By AAMI
Day three of the AAMI eXchange featured an open forum on whether medical device servicing should be subject to additional regulations. This debate comes hot on the heels of the “Final Guidance to Clarify ‘Remanufacturing’ of Devices that Need Maintenance or Repair,” issued by the U.S. FDA this past May, 2024.
While AAMI does not take a stance for hotly contested issues of policy, the association does provide a neutral forum for conversations among members. The session featured Dr. Binseng Wang, vice president of program management for healthcare technology management at Sodexo and G. Wayne Moore, founding partner at Acertara Acoustic Laboratories. Larry Hertzler, chief operating officer at The InterMed Group, moderated the event.
Moore took the floor first, indicating that right-to-repair issues are best resolved between stakeholders rather than by government intervention. Also, “my position is that third-party servicers … should be regulated, actively regulated, by FDA,” even if HTM professionals in hospitals should be allowed more leeway.
Wang strongly disagreed, stating that given FDA’s statutory authority to regulate, “everyone under the sun should be regulated equally.”
Hertzler then pressed on, presenting the pair with a number of questions to discuss.
If the Right to Repair legislation forces the OEMs to release service materials, would this require OEMs to reveal trade secrets and intellectual property (IP)?
According to Moore, “not necessarily.” State and federal right to repair legislation has stated that OEMs will not have to give up trade secrets or intellectual property. Right to repair legislation is likely to result in OEMs compartmentalizing service-related software and moving away from the integrated software approach. But if the right to repair were made retrospective, it could create vulnerabilities to cyberattacks.
Wang concurred, stating, “the answer is definitely no.” Trade secrets will remain safe, and there are plenty of legal remedies to protect intellectual property, such as NDAs. Further, international manufacturers have not faced this issue and software compartmentalization is a valid option.
If the third parties are not regulated by the FDA, how can one be sure that they are not exceeding servicing limits and venturing into remanufacturing?
According to Wang, the lack of available information on remanufacturing is comparable to a local government issuing speeding tickets without posting a speed limit. Also, the EU has explicit requirements for manufacturers to provide information, and America should do the same.
Moore stated, “I don’t believe in unintentional manufacturing.” He believes that FDA provides sufficient information to HTM professionals. It is their responsibility to look up available specifications. “Go find the information or don’t do it.”
What are the pros and cons of registration with the FDA for all non-manufacturers?
Per Moore, the fact that OEMs are required to be registered and third-party services are not creates a “blind spot” for FDA of between 15-20 thousand non-registered entities. Registration requirements for third-party services would create welcome clarity. Further, FDA registration would apply only to third-party ISO and OEM servicers, rather than hospital employed HTM workers. Notably, Moore did not see any major concerns that he would place in the “con” category.
Wang, however, was concerned with how in-house hospital employees and federal employees are unregulated. Good patient care should be the North Star, and Wang noted that OEMs were more cooperative during the pandemic. Even minor delays from OEMs can accumulate and result in harm to patients. Wang also expressed skepticism that FDA intervention would be effective, noting that there are still challenges for medical device manufacturers that current regulatory intervention does not always solve.
Should servicing information from OEMs be available to anyone who wants it?
“The short answer is ‘no,’” said Wang. He elaborated, suggesting that the U.S. should follow the EU’s example, and have manufacturers release information to buyers or owners of equipment.
Moore kept his remarks even more brief. “I agree.”
In its final version of the remanufacturing guidance, the FDA stated that “Consistent with promoting and protecting the public health, FDA encourages OEMs, as an industry best practice, to provide servicing instructions that facilitate routine maintenance and repair of their reusable devices.” Wouldn’t this statement preempt the need for a new regulation or right to repair law?
Moore noted that FDA encouragements are not legal requirements. If FDA established requirements this would create clarity, but the agency uses language such as “routine,” that are open to interpretation. He suggested that panel attendees check out an FDA training held on June 27 related to the issue.
Wang, however, reiterated his point about the speed limit. Without the right information, device servicers cannot know the right course of action. Wang would prefer equal treatment for hospital employees and third-party services alike. After all, they are “under the same pressure” and a distinction based on which entity disburses the paycheck is “really absurd.”
What’s your take on the optimal way to move the right to repair issue forward to a “final” conclusion?
Wang noted that the 2018 FDA Report on Device Servicing included no evidence of major public health concerns. In fact, more widespread inspections would tax FDA’s limited resources. In Wang’s words, full FDA regulation would amount to solving a cockroach problem with a nuclear missile. Instead, memoranda of understanding among OEMs and servicers is the best possible outcome.
Moore concurred that he would rather have third-party services and manufacturers solve this issue among themselves. But he believes that having third-party services registered with FDA would give the agency vital information. While FDA did not find evidence of a public health risk, “the absence of evidence isn’t the evidence of its absence.”
Remanufacturing and the future
The debate over this key issue is far from over, and longtime AAMI members will recognize the arguments and personalities on both sides. But watch this space, as any FDA action on remanufacturing will immediately impact AAMI’s members and AAMI will be sure to cover future developments.
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