Consumers are increasingly interested in extending the life of the things they own rather than getting rid of them. The newly coined “fixit culture” is gaining momentum as consumers become increasingly aware of the effect our product consumption has on the environment and our wallets. In reality, some items need more than a YouTube video and some patience to fix — things like highly technical medical equipment.
Today, more than 20 states are considering legislation to bolster consumers’ ability to repair their devices — known as the “right to repair.” Minnesota is the most recent state to pass a right-to-repair bill requiring electronic device manufacturers — like phones, laptops and household appliances — to provide device instructions, parts and tools to independent repair shops and consumers.
The bill goes further than comparable legislation signed by New York Gov. Kathy Hochul last year, but with one crucial similarity. The groundbreaking laws maintained necessary caveats for several product categories, including medical devices.
Medical devices are intricate and sensitive machines that require precision and expert training to conduct necessary repairs. While consumer benefits from the right-to-repair movement are clear with some items, like replacing the glass cover on a cell phone or fixing a household appliance, applying these principles to medical devices and other complicated hospital equipment is a much different story.
Fundamentally, not all products are equal.
The stakes are low if you try to fix your phone screen or tablet and fail. But what happens when the devices needing fixing are precision instruments used to diagnose and operate on you or a loved one? The consequences of a repair gone wrong could be severe.
This distinction showcases why right-to-repair laws should consider product categories on a case-by-case basis. Fortunately, states like New York and Minnesota purposefully defined the scope of their bills to ensure medical devices were left in the hands of trained repair experts. These legislators recognized that legislation — either state or federal — that gives broad access to untrained, third-party servicers could undermine the quality and safety standards that patients and medical professionals rely on to ensure patient safety.
Unfortunately, the system of regulatory oversight led by the Food and Drug Administration is inconsistent. Independent servicers, or ISOs, are not required to adhere to the FDA’s Quality System Regulations or report adverse repair events. We have strong federal regulations on the manufacturers in this market, but not on all the servicers. This gap puts patients at risk.
It’s a rational approach that consumers support. One poll by Patient Rising Now found that more than three-quarters of consumers believe the FDA should regulate medical device repairs conducted by manufacturers and ISOs.
Unfortunately, unregulated ISOs that repair medical devices have historically fought attempts to bring the more than 20,000 rogue repair businesses under the FDA’s regulatory regime. They cite a lack of evidence within the FDA database of adverse events from non-regulated repair operations. But again, these unregulated and untrained repair shops have no obligation to uphold the highest repair standards or report adverse incidents, potentially exposing patients to poorly serviced or malfunctioning medical devices.
While right-to-repair is making headway to bolster consumer choice in some sectors, allowing untrained, unregulated service repair people to access and repair complex medical devices introduces an unnecessary risk that could jeopardize patients.
The Federal Trade Commission has concluded that it seems unlikely “there is a one-size-fits-all approach that will adequately address this issue.” When considering right-to-repair legislation, elected officials should carve out reasonable exceptions for classes of products — like medical devices — while still accomplishing the goal of allowing consumers the ability to fix some of their devices.