By Chris Hayhurst                                                                                              

The HTM community had a lot to talk about in 2016. Here are a few of the year’s biggest headlines.

Every year around this time, we take a step away from latest news in HTM to recap the events of the previous 12 months. In 2015, you may recall, the spotlight was on the challenges of IT integration and cybersecurity, as well as nagging issues surrounding alarm management. There were also concerns about the “aging profession”—how biomed departments will deal with the fact that so many HTM professionals are approaching retirement. “Everything Old Is New Again,” our story read; things like patient safety and finding ways to trim costs were again at the top of everyone’s mind.

And in 2016? Well, if we were to base it on the popularity of the articles we ran—and on the comments we’ve received from many of our readers—cybersecurity remains a pressing point of interest, in large part because data breaches are becoming more and more common.

“We still haven’t figured out how to prevent hacking,” notes Binseng Wang, ScD, CCE, fAIMBE, fACCE, director of quality and regulatory affairs at WRP32 Management in White Plains, NY. “And unless we do,” opines Wang, who is also a member of the 24×7 editorial board, “the more devices we connect to the Internet, the worse it’s going to get.”

Also near the top of the year’s most talked-about reads was a February piece by Matthew Baretich, PE, PhD, president of Baretich Engineering in Fort Collins, Colo. In “How to Write a Medical Equipment Management Plan,” Baretich wrote that a well-organized and well-written medical equipment management plan is a must-have document for any health care organization seeking Joint Commission accreditation.

Related (and also popular) stories on asset management, including this month’s Service Solutions article by Joe Eichberger, CEO at EQ2, LLC, had a similar message: “It’s necessary to know what you have, how it’s being used, and how it’s being maintained,” Eichberger writes.

We could continue with a top-10 ranking of our 2016 stories as a means of shedding light on what matters most to our readers. Instead, however, we decided to reach out to a few HTM leaders—including Wang and Baretich—and asked them for their thoughts on the past year. Here’s what they said:

Demonstrating Value

From where he sits, says Wayne Hibbs, PhD, CCE, president of LifeStructures Technology Planning in Indianapolis, Ind., “the three biggest areas of discussion in the last year” can all be framed as difficult questions: “How well are we managing and documenting our assets and the lifecycle cost of them? How well are we helping the overall services of our facility with patient care and controlling expenses? And are we able to demonstrate that we”—HTM departments—“are the best solution” to meet facilities’ needs?

Hibbs admits that these areas focus mostly on management “and not the workbench biomed issues.” Still, he says, if HTM departments can’t prove their value, they could soon find themselves out of a job. “I am seeing even large facilities signing contracts with the major service providers and giving their staff the option of either going to work for [those vendors] or finding other work.”

Issues Around Servicing

Along similar lines, Patrick Lynch, CBET, CCE, CHTM, CPHIMS, FACCE, an independent consultant and president of Biomeds Without Borders, points to the FDA’s announcement back in March that it was seeking comments from “interested persons” around the issue of third-party servicing. “This was a huge development,” Lynch says, “and it’s a result of lobbying” by medical device manufacturers “who say that third-party servicing is harming patients.”

The FDA comment period was followed by a two-day workshop in late-October (“Refurbishing, Reconditioning, Rebuilding, Remarketing, Remanufacturing, and Servicing of Medical Devices Performed by Third-Party Entities and Original Equipment Manufacturers”) that the agency billed as an opportunity for stakeholders to discuss the “current regulatory environment for these activities… and whether these activities should appropriately be regulated by the FDA or a non-governmental organization.” It’s anyone’s guess how the FDA might rule in the end, Lynch notes. “We’re still waiting for the other shoe to drop.”

Another item at the forefront of the biomedical sector in 2016 has been “the continuing saga” of the Centers for Medicare and Medicaid Services (CMS) “requiring all hospitals to follow manufacturers’ exact preventive maintenance procedures for imaging equipment,” Lynch says. (See CMS S&C 14-07-Hospital.) “It makes no sense at all. For years, we’ve been using our experience in the field to modify manufacturers’ procedures based on what the equipment really needs.”

There’s no reason biomeds can’t do that with imaging as well, he says. “It’s a well-known fact that even the equipment makers themselves often don’t follow their own procedures.” Lynch hoped this rule might be modified this year—“but it wasn’t, and it’s not clear if it ever will be.”

The IT Challenge

Several of those we spoke with for this story, including Lynch and Baretich, thought the continuing convergence of medical technology with information technology was one of the biggest trends of 2016. In his consulting work, Baretich says he’s seen a growing interest in linking the computerized maintenance management system (CMMS) software for HTM with the service desk software used in IT. This includes the integration of help-desk tickets and CMMS work orders, but also connections “on deeper levels,” he says, “such as linking the CMMS database of medical devices with the IT service management software’s IT asset database.”

As increasingly more medical devices are connected through the digital network, “it’s essential to provide a complete picture of how all the pieces interact,” Baretich says.

Educational Matters

When she was asked her opinion on the top headlines of 2016, Barbara Christe, PhD, had no hesitations. HTM education, says Christe—the director of the Indianapolis, Ind.-based Purdue School of Engineering and Technology Healthcare Engineering Technology Management program—has, for many years, barely changed at all.

But this year was different, as two institutions (DeVry and Brown Mackie College) announced the pending closures of their HTM-related programs. “This is really big news,” Christe says. “Nationally, we were already faced with a shortage of programs, and now it has become a crisis.” Her big concern: What such closures will mean for hospitals that are looking for trained and qualified employees. “It’s going to put us in a deep hole, especially as more people reach retirement age,” she says. “Where are their replacements going to come from?”

On a more positive note, Christe says, 2016 saw AAMI step into its new role as a member of the Accreditation Board for Engineering and Technology, or ABET. (AAMI announced its appointment in August 2015.) While ABET accredits a wide variety of educational programs in science, computing, engineering, and technology, AAMI’s focus is on BMET-program accreditation.

“For me,” Christe says, “this is very exciting because it puts AAMI on a level playing field with other major professional organizations like the Institute of Electrical and Electronics Engineers.” It’s a significant step forward not only for AAMI, she says, but for the entire profession, as well.

More Top Stories from 2016

The last year also featured many other announcements, events, and developments worth mentioning, from the FDA’s approval of new technologies (and warnings against the use of others), to AAMI president and CEO Mary Logan’s retirement (Robert Jensen has taken her place), to the ongoing work to enable medical-device interoperability, to renewed concerns about the possibility of infection following surgical procedures that rely on devices like endoscopes.

“Infections, unfortunately, have become a real nightmare,” Wang says, noting that Congress has now taken up the issue as well. “And everyone is saying that it’s not their fault—they try to pass the blame to someone else.”

Lynch, for his part, looks back on 2016 and sees plenty to be happy about—even if he thinks the regulatory environment is still less than accommodating. For one thing, he says, “This year saw a number of really good, young engineers stepping up to take leadership positions” in hospital HTM departments.

“They’re taking charge, and I think they’re prepared to take our profession to the next level.” Sure, he says, people are retiring—and in the near future there may be fewer biomeds coming out of HTM-focused schools. But he’s convinced that all will be fine.

“These new people coming in are a different breed with a different mentality,” Lynch says. “When I used to work on equipment, I had to go in there and take it apart. Today there’s not as much of that—they’re troubleshooting through a circuit board, or replacing one circuit board with another. They’re not fixing things now nearly as much as they are just going in there and swapping them out.” Biomeds are also spending much more of each day working with clinicians, Lynch says—helping nurses, for example, “interface with these technologies to make sure they’re using them correctly.”

Lynch’s final take on the previous 12 months? Like most years, he says, the industry had plenty to talk about. “And I expect we’ll see the same in 2017.”

Chris Hayhurst is a contributing writer for 24×7. For more information, contact chief editor Keri Forsythe-Stephens at [email protected].