As states move forward with “right to repair” laws intended to give consumers and independent technicians more access to parts, tools and manuals, medical devices remain a contested segment – and legal barriers could prevent states from enforcing such measures.
Over the past several years, more than half of U.S. states have introduced some form of right to repair legislation. Many of the enacted laws focus on consumer electronics, farm equipment and appliances. In most cases, lawmakers included exemptions for medical equipment, citing safety concerns.
Advocates argue that the exemptions put hospitals and patients at risk. Gay Gordon-Byrne, executive director of The Repair Association, and a strong advocate of right to repair said smaller hospitals often face long delays waiting on manufacturer technicians.
Speaking at a recent industry forum, she recalled one case where a patient’s treatment was compromised because of repair wait times.
“It took six months before the MRI machine was repaired, and by that time, the cancer present in his system was far advanced,” Gordon-Byrne said.
Consumer advocates also warn that hospitals are often unable to use their in-house engineers to maintain equipment because manufacturers restrict access to software, replacement parts and repair manuals. Nathan Proctor, who leads the national right to repair campaign for the Public Interest Research Group (PIRG), made that point in congressional testimony last year.
“The inability of a health delivery organization to use its own in-house engineers to make timely repairs negatively impacts patient treatment,” Proctor said.
Manufacturers argue that independent technicians may not have the specialized training required to repair highly regulated equipment such as ventilators, MRI machines and defibrillators.
Jim Jeffries, senior vice president of public affairs with AdvaMed, emphasized the risks in a policy briefing.
“There is no credible evidence that providers have had any delays to medical device repairs,” Jeffries said.
The legal question: Can states enforce medical device repair laws?
Whether states could even enforce right to repair mandates for medical devices is uncertain. Federal law, particularly the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetic Act, creates what is known as “express preemption.” This clause prohibits states from imposing requirements that differ from or add to federal standards for device safety or effectiveness.
In the 2008 Supreme Court case Riegel v. Medtronic, justices ruled that state laws or lawsuits could not impose stricter requirements on devices that had already received FDA approval through the premarket approval process. That decision confirmed the strength of federal preemption in this area.
Still, there is a narrow exception. Courts have allowed state actions that “parallel” federal requirements – essentially, those that mirror existing FDA obligations rather than creating new ones. The scope of that exception remains contested, and courts have interpreted it differently.
The legal framework means that if a state were to pass a law requiring manufacturers to share repair materials for medical devices, it could face preemption challenges. If the requirements imposed additional safety obligations or conflicted with FDA standards, courts would likely strike them down.
Some experts say states could have more success by targeting categories of medical equipment not subject to the FDA’s most rigorous approval process, or by focusing on access to non-safety-critical information such as basic manuals and training materials.
Other state laws have sidestepped the issue by excluding medical devices entirely, while a few have included limited categories such as powered wheelchairs. Advocates argue that more sweeping federal action may ultimately be needed to create uniform standards.
The right to repair debate continues to intensify across the country, with consumer groups, hospitals and manufacturers all staking firm positions. For medical devices, however, the question is not only one of safety but also one of law.
Because of federal preemption, state legislatures are constrained in what they can require. Unless Congress or federal regulators step in, states may find themselves limited to incremental changes, leaving hospitals and patients caught between repair delays and regulatory boundaries.
“Right now, states are doing what they can,” Gordon-Byrne said. “But when it comes to medical devices, the real solution is going to have to come from the federal level.”
