Right To Repair Medical Devices

Farmers have been at the forefront of the Right To Repair movement as agricultural equipment manufacturers have used intellectual property claims to prevent farmers from repairing their own purchased equipment.  This is all part of the subscription business model, which offers new profit opportunities to big businesses.  Eventually, you will own nothing.

The subscription business model is now coming to medical devices.  Perhaps a distinction should immediately be drawn between implantable devices (e.g. pacemakers) and external medical analytical equipment (e.g. MRIs), but eventually this will become an issue in health care and yet another cost driver.

This article was written by the founding partner of a medical device servicing firm whose operation exists in the nether space between the big manufacturers and the big consumers of medical devices:

Let’s Keep Medical Devices and Right to Repair Separate
By G. Wayne Moore - May 26, 2023

There is a growing question in this country regarding an individual’s right to repair the products and devices they purchase for themselves or their business. It is being hotly debated by stakeholders from all sides of the business community, political spectrum, and on the international stage as well. The discussion also includes a host of technology-based products ranging in complexity from cell phones to Magnetic Resonance Imaging (MRI) medical imaging systems.

On its face, the argument from those who are for the unfettered right to repair is that “if you own it, you should be able to repair it.” However, what that remarkably simple statement really means is, give anyone access to a manufacturer’s service manual, device security codes, tools, and parts, all of which should be supplied at no cost or, in the case of parts, at “reasonable” cost.

But what are the consequences if you attempt a repair on your cell phone and you wind up breaking it? You have only harmed yourself financially as you would need to buy a new phone. On the other hand, what if someone attempts to repair an infusion pump in a hospital and the repair goes wrong? A patient can die. That patient was someone’s mother, or sister, or daughter. Therein lies the difference between the right to repair arguments for consumer goods versus for more high-risk products like medical devices.

Some industries like agricultural equipment and consumer electronics – think John Deere and Apple – have made reasonable concessions to the demands of the right to repair movement. Apple, for instance, now sells home-repair kits and has given the public greater level of access to replacement parts and tools. But with any industry or product that could impact public health, the options available to produce these kinds of compromises for medical device manufacturers are much more complicated.

The most complicating factor in my view is that medical device Original Equipment Manufacturers (OEMs) are highly regulated companies by the U.S. Food and Drug Administration (FDA) and must comply with the agency’s Quality Systems Regulation (QSR), a compliance that includes servicing their devices. And although the FDA’s oversight does extend to third-party service providers, the FDA has discretion in its enforcement and has chosen not to use it. This lack of oversight creates a significant patient safety blind spot for the FDA and frankly, for the public as well.

In fact in a 2018 report, the FDA acknowledged that there are more than 21,000 unregistered third-party medical device service companies currently operating in the United States. The report also concluded that “…currently available objective evidence is not sufficient to conclude whether or not there is a widespread public health concern when it comes to third-party servicing.” But why is that data not available?

If thousands of third-party servicers are not required to register with the FDA or report adverse patient events, how can we expect there to be a plethora of “objective evidence”? I’m reminded of an old saying concerning this paradox that goes, “the absence of evidence is not evidence of its absence.” In short, the FDA doesn’t know what it doesn’t know.

Unfortunately, some third-party service companies point to the report’s finding as proof that the FDA sees no problem’s asking manufacturers to share their intellectual property and often proprietary software data that is mostly kept close for cybersecurity reasons. That seems like an overly broad interpretation. Even the FDA declares that medical device reports should not be used for any type of risk analysis because the “system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”

Without significant regulatory and quality management guardrails on third-party service providers, legislation that includes medical devices in right to repair mandates would open Pandora’s box to even more unregulated and unknown third-party service providers entering a market where regulation and oversight are paramount to safeguarding patient safety.

Moreover, it is hard to justify including medical devices in right to repair legislation all in the name of potentially saving the hospital a few bucks at the expense of putting patients at greater risk. Especially when full-time hospital-based Health Technology Managers (HTMs) – the technical personnel in the hospital charged with keeping medical devices running smoothly – often already work closely with OEMs to ensure the safe and efficacious repair of devices. On top of that, most OEMs already contract with third-party servicers like my company, making the claim that these companies purposefully monopolize the marketplace to keep prices high is dubious at best.

Could we fix this paradigm through a cooperative effort between OEMs, HTMs, and third-party service providers without legislation? I am convinced it can, once the FDA releases guidance that would even the playing field for all service providers. Until that happens, the focus when considering right-to-repair legislation for medical devices, should remain on maintaining patients’ safety.

Wayne Moore, founder partner at Acertara Acoustic Laboratories, a medical equipment manufacturer and servicer, and a fellow of the American Society of Echocardiography.