Many members of the healthcare technology community say they expect the Food and Drug Administration (FDA) to take some kind of regulatory action regarding the third-party repair and refurbishment of medical devices, but they don’t know what specifically to expect or when. That was one of the messages that emerged from a session Sunday morning at the AAMI Annual Conference & Expo in Tampa, Fla.
Panelists for the session included Mary Logan, president and CEO of AAMI; Dave Francoeur, senior director of program development and support at Sodexo; Dale Munson, manager of service and biomedical training at Medtronic; Gabe Viscomi, vice president of service at Block Imaging; and Binseng Wang, vice president of quality and regulatory compliance at Greenwood Marketing LLC.
Viscomi speculated that the FDA will choose a select few comments that involve some level of evidence and scrutinize them further. He also said that “the cost for FDA to implement some type of licensing would be immense, and I don’t see that happening.” “From the imaging perspective, my greatest fear is that FDA implements labeling regulations. It would be discouraging if the few bad players end up causing the vast majority, who handle repairs responsibly, to face unnecessary labeling requirements,” added Viscomi.
Sunday’s session comes in the wake of an announcement by the FDA this spring that it was gathering information about the service, repair, refurbishment, reconditioning, rebuilding, remarketing, and remanufacturing of medical devices, with a focus on the work of third-party companies.
According to the FDA’s original comments in the Federal Register: "Stakeholders have expressed concerns that some third-party entities ... may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented. Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation.”
Of note, original equipment manufacturers (OEMs) often are uneasy about the quality of repairs made in the field, as the OEMs are the ones regulated and held liable by the FDA for any postmarket issues that may occur with their devices, not third-party repairers.
Wang said he was worried about what might be in store from the FDA. “I’m not as optimistic as when we fought this same battle back in 1997,” he said, noting that 20 years ago, reprocessors of “single-use devices” (SUDs) were subject to additional regulations. (Since 2000, the FDA has considered reprocessors of SUDs to be “manufacturers;" therefore, they are subject to the full range of requirements that apply to OEMs, as well as additional requirements that apply only to reprocessors.)
Wang called for “meaningful rules,” saying that a “shotgun approach would kill good birds as well as bad birds in the process.” Ultimately, he foresees “segments of devices coming under greater scrutiny and being controlled more rigorously this time,” similar to what occurred for reprocessors of SUDs.
While noting that the FDA’s call for information suggests that the agency does not have a predetermined path, Logan said that she was “neither optimistic nor pessimistic.” “Do I think they are going to do nothing? No. But I think it’s so complex that it’s going to take them a long time to figure out what they are going to do,” Logan added.
The FDA has stated it will be holding a public workshop this fall to gain more insight into the issue. Informally, the agency said it expects the workshop to be held by October. “It would be great to have frontline HTM professionals at this public workshop,” Logan said. “We need to have the complete diversity of perspectives represented-OEMs, parts companies, HTM professionals, and other stakeholders.”
AAMI has suggested speakers to the FDA for the public meeting. Although the association’s stance is to remain neutral on regulatory matters, Logan said that she expects to be present at the workshop to ensure that a “holistic view” of all the perspectives involved is represented.
In anticipation of the FDA’s June 3 deadline for comments on the Federal Register notice, AAMI outlined which organizations were best suited to respond to various portions of the FDA’s request, as well as some food-for-thought guidance to consider when answering each of the agency’s questions. This outline and a complete list of talking points were made available as a PDF. Subsequently, on May 25, in an effort to “provide context and a deeper understanding” of the service industry for medical devices-AAMI submitted formal comments to the agency.
In these comments, AAMI did not take a stance on who should repair or service equipment, neither did the association answer the FDA’s more detailed questions about service. Instead, AAMI provided an overview of the service industry, noted the different perspectives and players, acknowledged the various concerns, underscored the value of consensus-based standards in any solution, and encouraged the FDA to take a comprehensive and long-term view in deciding what to do.
“As is often the case with complex issues that involve multiple disciplines, multiple service models, lack of standardization, paucity of reliable data about the industry, uneven lobbying capabilities across the sector, strong opinions, and stories galore, there is a huge risk of unintended consequences from a regulatory answer,” AAMI noted in its comments. “AAMI applauds the FDA for taking a conservative approach of requesting information to help it assess the questions it asked.” “AAMI in general prefers standards over regulation and believes that consensus-based standards … can solve most technology-oriented problems,” continued the association. “Decisions made by the FDA, working alone, tend to have unintended consequences. Likewise, decisions made by industry or healthcare delivery organizations while working alone in their own silos tend to have unintended consequences. Standards that are developed through an open consensus-based approach-with all stakeholder perspectives represented in the process-tend to solve problems without creating new ones and also tend to build the strongest buy-in from all stakeholders because they contributed to the solution rather than being told what they must do.”