Lawmaker Attempts to Define Remanufacturing HTM Stakeholders Express Opinions on Proposed Legislation

“Remanufacturing” is a term that has befuddled healthcare technology management (HTM) professionals, original equipment manufacturers (OEMs), the FDA and other stakeholders for at least half a decade. H.R. 7253 appears to offer changes to 21 USC 360: Registration of producers of drugs or devices.

The desire to define remanufacturing tends to revolve around who is qualified and/or permitted to do what to a medical device. When does a repair become remanufacturing? This is just one question stakeholders have been asking for years.

The Association for the Advancement of Medical Instrumentation (AAMI) is among stakeholders that continue to seek answers in a collaborative manner that will stress patient safety.

AAMI Vice President of HTM Danielle McGeary provided the following statement regarding H.R. 7253.

“The definition of ‘remanufacturing’ has been on the AAMI HTM community’s radar ever since 2016 when the FDA hosted a public workshop addressing medical device servicing and remanufacturing. Questions surrounding ‘right to repair’ affect the maintenance of medical devices, and AAMI supports further conversation and collaboration on this important topic, especially as these developments relate to the day-to-day of our members,” she said.

It’s worth noting that in response to that 2016 FDA workshop mentioned, AAMI published a standard that specifies consensus terms relating to medical device servicing and repair: ANSI/AAMI EQ93:3019, Medical equipment management—Vocabulary used in medical equipment programs.

Of note, the EQ-Medical Equipment Management Committee specifically did not define “remanufacturing” and deferred to the FDA. The standard does define the terms refurbish, service, repair and remarket

AAMI invites and encourages stakeholders and HTM thought leaders who want to be part of important discussions about next steps for the HTM community to join the Medical Device Servicing Community (MDSC) for which AAMI is a neutral convener.

ECRI Engineering Director Chris Lavanchy shared his perspective on the issue.

“We are aware that there has been a longstanding debate between some OEMs and HTM professionals about whether repair services provided by entities other than OEMs are inferior and whether they contribute to adverse patient events,” Lavanchy said. “The debate motivated FDA to investigate this concern, culminating in a report published in 2018 concluding that, ‘currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing medical devices.’ ECRI independently conducted its own analysis of adverse events by looking back through 9 years of data from sources including the FDA MAUDE database, ECRI Alerts, ECRI Hazard Reports, and findings from ECRI’s independent contracted accident investigations, and concluded that no safety problem exists with servicing and repair of medical devices either by third-party organizations or OEMs. We are also unaware of any evidence that has since emerged suggesting the quality of service and/or repairs being performed by either OEMs or independent service entities presents a risk to patient safety.”

“Although ECRI has not undertaken an exhaustive analysis of the available data as we did for the 2018 FDA report, we have not observed any patterns or trends suggesting that new data has emerged to support the belief that there is a safety concern associated with the servicing or repairs being performed by either third-party organizations or OEMS,” he added.

Lavanchy said ECRI would like to be made aware of any instances regarding the safe service and repair of medical devices.

“If other organizations have become aware of evidence supporting safety concerns regarding the service and repairs of medical devices in the U.S., ECRI would be very interested in learning more and reviewing the data,” Lavanchy said. “It is unclear to us at this time why there is a need for a new Congressional bill to be passed with the intention of clarifying requirements for medical device remanufacturing, and we ask for the bill’s sponsors to openly share any evidence they may have supporting this need. FDA already distinguishes between servicing and remanufacturing, stating that remanufacturing is different in that it significantly changes the device’s performance or safety specifications, or intended use.”

Lavanchy cautions against legislative action that could have the unintended consequence of increasing the cost of health care for millions of Americans.

“We would like to ask the bill’s sponsors whether they are aware that trying to address a problem that really hasn’t been demonstrated would likely significantly drive-up health care costs without any tangible improvement in patient safety,” he said.

The FDA shared a flowchart on remanufacturing last year in its “Remanufacturing of Medical Devices Draft Guidance for Industry and Food and Drug Administration Staff.” The flowchart is on Page 11. The draft guidance was issued in June 2021 for comment purposes only.

The Medical Imaging & Technology Alliance (MITA) – the leading trade association representing manufacturers of medical imaging equipment, radiopharmaceuticals, contrast media, and focused ultrasound therapeutic devices – recently expressed support for H.R. 7253.

“We appreciate members of Congress taking up this technical legislative fix to provide clarity as to what does and does not constitute remanufacturing, and thus is subject to FDA oversight,” said Patrick Hope, executive director of MITA. “The current definition of remanufacturing is vague and requires updating, which this legislation would fix. This bill would also help enhance patient safety and device performance while also helping to mitigate cybersecurity concerns.”

A press release form MITA goes on to state, “H.R. 7253 would define remanufacturing in statute and clarify the activities that require registration, reporting and oversight. The bill also provides for public education and transparency measures to raise awareness of safety concerns and allow responsible actors to come into compliance.”

“This is a commonsense solution that deserves the support of any and all in the medical device engineering community. MITA encourages members of Congress to pass this legislation without delay,” Hope concluded.

The entire MITA press release is available here.

IAMERS President Diana Upton voiced concern regarding the attempt to define “remanufacturing” via legislation.

“To pursue remanufacturing legislation while we await the FDA remanufacturing guidance is troubling, particularly as there is no precipitating event which would require departing from the normal FDA rule-making/guidance process,” Upton said

A letter from U.S. PIRG signed by several stakeholders – including members of the Alliance for Quality Medical Device Servicing – addresses “remanufacturing” and the Medical Device User Fee Amendments (MDUFA V). The House Committee on Energy and Commerce held a hearing on “FDA user fee reauthorization: Ensuring safe and effective medical devices” on March 30.

“Along with our partners, including IAMERS, in the push for medical right to repair, we oppose efforts by medical device manufacturer industry groups to include language in the Medical Device User Fee Amendments (MDUFA V) that would change the definition of ‘remanufacturing’ to include activities that have long been considered as servicing or refurbishing,” the letter reads. “For example, the trade association legislative draft being circulated would drop from the definition of an equipment change deemed to be ‘remanufacturing’ the word ‘significant.’ This proposed change should be declined as it hardly clarifies. Rather it might well have the practical effect of making every change, however small, remanufacturing.”

“Should such a change be implemented, the ability of hospitals and independent service organizations to repair and maintain critical medical equipment could be severely curtailed or eliminated, drastically reducing competition in the process. Service delays and high repair costs have already been a problem throughout this pandemic and before it. Further reducing competition with this amendment would only make these problems worse,” the letter adds.

The letter goes on to state that legislation could eliminate all non-OEM service providers from the market.

“Congress should be increasing the competition that will improve hospital choices and patient safety towards the important goal of driving down health care costs – not advancing policy that might well result in only manufacturers being able to repair equipment. Congress should allow the FDA stakeholder engagement process to continue. It is for these reasons that we, the undersigned health care and public health groups, ask you to allow the process to run its course by not adding any language on the matter to MDUFA V,” the letter states.

The letter may be viewed here.

MITA issued a press release on March 30 that reiterated its support for the fifth iteration of the Medical Device User Fee Agreement (MDUFA) following the U.S. House of Representatives Energy and Commerce Health Subcommittee hearing to consider the U.S. Food & Drug Administration (FDA) user fee reauthorization. MITA also addressed “the need for clarity around the definition of remanufacturing.” The press release is available here.

H.R. 7253 was introduced about a week after right to repair legislation was introduced in the U.S. Senate. S.3830 – Fair Repair Act was introduced on March 14.

TechNation encourages all interested parties to contact their representatives in the U.S. House and Senate regarding H.R. 7253, S,3830 and similar proposed legislation. Contact information for lawmakers may be found at congress.gov/members.