TechNation Magazine March 2021 by MD Publishing

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Vol. 12

t h g i R to r i a p e R

ADVANCING THE BIOMEDICAL / HTM PROFESSIONAL

MARCH 2021

Small Victories Can Lead to Bigger Things PG. 50

12 Department of the Month

The Children’s Healthcare of Atlanta Clinical Engineering and Central Equipment Department

36 Tools of the Trade RTI Scatter Probe

42 Roundtable

Patient Monitors

58 Cybersecurity

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CONTENTS

FEATURED

HE ROUNDTABLE: T PATIENT MONITORS TechNation contacted industry professionals to discuss patient monitors, including the latest about these devices and what to expect in the future. Next month’s Roundtable article: AEDs/Defibrillators

RIGHT TO REPAIR: SMALL VICTORIES CAN LEAD TO BIGGER THINGS The right-to-repair topic received additional interest during the COVID-19 pandemic. There are roughly 25 bills expected to be active in states this winter. Of these, roughly half will focus on everything with a chip; including medical equipment. ext month’s Feature article: N Collaborative Approach to Downtime Planning for Critical Medical Device Systems

TechNation (Vol. 12, Issue #3) March 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

MARCH 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 Amanda Purser EDITORIAL

John Wallace Erin Register

CONTRIBUTORS

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

DIGITAL SERVICES

Cindy Galindo Kennedy Krieg

EVENTS

Lisa Lisle

WEBINARS

Jennifer Godwin

HTMJOBS.COM

Kristen Register

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

P.12 SPOTLIGHT p.12 Department of the Month: The Children’s Healthcare of Atlanta Clinical Engineering and Central Equipment Department p.14 Professional of the Month: Mark Weltz, Finding the Strength to Face Challenges p.18 Association of the Month: The Healthcare Technology Management Association of the Midwest (HTMA-MW) P.22 INDUSTRY UPDATES p.22 News and Notes: Updates from the HTM Industry p.28 AAMI Update p.30 ECRI Update p.33 Ribbon Cutting: Source Support Services P.35 p.35 p.36 p.39 p.40

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

P.55 EXPERT ADVICE p.55 Career Center p.56 Back to Basics Maintenance Tips for Puritan Bennett 840 Respiratory Ventilators, sponsored by Avante Health Solutions p.58 Cybersecurity p.60 Necessity of Premium Ventilator Service During COVID, sponsored by ReNew Biomedical p.63 The Future p.64 20/20 Imaging Insights, sponsored by Innovatus Imaging P.66 BREAKROOM p.66 Did You Know? p.69 The Vault p.72 MedWrench: Bulletin Board p.78 HTM Strong p.74 Service Index p.77 Alphabetical Index

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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MARCH 2021

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SPOTLIGHT

The Children’s Healthcare of Atlanta Clinical Engineering and Central Equipment Department is made up of 40 full-time employees.

DEPARTMENT OF THE MONTH Children’s Healthcare of Atlanta Clinical Engineering and Central Equipment Department BY K. RICHARD DOUGLAS

tlanta is an impressive city by any measure. It is a foodie’s paradise. It is hard to find bad food in the city’s competitive restaurant market. The greenery nearly everywhere, from mid-town to points north; the beauty of the Chattahoochee river and the botanical gardens surround the city’s skyscrapers and bring nature to many areas.

For kids in the city, who require professional pediatric care, there is a hospital that has treated children since 1915 in the eastern part of Atlanta. Children’s Healthcare of Atlanta celebrated a century of care in 2015. The system includes three hospitals with 673 licensed beds, 19 neighborhood locations, the Marcus Autism Center, the Center for Advanced Pediatrics and The Support Center. Managing the medical equipment needs at this important health care system is the Clinical Engineering and

TECHNATION

MARCH 2021

Toniki Childs trouble shoots an ultrasound unit at the Egleston campus. Central Equipment Department. The department’s director is Anthony McCabe MBOE, MBA, LSSBB. Other members of the leadership team include

managers Raymond White and Sonali Kamalasanan, CBET. The department consists of 40 full-time employees. Clinical engineering includes five senior technicians in Sandra Wiggins, James Bland, Craig Lowe, Emmanuel King and Kalombo Mwamba. The group also includes four radiology equipment specialists in Toniki Childs, Ellis Harris, Michael Sweeny and Michael Cameron. Rounding out the team are 14 biomed techs. Central Equipment includes two lead distribution aides and 13 equipment technicians. The department takes a very methodical and careful approach to service contracts with an analysis of all relevant facts. “Service contracts are managed through clinical engineering with a very collaborative process, with the equipment-owning departments and our sourcing partners. We have an online portal internally where the end-user

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SPOTLIGHT

The Arthur M. Blank Hospital is scheduled to open in 2025. departments or clinical engineering may submit the contracts for review, and any deviations must be justified, reviewed and signed-off on by our organizational leadership team,” McCabe says. He says that this helps ensure that if they are going to cover equipment on an agreement, that they are considering financial stewardship accountability with their stakeholders. It also makes sure that they are getting the appropriate coverage levels based on data of histories and experiences. “We are always looking at equipment end of life, equipment replacement schedules and how we may best serve the needs of our customers. We work with them on how we may best maximize opportunities to bring more services in-house to help us manage the service and risk,” McCabe adds. Working alongside their information technology and systems colleagues, the clinical engineering (CE) department has made efforts to keep networked devices safe from cyberthreats. “We have dedicated full-time employees in both our IS&T department and Clinical Engineering to work on cybersecurity and device integration. We have been integrating everything from anesthesia machines to vitals carts to get data into our EMR to reduce manual workloads from our clinical staff while providing them with the most up-to-date and meaningful data,” McCabe says. He says the team has great clinical expertise that is helping drive the path for the data integrations and leveraging it for big data and machine learning opportunities for even bigger possibilities.

“We are excited to have a new project dialed up for a 19-story, 1.5 million-square-foot facility that will be named Arthur M. Blank Hospital, which is currently on track to open in 2025. It will focus on cardiac, cancer and transplant services,” McCabe says. He says that the team just finished a years-long project for medical device security segmentation. “This was such an important effort to get through, as every day you hear some horror story on the news of a hospital being hijacked and having to pay a ransom of some sort to get operations of their systems back,” McCabe says. He says that a lot of time and effort went into the coordination of resources and implementing micro segmentation for the medical devices with both their partners in the IS&T department and end user stakeholders. “The last few months were the last remaining 20 percent of devices that had high complexities and high impact to operations. No matter how prepared we were, there always seemed to be some unknowns out there that made some days not go as well as we had hoped for going into it,” McCabe says. “A lot of the time, there were things

PLANNING FOR THE FUTURE Future expansion will no doubt keep the team very busy. Recent projects have allowed the team to button down the network.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

not at all a part of our project that would happen, and directly impact what we were doing. Availability of our equipment for the clinical staff is always priority, so having their involvement as far upstream as possible is critical for success,” McCabe adds. The future expansion plans are an area where the department has helped to problem solve and provide guidance. “We have and are continuing to be a primary guiding source for the rest of the organization on planning for our new hospital and how to get there between now and then. There is a lot of planning that goes into a hospital of that size, and not everything can be brand new of course,” McCabe says. “We are there helping the rest of the organization by being a very strong voice at the table,” he says. The team is able to assess what might need to be replaced before and after the move, what may wait, what areas will require some creative thought and what might need to be bought now and moved to other locations outside of the new hospital, he explained. “We all want to be good fiscal stewards, as well as make sure that we stay at the edge of new technologies,” McCabe says. That fiscal responsibility, along with protecting device information integrity and serving the needs of clinicians, is what allows this clinical engineering team to support the health of Atlanta’s children.

The Department includes specialists and general biomeds. MARCH 2021

TECHNATION

SPOTLIGHT

PROFESSIONAL OF THE MONTH Mark Weltz, Finding the Strength to Face Challenges BY K. RICHARD DOUGLAS

ucson is a city in the Sonoran Desert in the southern half of Arizona, surrounded by giant saguaro cactuses. The city sits at a slightly higher altitude than the state’s other largest city; Phoenix, and as a result, enjoys slightly cooler temperatures in the summer.

For more than 75 years, the city of Tucson, and all of southern Arizona, has been served by the 600-bed, locally governed nonprofit regional Tucson Medical Center (TMC). It is the leading provider for emergency care and pediatric care. Mark Weltz, senior diagnostic imaging engineer, is a member of the Tucson Medical Center Clinical Engineering Department. Like many in the profession, Weltz began his training in the military. “After leaving the Navy as an aviation electronics technician, I continued my electronics education in Boise, Idaho. After graduation, I started with GE Medical Systems in MRI/CT in the San Francisco Bay area,” Weltz says. His electronics education resulted in a degree in electronics engineering technology. After GE, he went to Philips Healthcare and worked in diagnostic imaging for 30 years. While at Philips, the company sent him to Holland to train in MRI and CT. Later in his Phillips tenure, he was trained in X-ray and cardiovascular systems.

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MARCH 2021

Mark Weltz’s is seen during his last bow hunting trip in Eastern Washington. Archery has been a hobby of his since 1995. MRI/CT and cardiovascular equipment remain Weltz’s specialty areas. “I decided to work for a nonprofit medical company. After researching TMC, I thought that it would be a great place to perhaps make a difference in a patient’s life somehow,” Weltz adds. “At Philips, I was the installation and site assignment champion. Here at TMC, I have been involved in all installation processes and implementation of every new MRI, CT and cath lab that has been installed since my arrival in 2017. Here at TMC, it is a team approach in regard to new major equipment.”

FAVORITE BOOK:

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FAVORITE MOVIE:

“Apocalypse Now”

FAVORITE FOOD:

Tough to say. I enjoy many different foods but a good pizza is always up there on the list.

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“As an imaging engineer; every day is a new challenge.”

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SPOTLIGHT

MOTIVATED BY BRAVERY Many biomeds and imaging service engineers face challenges in any given week; from a vexing problem with a piece of equipment to the added stress and precautions that have come with COVID-19 surges. Weltz has faced some physical challenges which might have put many people out of commission. “A couple of years before moving to Arizona, I had gone for a motorcycle ride with my wife and friend. I rode my Indian Chief, with my wife riding behind me on her Harley-Davidson and another biomed was on his Harley behind us. It was a beautiful summer day in the Pacific Northwest just north of Seattle,” he remembers. He says that after a day’s ride they had all stopped for some dinner along Highway 9. “After continuing to ride home, and only about 20 minutes, a buzzed driver pulled out from a side road and then stopped right on the highway in front of me. She stopped her black SUV, and never even looked for vehicles. I had about 15 feet, and at 45 miles per hour there isn’t much time other than to brace for impact,” Weltz says. He says that he made impact with the side of the SUV and his custom-painted bike was destroyed. “I had won many trophies at bike shows with this bike. I knew immediately that something was seriously wrong, so I laid in the road until first responders arrived. After a few months of rehab and physical therapy, I returned to work, perhaps a bit too soon. I think my wife was expecting more work from me at home so figured it would be easier at work. I had to cancel a lot of plans that year, from hunting to no longer being able to teach Judo; one of my life’s passions,” Weltz says. Weltz says that the first day back at work, he had a table problem on an MRI scanner at the University of Washington in Seattle. “I could just barely walk at that time. It was a long and grueling night, but I was able to get the table repaired and put back together. Every step was

difficult, but I just kept saying ‘one step at a time,’ ” he says. “The bad part was that I was already partially disabled from a prior military injury, so this only compounded things. Yes, I did get back on that bike after totally rebuilding it and rode again; gun shy a bit, but had to do it,” Weltz adds. “During this difficult time, I took a visit to Children’s Hospital in Seattle and as I walked through the cancer area and saw those children that had smiles on their faces and were tough as nails getting through their ordeals and some not knowing if they would even make it. This all made my challenges seem very small in comparison,” Weltz says. After breaking his back twice, he had no choice but to retire from teaching martial arts. “Then, a couple years after this had happened, I had a strange fall from a high chair and landed on the tile floor at work and received a nice compression fracture. I came to work every day and still got my PMs completed and work done. Sure, I was moving slow, but I just kept thinking about these small children and how they would keep their head up and never quit the fight,” Weltz says. Weltz says that time management may be the most important skill

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

working in the hospital environment since it is so easy to get pulled in different directions. The message that Weltz believes in, and has lived out, is not to give in to setbacks. “I am a U.S. Navy disabled veteran that has had his back broken on three occasions, five knee surgeries, one ankle surgery and still getting things done. Never give up,” he says. Weltz says that working for a hospital allows you to work on equipment that can truly make a difference in a patient’s life. “Always remember that at the end of the day, everything we do has a patient in the equation. Working for Tucson Medical Center has been a challenge, but with the help and support of a world-class group of peers, and a manager that is as brilliant as they come, it has made my transition from OEM to hospital so much smoother,” Weltz adds. For those who could use some motivation, this senior diagnostic imaging engineer has a story that speaks to tenacity. Those who motivated him will never know the impact they had in helping one person work through several challenges.

BELOW LEFT: Mark Weltz is seen along the Wallowa River during a winter vacation in eastern Oregon. It is near one of his favorite places to snowmobile and snowshoe. BELOW RIGHT: Mark Weltz is seen after winning first place and best paint at a bike show in Snohomish, Washington. The red bike is Weltz’s show bike; a 2003 Indian Chief that was totaled in a crash with a Subaru. He rebuilt the entire bike after the accident

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SPOTLIGHT

The HTMA-MW had to cancel its symposium in 2020 but will help host a HTM Mixer this year.

ASSOCIATION OF THE MONTH The Healthcare Technology Management Association of the Midwest (HTMA-MW) BY K. RICHARD DOUGLAS

t’s not easy running a biomed association while a pandemic dictates what can and can’t happen. Many of the things that can’t happen are very important activities on an associations’ annual calendar.

Like companies and other organizations, a shift to virtual or online meetings and collaborations becomes the only practical alternative. No part of the country has been exempted from this shift in protocols; including the Midwest. The leadership of the Healthcare Technology Management Association of the Midwest (HTMA-MW) had to deal with this challenge during much of 2020. They had to cancel meetings and their symposium. The HTMA-MW describes itself as “a professional society for BMETs in Kansas and Missouri.” The two states,

TECHNATION

MARCH 2021

which share a common border, are literally in the center of the country. You don’t get any more “middle-America.” The group’s current officers include President Cliff Allen; Vice President Robin Faut; Treasure Tim Cordes; Recording Secretary Victoria Friend and Membership Secretary Tommy Creal. Board members include Preston Braxton, Don Faith, Greg Stirton and Paul Wessler. A chance meeting of several biomeds served as the impetus for the group’s formation. “Sometime in the early 1980s, a few Kansas City biomeds; Larry Chapman, Dean Christ, Ted Brockman and Warren Lillygren ended up at the same training class at one of the area hospitals and decided to form a group,” says former-President Chris Coleman. Coleman says that the group started as the Kansas City Biomed Society;

which was officially recognized by the state governments of Kansas and Missouri and is now the HTMA-MW. The relationship between local biomed associations and biomed training programs has become more important than ever as the field needs to assure replacements for retiring biomeds are in the pipeline. HTMA-MW members have taken steps to accomplish this important measure by working with colleges within their states. “Last year Tim Cordes, Ken Ervin, Kevin Hashman, Dan DeMaria, Cliff Allen, Kevin Johnson, Drew McElroy and Kenny Brown formulated a concept to provide a path for students interested in HTM to obtain a BMET-degreed certificate program,” Allen says. “We’re happy that that idea has become a reality as Missouri State Tech College has accepted three in-seat classes at Johnson County Community

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SPOTLIGHT College that are required for the BMET Certificate Program. Johnson County Community College (JCCC) has also accepted A and P, medical terminology and job search strategies as electives to the electronics technology AAS degree. Two of the other three classes required for the certificate program are done on-line through Missouri State Tech College and the last requirement is the internship,” Allen says. He says that the program works like this; students would enroll in JCCC’s Electronics Technology Program and upon completion of the basic electronics technology requirements, students dual enroll at State Tech and to begin anatomy and physiology, medical terminology and job search strategies classes in-seat at JCCC, followed by biomedical instrumentation and diagnostic imaging online, then followed by the three-month internship at one of the local hospitals. “We are now focusing on job shadowing programs when COVID cases decline and we can get back to a more normal way of doing things,” Allen says. Allen adds that the association is in its third year of an agreement to provide scholarships for students that are in the biomed associate degree program with Missouri State Tech. “One of our very first recipients of this program currently works at Saint Luke’s Health System in Kansas City. We feel this scholarship program has been a great success and we have been very blessed to be able to help students with college expenses. We are planning to extend this scholarship program by the new board this year,” Allen says. The group has also been active in career fairs at Johnson County Community College, Missouri State Tech and Olathe Technical Center. VIRTUAL MEETINGS AND A SPECIAL EVENT Many annual symposiums were put on hold in 2020. These events often allow association members from more distant locations to rub elbows. The HTMA-MW symposium was no exception and had to be cancelled. This year, there are plans for a special event.

HTMA-MW supports members with educational opportunities. Coleman says that the group’s annual symposium has grown from a sort-of annual symposium with a few vendors in the extra space of an electronics supply store to a regular annual symposium in a banquet room of a nice hotel complete with speakers, food and prizes. “We typically have a two-day symposium and with education sessions with approved CEUs, so attendees can earn credits for recertification. We typically have around 30 vendors which is how we are able to fund the cost of the symposium,” Allen says. He says that they have great vendor support, including many vendors from other states, and many OEM vendors with a combination of local and out of state attendees. “Our vendor support is amazing and we are blessed with their support,” Allen says. He says that attendees come from Kansas, Missouri, Nebraska, Oklahoma and Texas. “We have many different speakers such as Herman McKenzie with The Joint Commission, Danielle McGeary from AAMI, Matt Baretich and Frank Painter. Our symposiums are always filled with education, excitement, plenty

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

of food and drinks, lots of fun and many free prizes,” Allen adds. While the symposium provides an annual event for membership, the group also hosts meetings that allow board members to meet as well. The association has had to adapt to the requirements of mitigation this past year. “We have six meetings per year and the board meets six times per year. We recently started Webex meetings because of COVID numbers increasing in the Kansas City area. We had a couple of issues in the beginning with these types of meetings, but are starting to become more successful at them. I believe they will be a great way for us to keep meeting safely,” Allen says. He says that the group also normally has a local vendor-sponsored outing at a park or baseball game. “This is a great time for our members to get together and have a relaxing good time,” Allen says. HTMA-MW has teamed up with MD Publishing for a special event in September. “This year, we are planning a HTM Mixer. Tim Cordes has been working with John Krieg of MD Publishing to schedule this in the fall of this year. We are planning on Heartland Biomed Association out of Nebraska and Gateway Biomed Society out of St. Louis being part of the HTM Mixer,” Allen says. The HTM Mixer will be held September 9 and 10 at the Kansas City Marriott Downtown. Free registration is available for hospital employees, students and active members of the military. For more information, visit HTMMixer.com. He says that the group also provides money for members to go on mission trips. “We have members apply for this and we give away up to $750 each to help cover the costs of these mission trips,” Allen adds. The effort to nurture and expand the HTM community is alive and well in the middle of the country. Despite some challenges last year, the HTMA-MW is finding ways to keep in touch and continue its valuable work.

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NEWS & NOTES

Updates from the HTM Industry Las Vegas • November 1-2, 2021

MD EXPO RETURNS TO VEGAS, CALL FOR PRESENTERS UNDERWAY Vegas is a go for the 2021 fall MD Expo! MD Expo Las Vegas is set for November 1-2 at the M Resort Spa Casino in Las Vegas. MD Expo has set the bar for HTM conferences for almost 20 years by providing world-class educational sessions, top-flight networking opportunities and an exhibit hall filled with the latest technology, service and equipment options. It also provides opportunities for meaningful interactions with HTM thought leaders and

peers from around the nation. MD Expo strives to provide healthcare technology management professionals with a safe, unique, intimate and rewarding conference second to none. Clinical engineers, biomedical technicians, directors and managers, procurement/asset managers and others responsible for medical technology will gather in a one-of-a-kind safe, clean and welcoming environment to network with peers as well as learn about the latest technologies and advances in HTM.

MD Expo is accepting Call for Presenters. MD Expo seeks presenters who can offer first-hand experience implementing new technologies and/or case studies of process improvement in healthcare technology management. Additionally, MD Expo seeks insightful presentations. Complete a Call for Presenters form online at tinyurl.com/MDExpoCall. • For more information, visit MDExpoShow.com.

TECHNICAL PROSPECTS TRAINING PROGRAM EARNS AAMI CERTIFICATION Technical Prospects, a leader in the medical imaging industry specializing in Siemens equipment, announced that its training program has gained certification from the Association for the Advancement of Medical Instrumentation (AAMI). The newly accredited program includes training in angiography/ catheterization equipment, computed tomography (CT), fluoroscopy, magnetic resonance imaging (MRI) and radiography equipment. Participants can earn up to 45 ACI-CEUs per class. “Earning this certification is an excellent addition to not only Technical Prospect’s training program, but the industry as a whole,” said Sam Dar-

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weesh, chairman of engineering at Technical Prospects. “Today’s world is filled with data-driven engineers who want and need these CEUs to be competitive as institutions want to hire accredited individuals.” Technical Prospects has transcended AAMI’s rigorous guidelines, which include proper instructor licensing and training, maintaining sufficient levels of presentation skills, upholding an appropriate class format, utilizing a customized approach and customer focus and much more. As premium engineering training programs meet or exceed eight CEUs per day, the company has surpassed this standard by offering nine

CEUs per day throughout their training program. With this certification, Technical Prospects can assist engineers working with medical imaging systems to maintain AAMI accreditation – a minimum of 30 CEUs from six approved categories during a three-year period. The certification will also help these individuals further progress their professional development and allow imaging directors to benchmark employee progress, qualifications and credentials related to imaging training. • For more information, visit TechnicalProspects.com.

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CE-TECH ACQUIRES SOUTH FLORIDA BIOMEDICAL COMPANY CE-Tech of Jacksonville, Florida, is expanding its presence in the southeast with the acquisition of Medical Instrumentation Technical Services LLC – a Miami-based company known for providing exceptional and timely medical equipment maintenance services to health care facilities in the South Florida region. “We are excited to continue to serve the Miami and surrounding areas by expanding our knowledge base and manpower with the acquisition of

Medical Instrumentation Technical Services LLC,” said Scott Long, president of CE-Tech. “We have always worked diligently and efficiently to provide our customers with reliable and timely service in order to keep their health care facilities up and running. Now more than ever, amidst the COVID-19 pandemic it is imperative that all health care facilities have medical equipment that is in safe working order. We are excited to have an extended reach in order to help more

facilities serve their wonderful patients.” CE-Tech’s service portfolio consists of technical services, management services, pre-owned and new equipment sales, life safety and facility management services. The service portfolio will not change with the acquisition of Medical Instrumentation Technical Services LLC. However, the number of facilities that can be served will increase. • For more information, call 1-800-333-7477.

IN MEMORIAM, ANNE GRANUM “The HTM community lost another wonderful human being,” the LinkedIn post read. Everyone who met Anne Granum knew she was fiercely loyal and independent. She loved her family and friends unconditionally. She dedicated her life to helping alcoholic women and men start a path toward sobriety. She guided them to a relationship with a higher power. Anne loved spending time with her family. She is survived by her husband, Clay, and her 5 children – Katie, Kelly, James, P.J. and Rocky. Her heart was always with her 4 grandchildren – Landon, Savannah, Ashton and Delilah. Her family will miss her dearly. Many in the HTM industry are feeling loss at the news of her death. She had more than 30 years of experience in healthcare technology management with a focus on imaging equipment. However, her successful career did not define her. She was an outgoing, strong, brave and caring person. The LinkedIn post by Christopher Nowak was one of many about this amazing woman who battled ovarian cancer for six years. Comments under Nowak’s post only begin to explain what Anne meant to her peers. A few of them are: “Such a beautiful soul.” “What a great, positive and wonderful person.” “Rest in peace wonderful lady, you will be missed.” “What an incredible spirit, wonderful person, fought the good fight, she will be missed!” “One beautiful, strong, amazing lady.” “Anne was an amazing person to work with and always so positive and helpful. Truly a role model for our community.” “Anne had a wonderful spirit and such a kind soul.” Anne diagnosed with ovarian cancer in 2015. She was 61 when she began her fight against cancer with a goal to also raise awareness regarding the disease.

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In lieu of flowers, Anne’s family would prefer that donations be made to ovarian cancer research. Individuals interested in making a donation in Anne’s memory are asked to consider one of the following charities: https://ocrahope.org or www.charitynavigator.org/ ovariancancer. Anne was a national spokesperson for Keytruda Immunotherapy for years – givAnne Granum ing hope to women all over the country as a success story for this treatment. She and Clay traveled together for years with this message of hope. Both Anne and her husband Clay fought battles with cancer. In lieu of a formal funeral, the family will hold a celebration of Anne’s life in the spring of 2021. Those interested in receiving a reminder may fill out the contact form at annegranum.com. Kim Rowland, who worked with Anne at Tri-Imaging Solutions, wrote, “Anne has been the picture of courage, tenacity – and always the brightest light in any room! Her longevity in the industry is a testament to her commitment to quality and the genuine relationships she has built over the years. She made such an impact on this earth and will be missed greatly!” “I know everyone shares the same gratitude about Anne and this could be unanimous from everyone that has ever had the privilege to know her,” Rowland said. • For more information, visit AnneGranum.com.

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TRIPATHI NAMED NATIONAL COORDINATOR FOR HEALTH IT TRIMEDX AWARDED SOC 2 TYPE 2, ISO/IEC 27001:2013 CERTIFICATIONS TRIMEDX, an industry-leading, technology-enabled provider of clinical engineering, medical device cybersecurity and clinical asset management solutions to health care systems, has successfully achieved the Service Organization Control (SOC) 2 Type 2 certification for its solutions, as well as being awarded the highly regarded International Organization for Standardization’s Information Management Security certification ISO/IEC 27001:2013. Each certification verifies TRIMEDX’s operational policies and security controls for service delivery, technology development, and the rigor around the security of client data protecting it from internal and external threats. “With the ever-evolving threat landscape, we have a responsibility to our clients to proactively and rigorously secure the data placed in our hands,” says TRIMEDX CEO Henry Hummel. “These widely recognized certifications confirm our commitment to protecting health care providers’ confidential data, ensuring patient safety, and demonstrating operational excellence and rigor around technology and data development and control.” ISO 27001 provides requirements to companies seeking to implement a comprehensive information security management system (ISMS) to effectively provide security of information assets, through a systematic risk management process covering people, processes and information technology systems. Meeting the standard demonstrates TRIMEDX’s achievement of worldclass safety and security management of information. Taking the commitment to quality a step further, SOC 2 Type 2 – a stringent, third-party industry standard among service organizations that handle client data – is designed to protect the safety and security of the data and its storage. At the core of TRIMEDX’s comprehensive clinical asset management solution is RSQ, a proprietary computerized maintenance management system that houses client data on over 4.4 million clinical assets. The achievement of SOC 2 Type 2 compliance showcases TRIMEDX’s visibility into client data and the associated safety and security controls in place to protect it, which has been successfully audited and proven effective by an independent third-party. The SOC 2 Type 2 certification validates TRIMEDX’s ability and commitment to protecting this data. The announcement of these industry certifications follows TRIMEDX’s ongoing commitment to excellence through the acquisition of Centurion Service Group, allowing TRIMEDX clients to gain maximum value from their excess medical equipment. • For more information, visit trimedx.com.

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MARCH 2021

Micky Tripathi, Ph.D., MPP, has a new leadership role as the National Coordinator for Health Information Technology (ONC) with the Department of Health and Human Services (HHS). Most recently, Tripathi served as Arcadia’s chief alliance officer and was responsible for developing strategic partnerships between Arcadia and other companies to further accelerate the use of advanced technology to improve healthcare. The Office of the National Coordinator for Health Information Technology is the principal entity charged with coordination of nationwide efforts to implement and use the most advanced health information technology and electronic exchange of health information. Tripathi will be at the forefront of the new administration’s health IT efforts, the adoption of health information technology and the promotion of a nationwide health information exchange to improve health care. •

ASTM INTERNATIONAL HONORS CLIFFORD WARNER WITH PATRICK G. LAING AWARD ASTM International’s medical and surgical materials and devices committee (F04) presented the Patrick G. Laing Award to Dr. Clifford Warner, senior principal engineer at W.L. Gore and Associates. The committee honored Warner for his significant and outstanding contributions to the committee in developing standards for medical and surgical devices. An ASTM International member since 2003, Warner has previously been recognized with the Robert E. Fairer Award (2009). He is also a member of the ASTM International committee on corrosion of metals (G01). Warner has served in his current position with the fuel cell team at W.L. Gore and Associates since 2019, having previously worked in the medical products division since 2001, and the fabrics division from 1997 to 2001. He held a position at IBM before joining W.L. Gore and Associates in 1997. He holds a bachelor’s degree and doctoral degree in materials science and engineering from the University of Pennsylvania. In addition to ASTM International, Warner is a member of the Shape Memory and Super Elastic Society, American Society of Mechanical Engineers, and American Society for Materials. •

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INDUSTRY UPDATES NEMOURS CHILDREN’S HEALTH SYSTEM SELECTS REAL-TIME LOCATION TECHNOLOGIES TO STRENGTHEN OPERATIONAL EFFECTIVENESS Nemours Children’s Health System is an Infinite Leap client for its real-time location technologies to strengthen operational effectiveness. Launched in August 2020, the Nemours Sidekick program aims to help Nemours’ associates perform their work efficiently and effectively through the use of a real-time location system (RTLS). Nemours Children’s chose to brand their RTLS initiative as “Nemours Sidekick” to highlight that this technology tool is always there for staff when they need it and is helping them make a positive impact on the lives of their patients. “We worked in partnership with Infinite Leap to develop a multi-phase, multi-year strategy and implementation plan to fully leverage IoT technologies to help our staff to be more efficient, deliver the highest level of safety for our patients, and enable us to personalize their experience while on our campuses” said Bernie Rice, enterprise vice president and chief information officer at Nemours Children’s Health System. RTLS-enabled temperature monitoring, asset location, and asset management, powered by CenTrak, have been deployed at Nemours Children’s Health flagship hospitals: Nemours Children’s Hospital in Orlando, Florida and Nemours/Alfred I. duPont Hospital for Children in Wilmington, Delaware.

The RTLS system provides real-time location and status for 6,000 pieces of mobile medical equipment and monitors over 1,000 temperature-controlled units, including low-temperature medical refrigerators. Infinite Leap was responsible for the installation and configuration of the RTLS system and will provide ongoing system maintenance to ensure optimum performance of the RTLS infrastructure. In addition, as part of a managed services agreement, Infinite Leap will also provide RTLS program management guidance to assist Nemours Children’s Health System with generating the greatest sustainable value from the program and executing on the organization’s IoT strategy. “Working with hospitals is what we do, but it is always a special pleasure when we get to work with those who specialize in caring for children. It’s always meaningful to help health care to use IoT to make things more efficient, reduce costs, and improve compliance, but it’s doubly special when we can lend our experience to an organization, such as Nemours Children’s, that raises the bar on caring for their pediatric patients, and spends the effort to make sure their staff has every advantage available for them to do so,” said Mark Rheault, CEO and founder of Infinite Leap. •

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INDUSTRY UPDATES FORMER HOSPITAL EMPLOYEES, MEDICAL DEVICE DISTRIBUTOR CHARGED IN SCHEME TO STEAL MEDICAL DEVICES An indictment was unsealed in January that charges two former Beaumont employees and a medical supply distributor with wire fraud based upon a scheme to steal medical devices and/or medical supplies from Beaumont Hospital and then sell them on the Internet, announced United States Attorney Matthew Schneider. Schneider was joined in the announcement by Special Agent in Charge Lynda Burdelik, Food and Drug Administration (FDA). Charged were Paul Purdy, 49, of Beavercreek, Ohio; Valdet Seferovic, 32, of Auburn Hills, Michigan; and Zafar Khan, 40, of Fenton, Michigan. According to the indictment, from 2003-2017, Purdy was employed at Beaumont Hospital. During his employment, he stole medical devices and/or medical supplies from the hospital and resold them via the Internet to customers throughout the United States. Purdy never informed the purchasers that the medical devices and/or supplies he sold to them were stolen. Purdy resigned from the hospital in 2017 and enlisted Valdet Seferovic, an employee of the hospital, to continue the scheme of stealing medical devices and/or medical supplies. Serferovic had access to the medical supply and the cleaning and disinfecting rooms at the hospital. Purdy and Seferovic primarily stole three types of medical devices: (1) cystoscopes, a thin tube with a camera which is inserted through the urethra and into the bladder, some of which may have been contaminated as they were stolen from the cleaning and disinfecting room after being used in surgical procedures; (2) Ophthalmoscopes, an instrument for inspecting the retina and the other parts of the eye; and (3) Otoscopes, an instrument for inspecting the ears. Purdy and Seferovic sold these devices and/or supplies via the internet to customers throughout the United States. The purchasers were never informed

that the medical devices and/or supplies were stolen. According to the indictment, in September 2017, Valdet Seferovic also agreed to steal and sell medical devices and/or medical supplies to Zafar Khan, the owner of Wholesale Medical & Surgical Suppliers of America LLC. Once Khan acquired the stolen medical devices and/or medical supplies he sold them to unsuspecting purchasers via the Internet. “An indictment is only a charge and is not evidence of guilt. The defendants are entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt,” a news release stated. United States Attorney Schneider stated, “These defendants used their employment status to circumvent the safety protocols established by Beaumont Hospital to profit from the theft of medical devices and put the health and safety of the general public at risk in doing so. This indictment should send a clear message that our office is committed to prosecuting anyone who would endanger the health and safety of the general public for personal gain.” “Medical devices that are removed from their rightful place in a hospital or other medical setting put patients’ health at risk by denying them access to needed diagnostic imaging and treatment,” said Special Agent in Charge Lynda M. Burdelik, FDA Office of Criminal Investigations Chicago Field Office. “We will continue to investigate and bring to justice those who jeopardize the public’s health for profit. And we commend our law enforcement colleagues for their assistance in this case.” This case is being prosecuted by Assistant United States Attorney Regina R. McCullough. The case was investigated by special agents of the Food and Drug Administration, Office of Criminal Investigations and the Royal Oak Police Department. •

UCI TO BUILD WORLD-CLASS HOSPITAL ON IRVINE CAMPUS Plans to build a world-class, acute care hospital on the northern edge of the University of California, Irvine academic campus advanced significantly in January, as the University of California Board of Regents granted approval of the project’s 144-bed acute care facility, ambulatory care center and cancer center. The hospital joins the previously approved UCI Health Center for Advanced Care to create the new UCI Medical Center Irvine-Newport, a full-service academic health complex that will bring a broad spectrum of

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the most advanced health care services to coastal and southern Orange County, including access to the hundreds of clinical trials underway at UCI Health. The medical center will connect with the UCI Health primary care network throughout Orange County, including its newest clinic in Newport Beach, creating the region’s only health system supported by one of the nation’s premier academic research institutions. The new UCI Health medical campus will complement the flagship

UCI Medical Center in Orange, home to Orange County’s principal tertiary-quaternary care center; only combined Level I adult and Level II pediatric trauma and regional burn centers; and specialty care at the UCI Health Digestive Health Institute and the Chao Family Comprehensive Cancer Center, the county’s only National Cancer Institute-designated comprehensive cancer center. “With today’s approval by the regents, UCI takes a giant leap toward fulfilling the visionary expansion of our campus and enhanc-

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ing service to the community,” said Chancellor Howard Gillman. “Once this project is completed, the UCI health care system will be unparalleled in this region, with two advanced medical centers, nationally recognized research units conducting hundreds of clinical trials, and a network of community locations stretching to all corners of Orange County. In addition to the extraordinary health care provided at the medical center, the surrounding grounds of UCI Presidential Gateway will offer educational programs, academic research, art and beautiful nature trails. It will be a place to nurture health and lifelong wellbeing

– truly advancing the three cornerstones of the university’s mission of teaching, research and public service.” The new medical center will be the home of the Center for Children’s Health, wellness programs, urgent and emergency care, specialty disciplines, research and clinical trials, and lifesaving surgical and acute care. Construction is expected to begin later this year with the groundbreaking for the UCI Health Center for Advanced Care, a multicare facility that will house the Center for Children’s Health, medical offices and an urgent care operation. The hospital will focus on key

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clinical programs such as oncology, neurology, neurosurgery, orthopedics and digestive health, and it will include a 24-hour emergency department. The first patients are expected in late 2022 in the UCI Health Center for Advanced Care, pending legal and regulatory approvals, and the hospital is set for completion in 2025. Costs for the complete project are expected to exceed $1 billion, funded by philanthropic donations, retained earnings and revenue from UCI Health operations. The project already has received philanthropic funding and will continue to seek further investment from community partners.

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AAMI UPDATE BY AAMI

FDA DEBUTS PLANS FOR ARTIFICIAL INTELLIGENCE-BASED MEDICAL SOFTWARE On January 12, the U.S. Food and Drug Administration (FDA) released its Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan. The action plan describes a “multipronged approach to advance the agency’s oversight of AI/ML-based medical software.” AI/ML technology has “the potential to transform health care by deriving new and important insights from the vast amount of data during the delivery of health care every day,” while AI/ML-based software has appropriate regulatory oversight so that it “delivers safe and effective functionality,” the document reads. “This action plan outlines the FDA’s next steps towards furthering oversight for AI/ML-based SaMD,” said Bakul Patel, director of the Digital Health Center of Excellence in the Center for Devices and Radiological Health (CDRH). “The plan outlines a holistic approach based on total product life cycle oversight to further the enormous potential that these technologies have to improve patient care while delivering safe and effective software functionality that improves the quality of care that patients receive.” The FDA also expressed an expectation for transparency and real-world performance monitoring that could enable evaluation and monitoring of a software product from premarket development through postmarket performance. The action plan, which Patel said is expected to evolve over time, was developed in direct response to feedback from a 2019 FDA discussion paper that provided a proposed regulatory framework for AI/ML-based SaMD. As part of the action plan, the FDA is having liaisons participate in the ongoing standardization efforts of the AAMI AI committee. The committee is currently collaborating with BSI to create new risk management standards for AI/ ML use in medical devices. “Outlining good practices specifically for the risk management of artificial intelligence is important because data-driven systems can reach conclusions that subvert human expectations,” said Emily Hoefer, senior manager of shared services at AAMI. “The FDA’s participation in developing this guidance helps the AI/ML community as a whole ensure patient safety even while staying in compliance with accrediting bodies.” The development of guidance on the application of risk management for AI/ML is a result of one of the seven recommendations made in the 2020 AAMI and BSI white paper, Machine Learning AI in Medical Devices: Adapting Regulatory Frameworks and Standards to Ensure Safety and

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Performance. Further AI/ML guidance documents is being developed by the AAMI and BSI collaborative based on the recommendations in the white paper, such as establishing a new Good Machine Learning Practice (GMLP), an important aspect of the FDA’s action plan. The FDA action plan includes five actions and goals in total: • Updating the proposed framework for modifications to AI/ ML-based SaMD through a draft guidance to include stakeholder’s feedback to FDA following the 2019 discussion paper and request for feedback. • Encouraging the development of good machine learning practice (GMLP) and its harmonization along with facilitating oversight through manufacturers adherence to GMLP. • Developing a patient-centered approach incorporating transparency for users and increased attention to how AI/ ML-based technologies interact with people, to include users and patients more broadly. The agency intends to hold a public workshop on how device labeling supports transparency and enhances user trust. • Supporting regulatory science methods related to algorithm bias and robustness to include the identification and elimination of biases known to exist in terms of socioeconomic status, ethnicity and race. The work will be done at FDA’s Centers for Excellence in Regulatory Science and Innovation (CERSI). • Clarifying real world performance (RWP) data, monitoring for AI/ML software, and adopting a total product life cycle (TPLC) approach to AI/ML-based (SaMD). AAMI ADDRESSING AI RISK MANAGEMENT The AAMI AI committee is now collaborating with BSI and representatives from the FDA to address the development of AI risk management guidance. According to Joe Lewelling, senior advisor on content and strategy at AAMI, this was a particularly high priority for the groups, because it directly impacts the safety of users and patients. “The uniqueness of AI creates a different risk profile than your average medical device – one where some risks may be hard to quantify or even unknown,” he said. “The guidance will help rectify that problem without reinventing the wheel.” So that the new AI guidance can be adapted quickly, the AAMI AI committee is borrowing heavily from familiar medical device risk management practices. In particular, the document will serve as guidance for applying the internationally used device standard ANSI/AAMI/ISO 14971:2019 to AI technologies. The new AI guidance will be available for public comment in early spring, 2021.

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COLLECTING THE AI STORIES OF TODAY AAMI is taking steps to better understand how artificial intelligence and machine learning are being used in the health technology space right now. In collaboration with the American College of Clinical Engineering and the Healthcare Information and Management Systems Society, AAMI recently collected statistics and qualitative data regarding AI use in hospitals. “We are conducting research to better understand how health delivery organizations and hospitals are currently utilizing AI to improve health care outcomes and safety,” said Danielle McGeary, vice president of HTM at AAMI. “We were encouraged to find many organizations willing to share their AI story.” Earlier this year, representatives from the joint organization – dubbed the Health Technology Alliance (HTA) – hosted short, remote interviews with professionals who have utilized AI for: • Monitoring Equipment Utilization • Predictive Maintenance and Other Monitoring • Alarm Management • Bed management • Clinical Decision Support Systems • IE: Advanced analytics on large clinical data sets • Other unique applications Results from these will be used to determine future HTA educational/resource offerings and potentially as part of a research presentation at the upcoming International Clinical Engineering and Healthcare Technology Management Conference in September of 2021.

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ECRI UPDATE

Portable Radiography in the Era of COVID-19

obile radiographic units are used to perform radiographic studies at the point of care. When X-rays are needed, these machines are wheeled to the patient, rather than transporting the patient to the radiology department. Portable radiography is seen as a way to help reduce the spread of COVID-19 by bringing care to the patient; thus its use has increased during the pandemic. ECRI addressed this trend in its lab webcast series and device evaluations.

From his days practicing emergency medicine, ECRI’s Andrew Furman, MD, knows the value of being able to bring X-ray technology to the patient: “Physicians like the convenience of being able to take a quick snapshot of what’s happening with the patient,” Furman explains. But that’s not the only factor to consider: “A patient may be better served by a two-view study conducted in the radiology department. So, you weigh the options.” One interesting aspect of practicing health care in the presence of COVID-19, Furman observes, is that “those risk-benefit calculations have changed.” Now, care providers are even more likely to decide that the risks associated with transporting the patient to the radiology department – specifically, the risks of spreading the SARSCoV-2 virus – outweigh the benefits. That assessment makes portable radiography an even more valuable tool, a development explored during a November 2020 ECRI webcast hosted by Furman in his role as ECRI’s executive director of clinical excellence

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Dr. Francisco Rodriguez-Campos tests a mobile radiographic unit in ECRI’s laboratory. and technology assessment. The webcast panel discussed how to safely adapt radiographic services during the COVID-19 pandemic, strategies for conserving personal protective equipment (PPE) during mobile imaging studies, and operational and image quality considerations with portable radiography. Also discussed were key findings from ECRI’s testing of mobile radiographic units. (Members of certain ECRI programs can access a recording of the webcast, “Key Considerations for Portable Radiography in the Era of COVID-19,” as well as ECRI’s evaluation findings.) MOBILE RADIOGRAPHIC UNITS: THE BASICS Mobile radiographic units are used to image patients for whom transport is contraindicated. Traditionally, these

machines have been used in areas such as intensive or critical care units, operating rooms, pediatric areas and emergency rooms. In the past year, their use has expanded to include areas where known or suspected COVID-19 patients are being treated. These devices are self-contained, battery-operated motorized carts with a telescopic column. An X-ray generator provides power to the device’s X-ray tube, which generates the X-ray beam. Movement of the machine is facilitated by highly maneuverable motor drives; the drives, which are controlled by a handlebar equipped with pressure sensors, allow the unit to perform a zero-radius turn, and they support fine-positioning movements to help set up the exam. A computer provides a graphical user interface and

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tools for selecting the patient, setting up the exam parameters, acquiring the image, reviewing and annotating the image, and sending the image to an archiving system. Additionally, the systems ECRI has tested have wireless flat-panel detectors for acquiring the images. When an exam is ordered, the technologist drives the unit to the patient, positions it at the bedside, places the detector behind the area of interest on the patient, selects the X-ray parameters and acquires the images. The images are displayed within a few seconds on the computer display. If the images are acceptable, they are sent to the PACS for reading by a radiologist. KEY SELECTION FACTORS IN THE ERA OF COVID-19 ECRI has tested a dozen mobile radiographic units in recent years. All the systems provide good image quality and deliver the necessary clinical functionality. Often, selection decisions will come down to differences in a few performance factors and workflow features that affect ease of use. A few of these factors warrant greater emphasis in a COVID-19 world: • Battery capacity: High battery capacity allows the user to perform a large number of exams without any delays caused by the need to charge the battery between exams. During testing, ECRI measures the number of exposures that were possible in a simulated workflow. “Battery life is always an issue, but it’s an even bigger consideration now,” remarks Francisco Rodriguez-Campos MSc, Ph.D., MRSO (MRSC™), a senior

project officer in ECRI’s device evaluation group. “You may be taking the machine outside the normal area of operation, or using it longer than previously, so you’ll want to know that the battery will last for the shift.” • Size and weight of the cart and the detectors: Smaller and lighter systems are easier to control, maneuver and position. Similarly, detectors that are lightweight and appropriately sized can more easily and quickly be positioned to acquire images for various applications. “These days, you want to minimize interactions near the patient to protect staff from infectious disease exposures,” explains Rodriguez-Campos. • Positioning tools and features: Fine-positioning tools improve ease of use and help shorten exam setup time. When imaging known or suspected COVID-19 patients, ease of positioning the tube head for an exam, for example, takes on added significance. • Cleaning and disinfection: With mobile radiographic units being moved from one potentially infectious patient to another, frequent cleaning and disinfection of the unit is essential. Consider the unit’s IPX rating, which describes its resistance to fluid ingress, and verify its compatibility with various cleaning supplies. The use of incompatible cleaning and disinfection solutions can cause expensive damage to the unit. Other performance and workflow factors, such as the following, will

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always warrant consideration: • X-ray generator power rating: Sufficient power is essential to obtain an adequate-quality image. Higher output power is an advantage: It allows shorter exposures, thereby reducing the effect of patient movements that degrade image quality. • X-ray tube heat capacity and cooling rate: Considerable heat is generated during X-ray production; thus the maximum heat that the X-ray tube can withstand and the maximum cooling rate should be considered together. The X-ray system will automatically limit the exposure options if the heat generated by an exposure would be too high. To avoid delays, it is important to have both a high heat capacity and a high cooling rate. • Ability to make exposures using AC power: All units are designed to make exposures using the battery. Some can make an exposure when plugged into to a standard outlet, which is an advantage when the battery becomes depleted. This article is adapted from ECRI’s Evaluation Background: Mobile Radiographic Units with Wireless Digital Detectors. The complete article – including model-specific test results and product ratings, along with additional guidance for purchasing and using mobile radiographic units – is available to members of ECRI’s capital purchasing and device evaluation programs. To learn more about ECRI membership, visit www.ecri.org/solutions/technology-decision-support, or contact ECRI by telephone at 610-825-6000, ext. 5891, or by email at clientservices@ecri.org.

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n 2001, Source Support Services’ founder Mark Oldfield recognized a need to provide onsite technical product support solutions on a global scale, leveraging an on-demand field service workforce instead of the traditional full-time model.

“Traditionally, we supported leading manufacturers in the Enterprise IT market,” said Source Support Senior Medical Technology Recruiter Jasmine Cajigas. “In the last decade, Source Support has expanded to include support solutions for biomedical equipment such as sterilization, ventilation, fluid waste management, ultrasound, dental and laboratory, PACS IT and diagnostics workstations. We continue to support advanced server, storage and networking as well.” TechNation learned more about Source Support in an interview with Cajigas. Q: WHAT IS THE MAIN FOCUS OF SOURCE SUPPORT? A: Source Support is a team that delivers streamlined global support solutions on behalf of technical product manufacturers. We strive to streamline the support experiences of our equipment manufacturer customers and their end-users to deliver best-in-class performance every time. Q: WHAT SERVICES DOES SOURCE SUPPORT PROVIDE? A: Our end-to-end, streamlined global support solutions include onsite product repair and preventative maintenance,

Jasmine Cajigas Senior Medical Technology Recruiter product deployment and installation and global service parts logistics. Our worldwide network of certified field service professionals and technical resource partners – called Source Techworks – provides the high-quality, onsite aspects of technical product support on behalf of our OEM customers in their local areas. Our Source Techworks field service experts are consistently on the ground, committed to exceeding the rising standards of our customers and progressive technologies. So, we work to equip them with the exceptional technical and soft skills to advance their careers through our comprehensive training and development program, Source Academy. We also provide additional technical support to our Source Techworks community during assignments to ensure their continual success. Q: HOW DOES SOURCE SUPPORT STAND OUT IN THE MEDICAL EQUIPMENT FIELD? A: Our experience and response time is what stands out. In the last few years, we

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have recognized a greater shift in the medical technology market as more OEMs consider outsourcing some or all of their field service capabilities. Source has 20 years of experience and expertise doing just that through Source Techworks. Instead of the days-long delays for field service delivery that can be common with medical equipment, Source holds ourselves to the same SLA standards across our markets to provide same-day or next-day onsite support, and 24/7 access to those services throughout the full life cycle of the equipment. This allows for more equipment uptime for end-users and more efficient allocation of internal resources for the OEM. Q: DO YOU HAVE ANY SPECIFIC GOALS THAT YOU WANT SOURCE SUPPORT TO ACHIEVE IN THE NEAR FUTURE? A: Source Support will continue to grow in the medical technology market, operating as an integral part of each customer’s support organization to deliver best-in-class performance every time. As such, we want to continue to partner with OEMs in medical technology to provide responsive, expert support in an industry that needs this efficiency the most. Source Support is always seeking field service professionals who share our commitment to providing the highest standards of quality and customer satisfaction and who are willing to continually learn and support bleeding edge technology throughout the medical technology, enterprise IT or industrial automation industries. For more information, visit www.sourcesupport.com/techworks.

MARCH 2021

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BIOMED 101 Valuing Time Over Titles BY KAMERON KANE

hen they said college was “the first step into the great unknown,” even my most outlandish thoughts didn’t consist of graduating amid a global pandemic. And as senior year fizzled out, many of us came to the stunning realization – what was there to do besides go to grad school?

Granted, maybe it’s because I attended an institution that centers on research programs, but my post-college paths seemed limited to staying in academia or diving into the “industry” abyss. Surely someone of your academic caliber would want to continue their education, right? Getting a Ph.D. in engineering is essentially free most places, so why not? Continuing education was assumed, not chosen. And when I pressed about what else was out there, the very narrow sect of jobs I was exposed to were research and development positions at very large, private companies. Alumni repeatedly told tales of long hours, extremely stressful work and lots and lots of red tape. On top of that, the chances of landing a position were slim at best, even if you knew someone, even if you could manipulate your credentials to eek past the resume filter. Soon it became painfully obvious that none of my professors had spent enough time, or at least recent time, working outside of academia to know what the “industry” required. Unfortunately, this also meant they subliminally pushed the narrative that it was the worse choice. And, with no one to tell me otherwise, I felt stuck while rapidly approaching a dividing path. However, I want to acknowledge that this is both the diamond and the rough

of biomedical engineering. The field is positioned at the intersection of medicine, health sciences and traditional engineering. In fact, that’s part of the reason I entered the field in the first place. This isn’t to say I won’t go to graduate school eventually, but rushing through degrees solely to complete them, or because you don’t know the other options, is at best problematic and at worst jeopardizes one of the last fields that doesn’t require a master’s for entry jobs. Being told I could do anything without further guidance felt more like an enigmatic prophecy than a token of reassurance. But at least I knew what I wanted most: to play some role in improving lives and avoid academic burnout. However, this didn’t stop imposter syndrome from clouding my job application process. I wasn’t entirely sure what I was hoping for, and instead of asking if a position met my qualifications, I wondered if my qualifications even existed. A few months later, and a few months into quarantine, I found my current position, and I could not be happier. Not only am I constantly learning new things, making me feel like a student, but I also get to see the physical manifestations of my work beyond a grade, a rewarding feeling unique to a job. But that doesn’t cancel out the need for change. Biomedical engineering curriculums all too often use lab research as the crutch of their programs instead of just one facet, hyperfocusing on the micro and not enough on the macro. Entering the workforce shouldn’t be a later, after, second-to-school option. Clinical engineering is extremely important, although maybe presently unrecognized, work. Managing medical

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

Kameron Kane

TCF Biomedical Engineer

equipment and crucial procurement projects should be held in the same regard as stem cell research. In my very short time here it’s become increasingly obvious that BME curricula should offer courses dedicated to the basics of clinical engineering, just as there are for mechanical and electrical engineering. On an even larger scale, there needs to be a more conscious effort to demystify and deromanticize engineering. Academics and industry professionals alike should focus on engaging with soon-to-be graduates in more meaningful ways than just reiterating their company’s mission statement. Offerings like facility tours and job shadowing are far more influential in recruiting people who want to join your line of work. This is particularly salient for clinical engineering, a discipline currently unknown to most BME undergraduates. In fact, the only reason I knew about my current position was because current employees came to speak on it. Education is incredibly important and valuable, but so is gaining professional experience. Understanding the pros, cons, overlap and intersections of the two is important. Properly equipping people with confidence at the most malleable point in their careers is a major part toward them to step into “the great unknown.” KAMERON KANE is a TCF Biomedical Engineer with the U.S. Department of Veterans Affairs.

MARCH 2021

TECHNATION

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WEBINAR WEDNESDAY

‘Zero Trust’ Kicks Off 2021 Webinars STAFF REPORT

he first Webinar Wednesday presentation of 2021 was titled “Why Biomedical Professionals Should Care About Zero Trust.” It was sponsored by Medigate and eligible for 1 credit from the ACI.

The 60-minute webinar featured experts Thomas Finn, director of market development of Medigate, and Karen McMillen, security analyst of Asante Information Technology Services. Most know Zero Trust (ZT) as a philosophical premise that no networked device or user can be trusted. Not surprisingly, it is viewed by biomedical professionals as a new set of security constraints. Contrary to this popular belief, ZT should be an enabler of connected medicine. Hours of relief to already overworked biomedical professionals should be a result. The network should take care of security so that devices under biomed management – devices essential to diagnosis and patient care – are always highly available. This means that biomed professionals must be fully present when ZT strategy is under development. This webinar provided the biomed audience an enlightened ZT context that will help define their participation in organizational discussions. The webinar recorded 240 registrations with 151 logged in for the live presentation. A recording of the webinar is available for on-demand viewing. Attendees provided feedback in a

survey after the webinar. One question they were asked is, “What did you like most about today’s webinar?” “The presenters were knowledgeable and made the material easy to understand,” shared J. Timson, CBET/BMET II. “The overlap between HTM (Biomed) and IT. This is a growing concern for my shop, especially when it comes to trusting devices, how and who updates/patches devices, middle wear, and specialty training needed in order to perform maintenance actions across the board with IoMT devices,” said K. Eckendorf, NCOIC equipment management branch. “This presentation was very informative. To have devices protected and everyone on the same page, instead of so many other confusing management systems. The hour flew by. Well done,” said B. Hayes, CBET. TIPS ON STARTING A BUSINESS The January 20 Webinar Wednesday presentation “How to Start Your Own HTM/Biomed Business” by William Bassuk was a hit. It was also eligible for 1 credit from the ACI. The webinar was sponsored by CER Technology LLC. The 60-minute webinar was designed by Bassuk to help service professionals better understand how to start-up a business or company specializing in biomedical service repair. He focused on the steps involved with getting a service company registered as a DBA or corporation and helped attendees understand the compliance needed to

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

work as a company in this industry. Bassuk addressed what is needed to start up a business, how to understand a vision from startup to implementation, budget, compliance, website and logo, essential items and how to attract a customer base. More than 200 people attended the live presentation and even more have viewed a recording of the webinar. Attendees provided great feedback via a post-webinar survey that included the question, “What did you like most about today’s webinar?” “Very good instructions and guidance was provided for starting your own business,” Site Manager J. Ruiz said. “Genuine experience and business knowledge sharing to new entrepreneurs,” Senior BMET S. Nadupparambath stated. “Some good suggestions/ideas on what it takes to start a business in the health care industry,” Biomed Specialist M. Breck said. For more information about Webinar Wednesday, including a list of upcoming sessions, visit WebinarWednesday.Live.

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MARCH 2021

TECHNATION

THE BENCH

SHOP TALK POWERED BY

MINDRAY BC-3200

TOSHIBA NEMIO 30

My machine gives the error “background abnormal and WBC clog.” It was checked, maintained, calibrated, cleaned all valves and reset software. I am asking for help. It needs to clean WBC Bath using cleaner (hypochlorite). It needs to check volumetric metering board, vacuum value and pressure value.

I’m having trouble saving the date in Nemio 30. It does not save the date for the year 2021. Please suggest how I can solve this problem. Hello, this is the procedure I have to change the date and time. 1. Press PRESET D on console

Never calibrate a machine with faults. For the Mindray, you only calibrate when the background is good, and results are consistent but not correct. For the problem you had, it could be the valve connects to the RBC volumetric tube. Check, clean and/or replace. Check the volumetric tube to see if the flow is within count time.

One of the problems is also usually the fact that your reagents are in poor condition. You know that after changing the reagents you must adjust the dates. I suggest you keep washing the equipment, analyzing tests with hypochlorite or 70% alcohol.

Or your WBC chamber of anode or cathode line is open. If that is the problem you can’t fix it, you just have to replace the chamber. Or if you have a good biomedical technician, he can manage how to get it working.

A WBC clog triggers blank abnormal. WBC clog means a longer counting time with two seconds longer than the expected time. The column of fluid is moving inside the metering tube (covered by a metal shield). It may be a clogged ruby/aperture or a faulty valve.

2. Select PRESET on screen 3. Select TIME CORRECTION on screen 4. Change Time or Date 5. Click OK, then click EXIT

You may want to inquire with Toshiba about this. It may be that the Nemio was not expected to last past 2020 and needs a software upgrade or it might be a date bug (try entering 2022 or greater). We no longer have our Nemio, so I can’t test it myself.

Can it be BIOS cell problem? That company put cell for 10-20 years life which expire on 31-12-2020 so every time we need to re-enter the date?

I doubt very much that it is due to the Bios cell. It would be very difficult to have it die exactly on January 1, 2021 on all units. Plus, if you enter an older date like 2019 or 2020 it keeps it, so that should rule out the battery.

SHOP TALK

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

TECHNATION

MARCH 2021

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ROUNDTABLE

ROUNDTABLE Patient Monitors

echNation contacted several industry professionals for this roundtable article on patient monitors. The goal was to find out the latest about these devices with feedback from service professionals and manufacturers.

Participating in the roundtable article are GE Healthcare Monitoring Solutions Chief Technology Officer Oliver Astley, Ph.D.; USOC Biomedical Vice President Duane Gilmore; Avante Director of Biomedical Engineering James Manley; Agiliti’s Dip Niraula; Elite Biomedical Solutions’ Alero Olomajeye; and BMES Director of Sales Nate Thomasson. Q: WHAT DO YOU SEE AS THE FUTURE OF PATIENT MONITORING? ASTLEY: We will see more focus on early detection of patient deterioration; it is not that patients suddenly deteriorate, it’s that caregivers suddenly notice. This means that we will see continuous

TECHNATION

MARCH 2021

GILMORE: I see remote patient monitoring (RPM) as a major future of patient monitoring. We have already seen that the prudent hospitals were able to implement RPM which helped them care for their non-critical patients during this pandemic when hospital resources were overextended. This, as well as other forms of remote care, is the future.

Oliver Astley, Ph.D. GE Healthcare Monitoring Solutions

monitoring proliferate in the low acuity wards, where patients are checked intermittently every four to eight hours. However, in the ward environment, patients are more active and generally encouraged to get out of bed and be mobile. This will demand that the technology applied is wireless, miniature and fits seamlessly into the caregivers’ workflow.

MANLEY: I see the future of patient monitoring as bright as ever. Manufacturers are making their equipment smaller and more intuitive, easier to set up and to operate. Self-diagnosing devices are not that far away. Some software does that now. I definitely feel we will see AI devices in our area soon. Telemedicine is becoming more and more popular. We may see monitoring devices designed for home use in the near future with wearable sensors and smaller-sized devices that can interface with a hospital or med center departments.

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ROUNDTABLE

NIRAULA: Wireless patient monitoring will impact how and where monitoring occurs. We anticipate that wireless medical body-sensor networks (BSNs) will replace the traditional lead set and bulky transmitter with the wireless body sensor with nano transmitter built within it. This will greatly help in patient transportation, flexible acuity monitoring, patient mobility and data integration, among other things. Additionally, with the availability of web interconnectivity, patient monitoring most likely will expand to remote monitoring from patient homes and 24/7 in daily activities. OLOMAJEYE: I see patient monitoring being more portable and accessible; on cellphones, watches and hand-held units that can connect to laptops and television displays; even video game consoles. THOMASSON: Patient monitoring will look much different as technology continues to evolve. If you consider that 15 years ago, we were monitoring a few vitals such as BP and ECG; now we have major pushes for end tidal C02 and, at a minimum, devices are accommodating Sp02, ECG, NIBP, temperature, arterial pressure, etc. Eventually, we will see an internal monitoring device that provides real time data of all bodily functions.

NIRAULA: COVID-19 has greatly changed the health care system. Reducing physical contact with patients who have contagious diseases will most likely lead to an increase in wireless connectivity. Touchless technology and remote monitoring could become more streamlined and common practice.

Duane Gilmore USOC Biomedical from a region remotely not in the same level of crisis. This can also help reduce exposure, and hence commutable disease risk, too, and can help to preserve PPE. COVID has also increased the need for disposable sensing devices, also known as disposable parameters. Disposable devices eliminate the workload required for cleaning, eliminate the risk of inadequate cleaning and eliminate the risk created when a virus is resistant to cleaning.

Q: HOW DO YOU SEE THE COVID-19 PANDEMIC AND SUBSEQUENT RESPONSE IMPACTING PATIENT MONITORING IN THE FUTURE?

GILMORE: COVID-19 was a wakeup call and hospitals will never again want to be caught unprepared. No hospital wants to be known as the one where lives were lost due to lack of equipment. So prudent hospitals will be prepared by having a reserve of supplies and equipment as a buffer against the emergencies of the future.

ASTLEY: Remote monitoring and disposable devices. In the height of a pandemic, medical staff from a range of specialties are called into action to help manage the patient load. Not all staff will have deep training on handling the COVID symptoms. This gap can be bridged by providing real-time monitoring data and control to specialists that could be thousands of miles away; this is powerful when one region is in the middle of a “wave;” they can get help

MANLEY: We will be flooded with requests for more monitors, pumps, etc. to be sold and repaired. As a result, our turn times will be impacted negatively. As parts become harder to get and priced higher when in short supply, we may lose the ability to repair devices within the typical turn times. We will work to keep the turn times as low as possible, potentially developing new work flows and procedures to manage the workloads today and beyond.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

OLOMAJEYE: This pandemic has led to the widespread use of telemedicine, compelling many to be familiar with their vital signs and what they mean. Patients will be able to place sensors and electrodes on themselves at home. I see people being able to measure their own basic vital signs and sending it to their physicians and nurses. This will lead to early diagnosis and treatment, thereby saving lives. THOMASSON: I think, in the past, monitoring equipment and monitoring in general has taken a back seat to imaging and higher dollar equipment. What COVID has proven is how important monitoring is across all departments of a health care facility. Monitoring equipment has proven itself to be absolutely essential in many cases and, as such, spare equipment and parts need to be ready at all times. Q: CAN YOU DISCUSS THE ABILITY FOR REMOTE PERFORMANCE INSPECTIONS, SELF-DIAGNOSTICS WITH TECHNICIAN NOTIFICATION AND SOFTWARE UPDATES AND PATCHES? ASTLEY: In the early 2000s, GE Healthcare began offering the ability to remotely view the operation of patient monitors; servers that support wireless patient telemetry; mission-critical networking; clinical data gateways; and clinical workstations by our Remote Online Center (ROC). This technology has evolved from sending critical notifications of component failures to providing real-time screen-sharing for technical support, pushing software

MARCH 2021

TECHNATION

ROUNDTABLE

images for staging updates and collecting device and system performance information. It continues to mature, looking to incorporate modern IoT fleet management technologies, including digital twin concepts. Devices could securely “call home,” reporting their status and any issues detected. Some conditions may turn into notifications directly to the customer via email or trigger a field service request. With redundancy in the system, it’s possible a failure of a component occurs and is corrected without any notice to the clinical users. GILMORE: It’s a must have for HTM professionals to have an asset management policy. Also consider asset management software that incorporates notifications and reminders. MANLEY: With Zoom, Teams and FaceTime we all have the ability to be virtually in the same space and looking at the same thing as the tech needing assistance. We have performed more of these calls in the last few months than pre-COVID. Self-diagnostic software makes our jobs easier. I expect to see more of that in smaller more portable devices. The next of generation of medical devices may recommend which

James Manley Avante

TECHNATION

MARCH 2021

staff and technician of not only a problem but the type of problem. The OEM technician can access the monitoring system and perform PMs remotely. For the inspections, troubleshooting, and updates that require physical access to the monitor, a tech on site can Zoom with the remote tech and/ or take a picture to do so.

Dip Niraula Agiliti

parts to replace, maintenance and calibration needs. Software updates may become more frequent in the future. As software being developed is more robust and harder to hack, I think we will see fewer patching needs for the next few years. NIRAULA: Remote performance inspections will enable technicians to inspect and diagnose the patient monitoring software and patches – as long as proper training and support is provided to them. Because of the fast-paced evolution of various medical technology, proper manufacturer training will greatly help technicians navigate any issues in medical care facilities. One key challenge technicians will face, however, is that in many cases, monitors are not networked and are used as bedside monitoring only. OLOMAJEYE: Most patient monitoring manufacturers have software updates and patches on remote servers that a technician can access and download securely. Patient monitors have a self-diagnostic software that is executed at power-up and stays on during operation. It sends alarms, PM times, error codes to display and emails (for certain servers), alerting the nursing

THOMASSON: While I am not a technician at all, based on experience and what I have seen, these are not only convenience features, but they could also be considered safety enhancements. The reason being is that the machines are smart enough to update themselves and diagnose themselves. In times like COVID where people need to be quarantined, this would be a huge benefit. It would allow the patient to be connected to the most updated monitor without risking another person being infected. Q: WHAT MEASURES ARE BEING TAKEN BY MANUFACTURERS OR CAN BE TAKEN BY HTM PROFESSIONALS TO SECURE THE OPERATING PLATFORM FROM CYBERATTACKS? ASTLEY: Manufacturers are utilizing the same security tools that are used in other fields. The challenge in patient monitoring is ensuring that security is met while not disrupting workflow nor patient safety. Hospitals have hundreds to thousands of patient monitoring devices and parameters; tracking them and updating them becomes a massive task. Remote update is complex because it must not disrupt the patient workflow. Our devices are on patients 24/7, we cannot simply do a force “reboot.” GILMORE: Cyberattacks garner attention after the damage is done. Health care providers cannot afford to be apathetic and we must be proactive. There are security tools and security professionals that can protect our high-risk institu-

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ROUNDTABLE

GILMORE: OEMs provide product specific training, certification bodies offer training, managers especially might benefit from quality process training such as Six Sigma. There are some great online options in this COVID-19 environment.

tions. My advice to health care institutions would be if you don’t have a cyber-attack policy, create one and begin to think about implementing financial-institutions level cybersecurity. MANLEY: We are seeing the development of a more “hack resistant” software. HTM professionals should close some of the entry points available and used by hackers if possible. It is important to stay abreast of the latest cyberattacks and the devices affected at other medical centers. Working with internal IT and manufacturers can also help reduce or eliminate their particular vulnerabilities. NIRAULA: The integration of clinical engineering with IT has proven to enhance service at the clinical level, but there is also increased risk with more interconnected devices. At minimum, HTM professionals and hospital staff should focus on removing, securing and isolating equipment as soon as an attack is identified. Many IT department are already equipped with the appropriate personnel to tackle these demands of cybersecurity. Yet, as technology evolves, so do cybersecurity threats – and the design of new devices should continue to emphasize better cybersecurity software and firewalls to protect the patient information. Also, in looking at the current technology, artificial intelligence could be integrated to make more statistically accurate security decisions. OLOMAJEYE: Manufacturers have security software already installed on the monitoring systems. They also have installation procedures that safeguard their systems from cyberattacks. Such as patient monitoring networks being isolated from the hospital network, strong passwords and network traffic monitoring. Manufacturers also work with IT departments during installation to ensure that the security and network

Alero Olomajeye Elite Biomedical Solutions

traffic monitoring software meets the standard of the hospital. During patches and updates this ensures that the security software is current and able to fight new cyberattacks methods. HTM professionals should involve their IT department in the process of purchasing patient monitors, installation and after, communicating any aberrant behavior in monitor operation, so they can plan and institute strong anti-cyberattack measures. THOMASSON: I think this closely relates to the previous question. Devices that self-diagnose and auto update could also be allowed security updates. Manufacturers should really treat devices as cellphones and push security updates to all connected devices. However, the security really starts at the facility level and the measures that are being taken locally to protect the entire facility network. Q: CAN YOU SHARE SOME TRAINING ACCESS OPTIONS FOR HTM PROFESSIONALS? ASTLEY: GE Healthcare technical training is available on both our external facing website and on GE Healthcare’s Service Shop.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

MANLEY: HTM professionals can look to their organization for guidance and support. Reach out to equipment manufacturers and dealers and inquire what type of training is available. There may be an independent that can fill the training needs. NIRAULA: The best advice is to not be afraid to ask for training if you’re interested. Many vendors will gladly send training manuals, videos and online training resources. Some training HTM professionals should seek includes Comp TIA A+, Security + and Network +. OLOMAJEYE: Training access options for HTM professionals include OEM technical training, AAMI website and the AAMI conference (annually). The HTM professional has access to service manuals for self-training, as well as HTM-to-HTM training and HTM association meetings. THOMASSON: For the equipment we service, we send our technicians to the OEM training courses. While industry trade shows such as MD Expo and AAMI are great continuing education opportunities, they do not provide the detailed training I interpret you to be asking about. However, the other benefit of going direct to the OEM training is that sometimes, the manufacturer will require this prior to allowing a BMET to order parts. In other words, attending the OEM classes and courses will sometimes unlock other levels of support and I can say this even from a third-party perspective.

MARCH 2021

TECHNATION

ROUNDTABLE

Q: WHAT CAN HTM PROFESSIONALS DO IN REGARD TO PARTS AVAILABILITY FOR PATIENT MONITORS? ASTLEY: GE Healthcare makes nearly all its parts available to HTM staff to better maintain our patient monitors. Parts can be ordered by calling our parts team at 800-437-1171 or online through our e-commerce portal Service Shop. We have increased our investment during the past 24 months, helping to ensure an ample supply of high-volume parts to meet our customers’ needs. GILMORE: Third-party service companies, like USOC Biomedical, have been instrumental in assisting HTM professionals with parts availably and overall costs savings. My recommendation is that HTM professionals give third-party service companies a try when a need for parts or service arise. MANLEY: 1. As part of the purchase of said equipment, med centers should include in the RFP or quote training and parts availability. 2. Check with the manufacturer to ensure they support in-house repairs. 3. Find a source of parts needed for repairs. 4. Use Avante patient monitoring for your parts, service and repair needs. NIRAULA: Failure rate for patient monitors has significantly decreased due to integration of technology. The most frequent failures are related to user interactions such as On/Off buttons and crashed displays. It is advisable to plan ahead, including building a stock of replacement parts of those items in order to improve turnaround time on repairs and anticipating equipment refreshes in advance. OLOMAJEYE: The HTM can stockpile commonly used parts (This pandemic

about the current patient state. GE Healthcare engineers are now designing systems that could help reduce length of stay, reduce transfers to high acuity units and improve patient outcomes. To do this, we are finding ways to make our devices wireless and as “invisible” as possible. We are liberating more data from “the monitoring box.” We see great potential to use heterogeneous and longitudinal data to predict and give deeper insights to the patient state. Nate Thomasson BMES

has shown the necessity for this). Always reach out to ISO or Elite directly. Elite carries not only OEM parts, but manufactures’ new, OEM-quality, replacement parts. THOMASSON: There are tons of resources out there for patient monitoring parts. BMES can provide parts for all of the products that we service; so, the obvious answer would be to always think of service companies as potential parts suppliers as well. However, the best advice I would give is that if a facility has equipment that is no longer supported and they have a unit go bad, purchase a used unit and keep the bad one for parts. Eventually those parts will be tough to come by and if there are no plans to upgrade, you may need those parts for a while. This is especially true for things like cases. The parts that take the physical abuse will be the ones that you need most often. Q: IS THERE ANYTHING ELSE YOU WOULD LIKE TO SHARE WITH TECHNATION READERS? ASTLEY: Patient monitoring is in the midst of a transformation. Patient monitors traditionally give information

GILMORE: 2020 was a year like none other. Due to the pandemic doctors and nurses get a lot of attention, deservedly so, they do great work. However, USOC wants to personally acknowledge the hard work of HTM professionals that might be behind the scenes but just as courageous and just as essential as the front-line medical workers. MANLEY: You will never find a better patient monitoring company to support your needs as well as Avante. We always go the extra mile, it’s just a habit. Thank you for your continued support. NIRAULA: The future of clinical engineering is now and will be increasingly more related to IT functions. OLOMAJEYE: Please stay safe, take precautionary measures, there is no harm in doing that. God bless you. And as always, we are here to help! THOMASSON: There are a lot of options in the patient monitoring service arena and that’s no secret. However, there aren’t many that have been in business, servicing monitoring equipment, for over 30 years. BMES is a great service provider and our longevity is a testament to how we take care of our customers.

For an informative video on patient monitors, visit 1TechNation.com/roundtable and select this months article! 46

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Small Victories Can Lead to Bigger Things

BY K. RICHARD DOUGLAS

hanging laws is often a grass-roots effort. The Founding Fathers believed that the political-legislative machine should be as close to the people as possible. That is why there are city councils and state legislatures. Keeping all the power vested in Washington, D.C. separates it from local decision-making.

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" We are prepared to discuss how existing regulations should already prevent rightto-repair monopolies in medical equipment but lack enforcement." – GAY GORDON-BYRNE There is a balance instead, a result of federalism. The nature of the American system is that new laws, and changes to existing laws, can be initiated at the grass-roots level. When laws are needed to protect or support the average citizen, then an effort can be made to influence lawmakers. This benefits taxpayers and consumers. The consumer exchanges hardearned wages for products. If the product breaks, a resourceful consumer can often repair it without incurring too much additional cost. When the ability to make a repair is withheld by a manufacturer, using the argument that restrictions on repair information and parts are meant to limit who can repair things to those the manufacturer deems qualified, then the consumer is left with few options. Manufacturers claim this is a safety and quality issue. More recently, they have expressed concerns about cybersecurity vulnerabilities if an unqualified person makes a repair. While many initiatives were put on hold during 2020, the right to repair movement gained more traction with legislation in 22 states. Indeed, the movement gained momentum. Changes in laws to support the right to repair have not been limited to the U.S. It has also been a focus of legislation in the European Union. In Europe, manufacturers are now mandated to make many common household appliances more easily repairable and long-lasting. In 2018, Apple customers in Australia won a right-to-repair lawsuit against the big brand when it told customers, who had devices that were inoperable, that they were not entitled to a fix because they had their devices previously serviced by non-Apple entities. While the right-to-repair topic was covered previously in TechNation cover stories, and the issues that impact the HTM community have remained largely

the same, the attention on the topic has increased. By the beginning of 2020, there were 15 states with active bills addressing the concerns of consumers focusing on all kinds of products. The issue has garnered substantial attention outside the HTM community also, as farmers, backyard mechanics and consumers have all found fault with the premises that handcuffed them in regards to self-service or repair. For HTM professionals, the questions often asked include “Why don’t I have easier access to operation and service documentation and special tools? Why are these things proprietary? If it is required, why is it not provided? How are you ensuring recommended procedures are followed if you do not have them? What is the effect on cost to the consumer of health care?” “There are roughly 22 to 25 bills expected to be active in states this winter. Of these, roughly half will focus on categories of equipment other than medical – ranging from bills for home appliances, farm equipment, mobile devices and batteries. The other half are more ambitious and include everything with a chip; including medical equipment,” says Gay Gordon-Byrne, executive director of The Repair Association. “We won’t know for another few weeks which bills will include the medical equipment category but we are prepared to discuss how existing regulations should already prevent right-to-repair monopolies in medical equipment but lack enforcement,” she adds. Byrne says that right to repair for medical equipment is being fought in Congress, led by Senator Ron Wyden of Oregon. “We think the bill has great merit but will dip deeply into the patents and copyrights that already legally protect manufacturers. I doubt he’ll be able to move the bill with these provisions,” she says.

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“Right to repair in states is being led by our Repair.org coalition – which now includes more biomeds and ISPs advocating with us in front of legislators. IAMERS has been a long-term member of Repair.Org and is engaged as well,” Byrne adds. EMPOWERING THE REPAIR MOVEMENT The year 2020 brought a renewed focus on the right to repair issue for several reasons. The ability of repair persons to interact with customers, or enter homes or businesses, was hampered in many ways. When Ralph Waldo Emerson first said, “build a better mousetrap and the world will beat a path to your door,” he was probably not thinking about creating a database of repair manuals, but that concept has proven successful. The website iFixit hosts 69,539 free repair manuals. The service was started in 2003 by two Cal Poly students in San Luis Obispo. It has 52 categories of brands/makes/models of ICU, transport, neonatal, and PAP ventilator repair documents. When OEM documents are not available, the website offers the potential for useful information. “Twenty-twenty was quite the year for right to repair. Our medical ventilator project was definitely a highlight, but here are a few other milestones we hit in the last half of the year,” says Olivia Webb of iFixit. “France announced that they are requiring repairability scores to be published on the packaging of specific products, and we started offering consulting services to help manufacturers comply,” Webb says. She says that a few months later, the European Parliament voted to make repairability and product lifetime labels mandatory “In the November election, Massachusetts passed the world’s most advanced right to repair legislation; a law that requires car

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manufacturers to allow consumers access to their car repair data,” Webb says. “We submitted requests to the Copyright Office to let us repair software-locked game consoles,” Webb adds. iFixit is just one online resource that provides technical information to help biomeds and others maintain and repair equipment. Another is MedWrench. MedWrench, available at MedWrench.com, is a product-focused support network where medical professionals, purchasing administrators, manufacturers, dealers and industry experts can provide opinions, share ideas and gather relevant information on medical technology and equipment. MedWrench has more than 111,000 registered users who help provide valuable information to the HTM community. It includes a service directory, forums and a link between medical equipment sellers and buyers. It covers topics such as calibration, training, preventative maintenance and technical support. Many of the site’s “gurus” provide advice, tips and more to help HTM professionals regarding a variety of topics such as PM tips, strategies, troubleshooting tips and ideas for career advancement. LONG AN HTM FOCUS With a renewed focus on right to repair, and alternatives to OEM-reliance availablity, the needs of the HTM department continue while being exacerbated by the impact of a pandemic. “When a caregiver’s needs, perceptions and/or expectations of a technology fails to be in alignment with the clinical situation, biomed is called in to solve the

issue. For this we rely on our relationships with our caregivers, our training and education, our knowledge of hospital and clinical systems, context and practices, our clinical engineering teammates and countless other things that one will never see in a factory service manual,” says J. Scot Mackeil, CBET, a senior anesthesia BMET at an academic medical center in Boston. He says that the biomeds of today are far more diverse in their capabilities and roles than they were in the past. “Having access to service manuals, procedures and parts are important to us for many reasons. We are capable of rising above challenges. BMETs and CEs are not defined or limited by what we have or don’t to work with. Our first priority is to the caregivers we serve and their need to have functional technologies to deliver safe, effective and equitable care for all our organization’s patients,” Mackeil says. He says that in a perfect world, all OEMs would collaborate with biomeds in this work but you can’t have it all. “Hopefully, things will change thanks to all those involved in the right-to-repair movement,” Mackeil adds. “Access to manufacturers’ service documentation and materials (e.g., troubleshooting guides, schematic diagrams, parts lists, etc.) has been a problem for in-house HTMs and independent service organizations (ISOs) for as long as I’ve been in the industry (more than 45 years),” says Stephen L. Grimes, FACCE, FHIMSS, FAIMBE, AAMIF, principal consultant at Strategic Healthcare Technology Associates LLC. “In-house HTMs and ISOs who are trying to ensure quality and safe support services (e.g., scheduled maintenance and repair) benefit when they have access to manufacturers’ service documentation

and materials. With this kind of information, they can both judge which services they are capable of delivering safely and effectively themselves [and] have the guidance they need on when and how to deliver those services,” Grimes says. He says that, unfortunately, many manufacturers (particularly the large, national medical device manufacturers) are very protective of this information. These medical device manufacturers (MDMs) variously claim that this information is 1) proprietary or 2) that it encourages non-qualified servicers to attempt to conduct scheduled maintenance and repairs. “Not surprisingly, most in-house HTMs and ISOs have a different view of MDMs’ actual motives for restricting access to these materials. Most HTMs and ISOs believe MDMs’ concerns (regarding proprietary material and risks of service materials falling into the hands of unqualified servicers) are disingenuous and that the MDMs’ reasons for not sharing are more often than not fear of perceived competition for service revenue from the in-house HTMs and ISOs,” Grimes adds. He says that the bottom line is that service materials are required for effective service. Failure by MDMs to supply the necessary tools, service keys, test equipment (including software) and education will undoubtedly compromise, or at least limit, servicers abilities. A DIFFERENT PERSPECTIVE Not everyone in HTM believes the issue of right to repair is focused on a bilateral contest of thought. Maybe there are other factors to consider. “Maybe this is a slightly different take than most when it comes to the right to repair issue – of which I’m supportive by the way – however I’ll

“ Access to manufacturers’ service documentation and materials has been a problem for in-house HTMs and independent service organizations for as long as I’ve been in the industry.” – STEPHEN L. GRIMES 52

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share it nonetheless. Sorry if it comes across more like a blog, however I’m sort of tired of how this issue is being debated because I’m not seeing many people support patient care/outcome advocacy and that should be front and center in my opinion. Maybe this belongs in an op-ed piece; however, I believe that most of us have it all wrong,” says Perry Kirwan, vice president of technology management at Banner Health. “This issue (I guess like most issues these day) tends to be one of polarization. Supporters of ‘right to repair’ galvanize around the shortage of qualified repair personnel, access/ restriction (tools, passwords, service personnel, etcetera), choice (the ability of the technology owner to make decisions on managing/supporting that technology), and the inherent costs of what that means,” Kirwan says. He says that opponents of right to repair typically cite patient safety/risk, that it’s giving unregulated, third-party medical device service companies unfettered access to proprietary service materials and tools to maintain and repair sophisticated, highly regulated medical devices, medical device cybersecurity implications, disparities in accountability (FDA oversight, adopting/ adhering to quality management systems, etc.) between original equipment manufacturers and non-OEM service providers, and denial of a labor shortage of qualified personnel. “What is seemingly missing in the discussion is who it is that we are all trying to collectively serve – and that is the patient. Many of us profess to engage in the concept of patient-centered care, however most issues cited by either side get tainted by things other than that. My supposition is that if the support of medical technology was evaluated through that all important lens – we wouldn’t be debating and, frankly, squabbling about that the things that we are, as they do not have much to do about the patient in the end analysis,” Kirwan says. “But the problem is that the patient doesn’t make for an easy punching bag.

Who is against optimal patient care? And so, both sides conjure up other points in the interest of sounding like they are championing patient care. These points make good soundbites, however, in the end they allow the larger discussion to completely reset based on how we choose sides to fight each other,” Kirwan adds. Kirwan asks; “And, what is the collective we are fighting for?” He says that if one didn’t know better, it appears to be revenue generation, market share, property rights, who gets it, who doesn’t, and the list goes on. “What we don’t hardly see is a discussion that is patient-centric, because if we did; sides would be sitting down with each other designing solutions that actually help realize the triple/quadruple aim for health care,” he says. THE FDA PERSPECTIVE In 2016, the FDA put out feelers to get a reading from the medical device manufacturer and repair communities. Responses came from OEMs, HTM professionals, ISOs, The Joint Commission and other stakeholders. The agency’s updated perspective is as follows.“The FDA’s authority to regulate the servicing of medical devices by any entity, including original equipment manufacturers (OEMs) and independent service organizations (ISOs), is grounded in the agency’s authority to regulate medical devices and radiation-emitting electronic products under the Federal Food, Drug and Cosmetic Act,” says FDA spokesperson Shirley Simson. She says that the act mandates that all devices have a reasonable assurance of safety and effectiveness. “The applicability and enforcement of regulatory requirements by the FDA depends largely on the specific activities performed by an entity. FDA generally has not enforced requirements for servicing activities, including those performed by hospital biomedical engineers and technicians, as long as they don’t significantly change the device’s performance or safety specifications, or intended use,” Simson says.

EMPOWERING THE BIOMEDICAL/HTM PROFESSIONAL

She says that while FDA is responsible for the oversight of servicing of medical devices, several other organizations play an important complementary role in the safe and effective servicing of medical devices, including the Centers for Medicare and Medicaid Services (CMS) (conditions for receiving federal payments for health services), state regulations for repair of medical equipment, standards development organizations such as the Association for the Advancement of Medical Instrumentation (AAMI) and the American National Standards Institute (ANSI) and health care facility accreditation by organizations such as The Joint Commission which operate independently. “The May 2018, FDA Report on the Quality, Safety and Effectiveness of Servicing of Medical Devices summarizes perspectives and needs of stakeholders based on FDA’s evaluation of the available objective evidence related to the quality, safety and effectiveness of medical device servicing, including information received via the 2016 public workshop and nearly 200 written public comments. Further, as indicated on CDRH’s Proposed Guidance A-List, FDA intends to issue draft guidance on Remanufacturing of Medical Devices in 2021,” Simson adds. During an otherwise dismal year, the right-to-repair issue gained some traction and that can’t hurt the overall effort. If victories are won for auto repair, cellphone repair or even harvester repairs, in state legislatures, it can help build the foundation for more access for medical device repair. It is all about momentum. There has to be a give and take which satisfies all parties. In the end, as Kirwan points out, the “true customer” must be the focus. “From the lens of the patient – we are actually stronger and more effective working together rather than against each other. So, if the voice of the true customer, the patient, says work together – how do we expect to further advanced patient care and outcomes doing the opposite?” he asks.

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CAREER CENTER

Should Grads Accept First Job Offer? BY KATHLEEN FURORE

ccording to the third annual Campus To Career Report from Handshake, a site that connects students with prospective employers, only 39% of students surveyed felt confident or extremely confident in finding a job or internship by summer 2021. The question many of these students have: Should I take the first job offer that comes along – even if it isn’t exactly what I’m looking for?

Here, career experts weigh in with their advice. “Often after graduation students are eager to take any opportunity that comes their way. In the current climate, as we continue to face a global pandemic and economic uncertainty, those feelings might be even stronger,” says Christine Cruzvergara, vice president of higher education and student success at Handshake. “While graduates shouldn’t lose sight of what truly motivates and interests them in the workplace, they should be more flexible when responding to job offers.” Being flexible, Cruzvergara explains, means focusing on opportunities that allow these young job seekers to build a strong, transferable skill set. “Even if the job isn’t exactly what they had envisioned, it is important to focus on what one can learn by being part of the larger organization – you’re able to learn about company structure and process, different roles and responsibilities, and general workplace habits and skills,” she says. “If they are fast learners and perform well in one

Kathleen Furore position, they’ll set themselves up for greater opportunities in the future.” Cruzvergara also says it is important to remember that there are different perks for different types of opportunities. “At a big company, entry-level workers might have fewer responsibilities, but higher pay; smaller start-ups tend to offer lower salary compensation, but often offer greater responsibilities and other perks like a stake in the company through equity,” she says. “Remember that there are always learning and networking opportunities in any position, and there can be opportunities to move into a different role at the company once one has proven oneself.” Laurie Berenson, of SterlingCareerConcepts.com, says she coaches her clients to understand that value of an entry-level position is often better viewed as part of the bigger picture. “For instance, consider the value of getting into a large, reputable employer

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with the plan of advancing or switching departments after a couple of years or accepting a junior position working for someone respected or well known in an industry,” Berenson advises. “A junior position at an up-and-coming startup or a company known for being an industry disrupter can also offer value. Junior sales positions can also teach valuable lessons in work ethic, communication skills, and follow up ... One position earlier in my career that taught me quite a few life lessons was a sales job,” she adds. But what if the job offer is in a completely different industry or area of interest? “One can always pivot back to an area of interest or industry,” Berenson says. “Or this initial job may open up or create opportunities that will unexpectedly take you in a different direction. All things [being] equal, if I were an employer interviewing young professionals during, say, the year 2023, I would much prefer to see someone who accepted a role out of college in 2021 and rolled up their sleeves, worked hard and gained experience versus someone who chose not to accept a position because it didn’t fit their expectations and ended up wandering around for a year after college. Employers value work ethic, drive and the ability to switch gears. Show them you have it!” KATHLEEN FURORE is a writer and editor who has covered personal finance and other business-related topics for a variety of trade and consumer publications. You can email her your career questions at kfurore@yahoo.com.

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