TechNation Magazine February 2022 by MD Publishing

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Vol. 13

FEBRUARY 2022

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

PROTECTING

PATIENTS

ANSI/AAMI ST91 INCLUDES HTM RESPONSIBILITIES PAGE 50

Professional of the Month: Bryant Hawkins

Company Showcase Medigate

Biomed 101 Good Is Never Good Enough

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WHAT’S INSIDE MATTERS WHAT’S INSIDE MATTERS WHAT’S WHAT’S INSIDE INSIDE MATTERS WHAT’S INSIDE MATTERS MATTERS

CONTENTS

FEATURED

PROTECTING

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TechNation (Vol. 13, Issue #2) February 2022 is published monthly by MD Publishing, 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290. POSTMASTER: Send address changes to TechNation at 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290. TechNation magazine is dedicated to providing medical equipment service professionals with comprehensive, reliable, information concerning medical equipment, parts, service and supplies. It is published monthly by MD Publishing, Inc. Subscriptions are available free of charge to qualified individuals within the United States. Publisher reserves the right to determine qualification for a free subscriptions. Every precaution is taken to ensure accuracy of content; however, the information, opinions, and statements expressed in the articles and advertisements herein are those of the writer and/or advertiser, and not necessarily those of the publisher. ©2022

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FEBRUARY 2022

TECHNATION

CONTENTS 844.879.9043 844.879.9043

PUBLISHER

John M. Krieg

VICE PRESIDENT

Kristin Leavoy

ACCOUNT EXECUTIVES

Jayme McKelvey Megan Strand

ART DEPARTMENT

Karlee Gower Taylor Powers Kameryn Johnson

EDITORIAL

John Wallace

CONTRIBUTORS

Roger Bowles K. Richard Douglas Jim Fedele Joie Marhefka Manny Roman Connor Walsh David Witt Steven J. Yelton

DIGITAL SERVICES

Cindy Galindo Kennedy Krieg

EVENTS

Kristin Leavoy

WEBINARS

Jennifer Godwin

HTMJOBS.COM

Kristen Register Sydney Krieg

ACCOUNTING

Diane Costea

EDITORIAL BOARD

Jim Fedele, CBET, Senior Director of Clinical Engineering, UPMC Carol Davis-Smith, CCE, FACCE, AAMIF, Owner/ President of Carol Davis-Smith & Associates, LLC David Francoeur, CBET, CHTM, Service Zone Vice President Midwest Imaging - Siemens Healthineers Jennifer DeFrancesco, DHA, MS, CHTM, System Director, Clinical Engineering, Crothall Healthcare Rob Bundick, Director HTM & Biomedical Engineering, ProHealth Care

INSIDE Departments P.12 SPOTLIGHT p.12 Professional of the Month: Bryant Hawkins p.14 Company Showcase: Medigate p.18 HTM Pioneer Retires p.20 Department of the Month: The Island Health Biomedical Engineering Department p.24 Shifting Gears: Making the Most of Water Sports P.26 INDUSTRY UPDATES p.26 News and Notes: Updates from the HTM Industry p.30 Welcome to TechNation p.32 AAMI Update p.34 ECRI Update P.37 p.37 p.38 p.40 p.42

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TECHNATION

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P.56 EXPERT ADVICE p.56 Career Center p.58 Medigate: Optimize Fleet Management by Eliminating Data Disconnects and Manual Routines p.61 Cybersecurity p.62 20/20 Imaging Insights: SafeTee to Save Thousands in TEE Transducer Cost of Ownership p.65 The Future: Co-Operative Education, Internships for 2022 p.66 Nuvolo: Crawl, Walk, Run: 3 Steps to Starting an Effective Medical Device Cybersecurity Program p.69 Witt's End: About Best Practices P.70 p.70 p.72 p.74 p.76 p.82

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SPOTLIGHT

PROFESSIONAL OF THE MONTH: BRYANT HAWKINS SR.

BIOMETRICS FAVORITE BOOK:

Bryant Hawkins Sr. and Bryant Hawkings Jr. are two biomeds who cheer for the Saints.

God’s Word; the Bible

FAVORITE MOVIE:

“Grease” (Don’t judge me).

FAVORITE FOOD:

Boiled Seafood (crawfish, crabs, shrimp), poboys and CheeWees.

Passing the Biomed Baton

HIDDEN TALENT:

Photography and DJ

BY: K. RICHARD DOUGLAS

WHAT’S ON MY DESK?

here has been a lot of concern in recent years about the challenge of replenishing the ranks of HTM professional as veterans retire and training programs close.

What is surprising is that more young people, who have a dad or mom who is a biomed, don’t sign up for what is a rewarding career. Thankfully, some biomeds do pass the baton to family members. That often means passing along the enthusiasm for the field as well. One HTM professional that is keeping biomed in the family is Bryant Hawkins Sr., unit director II with Crothall Healthcare, at AdventHealth-Palm Coast. Hawkins’ son Bryant Jr., who is 19, is a BMET 1 in Orange City, Florida. Hawkins Sr.’s decision to enter the biomed field was mostly unplanned and random. “When I graduated from high school, my father gave me three options – go to school, get a job or get out. I was looking through the local community college syllabus. I closed my eyes, and I thumbed through the pages. I said whatever I touch, that’s what I will do. I landed on biomedical equipment technology. Never heard of this profession. It seemed very interesting, so that’s

TECHNATION

FEBRUARY 2022

what I went with,” he says. Hawkins attended Delgado Community College in New Orleans and obtained an Associate of Science degree in biomedical equipment technology. “In 1992, I began my internship at United Medical Center, New Orleans. My mentor was a retired Navy veteran, Edward Lister, who was a very firm mentor. I thought he was just being tough on me, but he was as he would say: ‘Preparing me for the real world.’ That he did. I think, I worked harder as an intern, than on my real biomed job. We still keep in touch to this day, and he still is a tough cookie. I have to remind him, I’m a grown man now. I owe a lot to him, and ‘Thank you Lister,’ if you are reading this article,” Hawkins says. SUPPORTIVE COLLEAGUES No lengthy biomed career comes without challenges. Hawkins has not been exempted from this inevitability. Some of those challenges were tempered by the help of great colleagues. “In 1993, my first challenge was when I finished the biomed program. There were no BMET jobs available. The director of the biomed department at a local hospital helped me get a related biomed job, where I was a video tech/surgery orderly. I worked the laparoscopic equipment

during surgery cases. Basically, my first biomed job was not actually repairing medical equipment; it involved more cleaning of medical equipment. After a year of doing that, I finally was able to get my first biomed job,” Hawkins remembers. Jumping ahead 12 years to August 29, 2005, Hawkins was working for Modern Medical Systems as a site manager in New Orleans the day Hurricane Katrina hit. “The hurricane destroyed my city and the hospital I worked at. Clarence Dolese, my regional director at the time, kept me working. From August 2005 to Sept. 2006, I was working in Columbus, Georgia; Los Angeles, California; Flint, Michigan; Dayton, Ohio; Miami, Florida; Farmingdale, New York and Boston, Massachusetts. True story; during one trip, he picked me up from the airport on a Saturday, I was coming from California and he needed me in Miami Monday morning. I said, ‘You’re not just dropping me off; you’re coming inside to explain to my wife? Which he did,” Hawkins says. He says that Pat Meehan, the CEO of Modern Medical, was very supportive. “He and his wife, Abbie, would literally call me and check up on me, to make sure me and my family were OK during this challenging time. In

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My laptop, two screens, my thermos and New Orleans Saints cup.

FAVORITE PART OF BEING A BIOMED?

Bryant Hawkins Sr. enjoys photography and serving as a DJ when not working.

2015, when Crothall acquired Modern Medical, I placed a call to Pat, and he literally left a meeting to take my call to discuss the acquisition with me personally. I still keep in touch with both of them to this very day,” Hawkins adds. When not managing healthcare technology, Hawkins keeps busy in his off-hours with music and creating images. “I’m a DJ and a photographer (follow me on Instagram: BeeHawkPhotography). My saying is ‘I may not be the best DJ, but I’m the best DJ who can take pictures. I may not be the best photographer, but I’m the best photographer who can DJ,’ ” he says. He has been married for 27 years to Zondra (Zee). He has a daughter, Meaghyn, who is 21. She is a certified radiology tech in New

“I get to play a part in providing someone with proper health care that can improve their health or even save their life.”

Orleans. There is also his son, Bryant Jr. What’s the most important thing to know about Bryant Hawkins Sr.? “My wife always tells me I have never met a stranger. I looked that saying up. It means ‘You are friendly and approachable to anyone and everyone. No one is a stranger, just a friend you haven’t spoken to yet.’ I’m blessed to have both my parents (56 years married), two sisters and two brothers who are the source for my being. Growing up in New Orleans also plays a part,”he says. A more recent challenge for Hawkins was making another move and relocating to Palm Coast, Florida in 2018. His son was not happy about the move, but learned to like Florida over that past three years. His daughter stayed behind to attend college.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

The upside today is that Hawkins’ son not only learned to like his new home state but also entered the biomed field, just like his dad. “He is also working in biomed just like me. He completed his training at the College of Biomedical Equipment Technology and now we both work for Crothall Healthcare. Safe to say, this last challenge was a great move for our family. Crothall Healthcare was extremely supportive during this challenging time for my family,” Hawkins says. “The proudest moment of my career is the fact me and my son are in the HTM field and are both employed with Crothall Healthcare,” Hawkins adds.

FEBRUARY 2022

TECHNATION

SPOTLIGHT

SPECIAL ADVERTISING SECTION

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THE MEDIGATE DIFFERENCE The Medigate Platform discovers and profiles all connected assets – delivering a consistently detailed level of attribution. With a commitment to accuracy and techniques, like deep packet inspection (DPI), Medigate understands over 165 proprietary device protocols and confidently reports on device characteristics, security posture, and network behavior. All in all, these long-missing insights help you make better decisions about device deployment, procurement, and maintenance. CLINICAL DEVICE EFFICIENCY Medigate’s Clinical Device Efficiency (CDE) module fills the gaps in your computerized maintenance management system (CMMS), providing a live connection to all your managed assets. Workflows can be auto-triggered with the information required to make them more productive and cost-effective. And with access to relevant cuts of the same data

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foundation, related systems and processes can finally perform as intended. With CDE, you will know what the device is, what it is doing, and where it is: • Location: Integration with network management tools and real-time location system (RTLS) sources pinpoint devices in the hospital with a high degree of precision. Location services steadily improve asset allocations and dramatically accelerate remediation workflows. • Utilization: Knowledge of how, when, and where devices are used leads to dramatic improvements in device management operations and streamlining of preventative maintenance (PM) workflows. • Inventory: Continuous resolution of device location, status, and utilization information is autonomously reconciled against the CMMS list to ensure a complete, up-to-date inventory. If a device marked “lost” within the CMMS is still in use, CDE will find it, confirm its status, and remediate or replace it – all automatically. • Benchmarks: Industry benchmarks are brought into the CDE engine to better understand your environment against others of similar size or use (e.g., recommended number of devices per bed). Additionally, this data can be internally benchmarked, with multiple sites comparing the information and feeding the CDE engine with additional data points. WWW.1TECHNATION.COM

CUSTOMER BENEFITS UP-TO-DATE SYSTEM OF RECORD CDE transforms your CMMS into a connected, dynamic, and data-rich system of record. By eliminating data disconnects and manual routines, workflows can be automated. Automatically discover and understand the connected devices in your environment to maintain an accurate and comprehensive inventory. The level of detail provided by Medigate helps you better manage the life cycle of your assets, so you can make better decisions around utilization, maintenance, and risk management. OPTIMIZE FLEET MANAGEMENT CDE provides fleet utilization analysis aligned with industry benchmarks to facilitate device procurement, renting/leasing, retirement, and disposal decision-making processes to deliver significant CapEx and OpEx savings. For example, lost or missing assets can be found and automatically reinstated into inventory repositories or under-utilized devices redeployed to reduce unnecessary capital expenditures. BioMed can also use device location and utilization information to understand front-line care team preferences, improve patch planning, and automate asset distribution to support appropriate PAR levels. LOCATE LOST AND MISSING DEVICES Use CDE to locate devices labeled as lost or missing in the CMMS as soon as they connect and automatically reinstate them into inventory, thereby reducing alternative device purchase costs. Additionally, you receive alerts when lost devices store PHI, so you can take measures to mitigate any risks. EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

REALLOCATE DEVICES BASED ON DEMAND CDE analyzes device distribution and utilization rates across different locations in the organization to provide optimized re-allocation recommendations. With the wide-angle view of where devices are used, you can improve your PAR leveling. For example, by reallocating devices from under-utilized locations to over-utilized areas, you are able to optimize capacity and meet needs. MINIMIZE RISKS Automate vulnerability correlations so that you can pinpoint impacted devices (e.g., with an OS version-specific problem, outdated firmware, vulnerable application entity, etc.) and trigger associated remediation work orders to reduce the overall risk to operations. CDE also enables you to consider the risk posture of devices in your buying, renting, and leasing decisions.

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FEBRUARY 2022

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SPOTLIGHT

TRAILBLAZING HTM PIONEER RETIRES BY JOHN WALLACE

JIM BOWLES

ealthcare Technology Management (HTM) pioneer Jim Bowles recently retired after more than 40 years in the industry. Technically, he wasn’t in HTM all of those years because “HTM”did not exist when he embarked on his career.

Bowles retired as the director of operations excellence, TRIMEDX. He said that he was responsible for the entire East Coast and Cayman Islands. The Trailblazer Award, for being a leader and trail blazer within TRIMEDX and the industry, is among his accolades. It is the most prestigious award at TRIMEDX. His career began on September 4, 1979, at Sacred Heart Hospital in Pensacola, Florida as an electrician because there was no such thing as a biomed. In 1984, Bowles’ title changed to electronics technician. It was not until 1987 that the hospital updated his title to biomedical engineering. Bowles became a manager around 1994. “TRIMEDX came on board in 2001 and I became a manager with them, then became a director for the area, then strategic operations director in 2010,” Bowles recalled. In late 2016, TRIMEDX created its continuous improvement group and asked the strategic business directors to work in that area to help develop and accelerate change within the organization. Bowles was already actively involved

TECHNATION

FEBRUARY 2022

in developing the industry as a member of the Florida Biomedical Society. He attended his first FBS meeting in 1997 and remained active up until his retirement last year. His FBS involvement included two terms as president. He also served as the symposium education coordinator for over 20 years. All told, Bowles holds more than 40 years of biomed experience including 24 years with FBS. He has witnessed a lot of advancements during his long career. “I’ve seen a lot of changes. I remember working on the old bovie spark gap,” Bowles said. “We called it ‘the big green box’.” He is thankful for his long career. He said the support he received from others had a lot to do with his success. “The way I’ve always said it is that in order for you to be successful you have to create relationships and partnerships with people who can lead you in the right direction,” Bowles said. He said that Rick Lowe was a key person in his career. He gives Lowe credit for foreseeing the future of Sacred Heart and “giving me an opportunity to lead it.” He said that Greg Ranger (who was the president and founder of TRIMEDX) had the vision of providing service for Ascension as an independent service provider and “gave me the opportunity to be the first site for TRIMEDX.” “I also give credit to Robert Moorey

for teaching me patience and understanding,” Bowles added. Robert L. Moorey, FACHE, is the senior vice president of east operations at TRIMEDX. He quickly responded to a request for information about Bowles. “By virtue of his early entry into the industry, and his many years of excellence in the industry, he should be considered as one of the founding fathers of the industry,” Moorey said. “But it is his advocacy and passion for the industry that places him on the Mt. Rushmore of CE/HTM. He has been an active leader of the Florida Biomedical Society, helping to create one of the country’s premier CE/HTM associations. His mentorship of new CE/HTM leaders has helped mold and shape a generation of leadership. His coaching and guidance have helped to set benchmarks of excellence for the CE/HTM industry.” Longtime FBS member and officer Fred McMurtrie Jr. also praised Bowles. “First, let me say that Jim is very dedicated to his profession and to our professional group as a whole. I have shared many years on the Florida Biomedical Society and have grown to admire his leadership and passion,” McMurtrie said. “He has shaped our educational offerings in the society. With TRIMEDX, he has always worked to ensure quality biomedical services by providing his organization with the tools to succeed. He is the same way with our

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society! Jim is and remains dedicated to our profession.” Moorey said Bowles is a unique individual that means a lot to many different people within HTM. “Jim is the mayor of CE/HTM. He is an affable and gregarious individual who is easy to like. He spends considerable time getting to know people: what they like, their career aspirations, their strengths and needs,” Moorey said. “He then invests in people to help them be the best version of themselves. He is a giving person. He is driven by a desire to see people and the industry be its best.” “What separates Jim from others is his passion for CE/HTM and his deep care for people,” he added. Moorey applauded efforts to recognize a colleague on an amazing career. “I am glad to see Jim get the recognition he deserves,” Moorey said. “For those of us who know him best, we know how indebted we are to him. We know how our lives are richer and fuller because of Jim’s involvement in our lives. I have a hard time seeing how CE/HTM could have come this far without the contributions of Jim Bowles. He has left a legacy worthy of remembrance and imitation.” Bowles is grateful for the support he received from others, especially his family. “I want to be sure that I recognize my family because without the support of my family I never would have been as successful as I was. They are the ones who sacrificed me being away and mentoring others,” Bowles said. He recalled times when his wife was working out of town, and he had a call come in from the hospital. He said he would take his two daughters to the biomed shop with him so he could repair a device. When asked about his plans for the future, Bowles said he and his wife plan to set out in their new Winnebago. “We are travelling and doing what it is that we want to do,” he said. It is a well-deserved journey.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Jim Bowles is presented the 2018 TRIMEDX Trailblazer Award.

Jim Bowles (second from right) is seen at an FBS Symposium.

TRIMEDX Executives (from left to right) Jimmy Bowles, Bill Conrad, Rob Moorey, David Mohme, Bill Meyer and Jon Yow are seen with “Barney” the car. It was one of the first cars purchased by TRIMEDX and is still kicking. The Sacred Heart Hospital Engineering team of Pensacola used it to travel and repair equipment at all of the outlying sites. FEBRUARY 2022

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SPOTLIGHT

The Royal Jubilee Hospital Biomedical Engineering Department is seen in front of its new biomed shop in September 2021.

DEPARTMENT OF THE MONTH: The Island Health Biomedical Engineering Department

BY: K. RICHARD DOUGLAS

ust north of the U.S.-Canada international border sits the city of Vancouver in the province of British Columbia. Off the coast of Vancouver, and across the Strait of Georgia, Johnston and Queen Charlotte, is Vancouver Island. The island is large, measuring 283 miles in length and 62 miles at its widest point. The island has a population of approximately 850,000.

With the large population of island-dwellers, health care is an important matter. Those needs are served by Island Health. The health care system provides island residents with a network of hospitals, clinics, health care centers and longterm care locations. With such a large responsibility, the management of medical equipment is critical. That is the job of the Island Health Biomedical Engineering Department. With

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three tertiary care teaching hospitals, six community hospitals and many urgent care centers, supporting an acute care bed base of 1,824, along with 101 newborn beds, the task is a demanding one. The 50-person HTM team includes Director Martin Poulin, M.Eng., P.Eng., FCMBES; managers Tedford MacLaggan, M.Eng., P.Eng. and Heydar Khalil, M.Eng., P.Eng.; Biomedical Project Engineer Angela Varghese, M.Eng., EIT; Biomed IT Support professional John Bowdige, five biomed engineering technologist supervisors, an administrative clerk and 40 biomedical engineering technologists. “Our technologists have evolved by the investment in training into different areas of expertise including anesthesia and respiratory support, medical imaging, patient monitoring and hemodialysis,” Poulin says. The team handles a wide range of tasks from service contract management to the

disposal of medical technology, incident investigation to repair and maintenance and supervision of biomed student co-ops and practicums. The department manages service contracts to find the perfect balance for its needs and its employer. “Biomedical engineering optimizes service contracts to provide a level of service that best meets the needs of the customers and financial implications. The result is an array of different contract services ranging from time and materials contracts, shared service contracts to full-service contracts,” Poulin says. He says that business case reviews are completed to determine whether training should be invested in biomed engineering technologists to support the equipment, or whether some level of contracted service makes sense. The department is very diverse and

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includes members from a number of backgrounds. The team members continuously prove that they are not only up to the task, but able to meet all customer needs. “We have a very dedicated and customer-focused group of people who originated from all over the world, including Europe, Russia, Middle East, Asia, Africa and India. Our customer satisfaction surveys are always very positive, in addition to the many compliments myself and the managers receive regarding the great service our department provides,” Poulin says. He says that the team’s BME-IT support person is a leader in the development of provincial and local cybersecurity initiatives. His cybersecurity policy framework and patch management processes are being adopted by the provincial cybersecurity team. Poulin says that Angela Varghese is the new laser safety officer for the island. MANAGING EXPANSION AND COVID RESPONSE The department recently faced additional projects because of the COVID-19 pandemic. Prior to that, new facilities provided challenges. “Some significant projects that we were integrally involved with recently revolve around the response to the ebb and flow of COVID patients into the hospital. Our Royal Jubilee Hospital (RJH) and Victoria

General Hospital (VGH) staff recently set up a nine-bed high acuity unit within 24 hours at the request of our Ministry of Health. We had to move newly installed monitors from the VGH site to the RJH site,” Poulin says. He says that similarly, at the beginning of COVID, the Nanaimo Regional General Hospital staff set up an expanded high-acuity unit adjacent to the ER department within a short time frame. “One large project in 2017, that drew on staff throughout the island, was the set up of our two newest community hospitals. This project involved about 15 staff for the actual move days and weeks of effort prior to the move in. Every day was spent reviewing a list of problems to be resolved from network issues to patient monitor mounting challenges,” Poulin says. He says that going farther back, it was their supervisor from RJH, in conjunction with the clinical nurse educator, who identified the possible blood contamination associated with the pressure monitoring ports of the Baxter hemodialysis machines. “This identified problem resulted in a worldwide recall by Baxter with changes to their hardware and processes,” Poulin says. The team has also been a partner in the integration of biomed devices to the electronic health record. Integration projects have included vital signs monitors, anesthesia monitors, endoscopy images and

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

patient monitors. Helping the Canadian HTM community and serving the health care needs in their province, team members are active even outside of work hours. They even help provide assistance to health services in a developing country. Poulin says that manager Ted MacLaggan is the lead for the PM program in the province and is also the Awards Chair for the Canadian Medical and Biological Engineering Society (CMBES). “I am the past president of CMBES and currently work with the international outreach team. This team is working with Ghana Medical Help in conjunction with Ghana Health Services to assist with the establishment of clinical engineering in the northeast area of Ghana,” Poulin adds. “I am also a member of the ACCE educational webinar planning team.” He also sits on the advisory boards for the University of Victoria Biomedical Engineering program and the BCIT Biomedical Engineering Technologist program. When a large island community like Vancouver Island depends on a network of health care facilities for emergencies and health care needs, it is reassuring to know that the task is in capable hands. The HTM professionals that make up the Island Health Biomedical Engineering Department get the job done every day.

FEBRUARY 2022

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SHIFTING GEARS Making the Most of Water Sports BY K. RICHARD DOUGLAS

David Soffer says barefoot skiing is an “adrenaline rush”.

or many Americans, being on the water, in any capacity, is the ultimate mode of relaxation. For others, it can be the ultimate outlet for fitness and sports activities.

Water-based sports and fitness pursuits have grown over the years with many new and innovative activities that allow for aquatic fun. Some of those activities include skiing, surfing, kayaking, canoeing, wakeboarding, windsurfing and swimming. All requiring a specific skillset, level of confidence and level of fitness. One skilled watersports fanatics is David Soffer, a medical equipment I.S. specialist with WellSpan Health. Soffer has developed a high level of skill in several water sports. He relied on summers trips during his youth to hone his skills. “I must give credit to my aunt and uncle who lived in California for introducing me to waterskiing. I started visiting in the summers when I was 11 years old, and every weekend involved camping at Lake Berryessa. Lake Berryessa is a beautiful area near Napa and is a weekend hotspot for boating and water sports,” Soffer says. He says that ironically, growing up in Central Pennsylvania, the Susque-

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hanna River was in his backyard. Unfortunately, his parents did not own a boat, canoe or kayak. “I remember going to parks near the river and looking at the frozen structures the wind and water created in very cold winters,” Soffer says. Because waterskiing was Soffer’s entry into activities on the water, he had to go through the same learning curve as everyone else. “The first time I tried waterskiing was on double skis. I took a face full of water and I wanted nothing to do with skiing for a while. I gave it another go and fell in love with the feeling of riding on top of the water. Young kids have it easy. They barely weigh anything and can pop up out of the water with very little effort. My kids and their friends pop right up without much pull from the boat. The biggest challenge for anyone riding skis, wakeboards, surfboards is balance. There is a left/right and forward/backward balance required. It takes some tries,” Soffer says. His advice to novice skiers is: 1) Don’t pull the rope; let the boat pull you. 2) Don’t stand up too early; let the boat get to speed. 3) Look at the back of the boat and work on your balance when you stand up. His advice to boat drivers who do

not have experience pulling skiers: don’t slam the throttle trying to pull your rider out of the water and speed is not your friend for new riders. In addition to skiing, Soffer enjoys wakeboarding, wake surfing, riding a hydrofoil and barefooting. Yes, he skis barefoot. Although he says he is still a beginner at barefooting, he calls it an “adrenaline rush.”

MORE THAN WATER SKIS While the most familiar picture of an enthusiast enjoying water sports might be the person towed behind a boat, standing on two narrow skis, the popularity of other means of skimming across the water have caught on. Soffer enjoys wakeboarding, a sport that has gained a following just as its snow-dependent first-cousin has. It requires a single wakeboard with foot bindings and a tow vehicle. “Wakeboarding is similar to snowboarding. The boards are different, but the concept of bindings, and being able to carve and ride the edge, is the same. Obviously with wakeboarding, you need to have a boat, jet ski or cable pull you across the water. Most people think of waterskiing behind the boat with one or two skis. Wakeboarding is easier to learn than a single ski (slalom ski) and

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David Soffer is seen wake surfing. much easier for people to get ‘up’ and ride,” he says. While wakeboarding involves a wakeboard and tow line, wake surfing uses a board that looks more like a surfboard and allows the person being towed to disengage from the tow line and ride the boat’s wake. “Wake surfing is so much fun. With the correct setup and water conditions, it provides a consistent wave that you can ride until you run out of river or lake. Much like wakeboarding, you can ride the wave in any manner you desire. The size and length of the wave give you freedom to pump, trick or just cruise,” Soffer says. He says that with any water sport, you will get a great workout. He adds that you will have sore muscles you never knew existed. “Surfing for those who already ride wakeboards or skis is an easy transition. The rider needs to get the feel of being in the push of the wave so they can let go of the rope. For beginners, it will take some time. I found using a very long board or a skim style board (no fins) is much harder to control. A beginner should ride a board with fins and medium length,” Soffer says. Another water sport that Soffer participates in might look intimidating

David Soffer shares his love of water sports with his family. to beginners. That is because it results in the rider rising above the water’s surface while moving. Riding a hydrofoil looks like it would be a challenge. “Credit goes to my uncle again for the hydrofoil. We started riding this in the 1990s. Today, my wife and I ride a modified version of this same foil. Originally, the foil started as a piece of equipment you sat on to ride. Now, there is a type you stand on to ride and many use this to surf. I have also viewed on the web, a battery-operated stand-on foil (I have not looked at one in person). By far, the foil is my favorite thing to ride. This totally requires good balance. I equate it to friends, trying it for the first time, as riding a bike with no hands, but with a forward/backward portion to control elevation out of the water,” Soffer says. He says that most first-time riders either shoot left or right because they can’t balance or pop out of the water because they are leaning back. “The foil is easy to ride once you get the hang of the balance issue. The foil slices through the water and there is zero drag once you are moving. It is great for people that have knee or back issues and are afraid to wake, ski or surf. You are just sitting on the foil

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and enjoying the cruise. Jumping and inverts are optional,” Soffer says. While water sports are a hobby, Soffer spends his work time as an I.S. professional. “My role is called MEISS: Medical Equipment I.S. Specialist. I like to say my team of three is the small gear that goes between Biomed, larger I.S., Network, Clinical Informatics and the customer. Our primary focus is medical device integration to the EMR,” he says. “We have a large amount of integrated medical devices which include bedside monitoring, anesthesia, ventilators, infusion pumps, vital sign machines, dialysis, cardiac output and balloon pumps. Our secondary tasks include small project management, documentation to support our devices, cybersecurity support and capital review. As with any role, in or around biomed; every day is something new,” Soffer adds. He reminds those who would attempt any of these water sports that “the most important piece of equipment is a lifejacket.” Next time you see someone on the water completely engrossed in a water sport, it might just be a medical equipment I.S. specialist making the most of his off-hours.

FEBRUARY 2022

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INDUSTRY UPDATES

NEWS & NOTES Updates from the HTM Industry

MULTIMEDICAL SYSTEMS ACQUIRES TRINITY BIOMEDICAL SOLUTIONS

626 ACQUIRES X-RAY SALES AND SERVICE COMPANY 626 Holdings LLC has acquired California Radiographics Inc. (CRI). “CRI could not be a better fit. From a culture standpoint, a modality strengthening, a geographic expansion and a listening to our customers’ needs, CRI hits on all objectives. We are very excited about our future with CRI,” stated Philip Revien, CEO of 626. “The core question Phil and I continue to ask ourselves is: Is this the best move for our customer? If the answer is yes and it will increase our value to our customers and their patients, we have our answer,” 626 Preisdent Michael Fischer said. In business since 1977 and based in Soquel, California, CRI is a leading OEM and third-party provider in the X-ray space throughout most of California. From technical support with parts identification, to new and used equipment sales, service, installation and deinstallation, CRI delivers an end-to-end solution for medical X-ray to multiple channels.

“CRI and 626 have a lot in common. Both are family businesses, founded as a high quality, agile, cost advantageous solutions for OEM and aftermarket service and support for our varied customer base. We have been and will remain dedicated to our employees, customers and their patients. After spending time planning next steps for optimal CRI growth with Phil and Michael, there was no doubt that the best decision was an alliance with 626,” CRI General Manager Roger Buttacavoli said. 626’s purchase of Walsh Imaging in 2017, ISS in 2019, PhiGEM in 2020 and both ICE and DigitecMedical earlier this year, follows its approach to base acquisitions on what matters most to them; family. This method has proven to be successful as they were able to double Walsh Imaging and ISS business within two years and they plan to do the same with CRI.

FEBRUARY 2022

For more information, visit https://multimedicalsystems.com.

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value-driven organization that really takes care of their customers and team members alike.” “The MMS executive team truly enjoyed getting to know Jeff over the past year as we crafted this transaction together. We know Jeff had other options available, and we’re proud that MMS was chosen as Trinity’s partner to share the future with,” he added. MMS Senior Vice President of Business Development Mike McRoberts added, “The acquisition of Trinity Biomedical Solutions is in line with MMS’ strategy to expand our footprint into the eastern U.S., and to bring our scalable business lines to the already comprehensive HTM offerings of Trinity.” “The new, joint organization is committed to maintaining world-class service throughout the merger process, and service delivery to Trinity Biomedical Solutions customers will continue without interruptions,” said MMS Vice President of Operations Nicole Palmer. “We are excited to welcome Jeff and the entire Trinity team into our ever-growing MMS family!”

For more information, visit www.weare626.com.

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MultiMedical Systems LLC (MMS), a company that provides healthcare technology management (HTM) services nationally, has announced the acquisition of Trinity Biomedical Solutions, based in Valencia, Pennsylvania. MMS is part of the shared services group under the sponsorship of The Innovation Institute. A news release states that Trinity Biomedical Solutions, founded in 2014, provides the highest quality HTM services to acute care hospitals, surgery centers, clinic systems and physician offices throughout Ohio, Pennsylvania, West Virginia and Maryland. “I am excited about the incredible benefits that MultiMedical Systems will bring to our employees and our customers,” said Jeff Grimm, CEO of Trinity Biomedical Solutions. “Our pledge has always been to provide our customers with world class biomedical services, and now our capabilities are greatly enhanced with MMS’ remarkable resources and proven quality.” MMS President Daren Kneeland stated, “Trinity Biomedical Solutions and MMS share common values, both providing the highest quality HTM services to their clients. Trinity has gained a stellar reputation over the years as a quality and

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ADVANCED PATIENT MONITORS RECEIVE FDA 510(K) CLEARANCE Philips Patient Monitors MX750 and MX850 have received 510(k) clearance from the U.S. Food and Drug Administration. Initially cleared for Emergency Use Authorization in 2020, the MX750 and MX850 are Philips’ most advanced patient monitors uniquely designed to support scalability, alarm management, cybersecurity and enhanced infection prevention within the hospital. As health systems navigate the digital transformation, patient management solutions that can scale to meet hospital needs are in high demand. The MX750 and MX850 patient monitors are an integrated part of the company’s future-focused acute patient management solution, enabling hospitals to standardize at a system level and customize the solution in a particular care setting, even virtual or decentralized, to help optimize patient care. The monitors provide full modularity and are interoperable with other devices and applications, including Philips Patient Information Center iX and IntelliVue XDS software, to display critical patient data remotely or at the point of care. “Continuous patient monitoring plays a vital role in overall patient safety while

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providing clinicians and caregivers with the holistic view they need to best support their patients and manage their workload,” said Sandra Lesenfants, general manager, hospital patient monitoring, Philips. “Philips Patient Monitors IntelliVue MX750 and MX850 are our most advanced patient monitors and a key part of our modular portfolio of hardware, software, services and consumables that can be tailored to provide integrated monitoring solutions that meet the individual needs of each health care provider.” Data can also flow seamlessly between the MX750 and MX850 patient monitors and Philips Acute Care Telehealth command center to help to simplify clinical workflow with advanced clinical decision support, helping care teams better manage patient care across the continuum. The integrated system securely feeds patient data to a hospital’s electronic medical records via continuous, best in class, end-to-end encryption, meeting the industry’s evolving cybersecurity needs. The approach allows for virtually gap-free patient records from admission to discharge, even during transport, and connects care from the ICU to general

ward, and across care settings. This FDA 510(k) clearance allows Philips’ customers to expand their acute care and monitoring capabilities in the USA with the same MX750 and MX850 technology that has proven successful in hospitals across Europe since receiving CE mark in 2019. “In the ICU, conditions can change quickly, so having access to real-time data is important to ensure signs of deterioration are not missed,” said Remko van den Akker, Registered Nurse, intensive care/ critical care unit, Adrz Hospital, The Netherlands. “Philips’ solutions have helped us to improve the link between essential patient data and our hospital patient data management system, and allow us to automatically and securely share data. This level of interoperability has been key for successfully managing our acute care patients.” Philips MX750 and MX850 patient monitors also feature a rugged design that can withstand the strongest hospital-grade disinfectants to help minimize hospital acquired infections without degrading the device. This helps caregivers to increase efficiency, while ensuring high quality patient care.

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Nuvolo has announced that its single-cloud based solution, Connected Workplace, is now available to small and medium-sized businesses. Connected Workplace for SMB provides Nuvolo’s flagship solution to smaller organizations in a variety of markets including health care. While Nuvolo is known for partnering with large enterprise clients such as Wayfair, EuroFins, and the National Institutes of Health (NIH), the IWMS provider’s new offering brings those same capabilities to smaller organizations that may have budget constrictions, a lack of in-house resources, or utilizing outdated facility management systems and manual processes to track their facilities operations. Nuvolo was recently ranked as a leader in the IDC MarketScape for SaaS facilities management applications, and that same maintenance solution is now available to all businesses regardless of size for Facilities and Clinical HTM applications. “We recognized a gap in the SMB market when we heard customer stories about using spreadsheets or legacy systems from 20 years ago that have little relevance to their requirements in today’s world,” says Kristy Tupper, general manager, Connected Workplace for SMB. “By pre-configuring the core Nuvolo solutions, we can provide a more prescriptive and easy-to-use option to an SMB market that demands an agile, nimble, and responsive approach. Using this model, we’re able to offer a low-cost, fast time-to-value solution that has robust features and functionality – but at the same time, requires no infrastructure maintenance and virtually no administration on the client’s part. In the future, we anticipate this offering will expand to include all the Nuvolo solutions that are demanded by the SMB market.” “Small and mid-sized organizations will quickly realize the value of Nuvolo Connected Workplace for SMB, as it was designed to have clients up and running in a short timeframe with minimal implementation,” according to a press release. “Customers can begin to organize, streamline, report on and stay on top of maintenance schedules and work requests to maximize their return on investment.” For more information, visit nuvolo.com.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

BLOCK IMAGING ACQUIRES VAREX’S RHIT OPERATION Block Imaging has announced its acquisition of the Reliable Healthcare Imaging Technology (RHIT) operation from Varex Imaging Corporation. Located in Rancho Cordova, California, RHIT is a state-of-the-art X-ray tube and HV tank repair and reprocessing facility. The 17,000-square-foot RHIT facility is equipped with 20-plus staging bays utilized for parts validation and repair procedures. Block Imaging’s acquisition of the technology at RHIT is part of an ongoing strategic expansion of technical capabilities to serve parts and service customers, creating more affordable and high-quality parts replacement options for clinics, hospitals and service companies around the world. “The health care community is looking to service providers for creative solutions to stretch dollars and bring about added speed and efficiency, while simultaneously improving quality at every turn,” Block Imaging President Jason Crawford said. “This acquisition and expansion will be another step Block Imaging is taking to carry forward our mission to provide a second chance at life for imaging equipment, so that health care professionals can provide a second chance at life for people.” Block Imaging intends to carry forward the quality pre-owned X-ray tube and HV tank repairs that parts buyers have relied on RHIT for in recent years. Existing Block Imaging parts and service customers on the west coast and in the southwest will benefit from faster shipping turnarounds and increased parts availability, as RHIT’s facility will offer a depot for tubes, tanks and other imaging parts. For more information, visit blockimaging.com.

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AAMI UPDATE Free Downloads for HTM Professionals

AMI and the AAMI Foundation have recently released two new documents for healthcare technology management professionals looking to bolster their knowledge and efficacy. Both documents may be freely downloaded.

ANTHOLOGY OF COMPLEX TECHNOLOGY SOLUTIONS The AAMI Foundation has released the last in a series of free anthologies with solutions to seemingly intractable problems with healthcare technologies. Complex Technology Solutions offers guidance, best practices and practical tools for health care systems and hospitals and for industry – all developed by the AAMI Foundation National Coalition to Promote Safe Use of Complex Healthcare Technology. “New and complex healthcare technologies require close collaboration of administrative, clinical, human factors, risk and industry personnel for safe integration into the health care environment,” said Tandi M. Bagian, chief engineer at the National Center for Patient Safety at the U.S. Department of Patient Safety and a National Coalition team leader. “This coalition report, developed with a broad range

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of experts, provides guidance to facilitate such collaborative efforts.” The anthology features focus sections with actionable resources to help the health care and industry communities more effectively manage complex technologies and collaborate to keep patients safe: Focus on Health Care Systems and Hospitals • Developing a business case for effective acquisition • Guidance and templates for proper integration of new medical technology • Using risk profiles to plan training and introduce complex technology • Competence assessment for use of complex technology Focus on Industry • Human factors activities and associated standards • A capability maturity model to integrate human factors activities: guidance for product developers • Learning from device use issues “Establishing the practices recommended here will help make medical equipment easier to learn and easier to use,” said Peter Doyle, senior human factors engineer and national coalition team leader. “More importantly, it will

help to reduce the occurrence of failure modes that accompany the use of complex healthcare technology.” The National Coalition to Promote Safe Use of Complex Healthcare Technology, which launched in 2017, responded to overarching challenges that emerged in three other AAMI Foundation National Coalitions on infusion therapy safety, alarm management safety and opioid safety through continuous electronic monitoring. “All four anthologies of the national coalitions are freely and publicly available to ensure open access to this important information,” said Steve Campbell, AAMI Foundation executive director and acting president and CEO of AAMI. “We encourage you to share and use this valuable content with your colleagues in your organization.” All four anthologies include links to patient safety seminar presentations, peer-reviewed journal articles, case studies and podcast episodes. EMERGENCY PREPAREDNESS RESOURCE FOR HTM DEPARTMENTS The COVID-19 health crisis is hardly the first major emergency to beset healthcare technology management (HTM) departments. And it certainly won’t be the last. That’s why AAMI’s Technology

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Management Council (TMC) developed a new tool for assessing how prepared an HTM department is in the event of an emergency. Importantly, Emergency Preparedness Assessment for HTM Departments is free for all AAMI members! “This emergency preparedness assessment tool was designed to guide HTM professionals toward rapid and appropriate responses during an emergency,” the authors explain. The guide includes: • Emergency Preparedness Assessment for HTM Departments. A checklist to aid HTM departments in ensuring consistency and completeness when preparing for emergency situations. • Sample emergency travel authorization letter • HTM Department Service Continuity Plan. A scaled, prioritized list of work activities based on expected staffing variations during an emergency. • Guideline for Scheduled Maintenance Compliance during a Health Emergency. A written plan that provides clarification of revised definitions for timely completion of scheduled inspections during an emergency situation when they cannot be completed as normally planned. According to TMC member Mike Busdicker, system director of clinical engineering at Intermountain Healthcare, the inspiration to develop this document spun out of a unanimous, small-scale survey of HTM departments conducted by the TMC. A majority of the respondents were not sure if there was an emergency management plan in place for their health system, while “some of the survey respondent even went as far as to say they didn’t even know who their emergency management team was,” he explained. “That was really concerning.” “When you’re looking at all HTM departments, regardless of budget or the size of their health system, you’re really

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

going to get a gamut of preparedness levels,” added Danielle McGeary, vice president of HTM at AAMI “During the worst of the pandemic, I remember one technician called AAMI with an important question and I told him ‘Well I think that would be a great question for your emergency manager’ and he asked, ‘What is an emergency manager?’” McGeary said. “It was a startling reminder that we have to provide these documents for all kinds of departments and levels of preparedness.” Busdicker joined McGeary and four other co-authors hailing from health systems and HTM service providers in sharing best practices and professional insights when creating the document. “We wanted to make a document that is so extensive that it can apply to your health care system no matter the size,” he said. “Now anyone can make sure HTM is part of incident command. They look at performance improvement and quality and how they can best improve well before the next emergency.” AAMI members can download Emergency Preparedness Assessment for HTM Departments for free in the AAMI store. It is also available for purchase by nonmembers.

FEBRUARY 2022

TECHNATION

INDUSTRY UPDATES

ECRI UPDATE

Between-Use Electrical Leakage Testing of TEE Probes

ransesophageal echocardiography (TEE) probes must be tested for leakage current after every use, making it impractical for health technology management to conduct this testing. This means that ultrasound or cardiology staff need to be proficient at performing between-use testing, and they need to know when more extensive testing by the engineering team is required. Understanding the issues can both improve patient safety and prevent costly repairs.

THE IMPORTANCE OF LEAKAGE CURRENT TESTING Although TEE probes do not come into direct contact with the heart, the probe tip will be positioned near the heart during the imaging procedure. The risk is that electrical current leaked from the probe could cause potentially fatal ventricular fibrillation. Current can leak from a TEE probe if, during the course of handling and use, the probe sustains cuts or punctures in any of its outer protective components. Such defects can allow fluid to leak into the probe’s interior, thus producing a path for electrical current to the outside of the probe. In addition to an electrical hazard, fluid ingress via cuts and punctures can lead to other problems. For example: • Pathogens can enter parts of the probe that cannot be properly disinfected, potentially infecting staff or patients. • The probe’s electronic components can be damaged by saline, body

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FEBRUARY 2022

fluids, and disinfection fluids, all of which are corrosive. • If disinfection fluid leaks into an area of the probe that is impossible to rinse properly, it can cause an injury to a patient’s mouth, tongue or esophagus. “Visual inspection of the TEE probe shaft can identify obvious damage,” explains Ismael Cordero, senior project engineer in ECRI’s Device Evaluation group, “but it isn’t enough.” Small punctures may not be visually detectable and can lead to harm. That’s why an electrical leak test, which will help detect damage from any puncture, is needed between each use.

BETWEEN-USE TESTING Between-use testing should be performed after cleaning and reprocessing and before the next use. It also should be performed if the probe has not been used for an extended period after its last leakage test, or if you suspect that the probe may have been damaged by being dropped or struck against another object. Between-use testing can be performed by most technicians without assistance from health technology management personnel. Additionally, it can be performed without having the TEE probe attached to an ultrasound unit, and without the use of a standard electrical safety analyzer. Typically, a less expensive specialized TEE probe leakage tester can be used. Selecting a TEE probe leakage tester – Generally, ultrasound manufacturers consider the use of a TEE probe leakage tester an acceptable compromise to

avoid the inconvenience of performing the full electrical safety test between every use, particularly for higher-volume hospitals. The model of leakage tester should be selected based on the TEE probe manufacturer’s recommendations. Some manufacturers provide customers with a tester when they purchase their TEE probes. Some leakage testers display the measured leaked current in microamperes (µA), some have simple PASS and FAIL indicators, and others may both display a value and have a PASS/FAIL indication. Display of a measured current value allows observation of trends in probe deterioration. Leakage testers also test the conductivity of the bath solution where the probe leakage is being measured. A minimum conductivity level ensures that there is a conductive path for leaked current so that the leakage test can be considered valid. The probe’s pass/fail current leakage limits, as well as the conductivity thresholds of the bath solution, are provided by the probe manufacturer and are commonly programmed into the tester. Some testers can store manufacturer thresholds for multiple probe models. Generic between-use testing procedure – The methods and steps that should be followed for between-use leakage testing are indicated in the probe manufacturer’s instructions for use (IFU). Testing methods vary among manufacturers, but there are some common steps and considerations: • After the TEE procedure, the TEE

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•

probe is disconnected from the ultrasound system and undergoes high-level disinfection. Leakage current testing is then conducted with a portion of the probe immersed in the disinfectant solution. The technician connects the TEE probe to the tester via an ultrasound transducer adapter unique to the probe being tested. Note that only the model of tester recommended in the probe manufacturer’s IFU should be used. The portion of the probe that is inserted into the patient is immersed in a basin or soak tray with disinfectant. Alternatively, if the facility is using a dedicated probe disinfecting system, the probe may be tested while it is in the system, immediately following high-level disinfection. (These test setups are illustrated in the figure.) The leakage tester probes are immersed in the disinfection solution. To ensure that the electrical leakage test will be accurate, the conductivi-

•

ty of the cleaning solution is tested. Note that cleaning solutions with very low conductivity can yield false readings with some leakage testers. (See the full ECRI article referenced below for details.) Use only the solutions recommended in the probe manufacturer’s IFU. The leakage current is tested. Pass/ fail status and measurements are displayed on the tester. Results are logged for documentation as per facility policy.

If a TEE probe fails the between-use leakage test it should be immediately tested again. If it fails a second time, it should be tested by health technology management personnel or by a manufacturer service representative. Such testing may require following the standard electrical leakage current testing protocol outlined below. “Anytime there’s doubt about the between-use test result, do a full test,” advises ECRI’s Cordero. TESTING DURING IPM AND AFTER REPAIRS Standard electrical leakage current testing of a TEE probe is much more

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extensive than the between-use tests. It is performed by health technology management personnel, or by manufacturer service representatives, using an IEC 60601-1-compliant electrical safety analyzer. This testing is done after repairs, periodically at a frequency recommended by the manufacturer, or as specified in a formal alternative equipment maintenance (AEM) program. Testing is also done after users report electrical safety concerns. These tests are described by each manufacturer in their IFU and generally consist of: • Submerging the TEE probe in a conductive solution while connected to the ultrasound system, which has protective and isolation circuitry that reduces the amount of leakage current transmitted to the probe. • Testing the probe as an applied part with permissible single-fault leakage current of 500 μA or less for a Type BF device and 50 μA or less for a Type CF device. (“Applied parts” are parts of medical devices that come into physical contact with the patient. They have differing electrical safety requirements depending on their classification – i.e., BF or CF.) To Learn More This article is adapted from ECRI’s “Between-Use Electrical Leakage Testing of Transesophageal Echocardiography (TEE) Probes” (Device Evaluation 2021 Nov 3). The complete article is available to members of ECRI’s Capital Guide, Device Evaluation, and associated programs. To learn more about membership, visit www.ecri.org/solutions/evaluation-and-comparison, or contact ECRI by telephone at (610) 825-6000, ext. 5891, or by e-mail at clientservices@ecri.org.

FEBRUARY 2022

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BIOMED 101 Good Is Never Good Enough BY DEAN SKILLICORN

n this column, I will write about high reliability operations/organizations (HRO) which is the new buzz in quality management in health care and other industries. Balanced around safety, HRO is the concept that above all other aspects of operations, safety comes first. In health care that means patient safety comes first above all else. Our operations are built around patient safety. It has been that way for many years, with The Joint Commission’s focus on safety through the environment of care.

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So, why all the hoopla? HRO is about driving safety through every operational phase in your organization. It is about having the best safety outcomes. It is about a mindset, in my opinion, where “good” is never good enough. You have to be great! It’s about doing the right thing. It’s about high quality and not accepting average. It is not acceptive of the old phrase, “Good enough for government, good enough for me.” It’s about not looking the other way. It’s about standing up, taking responsibility and being held accountable. Why is this important in medical imaging service? Simple. Safety is a huge priority at any time. Most importantly though is safety and quality during the installation of medical imaging equipment or any clinical equipment systems. It is paramount. Managing installation projects can be difficult. Project managers, construction vendors, OEM staff, HTM, IT and end users are all working to ensure that a project is finished “on time.” Yet, what about

safety and quality? How many times have we been involved in projects where we get to the phase of turning it over to the OEM for their installation only to find things didn’t go as planned? We have weekly calls. We track progress. Yet, things still go awry. Why? In my experience, it’s because in these projects we fail to implement a simple procedure we are all familiar with from surgery procedures. It’s called a “timeout.” We fail to simply take a breath, hold for a minute and examine all phases of the project and if they were completed to the OEM’s specifications. All while we hold the construction crew and OEM accountable for performance. The challenge is the OEM itself. It places the responsibility of complying with the “specifications” on the facility and the construction crew, yet desire not participate in validation of the construction and installation of floor plates, Unistrut, rails, etc. The OEM will say it’s the construction crew’s responsibility to meet its standards. I say hogwash. It’s the team’s responsibility and the OEM is part of that team. Try managing the trifecta of two to three vendors all on the same project for an installation. It can be a recipe for disaster if you don’t hold construction crews and OEMs accountable. High reliability in installations is a must! Look the other way and disaster will loom in the future. Safety will be compromised … and this will all happen on your shift. Don’t look the other way, don’t deflect, don’t allow the “it’s only a small issue” excuse or accept poor to mediocre work. Your patients’ safety

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depends on you standing up, taking ownership and making certain all phases are acceptable to the vendor to be able to move forward. That means the vendor is involved in that review. It’s holding the construction crew and sub-contractors accountable for their work. No mediocrity is allowed. There can be no short cuts to save cost or time. If the project time frame needs amending, do it. The pressure to complete on time is real. That pressure can cause contractors nightmares. Those nightmares can create opportunities to take short cuts, use substandard materials or perform inadequate work. How do you avoid these pitfalls? “Timeouts.” They may create a slowdown, yet if you don’t slow down, mistakes will happen that can cause further issues after installation is complete – issues that compromise operations and, more importantly, patient safety. The fix? Timeouts and schedule plans that allow flexibility. Also, it requires courage. Courage to stand up, demand high quality and reliability. Make performance accountable. Remember … good is never good enough. You want high reliability, practice it, mean it, embrace it! – Dean Skillicorn, CBET, is currently the manager for medical imaging services, IHTHTM at St. Luke’s Health System in Boise, Idaho. He is a 36-year veteran of HTM with 28 years in management.

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Director L. Robert said. “I wanted to learn more about how to protect my equipment from cyber-attacks. Yes,” Tech Manager and BMET II C. Bottomley said.

WEBINAR WEDNESDAY Program Builds on Great 2021 STAFF REPORT

he 2021 Webinar Wednesday series recorded 5,346 registrations with just less than 100 attendees per session. The final numbers show an average of 90 attendees per webinar. Webinar Wednesday looks to be a popular online destination for continuing education with big plans for 2022.

CLINICAL ENGINEERING SECURITY SKILLS The Webinar Wednesday presentation “Extending Clinical Engineering Security Skills” was sponsored by Cynerio and was eligible for 1 credit from the ACI. In this 60-minute webinar, expert Chad Holmes dissected the health care ransomware risk landscape, discussed the motives of attackers and demonstrated the latest approaches to secure connected devices. With the rapid increase in recent ransomware attacks, health care providers are trying to adopt new and innovative strategies to prevent breaches and protect patients. A report shows that 1 in 5 hospital breaches originate from an IoT or medical device, leading to a growing interest in extending the skills of biomedical and clinical engineering team members to include a greater focus on security in their day-to-day routines. Holmes covered a variety of items, including:

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FEBRUARY 2022

• Identifying and determining next steps for active devices with manufacturer recalls; • Surveying devices with default credentials/configurations and researching the associated risk; • Analyzing device traffic to identify and prevent potential malware attacks; and • Investigating and addressing active attacks on devices such as MRIs and IV pumps. He also answered questions following his presentation. One question was, “How much of the security workload should we expect biomedical engineers to pick up?” “My dream scenario is that biomed engineers are security aware,” Holmes replied. “They have some baseline knowledge of what to look out for, and then when a command is given to them, a ticket is open, whatever the communication pattern is, they feel comfortable in making those changes on devices to improve security, much like they would if there were any other patches or updates that needed to be made for functionality.” “I don’t think the overall strategic or forward-thinking impact is going to be on biomedical engineers – that’s going to exist more in IT and leadership and security,” he added. “But in terms of updating devices to address specific security issues, I think most probably 30 to 40% of the actual effort is going to

be done by biomedical engineers. Now, that’s not saying you’re going to have a 30 to 40% increase in efforts. What it’s saying is, you may receive a few more tickets here and there to update devices. So, again, the responsibility is split. Another question was, “Lots of hospitals are getting hit by ransomware. Is this something that will get worse before it gets better?” Holmes predicted continued attacks. “I’d expect the health care industry to see more attacks before it starts to slow down,” he said. He answered more questions regarding cybersecurity. A recording of the webinar, including the Q&A session, is available for on-demand viewing. More than 100 individuals registered for the presentation, of 2021. Attendees provided positive feedback via a post-webinar survey that included the question, “Why did you attend today’s webinar? And was it worth your time?” “Cybersecurity is one of the hottest topics in biomed right now and we all need to be doing our homework to protect our patients and our organizations. Yes, this webinar was worth my time,” Clinical Engineer M. Barton said. “I attended to learn more about the current status of cybersecurity in health care. It was valuable to know the impact to the industry,” Associate

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TECHNOLOGY PROMOTES FASTER PMS The webinar “How to Use the Latest Technology to Speed Through Your PMs with Greater Accuracy and Simplicity” was sponsored by Pronk Technologies and eligible for 1 credit from the ACI. Pronk Technologies Sales Director Julio Castro discussed new technology that allows users to control test equipment from a smart device to increase accuracy and efficiency in performing PMs and service on medical devices. It automatically collects test results as you work, including tests performed, notes and images. It even generates a complete electronic report and grows your device library with hundreds of custom medical device types. The webinar was a big success with 110 attendees. Positive feedback included answers to the question, “How will today’s webinar help you improve in your role?” “Gives me a better understanding and insight about new technology to help simplify recording my services,” Senior Clinical Engineer T. Gardner said. “Knowledge of available tools that make performing tasks more efficient is important to growth,” Biomed J. Cozadd said. “Although I am no longer in a clinical engineering role, I still work closely with the CE team and can give them this information,” Clinical Equipment Project Manager G. McNeil said. The presentation took up the entire session which did not allow for a question-and-answer session. However, Castro received the questions submitted during the presentations so he can provide answers. Attendees were also invited to submit questions via email at sales@pronktech.com. For more information, including the 2022 schedule, visit WebinarWednesday.live.

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SHOP TALK POWERED BY

LASERSCOPE LYRA I

Q: A:

I have an Error 20. I need to know what to do?

Error 20 is “lamp failed to start.” Check the 12V and 24V. The manual also mentions checking water temperature and pressure. In my experience, it may also be low resistivity in the water. The easiest way to rule that out is to drain the coolant, replace the DI filter and refill with distilled or sterile water. STRYKER 1488 HD

We have two Stryker 1488 cameras that won’t white balance and they go dark after 3 minutes. Is there a way to reset the system? Might there be another setting that needs resetting?

It seems like something overheats inside your consoles or the heads. I would start with troubleshooting the issues with air flowing the units. Try also quick cross connecting the hot head or console with the other cold ones. That might give you an idea of what is out of order either the head or the console.

Unable to successfully complete startup phase. If this problem occurs frequently. please save patients on CD or network and remove those patients from the patient browser.” I tried to delete all patients but there was still an error. After that I got the error “ASP_ASM_E_70.” I also tried not restarting the system, just closing the system message window. It looked normal. The monitor shows tasks for both. I checked the battery and it is good, BIOS configuration is good and the graphic card configuration is good. I did not connect C-arm X10.

When you said both task cards are visible. Do you see the browser/acquisition task card on the left monitor and on right monitor the filming task card? You should not have identical task cards on both monitors. A: ABE_222 is a problem with the Exam task card. ASM_70 is a serious memory issue. Let’s consider E222 first. 1. Make sure the network cable is connected. 2. Make sure you have an IP number in the TCP/IP configuration within local service. 3. Make sure there is no duplicate IP configured.

SIEMENS ARCADIS VARIC

I have a problem with Arcadis Varic M460 error “ASP_ ABE_E_222 Examination Task Card:

E-70 Maybe related to above or there is a graphic card problem, make sure the two monitors show different task

cards. If they are the same this could be your problem. Remember if the DVI/DP connectors are removed from the PC and the PC powered the graphic card setting revert to default! Reply: This unit never connects to the network. Both monitors show different task cards as normal.

If the local LAN IP is missing it can cause problems, please check if an IP is present normally 192.168.0.1. The only other suggestion is to clear out any windows temp folder contents and Syngo temp folders. Use F8 at power-on to access windows “safe” mode. Then, look for the various temp folders to clear contents. One last thing, just in case the database is not corrupted but has a problem (even though the patients are deleted). While in safe mode, go to D:/ Data and look for the exchangeboard folder, rename by adding old, so it looks like exchangeboardold. Save and shutdown the PC, then restart. Syngo will count up to 99 and then restart. Be patient, it will re-create a new exchangeboard folder and browser will popup. Then, see what happens, if all OK you can then go back in using safe mode and delete the old exchange board and folder. Remember to remove anything within the recycle bin (again via safe mode).

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SHOP TALK

is compiled from MedWrench.com. Go to MedWrench.com community forums to find out how you can join and be part of the discussion. 42

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EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FEBRUARY 2022

TECHNATION

ROUNDTABLE

ROUNDTABLE Cybersecurity

ybersecurity continues to be a worldwide concern, especially in health care. Attacks continue to ramp up and at least one report predicts an increase in “big game” targets in the future. Health care facilities are major targets for a variety of reasons. One of those reasons is the amount of information patients provide to medical facilities that can be sold on the dark web. Cyber goons also profit via ransomware attacks on hospitals and health care systems.

TechNation magazine reached out to several cybersecurity firms and experts for information and advice. Participants in this month’s Roundtable article include Nuvolo OT Security Executive Ty Greenhalgh, HCISPP; Accruent Vice President of Healthcare Strategy Al Gresch; Cynerio Cybersecurity Evangelist Chad Holmes; Medigate Co-Founder and CEO Jonathan Langer; CyberMDX Chief Technology Officer Motti Sorani; and Cylera Chief Security Strategist Richard Staynings. Q: WHAT ARE THE BASICS HTM PROFESSIONALS NEED TO KNOW REGARDING CYBERSECURITY? GREENHALGH: Historically, medical devices have not been designed with network

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FEBRUARY 2022

implement new interdepartmental processes that are efficient, effective and scalable. This will require change and growth, which is always painful.

Al Gresch Accruent security in mind. Therefore, they are at best like open doors and windows allowing easy access to patient data on the network, and at worst vulnerable to device manipulation which could impact patient outcomes. Due to unique engineering and the criticality of a clinical environment, the cybersecurity of medical devices cannot be managed using the same approach and tools used for traditional information technology. This combined with volume of network connected devices, the limited bandwidth of HTM and the cyber inexperience of most HTM personnel requires health delivery organizations (HDO) to

GRESCH: First is to get tight with your IT security team if you haven’t already. Working hand-in-hand with them, you can develop a very comprehensive vulnerability management plan. You will need to capture all pertinent security information in your CMMS for all networked devices, such as operating system, software version, IP and MAC addresses, any known vulnerabilities, and whether those risks are either remediated or have been deemed a low enough risk to be acceptable. HOLMES: The recent increase in health care cyber attacks is driven by two things − greed and opportunity. Hacking collectives are well organized, financially driven businesses searching for the most profitable victims. Health care environments are often flatter, less protected and easier to breach than other industries. HTM professionals should follow the lead of other industries, both in security practices and collaborative style, which has resulted in better defenses and fewer successful attacks. LANGER: While it is not simple, the basics of cybersecurity can be distilled into three main categories − people, processes and WWW.1TECHNATION.COM

technology. No single factor can solve the challenges; rather it is the combination of extraordinary people who work with effective processes and use exceptional technology that helps keep the hospital safe and operational. For an HTM professional, it is helpful to realize that the devices they work with were not designed with security in mind and they can quickly become a source of breach to the hospital if they are not managed carefully and correctly. The HTM professionals can and should ally themselves with their security team!

tained. The team should promptly disconnect the affected network or devices from the Internet, disable all remote access and change passwords. Completely denying the attackers access to your system is critical. Given the unique nature of health care, it is not always plausible to simply unplug and disconnect. New asset discovery and security tools can assist in detecting security events and providing a more focused remediation like zero trust architecture or quarantining.

SORANI: Health care is one of the most targeted sectors for cyber-attacks. While many hospitals now have dedicated security teams accountable for mitigating and remediating risk, the responsibility for cybersecurity extends to nearly everyone on the staff. HTM professionals are front and center – they are responsible for the medical device life cycle, including pre-purchase assessments, procurement, the onboarding process, ongoing risk management, maintenance and decommission. Throughout this life cycle, proper cybersecurity protocols should be applied and executed to protect health care organizations from patient care issues and safety, data security, financial loss and reputational impact that result from ransomware or other cyber-attacks.

GRESCH: First and foremost, you should ensure you have a plan in place before a cyberattack happens. The quicker you can identify and isolate a compromised device or group of devices, the more you can limit the impact. Then work with your IT security team and your vendor to begin remediation efforts that should already be outlined in your incident response plan.

STAYNINGS: Cybersecurity is everyone’s concern, and everyone’s responsibility just as patient safety should be. However medical, and other health care IoT devices, are often highly vulnerable to cyberattack. Yet, HTMs are not currently trained to look at devices for indicators of compromise or to understand how these may introduce patient safety risks. With focused security awareness training HTM professionals can be the first line of defense, yet with current training many are unprepared. Q: WHAT IS THE FIRST THING A HEALTH CARE FACILITY (HTM DEPARTMENT) SHOULD DO WHEN A CYBERATTACK HAPPENS? GREENHALGH: Assuming the organization has already mobilized the cybersecurity response team and identified the type of attack, the breach needs to be con-

HOLMES: In an ideal world health care facilities would have printed copies of a well-defined incident response (IR) plan to follow during an attack. If that sounds aspirational, find time today to begin the process of creating one. More practically, patient safety must always be the top concern. Organization leadership should focus efforts on ensuring devices remain operational and highly monitored by caregivers, while IT and related staff work to identify, isolate and eventually eliminate the attack. LANGER: First, the hospital is always under attack and the bad guys only need to be right once to cause problems! When/if a breach does occur, the goal is containment and remediation as fast as possible. Most organizations will run “table-top” exercises to prepare for these events, and HTM should be involved in them. So, when/if the breach occurs, HTM can refer to their training, bring out the playbook and execute it. If the HTM team notices anomalous behaviors or issues with their devices, they should sound the alarm immediately to initiate the containment and remediation process.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Ty Greenhalgh Nuvolo

SORANI: The HTM department’s involvement in cyberattacks should start before an attack even happens, by ingesting their expertise into the response plans. This includes providing the knowledge and answers to questions such as: • When a certain kind of medical device is being attacked, what’s the potential impact to patient safety or care delivery? • Can we safely disconnect a device to contain a cyberattack? What will be the implications? • What devices are impacted say a vendor cloud service is under attack? Ideally these answers are ready to be used upon an incident, yet assuming not every scenario is covered, in case of a cyberattack, an HTM professional should be available to provide the answers and take part in the containment process. STAYNINGS: First of all, don’t panic! Health care workers should fall back upon the training they have received in security incident response, disaster recovery and business continuity planning. All staff should receive this training and participate in tabletop exercises annually while all managers and above, including the CEO, should participate in quarterly exercises. Regularly updated runbooks will be

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critical so staff know the what, when, how and who should be engaged in response to any cyberattack. Providers that do not invest in adequate planning and preparation for security incidents are asking for trouble and may not be in business after a devastating attack. Patient safety, morbidity and mortality may also be negatively impacted if a provider has not made adequate preparations including staff training. Q: CAN YOU TELL US ABOUT ONE TECHNOLOGY, PRODUCT OR SERVICE BIOMEDS CAN USE TO HELP PROTECT A FACILITY? GREENHALGH: There is a common axiom in cybersecurity: “You can’t protect what you can’t see.” Visibility is crucial. Security orchestration and automated response (SOAR) can create a single source of truth for all medical devices, integrate the cyber vulnerabilities for each device and automate the remediation within the normal operations of an HTM department. This technology increases the value of the existing CMMS through data enrichment, integrates cybersecurity maintenance work orders with step-by-step instructions for remediation and automates processes like onboarding, risk management, manufacturer inquiry, security event notification, combined PM and security work orders, etc. Having an accurate inventory with device-level detail on vulnerabilities with remediation practices and an automated workflow is a systematic approach for operationalizing cybersecurity for medical devices. GRESCH: There are a vast number of network monitoring solutions available that will establish normal network operating profiles for the networked devices in your inventory. Once a breach is identified, getting a notification through an interface to your CMMS can quickly put you on a path to remediation. Unfortunately, less than half of U.S. hospitals employ such technology today.

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Chad Holmes Cynerio HOLMES: Cynerio’s IoT security platform provides a wealth of information to better protect the thousands of devices in a typical hospital environment. From identifying dormant attacks waiting to be activated to generating automated rules that greatly reduce risk, Cynerio helps guide biomeds, clinical engineers, IT, network and many other team members on a clear risk reduction path. LANGER: The Medigate platform allows HTM to maintain an accurate device inventory by comparing the CMMS to the devices transmitting on the network. With a consistently updated database, they can better manage known vulnerabilities and patch the most critical devices, reducing the overall attack surface. SORANI: Biomeds can enhance the facility’s cybersecurity by leveraging a solution that provides a layered approach to cybersecurity, protecting each individual device and driving remediation and mitigation directly on your medical and IoT assets as well as the broader network. A solution like this should offer a prioritized list of the devices most at risk, then allow security teams to apply actions to remediate or mitigate the associated risks and enable IT to authorize and manage traffic to and from the devices using allow-list or blocklist policies. STAYNINGS: The complexity and number of biomedical devices in hospitals has

massively increased over the past decade yet most providers have at best an inaccurate count of connected devices and little to no understanding of the risks each device and device type my introduce to the health care network, to HIT systems and to patient safety. This is why it is critical to implement tools to manage the wide array of connected unmanaged assets and especially those claimed to be managed by vendors. This is so risks can be accurately assessed, remediated by patching/reconfigured where possible, or segmented where no immediate remediation is possible. This needs to be intelligent and automated unless hospitals are prepared to hire hundreds of additional BMETs and other staff. Q: WHEN IT COMES TO OLDER EQUIPMENT, WHAT STEPS CAN BE TAKEN TO PREVENT CYBERSECURITY ISSUES? GREENHALGH: “Legacy” technologies are those devices, IT systems, programs and applications, and other technologies present in health care environments that cannot be reasonably protected against current cybersecurity threats. Many legacy devices may present risks that cannot be sufficiently mitigated (e.g., patched or otherwise updated) to address cybersecurity threats, as current best practices recommend. Others contain insufficient, poor or no security controls. They may have contained state-of-the-art security controls at the time they were deployed but, because of the long lifetimes of health care technologies, are now faced with unanticipated threats against which they cannot defend. HDOs should develop a security lifecycle plan (SLP) to include: 1) Identifying devices 2) Tracking and managing inventory 3) Planning device replacement 4) Establishing risk remediation processes 5) Planning risk mitigation strategies at each life cycle phase. GRESCH: Understand what the vulnerabilities are and whether the risks can be mitigated or minimized through configuration or patches. Incorporate cybersecurity risk assessments into your capital equipment replacement planning

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process and work toward replacing the devices that represent the greatest risk. I think there is enough recent evidence of the immense cost of cyberattacks to health care systems as to make this a much higher priority than it has been in the past. HOLMES: In many cases cybersecurity issues in older equipment can’t be fully remediated for one simple reason old equipment includes dozens of old components that are no longer supported by manufacturers. That said, reducing and preventing cybersecurity issues often doesn’t require full remediation. Implementing mitigating controls will typically provide an incredibly high level of security at a greatly reduced effort. At Cynerio, we’ve found great success in implementing mitigations with network segmentation, an approach that reduces both the likelihood and impact of attacks.

Jonathan Langer Medigate

LANGER: Knowing what devices are connecting to the network is always the first step to address cybersecurity issues. Often these older devices will be phased out, or in process of retirement, but will remain on the network. When a device that is listed as “retired” in the CMMS is still being used, that is a problem and should be immediately rectified. The key to solving this is accurate and active device data, so you can see if that “retired” device is still being used and act accordingly.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Motti Sorani CyberMDX

SORANI: Knowing whether older devices carry protected health information (PHI) and understanding what level of criticality the devices have with regards to patient safety and continuing care is essential to preventing cybersecurity issues. Biomedical teams should take a systematic approach to patching older devices with the help of the vendors. New vulnerabilities are being discovered daily and medical devices must be monitored and updated constantly. Having protocols in place and good relationships with vendors to help with patching is an important building block in any cybersecurity framework. STAYNINGS: Older equipment should be patched, and if vendors are not providing timely patches to security vulnerabilities in their devices within the expected, agreed, or a reasonable lifetime of a system, then that vendor should be struck from the approved vendor list for all future procurement. Where risks cannot be remediated, compensating security controls such as micro-segmentation should be implemented to safely allow the continued use of devices or systems without introducing risks to patients or the health care network. End of life systems should be retired, scrubbed of PHI and their components recycled.

Q: HOW IMPORTANT IS COLLABORATION BETWEEN A FACILITY’S DIFFERENT DEPARTMENTS WHEN IT COMES TO CYBERSECURITY? GREENHALGH: Building on the concept of a security lifecycle plan (SLP), organizations need to integrate the operations of various stakeholders and departments into a streamlined process that provides accountability for the various stages along the life cycle. The integration should improve communications, cyber effectiveness and business mission efficiencies. E.g., data gathered during the device procurement and security evaluation is consolidated into the CMMS where risk assessment will drive security maintenance work orders within the same workflow as preventative maintenance work orders. These security work orders can then be assigned to HTM, IT or a service organization based on the complexity, control required, manufacturer, contract restrictions, device location, etc. GRESCH: Extremely important. Even in the company I now work for, there is mandatory cybersecurity training, so we all understand the risks and the things each of us needs to do to keep our systems safe. A fair number of vulnerabilities are created by staff doing things they shouldn’t be doing. HOLMES: Collaboration is critical, but needs to happen in a coordinated, efficient manner. It’s unlikely that IT professionals will ever become caregivers, so we can’t expect the caregivers to become cybersecurity professionals. Instead, one or two core teams (often IT security and networking) must provide clear, concise guidance in a productive and respectful way. This will help build a dynamic that is both productive and successful for years to come. LANGER: Cybersecurity is everyone’s responsibility, so HTM should contribute their unique skill sets to the overall organization’s plan to secure the hospital. The collaboration is vital, as each stakeholder will bring a

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different level of input and expertise to the table. I would argue that HTM professionals should work to insert themselves in the security working groups if they are not there already! SORANI: Cybersecurity in health care is a collaborative effort across the HTM, security, compliance and IT teams with the support and understanding of management. Even if your direct title isn’t “cybersecurity professional” you still play a major role in the process. IT, security and biomed teams must work together to ensure that the right devices are purchased, that they are on boarded correctly, patched in a timely manner when needed and ultimately that proper cybersecurity practices are followed during the lifetime of the device. Cybersecurity teams can establish all the guidelines they want, but without the participation of the other actors within the hospital they will be fighting an uphill battle. STAYNINGS: Collaboration between all parts of the health delivery system is vital when it comes to effective cybersecurity. Cross-departmental working groups should be established so that when a security incident occurs, communication channels are well known and practiced, and staff are not left wondering who to contact and where responsibilities lie. Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT CYBERSECURITY? GREENHALGH: The need to protect the devices from cybersecurity events is increasing. CMS is considering the addition of a cybersecurity review of connected medical devices to their accreditation through expanded interpretive guidelines. But with the right tools and process redesign, HTM can be the front line in remediation of the vulnerabilities without being overwhelmed. New technologies are identifying the devices and operationalizing a step-by-step instruction set to

apply the right control to the right device to reduce risk and increase compliance. The more complex IT related controls can be routed to network engineering, but the vast majority can be addressed by HTM and integrated into their daily operations and reporting.

everyone understands the connection, that’s the foundation on which you can grow the security-minded culture. Once the connection between security and these values is established, it is much easier to build the awareness to the issue, and have the employees consider themselves enablers of the security effort, rather than just consumers.

GRESCH: This is not an issue that is ever going to go away. The number of cyberattacks in health care has increased exponentially since the start of the pandemic. As most of us in health care were focused on getting the equipment and space allocations that were needed to take care of COVID-19 patients, the bad actors were very busy upping their game relative to the level of sophistication of attacks. There is enough money to be made in this realm where RaaS (Ransomware as a Service) is now an actual thing. HOLMES: The increase in ransomware and other attacks on health care providers is not accidental, nor is it as widespread in other industries. Attackers have found a target-rich environment motivated by failures that result in loss of lives, not just loss of dollars. Luckily, it’s not all doom and gloom. The root causes of many attacks are becoming more well known, and practical technologies like Cynerio that help prevent and react to attacks are readily available. LANGER: Ultimately, every hospital must be consistently right in its battle to remain secure, while the bad guys need to be right only once. The pressure to remain vigilant and protect the hospital is intense, and the security teams will usually welcome all the help they can get. SORANI: To excel in cybersecurity, an organization needs to create a security-minded culture, that starts with the core values − quality care delivery, patient safety and patient data privacy. When security is connected to these values in a meaningful way, and

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STAYNINGS: Cybersecurity threats are growing at an exponential rate. Between 2019 and 2020, ransomware attacks rose by 62 percent worldwide, and by 158 percent in North America alone, according to SonicWall’s 2021 report. The FBI received nearly 2,500 ransomware complaints in 2020, up about 20 percent from 2019, according to the FBI’s annual Internet Crime Report. Cybersecurity should not be an afterthought or considered a cost center or price of doing business. Done right, cybersecurity enables new business and clinical services. It helps to drive revenue and customer/patient satisfaction. It enables new risky technologies that drive improvements to patient outcomes and reduce morbidity and mortality. Good cybersecurity is in everyone’s best interests.

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procedure, the safety of these instruments is critical. Although HTM plays a peripheral role in endoscope reprocessing, it is good to be aware of updated procedures in this crucial area. Most of the responsibility for this task falls to the sterile processing department (SPD) in the hospital environment. As of late December, AAMI ST91:2021 earned final approval from the American National Standards

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PATIENTS

ANSI/AAMI ST91 INCLUDES HTM RESPONSIBILITIES BY K. RICHARD DOUGLAS

he Centers for Medicare & Medicaid Services (CMS) suspended healthcare associated infection (HAI) reporting requirements through June of 2020, leaving less oversight and prevention of these infections. The focus was instead on activities related to the COVID-19 response and surges.

By December of 2020, a review of HAIs for the year showed an uptick related to the pandemic. A survey conducted that month by the Association for Professionals in Infection Control and Epidemiology (APIC) found HAI rates

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between 17 and 28 percent. These rates were most closely associated with central line-associated bloodstream infections, ventilator-associated pneumonia or ventilator-associated events and catheter-associated urinary tract infections. Because most elective procedures and surgeries were put on hold, the rate of infections from flexible and semi-ridged endoscopes were less than in previous years. Researchers anticipate that when more thorough numbers of HAIs are available, the rate of CLABSI, which COVID-19 patients are at higher risk of

contracting, will have risen more than all other HAIs. The pandemic changed this dynamic since pathogens remaining on endoscopes was the leading risk for these infections not long ago, and a combination of new protocols and fewer elective procedures, has displaced the endoscope from the top of the list. That doesn’t mean that the cleaning, sterilization and safe storage of these instruments can be ignored now. For every patient who has to undergo a colonoscopy, ERCP biliary study, upper GI endoscopy, small bowel manometry, double balloon enteroscopy or other

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care Organizations” every year. In 2016, the number four entry on the list was “Inadequate Cleaning and Disinfection of Flexible Endoscopes.” In its outline of the concern, ECRI stated that “A series of deaths due to carbapenem-resistant Enterobacteriaceae (CRE) infections has highlighted the importance of effectively cleaning and disinfecting flexible endoscopes – a problem that has been on ECRI Institute’s radar for years.”

strips and cleaning agents, water quality used by installed reprocessing or sterilization devices, and cleanliness of storage cabinets. “Endoscopes that are very difficult to clean. In some cases, even when facilities follow all of the validated reprocessing instructions, endoscopes can still be contaminated,” Smith says. She says that there have been some major changes over the last few years that may help to reduce the risks. Some

As of late December, AAMI ST91:2021 earned final approval from the American National Standards Institute (ANSI). The updated ST91 is available at the AAMI store; those with an electronic subscription will have immediate access to the revised standard. The printed standard is also available to HSPA members (formerly IAHSCMM) at a reduced rate. Institute (ANSI). The updated ST91 is available at the AAMI store (aami.org); those with an electronic subscription will have immediate access to the revised standard. The printed standard is also available to HSPA members (formerly IAHSCMM) at a reduced rate. The HSPA website is myhspa.org. Outside of the hospital setting, the cleaning and sterilization of endoscopes is carried out in GI and pulmonary endoscopy units, respiratory therapy departments and ambulatory care clinics – especially urology and ENT, ambulatory surgery and/or endoscopy centers, according to John Whelan, BSN, RN, clinical education specialist at Healthmark Industries. “More commonly – outside of SPD areas – clinical staff are processing reusable devices. Endo areas commonly have endo techs or RNs processing scopes. In ambulatory care clinic settings, it is commonly medical assistants who have been trained in processing,” Whelan says. NOT OFF THE RADAR YET A review of the ECRI Institute’s lists of health care concerns in past years found that endoscope reprocessing was a critical issue that resulted in HAIs. The organization publishes it’s “Top 10 Patient Safety Concerns for Health-

ECRI pointed out that endoscopes had become more intricate and complex as technology had advanced and that this posed a greater challenge in making these instruments clean. Duodenoscopes were of particular concern that year. Endoscopes also made the ECRI list the previous year. “Device Cleaning, Disinfection, and Sterilization” was also highlighted on the list in 2018, but endoscopes were not singled out. Despite the focus on endoscopes, and measures to improve sterilization, there continues to be concern. Mairead Smith, senior project engineer with ECRI, says that endoscope reprocessing continues to be a major challenge for health care facilities. She is part of the organization’s medical device evaluation team. Smith says that, in particular, facilities struggle with workflow challenges. The pre-cleaning and manual cleaning processes that are required for flexible endoscopes are long and labor-intensive. Staff deal with physical strain and time constraints, as well as the challenge of remembering and following the very detailed instructions, which vary by model. Other challenges include managing equipment, including the proper accessories as recommended by the manufacturer, expiration dates on test

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

of the highest profile changes with great potential include: • Duodenoscopes. In August 2019, the FDA recommended that facilities consider using duodenoscopes with single-use components. They believe that, “Disposable designs may reduce between-patient duodenoscope contamination by half as compared to reusable, or fixed endcaps.” • Single-use endcaps are used with reusable duodenoscopes. They allow staff to better access the intricate geometry of the tip of the duodenoscope, where the forceps elevator is. Reusable duodenoscope reprocessing IFU now recommend detailed manual brushing on all sides of the tip, including the front and back of the forceps elevator. Single-use endcaps allow much easier access than with traditional fixed endcaps. “Fully single-use models should be disposed of after each procedure. They arrive sterile and are not validated for reprocessing. Although relatively costly, they may offer particular benefit under selected circumstances, such as when a patient has a known or suspected infection, or if a patient is immunocompromised,” Smith says. She says that there has also been FEBRUARY 2022

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recent FDA guidance as it pertains to bronchoscopes. One more recent example of concerns with the cleanliness of endoscopes appeared in an FDA notice issued in April of 2021 titled; “Infections Associated with Reprocessed Urological Endoscopes - Letter to Health Care Providers.” The FDA specified cystoscopes, cystourethroscopes and ureteroscopes and stated that since 2017, the agency had received 450 Medical Device Reports (MDRs) related to post-procedure infections in patients. This FDA notice was cited in a presentation at the 2021 AAMI eXchange Rewired given by Mary Ann Drosnock, MS, CIC, CFER, RM (NRCM), AAMIF, FAPIC, director of clinical affairs for Healthmark Industries. Drosnock is also the co-chair of AAMI’s ST91 working group. The title of the presentation was: “Updated AAMI ST91:2020 for Endoscope Reprocessing: An HTM Perspective.”

the standard includes best practices in any health care setting and covers all steps of processing from precleaning through reuse. It excludes TEE/ ultrasound probes/dilators/manometry and rigid scopes. Some of the changes in ST91 include point of use treatment re-termed, cleaning verification, inspection of borescopes and standards for drying, storage and handling. There are also recommendations against manual disinfection, the adding of FDA Maude database citations and appendix on inspection, simethicone and cleaning verification. A portion of the ST91 presentation that has direct implications for HTM is the section that details quality assurance policies for logging endoscope inventory, accessories, processing equipment, serial numbers or other assigned numbers and unique identifiers. “HTM has a huge role in inventory management of devices and lists of endoscope models with serial numbers. HTM would also be responsible for keeping an inventory of the various endoscopes in their health care setting and maybe having some type of

mated leak testers should be placed on a calibration schedule to verify the leak tester is producing the correct pressure.” “Historically, the only thing HTM (or anyone else) could do for leak testers was electrical safety testing. It’s been only the last two years since devices exist for testing pressure outputs from leak testers. This can and should be now incorporated as part of standard QC practices for this automated equipment,” Whelan says. ADDITIONAL HTM CONSIDERATIONS In HTM’s peripheral role, biomeds are responsible for maintaining the equipment and managing the devices that allows the cleaning process to work. Most of the direct hands-on work of cleaning these devices falls to the sterile processing department in a hospital setting while this function can be undertaken by others in other health care settings. Examples of HTM’s involvement in the process may be to maintain the TEE probe reprocessors, leak detectors, drying cabinets and manage the contracts for the washers. “HTM would be responsible for

“Endoscopes with damaged surfaces can trap water and contaminants, harboring pathogens and allowing for cross-contamination.” - Mairead Smith The presentation looked at the AAMI ST90 and the goal of the standard. She said that “This standard specifies the minimum requirements for a quality management system that can be used by health care organizations that process medical devices.” “It was developed to help health care professionals more effectively, efficiently and consistently reprocess reusable medical devices in order to prevent infections, pyrogenic reactions or other adverse events,” she added. ANSI/AAMI ST91 sets a standard for health care facilities for the processing of flexible and semi-rigid endoscopes. According to Drosnock’s presentation, 52

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notation when each instrument was last repaired but not when it was sterilized. That falls to SPD,” Drosnock says. In addition to the inventory items, section 12.2 of policies for quality assurance states: “Development and implementation of procedures that address specification evaluation, acquisition management, scheduled maintenance and removal of equipment from use.” Drosnock’s presentation also highlighted Section 6.4.1 of the standard, which deals with quality assurance of leakage testers. Some general considerations include: “auto-

calibrating the leak tester units for PMs on a routine basis (like annually or biannually), but daily testing of the leak test units would be up to the sterile processing department to do,” Drosnock says. She says that HTM may have a role in water management. Especially since there will be recommendations for testing water in the AERs. Sterile processing may need help setting that up initially or HTM may do that for them. Drosnock says that HTM would also be responsible for checking the integrity of loaned endoscopes and tracking those loaned out. “HTM should also have a team WWW.1TECHNATION.COM

member who sits on any committees related to endoscopes, new purchases for SPD/ endoscopy, and likely any cross-functional that makes risk-management type decisions for the sterile processing/endoscopy processing areas,” she adds. “In my experience, this has not been the norm; but would certainly be an asset. This should include existing committee structures for: infection prevention, risk management, purchasing,” Whelan says. Smith says that there is definitely a role for the HTM department in supporting the cleaning/disinfecting/sterilization process. In particular; equipment management and maintenance. “As mentioned earlier, management of reprocessing, sterilization, drying and storage equipment is a challenge for sterile processing departments. The equipment should undergo appropriate inspection and preventive maintenance, and service as recommended by the manufacturer. In conjunction with the infection prevention team at a facility, HTM departments can also perform water quality tests and take appropriate preventive measures (e.g., changing filters at regular intervals) to meet the needs of sterile processing departments,” she says. She adds that in addition, endoscopes must be properly maintained. As part of the reprocessing procedure, staff should perform leak tests to look for damage to the endoscope insertion portion or working channels. “If damage is found, such as punctures, tears,or grooves, it should be repaired promptly by the device manufacturer or another qualified service organization. Endoscopes with damaged surfaces can trap water and contaminants, harboring pathogens and allowing for cross-contamination. HTM departments can help manage the process of gathering damaged scopes, returning them to the manufacturer for repair, requesting loaner devices to meet the facility’s workload, tracking the serial number of loaner devices, and finally, returning repaired endoscopes to service,” Smith says. Depending on the health care environment, those tasked with endoscope processing may work in a variety of capacities. “It is common that most of high-level disinfection (HLD) and endoscope processing occurs outside of the standard sterile processing domain. For example, endoscope processing often occurs locally for GI and pulmonary endoscopy units, respiratory therapy departments, and ambulatory care clinics – especially urology and ENT,” Whelan says. He says that in recent years, a significant portion of clinical outpatient procedures have transitioned to ambulatory surgery and/or endoscopy centers. Depending on the organizational structure, HTM may or may not be actively supporting this “wider net” of reusable device processing. Whether in a hospital or other health care setting, the integrity and cleanliness of endoscopes is a team effort. The safety and health of patients undergoing procedures that uses these devices are on the line.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

MAIREAD SMITH,

senior project engineer with ECRI

JOHN WHELAN,

BSN, RN, clinical education specialist at Healthmark Industries

MARY ANN DROSNOCK, MS, CIC, CFER, RM (NRCM), AAMIF, FAPIC, director of clinical affairs for Healthmark Industries

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