By Nathan Proctor
If I am not allowed to read the service instructions, how am I supposed to know that I am servicing the equipment in the way the manufacturer intended?
This was a question asked by many in the medical device servicing field around the Food and Drug Administration’s (FDA) draft remanufacturing guidance. The agency has now issued their revised guidance document to help the medical device field understand what constitutes “remanufacturing” of a medical device – but the answer to this core question remains unclear.
There are different standards in place for regulating and approving a manufactured or remanufactured device versus repair or servicing of an existing device. There have been disputes over whether some repaired devices should trigger the stronger rules for remanufactured devices. I’m among those who are disappointed that the FDA didn’t address the core underlying issue which animates the debate on remanufacturing, and which is connected to Right to Repair.
The remanufacturing conversation has been a lightning rod in the biomedical community for years. Manufacturers’ trade associations have pressed Congress to rein in aftermarket servicing of medical devices. As a result of their concerns, Congress required the Secretary of Health and Human Services, working with the FDA, to “issue a report on the continued quality, safety, and effectiveness of medical devices with respect to servicing.”
In May of 2018, that report came out, and it found that “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. healthcare system.” Instead of finding safety issues, the FDA’s report found that third-party repair carries no additional risk and that both they and manufacturers “provide high-quality, safe and effective servicing of medical devices.”
It should be noted that hospitals’ own in-house repair teams seemed to be invisible to this report … it’s either the manufacturer or a third-party.
The report noted that negative effects, to the extent that they existed, related to remanufacturing equipment, not normal servicing. So, the next request from manufacturers’ associations was to create new rules to prevent unregulated remanufacturing.
The problem with drawing a line between servicing and remanufacturing is that the easiest way to define servicing is to say you are returning the equipment to the manufacturer’s intended specs. So, what if the manufacturer actively hides the documentation so that only the manufacturer has the information needed to know exactly how the device is supposed to operate?
This was the concern raised by many stakeholders after the draft guidance came out. Here’s how the FDA addressed it (found on Page 24):
“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.”
Something tells me this “encouragement” will not cut it. There are way too many financial incentives at play for manufacturers to consistently and voluntarily share this documentation even if, according to the FDA, “the continued availability of third-party entities to service and repair medical devices is critical to the functioning of the U.S. health care system.”
The rub seems to be that the FDA can’t make up its mind about whether repair documentation is a “trade secret.” The guidance document notes that: “FDA’s recommendations are not intended to encourage the disclosure of trade secrets or confidential commercial information.”
Firstly, the information you use to fix equipment is not a trade secret, especially if you are training biomeds across the country to do these repairs. Trade secrets are by definition secret, not widely distributed information. The second criticism I have with this approach is that there isn’t anyone besides the manufacturer who will be determining what is a trade secret or not, which just extends the current situation where sometimes you can access what you need, and sometimes you can’t.
It is bad for patients and the whole health care system for medical device manufacturers to monopolize repair services. I think it’s time to step up for clear rules that protect competition in this space, while maintaining a high standard of quality. It’s clear that more work needs to be done to make this case to regulators.
