) or different application version. This means that it would require a whole new ERA. For example, if a medication dispensing system including a Windows 2012 server needs to have its server OS upgraded to Windows 2019, that OS upgrade cannot happen until an ERA specifically for Windows 2019 is approved if the system wants to remain on the network. An existing approved ERA for Windows 2012 would not work. However, if there are only minimal differences between an existing ERA and the desired medical equipment, such as the addition of supplemental software or a wireless component, an ERA modification can be requested. Regardless, the process for new ERAs and modifications follows the same steps. Five standardized documents must be completed to submit a new medical device/system ERA or modification request. These documents include: 1) the VA Directive 6550 Appendix A; 2) an MDS2 Spreadsheet; 3) a Medical Device (MD) Inventory List; 4) an MD Ports and Protocols Services List; and 5) an MD Network Topology Diagram. The first of these documents is the VA Directive 6550 (called a 6550 for short). It is specific to the VA and builds the foundation for why an ERA is needed as well as what the device is for. The 6550 is a general form for system details related to cybersecurity features such as FIPS 140-2 or 140-3 certification, antivirus and OS patching, data encryption capabilities and electronic health record compatibility. Overall, the information this form requests is to

be used for an initial assessment of risk and forming vulnerability mitigations needed. The HTM/biomed team and OEM should work together to complete the 6550 form prior to submission. Similarly, the Manufacturer Disclosure Statement for Medical Device Security (MDS2) spreadsheet answers questions about various topics related to the cybersecurity of a medical device/system. However, it differs in the number and depth of its questions. The MDS2 spreadsheet is a voluntary standard used by medical device OEMs to document and convey cybersecurity information about their equipment. A complete MDS2 spreadsheet may already be available from the OEM. Most of the spreadsheet itself is heavily technical and would not be known by the HTM/biomed team, so the OEM is advised to fill out this spreadsheet. This portion of the documentation can be the most exhaustive and would most likely require more time to complete than the rest of the documents, so it is recommended to start working on this spreadsheet first. The MD inventory is a detailed spreadsheet that asks for every networked device included within the medical equipment system along with any peripherals. Examples of components to the inventory list are workstations, servers, scanners, detection plates, wireless access points and much more. For each component, the ERA would like to know its device name, type, model, operating system, OS version and application name. There is also a comment section for each component in case there are important notes to make. Only the information available needs to be provided, so components without applications or OS versions can skip those data points. Otherwise, all components that contain applications should list out every application they utilize on the spreadsheet. Next, the Ports, Protocols and Services (PPS) List works similarly to the Inventory List, but it is specifically concerned with all network communication between the medical equipment system and the rest of the network. Here, every communication service (SMTP, DNS, DICOM, Custom Comms, etc.) should be listed with accompanying port numbers, protocol (TCP/UDP/IP), direction of communication, whether the communication is to an external IP address or not and reason for use. If there is communication to an external IP address outside of the VA network, the associated external IP addresses and an approved MOU# must be provided. The PPS List is extremely helpful in setting the ACL for a new

device or system. Following the PPS List, a Network Topology Diagram should be created based on the identified communication services in the PPS. The diagram contains several key pieces of information, namely the Accreditation Boundary of the ERA’s medical equipment system, all directional Communication Services as identified by the PPS, and any External Data Flow (communications to systems outside of the VA network). The Accreditation Boundary is a red box that depicts what components of the medical equipment system are allowed within the same VLAN, providing those components free and open access to each other’s ports. Outside of the Accreditation Boundary are arrows going to and coming from various objects, showing the flow of all network traffic. The traffic flow can be bidirectional, outbound or inbound. It is important to note that the ports specified in the diagram along with the direction of the arrows must match exactly with what is listed in the PPS list. Finally, the External Data Flow shows which ports are open for access to outside vendors. These should also have been detailed out in the PPS list. The information portrayed here should indicate what approved MOU these external communications are based on as well as the direction of communication. Once all these documents have been completed by the OEM with support of the HTM/biomed team, a formal ticket is submitted to OIT (specifically the OIS) by HTM/biomed to review for approval of a new ERA or modification to an existing ERA. Typically, the process of reviewing will take half a year to a full year for a new ERA while a simple modification may be completed within a few months. Throughout the process, a contact from the OIS will reach out and schedule meetings with the OEM point of contact and the HTM/biomed team for clarification of any documents and to ensure completeness of the ERA. Once the ERA is complete, both the local HTM/ biomed team and OEM are cleared to proceed with networking the medical device. The ERA will show them exactly how to do it.

Tony Pham, MS, is a staff biomedical engineer at VA North Texas.

February 2024 | TechNation 67

Tech Choice Awards ( Th e W r e n chi e

The 13 Tech Choice Awards are: 1. Professional of the Year 2. ISO Employee of the Year 3. Department of the Year 4. Director/Manager of the Year 5. YP of the Year 6. Lifetime Achievement Award 7. Humanitarian Award 8. Women in Leadership Award 9. Ingenuity Award 10. Outstanding Vendor of the Year 11. Association of the Year 12. Industry Influencer of the Year 13. Military BMET of the Year Winners will be announced in the March 2024 issue of TechNation and a supporting digital supplement. 1technation.com/tech-choice-awards

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SHOW US

YOUR SH P The Show Us Your Shop feature is where TechNation will share submitted photos of your biomed/HTM shops. Clean? Messy? We want to see them ALL! Simply post your photo on social media and use the hashtag #ShowUsYourShop. A member of the TechNation team will contact you for approval.

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“Does anyone else love/hate coming home and after working on problems all day and getting to take the dryer apart to change the thermal fuse…. Just me?”

“Late night PM the other day on this Inegenia 3T! Keeping this system imaging at peak performance.”

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72 TechNation | February 2024

BULLETIN BOARD

An online resource where medical equipment professionals can find all the information needed to help them be more successful! The easy to navigate Bulletin Board gives you access to informative blogs, expos and events, continuing education opportunities, and a job board. Visit MedWrench.com/BulletinBoard to find out more about this resource. Follow MedWrench on facebook.com/medwrench & linkedin.com/company/medwrench

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SAVE TH MD Publishing continues to offer outstanding conferences in 2024 at convenient locations across the nation! The 2024 lineup includes the Imaging Conference & Expo in Southern California, the spring MD Expo in Las Vegas, an HTM Mixer in Indianapolis and the fall MD Expo in New England.

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New England • October 8-10, 2024

HTM Mixers serve as a regional conference for HTM professionals eager to earn continuing education credits, explore solutions in an exhibit hall and network with peers. Our 2024 event is proudly sponsored by the Indiana Biomedical Society.

In line with the spring MD Expo, our fall event provides opportunities for meaningful interactions with HTM thought leaders and peers from around the nation. In addition to educational sessions, networking opportunities and an exhibit hall filled with the latest technology, service and equipment options, the fall MD Expo offers a Reverse Expo, directly connecting decision makers and vendors with valuable face-time.

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1technation.com/subscribe

February 2024 | TechNation 77

SERVICE INDEX 5

www.ambickford.com • 800-795-3062

USOC Medical

usocmedical.com • 855-888-8762

TruAsset, LLC

P P

Computed Tomography

Asset Management 31

Diagnostic Solutions diagnostic-solutions.com • 330-296-9729

Renovo Solutions

renovo1.com • 844-4RENOVO

P P

International X-Ray Brokers

77,81

KEI Medical Imaging Services Maull Biomedical Training

BCGroupStore.com • 314-638-3800

College of Biomedical Equipment Technology J2S Medical www.j2smedical.com • 844.342.5527

Maull Biomedical Training maullbiomedicaltraining.com • 440-724-7511

MultiMedical Systems multimedicalsystems.com • 888-532-8056

Probo Medical probomedical.com • 3174947872

Pronk Technologies, Inc. pronktech.com • 800-609-9802

Renovo Solutions renovo1.com • 844-4RENOVO

11 77 71 21

P P

triimaging.com • 855-401-4888

P P P

NVRT Labs Inc.

P P

Contrast Media Injectors

27 2,36,77 77

C-Arm International X-Ray Brokers internationalxraybrokers.com • 508-559-9441

Probo Medical probomedical.com • 3174947872

P P

Cardiac Monitoring Jet Medical Electronics Inc www.jetmedical.com • 714-937-0809

The Soaring Hearts Group soaringheartsinc.com • 855.438.7744

P P

Cardiology Southeastern Biomedical, Inc sebiomedical.com/ • 828-396-6010

CMMS EQ2 eq2llc.com • 888-312-4367

College of Biomedical Equipment Technology cbet.edu • 866-866-9027

Renovo Solutions

P P P

Diagnostic Imaging CM Parts Plus cmpartsplus.com • 877-267-2784

Diagnostic Solutions Innovatus Imaging innovatusimaging.com • 844-687-5100

International X-Ray Brokers internationalxraybrokers.com • 508-559-9441

Probo Medical probomedical.com • 3174947872 renovo1.com • 844-4RENOVO

Tri-Imaging Solutions triimaging.com • 855-401-4889

78 TechNation | February 2024

Cyber Security

Renovo Solutions 31

maullbiomedicaltraining.com • 440-724-7511

P P

P P P

Maull Biomedical Training

Maull Biomedical Training 51

36,83

nvrtlabs.com •

diagnostic-solutions.com • 330-296-9729

P P P

Consultancy

renovo1.com • 844-4RENOVO

rsti-training.com • 800-229-7784

Tri-Imaging Solutions

P P

P P P

RSTI

maullbiomedicaltraining.com • 440-724-7511

P P

keimedicalimaging.com • 512-477-1500

BC Group International, Inc

internationalxraybrokers.com • 508-559-9441

Biomedical

cbet.edu • 866-866-9027

77,81

cmpartsplus.com • 877-267-2784

eq2llc.com • 888-312-4367

truasset.com • 214-276-1280

2,36,77

CM Parts Plus

EQ2

TruAsset, LLC

truasset.com • 214-276-1280

TRAINING

pronktech.com • 800-609-9802

SERVICE

Pronk Technologies, Inc.

A.M. Bickford

PARTS

Anesthesia

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

P P

8 33 71

P P P

P P

77 36,83

P P

SERVICE INDEX Maull Biomedical Training maullbiomedicaltraining.com • 440-724-7511

NVRT Labs Inc. nvrtlabs.com •

RSTI rsti-training.com • 800-229-7784

Tri-Imaging Solutions triimaging.com • 855-401-4892

Webinar Wednesday http://webinarwednesday.live/ •

www.htmjobs.com •

Multimedical Systems multimedicalsystems.com • 888-532-8056

hmark.com • 800-521-6224

Multimedical Systems multimedicalsystems.com • 888-532-8056

eq2llc.com • 888-312-4367

hmark.com • 800-521-6224

aiv-inc.com • 888-587-6759

BC Group International, Inc BCGroupStore.com • 314-638-3800

J2S Medical www.j2smedical.com • 844.342.5527

Multimedical Systems multimedicalsystems.com • 888-532-8056

PM Biomedical pmbiomedical.com • 800-777-6474

Pronk Technologies, Inc. pronktech.com • 800-609-9802

USOC Medical usocmedical.com • 855-888-8762

Labratory 55

P P

P P P

P P

Mammography RSTI rsti-training.com • 800-229-7784

Monitors/CRTs

Tenacore LLC tenacore.com • 800-297-2241

Diagnostic Solutions

cmpartsplus.com • 877-267-2784 diagnostic-solutions.com • 330-296-9729

Innovatus Imaging 6 21

P P

innovatusimaging.com • 844-687-5100

P P

internationalxraybrokers.com • 508-559-9441

International X-Ray Brokers KEI Medical Imaging Services keimedicalimaging.com • 512-477-1500

Probo Medical probomedical.com • 3174947872

Tri-Imaging Solutions 6

P P

Infusion Pumps AIV

cbet.edu • 866-866-9027

CM Parts Plus

Infection Control Healthmark Industries

College of Biomedical Equipment Technology

General EQ2

Laboratory

MRI

Endoscopy Healthmark Industries

keimedicalimaging.com • 512-477-1500

ozarkbiomedical.com • 800-457-7576

36,83 38

KEI Medical Imaging Services

Ozark Biomedical

Employment/Recruiting HTM Jobs

TRAINING

ecri.org • 610-825-6000

SERVICE

College of Biomedical Equipment Technology ECRI Institute

PARTS

Installs/Deinstalls

Education/Training cbet.edu • 866-866-9027

Company Info

AD PAGE

TRAINING

SERVICE

PARTS

AD PAGE

Company Info

triimaging.com • 855-401-4891

P P

BC 77

P P

2,36,77 3

P P

33 55 27

P P

36,83

P P

Nuclear Medicine Diagnostic Solutions

diagnostic-solutions.com • 330-296-9729

International X-Ray Brokers internationalxraybrokers.com • 508-559-9441

Online Resource MedWrench www.MedWrench.com •

Oxygen Blender Tenacore LLC tenacore.com • 800-297-2241

P P

Patient Monitors AIV aiv-inc.com • 888-587-6759

BC Group International, Inc BCGroupStore.com • 314-638-3800

BC February 2024 | TechNation 79

SERVICE INDEX CONTINUED

sebiomedical.com/ • 828-396-6010

Tenacore LLC tenacore.com • 800-297-2241

USOC Medical usocmedical.com • 855-888-8762

2,36,77

innovatusimaging.com • 844-687-5100

aiv-inc.com • 888-587-6759

BC Group International, Inc BCGroupStore.com • 314-638-3800

CM Parts Plus cmpartsplus.com • 877-267-2784

Innovatus Imaging innovatusimaging.com • 844-687-5100

International X-Ray Brokers internationalxraybrokers.com • 508-559-9441

PM Biomedical pmbiomedical.com • 800-777-6474

Tenacore LLC tenacore.com • 800-297-2241

www.j2smedical.com • 844.342.5527

aiv-inc.com • 888-587-6759

Diagnostic Solutions diagnostic-solutions.com • 330-296-9729

J2S Medical www.j2smedical.com • 844.342.5527

KEI Medical Imaging Services keimedicalimaging.com • 512-477-1500

PM Biomedical pmbiomedical.com • 800-777-6474

Tenacore LLC tenacore.com • 800-297-2241

USOC Medical usocmedical.com • 855-888-8762

80 TechNation | February 2024

truasset.com • 214-276-1280

P P

aiv-inc.com • 888-587-6759

multimedicalsystems.com • 888-532-8056

AIV PM Biomedical pmbiomedical.com • 800-777-6474

31 77,81

Surgical

Telemetry

USOC Medical usocmedical.com • 855-888-8762

P P

Test Equipment 25

P P

BC 57

P P

BC Group International, Inc BCGroupStore.com • 314-638-3800

Healthmark Industries hmark.com • 800-521-6224

IMT Analytics imtanalytics.com •

Pronk Technologies, Inc.

QRS Solutions

P P

pronktech.com • 800-609-9802 qrs-solutions.com/ • 877-254-7086

Southeastern Biomedical, Inc sebiomedical.com/ • 828-396-6010

innovatusimaging.com • 844-687-5100

MW Imaging www.mwimaging.com • 877-889-8223

Probo Medical 25

P P

probomedical.com • 3174947872

P P

RSTI

55 57

P P

17 3

35 2,36,77

P P

Ultrasound Innovatus Imaging

Replacement Parts AIV

TruAsset, LLC

P P

Rental J2S Medical

eq2llc.com • 888-312-4367

Repair AIV

EQ2

MultiMedical Systems

Refurbish Innovatus Imaging

Software

P P

TRAINING

Southeastern Biomedical, Inc

P P

SERVICE

pronktech.com • 800-609-9802

PARTS

Pronk Technologies, Inc.

Company Info

AD PAGE

pmbiomedical.com • 800-777-6474

TRAINING

PM Biomedical

SERVICE

www.j2smedical.com • 844.342.5527

PARTS

J2S Medical

AD PAGE

Company Info

8 7

P P P

P P

P P P

X-Ray rsti-training.com • 800-229-7784

Tri-Imaging Solutions triimaging.com • 855-401-4890

36,83

P P

ALPHABETICAL INDEX A.M. Bickford……………………… 5 AIV……………………………… 25 BC Group International, Inc…… BC CM Parts Plus ………………… 57 College of Biomedical Equipment Technology… … ………………… 11 Diagnostic Solutions…………… 59 ECRI Institute… … ……………… 16 EQ2……………………………… 31 Healthmark Industries…………… 6 HTM Jobs……………………… 44 IMT Analytics…………………… 35 Innovatus Imaging………………… 8 International X-Ray Brokers…… 33 J2S Medical…………………… 77 Jet Medical Electronics Inc…… 59 KEI Medical Imaging Services… 55 Maull Biomedical Training…… 71 MedWrench…………………… 29 Multimedical Systems………… 21 MW Imaging……………………… 7 NVRT Labs Inc.………………… 26 Ozark Biomedical……………… 55 PM Biomedical………………… 57 Probo Medical………………… 27 Pronk Technologies, Inc. … 2,36,77 QRS Solutions………………..... 23 Renovo Solutions……………… 77 RSTI……………………………… 4 Southeastern Biomedical, Inc… 51 Tenacore LLC…………………… 17 The Soaring Hearts Group…… 51 Tri-Imaging Solutions……… 36,83 TruAsset, LLC…… …………… 77,81 USOC Medical…………………… 3 Webinar Wednesday…………… 38

February 2024 | TechNation 81

DISCOVERING THE POSSIBILITIES

SAVE THE DATE LAS VEGAS | APRIL 7-9, 2024

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