At the 2025 AAMI eXchange, Dr. Binseng Wang of Sodexo and G. Wayne Moore of Acertera Acoustic Laboratories met for a rematch of their 2024 debate on medical device remanufacturing and servicing regulations.
The session was conducted in point-counterpoint format, with attendees voting on which questions the speakers debated. AAMI Board member and COO of The InterMed Group Larry Hertzler graciously moderated this discussion on what he called “regulating the unregulated.”
As a neutral convener, AAMI does not take a stance on contested policy areas like remanufacturing and right to repair. But the Association gladly provides an open forum for debate among members. If you missed this session, be sure to look out for future events like it – the debate over remanufacturing is unlikely to go away soon.
HERTZLER: IF ORIGINAL EQUIPMENT MANUFACTURERS (OEMS) SHOULD PROVIDE THE MATERIALS FOR SERVICE, THEN SHOULDN’T THE SERVICERS BE REGISTERED JUST AS THE OEMS ARE?
Moore answered with, “It depends on what type of servicing that we’re actually talking about.” He sees a fundamental difference among repair, parts replacement, and making a modification that may not be appropriate to add to a finished, cleared medical device in the field. That said, Moore believes manufacturers should make the necessary information to make on-site repairs available to independent service organizations (ISOs), provided they act on behalf of a hospital.
But Moore made his position clear. If an ISO asks for information beyond the scope of what an OEM feels is appropriate or necessary to perform repairs in a hospital setting, then that activity has “crossed a line into potential remanufacturing.” If so, that ISO should be regulated in the same fashion as any OEM.
Wang responded by pointing out that FDA already has the legal authority to regulate ISOs in the same way as OEMs if the agency deems it necessary. “First of all, we are all regulated, like it or not.” He cited a 2018 FDA report that concluded there is no significant record of major issues related to ISO remanufacturing activities. To date, FDA has chosen not to regulate ISOs in this way. Based on this finding, Wang argued that there is no reason for FDA to invest its limited resources in regulating ISOs in same way as OEMs. Further, he posited that the remanufacturing issues discovered by FDA were likely the result of a lack of access to OEM information.
Wang then drew an analogy to the U.S. Constitution, stating, “If I am required to abide by the Constitution but I’m not allowed to read the Constitution, how am I going to be able to abide by it?” He also noted that the existing inspection and regulation regime for medical device manufacturers does not prevent all recalls or safety issues. Thus, he sees no reason why analogous regulations on ISOs would result in massively improved patient safety outcomes.
Moore offered a rejoinder, saying that “servicing can include component level change or a field replaceable unit modification,” but reiterating his point that there is no FDA definition for “bad servicing.” Instead, FDA differentiates servicing from remanufacturing, and defines servicing as an “activity that returns a finished medical device to original equipment specifications, substantially … anything that doesn’t do that is classified as remanufacturing.” Moore indicated that he sees no issue with buying parts from the manufacturer, but it is vital to validate that those parts work as intended and align with the OEM’s intended purpose and function.
In Wang’s view, if ISOs do not have access to materials for software and software codes, “how can we be sure” if an intervention is correct and safe? He nevertheless clarified that he is not advocating for “anyone under the sun” to have access to OEM service material but rather the purchasers or owners of medical devices who could then share as needed with their contracted third parties.
HERTZLER: WHY DON’T ALL HDOS REQUIRE MANUFACTURERS TO PROVIDE SERVICE DOCUMENTATION, SERVICE KEYS, ETC., AS A CONDITION OF PURCHASE?
In Hertzler’s words, “Why isn’t this a requirement of purchase?” After all, there is an inherent pressure created by the fact that “hospitals are going to buy equipment no matter what.”
Wang stated that if OEMs included this demand with their purchases, it would benefit HTM professionals. Ideally, this would be a “standard demand” made by healthcare delivery organizations. He also said that the U.S. Secretary of Defense recently issued a memo to secretaries of the various service branches demanding that equipment acquisitions by service branches include OEM information. However, “The issue is very simple. It’s called money.”
Healthcare delivery organizations like hospitals do not have the same resources as the U.S. Department of Defense. Further, Wang noted that some OEMs offer financing packages to HDOs that stipulate service contracts with the OEM. How many hospitals can say, “No, I don’t want the equipment?”
Moore countered, stating that while DOD has a great deal of taxpayer resources, they are “not infinite.” During his career, he did observe some HDOs successfully make demands of OEMs. “It can be done.”
Wang also expressed concern with OEMs discontinuing devices deemed legacy devices and then indicating that it is unsafe to allow third parties or in-house staff to work on their cyber capabilities or software. Without concrete action by Congress or FDA, he believes this trend could become “more and more aggressive.”
Moore responded by pointing out that “The FDA does not know everything.” While he acknowledged the agency’s efforts and expertise, FDA simply does not have subject matter experts for every issue that may arise in HTM. Given the pace of technological change, this can create a challenging environment.
HERTZLER: INSTEAD OF EACH STATE CREATING ITS OWN RIGHT-TO-REPAIR LAW, SHOULDN’T THE FEDERAL GOVERNMENT ESTABLISH A SINGLE, UNIFORM LAW FOR THE COUNTRY?
“Yes. Thank you.” But Moore elaborated, saying that he is skeptical that the U.S. Congress has the ability or willingness to act. If Congress does not settle the question of right-to-repair, a state-by-state approach may be a viable alternative.
Wang also favors a national right-to-repair law. Even if it is difficult to get Congress to act, “We still can come to some type of understanding even if we don’t have a nationwide law or regulation.” Given patients’ needs, ISOs “need a tool to provide prompt care.” His priority is ensuring that HTM professionals promote good patient outcomes by servicing medical devices.
