At this year’s Association for the Advancement of Medical Instrumentation (AAMI) conference, health technology management (HTM) departments were a core focus. Attendees discussed the blurring lines that separate HTM professionals from IT professionals — and the variety of challenges that come with keeping pace in an evolving health care system.

The FDA's docket on refurbished equipment and service was a central part of that conversation, as professionals from different sectors shared their views on why the FDA is investigating the topic and what it means for the industry. In a session entitled What’s next for the FDA initiative on service, refurbishment, and third-party repair, Dave Francoeur, senior director of brand and quality at Sodexo, moderated a conversation to explore the docket in detail.

The FDA was accepting comments on the docket until May 26, and after reviewing what individuals and companies had to say, the panelists shared their takeaways with attendees.

Mary Logan, president and CEO of AAMI, said that her organization tried to offer a very "big-picture" response in its comment so that its insights could be interpreted neutrally and be useful to the FDA regarding the entire service business. But Logan acknowledges that even with this approach it was difficult to encompass every relevant aspect.

"As to the future of servicing equipment, AAMI encourages the FDA to not develop definitions but rather standards through a consensus-based process," said Logan.

Underreporting from hospital staff members as a roadblock to greater transparency was emphasized by Binseng Wang, vice president of quality and regulatory compliance at Aramark. If organizations reported the problems they are having, the FDA would be more informed about the nature of equipment-related problems as a whole and could “prosecute those who cause trouble.”

Wang also reminded attendees that the FDA is not about cost, but making sure that a patient is safe. If patient care will be affected, that is under mandate for Congress to have the FDA look more into the situation.

AAMI's position that standards are a better solution than regulations was echoed by Dale Munson, manager of service and biomedical training at Medtronic, who said such a solution would ensure the HTM community was not only properly trained, but certified in their ability to service equipment. He believes that as a result of the docket, tiers will be established with maintenance responsibilities that are focused upon patient safety.

Then again, it's possible that the FDA docket will ultimately amount to nothing. Gabe Viscomi, vice president of service at Block Imaging, predicted there will not be enough evidence for a change to happen within the industry. Even though the FDA will look through the comments made and select the few with substantial evidence, the information may not be sufficient.

The gray area between Health IT and HTM departments

In a session entitled The new health care technology world closing coverage gaps through health care management and information technology collaboration, speakers Michael Byrne, Joseph DeLuca and Scott Nudelman, all from GE Healthcare, addressed the rapid growth of networked system integration and allocating specifying roles to a specific department.



The path between a patient monitor and hospital network of wireless monitors is often filled with "gaps" such as an OEM switch, a core switch, and router. For a hospital that has no specific department in charge of these areas, problems may arise.

The presenters gave a real-life example of a hospital (kept anonymous) in which the patient monitors were run by IT and the wireless monitors were run by HTMs, and how the two departments worked together to resolve any confusion about who was responsible for what.

Steps were created to identify the gaps, and figure out how to assign them to a team before a “breakdown” occurs, as follows:

• Identify gaps in service stratification and tech issues


• Prioritization: understand impact of failure on patient safety and impact to organization


• Service strategy: understand service stratification requirements


• Develop solutions for each gap identified


• Implement solutions and put them into action


• Monitor solution performance: confirm implemented solution meets the needs identified


• Continue to develop solutions: work through identified issues and add new systems as they come online

“We have to stop saying ‘biomed.’ We have to stop saying ‘IT.’ We have to starting saying ‘we,’” said Scott, which was met with loud applause and cheering from the audience.

Keep smartphones out of medical device USB ports

During an open discussion about issues facing HTMs, misuse of USB ports — which can cause medical devices to malfunction — was a prevalent problem expressed by many attendees. The issue was also big enough to land it on ECRI's list of Top 10 Health Technology Hazards of 2016.

With so many medical devices hooked up to a USB port, and most hospital staffers carrying cell phones that require a USB to charge, these ports are frequently working overtime as charging stations. This can lead to technical issues since the medical device is now reading information that it does not know how to process.

One effective solution to mitigate the problem came from Chris Wright, an attendee who works for the Department of Veteran Affairs. “Understand now, if you plug [your phone] in and the government catches you doing this, our IT specialists are authorized to pull every bit of data off of your phone," he tells staff members.

Another audience member, a clinical engineer at UC Health in Colorado, suggested a policy that states if a staffer, other than cardiologists and physicians, brings in a phone charger or other USB cord, he/she could be fired. The reason for this serious consequence, she said, is that the misuse of a USB port not only fails a device, but can also result in costly and dangerous HIPAA violations.