FDA Issues Cautionary Guidance on Right-to-Repair

Technology is a critical to the current and future success of our healthcare system. Innovation will continue to transform the system, improving patient outcomes, enhancing operational efficiency, and reducing costs. On the other hand, ensuring this technology infrastructure maintains specific regulatory standards necessary for protecting patients takes care and accountability.

In fact, a guidance recently published by the U.S. Food and Drug Administration (FDA) outlining thoughts on the repair of medical devices and technology used by our nation’s health professional had one major takeaway - "proceed with caution."

Some believe that a consumer's so-called "right to repair" should include FDA-regulated medical devices like MRI machines, ventilators, and dialysis machines. On the other side, many argue that serious unintended, negative consequences for patient health and safety will result when unregulated third-party repairmen are allowed to work on such highly sophisticated and sensitive devices.

Right to repair advocates point to a 2018 FDA report to argue the agency agreed to "take a pass" on regulating third party device servicing because they could find no evidence of a problem. Cherry-picked quotes describe third-party servicers as providing "high quality, safe, and effective servicing of medical devices ... critical to the functioning of the U.S. healthcare system." But these messages are out of context, wrong and dangerous.

The fact of the matter is that the FDA is very concerned about allowing third party repairs by entities that are unregulated by the agency and often ignore important components of regulatory oversight such as adverse reporting. The FDA is very aware that unrestricted right to repair would likely open the flood gates to a host of unknown servicers who could negatively impact both the safety and effectiveness of crucial medical technologies, putting patients' lives at risk.

The agency's concern is multiplied by the dearth of facts and figures. The FDA doesn't have enough data to make a definitive conclusion about third party servicing because unregulated service providers aren't required to register with the agency. The FDA can't even establish how many third-party servicers are out there - though the agency estimates there are between 16,000 - 21,000.

But the subject at the heart of the issue is the definition of when “servicing” becomes “remanufacturing.”  In the FDA's Final Guidance, the agency writes, "the distinction between 'remanufacturing' and 'servicing' is important to understand." Not only is it a distinction with a difference – it is a distinction that makes a difference.

Defining a repair as remanufacturing requires a heightened applicability of enforcement and regulatory standards as opposed to run-of-the-mill servicing. The new guidance makes clear that if an entity is remanufacturing, they will be subject to the same strict regulatory requirements as the original manufacturer of the device. That includes sharing detailed records and adverse reports the FDA needs to enforce the high standards these technologies require to operate properly - standards not currently enforced on third party right to repair organizations.

In short, if a third-party service company isn't familiar with FDA regulations, doesn't have an internal compliance department, or is ignorant as to ow to identify, collect, and report adverse events on the advanced technologies it services, well, "White Oak, we've got a problem."

The FDA doesn't have the regulatory authority to allow or ban third party repair. So, to portray this Final Guidance as, in any way, supportive of the right-to-repair philosophy is intellectually dishonest. It's more accurate that the agency is offering advice to protect the healthcare ecosystem against some very dire - and predictable - unintended consequences.

When it comes to healthcare technologies, responsibly, transparency, and accountability are paramount. If history is any guide, lawsuits aimed at faulty medical devices aren't aimed at small "servicing" concerns, they're laser focused on the deep pocket of the original manufacturer. And frivolous lawsuits inevitably raise the costs of these important technologies, exacerbating reimbursement issues, and further limiting access to urgent medical tests among health care systems already facing strapped budgets. 

Kudos to the FDA for addressing the issue head-on and admitting the scope and severity of the problem we are facing when it comes to the continued quality, safety, and effectiveness of medical devices. And while right to repair has merits when applied to a whole host of products, caution is not something we can throw aside when it comes to medical devices.