Four of HTM’s biggest names tackle 2021, what’s to come
How do you assess a year—particularly one as eventful as 2021? Below, four of the top luminaries in healthcare technology management (HTM)—Binseng Wang, ScD, CCE, fAIMBE, fACCE, vice president of program management at Sodexo HTM; Clarice M. L. Holden, BSE, supervisory biomedical engineer at Dallas VA Medical Center; Matthew F. Baretich, PE, PhD, president of Baretich Engineering; and Paul Kelley, CBET, AAMIF, director of biomedical engineering, the Green Initiative, and asset redeployment at Washington Hospital in Fremont, Calif.—discuss lessons learned from 2021 and what to expect in 2022 and beyond.
24×7 Magazine: Like last year, the COVID-19 pandemic vastly affected hospital operations. From an HTM perspective, what were the biggest changes COVID-19 brought to the industry in 2021? Do you think they are here to stay?
Paul Kelley: We’re seeing a shift to telemedicine, with devices moving from the hospital to the home. I don’t not see that reversing. Also, facilities have recognized the need for emergency supplies, including still usable “retired” medical equipment.
Many of us had to go to storage rooms to collect and revive equipment that had been retired. I hope that won’t be forgotten in the future. I think because of the supply chain issues, organizations accepted more non-OEM parts and accessories. In the past, they may not have considered such things, but now that hospitals are using non-OEM parts, the trend may be here to stay.
Binseng Wang: The pandemic made healthcare delivery organization (HDO) leaders more aware of the critical nature of CE/HTM for the HDO’s mission of patient care. This will help us to get more attention and support for our operations. Like most disasters, it’s unfortunate that, with time, such awareness may wane, and we will again need to remind those leaders of the essential nature of our services. Another lesson learned by HDO leaders is that they can’t rely solely on the OEMs for service, as many were not able—or even declined—to send their field-service personnel to the HDOs during the pandemic.
While a few OEMs were willing to assist the onsite teams to keep their equipment running, some still refused to cooperate. In other words, HDOs will have to depend on their on-site CE/HTM teams—whether in-house or outsourced—to perform most of the maintenance services in order to provide continued care and avoid patient diversion. Finally, like with many other industries, we have experienced a significant exodus of CE/HTM professionals, mostly due to retirements and sometimes due to personal and family issues. Unfortunately, this labor shortage is likely to continue for a few years.
Matt Baretich: To respond to the pandemic, hospitals spent a lot of money that they [didn’t budget for]. Now, as hospitals deal with pent-up demand—elective surgeries, delayed care, etc.—there will be pressure to contain costs. Therefore, HTM needs to continue to find ways to work cost-effectively.
Moreover, the healthcare delivery system has expanded its telehealth capabilities—and that’s likely to continue, so HTM needs to build its capacity for supporting telehealth services.
Clarice Holden: Two things were very evident: the cleanliness of devices from infectious particles came into laser-focus, as well as the need to prevent burnout while also adequately staffing hospital biomed departments. At the start of the pandemic, with a good number of unknowns regarding COVID-19, equipment used for COVID-19-positive or suspected positive patients was sequestered in areas and subsequently cleaned before it was delivered to shops. In some hospitals, an area of the shop was cordoned off specifically for soiled equipment. If shops had only paid cursory attention to equipment cleanliness, it became paramount after that.
From a staffing perspective, when some [regions] shut down, biomed techs and engineers kept coming to work. Instead of a few weeks of no activity, staff kept up their important work. The stress of being on the front lines—wondering about having enough equipment to treat patients, worrying about friends or family who may be stricken by COVID-19, and enduring screenings and questions getting into work—was enough to cause exhaustion.
Some new work situations alleviated that—for instance, some engineers were able to telework for part of the time—but technicians’ work did not lend itself as easily to that arrangement. Even so, having biomeds out of the shop helped to alleviate spacing and allow for physical distancing. The flexibility in workplace will most likely be a part of the industry in the future for HTM managers and biomed engineers—as other industries are also adopting part-time telework as a benefit to employees to reduce stress by lessening a commute.
24×7: Cybersecurity is, without a doubt, one of the biggest issues impacting HTM. What are some steps biomeds can take to promote medical device security?
Baretich: Medical device networking will continue to grow. HTM needs to expand its role in promoting safety and effectiveness for these devices, including attention to cybersecurity. It’s another opportunity for learning and growth in the HTM community.
Holden: Biomeds can educate themselves about the reasons for encouraging medical device security and practice those tenets. Taking these concepts and being able to discuss them in a non-technical way with clinicians and executives will promote device security. Reading a cybersecurity news website to have examples of why to follow the tenets of medical device cybersecurity is also a good strategy to increase awareness.
Kelley: Get involved early. When departments are looking at new devices, find out if they will be connected to anything—and preferably how. Get the Manufacturer Disclosure Statement for Medical Device Security early and start planning.
There are some great reference tools, from several sources, including AAMI, ACCE, ECRI, 24×7, and more. I highly recommend subscribing to received notices from Health-ISAC (https://h-isac.org/ and the Cybersecurity & Infrastructure Security Agency, which is part of the Department of Homeland Security, at https://us-cert.cisa.gov/ics and https://www.cisa.gov/. And working with the IS security team is huge. Get to know them and earn their trust.
Wang: Above all, HTM professionals need to learn the basics of cybersecurity, including the jargon and techniques. Next, we need to communicate well with our IT counterparts and explain to them the special care needed for medical equipment (e.g., one cannot allow it to reboot itself automatically after updating operation system and antivirus software because it could put patients at jeopardy).
Another challenge that some of our IT colleagues are unaware of is that some equipment may have open ports, such as USB ports, that need to be secured to prevent inadvertent introduction of malware by clinicians or patients trying to charge their cellphones. Finally, we need to help clinicians understand how to prevent cyberattacks coming through medical equipment.
24×7: In addition to cybersecurity, what other medical device-related issues are keeping you up at night?
Holden: The future of the workforce keeps me up at night. There seems to be waves of knowledgeable professionals retiring, and while they have absolutely earned it, I think HTM is still a fairly well-kept secret to students. The medical device managers of the future are the middle and high school students of today—are we reaching them effectively? Are we advertising the HTM field as an engrossing and fulfilling one? I think there are more opportunities for us to do so.
Baretich: There is some evidence that adverse incidents have become more common during the pandemic. That could be because of staff shortages, dismay with the politicization of vaccination and public health measures, and general burnout. Be kind and be vigilant.
Wang: Even more important than cybersecurity is the Right to Repair (RtR). Some OEMs are becoming more aggressive in preventing others from maintaining and repairing equipment that they manufactured. The RtR issue is no longer limited to service manuals and proprietary parts. More significant are the keys to the software locks (software codes) needed to access the diagnostics, calibration, and configuration software embedded into the equipment.
If the RtR issue is not solved properly, not only will CE/HTM professionals not be able to promptly repair the equipment and, thus, ensure HDOs’ ability to provide timely and safe care, but it will also force HDOs to spend billions of dollars to buy back-up equipment and replace equipment more often. I explained this in detail in my July 24×7 Soapbox article, published here.
Kelley: The Right to Repair is a really big thing, and it handcuffs us a lot. This, combined with the ever-shortening lifecycles and quicker obsolescence of equipment, is a much greater drain on resources than ever before. Another huge resource drain is the ever-increasing recalls. My personal feeling is that these companies are pushing new devices and improved ones to market as fast as possible because they have less time before the next technology moves in.
24×7: What emerging healthcare technologies are you most excited about and why?
Kelley: I am excited—albeit a bit hesitant—about artificial intelligence and machine learning. AI and machine learning are especially making huge advances in diagnostics, which will help save lives and reduce risks. But my hesitation lies in the fact that the programing is only as good as the programmers were. We have seen inadvertent biases incorporated into some of these programs.
Holden: I’m most excited about the integration technologies. As devices are able to be networked, being able to collect, display, and utilize the information and diagnostics remotely is what will differentiate highly effective department management from adequate management.
Wang: While AI—or, more appropriately machine learning—has dominated the media and even academia, the technology that I’m most excited—and, at the same time, concerned about—is genetic engineering. More specifically, the gene splicing and editing technology that was recognized with the Nobel Prize in Chemistry 2020. This technology will likely make many medical and surgical procedures obsolete and, thus, affect the medical equipment associated with those diagnostic and therapeutic procedures. For example, it’s likely that kidneys transplanted from donors will be replaced by kidneys grown from the patient’s own tissue, thus almost eliminating the need for hemodialysis (except for a very short-term during the growing of the new organ).
Baretich: We have learned a lot about infection prevention during the pandemic. There is a lot of interesting work underway to make autonomous robots practical (and economical) for application of UV disinfection procedures.
24×7: Why should someone pursue a career in healthcare technology management?
Wang: Despite the rapid advancement of healthcare technologies, someone still needs to manage and maintain medical equipment in healthcare delivery organizations. Unlike manufacturing, CE/HTM cannot be offshored to other countries, since patients need care—and equipment—near them. Obviously, the equipment will become much more complex and move into the laboratory side. So, CE/HTM professionals will have to learn new technologies throughout their career.
Holden: There are few jobs as rewarding, versatile, interesting, and variable. Every shop is a different environment, but each shares the same goal of taking care of patients through effective healthcare technology management. HTM is a secure job—it’s not a profession that lends itself easily to automation. It’s also not one that you can just internet search how to do (at least, not for most procedures).
Baretich: There are lots of interesting problems to solve and lots of good people to work with. It’s also very satisfying to know that you have improved the safety and efficacy of patient care.
Kelley: In short, you indirectly save lives and help people. You get to be on the bleeding edge of technology and learn about the latest devices. You get to be the hero when you are the expert who can resolve an urgent issue. Plus, no two days are ever alike in HTM.
24×7: The U.S. Copyright Office recently submitted new exemptions to the Digital Millennium Copyright Act that relate to the repair of digital devices, including medical equipment. The new rules also loosen a 2015 exemption granting access to medical device data. What do you think about this development and why?
Baretich: It’s movement in the right direction, but it remains to be seen what impact it will have on our day-to-day HTM work.
Wang: This is certainly a step in the right direction. However—and this is a big however—this step is not enough to ensure the ability of CE/HTM professionals to maintain medical equipment. As stated in my July Soapbox article, some OEMs are likely to use cybersecurity as an excuse to limit access to the embedded diagnostic and maintenance software (aka: “privileged access”).
So even though it’s not illegal, per the U.S. Copyright Office, to access medical device data, such access is very difficult—if impossible—without the OEM-embedded software keys. Certainly, CE/HTM professionals should not break into the embedded software as that would violate FDA medical device regulations.
Kelley: Another big step in the right direction? The Presidential Executive Order pushing the Right to Repair. Over the years, we;ve allowed manufacturers to squeeze us out, so that their own service teams can keep the profits. Even though we’re capable—and available—to service a device, in some cases surgical patients have been closed up and their surgeries rescheduled due to the OEM rep having to travel a long distance to the hospital.
Holden: This sounds like a promising move toward greater sharing of medical device information, possibly to encourage hospitals to be able to service and strategize with data previously unavailable to them. Medical devices often require service keys, which are unobtainable unless a technician is factory-trained, or with a costly service contract. Making equipment information more accessible at a smaller cost is beneficial for hospitals that need to find ways to conserve funds while maintaining service.