Such effects would run contrary to the FDA's latest findings on the need to regulate third-party servicers, when it determined there was "insufficient evidence" of a need to do so. Indeed, the FDA noted last year in its letter to the U.S. Copyright Office that “[d]evice servicing entities may be well positioned to help identify and address security vulnerabilities, and [FDA] observes that ISOs may play an important role in maintaining the overall quality, safety, and efficacy of medical devices.”

Cybersecurity activity deemed 'remanufacturing' activity in new definition

The proposed definition of "remanufacturing" activities includes cybersecurity. If passed, this legislation could complicate cybersecurity activities for equipment servicers. As co-editor of the AAMI Cybersecurity Guide for Medical Devices Stephen Grimes commented, “The nature of the security risk today is such that mitigations need to be prompt, and although the manufacturer should vet and approve the cyber solutions, there is no current requirement that the FDA also review the cyber solutions for discovered vulnerabilities. Imposing this requirement could unduly delay and substantially increase the risks to patient safety.”

Legislation would require annual FDA reports in consultation with Congress
The proposed legislation also has inspection and enforcement provisions. It would task the FDA with establishing a risk-based schedule of inspections to ensure that there is adequate education and representation of establishments as "remanufacturers" and that the annual FDA report be made available on the internet, identify the number of establishments registered as remanufacturers that were inspected, and the percentage of the FDA budget that was used to fund the inspections. As mentioned earlier in this article, the FDA has already concluded that “the currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern related to servicing, including by third parties of medical devices, that would justify imposing additional/different burdensome regulatory requirements at this time.”

The FDA would also be required to prepare a report within 18 months of enactment after consultation with the House Energy & Commerce Committee and the Senate HELP committee regarding the findings of the report. The FDA would also receive from state regulatory bodies and other state authorities reports on remanufacturing activity. No explanation is offered as to why the FDA would be consulting the Congressional Committees. Notwithstanding, there are stakeholder groups who should be consulted on impactful changes to the Federal Food and Drug Cosmetic Act, such as that apparently proposed in the legislation. These groups include prominently the Medical Device Servicing Community (“MDSC”).

Samantha Jacques, vice president of McLaren Clinical Engineering Services and a member of the MDSC Steering Committee recently observed MDSC’s progress as a forum to consider issues: “The Medical Device Servicing Community has created and continues to expand a vibrant environment in which different constituents including manufacturers, hospitals and third-parties can come together to develop consensus on topics such as training best practices and minimum requirements for quality management systems across the country.”

So, the question remains: if there are industry recognized and FDA forums for discussion of important changes, why are they not being pursued? Are there overreaches in the legislation which, if filed and passed, may affect patient safety, cybersecurity responsiveness and compliance with the new Executive Order on Competition?

With deference to the Yankee great, Yogi Berra, this seems like "deja vu all over again", as some in 2017 tried without significant stakeholder notice and opportunity to be heard, passage of an amendment to the Federal Food Drug and Cosmetic Act to directly (or indirectly) regulate servicers. The FDA report that followed noted that servicers were necessary for the healthcare ecosystem and that the FDA intended to proceed with clarifying remanufacturing activities. If the FDA has announced it is amending its quality system regulation and proceeding with a final Guidance on Remanufacturing, it is unclear why Congress should be getting involved at this point. If this remanufacturing legislation is filed and passes, it will no doubt leave a bad taste in the mouths of the many stakeholders who have offered and are continuing to offer the FDA comments on its impactful initiatives. It may also limit hospital choices. We hope those advocating for the proposed legislation will reconsider. Alternatively, let’s hope that Congress will recognize that this proposed legislation may have competition implications, and "clarification" is the last thing it may achieve. Perhaps it may be time to check in with your Congress member?

About the author: Robert J. Kerwin is general counsel for IAMERS, the International Association of Medical Equipment Remarketers and Servicers.
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