Broad Right to Repair Policies May Put Patients at Risk

Tirzah Duren
| Detroit News

More than halfway through 2024, six states have already codified some version of right-to-repair legislation, challenging companies that threaten individuals’ rights to repair devices and appliances they own. It’s a clear indicator that the right-to-repair movement is gaining momentum.

Michigan introduced a right-to-repair law earlier this year. If passed, Senate Bill 686 would be one of the broadest of its kind, exempting only cars from its guidelines.

Lawmakers must proceed with caution when implementing broad right-to-repair policies, especially when those policies affect life-saving and life-enhancing medical devices. When it comes to patient safety, shortcuts should not be allowed.

The ostensible goal of the right-to-repair movement is to make it easier and more affordable for consumers to repair products. But replacing a phone screen or changing a tire on a tractor shouldn’t be lumped together with the right to repair highly technical equipment. This is especially true in the medical field, where the stakes are literally life or death.

Allowing unregulated third-party companies access to sophisticated medical equipment is a dangerous and unnecessary risk to patients. This reality should give lawmakers pause before passing sweeping legislation. Especially in the case of medical devices, where more research is needed.

It doesn’t take an expert to realize that repairing medical devices requires more specialized training than repairing other consumer goods. This is also a major reason why these devices are strictly regulated by the U.S. Food and Drug Administration (FDA).

Unlike the original equipment manufacturers (OEMs) behind these products, independent repairers are not required to comply with FDA quality system regulations (QSR) or report adverse events that may occur during repairs.

For example, the FDA report identified only about 4,300 reports in 2018 in which a medical device was serviced by a third party. Those reports included 40 deaths, 294 serious injuries and more than 3,700 cases of device malfunctions.

However, due to the lack of third party reporting obligations, thousands of other incidents of improper servicing may occur.

In short, more research is needed to determine whether a right-to-repair law would put patients at risk. And the FDA should base its decision on safety and effectiveness, not market dynamics.

Risk, whether perceived or real, has become a rare unifying issue for Americans. In a survey conducted by AdvaMed, a trade association for medical technology companies, 95 percent of participants agreed that people who service or repair complex medical technology used in patient care should be trained and authorized.

Patient well-being must remain at the forefront of health care policy discussions — including right-to-repair efforts. Michigan lawmakers now have an opportunity to ensure that any proposed right-to-repair legislation prioritizes patient safety through necessary exceptions — a model already implemented by states like New York, Minnesota, Oregon, and now Colorado.

The public, voters, and legislators must come together to ensure that any right-to-repair policies do not extend to medical equipment, and to consider the potential consequences of unregulated medical devices on our nation’s healthcare system.

Tirzah Duren is Vice President of Policy and Research at the American Consumer Institute.