TechNation Magazine May 2021 by MD Publishing

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ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

MAY 2021

MEDICAL DEVICE RISK SCORING Measuring Risk and Preparing for its Eventuality PAGE 48

18 Department of the Month

McLeod Health Biomedical Services Department

34 Biomed 101

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61 Cybersecurity Address Service Requested MD Publishing 1015 Tyrone Rd., Ste. 120 Tyrone, GA 30290

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CONTENTS

FEATURED

HE ROUNDTABLE: T IV PUMPS In this installment of the monthly roundtable feature article, experts from throughout the healthcare technology management (HTM) industry share insights and tips regarding IV pumps.

MEDICAL DEVICE RISK SCORING: MEASURING RISK AND PREPARING FOR ITS EVENTUALITY With medical devices, the safety and security of a device has to be carefully managed. Risk has to be managed throughout the product life cycle. . ext month’s Feature article: N Continuing Education: Overlooked COVID-19 Casualty

Next month’s Roundtable article: Training/Education

TechNation (Vol. 12, Issue #5) May 2021 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. ©2021

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

MAY 2021

TECHNATION

CONTENTS

PUBLISHER

John M. Krieg

VICE PRESIDENT

Kristin Leavoy

ACCOUNT EXECUTIVES

Jayme McKelvey Megan Cabot

ART DEPARTMENT Jonathan Riley Karlee Gower Amanda Purser EDITORIAL

John Wallace Erin Register

CONTRIBUTORS

Roger Bowles Jenifer Brown K. Richard Douglas Jim Fedele Joe Fishel Manny Roman Cindy Stephens Steven J. Yelton

DIGITAL SERVICES

Cindy Galindo Kennedy Krieg

EVENTS

Lisa Lisle

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, Senior Vice President Marketing and Sales, Tech Know Associates - TKA 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: Liana Lucky p.14 Association of the Month: Gateway Biomedical Society (GBS) p.18 Department of the Month: McLeod Health Biomedical Services Department P.22 INDUSTRY UPDATES p.22 News and Notes: Updates from the HTM Industry p.29 AAMI Update p.30 ECRI Update p.32 Ribbon Cutting: Kontakt.io P.34 p.34 p.37 p.38 p.40

THE BENCH Biomed 101 Tools of the Trade Webinar Wednesday Shop Talk

P.55 EXPERT ADVICE p.55 Career Center p.56 How to Troubleshoot Suspected Environmental Interference in Ultrasound Systems, sponsored by Avante p.59 The Future p.61 Cybersecurity p.62 20/20 Imaging Insights, sponsored by Innovatus Imaging P.66 BREAKROOM p.66 Did You Know? p.65 iMed Biomedical: Get Up Clean Up Contest p.68 The Vault p.70 MedWrench: Bulletin Board p.78 HTM Strong p.74 Service Index p.77 Alphabetical Index

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MAY 2021

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SPOTLIGHT

PROFESSIONAL OF THE MONTH Supervising the Unsung Heroes BY K. RICHARD DOUGLAS

onths of dealing with the COVID-19 pandemic has tested the mettle of even the best biomeds. This has been true in many health care settings, including the VA.

Liana Lucky is one clinical engineer who has risen to the challenge. Her boss remarked that she has been an integral part of her facility’s response to the pandemic. “She worked with our physiological monitoring and telemetry vendor to expand our physiological monitoring coverage from 24 ICU beds to all 120 med/surg and ICU beds,” Jennifer Boudreaux Harrison, acting chief of clinical engineering said. It is that type of effort that reinforces the importance of those in the HTM profession among all health care professionals. Lucky is a supervisory clinical engineer with the Southeast Louisiana Veterans Health Care System in New Orleans. Lucky knew she had a mechanical acumen from an early age. Although she was interested in medicine, she was not ready to put on a white smock. “As a little girl, I was always taking things apart and putting them back together. I also loved spending time with my dad under the hood of the car all greased up. The engineering mindset was evident at a very young age. As I got older, I was fascinated with the medical field but not necessarily the clinical side of the house (i.e. the blood and guts),” Lucky says.

TECHNATION

MAY 2021

Liana Lucky discusses an imaging procedure with colleagues at the Southeast Louisiana Veterans Health Care System in New Orleans.

She says that by combining the health care environment and engineering; biomedical engineering was a match made in heaven. “It is also a positive that we get to help people every day,” she says. “I graduated with a Bachelor of Science in biomedical engineering, followed up by a fast-track program for a Master of Science in engineering management. Right out of college, I was selected for the Technical Career Field (TCF) Program through the Veterans Affairs (VA),” Lucky adds. She says that the TCF program is an “awesome” two-year program that consists of paid technical training, access to a preceptor and hands-on training. “There are several career fields available, not just biomed. The VA does an exceptional job investing in the TCF program participants. I spent my internship in Boston learning the HTM ropes from some really great people,” Lucky says. The experience and training paid off and led to a leadership role. “After graduating from the TCF program, I took a systems clinical

engineer position at the New Orleans VA Medical Center. This position focused on highly complex, technical systems throughout the medical center. It forced me to look at the big picture. The responsible equipment was not limited to only medical equipment, so it also was a great learning experience,” Lucky says. Recently, Lucky was promoted to supervisory clinical engineer. “I lead a great team of biomedical equipment support specialists and electronics technicians. It has been an interesting shift from the technical side to management. Every day is a challenge, but that is the best part of what we do. This field is constantly changing, and I learned very quickly whether you are on the technical side or management; you better hold on,” she says.

ACCOMPLISHMENTS DURING A PANDEMIC When asked about challenges, Lucky reflects on the past year and the unrequested ride that so many in health care have been on. “The biggest challenge of my

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SPOTLIGHT

Liana Lucky is seen near a sign in front of the Southeast Louisiana Veterans Health Care System.

career has been working through the pandemic. It was a struggle managing all the uncertainty in the community and in our personal lives. We are resilient and definitely believe we have come out stronger because of this,” she says. Lucky explains that another special project she was involved with as a systems clinical engineer was the medical center’s emergency power system repairs. “I came into the project without any knowledge of generators, utility feeders, etcetera. This was a challenge that involved many hours researching. It has definitely opened my eyes to a medical center’s behind-thescenes facility operations,” she says. “Last, but not least, I’m actively learning the tools of the trade for new supervisors. I’ve been focusing on workload management, updating standard operating procedures and figuring out creative ways to motivate the team. It helps that we have a great shop culture and supportive upper management. I’m excited to see what our future holds,” Lucky adds. When not working with a team of top-notch HTM professionals, Lucky can be found enjoying outdoor activities as a newlywed. “I love water sports – scuba diving, surfing, swimming, boating, fishing. You name it,” she says. “I recently got married in May 2020. We are about to celebrate our one-year anniversary. I can’t believe it,” she says. What would she like readers to know about her? “Instead of talking about me, I wanted to highlight some amazing things that our community has accomplished over the past year. COVID-19 has been one crazy ride. In the news, we hear kudos to all the frontline workers. Biomed/HTM is

often left out of the conversation; but please know that your hard work does not go unnoticed,” she says, speaking directly to readers. She also reflects on some of the accomplishments of her department during the past year. “We converted a med-surg unit to a COVID ICU unit from practically thin air. This involved redistributing medical equipment from all over the medical center and doubling ICU bed capacity. We managed additional ventilator and infusion pump procurements at exceptional speed. We made sure high-risk PMs were completed ahead of time; forecasting the surge during the due dates,” Lucky says. She said that they entered COVID precaution rooms just to fix patient TVs; all while upholding safe patient care. “It truly is remarkable what this community has accomplished during the pandemic. I am proud to be a member of the HTM field and to work alongside such incredible, passionate people,” she says. From one unsung hero to the many others.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FAVORITE BOOK:

“5 People You Meet in Heaven” by Mitch Albom

FAVORITE MOVIE: “Bridesmaids”

FAVORITE FOOD: Gumbo

HIDDEN TALENT:

I love a good home improvement project. Fixer-upper is my middle name!

FAVORITE PART OF BEING A BIOMED:

Networking with colleagues all over the country

WHAT’S ON MY BENCH? • • • •

Coffee IPv4 subnetting cheat sheet Way too many sticky notes Picture of my family

MAY 2021

TECHNATION

SPOTLIGHT

ASSOCIATION OF THE MONTH The Gateway Biomedical Society (GBS) BY K. RICHARD DOUGLAS

ealthcare technology management (HTM) professionals in the St. Louis metro area and other parts of Missouri and Illinois have had an organization devoted to their profession since 1990. The Gateway Biomedical Society (GBS) has provided education, networking and community awareness of the biomed profession for more than two decades.

The group’s current officers include President Douglas Dreps, Vice President Jason Crawford and Secretary Mark Milster. The position of treasurer is currently open. “The Gateway Biomedical Society was formed in March 1990 and consists of clinical, biomedical and radiological engineering professionals. Also represented are manufacturer sales and service representatives and other individuals in the medical instrumentation community in the St. Louis metro area and all parts of Illinois and Missouri,” Dreps says.

TECHNATION

MAY 2021

He says that Bill Collier was one of the main founding members of the Gateway Biomedical Society. “Many of you might know Bill as being the founder of BC Group International with his wife, Joyce, in 1988. After selling BC Group International, Bill continued his entrepreneurial talents and later formed Collier Business Advisors LLC,” Dreps says. “The Gateway Biomedical Society was formed to bring colleagues in our field together for education, events and socializing,” Dreps adds. He says that biomedical technicians, imaging technicians, clinical engineers, OEMs, ISOs and leaders in the biomed field are all welcome to join GBS. Why would area HTM professionals want to join the organization? “That’s a question that has been raised at both of our first two meetings of the newly formed GBS, and it’s a valid question. The annual individual membership fee has been established at $20. Why should an individual spend $20 to join such an organization? Each person’s personal and

professional situation is unique, so no one answer covers all the bases, but I’d like to outline some of the ideas I have on the subject. This fee has not increased since GBS was formed in 1990,” Dreps says. He points out that an affirmation of the role of the HTM professional is key to membership in this group. “First, most biomedical engineering technicians and clinical engineers, whether in a hands-on or a management role, consider themselves professionals. This field is their profession of choice. If you are in that category, then I suggest that GBS has something for you,” he says. The group has done its part in promoting the HTM field and highlighting it in a unique way. “For years, GBS has had a booth for Engineer’s Week at the St. Louis Science Center, usually held one weekend in February. The average attendance for the two days is about 8,500 at the Science Center. We have partnered with local colleges and handed out brochures promoting the HTM field during this event,” Dreps says.

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SPOTLIGHT

Dreps (far right) poses with his fellow GBS colleagues. GBS is supporting an HTM Mixer scheduled for September.

BRINGING TOGETHER MEMBERS The group has traditionally maintained periodic meetings every year. Last year, COVID-19 threw a wrench into that plan – as it did for most biomed associations and societies. “The group meets the third Thursday of every other month (January, March, May, etcetera) at different hospitals and medical facilities in the area. Most meetings consist of a technical presentation by an equipment manufacturer or a member of the society, followed by a general business meeting to discuss issues involving our society and the communities we work in,” Dreps says. GBS members also benefit from some fun activities. “We have grown to hold two pool tournaments; our annual one in January, and now [we] added one at our holiday party each year. We even had a summer fishing tournament a few years back that was a lot of fun,” Dreps says. He says that the group has never held a symposium but has talked with both the Healthcare Technology Management Association of the Midwest (HTMA-MW) and the Heartland Biomedical Association (HBA) about having a joint conference every several years. This year, the lack of a formal symposium will be more than made up

for as the group will be a part of MD Publishing’s HTM Mixer set for September 9-10 in Kansas City, Missouri. The event, held at the Kansas City Marriott Downtown, will feature two days of networking, education and fun, according to organizers. The event will be jointly sponsored by GBS, the HTMA-MW and HBA. More information is available at https://kc.htmmixer.com. COVID cancelled most of the GBS meetings that were scheduled for 2020. The group planned to hold its first in-person meeting of 2021 on March 18 with more on the calendar. GBS is currently considering a scholarship to further promote the profession. “We do not have a scholarship program in place right now, but we have been discussing starting one up. We have had many relationships with programs over the years. Unfortunately, most of them have stopped having programs in recent years. St. Louis Community College still has a program and some of our members sit on the advisory council,” Dreps says. The challenge today for many HTM associations and societies is to bring new recruits into the industry to replace the many retiring and retired baby boomers.“For years, we have had many educational programs that benefitted

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

our members. We have covered many topics several times as we get new members. We had about five years where most of our members were all baby boomers. Most of our meetings now have been social gatherings that vendors and sponsors support as we share the challenges of today,” Dreps says. He says that over the past two years, GBS has been getting new BMETs to join and come to meetings. “With many of the young BMETs volunteering at the Science Center event, we look forward to bringing back some educational sessions,” Dreps says. “We think the HTM Mixer in Kansas City this September will be a great opportunity for our members to get exposed to a mini conference and educational sessions,” Dreps says. There are signs that 2021 may be able to reverse some of the trends of last year. Bringing biomeds back together will help to restore a sense of normalcy. In the heart of the nation, HTM professionals can build on these positive signs via the Gateway Biomedical Society. For more information, visit gatewaybiomedicalsociety.camp9.org.

MAY 2021

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SPOTLIGHT

DEPARTMENT OF THE MONTH McLeod Health Biomedical Services Department BY K. RICHARD DOUGLAS

n 2011, TechNation profiled the McLeod Health Biomedical Services Department. The world of health care looked very different in 2011. The specter of a global pandemic was not even a thought for most.

Today, McLeod HTM professionals face a new reality. Biomeds everywhere are on the front lines of the COVID-19 pandemic and have been for more than a year. McLeod Health serves patients in North and South Carolina. The health system serves the health care needs of more than a million people in the region. The McLeod network includes seven hospitals and more than 125 physician offices in northeast South Carolina and southeast North Carolina. There are nearly 1,000 beds at McLeod Health that are available to serve people in 18 different counties. Managing the system’s medical

TECHNATION

MAY 2021

equipment is a team that includes six imaging service technicians and 12 biomeds, two equipment technicians, an administrative assistant and a director. Department leadership is made up of Director Roger Moore, CRES, CBET; Supervisor Jonathan Hatley, CBET; Supervisor Mike Williams; and Robert Fuller, CBET, BMET III. The McLeod Health Biomedical Services Department reports to Todd Hazzard, vice president of patient services. KEEPING THE VENTS RUNNING Along with the challenges presented by the pandemic, the biomed team has been busy problem-solving and integrating devices to allow for electronic medical records. “Recently Biomedical Services has participated in our systemwide EMR go-live of Cerner. This included many hours of preparation to interface multiple medical devices using

different interfacing platforms. We have expanded at multiple hospitals in our organization. Some of these include new patient bed towers, surgical suites, multiple emergency departments, intensive care units, endoscopy, neonatal intensive care unit, women’s care unit and ambulatory surgery centers just to highlight some recent projects,” Hazzard says. He says that Biomedical Services participates in the planning, selection, implementation and maintenance strategy of the medical and imaging equipment for these projects. The team has employed its troubleshooting skills to the accreditation process and assisted clinical colleagues. “Recently, Biomedical Services assisted Mammography in obtaining ACR and MQSA certification. There was an issue with the media that Mammography had in sending images for review in the certification process. Biomedical Services was able to

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SPOTLIGHT The McLeod Health Biomedical Services Department includes imaging service technicians, general biomeds and equipment technicians.

problem-solve and come up with a solution that met the needs and requirements of all parties. This is just one example of a problem that Biomedical Services encounters on a weekly basis,” Hatley says. He adds that the department sees problems as opportunities, knowing that every opportunity has a resolution. “Since the beginning of the COVID-19 pandemic, ventilators have been high priority. When one is down it puts a major strain on Respiratory Therapy to find another vent with the software options that can be used to treat that patient’s needs, especially when all of our hospitals were at/near maximum capacity for vent patients,” Hatley says. He says that the department always tries to keep a limited number of stocked parts and PM kits on hand to fix a vent as quickly as possible. “And, pre-COVID, if we didn’t have the part we needed on hand to make the repair, it was fine to order the part and install it when the part arrives because there would be enough spare vents available for the respiratory therapist (RT) to use. So, even though you have a broken vent, it was a high priority repair, but a ‘low pressure’ type of repair because it was not likely that this one vent being down was going to delay treatment of any patient due to the number of spare vents the RTs can pick from,” Hatley says. He says that earlier, at the beginning of the pandemic, and during the different spikes of COVID-19, when a vent was down, it was even “higher

than top priority” to get it repaired. Hatley says that much like he uses tools and simulators to fix equipment, the RT uses vents, bi-paps and sat monitors to help fix the patient. RNs use medications, pumps and monitors to care for the patient. “It’s that kind of situation that reminds me how much of an impact biomedical equipment technicians have in the recovery of any sick patient,” he says. The biomed team was even able to help facilitate the addition of an option to some of the health care system’s ventilators during this period of increased use. “Recently, McLeod has purchased quite a few of the Philips V60 ventilators. After having them for a while, it was determined that these units would be more versatile if they had an option added to them. Software and licenses were purchased for some of these vents across all of the McLeod campuses,” Williams says. He says that because of the COVID-19 pandemic, the ventilators had been in high use and were often hard to access for maintenance. “Biomed was able to coordinate having a person come to multiple campuses and update the software and install these upgrades. This took cooperation between the biomed that was on site with the person coming in to do the upgrades. It also took a great deal of cooperation with the respiratory departments to get the

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

affected machines available to be upgraded,” Williams says. He explains that, in some cases, it took the biomed working with the respiratory department to get the patient taken off of one machine and put onto another so that the work could be completed in a timely manner. This had to be done in order to provide the respiratory department with upgraded equipment that better suited their needs and provided for improved patient care. Away from work, many of the team continue their contributions to HTM. “Biomedical Services has members that participate in the North Carolina Biomedical Association (NCBA) and the Healthcare Technology Management Association of South Carolina (HTMA-SC),” Hazzard says. This HTM team continues to ensure that treatment is available to patients during a critical time in American history and into the future.

MAY 2021

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NEWS & NOTES

Updates from the HTM Industry

AAMI EXCHANGE GOES VIRTUAL To ensure that all members of the HTM community will be able to safely participate, AAMI announced that the 2021 AAMI Exchange is being re-developed into a fully virtual event, which will be held June 7-11. “This decision was made after carefully reviewing the status of the pandemic and vaccine roll out and after consulting many members of our AAMI community. We are grateful for the strong support we’ve received and look forward to harnessing that energy to

create a truly rewarding virtual event, enhanced by the simple fact that all of us – regardless of circumstances – will be able to take part,” said Steve Campbell, acting president and CEO of AAMI. “Though we would have liked to have come together in person, we are enthusiastic about the unique opportunities of a virtual Exchange. We hope you’ll join us at the reimagined AAMI Exchange in June.”    AAMI, in mid-March, said it would soon announce key details and new

program features of the 2021 AAMI Exchange, which is being re-developed as a multifaceted and interactive format that will empower not only the exceptional learning that the Exchange is known for, but also offer opportunities for genuine connection and community networking. • For more information, visit www.aami.org/ aamiexchange.

AGILITI ACQUIRES NORTHFIELD MEDICAL INC. Agiliti Inc., an essential service provider to the U.S. health care industry, has acquired Northfield Medical Inc., a nationwide provider of surgical equipment repair services, in a stock purchase transaction valued at $475 million. Northfield Medical provides service and repair of medical devices, specializing in the repair of endoscopes, surgical instruments and other operating room equipment. The company is headquartered near Detroit and operates a nationwide network of local, in-market repair centers and five ISO 13485:2016 Centers of Excellence. Agiliti Inc. offers solutions that help support a more efficient, safe and sustainable health care delivery system. Agiliti serves more than 7,000 national, regional and local acute care and alternate site providers across the U.S. For more than eight decades, Agiliti has delivered medical equipment management and service solutions that help health care providers reduce costs, increase operating efficiencies and support optimal patient outcomes. •

CFBS ANNOUNCES NEW BOARD The Central Florida Biomedical Society (CFBS) – a nonprofit chapter organization under the Florida Biomedical Society (FBS) covering the Central Florida region CFBS President Ric Downs – has announced new board members for 2021. Bringing diverse and extensive industry experience, the new board members share a goal to grow the society and support the greater FBS. The 2021 board members are CFBS President Ric Downs, Vice President Luis Rodriquez, Treasurer Jennifer Vazquez, Volunteer Tracy Vazquez and Chapter Representative Bruce Wells. •

For more information, visit www.agilitihealth.com.

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MAY 2021

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INDUSTRY UPDATES

TKA, AMI ANNOUNCE PARTNERSHIP The formation of American Medical Imaging (AMI) from six medical imaging technology sales and service companies across the continental U.S. was announced by The Innovation Institute and Tech Knowledge Associates (TKA), its subsidiary specializing in full-risk healthcare technology management (HTM). The new AMI partnership of experienced imaging technology firms was brought together to deliver the entire spectrum of sales, repair and maintenance solutions to health care facilities nationwide. AMI is led by Steve Cannon as president and CEO. He played a pivotal role in bringing together the six foundational companies that formed the AMI partnership. Cannon has over 40 years of experience in the health care technology and asset management industry. He has held senior leadership roles with SunHealth and the national GPO Premier, and served as the inaugural president at the new AllParts Medical in 2009. Cannon has also held executive leadership positions at Aramark, Philips Healthcare and Sodexo. In late 2020, Cannon took the helm of the asset management firm, Healthcare Technology Group. (HTG) The AMI partnership was founded on the aggregation of medical imaging technology sales and service companies in varied geographies, with presence in 16 states. By building on The Innovation Institute’s business model, and with the immediate breadth of service from the six foundational companies, AMI will bring customized technology solutions to health care providers of all sizes and needs. Speaking to AMI’s capabilities, Cannon noted, “With the experience and strength of our multi-regional presence, AMI is able to offer a spectrum of high-quality services – from equipment sales, to maintenance and repair, to installation and removal, to IT solutions such as PACS. And we can do so with greater efficiency and at a lower cost to the health care providers we serve.” “We plan to expand to even greater national coverage in the coming months, with the addition of several new companies to the AMI partnership,” he explained. “Our vision is that 2021 will be a banner year for us in the improvement of medical imaging technology service delivery, with reach across the majority of the United States.” •

ARGO BIOMEDICAL SERVICES ANNOUNCES NEW SALES MANAGER Argo Biomedical Services has hired Todd G. Schmechel as its new sales manager. Schmechel has over a decade of medical sales and service experience in the health care industry. He is a product matter expert in multiple healthcare technology fields and is the former president of HTMA-Texas in Houston. According to Schmechel, “I have worked very hard to build strong relationships with vendors and customers alike.” Eric Ebejer, president and founder of Argo Biomedical Services, said, “We are very lucky to find a person with the experience and wealth of knowledge specific to our industry. Todd will give us a unique perspective that will allow us to strengthen our sales program and expand our current customer base.” “I am really looking forward to sharing my expertise to help Argo Biomedical Services grow rapidly. I feel like this is one of the most exciting moments of my professional career,” Schmechel said. “Todd is perfectly placed to help us expand into new territories, bring on new vendor partners, and, eventually, build and take command of a new national sales team,” Ebejer added. Argo Biomedical Services, an ISO 9001:2015 certified company, is a supplier of medical motoring equipment repair services, rental and the sale of used medical equipment. Argo Biomedical Services has been working with the health care industry since 2005. •

For more information, visit www.ami-ii.com.

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BC GROUP HIRES NEW NATIONAL SALES AND MARKETING MANAGER BC Group International Inc. has hired Tim Welby as its new national sales and marketing manager. Welby brings a strong background of working in the health care industry and a successful career with the laboratory division of Siemens. Welby stated, “I’m excited to be part of BC Group and look forward to working with and supporting our customers.” BC Group President Mel Roche said, “We are excited to welcome Tim to BC Group. His addition to our management team will provide further depth to this group of incredibly talented people. Tim’s skills and background fit well with our continuing effort to provide our customers with the best in test equipment and services.” “Being involved in health care is rewarding, and during this COVID-19

pandemic, the role of an essential worker is even more significant,” Welby said. “We have numerous opportunities for the company to build on our already successful BC Biomedical product line and the marketing of our 75 other distributed product lines. Tim will play a key role in the introduction of several new products and services this coming year,” Roche said. “Our in-house engineering department continues to develop new and exciting test equipment for this ever-changing market. It will be Tim’s responsibility to bring those products to market.” “The leadership, innovation and caring about the customer are the main reasons I chose to join BC Group,” said Welby. BC Group is a supplier of test equipment and services for the biomedi-

Tim Welby, National Sales and Marketing Manager cal and clinical engineering fields. BC Group is located in St. Charles, Missouri and has been providing test equipment and services since 1988. •

CYBELANGEL REVEALS HOW CYBERCRIMINALS TARGET HEALTH CARE SECTOR CybelAngel, a global leader in digital risk protection, has published in-depth original research revealing how cybercriminals plan health care-related fraud, ransomware and other attacks by obtaining stolen credentials, leaked database files and other materials from specialized sources in the cybercrime underground. In the new paper, “Healthcare Data Actively Targeted and Sold on the Dark Web,” CybelAngel analysts describe how the ongoing COVID-19 pandemic’s strain on hospitals, coupled with the health care industry’s porous cybersecurity defenses, give criminals ample ability and resources to methodically launch lucrative intrusions jeopardizing patient safety. “Cybercrime attacks that disable hospitals and weaponize stolen medical records are unconscionable – and particularly ruthless during a pandemic, when the uptime of every care facility and accuracy of every health record determines whether lives are saved,” said Camille Charaudeau, vice president of product strategy at CybelAngel. “While the volume and stakes of these attacks can feel overwhelming, our research shows that sealing off a few specific types of exposed data

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could have a meaningful effect by disrupting the supply chains adversaries rely on to execute these attacks.” To better understand threats to health care facilities, CybelAngel researchers tracked bad actors targeting French hospitals, the criminals’ methods and perceived gains. Available online, the research includes in-depth analysis with attackers’ conversations and security recommendations. Key findings include: • Open databases mean hospitals often leak the data used against them • Attackers combine credential-stuffing with third-party access to beat detection • Sharing medical records comes at the cost of control CybelAngel is a Digital Risk Protection Platform comprehensively monitoring for data leaks across every layer of the Web, including the billions of exposed Internet-connected devices that exist outside organizations’ defended perimeters. CybelAngel’s AI-powered platform and analyst team additionally study underground activity to identify credible threats to customers and inform the wider security community. •

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ECRI, ONESOURCE PLAN ALERTS MANAGEMENT COLLABORATION ECRI and oneSOURCE Document Management Services have announced a joint collaboration focused on improving medical device safety and responsiveness of health care facilities. This new collaboration creates a link between ECRI’s medical device alerts and recall system and oneSOURCE’s instructions for use (IFU) and service manual database, helping health care providers ensure regulatory compliance and the ongoing safety of patients and their clinical staff. It integrates ECRI’s Alerts Workflow Solution and the oneSOURCE Document Management System to facilitate safer and more efficient recall and healthcare technology risk management. ECRI’s Alerts Workflow automatically notifies appropriate health care staff of safety-related risks and recommended actions associated with medical devices, pharmaceuticals, blood and food. “Prompt and efficient handling of medical device notifications can mean the difference between life and death, especially in today’s pandemic-paced health care environment,” says ECRI Vice President Michael Argentieri. “With oneSOURCE, we are speeding vital information directly to the appropriate hospital and ambulatory care facility staff who are charged with ensuring the safe use of medical products.” With the new integration, health care workers an vc_TechNation_Clr Ad_7x4.5_21Mar24.pdf 1 accessing 3/18/21 3:34

ECRI Alert will be able to directly link into their oneSOURCE account to access relevant IFUs and/or service manuals. Similarly, those accessing oneSOURCE documents for a particular medical device will be able to link into the ECRI system to search for any related recalls and active critical hazard alerts. Access to both the ECRI and oneSOURCE platforms is required and available for purchase separately. “By connecting ECRI’s alerts with oneSOURCE’s database, we are removing the barriers that hospital and ambulatory surgery center staff have had in managing multiple systems,” says Heather Thomas, CMO and executive vice president of sales and marketing, oneSOURCE. “Faster response time ultimately leads to better patient care.” COVID-19 has increased the need to have ready access to the latest infection prevention information based on the most recent hazard and recall reports. ECRI and oneSOURCE are working together to ensure that hospitals and ambulatory surgery centers have 24/7 access to the latest documentation and best practices for the proper sterilization and cleaning of medical equipment, including current IFUs, service manuals, recalls and hazard reports. • For more information, visit PMECRI.org/alerts-workflow-and-onesource-collaboration.

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PHUNWARE PARTNERS WITH VIZZIA TECHNOLOGIES Phunware Inc. has partnered with Vizzia Technologies to offer its digital front door solution on mobile solution to leading health care organizations that leverage Vizzia’s real-time location systems (RTLS) technology. Phunware’s digital front door solution is optimized for mobile, on the company’s Multiscreen-as-a-Service (MaaS) enterprise cloud platform, to deliver critical features and capabilities to health care providers, all while enabling seamless integrations with everything from electronic health records (EHRs) such as Epic, to tele-

health providers such as Amwell. This end-to-end, holistic approach eliminates the pain of having to manage dozens of point solutions, while simultaneously offering staff, patients and visitors a far more simplistic, cohesive and integrated health care experience. Additional capabilities include, but are not limited to: • Mobile engagement for contextual notifications, including appointment reminders • Real-time “blue dot” indoor positioning, including mapping, navigation and wayfinding

• Multi-site support for disparate locations • B eacon Maintenance to ensure optimal MaaS Location Based Services (LBS) performance • Epic MyChart integration with face ID biometric login medical record access • Prescription management with E-Visit functionality • Mobile bill pay • Staff directory • Analytics • For more information, visit vizziatech.com.

BIOMEDICAL TEST TECHNOLOGY BOOSTS HERMED SPAIN EXPANSION PLANS Continuing investment in advanced test technology is helping one of Spain’s leading biomedical device service companies with a significant expansion of its operations. Hermed Spain was established in 2017 and provides specialist assistance to hospitals and health care providers with the regulatory testing and management of its electromedical technology. Already responsible for medical device service, maintenance and repair for Madrid City Council’s emergency ambulance service and a number of private and public hospitals in Madrid, Barcelona and Zaragoza, Hermed has further extended its operations to include four more public hospitals in Madrid. As a result of the new contract, the company’s team of biomedical service engineers and technicians has grown from 35 to 50 and all are equipped with the latest Rigel Medical test technology to help them undertake their compliance testing more effectively and time efficiently. Given the wide variety of health care facilities and types of medical devices that come under Hermed’s supervision, Rigel provides the service teams with a full suite of specialist biomedical test analyzers and patient simulators. These include the Uni Sim vital signs simulator, the Uni Pulse 400 defibrillator tester, the Uni Therm high current electrosurgical analyzer and the Rigel 288 Plus biomedical equipment safety tester. This specialist range of equipment enables field engineers and hospital technicians to carry out their critical work to ensure that vital healthcare technology and patient-connected medical equipment is properly maintained, checked for electrical safety and continues to perform accurately.

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Dr. Marta Villarejo, general manager of Hermed Spain, explains, “In supporting our clients, our aim has been to develop a new service model for managing electromedical devices that combines value, safety and economic stability.” “To achieve this, working efficiently is essential and with so many different medical devices to inspect, test and maintain across different health care sites, ease of use and portability of test equipment are very important considerations for our electromedical engineers,” Villarejo adds. “In this respect, the versatility and compact, lightweight design of the Rigel units means they provide very mobile test solutions, allowing us to carry out very efficient testing schedules that help us to provide better standards of customer service.” • For more information, visit rigelmedical.com.

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OBA ANNOUNCES NEW OFFICERS The Oregon Biomedical Association announced the results of its recent election via email. Brian Judah was elected president. Ryan Keene is the new vice president. Adam Byrd will stay on and continue to be the treasurer. Adam Ondrusek will step into the role of secretary. New board members are Maria Manzo-Barr and Jason Velick. The email was signed by former OBA President Peter McNamara. •

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OHIO MERGER CREATES ONE-STOP SHOP Tristate Biomedical Solutions and Nightingale-Alan Medical Equipment Services announced a merger earlier this year. Officials said the merger will offer streamlined delivery, by placing more services at one central facility. Another aspect of the merger is that it will facilitate a transition to retirement for members of Nightingale-Alan leadership. Terms of the deal were not disclosed. The merger was completed Jan. 1 and announced to employees, customers and vendors that same month, according to the release. “The merger with Nightingale-Alan is all about broadening the range of service we can provide under the same roof,” says TBS Founder and President Tyler Thornberry. “This is an exciting step which allows us to streamline our capabilities in providing excellence through customer service.” Founded in 2009, Tristate Biomedical Solutions has grown into a source for medical equipment sales and service. TBS was first located in Thornberry’s garage in Independence, Kentucky. The business grew rapidly — primarily by working with customers as partners, learning their needs and making efforts to save them money while providing them top customer service, according to the company’s website. In 2018, TBS purchased Medical Equipment Services (MES), adding imaging sales and services to its range of services. The growth of the company enabled it to purchase a 20,000-square-foot building in Franklin, Ohio which was converted to the company’s headquarters in April 2019. The company still maintains an office in Verona, Kentucky. “Having a location both north and south of Cincinnati has enabled us to work in the field more efficiently,” the TBS website states. Nightingale-Alan, according to its website, specializes in respiratory-related equipment sales, exchange and service. The company was founded in 1972. •

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AAMI UPDATE BY AAMI

he U.S. Department of Labor (DoL) has approved the creation of a modern apprenticeship program for prospective biomedical equipment technicians (BMET). The new program, launched by the Association for the Advancement of Medical Instrumentation (AAMI), replaces a decades-old curriculum and is designed to streamline the accreditation process while introducing modern information technology know-how early in a technician’s career.

Gaining recognition as a Registered Apprenticeship Program (RAP) with the DoL is an important step because it allows the program to exist on a national scale, while matching employers and apprentices locally. This can help maintain workplace retention rates of up to 94 percent, explained Maggie Berkey, CBET, a senior BMET for Common Spirit Health and a member of AAMI’s Technology Management Council, who co-designed the new apprenticeship program. “The idea is to take individuals practically right off the street, near wherever positions need filling, and train them on the job. They learn from other BMETs with 20 or 30 years of experience while getting valuable hands-on experience, and by the time they’re done training, they’re ready to go on call,” she said. “They already know the policies and safety procedures of the facility they worked at. They know the equipment and customers, and they’ve had those critical interactions that you can’t train for with a textbook!” The program consists of 4,000 to 6,000 hours of paid, on-the-job training in safety, electronics, anatomy, information technology and more. Apprentices will study and acquire AAMI’s premiere CABT certification for professionals entering the BMET field, a certification in IT Fundamentals, and finally become a Certified Biomedical Equipment Technician. “With the certification being built right in, you know that this person has at least this minimum knowledge base, that they’re teachable, and they have a broad understanding of what their job is and what their responsibilities are,” Berkey added. “It sets a bar of excellence for our industry, and that’s what we all want!” For trainees who already have some of the required training completed, an employer can fast track the apprenticeship. Program graduates earn a certificate from AAMI and the DoL, asserting that their training meets a national standard of excellence. Employers cover the expense of training and certification with support from the DoL. In-turn, participating organizations are offered state tax credits for taking on apprentices. The National Apprenticeship Act of 2021, recently passed by the U.S. House of Representatives, may also provide support as early as 2022.

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This makes participating “a no-brainer” for organizations looking to fill a BMET position, as it saves them the money and time that is normally sunk into an uncertain recruitment process, said Danielle McGeary, AAMI’s vice president of Healthcare Technology Management. “Across the U.S., we’re seeing job openings for BMETs not getting filled for eight or nine months at a time, and colleges are being forced to drop their BMET programs due to budgetary constraints,” McGeary said. “This exacerbates a problem that healthcare technology management has been facing for the last 10 years: a training gap between the county’s most senior and soon to be retiring BMETs and the next generation of HTM professionals.” It has been estimated that more than half the existing BMET workforce is over the age of 50. When experienced BMETs retire, they become unavailable to train the next generation of technicians. AAMI’s entry-level CABT certification was an important step toward addressing this problem. The “HTM Training Guide for BMET Students, Interns and Volunteers,” was then released to help guide in-house training and student programs. The apprenticeship program is yet another step toward a more secure future for hospitals and industry. The new AAMI program replaces a four-year BMET RAP that was established in the 1990s. Aside from boasting a shorter term, the program has been overhauled to cover new subject matter necessary for modern medical device management. For example, the program now requires trainees to undergo 700 to 1,100 hours of information technology training – an essential focus for workplaces where software, cybersecurity and even machine learning is prevalent. “The program is an open door, offering a great career with no student debt,” added Berkey. “Success will be seeing more positions getting filled more quickly, and not just by warm bodies, but by people ready to do the job safely and effectively!” For more information, visit bit.ly/3cwtUs9

MAY 2021

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ECRI UPDATE

Managing Medical Devices with COVID-19 EUA: A Top Hazard for 2021

o meet the unprecedented need for medical equipment and supplies during the COVID-19 public health emergency, the FDA issued Emergency Use Authorizations (EUAs) to temporarily permit the use of hundreds of products. For health care providers, the resulting need to manage large numbers of devices that are authorized only for temporary use poses a unique technology management and patient safety challenge. The scope and complexity of that challenge prompted ECRI to place EUA device management at the top of its list of the Top 10 Health Technology Hazards for 2021.

EUAS IN BRIEF FDA’s Emergency Use Authorization authority allows the agency to designate previously unapproved products as acceptable for use during an emergency or to permit the temporary use of an approved product for a previously unapproved application. With an EUA designation, a product that has not otherwise received FDA clearance can be deployed to meet emergency needs. When determining whether to issue an EUA for a product, the FDA must find that: (1) An emergency exists involving an agent that is capable of causing a serious or life-threatening disease or condition. (2) Evidence demonstrates that the product “may be effective” to prevent, diagnose or treat that serious or life-threatening disease or condition. (3) A risk-benefit analysis concludes that the known and potential

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benefits of the product outweigh the known and potential risks. (4) Approved alternatives do not exist or, for example, are not available in sufficient quantities to fully meet the emergency need. Once an EUA has been issued, the product can be deployed much like any other medical device, but only for the period of time that the EUA is active. That last phrase is key: this authorization is temporary. All device EUAs issued in response to the COVID-19 public health emergency will terminate when the Secretary of Health and Human Services (HHS) ends the medical device EUA declaration. Additionally, even before that time the FDA may revoke or revise an EUA if it determines that the criteria supporting the EUA are no longer met or if it otherwise determines that the action is needed to protect public health or safety. When a pertinent EUA ends, the EUA device reverts to unapproved status. At that time, the legal protections that support the use of the product on new patients are terminated. The FDA consults with the manufacturers about appropriate disposition of the device, which may include disposing of the product, modifying the device or its instructions for use, returning the product to the manufacturer or some other action, depending on the circumstances (e.g., the nature of the EUA, the type of product). CAUSES FOR CONCERN EUAs are not new. What’s different now, though, is the scale. The FDA has

granted EUAs for more than 600 products to help address the COVID-19 pandemic. The need to manage large numbers of medical devices and supplies that have been authorized only for temporary use is a challenge that is unique to this moment, and one that requires careful planning on the part of health care providers. ECRI’s coverage of this topic for its 2021 list of the “Top 10 Health Technology Hazards” focuses on two concerns, according to Amanda Sivek, Ph.D., a principal project officer in ECRI’s device evaluation group: “The first is that EUA devices may not be safe or effective.” the FDA can issue an EUA if it determines that the device may be effective for the specified use, and if it assesses that the benefits outweigh the risks. “But note the wording – may be effective; that’s a lower standard for checking safety and effectiveness than the FDA uses for its normal clearance process,” Sivek explains. Thus, health care facilities that use EUA devices must be mindful of the potential for problems with these devices. “Second – and this is the main reason that facilities need to pay attention – is that EUAs are temporary.” Sivek cautions. “FDA can revise or revoke an EUA at any time. When that happens, health care facilities need to be prepared to act. They need to know what EUA devices they have, where they are in the facility and what needs to be done with them.” In practice, that means health care facilities must have measures in place to manage inventories of EUA devices and their documentation, to monitor the

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save date the

safety and effectiveness of those devices, to track each device’s EUA status (daily) to determine whether the EUA remains active and unchanged, and to determine what to do with these devices when the EUA status changes. Specific plans are needed for when an EUA for a device in inventory has been revised, revoked or terminated. ECRI’s 2021 “Top 10 Health Technology Hazards” report, specifically the article “Complexity of Managing Medical Devices with COVID-19 Emergency Use Authorization,” provides step-by-step recommendations for each of these scenarios. THE NEED TO BE PROACTIVE “The bottom line is that health care facilities that are using EUA devices need to be proactive,” advises Tom Toczylowski, assistant director of the ECRI’s Alerts service. FDA’s COVID-19 medical device EUA websites include the information you need, but you need to know where to look, and when. “EUAs have been modified quite frequently, so you need to have a system for monitoring all those changes.” As a first step, ECRI recommends that health care facilities subscribe to the email feed distributed by the FDA’s Center for Devices and Radiological Health (CDRH). These daily emails summarize and link to any changes in EUA authorizations. To subscribe to this email feed, visit https://www.fda. gov/medical-devices/news-events-medical-devices/cdrhnew-news-and-updates#subscribe.

When you receive a notification that the EUA status has changed for a device in inventory, ECRI recommends checking the relevant EUA device website as soon as possible to confirm the current EUA status. Then complete the required steps to address the change: If the EUA has a new date of issue/update, activate your plans for an EUA that has been revised. If, on the other hand, the relevant EUA device list has been removed from the website or the specific model has been removed from the EUA device list, activate your plans for an EUA that has been revoked or terminated. TO LEARN MORE . . . This article is adapted from ECRI’s “Top 10 Health Technology Hazards for 2021” and related content, including ECRI’s February 2021 webcast “Top 10 Health Technology Hazards 2021: An In-Depth Look at Managing Medical Devices with COVID-19 Emergency Use Authorization.” Each year, ECRI produces its “Top 10 Health Technology Hazards” report to help hospitals direct their time and energy toward technology management activities that can have the greatest impact on patient safety. An executive brief version of the report is available for complimentary download at www.ecri.org/2021hazards. The full report, accessible to ECRI members, provides indepth discussion of each hazard, including detailed steps that organizations can take to prevent adverse incidents. To learn more, contact ECRI at 610-825-6000, ext. 5891, or by email at clientservices@ecri.org.

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RIBBON CUTTING Kontakt.io BY ERIN REGISTER

ontakt.io was established in 2013 as a Bluetooth Low Energy (BLE) hardware company to help retailers push location aware, contextual information to consumers on their mobile phones. Kontakt.io has deployed over three million beacons worldwide since then.

Kontakt.io Head of Healthcare Practice Kapil Asher said, “Many vendors in the space tried to use BLE beacons for traditional asset tracking in health care but fell short because of lack of an enterprise strategy. Kontak.io saw this as an opportunity and strategized a robust plan that included developing specialized hardware products, a self-learning location engine plus a web-based end-user interface that included maps, reports, events and notifications. Combining the product strategy with some key partnerships helped in commercializing a turn-key solution for this market. Geared specifically to target the HTM use cases, we have also developed integrations with major CMMS and cybersecurity platforms for seamless workflows.” TechNation learned more about Kontak. io in a recent interview. Q: WHAT IS THE MAIN FOCUS OF KONTAK.IO? A: Kontak.io’s mission is to provide better location visibility into people and

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MAY 2021

valuable physical assets to create meaningful insights, efficient health systems and lessen waste. We achieve our mission using cutting-edge technology that follows design principles of consumer IoT products with an enterprise grade robustness in mind. We believe that customer satisfaction is the most important deliverable of any product and is achieved only if it is a) easy to use, b) easy to maintain, c) has a quick time-tovalue. Q: WHAT SERVICES DOES KONTAK.IO PROVIDE? A: Kontakt.io offers a long-awaited breakthrough in indoor location solutions. Our open source, easy-to-install, Wi-Fi network agnostic, cloud-managed, completely wireless devices provide IR-based 100% room-level location accuracy of medical devices, staff and patients. These devices, called the Portal Beam, enable asset management and utilization use cases such as device search for preventative maintenance, PAR level management, loss prevention, bed and wheelchair management and can scale into other offerings, such as staff duress, patient elopement and temperature monitoring. We also offer location services without any infrastructure for simpler use cases over BLE-enabled wireless access points. Kontakt.io has taken indoor IoT to the next level by offering holistic visibility into a physical space by monitoring six

Kapil Asher

Head of Healthcare Practice, Kontakt.IO

major environmental conditions including human occupancy, temperature, humidity, air quality, light and smoke detection all within the Portal Beam. Q: HOW DOES KONTAK.IO STAND OUT IN THE INDOOR LOCATION SERVICES FIELD? A: Kontakt.io outperforms traditional location services companies in two major attributes — cost and ease of use; without compromising performance in target use cases. Installing our devices requires no cable pulls, fingerprinting or onsite surveying. Our average tag price is less than 50% of leading indoor location service providers, and since our solution is entirely cloud hosted, the hospital saves on server provisioning and maintenance as well. In addition, the Portal Beam uniquely offers ambient awareness data that can be streamed to a

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INDUSTRY UPDATES number of HTM and facility management systems enabling real-time decision making in resource and cost optimization. Q: DO YOU HAVE ANY SPECIFIC GOALS THAT YOU WANT KONTAK.IO TO ACHIEVE IN THE NEAR FUTURE? A: The next two years are going to be an exciting time for Kontakt.io. We have a number of live deployments in the North American and European markets and strive to accelerate our growth with additional strategic partnerships that provide unmatched value to our customers. We have a robust platform roadmap over two to five years that will continually improve performance and react to change in market requirements at a lightning speed. We will be the transformative force that modernizes indoor location services and opens up opportunities to use cases that were either limited by technology or cost; thus far. For more information, visit https://kontakt.io/solutions-healthcare/ or email k.asher@kontakt.io.

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BIOMED 101 A Sense of Worth BY JOHN A. EIDSON

t’s 4:25 p.m. I’m getting ready to go home and the phone rings. What!? I think to myself. My mind drifts to the worst possible scenario. They probably waited all day before calling. “Biomed, may I help you?” “Yes, sir. I am trying to call my husband to come get me. I’ve been in the hospital for 5 days and I just want to go home.” “Yes, ma’am. Just dial 9 to get an outside line.”

Sitting, ready to panic when the phone rang, I did some interesting self-reflection and realized that my life could improve. Henry David Thoreau said, “The mass of men lead lives of quiet desperation.” Sounds about right to me. A task may only take a short while to accomplish, but if left undone, it can hang in our minds and cause us to think about it many times. Procrastination keeps our minds in an “I need to do something” mode, which makes us anxious. Don’t put things off until you are worried. Stay focused, accomplish one thing at a time and move on. Ask for help, but don’t lean on it. Don’t worry about the mule going blind, just load the wagon. At least try to accomplish a task. It is usually easier than we anticipated. If we fail, we will have the pride of trying and usually a good grasp on what needs to be done. Action leads to self-pride. Everybody knows the great feeling of accomplishment. Motivation yields results, improves morale and self-esteem. Self-esteem is feeling that you are perfectly acceptable as you are

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MAY 2021

and the feeling that you are up to the challenge. Motivation is based on an individual’s desire to achieve. “When an individual gains or maintains self-efficacy through experiences of success, however small, they generally get a boost in motivation to continue learning and making progress” (Mayer, 2010). Self-efficacy is “one’s ability to succeed in a specific situation or accomplish a task.” One’s sense of self-efficacy is the “belief we have in our abilities, specifically our ability to meet challenges ahead of us and complete a task successfully,” is how psychologist Albert Bandura described it. It is our overall belief in our ability to succeed. Self-efficacy can play a major role in how one approaches life. Self-regulation refers to “an individual’s self-generated thoughts, feelings and actions that are all systemically designed to affect one’s learning,” according to Schunk and Zimmerman, 2007. It seems to me that self-regulation is the way to control our future. Decide to enjoy life, promote and act on good thoughts. If you have problems, resolve them. I realize that problems can run deep. In 2018, 48,344 people took their own lives according to Wikipedia. Don’t drown in negative thought. The water may not be as deep as it seems nor the bank as far as it looks. Once on the bank, the problem seems so distant. Hopefully, the audience of this article is not so dire. Happiness seems to elude us sometimes. It is not hidden very well, but you do have to look for it and know that it can be found. We can learn to improve our lives.

John A. Edison

Senior CBET at Saint Joseph London, Catholic Health Initiatives.

Inactivity, diversion and procrastination will cause problems financially and personally. You should be grateful for the opportunity to make a difference in people’s lives, especially your own. I learned in an economics class that the most money was not lost due to parts, labor or overhead. Good management is essential and key to success. Use time wisely, stay busy and inspired. Proverbs 16:27 states, “Idle hands are the devil’s workshop; idle lips are his mouthpiece.” As for supervision, I think Edgar Guest said it best, “I would rather see a good sermon than hear one any day. I would rather one walk with me than merely tell me the way. The eye is a better pupil and more willing than the ear. Fine counsel is confusing, but examples are always clear.” Working as a team or in pairs makes for a better repair, and the burden feels shared and not laid solely on an individual. Coworkers

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will feel more accepted, accomplished and proud. We all have different talents. Somebody is going to be the best and somebody is going to be the worst by default. We all need to feel accepted and important. Our attitude should reflect our faith in others and their ability to be an integral part of a successful team and operation. Treat others as equals because they are. Philippians 2:17-18 reads, “Even if I am poured out like a drink offering on the sacrifice and service coming from your faith, I am glad and rejoice with all of you. You should be glad and rejoice with me.” Promote training as much as possible. Don’t let wisdom slip through your fingers. If a vendor is repairing or explaining something, learn from it. Never call a vendor without investigating the problem. Try to be on-site in front of the equipment to accept instruction. It is harder to translate from memory or notes and, for goodness sakes, take pictures. When you do call, you will have firsthand experience of the problem. Keep up with the vendor’s preventive maintenance Ad_new.ai 1 12/6/2019 10:16:03 AM schedule. Understand

what a preventive maintenance check includes and call them on it if the procedure is not followed. Teach your expertise and learn from others. Watch the operators. “If you can operate it, you can repair it,” an USAF biomedical instructor said. I set out to write a biomedical article. I am now undecided as to whether I have written a biomedical, psychological or religious article. In my mind, they seem related, if not integral. Simply put, hard work accomplishes many things. First of all, it gets more done. Second, you sleep better being tired and retire with your mind more at ease. Good rest will give you a better outlook on the day ahead and maybe life in general. Who knows? Maybe we can improve our lives. As Rose Tremain once said, “Life is not a dress rehearsal.” JOHN A. EIDSON is a senior CBET at Saint Joseph London, Catholic Health Initiatives.

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MAY 2021

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MAY 2021

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WEBINAR WEDNESDAY

Sessions Deliver Valuable Insights STAFF REPORT

DEVICE-CENTRIC RISK MANAGEMENT The Webinar Wednesday session “Device-Centric Risk Management (DCRM): 5 Use Cases for Streamlining Vulnerability Remediation and Mitigation” featured Ido Geffen, vice president of customer experience and support at CyberMDX. The webinar was sponsored by CyberMDX and was eligible for 1 credit from the ACI. Geffen discussed how to conduct an ongoing risk assessment of connected assets including vulnerability and compliance profiles, as well as prioritizing asset groups and recommended actions to remediate or mitigate the risks associated with these assets on three distinct layers of protection: on-device, on-network and on-perimeter. Geffen also discussed a new method – Device-Centric Risk Management (DCRM) – a layered approach to cybersecurity that protects each device, streamlining vulnerability remediation and driving mitigation directly on medical and IoT assets. Attendees gained more information during a question-and-answer session. The webinar, including the Q&A session, is available for on-demand viewing at WebinarWednesday.Live Attendees provided feedback via a post-webinar survey that included the question, “What did you like most about today’s webinar?” “There was a ton of information and ideas on how to get started and keep going,” said K. Waters, BMET 3. “It brought to my attention just how

TECHNATION

MAY 2021

many cyberattacks to hospitals there actually are,” said R. Garrity, BMET I. “I can use the information provided to improve medical device security,” Clinical Engineering Manager P. Graham said. CONNECTING HTM DEPARTMENTS VIA CMMS The March 10 webinar “Connecting HTM Departments Using a Single CMMS Database” was presented by Phoenix Data Systems Product Manager Aaron Peters. He demonstrated how HTM departments can increase their efficiency by having multiple departments use the same system. The enhanced flexibility of this approach gives the appearance of a unique system for each department, while allowing a single CMMS team to manage the entire system. Reports were generated so participants could see the efficacy of integrating their CMMS using this proven method. The session was sponsored by Phoenix Data Systems and was eligible for 1 credit from the ACI. About 100 people tuned in for the live presentation, and a recording is available for on-demand viewing. Attendees provided positive feedback via a survey following the webinar. The survey included the question, “What did you like most about today’s webinar?” “Great to see a functional CMMS program,” Biomed Coordinator S. Richardson said. “How the new AIMS3 will help clear the clutter of other departments’ work

being displayed with my department’s work,” Assistant Chief of Engineering D. Holliday said after the webinar. “I liked the products adaptability to a facility’s needs,” Senior Technical Service Manager T. Santiago said. The webinar included an informative question-and-answer session. One attendee asked, “We have two different departments using different databases. How do they get merged during that conversion?” “So, product manager is my official title, but I still handle the conversions and implementation. So, I’m very familiar with this,” Peters said. “We can easily combine any number of databases. I think our record is 11 databases, 13 maybe, that we combined into a single AIMS database. Obviously, the timeline for that changes. It’s usually a little bit longer than a standard single database. But it’s as simple as we get copies of the databases, and we work with you to figure out what the ‘best one’ is, the best cleanest data and that’ll be where we start. That’s the one we want to merge everything else into. And, so, we can match things up and not corrupt the data too much during the conversion. So, we take one database. We get it into AIMS, that’s our core, every other database that comes in gets matched to that. We create as few new, again, what we call ‘data managers.’ Your different drop-down lists, as few as possible. So, if there’s already a GE Healthcare in there, we don’t want

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save date the

to create a second one, with a slightly different code or a different address. So, the conversion will happen and keep your original GE Healthcare, add the new address, or phone number, or whatever it is in, and then, when we bring the data in, it just uses the one that you have. We do that over, and over, and over again. So, for each database you want brought in, it’s the same process. We merge it, we do a lot of data cleanup as part of the conversion, and we do all of that in house.” “It’s a guy that works here in Michigan with us. He does most of the conversion work and then we review it with you constantly. We do a first conversion. We sit down and review it with you,” he explained. “We do cleanup conversion. We review it with you all the way through go live, dress rehearsal and go live. Even at go live, we still do an extra day to review with you to make sure that everything came over properly. Our goal is no data lost at all.” PROS SHARE SECURE HEALTH CARE ENVIRONMENT TIPS The Webinar Wednesday presentation “Higher Risks, Lower Budgets, COVID Chaos: The Scary Reality of Securing Healthcare Environments” was presented by Mark Heston, director of clinical engineering at Children’s Hospital Colorado; Ben Stock, director of healthcare product management at Ordr and Dylan Winthers, network and cybersecurity analyst at HSS. It was sponsored by ordr and eligible for 1 credit from the ACI. The presenters discussed the potential challenges facing health care in 2021. This year is shaping up to be a perfect storm with challenges for delivering care as budgets shrink, increased cyber risks and an unprece-

dented number of caseloads. The presenters discussed a combination of products and managed services that allowed Children’s Hospital Colorado to cost-effectively discover, protect and maintain the facility’s medical devices in a time of crisis, and how these tools will be imperative to transition back to a compliant and secure biomedical environment as normalcy returns. Attendees shared feedback via a survey that included the question, “What did you like most about today’s webinar?” “Different perspectives on how realities faced today can be handled and how different every department has been affected,” Field Service Engineer K. Saager said. “The ongoing and very lively discussion. Very close to what really happens, not so theoretical,” Senior Account Manager D. Bednarek said. “The information provided, and experience shared,” was what R. Walter, BMET II, liked the most about the webinar. For information, visit WebinarWednesday.Live. Thank you to our sponsors:

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SHOP TALK POWERED BY

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GE MAC 5500

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Has anyone had an issue with the C-arm drifting? The arm will not stay in any position unless you lock it. Is that normal? If you are talking about it drifting down toward the floor, you need to replace the arm, as the gas tubes are weak.

GAYMAR TP500

The pump still works well without leaks but the water is not getting hot. I would like to buy a heating element but don’t want to spend the money if there could be a different heat-related issue.

It could be the heater or the PC board. Check to see if you have 120 volts going to the heater (red and blue wires). If you have voltage, it’s the heater. No voltage, it’s the board. Also make sure the over temp light is not on and the unit is on a level surface. Also make sure it is pumping water. A lot of complaints I get about “not heating” are because it is actually not pumping any water. REPLY: Thank you. That is just the info I needed.

How do I enable the message window on the printout? This machine will not print the EKG interpretation. Make sure your MAC5500 has the DIAG option purchased and enabled in system setup/basic system/option activation tab. An asterisk (*) will indicate the DIAG is enabled. (If purchased, you can find the 12-digit option code for DIAG on the silver sticker under the printer paper in the printer tray.) Next, check to verify that your unit is not suppressing the interpretation statement for ECG printouts. This can be found in system setup/ECG/ ECG analysis/suppress NORMAL statements (NO) – suppress ABNORMAL and BORDERLINE statements (NO).

Check your options. Turn on the unit, click more, select system settings, password is usually BIOMED, select basic system, scroll down to option activation, and when the next window opens, look for DIAG, there should be asterix (*) before it. (If purchased, you can find the 12-digit option code for DIAG on the silver sticker under the printer paper in the printer tray.)

My ventilator is failing to pass a leak test. I have tried to check for possible leakages but I can’t find it. Is there anything I could possibly do to overcome this challenge?

That is a common problem. Go into diagnostic mode and select d3. Set flow to 3L/min. Hit manual breath to start the gas flow. Plug the inspiratory port and see if the inspiratory pressure LEDs keep going up until the safety regulator pops open. If it does not build enough pressure, then you have a leak in your inspiratory side. It should be able to build pressure with 1L/Min. If you have a leak you can increase or decrease the flow to see how much you need to pop the safety regulator. That gives you an idea of how large your leak is and where to look. To troubleshoot a leak, increase the highest flow you can get with the inspiratory port plugged and not popping the safety regulator. Then listen and feel around for the leak. You should be able to hear a hissing sound. The inspiratory side is all low voltage so it is OK to feel around with your finger for the leak.

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.

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ROUNDTABLE

ROUNDTABLE IV Pumps

n this installment of the monthly roundtable feature article, experts from throughout the healthcare technology management (HTM) industry share insights and tips regarding IV pumps.

The panel of insiders participating in the roundtable discussion are Atlantic Biomedical’s Richard Broseker, Elite Biomedical Solutions BMET III Michael Carroll, Avante Patient Monitoring’s Lead Technician for Infusion Pumps Dorian Davis, MultiMedical Systems LLC Regional Service Manager Jose Jimenez, Infusion Pump Repair Corporation President and CEO Hassan Serhan and AIV Inc. Vice President of Sales and Product Development Jeff Taltavull. Q: WHAT IS THE ONE THING EVERY HTM PROFESSIONAL SHOULD KNOW ABOUT IV PUMPS?

TECHNATION

MAY 2021

one you’re familiar with. CARROLL: IV pumps have the ability to deliver small and large volumes accurately, as well as deliver at automated intervals, provided the pumps are maintained according to OEM requirements.

Richard Broseker Atlantic Biomedical

BROSEKER: One thing every HTM professional should know is not all IV pumps are the same. They all may be designed to do the same thing, but they are different. Don’t go into a repair on a new IV pump that you’ve not seen before expecting them to be the same as

DAVIS: IV pumps are a critical part of patient care and play an important role in a patient’s treatment. But pumps use a lot of moving parts, which will wear down over time, similar to brake pads on your car. Maintaining your pump is a necessity. JIMENEZ: The staff using the pump should know what type of cleaning solution to use on their infusion pumps (and other devices). Depending on the infusion pump, the solutions that can be used varies greatly. Using the wrong solution can dry out the plastic, causing cracks and/or hinges on the door

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ROUNDTABLE

DAVIS: Use refurbished or aftermarket parts when possible. The cost of parts has increased a lot during the pandemic. Using alternative and certified sources for parts could save you hundreds to thousands of dollars.

causing flow rate issues. If the pump is accidentally dropped during transport, it should be sent back to clinical engineering so they can inspect the internals and/or verify the calibration. Even if the pump does not look physically damaged on the outside, it could be cracked internally. If the inside of the pump is cracked, it will cause the pressure and rate accuracy to be off and even make it to where it will not be able to calibrate properly. SERHAN: When the pandemic started last year in March, all the media attention was directed toward ventilators and their necessity to save COVID-19 patients’ lives. What the media missed, and what most people weren’t aware of, is that second in line after ventilators were the infusion pumps. All hospitals in the country purchased and stocked as many IV pumps as they could find or afford regardless of the immediate need. IV pumps are common and vital in every clinical setting such as hospitals, medical centers and homecare facilities. Therefore, every HTM professional should know how to maintain and perform preventive maintenance (PM) and calibration for the IV pump models used at the hospital where they work. TALTAVULL: They have options when it comes to servicing. There are third-party services that offer great alternatives to the OEM. I suggest researching to ensure those partners meet the quality standards for your facility. High-quality, ISO-certified partners can provide parts and services to help reduce costs of maintenance and repairs. If a

Hassan Serhan Infusion Pump Repair Corporation company is ISO certified, they should have a strong quality policy and traceability on all products that come in and out of their facilities. Q: WHAT ARE SOME COST-SAVING TIPS YOU CAN SHARE REGARDING IV PUMPS? BROSEKER: Some IV pumps have small pieces that can easily break. Taking it slow when opening a device is a good way to insure you won’t break things. The last thing you want to do is add more problems to a device by mishandling it. CARROLL: Perform regular maintenance and replace worn parts as needed, do not wait until there is a major failure with the device to have it serviced. It is also important not to overlook cosmetic damage like a cracked case, which could allow for fluid intrusion causing major internal damage. This could have been prevented if the case had been replaced.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

JIMENEZ: Proper cleaning and calibrations are critical. The micro-adjustments to flow and occlusion can keep the unit running until repairs are needed. Proper training for the medical staff can also help. Replacing batteries on a timely basis (every two years is recommended) prevents excess battery acid buildup. SERHAN: There are multiple easy and simple tips that can help extend the life of IV pumps and prevent them from breaking down frequently. • Clean the pump after each use and make sure there are no liquid intrusions inside the pump because that may cause other severe issues in the long run. • Keep the pump plugged in when it’s not in use. Make sure the main battery doesn’t deplete. • Handle the pump delicately to prevent drops and physical damages. • Use original OEM parts during repairs to prevent accidental malfunctions. TALTAVULL: Stay in front of problems and make sure all your equipment is following recommended PM schedules. Little things like changing out your power cords regularly and keeping pumps plugged in and charged when not in use can have a big impact.

MAY 2021

TECHNATION

ROUNDTABLE

Q: HOW HAS THE COVID-19 PANDEMIC IMPACTED THE USE AND MAINTENANCE/ REPAIR OF IV PUMPS?

do our part to help everyone continue to battle the front line. Q: HOW IMPORTANT ARE PMS AND WHY?

BROSEKER: COVID-19 has put a strain on the repair of some IV pumps. There has been a much greater demand for IV pumps. This means they are being used more frequently, and this has made it harder to access pumps when they are defective, as some are in COVID designated areas. CARROLL: COVID-19 caused a widespread demand for IV pumps. This forced otherwise unrepairable pumps, pumps that had been put aside or damaged, to ultimately be repaired. We have had the privilege to come alongside and help with this demand through new parts, rentals and repair services. DAVIS: The COVID-19 pandemic has been a rough time for people across the world and has had many adverse effects over multiple aspects of our daily lives and the lives of our loved ones. One of the more severe effects it has had is the increased hospitalizations of people. Many facilities reached maximum capacity and needed more equipment to facilitate the influx of patients needing care. Infusion pumps have played an important role during this time. These devices are used to feed nutrients, medications and other fluids – more patients means more use and, subsequently, more maintenance. Since the pandemic hit, we have seen a major increase in the number of devices being ordered and needing maintenance. Infusion/syringe pumps have more mechanical parts and can start to lose performance with wear and tear. Fortunately, we planned ahead and were able to prepare for the maintenance. These devices also have built in alarm settings that help notify the users of potential errors and most are caught without putting the patient at risk. JIMENEZ: Getting access to the equipment has been the most difficult piece of the puzzle for most health care provid-

TECHNATION

MAY 2021

Michael Carroll Elite Biomedical Solutions

ers. We have also seen a high demand for Alaris 8100 pump repairs, mainly due to the bezels cracking and transducers failing from excessive use. One of the biggest problems we had was getting a hold of replacement parts, especially from the OEM. Our biggest savior during the height of the pandemic was that many third-party manufacturers were able to provide replacement parts that are OEM approved. It would take us days to get parts from third-party suppliers when the OEM would take months due to shortages. SERHAN: We took extra precautions while servicing IV pumps during the pandemic. Most of the pumps coming from hospitals were used on COVID-19 patients. Therefore, we started disinfecting the pumps before repairing them to make sure the surface was clean from viruses. We also purchased and stocked up on replacement parts in order to accelerate the repair turnaround time. TALTAVULL: Unfortunately, COVID-19 has set everyone back. In a state of crisis hospitals have been forced to use whatever they had available to save lives. This has meant pulling equipment out of retirement and in many cases disregarding maintenance. We have seen an onslaught of equipment that we haven’t seen in years. But, like everyone else, we have been finding solutions to

BROSEKER: Preventative maintenance is highly important for all devices. Routine checks on a device’s functionality and minor repairs to keep a device in service could be the reason why a patient lives or dies. A device can fail during a surgery for an issue that could have easily been caught during a PM. CARROLL: PMs are very important. The PM procedure allows technicians to verify the device, being hooked up to a patient, is performing within the OEM specs. During the PM is also when we can notice an error code or physical damage and fix the issue.

Dorian Davis Avante Patient Monitoring

DAVIS: Preventive maintenance is a critical component in the care of your infusion pump or any medical devices for that manner. The PM procedure is often outlined in the manufacturer’s service manual and is designed to notify the BMET or individual performing the test of any issues currently present and of issues on the way. These should be performed annually or semi-annually and daily on life-saving equipment on the floor,

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ROUNDTABLE

such as a Heartstart MRX. Even if the pump has not exhibited any failures or error, it is wise to have the device on a scheduled maintenance cycle that includes the PM being performed. After we complete our repairs in house, we will then follow up with the PM in order to recheck our work and make sure we didn’t miss anything. In some cases, the PM can also be used to troubleshoot devices and help the technician get to an issue sooner.

specified ranges. If PMs fail, then calibrate the pump or perform the necessary repair. TALTAVULL: Again, preventive maintenance is crucial in controlling costs on infusion equipment. Keeping pumps on a routine maintenance schedule keeps the little problems from becoming big ones. It’s also crucial in these times of extremely high usage to make sure products are staying within their delivery tolerances.

Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT PURCHASING AND SERVICING IV PUMPS? BROSEKER: I would say taking things slow is good advice when servicing IV pumps. Working too quickly you can miss things or have trouble calibrating a device. Having to take apart a device to tweak one potentiometer after having it all closed up is never fun. Jose Jimenez MultiMedical System LLC

JIMENEZ: PMs are to prevent issues or address something that may become an issue before it arises. By completing PMs with a set cycle and recording the outputs for flow and occlusion pressure values it is possible to predict what parts will fail. Parts can be ordered in advance to reduce downtime. This is critical for repairs to get completed in a timely manner. SERHAN: Preventive maintenance is very important and crucial for IV pumps for many reasons. PMs have to be done routinely (at least once a year) in order to help prolong the life of the pump. Performing Ps helps with checking the battery life inside the unit and replacing it if necessary. Third, it keeps the pump’s specs in check where the accuracy rate and occlusion pressures are tested to make sure they fall within the OEM

parts starting to fail? They should be stress tested to confirm they are not. Look for cracks in the bezel and case. A crack that is too big can create a nesting point for excess bacteria. SERHAN: During the pandemic, most hospitals purchased more IV pumps than they need. Better management of the IV pump fleet at the hospital can help reduce unnecessary costs and expenses. Purchasing pre-owned IV pumps can save the hospital over 50% than buying new ones. Make sure you seek reputable third-party companies with high-quality certifications and expertise on the pump model you’re interested in. In addition, having a trained HTM professional on site helps taking care of minor repairs and saving the hospital on repair costs.

CARROLL: It is important to maintain proper PM procedures and stick to OEM guidelines/specs. Another important item for servicing equipment is making sure the test equipment you are using has been calibrated as well, scales, pressure meters, etc. DAVIS: Purchase the right pump for your needs and facility. Some pumps are better suited for certain types of treatment and infusions. Some pumps are large and others small, so the size of your facility may play a factor. Care providers may want to consider maintenance costs as well as availability of parts. Generally, the more used a pump is the more available parts are, though there may be exceptions to this rule. Jimenez: When was the battery last replaced? These are recommended to be replaced every two years. Look at values from previous PMs to see if pressure transducers are swaying out of calibration. Are the high failure

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Jeff Taltavull AIV Inc.

TALTAVULL: Do your homework. There have not been many new products coming on the market over the past few years. So that means of the choices available, you should easily be able to consult your peers about their experiences with those products as well as the OEMs. Key questions need to be warranty, warranty exclusions, parts and service availability, and turn time on repairs. Last, but not least, remember you have service options.

MAY 2021

TECHNATION

SPECIAL REPORT RELEASE

Top 10 Health Technology Hazards for 2021 Prevent dangerous device hazards and improve patient safety DOWNLOAD THE EXECUTIVE BRIEF | ECRI.ORG/2021HAZARDS

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COVERSTORY

MEDICAL DEVICE RISK SCORING Measuring Risk and Preparing for its Eventuality

By K. Richard Douglas

As humans, we make risk evaluations every day. Do we eat unhealthy food versus healthier alternatives? Do we use tobacco products? Do we visit high-crime areas? Do we make a home electrical repair without first shutting off the power at the breaker box? While most of these decisions would seem to come down to common sense; they are conscience decisions we make just the same. They are based on personal experience, deeply held beliefs, empirical evidence, accumulated knowledge or published historical data.

TECHNATION

MAY 2021

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COVERSTORY

In the world of investing, it is common to compare risk with reward and gauge what level of risk one is willing to accept with the hope of rewards. This is called a risk tolerance profile and every individual is unique in this regard. The investment community has devised many measures of risk. Stocks, mutual funds and exchange-traded funds all feature a risk profile. In daily living, we seek out best practices and avoid unneeded risk whenever possible. With medical devices, the safety and security of the device has to be carefully managed. There is little room for risk and the evaluation of each device for risk has to be made using a ranking system and hierarchy based on the critical nature of that device. Risk has to be managed

throughout the product life cycle. A measure of risk in a medical device is the potential of an adverse event occurring with that device. The severity and probability of an adverse event is then quantified into a score. The score reflects the likelihood of an adverse event and the potential consequence resulting from that event. On a continuum, the range of risk can vary from negligible to catastrophic, and the probability for any given device could range from improbable to probable. Risk assessment can rely on a number of “tools” including manufacturer disclosures (MDS2), the “Medical Device Innovation, Safety and Security Consortium (MDISS) Medical Device Risk Assessment Platform,” FDA resources and ANSI/AAMI/ISO 14971:2007/(R)2016 “Medical devices – Application of risk management to medical devices.” To measure cybersecurity risk, there is also “The Common Vulnerability Scoring System (CVSS).” This rubric was developed by MITRE Corporation under contract to the FDA, in

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collaboration with medical device manufacturers, health care delivery organizations, security experts and safety/ risk assessment experts. Part of standardizing a risk scoring system is the acceptance and understanding of the terms involved – such as residual risk, risk management, risk estimation, harm or severity. The process of risk management for medical devices involves several steps including risk analysis, risk evaluation, risk control, the evaluation of residual risk acceptability, a risk management report and risk monitoring analytics. The analytics include production and post-production information.

History of Quantifying a Risk Score In the past, a scoring system developed by Larry Fennigkoh and Bridget Smith was widely embraced by HTM departments and published by The Joint Commission. The guide included categories that allowed for scoring based on things like equipment function, physical risks associated with clinical application and/or maintenance requirements. The equipment function category provided the application of scoring from 1 to 10. Life support equipment would be an example of equipment receiving the highest score. The physical risks category allowed for a five-point scale. For instance, if a piece of equipment was capable of causing death, it would be scored as a five; if it would cause patient or operator injury; a four and then with less risk; a lower score. The maintenance requirements category was also scored on a five-point scale and topped out with equipment that required extensive maintenance receiving a five-score and moving down to equipment requiring average maintenance at three and further down. When taken together, the resulting score under each of the three categories provided a score aggregate, with a maximum potential score of 20. The number was referred to as an equipment management (EM) number. An EM number of 12 or higher meant that the MAY 2021

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piece of equipment should be included in an equipment management program. Those devices with scores of 11 or less could be excluded from such a program. Under the equipment maintenance component (or planned maintenance [PM]) of the approach, those devices scoring a four or five would get maintenance every six months, and those devices scoring a one to three would be maintained every 12 months. “The Fennigkoh-Smith algorithm has long been used as a ‘risk assessment’ tool, even though its primary author, Larry Fennigkoh, does not regard it as such. The definition of ‘risk’ that is recognized by our clinical colleagues, and by professionals in other domains, is that ‘risk’ is a combination of the ‘probability’ of an adverse event and the ‘consequence’ of that event. Under that universally accepted definition, the pioneering Fennigkoh-Smith method does not actually calculate risk,” says Matthew Baretich, P.E., Ph.D., president of Baretich Engineering Inc. in Fort Collins, Colorado. In June of 2020, Baretich co-presented the Webinar Wednesday session “Don’t Take Risks with Medical Device Risk Scoring” with Carol Davis-Smith, CCE, FACCE, AAMIF, president of Carol Davis-Smith and Associates LLC. The webinar was sponsored by Nuvolo. “For risk assessment of medical devices, the ‘consequence’ of a device failure is usually assessed qualitatively rather than quantitively. This can range from death and serious harm on the high end to inconvenience and negligible effect on the low end,” Baretich says. He says that the “probability” of a medical device failure can be assessed quantitatively by looking at CMMS data. “If your CMMS is configured effectively and if the data in the CMMS are accurate, failure rates can be easily calculated for various equipment types or for individual devices,” Baretich adds. Some time after the Fennigkoh and Smith approach was introduced, the American Society for Healthcare Engineering (ASHE) introduced its own algorithm or approach. That formula was more complicated than the Fennigkoh-Smith 50

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“ CMS regulations and accreditation standards require us to make sure that putting equipment into our AEM program does not reduce safety and effectiveness. We need a performance metric to track how we’re doing.” Matthew Baretich

algorithm. Both approaches could be found as components of some CMMS software. More recently, The Joint Commission and other accrediting organizations have required all equipment to be included in an equipment management program. The requirements have also changed for PM requirements. The Centers for Medicare and Medicaid Services (CMS) and The Joint Commission each have all-encompassing standards. An alternative equipment maintenance (AEM) program normally addresses these requirements. The Joint Commission uses the terms “seriousness” and “prevalence” of harm. These terms allow for a clearer measure of risk. These terms can be applied to whole devices as well as to note an analysis of specific failures that are more likely with one component of a device. Severity ratings can be somewhat subjective while probability data can be found in CMMS. This is where failure data can be found. Some CMMS automatically calculate the mean time between failures (MTBF) statistics. Some other areas within health care where quantifying risk are important include cybersecurity, emergency preparedness, patient risk score and community health.

Risk from an External Threat While most of the media attention on the health care industry in 2020 was focused on the response to a serious viral illness, the story that was mostly missed was the steep spike in cyberattacks on hospitals. The COVID-19 pandemic emphasized the need for standardized practices in HTM. “The pandemic has meant that HTM work is carried out under difficult conditions and with increasingly limited resources. One effect is that AEM programs have become standard practice. A well-crafted AEM program can reduce resource requirements for PM, which saves time and money. It can also keep the levels

of equipment safety and effectiveness high and, in some cases, increase them,” Baretich says. He says that a critical aspect of an AEM program is having a metric in place to monitor the effectiveness of the PM program. “CMS regulations and accreditation standards require us to make sure that putting equipment into our AEM program does not reduce safety and effectiveness. We need a performance metric to track how we’re doing,” Baretich says. He adds that an emerging metric is “MTBFPM.” “This is based on the familiar MTBF (mean time between failures) metric that our CMMS software should already be configured to compute automatically. But, as we know, not all equipment failures can be mitigated by better PM (s). For example, infusion pump failures caused by incorrect programming cannot be made less likely by more PM(s). To focus on PM-specific performance, MTBFPM tracks the mean time between PM-related failures only,” Baretich says. Baretich explains that to implement the MTBFPM metric, one needs CMMS data that (a) accurately records medical equipment failures and (b) distinguishes between PM-related failures and other types of equipment failures. A recent AAMI-sponsored CMMS collaborative project recently tackled that issue, as described in a white paper (www.aami. org/HTM/htm-resources/cmms-collaborative-white-papers). In addition to the challenges brought about by the pandemic, the risk inherent in adding medical devices to a network continue to escalate. “There has been constantly increasing focus on cybersecurity year on year. While there hasn’t been a widespread event like WannaCry and NotPetya in 2017, there has been an increase in the incidence of WWW.1TECHNATION.COM

COVERSTORY

ransomware at hospitals. Ransomware is typically targeted on organizations that may have weak security but have mission critical computing systems that might make them willing to pay rather than go through a lengthy restore process,” says Ken Hoyme, senior fellow, global product cybersecurity, global technology and services at Boston Scientific in St. Paul, Minnesota. He says that as a result hospitals have higher expectations regarding the security of the devices that they bring onto their networks. Contract language is specifying patching expectations and communications of security test results. The MDS2 form, that is asked for, has been updated with many more questions about the device’s security configuration and controls. So, there is more transparency between manufacturer and health care delivery organizations regarding security information. “The FDA has been communicating their expectation that threat modeling — also known as security architecture analysis — should be performed during product development and as a means for assessing new vulnerabilities/exploits against fielded equipment. This has resulted in the industry increasing use of these techniques. The FDA funded the Medical Device Innovation Consortium (MDIC) and MITRE to develop a threat

“When we develop new products or encounter changes in a product’s operating environment, we take a step back to the initial design from a cybersecurity standpoint – threat modeling. Similarly, when new vulnerabilities emerge, we look at these from a threat standpoint first,” says Jaap Qualm, vice president of product cybersecurity for GE Healthcare. He says that from there, the next step is to understand the associated risks and ensure implementation of the appropriate security controls to address the risks. “The need to continuously step back to these fundamentals of the risk function is not only applicable to the medical device manufacturers in their design and support processes, but also to health delivery organizations in the operation and networking/connectivity of the medical devices. The need to prioritize security is now more critical than ever to protecting health care, combined with a greater need for close collaboration within the health care sector. The better we all work together, the more effective we will be in achieving our common goals of ensuring confidentiality, integrity and availability in this sector,” Qualm says. Hoyme adds that the pandemic has increased the use of telehealth and remote device support. This is increasing the potential threats, which have to be addressed as these technologies are developed and put in “ Throughout this space of shared use. responsibility, all should have a process He also suggests the to understand the assets, apply MITRE structured threat modeling, understand rubric as a and minimize vulnerabilities and source for best practices implement appropriate risk-based in this area. controls.” Jaap Qualm “MITRE has released a modeling boot camp, and later this year a ‘rubric’ to allow CVSS scoring to be more threat modeling playbook to assist industry readily applied to medical devices,” he in consistently applying these techniques,” says. Hoyme says. “Deployment of tools to allow for This approach means that the manufac- remote device software distribution and turer considers the current known threats security log collection is getting more during product design. traction. With the need to patch more EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

frequently, the cost of deployment (the last mile problem) if each device needs to be visited by a service tech, can be a backpressure on how frequently patches are done. Of course, if remote software update is the reason to ‘add’ connectivity, the threat surface is greater and the need for patching becomes more important. But traditional service models are not sustainable if several patch cycles per year becomes a norm,” Hoyme adds. Another best practice in this area is that medical device manufacturers should apply systemic threat-based security risk analysis in device designs, and health care delivery organizations should work with manufacturers to apply this in their operational security practices, according to Qualm. “Throughout this space of shared responsibility, all should have a process to understand the assets, apply structured threat modeling, understand and minimize vulnerabilities and implement appropriate risk-based controls from a well-defined controls catalog,” he says. “After implementation, focus should go to life-cycle support processes and mechanisms for transparency of risk information and solutions. Operationally, we do offer managed security services backed by our extensive knowledge of medical devices, which can be a great help in ongoing management of existing risks and new threats as they come up in the health care delivery organization’s clinical network environment,” Qualm adds. Determining risk and applying safeguards allows medical devices to provide safe and reliable operation throughout the life cycle of each device. Mitigating risk that is introduced by connections to the Internet also require quantifying and attention based on best practices. Through the use of several tools developed to measure risk and incorporate it into an effective equipment management program, the HTM department can best allocate resources during a period of substantial demands. The science will evolve and technology will improve to provide data and decision-making information readily available. MAY 2021

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EXPERT ADVICE

CAREER CENTER Save Ghosting for Halloween BY CINDY STEPHENS

oday’s job market has more opportunities than ever before with fewer qualified candidates to fill positions. There are a number of reasons for the shortage, especially within the healthcare technology management (HTM) field. For example, baby boomers are retiring leaving positions open to a less experienced workforce. Further compounding this is the reality that few community colleges or trade schools are offering specialty biomed programs. All this significantly impacts health care organizations nationwide as fewer qualified and experienced candidates are available for hire.

The hiring process can be very lengthy and can feel frustrating for the candidate and the employer. Candidates often apply for several positions, creating a situation where multiple job offers are on the table from different companies. On the flip side, employers frequently take too much time within their internal hiring process, leaving candidates to question their status and to ultimately pursue other opportunities. Ghosting refers to the sudden stop of communication between two or more parties. While the term is typically used to reference a personal relationships, it certainly happens in the work environment too. Unfortunately, ghosting can be a common

Cindy Stephens Stephens International Recruiting Inc. occurrence during the hiring process, and across all fields. But it shouldn’t be. Ghosting is very unprofessional behavior. The HTM community is a small world, so do not burn bridges. Ghosting a hiring authority may come back to haunt you when applying for future opportunities. Networking and reference checks are important in an individual’s career success, and you never know when the person you ghosted will impact your next potential career move. As tempting as it may be to assume the hiring authority is ghosting you … don’t. Recognize that the hiring authority has multiple priorities and, as hard as it is to hear, your job application may not be the top

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priority. That does not necessarily mean they are ghosting you. Ask questions during the process, including what the next steps are, and certainly follow-up. In the occasions when you do not hear back, stay professional. Remember that as much as we change positions within our field, others do as well. The last thing you want to do is burn a bridge now that can impact your career advancement later. If you change your mind about a position, it is important to remain professional and reach out to let the hiring authority know you are declining to move forward. David Hailberstam once said, “Being a professional means doing your job on the days you don’t want to do it.” This applies during the hiring process too. How you behave and respond says volumes about you and your character. So, stay positive and professional even when you aren’t feeling it! CINDY STEPHENS is the president and CEO of Stephens International Recruiting Inc. The views expressed here are those of the author’s and do not necessarily represent or reflect the views of TechNation or MD Publishing.

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