All 50 states have introduced Right to Repair legislation, and seven have passed laws—largely focused on electronics and appliances—leaving questions about whether, and how, medical devices should be included.
By Pat Munsey
Right to Repair legislation has now been introduced in all 50 states, following Wisconsin filing its first bill in February 2025. While the movement has gained traction, the seven states that have enacted laws—California, Colorado, Maine, Massachusetts, Minnesota, New York, and Oregon—have focused primarily on consumer electronics and household appliances, largely excluding medical devices.
Colorado’s law, for instance, applies to digital electronic equipment but exempts medical devices, except powered wheelchairs. Similarly, Minnesota’s Digital Fair Repair Act—which has been described as the “broadest” one passed to date—also excludes medical equipment. While California’s Right to Repair Act does not name medical devices among its listed exemptions, it allows exclusions for products that pose “significant safety or security risks if repaired improperly.”
Despite this legislative momentum, more recent efforts to include medical devices have stalled. “There was considerable support for removing barriers to repair medical devices during the pandemic, but those challenges remain for hospitals and independent medical device repair technicians—with no approved legislation to address this equipment,” according to US Public Interest Research Group (PIRG) Education Fund’s The State of Right to Repair report.1
Repair Access and Its Role in Clinical Operations
The continued exclusion of medical devices from state Right to Repair laws reflects ongoing concerns about patient safety, regulatory oversight, and intellectual property.
Medical device manufacturers argue that third-party service providers often lack US Food and Drug Administration (FDA) oversight and specialized training required to safely repair complex clinical equipment, while Right to Repair advocates say that manufacturer-imposed restrictions—such as limiting access to repair manuals, parts, and diagnostic tools—can hinder hospitals’ ability to maintain equipment and may lead to delays in patient care.
Gay Gordon-Byrne, executive director of The Repair Association, a nonprofit that advocates for Right to Repair, believes repair restrictions can have serious consequences in healthcare settings. She recalls how, years ago, her husband received life-saving care following a traumatic fall, thanks to a rapid MRI diagnosis at a well-equipped trauma center. In contrast, she says a friend’s father faced delays at a smaller facility when its lone MRI machine was down for repair. It was six months before the man received the scan, and by that time, the cancer that was present in his system was far advanced.
“Prompt diagnosis is essential,” says Gordon-Byrne. “The smaller hospital did not have multiple machines. Used machines that might have been useful are not deployed because of manufacturer service limitations on repair and a refusal to share patches and fixes to known defects beyond an arbitrary ‘End of Service Life’ date.”
Nathan Proctor, senior director of the campaign for the Right to Repair at PIRG, says, “There are many cases in which the inability of a health delivery organization, like a hospital, to use its own in-house engineers to diagnose and repair equipment in a timely way, negatively impacts patient treatment.”
He adds, “Some patient needs a procedure that requires a piece of equipment. The equipment is offline because they’re waiting for the manufacturer to come in, and there’s no other way to get it repaired, given the way that the manufacturer has programmed it or restricted the information or parts or other necessary materials to complete those repairs.”
However, Jim Jeffries, senior vice president and head of public affairs with Advanced Medical Technology Association (AdvaMed), who advocates for original equipment manufacturers (OEMs) in the Right to Repair debate, contends “there is no credible evidence that providers have had any delays to medical device repairs.”
He points to a 2018 FDA report estimating that more than 21,000 servicers operate in the US, which he says demonstrates a competitive repair market with ample provider options.2 “In fact, many OEMs are hired to perform third-party service on their competitors’ products,” he says.
Balancing Repair Access and Intellectual Property Protections
AdvaMed highlighted in its annual report its successful lobbying last year to block a medical device Right to Repair provision from being added to the National Defense Authorization Act for fiscal year 2025. In a joint letter with other industry associations, the group raised concerns that the provision—Section 828 of S. 4638—would have required companies to provide repair materials and information to the federal government at regulated prices and without protections for trade secrets, potentially discouraging participation in the defense supply chain.
More broadly, AdvaMed and other industry groups say that many Right to Repair efforts threaten to erode critical intellectual property protections across the board. “Proponents of Right to Repair policies have made expansive demands for extensive intellectual property access, including proprietary servicing materials from OEMs, such as service manuals, software keys, schematics, and tools,” says Jeffries. “The wide release of proprietary servicing materials, and the investment they represent, will create an irreversible loss of trade secret protection for innovators, damaging competition and innovation.”
Gordon-Byrne’s position is that intellectual property isn’t at risk when it comes to medical devices. “It is legal to modify equipment under copyright law, but the FDA does not allow modifications without formal approval,” she says. “Modifications and customizations that are common in the IT world are not allowed for medical equipment.”
She argues that such concerns are often used to obscure a more fundamental motive: profit. Limiting repair options, she contends, helps OEMs preserve high-margin service contracts and maintain control over the aftermarket. Proctor supports this view, noting that industry profit margins for repair and maintenance services can reach as high as 80%.
“OEMs are not harmed by repair,” says Gordon-Byrne. “There are no legal risks to copyrights, patents, or trade secrets. Personal injury law is not altered. Hospitals remain fully responsible for work done under their roof.” She adds that once a device is sold, the OEM has already been compensated for its design and production costs and that restricting service materials afterward amounts to limiting competition.
Safety Concerns Cited in the Repair Discussion
According to AdvaMed’s Jeffries, repairing and servicing highly complex and sensitive medical devices without extensive training and expertise poses a risk to patient health. “For this reason, quality service is dependent on more than just the possession of manuals and materials,” says Jeffries. “Expertise, adherence to a quality system, and compliance with regulatory requirements set by the FDA are essential to ensuring medical devices are serviced properly and safely.”
Jeffries explains that medical device manufacturers are regulated by the FDA, whereas third-party service providers are not. “Allowing non-regulated repair companies to tinker with sophisticated FDA-regulated medical devices needlessly raises patient safety risks,” says Jeffries. “In fact, a 2018 FDA report found more than 4,300 adverse events, including 294 serious injuries and 40 deaths, from devices repaired by unauthorized third-party repair companies.”2
PIRG’s Proctor disagrees with Jeffries’ reading of that FDA study. Adverse events also took place from devices repaired by technicians authorized by the manufacturers.
“The FDA report on the quality, safety, and effectiveness of servicing of medical devices found that there was no difference in outcomes between manufacturers and third-party medical device servicing organizations,” says Proctor. “Therefore, restrictions on which repairs could be done by those independent service organizations (ISO) were unjustified based on the review of the data.”
Further, Gordon-Byrne asserts that ISOs hired by hospitals, physicians, and health technology managers aren’t just “tinkering” with these medical devices. “Technicians are selected for their credentials and are fully supervised,” she says.
Growing Support, Lingering Gaps
According to a PIRG survey that included more than 100 US-based repair professionals, hospitals and independent technicians face challenges due to repair limitations.1 The survey found that nearly 70% cited lack of access to board schematics as a common repair barrier, and enterprise IT technicians reported little to no improvement in accessing necessary tools or documentation.
However, Gordon-Byrne points to growing international momentum for Right to Repair legislation as a sign that resistance to broader access may be weakening. In 2024, several countries—including the European Union, Canada, New Zealand, Brazil, and Colombia—introduced or advanced repair-friendly policies. Yet most still exclude medical devices, reflecting the same limitations seen in US laws.
Access to medical device servicing materials remains restricted, and the broader debate over how to balance safety, access, and innovation continues. Whether future laws will include medical technology—or remain carved out—may depend on how policymakers weigh the competing priorities of safety, transparency, and market competition.
References
- Proctor N, Goodrich J. The state of right to repair: repair access is improving, but more needs to be done to ensure our devices get fixed. US PIRG Education Fund. 2025 Jan. Available at https://publicinterestnetwork.org/wp-content/uploads/2025/01/State-of-Right-to-Repair_USPEF_Jan_.2025.pdf
- US Food and Drug Administration. FDA report on the quality, safety, and effectiveness of servicing of medical devices. 2018 May. Available at https://www.fda.gov/media/113431/download
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