TechNation July 2021 by MD Publishing

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ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

M E O t s o P dus Exo ess Progr

JULY 2021

Medical Device Servicing Community

Up dat e 18 Department of the

Month The Children’s of Alabama Biomedical Engineering Department

31 Ribbon Cutting

BK Workstations

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Vol. 12

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Real Time Threats

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CONTENTS

FEATURED

HE ROUNDTABLE: T CYBERSECURITY Cybersecurity remains an important aspect of HTM work. TechNation asked experts to share their insights on this topic.

Next month’s Roundtable article: Radiography

MEDICAL DEVICE SERVICING COMMUNITY UPDATE: POST OEM EXODUS PROGRESS The question of who can provide competent and reliable servicing of medical devices remains a hot topic among HTM professionals.

ext month’s Feature article: N Biomeds on a Mission: HTM volunteers make a difference

TechNation (Vol. 12, Issue #7) July 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

JULY 2021

TECHNATION

CONTENTS

INSIDE Departments

PUBLISHER

John M. Krieg

VICE PRESIDENT

Kristin Leavoy

ACCOUNT EXECUTIVES

Jayme McKelvey Megan Cabot

ART DEPARTMENT Jonathan Riley Karlee Gower Taylor Powers

P.12 SPOTLIGHT p.12 Professional of the Month: A Mindset Comes Full Circle p.14 Association of the Month: The Heartland Biomedical Association (HBA) p.18 Department of the Month: The Children’s of Alabama Biomedical Engineering Department

EDITORIAL

John Wallace Erin Register

CONTRIBUTORS

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

P.21 INDUSTRY UPDATES p.21 News and Notes: Updates from the HTM Industry p.26 AAMI Update p.28 ECRI Update p.31 Ribbon Cutting: BK Workstations p.32 Welcome to TechNation

DIGITAL SERVICES

Cindy Galindo Kennedy Krieg

EVENTS

Lisa Lisle

WEBINARS

Jennifer Godwin

P.34 p.34 p.37 p.38 p.41

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

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

P.55 EXPERT ADVICE p.55 Career Center p.56 20/20 Imaging Insights, sponsored by Innovatus Imaging p.59 Cybersecurity p.61 The Future p.62 The Future Is Here: Make the Blue Sky Dream a Reality for Your HTM Department, sponsored by Nuvolo P.64 BREAKROOM p.64 Did You Know? p.66 The Vault p.70 MedWrench Bulletin Board p.78 HTM Strong p.74 Service Index p.77 Alphabetical Index Like us on Facebook, www.facebook.com/TechNationMag

MD Publishing / TechNation Magazine 1015 Tyrone Rd., Ste. 120, Tyrone, GA 30290 800.906.3373 • Fax: 770.632.9090 Email: info@mdpublishing.com www.mdpublishing.com

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SPOTLIGHT

PROFESSIONAL OF THE MONTH A Mindset Comes Full Circle BY K. RICHARD DOUGLAS

ost, if not all, biomedical technicians and imaging service engineers approach the servicing or repair of medical equipment as if a family member may be the next patient who depends on it. A local newscast in Missouri introduced viewers to this approach to equipment servicing and how it can hit close to home.

A segment on CBS KSDK-TV channel 5 in Missouri told the story of a 6-yearold boy named Isaiah Neil who was suspected of having a nasal polyp, but who was also losing weight. His mother suspected that it was something more than a sinus infection or polyp. Diagnostic testing revealed that Isaiah had rhabdomyosarcoma, a soft tissue cancer in his nasal cavity. He was air lifted to St. Louis Children’s Hospital. Isaiah’s dad, Matt Neil, is a radiotherapy service engineer III with the clinical asset management team at BJC Healthcare in Springfield, Missouri. “My youngest was diagnosed with cancer back in January. We went in for a routine surgery to remove a polyp from his nasal cavity and they ended up flying him from Branson, Missouri, where the surgery happened, to St. Louis Children’s Hospital,” Neil says. “St. Louis Children’s Hospital is part of BJC Healthcare; who I work for. As part of his treatment plan, he had to have six weeks of radiation. Due to COVID restrictions, I had to make a choice to either go to St. Louis for the entirety of his radiation treatment course, or not get to see him or my wife for that whole time,” Neil adds.

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JULY 2021

Matt Neil is responsible for maintaining the Varian HyperArc used to treat his son Isaiah’s cancer.

He says that his manager and coworkers stepped up to fill the gap while he was away. “They allowed me to work at the main cancer center in downtown St. Louis, and my other coworkers stepped up to go down to Springfield and cover for me. My son has to have weekly chemo treatments in St. Louis through November of this year. They continue to step up and come down here every week, allowing me to drive my wife and son and be with them during this difficult time,” Neil adds. Neil is one of those medical device service specialists who has always approached the servicing of devices as if a loved-one would be the patient. His path to servicing imaging equipment goes back to his military days. “I went to a conference for people separating from the military several

months prior to getting out of the Navy. I learned about many different career paths for someone with my training from the military, but working on medical imaging equipment interested me the most. I ended up interviewing with several companies, and after learning about Varian Medical Systems and what they did, I knew that was the path I wanted to take,” Neil says. Most of Neil’s early training came from the military. “I was a fire control technician in the Navy serving onboard submarines. So, I had most of my technical training from there. When I was hired on at Varian, I went to many of their classes to learn all of their equipment in depth. But like much of what we do in this industry, I learned the most through on-the-job training. I’ve also been to several other classes since becoming an in-house engineer including ultrasound, X-ray

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SPOTLIGHT

Matt Neil’s service experience is vast. He is well-equipped in many different imaging and biomed devices.

and other linear accelerator training courses,” he says. CIVILIAN LIFE AS A SERVICE ENGINEER Neil spent eight years with Varian as an installer. Upon leaving, he took a position with Mercy Hospital in Springfield, Missouri as a radiological equipment service tech. “My primary responsibility was the linear accelerators, but I worked on virtually all imaging modalities while I was there. After doing that for three years I became the manager of clinical engineering at Mercy. This allowed me to learn much more about the biomed side of our operation where most of my career was spent on the imaging side. I enjoyed that job, but after about a year, I had an opportunity to go to work for BJC Healthcare out of St. Louis while still living in Springfield, Missouri. I have been here for two and a half years as a radiotherapy service engineer. I am responsible for maintaining the Varian linacs for two cancer centers. I have TrueBeams and an Ethos as the equipment I maintain,” Neil says. Off the job, Neil and his wife are investing a lot of time and attention to their children’s education. “I’m a homeschool dad. After my oldest was born, my wife and I decided to homeschool our children. This makes some things in life harder, but it has been so worth it. Having my children home, and knowing my wife is teaching and taking care of them while I provide, is so rewarding,” he says. He has been married to his wife, Amber, for more than 16 years. “We met working at the Dairy Queen in high school. We’ve got four kids. I’ve got a teenage daughter, a wild boy and boy/girl twins,” Neil says. In addition to education, he has also

been involved in his kids’ athletics. “For several years now, I have helped coach my kids’ baseball/softball teams. While I played other sports as a kid, I have really enjoyed coaching these kids. Watching them develop through the course of a season and come together as a team is so rewarding,” he adds. Neil says that many calls can have a 24-hour response time. However, when it comes to the accelerators in the cancer centers, they have to respond much quicker. The goal is to repair the machine and get it back to treating patients as soon as possible. With that concern for patients, and attention to detail, Neil’s son has doctors and nurses and his own dad to thank for his treatment. Treat the device you are servicing as if a member of your own family will depend on it. Matt Neil knows that mindset has real-life relevance. From one unsung hero to the many others.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

FAVORITE BOOK: Bible

FAVORITE MOVIE:

The Star Wars movies. My kids are even bigger fans than I am; we all love watching them together.

FAVORITE FOOD:

Chicken wings or pizza

HIDDEN TALENT:

I’m able to annoy my teenage daughter by simply breathing.

FAVORITE PART OF BEING A BIOMED:

Ability to get the system back operational and able to treat patients again

WHAT’S ON MY BENCH? • • • •

5-in-1 Klein screwdriver sets of Allen wrenches multimeter quarter-inch socket set and a bottle of tri-flow

JULY 2021

TECHNATION

SPOTLIGHT MultiMedical Systems’ Chyrill Sandrini recently presented at an HBA meeting.

ASSOCIATION OF THE MONTH The Heartland Biomedical Association (HBA) BY K. RICHARD DOUGLAS

iomed associations from coast to coast have been happy to wave good-bye to 2020. It was not a particularly productive year for events, networking and training. Any real beneficial assembly had to be replaced with a virtual environment that just didn’t quite stack up.

One of those groups, right in the middle of the country, is the Heartland Biomedical Association (HBA) which holds many of its events and activities in the Omaha, Nebraska area. The association is replete with members who hail from Iowa, Kansas, Missouri, Nebraska and South Dakota. The association has a long history dating back to 1994, President Scott Ostrand says. Back at that time, Ostrand says the most influential persons who got the group up and running were Dale Rose and Paul Straub. Rose was the director of clinical engineering at Immanuel Medical Center in Omaha, Nebraska. Straub was the director of clinical engineering at the University of

TECHNATION

JULY 2021

Nebraska Medical Center, also in Omaha, Nebraska. Ostrand says that the HBA started with a handful of managers and techs in a reserved meeting room who developed the bylaws and determined the meeting formats. “Originally, we held meetings according to Robert’s Rules, but over time we felt a more casual meeting environment would be better attended. Some of the first official meetings were presentations of new equipment and their clinical uses. We relied on our relationships within the hospital and received education on clinical aspects of EEG, ophthalmic surgery and other local presenters,” he says. The group offers an annual scholarship to local students to foster a relationship with new graduates and their job opportunities. The first scholarship was offered in February of 2020. “Our second annual scholarship was presented to Iowa Western Community College, and we are waiting on the recipient announcement. We have five recent graduates from the electronics and laser

program actively seeking HTM jobs,” Ostrand says. THROWING A WRENCH IN THE 2020 SCHEDULE The group was not able to hold scheduled meetings after January of last year. The first quarter of this year provided members with the first steps back toward normalcy. “We began meeting again in March. We met in a large space, socially distanced, and allowed members to decide for themselves whether they wanted to mask or not (most did). We allowed the presenter to be mask free. All food items were single serve (no buffet) to follow CDC guidelines. The topic was UVC sterilization equipment presented by Jeff Kloster of The Rhino Group. We had about 30 in attendance,” Ostrand says. The HBA normally holds scheduled meetings in January, March, May and November. The group’s May meeting was scheduled for a similar location as the

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SPOTLIGHT

March meeting, maintaining social distancing and the other rules. Presenters included Chyrill Sandrini, director of surgical services and biomedical solutions at MultiMedical Systems, and Scott Wooster, account executive for MultiMedical Systems. The presentation covered the safe handling and care of scopes. Ostrand says that they generally record presentations and put them on the group’s website heartlandbiomedical.org. Although HBA had to miss its scheduled 2020 symposium, the group did hold the event in 2019. “We had about 75 attendees over two days of education and a vendor fair with another 60 participants in the Saturday golf outing,” Ostrand says. “One thing we do is on Friday night, after the symposium, we host all of our vendors, presenters and attendees and have dinner at local favorite restaurants as a thank you to everyone’s hard work,” Ostrand says. The 2019 event included courses such as “BMET to Imaging Path,” “Automate, Optimize and Secure your Clinical Network” and “Implementing a Support Strategy for Diagnostic Ultrasound.” BIG FALL LINE-UP In addition to the scheduled meetings that were upended, the association also had to postpone its efforts to recruit students into the biomedical field. “We were invited to a job fair, but it was cancelled due to the recent COVID pandemic. We don’t have any local biomedical technical schools, but we are focusing on electronics students who agree to take medical terminology and anatomy courses as electives. We are really trying to recruit and train local talent,” Ostrand says. The group has also made an attempt to replace retiring baby-boom biomeds with the newest members of the profession.

“We are stepping up efforts at the local level. I’ve begun calling local colleges, asking about job fairs; reaching out. It’s very difficult to find replacement positions, but this is how we have to do it in ‘fly-over’ country. Our new recruits are keeping membership steady,” Ostrand says. The reason behind the loss of last year’s annual symposium was that the group lost its venue. The annual event is normally scheduled in August; but 2021 is proving to be a big improvement. There will be two exciting fall events.

HTM Mixer in Kansas City, Missouri on September 10, 2021. We have teamed with Gateway Biomedical Association in St. Louis, Missouri and HTMA-Midwest in Kansas City, Missouri. We’ve met several times over the winter/spring and are assisting with obtaining presenters,” Ostrand says. The HTM Mixer is 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.

This August, the association will host its annual golf outing to raise scholarship money and provide local vendor/partners opportunities to meet with membership in a more casual environment. The following month will be a more all-encompassing event that will bring together even more HTM professionals. “This year we will not be having a symposium in Omaha. We are proud to announce we are co-sponsoring the

The event will be jointly sponsored by GBS, the HTMA-MW and HBA. More information is available at https://kc.htmmixer.com. With increasing numbers of Americans receiving vaccinations, the schedules of HTM associations can begin to look like they once did, and biomeds can benefit from all the networking, training and activities that go with meetings and events like the HTM Mixer.

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JULY 2021

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SPOTLIGHT

DEPARTMENT OF THE MONTH

The Children’s of Alabama Biomedical Engineering Department BY K. RICHARD DOUGLAS

here is a certain reverence that is earned by hospitals devoted to caring for the youngest patients. Pediatric facilities have a special mission and focus that has addressed the anxiety of many a parent.

In Alabama, that noble slice of health care has been the focus of Children’s of Alabama, going all the way back to 1911. The hospital treats patients from every county in the state, as well as from nearly every state in the country. Children’s of Alabama is the only health system in Alabama dedicated solely to the care and treatment of children. Among those devoted to the health system’s mission to heal children is its 13-member biomedical engineering department. “The Children’s of Alabama Biomedical Engineering Department consists of 13 individuals including nine biomedical technicians, one clinical engineer, a supervisor, a secretary and director,” says Kelvin Knight, CBET, the department’s director.

TECHNATION

JULY 2021

Other members of the team include Supervisor Jason Head, CBET; Clinical Engineer Alexander Flemming, CBET, CLES; BMET IIIs Gerceia Lee, CBET, and Morlon Lee, CBET; BMET IIs Dan Mulvihill, Lucas Varnedore, Doug Smith, Cortney Porter and Bron Palmer; BMET Is Katelyn Reynolds and Allen Dunsmore and Secretary Rita Bowen. “The Children’s of Alabama HTM department supports one of the largest and busiest children’s hospitals in the nation with 332 beds and 48 NICU bassinets. The department supports the entire hospital, clinics with about 37 service lines, (14) offsite pediatric practices and an outpatient combination surgery center, imaging center and primary care clinic center,” Knight says. Service contracts are a coordinated effort, working in combination with several departments including supply chain, risk management and the biomedical engineering department. “The system is a combination of electronic and paper signatures with a wet signature from the COO to finalize the contract,” Knight says. The team provides the hospital

with several services including biomedical technology and clinical engineering. “We have developed a device management committee which includes IT security, IT network services, HIPAA IT, risk management officer and facilities department to ensure medical equipment is safe before it is approved for purchase,” Knight says. He says that the department has worked closely with IT to develop customized alarm systems for medical equipment which integrate the nurse call system, clinical staff Voalte phones and medical record data. “We have been the primary resource for testing and data collection of alarm systems to help reduce alarm fatigue with the clinical staff,” Knight adds. The biomeds also lend their skill sets to assist with surgical video systems integration setup and troubleshooting – which are usually a combined effort with IT. CONTRIBUTING TO HEALING The team has been involved in a number of special projects including

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SPOTLIGHT Kelvin Knight is the director of biomedical engineering at Children’s of Alabama.

one that helps four-legged therapy companions acclimate to life in a hospital. “Children’s of Alabama donated a simulation room to Hand in Paw, a local nonprofit company, that specializes in training animals for animal-assisted therapy. Hand in Paw brings therapy animals to the hospital to visit patients routinely,” Knight explains. He says that the biomedical engineering department was instrumental in outfitting the animal training simulation room with medical equipment reflective of a typical Children’s Hospital patient room. “Equipment was donated and set up with the sights, sounds and smells of a hospital room. A special digital recording was made to duplicate the sounds of medical equipment running and alarming to help the animals become accustomed to sounds they will hear in a hospital setting,” Knight says. In addition to helping four-legged therapy animals become accustomed to the hospital environment, the team was addressing the PPE shortage problem and helping clinical colleagues from the start of the COVID-19 pandemic. “The Children’s of Alabama Biomedical Engineering Department worked with other departments in the hospital to build a system for reprocessing N95 masks using UV lights during the early stage of COVID. This system is still being used today,” Knight says. “The Children’s of Alabama Biomedical Engineering Department has provided the simulation center with 3D printing of various body parts for training clinical staff. A 3D head was printed to help staff learn proper COVID swab technique,” Knight adds.

He says that the department has worked closely with performance improvement and clinical departments for developing and testing of software processes for alarms being sent to the clinical staff’s mobile phones. Another project the team tackled was to create a way for the clinical staff to display patient waveforms on large screen TVs for special procedures in critical care rooms. “The department provides medical equipment to the city of Birmingham for their ‘Doctor Day’ event. This event allows children throughout the city to have access to medical care assessment,” Knight says. Along with projects, the group has contributed to problem-solving through its collective expertise. One example was when the department identified a problem with EKG cart connectivity in a new building. “The EKG carts had intermittent connectivity on two of the ten floors of the new building. After weeks of troubleshooting and verifying operation of the wireless EKG carts and access points, the problem was identified as the EKG cart antenna was mounted to the bottom of a metal plate on the cart. The carts were having trouble connecting to overhead access points. The carts usually connected to access points on the floor below the cart,” Knight says. The team discovered that the problem was two of the floors in the new building did not have access points on floors below, and the carts

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

had trouble connecting to overhead access points. “The EKG cart connectivity issues were resolved by replacing the metal plate of the EKG cart with a piece of plastic. The EKG cart antennas have been able to reliably connect to the overhead access points since the plastic plates were installed,” Knight says. Other efforts have included creating unique mounting solutions for care panels and splitting alarm signals from pulse oximeters for nurse call connections as well as Voalte phone notifications. The team’s efforts extend beyond routine biomed activities and include involvement with the larger biomed community. “As a hospital, we are involved with AAMI and are starting to become more involved with the ACCE. We have worked with other hospitals to organize a state HTM organization,” Knight says. For the youngest patients in Alabama, the confidence that medical devices will perform as expected can be credited to the hard-working biomedical engineering team at Children’s of Alabama.

JULY 2021

TECHNATION

INDUSTRY UPDATES

NEWS & NOTES

Updates from the HTM Industry 2021 HTM MIXERS PROVIDE EDUCATION, NETWORKING The proverb “necessity is the mother of invention” proved true once again in 2020 as MD Publishing introduced HTM Mixers as a means of connecting industry leaders in smaller, safer conference-like setting amid a global pandemic. HTM Mixers are back in 2021 as MD Publishing teams up with state and regional associations to host events in Milwaukee, Wisconsin and Kansas City, Missouri. The first HTM Mixer, think of it as a smaller MD Expo, will be held July 14-15 at the Hyatt Regency Milwaukee (333 W Kilbourn Ave., Milwaukee, WI 53203). The Wisconsin Biomedical

Association (WBA) is once again lending it support to help provide a venue for HTM professionals to meet in person and discuss industry trends. The second HTM Mixer is set for Kansas City his September and is supported by a trio of regional associations in the Gateway Biomedical Society, HTMA-Midwest and Heartland Biomedical Association. The HTM Mixers feature top-notch educational opportunities, an exhibit

hall and superb networking opportunities. Each event is free for hospital employees, students and active members of the U.S. Armed Forces. Find out more information and register at HTMmixer.com.

ONESOURCE ANNOUNCES NEW GENERAL MANAGER oneSOURCE Document Management Services, an RLDatix company, announced that Lindsay Frkovich-Nelson was named general manager after nearly a decade with the company. Frkovich-Nelson will lead a team in developing platforms and databases that solidify the company as the leader in patient safety, risk management, and medical and dental compliance. Working directly with the RLDatix executive team, the general manager is set to lead the entire oneSOURCE organization and will play a critical role in business growth and continuing to bolster key partner relationships. “As a long-time member of the oneSOURCE family, I’m honored and ecstatic to lead the charge in this new position,” said Frkovich-Nelson. “My goals in this position include positioning oneSOURCE as the one and only must-have resource for maintaining compliance through a variety of health care sectors – dental, surgical, facilities maintenance – and continuing to develop cutting-edge programs that expand oneSOURCE’s market leadership status by leveraging the power behind the RLDatix portfolio.”

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Throughout her career in sales and marketing, Frkovich-Nelson’s deep understanding of oneSOURCE’s mission has proven to be beneficial in creating an efficient approach to product development and deployment. Along with her mastery of partnerships and sales, she has the innate capabilities to aid in the strategy of creating a seamless platform with an emphasis on patient safety. “Lindsay has served as an integral part of our operations since 2012 and, after working with her year after year, I’m proud to see her excel and advance within our organization,” said Heather Thomas, chief marketing officer. “Lindsay’s commitment to pushing oneSOURCE forward as a commanding voice in the healthcare management industry, while producing partnerships with industry pioneers is phenomenal. She is truly an asset to our team and we look forward to supporting her in this next phase.” Frkovich-Nelson brings 10 years of experience in sales, marketing and business development to this role. For more information, visit onesourcedocs.com.

JULY 2021

TECHNATION

INDUSTRY UPDATES WORLD’S LARGEST CIVILIAN HOSPITAL SHIP PASSES FINAL SEA TRIALS Mercy Ships announced that the Global Mercy has now completed deep water sea trials, one of the final milestones in the countdown towards the hospital ship’s delivery, equipping, maiden voyage and launch into service to sub-Saharan Africa in 2022. Deep water trials are designed to test the vessel during extended sailing time to ensure that all systems are fully operational and in line with strict standards and specifications. Tests include engine performance and fuel consumption, navigation and radio equipment, emergency systems, speed tests, maneuverability, engine, and thruster tests as well as safety evaluations. “These deep-water trials represent a critical checklist before delivery of our new purpose-built ship to become the platform for service it is designed to be. Trials systematically test operational aspects by putting the vessel through paces for an extended period at sea. I am pleased to say that the Global Mercy successfully passed every test,” stated Jim Paterson, marine executive consultant for Mercy Ships. “We are then left with some finishing touches in the interior, particularly the hospital area before we take delivery.” Robert Corley, chief operations officer, confirmed that after Mercy Ships takes final delivery of the vessel, the ship will make its maiden voyage to Belgium as a guest of the Port of Antwerp. While docked, the Global Mercy will complete several months of final outfitting and crewing. This includes installation of medical equipment and IT systems as well as stocking the vessel with

supplies through the Mercy Ships European Distribution Center in the Netherlands. The visit to Europe will culminate in a final send-off from Rotterdam for the ship’s first voyage to Africa. Mercy Ships also plans to hold an Africa commissioning event for the arrival of the Global Mercy in Dakar in early 2022, at the start of the ship’s first field service in Senegal. The purpose-designed hospital decks represent the unique heart of the ship, consisting of six operating theatres and hospital wards for 200 patients, laboratory, general outpatient, ophthalmology and dental clinics. The ship has space for up to 950 persons in port including 641 crew, comprised of volunteers from around the globe. The Global Mercy is especially equipped with first-class training facilities to allow Mercy Ships to contribute to the sustainable support of essential surgical and related skills for local health care professionals when docked. Mercy Ships expects to more than double the charity’s current impact with both life-changing surgeries and training of health care professionals during the anticipated 50-year lifespan of the vessel. The Global Mercy represents an international collaboration. With an overall length of 174-meters, a beam of 28.6 meters, with a gross tonnage of 37,000, the ship is a tailored passenger ship-class vessel.

As the first of its kind, the ship has undergone construction at Tianjin Xingang Shipyard, with project management by Stena RoRo AB of Gothenburg, Sweden, and construction design by Deltamarin of Turku, Finland. The French ship brokerage company Barry Rogliano Salles (BRS) was instrumental in helping negotiate the contract. The new ship is classed by Lloyd’s Register in the UK who was in attendance to witness these important tests. The Global Mercy is flagged by Malta and will initially serve within Africa. As the world’s largest purpose-built civilian hospital ship, the Global Mercy has received wide attention from all over the world from the very beginning of its construction in 2015. The Global Mercy has a design draft of 6.15 meters and a service speed of 12 knots. This new vessel is the first ship built from design to implementation by the charity as all previous ships were adapted from other purposes. The Global Mercy will join the current Mercy Ship, Africa Mercy in service to sub-Saharan and Central Africa.

TRUASSET CMMS SOFTWARE COMMUNICATES WITH FLUKE BIOMEDICAL ONEQA TruAsset CMMS software is continually evolving to meet the ever-changing needs of its customers in health care. As changes occur in the industry, it continues integrating with the products customers are using to streamline the process for HTM professionals. These integrations allow increased efficiency in the preventative maintenance process and solid reporting through the CMMS software. TruAsset has implemented direct communications with Fluke Biomedical OneQA workflow automation software. This integration allows clients of TruAsset and OneQA to

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JULY 2021

automate their preventative maintenance testing by creating procedures in TruAsset and OneQA that will transfer the OneQA testing results to a TruAsset work order with the push of a button. Setting up the integration on both programs can be done in a matter of minutes and clinical engineering technicians can be simplifying the preventative maintenance and documentation process, saving valuable time. For more information, visit flukebiomedical.com/oneqa and truasset.com.

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INDUSTRY UPDATES

PARTSSOURCE EXPANDS EVIDENCE-BASED MARKETPLACE PartsSource has added more than 1 million facilities maintenance and repair products to support clinical engineering and facilities management health care resources. Health care facilities management professionals face similar challenges supporting essential operations and maintenance, found in healthcare technology management (HTM) and clinical engineering. This includes managing the procurement process manually, including relationships with hundreds of suppliers, insufficient quality data, time consuming product searches and limited performance analytics. The result is significant overspending, high variability and staff inefficiencies. PartsSource’s evidence-based marketplace streamlines the procurement process, promoting facilities supply chain reliability and resiliency through: • Curated multi-vendor resource that consolidates a network of OEM and alternative high-quality suppliers across more than one million product options • Value and quality using the industry’s only evidence-based Precision

procurement platform that consistently delivers high-quality, reproducible product quality and logistics outcomes • Spend tracking and enterprise analytics that provides supply chain visibility and monitoring to reduce risk, and better manage supplier performance KPIs and value “Health care is undergoing a necessary digital transformation of its supply chain with the express goal to improve asset uptime and clinical availability as facilities management and clinical engineering maintenance is becoming increasingly mission-critical,” said Philip Settimi, MSE, M.D., president and CEO of PartsSource. “By offering a dedicated clinical resource management platform, purpose-built for facilities management and clinical engineering, our clients are now able to speed the availability of their product or service, with the oversight of specialized product experts and billions of data points to improve the cost, quality, reliability and productivity of their supply chain.” Facilities management and clinical engineering will be able to further streamline the procurement process via PartsSou-

rce’s partnerships with the world’s leading healthcare computerized maintenance management system (CMMS) providers including Nuvolo, Accruent and Dude Solutions. PartsSource integration with CMMS platforms enable facilities management and clinical engineering to manage every aspect of clinical and facilities operations easily and quickly – from following and completing a service request, to managing work orders and data, to ordering repair and maintenance products – on any mobile device, online resulting in improved quality, greater efficiency and cost-savings for providers. “Digitizing the health care supply chain plays a critical role in the delivery of health care, and we share a vision of reduced complexity, increased resilience, and organizational agility,” said Tom Stanford, CEO of Nuvolo. “Our partnership with PartsSource into the facilities market provides our customers with the industry’s most advanced integration and world-class technology to accelerate and better coordinate the future of workplace service management across the enterprise.”

RELINK MEDICAL OFFICIALLY OPENS ATLANTA FACILITY reLink Medical has announced the official opening of its second location in Atlanta’s College Park community. The new state-ofthe-art logistics facility expands the company’s footprint to 140,000 square feet and promises to help hospitals and health care systems turn equipment disposition problems into economic advantages. “Our customers asked, and we’ve delivered,” says Jeff Dalton, CEO of reLink. “The medical community is hungry for an intelligent, consistent and revenue-maximizing disposition solution. Our new Atlanta facility allows us to better support health care providers in the region.” reLink currently works with over 3,000 hospitals and health systems across the country, processing over 10,000 devices monthly. Opening a second location in the Southeast allows reLink to build on its mission to advance health care by ensuring providers have the equipment they need when they need it. The reLink 360 program provides onsite and offsite storage for surge-related needs, inventory management, recycling, capital purchasing, move management and quick access to local

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on-demand logistics. “Our success can be tied directly to our clients,” says Dalton. “We constantly evolve our equipment disposition solutions based on their feedback and work hard to bring hospitals and buyers together in a more efficient way.” Looking ahead, reLink plans to continue its aggressive expansion efforts, investing in staff and additional facilities across the country to help rural community hospitals and sizable metropolitan healthcare organizations alike meet their disposition needs.

JULY 2021

TECHNATION

INDUSTRY UPDATES

FTC EXAMINES ANTI-COMPETITIVE REPAIR RESTRICTIONS In a new report to Congress, the Federal Trade Commission identifies numerous types of repair restrictions, such as using adhesives that make parts difficult to replace, limiting the availability of spare parts and making diagnostic software unavailable. The report’s findings, including that “there is scant evidence to support manufacturers’ justifications for repair restrictions,” are primarily based on responses to the Commission’s requests for public comments and empirical research issued in connection with its July 2019 workshop, “Nixing the Fix: A Workshop on Repair Restrictions.”

The report explores means of expanding consumers’ repair options and how the Commission could assist in that expansion, consistent with its statutory authority. In addition, the Commission notes that it stands ready to work with lawmakers, either at the state or federal level, to ensure that consumers have choices when they need to repair products that they purchase and own. Congress directed the FTC to issue the report, noting that it “is aware of the FTC’s ongoing review of how manufacturers – in particular mobile phone and car manufacturers – may limit repairs by consumers and repair shops, and how

those limitations may increase costs, limit choice, and impact consumers’ rights under the Magnuson-Moss Warranty Act.” Congress specifically directed the FTC to include recommendations on how to best address these problems. The Commission voted 4-0 to authorize staff to send the report to Congress. The report is available at tinyurl.com/y9b9yhcj.

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AAMI UPDATE BY AAMI

BMET APPRENTICESHIP PROGRAM SECURES FIRST OFFICIAL PARTNER The new AAMI BMET Apprenticeship Program is off and running thanks to Jackson, Tennessee-based ReNew Biomedical Services. ReNew signed on with the Association for the Advancement of Medical Instrumentation (AAMI) in April to become its first official partner in the one-of-a-kind program, which combines online and classroom education with up to 6,000 hours of on-the-job learning time. Program partners hire apprentices directly and provide them with training – and paid work experience – at their own facilities. Participants in the two-year program can earn three industry-recognized credentials: AAMI’s CABT and CBET candidate status; and the ITF+ certification. Upon successful completion of the apprenticeship, they also receive a journeyman certificate from AAMI and the U.S. Department of Labor. Program employers, on the other hand, become eligible for grants from the federal government that can offset the costs associated with training. But more importantly, says Mark Taylor, one of the three managing partners at ReNew Biomedical, they gain access to potential “biomed talent” that most would probably agree is in very short supply. “Fortunately for us,” Taylor says, “we’ve been growing exponentially. But hiring has been difficult, to say the least. It’s been hard to find people who even know what HTM is.” ReNew offers biomedical field services in all 50 states. The company has 18 full-time employees, including 13 technicians, and has five vehicles that cover

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JULY 2021

the country serving as mobile biomed workshops. “We literally work on anything and everything except for large imaging machines,” Taylor says. A few years ago, as the company was expanding, Taylor and his partners approached a local community college about creating a trade program for students who were interested in healthcare technology management (HTM). That idea sputtered out when they realized how little people knew about the field, but later they managed to bring it back to life as the “ReNew Biomedical Training Academy.” “We’d contacted AAMI right before COVID to figure out how we were going to reach people,” Taylor says. “And then almost overnight, our problem got even bigger with all the equipment facilities suddenly needed to handle the surge of sick patients.” The academy was created shortly thereafter, with financial assistance from the Tennessee Department of Labor and a curriculum AAMI had just developed for its fledgling BMET Apprenticeship Program. The association’s goal with the program, says Danielle McGeary, CHTM, AAMI vice president of HTM, is to provide anyone who wants to enter the field with the hands-on experience required to get started. “It could be someone who’s ready for a career change, or it could be someone just out of high school. This is intended to bridge that gap to get them the training they need to be successful.” Employers who take part in the program, McGeary adds, benefit from having entry-level workers on their payroll they can train to their equipment and service specialties. “When they’re finished,

if you want them to stay, they’ll already be up to speed – they won’t need retraining.” “To be honest,” Taylor says, “our involvement is self-serving – we’re a business that needs trained biomeds. At the same time, though, programs like this are for the greater good of the future of HTM.” He encourages other employers who may be interested in apprenticeships to contact them to hear more about their experience. More information on how to become a BMET Apprenticeship partner can be found at www.aami.org/training/ bmet-apprenticeship. PARTICULATE GUIDANCE UPDATE DRIVES NEW RISK DISCUSSIONS An overhauled technical information report from AAMI may change how device designers and industry consider risks associated with intravascular medical devices. The extensive 2021 update to the Technical Information Report (TIR) 42, Evaluation of particulate associated with vascular medical devices, comes more than 10 years after the previous version debuted. According to project lead Eleni Whatley, biomedical engineer at the FDA’s Center for Devices and Radiological Health (CDRH), the AAMI document has kept its primary purpose of providing recommendations for determining the source of harmful particulates, establishing particulate limits and defining appropriate test methods to achieve these goals. However, the new version also thoroughly explores clinical risk assessment. “By providing much more specific details and in-depth discussion points about the benefit-risk analysis, the TIR is

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INDUSTRY UPDATES

Operate Efficiently, Perform Real Time, Simplify Compliance

enabling individual manufacturers to take their specific device and their specific treatment scenario and consider strategies to lower risks related to particulate introduction into the vascular system,” Whatley said. TIR42:2021 focuses on intravascular medical devices – those that are used within a blood vessel – as opposed to long-term implants such as pacemakers. This latter group of complex implantable devices have their own standards, but the acute tools and devices that facilitate the surgeries to implant permanent devices also come with their own risks that should be accounted for. If any one intravascular medical device sheds particulates into the bloodstream, it can be a serious and unforeseen threat to a patient. The AAMI working group that developed the updated TIR was co-chaired by Dinesh Patwardhan, material scientist at CDRH, as well as Terry Irwin, a distinguished quality engineer with 25 years of industry experience. “Over the last 10 years, there was a significant advance in these kinds of technologies. The benefits versus risks for each have to be thoroughly evaluated by the industry and by reviewers,” explained Patwardhan. “Because these technologies are changing, it becomes important to figure out where to draw the boundary. A ‘catch all’ standard may have limited utility for stakeholders, so this TIR includes very specific criteria for what this document and these methods apply to.” For example, the document touches on specific benefit-risk analysis scenarios for particles from intravascular catheters or guidewires but will not account for the risks posed by particles from the operating room, such as lint from a gown or gauze. And while the document could not outline specific particulate limits due to the vast number of different devices, diseases, and vascular territories, it does include a comprehensive discussion for how individual manufacturers can go about developing these specifications. According to Cliff Bernier, director of standards at AAMI, it is thanks to the contributions of a diverse cast of professionals – including physicians, researchers, industry and regulatory representatives – that the updated document can build upon existing knowledge while also providing a new level of clarity. “If somebody who is not 100% familiar with particulate assessment takes a look at this technical information report, it is written in a way that they can still follow,” he said.

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ECRI UPDATE

Don’t Overlook Third-Party Software Vulnerabilities When Assessing Medical Device Cybersecurity

t’s a nightmare scenario for hospital administrators and health technology managers: A ransomware attack locks the facility’s data, disabling information systems and disrupting hospital operations. Successful cyber attacks can have far-reaching effects on patient care and staggering financial impacts. Avoiding that scenario (and preventing sleepless nights) requires a robust cybersecurity program. ECRI explored a sometimes overlooked security risk vector – third-party software components that are incorporated into medical devices – as topic No. 7 on its list of the Top 10 Health Technology Hazards for 2021.

Any device that is networked or that processes protected health information (PHI) poses a cybersecurity risk to a health care organization. Ransomware programs and other forms of malware infiltrate a network and propagate through connected devices and systems to wreak havoc, often by encrypting data, disabling user access or otherwise compromising software and IT assets. Medical devices are not immune to such attacks. If security vulnerabilities in these devices are not properly managed, the devices can provide an entry point for malware to infect other assets on the network or could themselves become the source of a safety concern or data breach. In just the past year, ECRI has published more than 50 alerts detailing known security vulnerabilities with specific types, makes, or models of medical devices. Preventing security issues like those from affecting hospital operations requires identifying vulnerabilities on the devices

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JULY 2021

at your facility and then taking steps to eliminate the vulnerability, if possible, or to minimize the risk that it will be exploited in a manner that could cause harm. An added challenge with medical devices is that many include software components from sources other than the medical device manufacturer. Think operating systems (e.g., Windows), network drivers within a device, or other off-the-shelf software components. “Those components may not be well identified by the device manufacturer,” explains Chad Waters, a senior security engineer in ECRI’s device evaluation group. “That makes it hard for facilities to know which of their devices could be affected by a known software vulnerability.” In recent years, vulnerabilities like Urgent11, Ripple20, and SweynTooth, to name a few, have impacted a wide range of medical devices, including physiologic monitoring systems, infusion pumps, and cardiac monitors. Health care organizations also have had to contend with several Microsoft operating system vulnerabilities, including those associated with the end of support for Windows 7. (Software that has reached its end-of-support date poses a particular concern.) For health care facilities, remediating such vulnerabilities is a mission-critical activity – but one replete with obstacles. ROADBLOCKS TO REMEDIATION As third-party software vulnerabilities are disclosed, it can be a challenge for health care facilities to identify affected devices and remediate them in a timely manner. As noted, vendors may not specify the

third-party software components that are incorporated into their devices. But even when such information is provided, health care facilities may not have easily accessible records of which of their devices include specific third-party software. Additionally, health care facilities require information from the medical device vendor before they can remedy a vulnerability. For various reasons though, information from vendors may be slow in coming. For instance, the vendor will need to audit its product lines to identify devices that incorporate the affected software, and then assess the impact of the vulnerability on its products. It will need to validate any third-party patches for addressing the vulnerability, which involves verifying that the patch does not adversely affect the function of the medical device. And it will need to develop recommendations for remediating the problem and communicate this information to all affected customers. “That process can take time,” advises ECRI’s Waters. “But it’s important to wait for the vendor to complete its process.” In addition, health care organizations face practical challenges associated with applying the mitigation in a clinical environment. For example, the affected equipment might be in continuous patient use or delivering life-sustaining therapy. Furthermore, updates may require hands-on access to each device (as opposed to being implemented centrally), requiring time and staffing resources that may be in short supply. And some medical devices may require the support of a field service engineer or application specialist

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ECRI RECOMMENDATIONS ECRI outlines three key activities for addressing third-party software vulnerabilities in medical devices: 1. Assess a medical device supplier’s ability to manage the software on its devices. For instance, ask whether the vendor maintains an inventory of the third-party software built into its devices. This may take the form of a Software Bill of Materials (SBOM), which is an “ingredients list” of software components that are incorporated into a product. Also ask about the vendor’s vulnerability disclosure procedures, and how the company communicates issues with its customers. 2. Obtain security information for the devices in inventory. The vendor’s Manufacturer Disclosure Statement for Medical Device Security (MDS2) form for the device will provide much of the information you need. ECRI recommends requesting the 2019 version of this standardized form, which incorporates much more information than previous editions. An SBoM, if available, would also be useful, as would details about the operating system (including whether it is nearing its end-of-support date). “SBoMs for medical devices are becoming more commonly available,” an encouraging sign that “we’re moving away from medical devices being treated as black boxes,” notes ECRI’s Waters. “Health care is leading the way in efforts to promote software transparency.” Such transparency will help health care organizations counter growing cyber threats. 3. Use appropriate tools to store and retrieve device security information. Be sure to record medical device security information in an appropriate inventory management system, such as a computerized maintenance management system (CMMS) or other system that can be accessed by both clinical engineering and IT personnel. Facilities may also want to investigate whether an Internet of medical things (IoMT) security solution would prove useful. These solutions discover and identify medical devices that are on your network and, to varying degrees, can identify operating systems.

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to apply any security update or patch. A software vulnerability that is not remedied could allow a medical device to be compromised, which could lead to a degradation or disruption of patient care by causing a device to malfunction or become unavailable. It could even trigger a system-wide security incident (e.g., a ransomware outage). Or there could be a data breach that compromises the security of PHI.

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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 in-depth 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 BK Workstations BY ERIN REGISTER

ruce Kudick’s HTM career started as a driver for a local blood center, doing mobile blood drives. He helped set up for the blood drives, including loading and unloading the truck. “The phlebotomy carts they used were not good,” said Kudick. “They were top-heavy, had fold up shelves that were plastic and broke all the time. Because they were exposed, it was bad to put on a truck to be moved around to mobile drives. It became a mission for me to design something dependable that would be built to last and easy to move around, have plenty of workspace and storage. I wanted a workstation that would be able to close up, load and travel without getting damaged.”

Kudick went to a friend in manufacturing, and they came up with their cart/ workstation. “It’s built to last, too,” added Kudick. “Made from aluminum to keep it light but also strong, the units were purchased by the company I worked for. They have been using them for two years now with no issues. I am proud of what we have done. Best of all, it’s made in the USA and manufactured in Newton, Wisconsin.” TechNation learned more about BK Workstations in a recent interview. Q: WHAT IS THE MAIN FOCUS OF BK WORKSTATIONS? A: My focus was to build the best workstation/cart possible and to make it strong, easy to load and secure on a truck, as well as easy to move around a classroom, warehouse environment or the area of a mobile blood drive. Q: WHAT SERVICES DOES YOUR BK WORKSTATIONS OFFER? A: I have manufactured a workstation/cart for use in the medical, education and manufacturing fields. I also have manufactured a cover to cover the units up for protection when being

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transported or stored. We are now working on making them out of stainless steel, something even better for the medical field. Q: HOW DOES BK WORKSTATIONS STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: I believe my workstaBruce Kudick’s tion/cart is the best on BK Workstations the market, with over 40 inches of work space, four drawers with plenty of storage and swivel-locking wheels for easy movement or locking in place. It’s built to last with very few replacement parts if you ever need any. Q: DO YOU HAVE ANY SPECIFIC GOALS YOU WANT BK WORKSTATIONS TO ACHIEVE IN THE NEAR FUTURE? A: My goal is to provide the best product and to make a product that is worker-friendly. I want it to be easy for a driver to load or unload off a truck, an educator that is using a computer in class to take up and down the classroom rows, the person doing inventory in the warehouse and, last but not least, the phlebotomist working at a mobile blood drive. The possibilities are endless. My hope is to see growth. Pricing of the workstations/carts are on the website. Pricing might change due to shortages of aluminum, but I will do my best to give the best price I can. For more information, visit www.bkworkstations.com

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this approach and the people of First Health have strong HTM/CE and clinical backgrounds to balance the technical know-how we bring to each engagement. When we put risk into a clinical context, the approach is different from pure security firms, creating a unique solution for HTM/CE departments that are challenged with mitigating risk or finding the talent to do so. •

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Key to Ending Imaging Engineer Shortage: AAMI ACI-Accredited Training BY SAM DARWEESH

n recent years, clinical engineering and imaging leaders have been working to mitigate an increasingly alarming issue: the growing shortage of qualified imaging engineers – due in large part to a lack of opportunity for training. Most colleges and technical institutes simply don’t offer degree programs for imaging engineering diagnostics. Existing engineers were likely trained in the military or worked previously for an OEM. The issue is compounded by the long-established practice of hospitals and other facilities to not develop new engineers from within their own ranks. Whether because of liability concerns, tradition or a lack of awareness, a slight bias against promoting from within often exists.

Under ordinary circumstances, this situation would be addressed over time. The industry could evolve to prevent a staffing challenge from becoming a health care crisis, but the pandemic created a drastic drop in imaging procedures that caused many decision makers to lose sight of the problem. Now, thanks to the availability of COVID-19 vaccines, people are beginning to feel safer about resuming normal health care. The growing need for imaging procedures comes as a welcome relief to budget-conscious health care facilities. Unfortunately, the ensuing rise in imaging equipment usage also means more frequent maintenance and repair. When coupled with the shortage of engineers, this creates a

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frightening scenario: inoperable equipment sitting dormant, waiting for vital maintenance or repair. The result? Delays in potentially life-saving procedures for consumers and millions of dollars in lost revenue for hospitals and imaging facilities. TRAINING AND PROMOTING IN-HOUSE PROFESSIONALS There are many in the medical community who are only now realizing the magnitude of the impending talent shortage and searching to find a solution. What they’ve found is a previously overlooked opportunity: training and promoting from within. By identifying team members who want to advance their career, particularly BMETs, managers can assist those individuals in advancing into the engineer role by encouraging them to grow their skills. The potential for heightened job relevance, continuous improvement and increased salary makes it an exciting opportunity. BENEFITS OF UPTRAINING EXISTING STAFF Promoting from within also brings considerable benefits for leadership and the health care organization that go beyond the typical cost savings associated with staffing versus outsourcing. By showing interest in staff development, leaders can expect increased loyalty and decreased turnover. As an added benefit, mentorship, in-house workshops and formal training help encourage team members to climb the organizational ladder.

Sam Darweesh

Vice President of Operations/Chairman of Engineering at Technical Prospects

For facilities that don’t currently have in-house service capabilities, there’s an added bonus: increased speed. When an MRI or CT device goes down, time is of the essence for getting it up and running again. Every hour that’s lost leads to delays in patient care and can cost thousands of dollars in lost revenue. Having an onsite imaging engineer, an in-house inventory of parts and supplies and an ISO with experts who are only a phone call away, all leads to faster repairs and helps ensure the organization’s long-term success, patient satisfaction and profitability. Finding a qualified biomed staff member, as well as an ISO that provides training, parts and expert technical support, is the holy grail of a fledgling in-house service program. CHOOSING THE BEST AAMI-CERTIFIED TRAINING CENTER When searching for training courses, managers should look for AAMI-certified training centers that provide eight

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trustworthy service. For health care organizations, staff certification strengthens the public’s confidence in the safety and capabilities of that facility. It also validates the quality and reliability of imaging team members and the equipment they maintain. This level of professional commitment is easily recognized by patients and coworkers alike, and ultimately leads to a higher level of medical care. PUTTING AN END TO THE IMAGING ENGINEER SHORTAGE The imaging engineer talent shortage poses a significant challenge for the industry, particularly in light of the surge in procedures resulting from the COVID-19 vaccines. Qualified people need to be in place to prevent equipment downtime so patient care continues without interruption. While unintentional biases and academic short-sightedness have made it difficult to secure qualified individuals in the past, the good news is that a more substantial source of potential candidates already exists within the industry – biomedical professionals looking to advance their careers. SAM DARWEESH is the vice president of operations/chairman of engineering at Technical Prospects.

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ealthmark Industries has introduced Light Cord Adapters to its ProSys Instrument Care product line. Designed to connect light cords to a light source for inspection, the Light Cord Adapters assist health care workers with testing the integrity of light cords for intensity of light and fiber optic damage. Simply choose the appropriate light cord adapter, attach to the light cord and secure together. Then, attach a light source to the light cord adapter and secure together, activate the light source and inspect. If any defects or damage are identified, remove the light cord from service. The Light Cord Adapters are offered for the following makes of light cords: Storz, Stryker, ACMI and Wolf. The Light Cord Adapters are available for individual purchase. Available light sources are sold separately. For more information, visit www.hmark.com.

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Experts Share HTM Insights STAFF REPORT

he 2021 Webinar Wednesday series delivers excellent insights from healthcare technology management leaders at least once a month. Attendance continues to increase as more and more HTM professionals tune in for continuing education credits via these free sessions.

EXPERTS EXPLORE COMPLEX INSTRUMENT TESTING A trio of experts presented the recent webinar “Building Quality into Complex Instrument Testing.” The webinar, sponsored by Healthmark, was eligible for 1 credit from the ACI. Healthmark clinical affairs experts Jahan Azizi, Kevin Anderson and Seth Hendee examined the design of several complex medical devices and pointed out why their designs create a greater challenge for processing staff. The session also explored damage to these devices and how the damage may have occurred. Lastly, the program discussed quality processing steps that can be implemented to improve patient and staff member safety. The webinar drew 88 attendees for the live presentation and a recording of the session is available for on-demand viewing. Attendees provided positive feedback via a post-webinar survey that included the question, “What do you like best about the Webinar Wednesday webinar series?”

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“It’s a great help to me to be able to take these webinars and keep up to date on current happenings, without spending a lot of time or money to go out of state. I’m a sole proprietor and leaving town entails leaving my clients without anyone to take care of any problems. I love Webinar Wednesday!” said M. Mortensen, owner, CBET. “The wide variety of topics that are offered on webinars,” answered J. Velazquez, Field Service Specialist 2. “The real-world demonstrations of what to look for and how to overcome the issues,” Senior Biomedical Electronics Technician J. Pleiman said. REAL-LIFE SECURITY AND ASSET MANAGEMENT CHALLENGES The May 12 Webinar Wednesday presentation “How America’s 5th Largest Public Hospital Solved its Security & Asset Management Challenges” by Medigate CEO and co-founder Jonathan Langer, TRIMEDX Vice President of Information Security, Compliance and Disaster Recovery Dennis Fridrich and Executive Director of Technology Tom Beaver was eligible for 1 credit from the ACI. The webinar, sponsored by Medigate, was popular with more than 100 individuals registered. In this 60-minute webinar, the presenters discussed how a health system is working with TRIMEDX and Medigate to create a scalable, security-integrated asset management

platform. The presenters examined the health system’s evolving capabilities, delivered impacts to its overall security posture and how its newly integrated foundation has improved IT and clinical engineering workflow coordination. They also discussed the challenges of connected care delivery and how recent gains in operational efficiency are delivering returns on investment (ROI) that are pushing its program forward. The trio of presenters provided additional information during a question-and-answer session. The webinar was well received and received positive feedback in a post-webinar survey that included the question, “What do you like best about the Webinar Wednesday webinar series?” “Not the run of the mill topics. The ones I have joined are customers sharing real-life experiences, not just vendors (talking heads),” Clinical Engineering Supervisor M. Walker said. “I like being introduced to different equipment, programs and point of views. I really appreciate getting credit to help maintain my CBET certification,” said S. Sirois, BMET III. “The webinars provide me with an introduction to unique solutions that I would otherwise not know anything about,” Vendor Services Manager L. Reynolds said. “I think it provides great information on relevant topics for the CE field. I also like that there is an opportunity for people to ask questions and talk to the

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subject matter expert,” said M. Dowling, associate director. EXPLORING IOMT CYBERSECURITY The presentation “Navigating the World of IoMT Cybersecurity” presented by Cynerio Senior Director Alex Masten was eligible for 1 credit from the ACI. The session was sponsored by Cynerio. Masten, a cybersecurity and IoT risk management expert, discussed how HTM professionals can secure medical and IoT devices to reduce organizational risk relative to patient safety, data confidentiality and device availability. He reviewed health care IoT cybersecurity trends and IoT security challenges. Masten also shared what other health care organizations are doing to solve these challenges and some best practices for solving health care IoT security challenges. Masten shared additional insights during a question-and-answer session immediately following his presentation. One question was, “How are the MDS2 forms used exactly?” “There’s a few different ways that the MDS2 forms can be used. For the most part, it’s kind of checking the box of understanding the security capabilities of the devices that are coming onto your network,” Masten explained. “But that information is similar to what you may see in a vendor security questionnaire that goes out to a services provider vendor, or a vendor who’s going to be doing some kind of a SaaS tool for your organization.” “The MDS2 form is kind of that level of assurance that helps you understand the security capabilities,” he added. “So, organizations will collect those as a part of their procurement and their IT security, due diligence process for bringing on new devices. Now, a lot of the information in there is really just used, again, to understand the security capabilities. But there are some good nuggets of information.” He said one example of how to use the forms is that some devices will allow you to install your own antivirus software.

The question-and-answer session included more great information and is included in the webinar recording that is available for on-demand viewing at WebinarWednesday.live. Attendees provided positive feedback regarding the webinar via a survey. The survey included the question, “How well did the content that was delivered match what you were promised when you registered?” “Provided lots of great materials,” said. J. Jones, operations manager. “Yes, the presentation was very informative. Cyber threats are becoming a serious issue in the health care industry. I appreciate what you do to find weaknesses and solutions to prevent them,” said B. Hayes, CBET. “Very well and was very helpful for my evaluation of our plan,” Clinical Engineering Manager M. Woods said. “Interesting topic for cybersecurity – especially segmentation factors,” said R. Maddox, manager.

More than a 100 people attended the live presentation, and a recording of the session is posted online for on-demand viewing. Many of the attendees participated in a question-and-answer session following the presentation. The webinar received positive feedback via a post-webinar survey that included the question, “How much new information did you receive from today’s webinar?” “Enjoyed hearing their approach to the subject matter and was excited that they are trying to engage kids into our field,” Site Manager S. Wright said. “Good ideas for partnering with schools to develop a pipeline for new graduates to enter the workforce,” HTM Chief J. Patterson said. “I enjoyed hearing about the collaboration with the educators,” Biomedical Engineering Director K. Knight said.

CROWDSOURCING BMET EDUCATION The April 28 webinar “Crowdsourcing BMET Education: Why the Future of HTM Education Requires All Hands on Deck” was presented by Dr. Ashlee Spannagel, dean of career and technical education at Southeastern Community College (SCC), and Monty Gonzales, president of the College of Biomedical Equipment Technology (CBET). It was eligible for 1 credit from the ACI. Spannagel and Gonzales provided an overview of the challenges facing existing, traditional biomedical training programs. They discussed the value of the programs to potential students, industry partners and the profession made possible through creative and innovative educational partnerships. They also identified training opportunities to credential existing professionals in the industry and provided a baseline, entry-level training to promote the profession to the emerging workforce. In addition, they provided an explanation of the future of education from an innovative lens focused on supporting the future of the industry.

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I am having an intermittent error #157 that comes at the end of the scan and while the tech is getting the patient out of the bed. Has anyone had this error before? I checked all the cables from the SEM to motor drivers, all good. Is there anything else that I am missing?

On which axis is it occurring? Since you have already checked the cables, I would look at either the SEM PCB or the driver. Reply: Every time the error comes up it has a different axis # with it, which makes it very confusing, and I don’t know which way I should go.

Info on the drivers. The Motion Controllers comprise two drivers: Driver for Table Up/Down, Radial 1 and 2 (and Lateral when Radials are disabled). Driver for Table Backward/Forward and Swivel 1 and 2. No guarantees, but I would go for the SEM board.

My Harmony LA300 is drifting. What can I tighten so the light doesn’t drift? It will get to a certain point when I’m moving it down then just drop the entire way.

Do you see a covering on the arm that is dropping? You’ve got vertical drift, there should be a cover you can remove, maybe halfway up the arm. Pull off that cover and you should see a castle nut, if you don’t, move the arm up until it comes into view. If you don’t have a spanner wrench, you can use an Allen key or screwdriver to adjust it, just put something between it and the hole so you don’t scuff it. SMITHS MEDICAL CADD-SOLIS

Is it possible to deactivate (set the default to “off”) for the requirement for entering a three-digit code when initiating a pre-programmed therapy?

CR doesn’t complete the self-test. It shows error service 2249F.

The error means: 2249F E_CAM_INIT_TOBELTHOMEBACK Reason: Cassette module: Timeout of stepper drive belt Action: Home positioning Meaning: Drive doesn’t reach home position because of any mechanical problems • No stepper power supply • Problems with stepper motor • Problems with home position light barrier • Problems with stepper nodes Cure: Check mechanics • Check stepper power supply • Check motor (connected?) • Check/replace home position light barrier and cable • Check/replace a stepper node Reply: Thanks, I found the problem. One bid belt is broken.

You should be able to change the keypad code from “code” to “key” so programming will be available whenever the latch is unlocked. Go to tasks > adjustadmin settings > enter admin code > Security > keypad security

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ROUNDTABLE

ROUNDTABLE Cybersecurity

ybersecurity remains an important aspect of the work healthcare technology management (HTM) professionals perform. Ransomware attacks are just one way cyber criminals are targeting health care facilities around the world. TechNation invited experts from throughout the HTM landscape to contribute their knowledge and insights on this hot topic in this month’s roundtable article.

Participants in the article are Medigate Director of Business Development Thomas Finn, Accruent Vice President of Healthcare Strategy Al Gresch, Cynerio CEO and Co-Founder Leon Lerman, Asimily CEO Shankar Somasundaram, CyberMDX Chief Technology Officer Motti Sorani, Ordr Director of Healthcare Product Management Benjamin Stock and U.S. Department of Veterans Affairs Biomedical Engineer Connor Walsh, CISSP.

to stay, and as the number of connected devices increases every year, so will the opportunities for attacks. Our devices now are software driven, and all software contains certain vulnerabilities that provide hackers the opportunity to gain access into the device and the network the device is connected to. I am baffled by the number of HTM departments who still haven’t taken a stronger role in cyber risk assessment and mitigation. This is every bit as important, perhaps even more so, than any of the other work we do to keep our patients and staff safe.

Q: WHAT ARE THE BASICS HTM PROFESSIONALS NEED TO KNOW REGARDING CYBERSECURITY? FINN: Improvements to the cybersecurity posture of any health care enterprise require HTM’s active involvement, especially in clinical settings. Good security provisioning cannot occur in traditional HIT vacuums. Front-line security-enlightened workflows must be executed in concert with backroom monitoring capabilities. Asset remediation and mitigation workflows, as well as maintenance and procurement operations, should be coordinated cross-functionally throughout asset life cycles. Getting staff together in times of emergency is not sustainable practice. GRESCH: First, cybersecurity threats are here

Leon Lerman Cynerio

LERMAN: The cybersecurity basics for every HTM professional should include keeping track of connected medical devices with outdated OS/firmware and which devices can be patched and updated. This means keeping a close eye on vendor-issued patches and device utilization patterns. HTM professionals must also foster close alignment with the IT/security team to

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pinpoint when cybersecurity procedures and maintenance can safely be administered on devices without affecting patient outcomes. SOMASUNDARAM: There are a few basic things to know about cybersecurity. Good cybersecurity is both a combination of the right practices to follow in your environment and technology. For example, if you are plugging in unscanned external drives into your devices, you might infect your device irrespective of how good your technology is. So, ensure you are following good cyber practices and processes, as well as adopting the right technology. There is no magic bullet to cybersecurity. Everything makes your security posture better, so this is a continuous improvement process. Cybersecurity will not change overnight. Educate your teams and your management that cybersecurity improvements will need investments and efforts over time to minimize the risk in the environment. SORANI: The first thing to realize is that cybersecurity is not only a technical imperative, but also a business one. Poor cybersecurity has the potential to impact patient safety, data security and financial and reputational stability. It needs to be viewed as a major factor in each part of the medical device life cycle: from pre-purchase, to procurement, device onboarding process, ongoing risk management, maintenance, and device decommission – proper cybersecurity protocols need to be taken into account to protect medical institutions from both potential patient care issues as well as the financial implications of ransomware and other attacks.

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ROUNDTABLE STOCK: Outside of basic knowledge of IT systems and hardware, a good understanding of networking, including the basics of NAC and firewall management, would be a great start. In addition, knowledge of risk management strategies, the NIST 800-53 security framework and CIS benchmarks will go a long way.

Today, medical device and health care IoT cybersecurity is a growing market niche with technologies that evolve to meet the challenges posed by advances in medical devices and cyber threats.

STOCK: Keeping an inventory of devices has been something HTM professionals have been doing for years, but knowing what they are doing and who they are talking to is relatively new. IT has had active scanning tools to provide this information for many years, but it has only been the last three years or so that we could passively get this information for medical devices. With this information, profiles can be built to monitor and protect devices previously left wide open or with minimal controls.

WALSH: The CIA triad is the foundation of all cybersecurity and its fundamental concepts should be understood by all HTM professionals. Applying these ideologies to all medical system procurement, installation and sustainment will ensure unnecessary risk is not introduced into medical facilities. Q: WHAT ARE THE LATEST DEVELOPMENTS IN CYBERSECURITY? FINN: Actionable levels of visibility and delivered automation are not only eliminating outdated manual routines but also driving workflow convergence across HIT and HTM. The resulting operational efficiencies have elevated the profile of HIT and HTM staff by strengthening their ROI missions to the enterprise. Specific new developments include: • Automation of network policy baselines • Automation of remediation instruction sets • Identity-based scanning (“scanning orchestration”) • Hybrid MSSP models GRESCH: The increase in the sophistication of hackers, which have mostly moved from individuals motivated by testing their own abilities to the level of terrorism and organized crime. These groups are more financially and politically driven. Not only can they more easily identify the pathways into the network and/or devices, but they have also figured out ways to thwart incident response and recovery efforts. This further increases their opportunity to hold a health care system hostage and extort money in the form of ransomware. LERMAN: As the need for medical device security has become clear, health care-specific cybersecurity technologies developed to ensure service continuity, data integrity and patient safety have broken into the market.

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all of the various tasks, including creating the inventory, assessing the cyber risk, applying mitigation and remediations and getting compliance alignment reports. These technologies enable a proactive approach to secure medical devices.

Shankar Somasundaram Asimily SOMASUNDARAM: These are some of the latest developments in cybersecurity There have been a number of solutions which have developed including Asimily for inventory, cybersecurity and operational management for medical devices. In addition, some solutions also go deeper into aspects like vulnerability management to better prioritize and mitigate vulnerabilities which otherwise would require extensive and expensive segmentation or blocking. And finally, a solution to automatically assess and pre-emptively mitigate risk of medical devices at procurement has emerged allowing health systems to incorporate security into the procurement of the device. SORANI: Securing connected medical devices is a challenging task, due to the myriad of device types and vendors, unique protocols and manual actions, which are resource intensive along the life cycle. Consider that the average hospital has thousands of devices they need to be secure, and the scale of the task becomes clear. I would say that latest developments are centered on helping healthcare delivery organizations (HDOs) keep pace with the growing scale of their networks and connected devices. New technologies now exist to automate some or

WALSH: The FDA just took a major step forward in prioritizing medical device cybersecurity by appointing the first ever director of medical device cybersecurity. Additionally, new developments in the Solarwinds Sunburst case are popping up, as most recently the North American Electric Reliability Corp. (NERC) stated that about 25% of all electric utilities on the North American power grid downloaded the affected software. The exploit continues to appear as one of the worst cyber-breaches in U.S. history. Q: WHAT ARE SOME MEASURES BIOMEDS CAN USE TO ENHANCE A FACILITY’S CYBERSECURITY MEASURES? FINN: Most fundamentally, biomed leadership should insist that the tools used by their staff members and the tools used by their peers in HIT share the same data. A common, shareable foundation is key. For example, that HIT professionals would be using a CMDB where the underlying data are not synced with the CMMS used by biomed is antithetical to good security practice. The efficiencies required to manage the explosive growth in connected medicine cannot be achieved until a single source of truth (a common data foundation) is well-orchestrated and synced across the asset management and security ecosystem. GRESCH: Having a cybersecurity profile and risk assessment on every connected device

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in your inventory is key. MDS2 information is readily available and, with most modern CMMSs, can be easily consumed from a reliable content management platform. Partner with your IT group to adopt any of a myriad of network monitoring tools, which can also likely be integrated to your CMMS. Push to add a cybersecurity position to your team, as the risks and associated workloads are only going to increase. LERMAN: Close the gap between siloed HTM and IT/security departments. It’s imperative teams distribute responsibility for medical device security between them. This means sharing their expertise in health care industry intelligence to ensure IT/security teams understand the specific behaviors of medical devices and their criticality within the clinical workflow. Sharing this knowledge is critical to building and maintaining operationally safe security programs for any health care organization. SOMASUNDARAM: These are some measures biomeds can tale to enhance cybersecurity: • Assess cyber-risks and incorporate it into your process right at procurement • Understand inventory of your devices • Prioritize vulnerabilities and mitigate their risks • Continuously monitor your environment for risks • Set policies so you are aware when devices are not following expected guidelines SORANI: One way biomeds can enhance the facility’s cybersecurity is by understanding the clinical context of devices. Knowing whether devices carry protected health information (PHI) and understanding what level of criticality the device possesses with respect to patient safety and care continuity is essential in prioritizing response to issues being detected. Some of this domain expertise is augmented by MDS2 documents, and some overlap other processes related to equipment maintenance programs. The other important measure biomeds can implement is ensuring they have a systematic approach to patching, with the help of the vendors. With new

vulnerabilities discovered daily, cybersecurity for any device, but especially medical devices is not a “set it and forget it” task, and instead must be monitored and updated constantly. Having protocols in place and good relationships with vendors to help with patching is an important building block in any cybersecurity framework. STOCK: One of the easiest and most overlooked measures to help an organization’s cybersecurity resilience is physical security. The likelihood of a portable medical device walking out the front door is significantly higher than a data breach and much easier to prevent. Implementing a process to identify, secure and limit the PHI on these portable devices is a small lift with big rewards. WALSH: By relying on the concepts of CIA, biomeds can use due diligence to ensure they are accurately identifying risk of new/ existing medical systems during procurement, installation and sustainment. Additionally, they can exercise due care by ensuring any identified risk is properly documented and mitigated in a timely fashion. Q: WHEN IT COMES TO OLDER EQUIPMENT, WHAT STEPS CAN BE TAKEN TO PREVENT CYBERSECURITY ISSUES? FINN: Legacy equipment is going to be managed based on time-based maintenance interventions and compensating security controls. Good location data, network status and knowledge of how assets are being utilized (which are relevant examples of the visibility data now available) can be used to accelerate/dispatch more appropriate interventions, extend life cycles and inform decommissioning processes. Assuming physical inventory processes have been replaced by real-time digital processes, the detailed security posture of all connected assets should be available, and it should be inclusive of an audit trail of any/all compensating controls. GRESCH: Understand the vulnerabilities and risks associated with that equipment, and be proactive in working with the manufacturer

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and your IT department to mitigate the risks as much as possible. Going forward, leverage MDS2 data to know the risks before you purchase. LERMAN: Closely monitor medical device inventory and employ an AI-powered asset management solution that can automatically identify devices with outdated OS/ firmware and any suspicious behaviors. This includes monitoring and identifying unnecessary or unauthorized communications with third parties (including vendors) or other in-network devices (e.g. an IV pump shouldn’t be able to communicate with an MRI machine). These measures will reduce the attack surface and prevent threat actors from being able to connect with and infect medical devices. SOMASUNDARAM: One key point to understand with older medical devices is that just because they are older or run an outdated operating system does not necessarily put them at risk. There might be some older devices which might be less at risk than some of the newer devices. So, with older medical devices, analyze for which ones the vulnerabilities are critical in your environment. Then for those vulnerabilities mitigate the risks by applying workarounds.

Motti Sorani CyberMDX

SORANI: Older equipment might run unpatchable software, including end-of-life or deprecated operating systems. Without the updates and support from the OS

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ROUNDTABLE provider, they often lack essential cybersecurity controls such as an anti-virus, credential management, encryption, proper authentication, and authorization on one side, and tend to gain critical vulnerabilities over time on the other side. In many cases network mitigation, on the internal network and on the perimeter, is the only feasible solution to control the risk. So, the vulnerabilities are still in there, but the likelihood of them being exploited is significantly reduced. The other key would be to ensure you have proper segmentation. Because you often cannot replace the older operating systems, being able to segment or isolate a device, or group of devices, in the case of a breach is critical. This will allow you to prevent the attacker from moving laterally within the network and will limit the potential damage and downtime for the network.

when it comes to older equipment, accurately identifying and inventorying this equipment is the first step. This will give visibility and help plan for future upgrades. If the system holds PHI/PII, ensuring it is located/stored somewhere not accessible to public access. VLAN segmentation and isolation from the production hospital network is also necessary. Confirming that any data on the system is properly backed up in case of equipment failure is another step that can be taken. Q: WHAT TRAINING/EDUCATION DO CLINICIANS NEED TO PREVENT CYBERSECURITY ATTACKS? FINN: Value-based care is driving connected medicine. And connected medicine is driving a revolution in care delivery. Care protocols will continue to fragment, and cybersecurity controls will ultimately rationalize around protecting the connected patient. That means, both patient-facing and non-patient-facing health care professionals are going to have to stay on the same “security page.” Continuing education is essential, as all workflows are going to be impacted (directly or indirectly).

Benjamin Stock Ordr STOCK: Due to the volume of older equipment with unsupported operating systems found in the health care environment, it is essential to do risk assessments to identify those devices that are the most vulnerable. After establishing a risk tolerance level, any devices over the acceptable risk level should be protected by implementing compensating controls such as NAC or isolated with a firewall. WALSH: This is a tough question to answer, as each medical system is unique and determining what controls to apply to mitigate the risk would require in-depth analysis. However, generally speaking,

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Al Gresch Accruent

GRESCH: Incidents of clinical staff using medical device workstations for purposes other than their intended use has represented a huge risk. Getting them to understand the implications of that activity will help mitigate those risks. The use of portable USB devices also is a major source of risk. Again, training staff on the risks this

activity represents can reduce the risk. LERMAN: Training on cybersecurity best practices, plus an in-depth explanation of how cyberattacks like ransomware can affect medical device functionality and disrupt clinical workflow, ultimately leading to negative patient outcomes. Cybersecurity training should also include patch management and how to best utilize MDS2 forms. It’s also best for training to include a high-level explanation of network security to provide insight into medical device connectivity and devices’ relationship with the threat landscape. SOMASUNDARAM: Clinicians need two levels of training. Training to understand how to practice good cyber hygiene. For example: being careful with USB sticks of external hard drives, not opening email attachments from unknown sources, not sharing passwords on social platforms, etc. Many times, attacks stem from human errors and knowing what not to do is important to prevent cybersecurity attacks for the organization. Training to understand basic terminology in cybersecurity and networking. E.g.: Anomaly versus Vulnerability, What is a firewall?, etc. Clinicians don’t need to know the details but having a broad understanding of cybersecurity will make them aware of events around them and help them understand and appreciate the actions needed or taken to protect medical devices. SORANI: Training is key in promoting the cybersecurity culture and improving the bottom-line outcomes for hospitals. For the cybersecurity professionals within the hospital, it starts with getting familiar with the threat landscape and the common cyber risks found in medical devices. It continues with learning the industry’s standards and best practices for risk management including common security controls, possible remediation and mitigation options, and corresponding processes. Preparing for a security incident is important, including understanding how incidents are detected, managed and the role of the HTM professional in this process. STOCK: Clinicians should be required to take

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ROUNDTABLE annual educational sessions to help them identify phishing and malicious emails. They should also have a clear understanding of PHI and PII and the proper handling of both. WALSH: In any organization, employees are considered the “weakest link” when it comes to cyberbreaches. Due to this fact, security awareness training is extremely important for clinicians. Phishing campaigns are on the rise, and clinicians that can accurately identify these malicious emails/phone calls/texts is essential. Additionally, during EOC rounds, ensuring they are aware of any HTM department’s developed cybersecurity policy is important, such as vendor escort/access, USB scanning, hard drive removal and preventative maintenance policies. Q: WHAT ELSE DO YOU THINK TECHNATION READERS NEED TO KNOW ABOUT CYBERSECURITY?

Thomas Finn Medigate

FINN: We tend to view cybersecurity through the lens of traditional bad actor attacks – and this is wrong. We need to expand our perspective. While we must learn to protect ourselves against the headline grabbing “lightning strikes” (e.g., ransomware attack, data theft, etc.), there are other pressing concerns that should compel our

attention. For example, the operational inefficiencies born of poor collaboration/ interoperability between HIT, HTM and finance must be treated as enterprise risks, as they are far more prevalent and no less dangerous to patients. Connected medicine is driving a revolution in care delivery. The underlying management processes can’t just try to keep up – they must get ahead. GRESCH: Expect that for the remainder of 2021 and into 2022, cyber-attacks are going to increase. Unfortunately, the bad guys haven’t been sleeping through this pandemic. In fact, a weakened workforce has only served to increase their opportunities. LERMAN: Cybersecurity can’t be achieved by one person or by one, simple IT security solution. It takes coordination between team members and a healthy combination of AI and human health care industry intelligence to achieve real and lasting cybersecurity in health care environments that ensures operational continuity, data integrity and patient safety. SOMASUNDARAM: You should not think of cybersecurity as a three-month or sixmonth problem. Cyber-attacks are evolving and are here to stay. So, whether you are looking for a solution or implementing a new process or hiring someone to manage cybersecurity, take a longer-term view on how this would enable you to better manage cybersecurity. E.g.: If choosing a solution, ask if the vendor has a roadmap and is continuing to improve its capabilities. When implementing a process, ask if the process is going to scale as more needs arise. When hiring a person, ask if the person is going to be able to take more responsibility. At the end of the day, a long-term view is critical. SORANI: Cybersecurity in health care is a collaborative effort across the HTM, security, compliance and IT teams – with the support and understanding of management. Even if your direct title isn’t “cybersecurity professional” you still play a major

role in the process. IT, security and biomed teams must work together to ensure that the right devices are purchased, that they are on boarded correctly, patched in a timely manner when needed and ultimately that proper cybersecurity practices are followed during the lifetime of the device. Cybersecurity teams can establish all the guidelines they want, but without the participation of the other actors within the hospital they will be fighting an uphill battle. STOCK: With the vast number of vulnerable devices and external threats facing a modern health care organization, cybersecurity can seem like an impossible task. It is important to have a risk management strategy that considers the vulnerabilities and threats and the likelihood of exploitation. Identifying the highest risks and tackling them first creates a more manageable situation and makes the most significant impact on your overall security profile.

Connor Walsh, CISSP U.S. Department of Veterans Affairs

WALSH: Last year alone, there was over a 50% increase in cybersecurity breaches against medical facilities. Threat actors are targeting hospitals more and more, and cybersecurity is going to continue to play a vital role in the average HTM professional’s job function. Taking the time to self-educate on basic principles of cybersecurity will go a long way in protecting each medical facility.

For an informative video on cybersecurity, visit 1TechNation.com/roundtable and select this month’s article! EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

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Medical Device Servicing Community

Up dat e By K. Richard Douglas

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n any given hospital, on any given day, the servicing of medical devices may be carried out by in-house technicians, a third-party ISO or an OEM servicing engineer. It is not uncommon to find some combination of these service providers working in tandem to keep equipment maintained, calibrated and repaired.

A question that has sparked tension in recent years is the contention, in some quarters, that only original equipment manufacturer (OEM) servicers can provide safe and effective servicing of the medical equipment produced by their companies. The question of who can provide competent and reliable servicing of medical devices gained further traction in 2016 when the FDA opened a “docket” requesting comments from the servicing community, including OEMs. The docket was later followed up with an FDA public workshop titled; “Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers, October 27-28, 2016.” What the FDA took away from the input of the many stakeholders in the medical device ecosystem was that there were opposing views on the safety, quality and effectiveness of the service provided by OEMs and third-party service providers. Later research by the agency seemed to provide assurance that there was not a compromise of safety when a non-OEM technician provided service and that the service provided by non-OEM service technicians is critical to the functioning of the U.S. health care system. This was published in a report by the FDA in May of 2018 titled: “FDA Report on the Quality, Safety, and Effectiveness of Servicing of Medical Devices.” Included as a footnote in the report, the FDA stated: “CDRH (Center for Devices and Radiological Health) has committed to establishing ‘Collaborative Communities.’ The hallmark of a Collaborative Community, is a continuing forum where public and private sector members proactively work together to solve both shared problems and problems unique to other members in an environment of

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trust and openness, where participants feel safe and respected to communicate their concerns.” As a result, the FDA suggested bringing all stakeholders to the table to discuss this issue, and determine any consensus that was something they were willing to be a part of. After all, if a regulator is going to issue regulations that have a profound impact on many groups, those regulations should be grounded in reliable and accurate information. It should also be noted that the FDA’s 2018 report recognized that additional layers of regulations would be viewed as “burdensome.” That view may be different today under a new administration and any evidence to reinforce the view that non-OEM service is safe and effective may need to be buttressed through a further demonstration of industrywide standards. The Medical Device Servicing Community (previously, the Medical Device Servicing Collaborative Community) was created to bring together thought leadership to address the concerns of regulators and develop consensus among disparate factions and viewpoints within the medical device community. The procedures and standards developed within the MDSC can also provide assurance to regulators that the highest standards in medical device servicing are utilized among all service-providers and that additional regulations are not warranted. The initial roster of participants in the MDSC included OEMs, healthcare delivery organizations (HDOs), independent service organizations (ISOs) and the regulators. Although all groups represented the most important stakeholders – the patients – the regulators officially took their position. DEVELOPING STRUCTURE AND RULES Outlining its purpose, structure and framework was a primary goal of the Medical Device Servicing Community ahead of determining deliverables. The group’s LinkedIn page states, “The mission of the MDSC is to bring together the community of stakeholders to advance the safety, effectiveness and quality of medical device servicing. Created as an outcome of the FDA report on Quality, Safety, and Effectiveness of Servicing of Medical Devices in May 2019, the scope of the MDSC is to define and

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Servicing Community’s LinkedIn page for review. Those in the HTM community should consider becoming a member of that LinkedIn group. encourage implementation of actions that advance the community’s mission, including, but not limited to: • Develop best practices among stakeholders. • Issuance of white papers and thought leadership papers related to the MDSC’s mission. • Conduct community engagement activities (e.g., conference calls, workshops). • Publicize and periodically report community engagement activities. • Solicit input and feedback via appropriate channels.” The community’s subgroups include: the Standardize Benchmarking, Data Collection, and Analytics (BDCA) subgroup, chaired by Dave Francoeur; the Cross-Stakeholder Education subgroup, chaired by Samantha Jacques; the Best Practices for Servicer Training subgroup, chaired by Dave Anbari; the Best Practices for Quality Management Systems sub-group, chaired by Scott Trevino; and the newer Recruiting subgroup, chaired by Katrina Jacobs. The initial focus of the subgroups was to determine their mission and articulate that into a written mission statement. Because of the disparate sectors that the groups represent, there was the need to have written rules to prevent each from violating antitrust laws and to outline the structure of the work they would perform as a collaborative body. The hoped-for outcome of these subgroups – that bring together representatives from often competing interests – was to benefit patients in the end.

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With the HTM community’s representative before regulators lacking in comparison to the political strength of major medical equipment manufacturers, the sub-groups are developing standards that will strengthen HTM’s case before these bodies. This is the point that Francoeur made in a 2021 MD Expo presentation, which provided an update on what the MDSC was working on. The Training subgroup that Anbari chairs, developed an outline describing the goals of the subgroup titled “Draft Guidance for the Collaborative Community – Technician Training Best Practices.” The subgroup describes its purpose as; “The Technician Training Best Practices Work Group was to identify common best practices for training technicians to perform quality, effective service on reusable medical devices.” The document goes on to say that: “The Medical Device Servicing Collaborative Community believes that there ought to be common best practices for training technicians across all types of service organizations, including original equipment manufacturers, in-house healthcare technology management organizations, and independent service organizations. Medical device servicing quality and effectiveness can be improved by identifying these best practices and sharing them among stakeholders.” The draft guidance the subgroup has set forth seeks input or feedback from the HTM community and all other interested parties. The document will be available on the Medical Device

ACHIEVEMENTS IN A VIRTUAL ENVIRONMENT The MDSC is in the process of ratifying a charter and developing voting processes and procedures, shoring up industry participation and establishing a steering committee. The pandemic has not slowed the forward progress of the sub-groups very much, and they have continued to meet virtually. The steering committee meets monthly as does the entire committee. The leaders of the subgroups dictate how often they meet based on their goals. Francoeur believes that one of the most significant steps could be achieved through a concerted, cohesive effort of the HTM community. There need to be many voices heard in large enough numbers to challenge the OEM representation. Francoeur also believes that the OEM involvement in what was the Medical Device Servicing Collaborative Community bailed out because the effort was strengthening the non-OEM perspective. Those participants included the Medical Imaging and Technology Alliance (MITA), who resigned from the MDSCC in June of 2020, Philips, who left the group in June of 2020 and AdvaMed, who also left at the same time. Francoeur says that there have been some substantive developments in what the MDSC has achieved despite the restrictions caused by the pandemic. “We have added a new subgroup being led by Katrina Jacobs that she and her team have labeled as Recruiting. They are doing an awesome job creating criteria, establishing guide-

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lines and finding individual groups that would be willing to fill the vacant seats of the steering committee. To date we need additional participation/ representation from organizations, end users and OEMs,” Francoeur says. He says that the Training subgroup has created a draft guidance tool that they intend to be posted (online) shortly, with the intention of having a comment period in an effort to make sure everyone has an opportunity to weigh in. “The committee has taken the approach that we are developing guidance that can be used by any medical device servicer (OEM, ISO or in-house). Internally this document has been vetted and now we’re seeking wider input on feedback,” says Samantha Jacques in describing the Training subgroup’s draft guidance. “Education has created a tool that was initially intended to be used internally to ensure everyone within the MDSC was working from the same perspective as it relates to who we are and what each entity represents. It appears it will have much greater value and further reach as it has been met with great response to the HTM community at large in terms of definitions and explanations as to whom and what we are. It’s still in the air as to if this document would go to public comment as well,” Francoeur says. That “further reach” was part of Jacque’s subgroup’s focus with their recent work. “The goal was to develop some education so that each constituent group (OEM, ISO, in-house, government/regulatory and users/customers) can understand each other’s perspectives around medical device servicing,” Jacques says. “It covers the role of each constituent in servicing, the value each brings to the ecosystem, the regulatory burdens that each team faces as well as pain points from each constituent’s point of view. The theme — and

take-home message — is that the ecosystem needs all these players and we need to work together to ensure safety and quality in the medical device servicing ecosystem,” Jacques adds. Jacques says that the MDSC is also working with AAMI to incorporate more work out of the groups into existing AAMI Standards groups. “For example, there is a team working on QMS standards that align well with a new initiative AAMI has – ISO 5137 – Good Engineering Maintenance Management of Active Medical Devices,” she explains. Of the QMS group, Francoeur says the group’s role from establishment was, by working with several different existing QMS, they would define which components are best suited for the industry and attempt to provide a draft working document that the industry could use as a reference in an effort to demonstrate their desire to perform safe/quality maintenance of medical equipment. “They are doing a great job of working through the details,” he says. “Lastly, would be the Key Performance Indicator (KPI) sub-group; to date they have established the list of KPIs that they feel would best provide data/information that could be used as evidence of an effective program where you as an individual and/or organization could use these to demonstrate that you are providing safe/quality maintenance of medical equipment,” Francoeur says. GATHERING INPUT; STRENGTHENING NONOEM RESOLVE Francoeur says that it is important that the totality of the useful resources coming out of the MDSC effort can be channeled in a way to give the HTM community a unified voice when new laws and regulations are being considered. Francoeur points out that the OEM community has the means and the resources to lobby lawmakers. “First, in an effort to be as inoffen-

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sive as possible, I would probably state that to ensure everyone is made aware of the opportunity, and to ensure all sides are having as much as possible of an equal voice to speak and be heard, I’m attempting to utilize the industry platforms to educate the HTM professional, regardless of their employer, so they can at least be aware, informed and have the ability to participate at the level they feel best suits them and their concerns. At the end of the day, every person that walks into a health care facility deserves the right to have safe/quality medical equipment for their needs,” Francoeur says. He says that finding the most effective ways to make that happen is what should be the most important topic/issue for all of us. “My comments, when I speak to this opportunity, are with the intent in some small way to share what’s going on,” Francoeur says. He says that among the dozen or so presentations he has given on this topic to 100 or so individuals sitting in the room each time, when asked who knows what’s going on, the largest response yet was a handful or so of individuals. He says that most of those individuals had sat in one of his previous presentations. “This concerns me; based on the fact we are a small community in the first place,” Francoeur says. Regarding the work of all the MDSC sub-groups, Francoeur says; “Wonderful progress is being made.” The training tool developed by Enbari’s, sub-group, can standardize an approach to training that will defend against any OEM assertions that there is a mishmash of training approaches. To view this discussion or keep up with the latest developments with the MDSC, follow the group page on LinkedIn at linkedin.com/ groups/12529335.

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CAREER CENTER

How has the term ‘culture fit’ evolved during the COVID-19 pandemic? BY KATHLEEN FURORE

ill you fit in with the culture of the company you’re interviewing with? That has been a topic of conversation for quite some time, but as COVID-19 upended the workplace and brought remote work to the forefront, the definition of “culture fit” has been upended too.

How has the new work-from-home situation (which is likely to continue in some fashion) changed what companies are looking for when they’re considering if an applicant will be a good “culture fit”? And how can prospective employees be prepared to demonstrate they’re a good fit during an interview? According to the 2020 Employer Branding Study from Hinge Research Institute, those questions are important to answer considering how important culture is to employees and employers alike. “Having a strong company culture is absolutely essential for both evaluating talent and attracting new talent,” says the study. “Cultural fit” is just as important as compensation for 57% of job seekers, and it’s the top criteria for 75% of recruiters, who place it above work history and experience when hiring, the data shows. Anthony Rodio, CEO YourMechanic.com, agrees about the important role culture plays, but he says his definition of what a “culture fit” means during the era of remote work has changed. “When teams all sat in an office together, it was important for people to

Kathleen Furore Need Place of Work

be able to get along. We used to apply the airplane ride test to new hires: ‘Could I sit and get along with this person for a four-hour plane ride?’ “ Rodio explains. “In the new era of working from home, the definition of ‘culture fit’ comes down to whether or not an employee is a self-starter.” So, what does Rodio look for now that managers don’t have the luxury of meeting team members in person on a regular basis? “It’s more important than ever to hire people who are motivated and are comfortable with ambiguity,” he says. “Workers need to have an owner-like mindset, intellectual horsepower, leadership, self-awareness and accountability. Part of the onus is on leaders to foster an environment where employees are comfortable asking questions, but it’s also important to screen for people who are able to ask for help.” What does that mean for prospective employees? What kind of questions should someone interviewing for a

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position be prepared to answer? Rodio says he screens for a problem-solving mindset by asking candidates to describe a time that they stepped up in a situation in which their teammates weren’t pulling their own weight. “I also ask them to describe a time they failed and what they would have done differently ... you can also have workers describe their ideal work culture to get a sense of whether or not independence is something the candidate values,” he adds. “The answers to those questions will tell you a lot about the candidate’s self-awareness, proactivity and independence.” Asking “lots of questions” of the prospective employer during an interview is also key – and Rodio says one of the most important questions is, “What will success look like during the first 100 days on the job?” “The answer to that,” he says, “will not only give workers a more granular sense of the employer’s expectations, but also signal a motivated, proactive mindset to the employer.” KATHLEEN FURORE is a Chicago-based writer and editor who has covered personal finance and other business-related topics for a variety of trade and consumer publications. You can email her your career questions at kfurore@yahoo.com. 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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