How do you measure a year? That was a question posed to six members of 24×7 Magazine’s editorial board—members who are arguably some of the biggest names in healthcare technology management.

In this expert roundtable, these HTM heavy-hitters—Benjamin Esslinger, CHTM, CBET, clinical engineer/manager at Eskenazi Health in Indianapolis; Clarice Holden, BSE, chief biomedical engineer at the Dallas VA Medical Center; Wayne Hibbs, CCE, senior technology adviser at Indianapolis-based BSA LifeStructures; Jeffrey Ruiz, manager of healthcare technologies for Aramark at Holland Hospital in Michigan; Binseng Wang, ScD, CCE, principal consultant with health technology consulting firm BSI; and Gordon Hosoda, chief of healthcare technology management at VA Portland Health Care System—sit down with 24×7 Magazine Chief Editor Keri Forsythe-Stephens to discuss the last 12 months in HTM and reveal what they expect to see in 2019.

Keri Forsythe-Stephens: In your opinion, what have been the biggest issues in HTM in 2018?

Binseng Wang: [The top issues have been] the FDA servicing regulation report issued in May and the FDA’s recently announced intention to issue a guidance on the differentiation between service and remanufacturing. Almost hidden in the FDA’s October white paper is [the agency’s] willingness to include service manuals in the “labeling” requirement.

Other key issues include the Right to Repair legislation currently in consideration in several states, as well as [general] confusion [regarding] implementing alternative equipment maintenance mandated by CMS and its accreditation organizations.

Jeffrey Ruiz: With more of the industry advancing to cloud-based CMMS and cybersecurity scanning solutions, we now have instant and transparent data that we must immediately respond to. In doing so, we will be asked to respond according to our established processes and procedures. This will test how effective these processes and action plans will be in response to these events.

We need to make sure these are updated and [communicated properly] to our respective teams. Technology and risks are ever-increasing, and we have to make sure our teams have the [appropriate] tools and, more importantly, know how to use them.

Gordon Hosoda: From my perspective, the biggest issues we’ve encountered have been obtaining sufficient staffing levels to handle the new Joint Commission requirement to follow OEM procedures and manage the growing number of networked medical systems. [After all, networked medical systems] now have increasingly stringent approval processes (at least within the Veterans Affairs system) that are required in order for the system to gain access to the hospital network, and they also require long-term support to manage the security requirements and upkeep.

From a more global perspective, I think one of the biggest issues that HTM has been facing in 2018 is becoming aware of, and addressing, the vulnerability of medical equipment to cyberattacks. While medical equipment is probably much lower on the menu than other higher-value targets (such as the recent Experian hack), it is likely that medical equipment could become a relatively easy access point to the main hospital network once hospital systems become a more valuable target to hackers.

Clarice Holden: Yes, one of the biggest issues in HTM during 2018 has been the cybersecurity of patient information. Working with vendors and encouraging safe information practice within the hospital has been paramount. While HTM staff members have a handle on the dangers, it seems there is room to improve for clinical staff, many of whom will still plug in personal devices to hospital computers.

Also, the perception of the field has been a topic for the general public—indirectly. Through the documentary “The Bleeding Edge,” released in late 2018, medical equipment innovations have rightfully been presented as at times hazardous (when misapplied or rushed through approval processes). While not everyone in HTM is in a position to act or support implant devices (which were two of the main products explored in the film), HTM does play a key role in many hospitals regarding the selection and procurement of new technology. Audiences were aggressively reminded of the No.1 priority in hospitals and the HTM world: putting patients first and keeping them safe while they receive care.

Benjamin Esslinger: [In a phrase,] professional development/education. The current issues in the HTM industry are ever-changing. Whether it is cybersecurity, high-level disinfection, sterile processing, risk, compliance, quality, or a multitude of other possibilities, the one thing that impacts our industry’s capability to handle these issues is professional development and education. All HTM professionals should view the growth of knowledge as the overarching prerequisite to fixing these identified issues.

Wayne Hibbs: I believe there have been three key issues: justifying staff and training expenses [to hospital administration]; recruiting and training qualified employees; and [keeping up] vendor relations for documentation, training, and service contract options.

Forsythe-Stephens: ECRI Institute cited cybersecurity concerns as the top health technology hazard for 2018. Have you found this to be true in your line of work? Why or why not?

Hosoda: I concur with ECRI’s opinion and have found it to be true in the VA system. The VA Office of Information Technology has been focused on cataloging, monitoring, and ensuring the hardening of medical equipment systems against all recent threats, such as WannaCry and Meltdown. In addition, the approval process required for medical systems to access the VA Internet is becoming increasingly stringent.

Hibbs: Well, ECRI has focused on concerns, which include the hospital IT network and electronic medical records. And although we have seen hospitals in our region subjected to ransomware and hacking, we have not seen medical equipment software or data targeted. [Even so], we continue to see software and firmware upgrades used by vendors to justify service contracts and used as up-charge sales tools.

Esslinger: [Similarly to what I mentioned earlier], cybersecurity has an educational gap that has proven to be difficult. The time it takes to grow knowledge versus the threats associated with cybersecurity make this topic even riskier within healthcare. [Moreover,] cybersecurity has impacted HTM professionals across the globe and will continue to be a major topic. I do agree that this is one of the larger health technology hazards for 2018, but it’s far from the only significant issue we face.

Holden: Yes, safeguarding patient information has been a huge priority for hospitals in my region, and not just patient information, but also the software that controls the functions of medical devices and systems. If the information is jeopardized, patients are at risk of having their identities stolen (in the case of personal or medical details)—but if the medical equipment fails to function due to software or networking infrastructure becoming infected (such as routers), patients are again put at risk due to delays in their care.

Wang: I don’t agree totally [with ECRI] for these reasons: While cybersecurity is important, most of the attacks are not aimed at medical equipment but at hospital IT systems for monetary reasons (aka: ransoms). Equipment attacks are typically collateral damage. Individual pieces of equipment are more at risk from unintended contamination by viruses and malware through USB and other ports, including WiFi and Bluetooth. Further, most hospitals are now managing external threats fairly well, but they’re unable to deal with the internal ones due to the vast amount of open ports and access means.

Ruiz: Absolutely this is a focus, and I think we as an industry are making great strides; however, we are not there quite yet. I saw some great presentations at last year’s AAMI convention showing key steps to setting up medical device security programs. My hospital has been laser-focused on cybersecurity and we are working on finalizing our security program and looking at various medical device scanning programs. The end goal is to have a process established where vulnerabilities can be identified preemptively and, therefore, acted upon to help mitigate the risk.

What’s interesting is which of these medical device scanning vendors will survive. A majority of these vendors were not around even 10 years ago so their long-term focus [isn’t fully apparent.] Having an established program and staying current with the latest developments will be a key challenge for the industry.

Forsythe-Stephens: The greying of the biomed field has consistently been mentioned as a top concern among HTM professionals. How do you think HTM departments can recruit new blood to the field?

Esslinger: HTM professionals should join efforts with AAMI, state HTM societies, and educational institutes that provide [biomedical engineering] degree. The initiatives these groups have already set in motion need all the help they can get to improve upon the recruitment to our field. Get involved early and often.

Ruiz: Unfortunately, our industry is in the same position as many of the skilled trades. We can’t just hope that our local biomedical engineering programs are going to keep churning out talent. We are in direct competition with the skilled trades and four-year colleges. We can take some short-term steps, such as actively sharing our stories with local high schools, technical schools, and veteran programs to help draw interest to our programs.

We could also have members from our respective teams provide a guest lecture at these programs to help connect with students and give them a glimpse of the real world. I would also say we should look at programs like Hope Builders, where they focus on opportunities for inner-city students to better themselves.

Finally, are we able to look at recruiting talent from overseas? While attending 2018’s AAMI convention, there was a Canadian instructor who had close to 30 students who were willing to relocate to the U.S. for work. I know that I may be grasping a bit here; however, we are fast approaching a critical crossroad. If we do not start developing effective, actionable plans to develop talent, then we may be faced with insurmountable deficits that we can’t turn around. And this is not just for the HTM industry; it includes the manufacturers, as well.

Wang: When wages start to rise due to the shortage of professionals, newcomers will flood in. Unfortunately, this influx does not ensure quality; therefore, HTM professionals must finally lobby for professional licensure by states, so young talents know that they have a secure future instead of unfair competition by unqualified individuals. In addition, those in the HTM industry must better explain to the general public and students the benefits—and career opportunities—provided by HTM.

Holden: Get out and talk to high school and college students. Invite them to shadow engineers and technicians on the job; go to career fairs; work with human resources to discover opportunities to present the job and encourage applicants for open positions; visit schools; etc. HTM, as a whole, needs to do more self-promotion. We need to energize students to encourage them to study HTM and show/tell them what a fulfilling field this is.

Hibbs: As a certified clinical engineer since 1979 and someone who has worked in the field since 1975, I have been one of the whistleblowers. [One issue I’ve seen is that] college [students] and those in the military are choosing IT/information systems careers instead of HTM because they fit in better with their interests. Also, a high percentage of the undergraduate biomedical engineering students that I work with and try to recruit [to the field] decide to go to medical school instead of expanding their biomedical engineering education. They do make excellent medical students, though.

Hosoda: I find the “greying” of the biomed field to be an opportunity, rather than a risk. Years ago, medical equipment was mostly standalone with proprietary circuit boards comprising the operational unit, and biomedical support was typically more limited to board-level repair. Medical equipment has clearly become increasingly PC-based, server-connected, and networked.

Support now may involve board-swapping to repair operational issues, but also a much higher level of software, server, and networking knowledge to troubleshoot and remedy operational issues. To this end, I feel that HTM needs to increase the depth of knowledge of PCs, servers, and network requirements that are required for IP-based medical equipment systems. I see this as an opportunity to expand the reach of our field into areas that had previously been more relegated to the silo of hospital IT.

Forsythe-Stephens: Along those lines, the division between biomed and IT is increasingly being blurred. How is the rise in networked systems changing the face of the HTM sector?

Holden: I think we are seeing a lot of crossover and higher-level thinking among engineers and technicians. Managing networked systems requires troubleshooting knowledge and skills—something technicians generally have ample amounts of. The system management/project management skills attuned to engineers are well suited to the myriads of networked or networkable devices which are coming into hospitals.

So, technicians are developing project management duties and engineers are learning to more effectively troubleshoot systems in order to successfully take care of the networked systems. An array of both skill sets is needed for a biomed to be successful with a hospital’s medical information technology.

Wang: Just like how almost everyone uses smartphones these days, IT is simply an integral part of medical instrumentation. With the Internet of Things, this will be even more pervasive. Many people seem to forget that 60 years ago, we did not have computers and, 90 years ago, electronics [didn’t exist]. However, watch out for “wetware” (tissue and bio-engineering) coming and making both hardware and software almost totally obsolete in the not-so-distant future.

Hibbs: When I was an electrical engineering student, we studied circuit diagrams, troubleshooting, and board-level component replacement. Nowadays, biomedical and computer hardware students study diagnostic service applications—not clinical diagnostics—and board-level replacement.

Ruiz: I feel that we have been given a second chance to take a more active role in networked systems. I remember, years ago, the industry took a pass on fully engaging with early IT/networking tasks. For people who have always viewed themselves as problem-solvers, we now have a second chance to draw from both our clinical and technical experience to help our brothers and sisters in IT solve the various networking challenges.

By partnering with IT, we can combine our strengths for the benefit of our patients. But we have to get out of our comfort zones to help out. Our team, for instance, took a chance a few years ago in supporting our hospital’s EHR device integration project. By opening the lines of communication between our team and IT, we were able to successfully implement the project. Not only was this a success for both teams, but our team took pride in the skills that they learned and were able to implement.

Hosoda: Overall, HTMs need to increase their focus, awareness, and knowledge of computers, servers, and network requirements for IP-based equipment. This will require additional education and possibly certifications to boot.

The HTM support team will need to pursue knowledge in these areas in order to manage the increasing number of PC/server-based networked medical equipment. At my site, we welcome the blurred lines, and are taking ground in the IT area wherever and whenever we can. This impetus is assisted by the nationalization of the VA Office of Information Technology support, which is reducing both the number of staff at the local site, as well as their IT access and rights to effect repairs at the site level.

Esslinger: HTM professionals should ensure that they are keeping up with technology. With the new ecosystem of equipment, HTM professionals must have basic networking skills as a minimum. I believe we are now working to define the partnership and job duties shared. Working together makes us better and more capable of accomplishing larger goals.

Blurred lines are no longer an option, but a hindrance to the risks associated with the Internet of Medical Things. Additionally, HTM leadership should work to ensure that educational opportunities are available for staff to ensure that the knowledge/language barriers between HTM and IT no longer [exist].

Forsythe-Stephens: 2019 is only weeks away. From an HTM standpoint, what do you think will be the biggest issues in the field in 2019?

Hibbs: [The biggest issues will likely be the fallout from the] September TriMedx acquisition of Aramark (For instance, will manufacturers continue to provide direct service contracts or will they begin to negotiate with TriMedx for their warranty and service contract offerings?) and whether IT/information systems and biomedical services departments will merge into “technology services.”

Ruiz: [The biggest issues will likely be the] continued focus on cybersecurity solutions, the further migration to cloud-based CMMS’, and possibly artificial intelligence-infused alternative equipment maintenance solutions that could help reallocate our resources from PM tasks to transition to cybersecurity and device integration assignments.

Hosoda: I seem to keep harping on the same subject, but sufficient staffing is required to manage the increasingly complex networked medical equipment, and all the related needs for vetting, integration, and long-term support of servers, network communications, virtual local area networks, access control lists, etc.

Holden: The biggest issues will be finding responsible parties not just for FDA-cleared medical equipment, but the medical technology in the hospital as a whole. Being able to manage the increasingly networked environment of not just medical devices but also other patient-utilized technology in the hospital, such as wayfinding and temperature monitoring, will be a huge opportunity for the development of HTM departments into greater stewards of technology. This will most likely help fill the chasm between straight-IT duties and the developing HTM department.

Wang: The Medical Imaging & Technology Alliance (MITA) and others will continue to push Congress to set servicing regulations and oppose the right to repair at the state level. Also, healthcare costs will continue to put pressure on all healthcare professions—including HTM—so now more than ever, HTM professionals will have to be proficient, if not experts, in managing their finances and justifying their existence based on value (i.e., cost/benefit ratio) instead of just hanging on to “safety” and “preventive maintenance.”