Americans are becoming more familiar with the rights of repair operations, which shocked the industry from agriculture to consumer electronics. The idea is that consumers should have the right to hire anyone who wants to fix their own technology, regardless of expertise or supervision.
In fact, as of 2025, all 50 states have proposed some form of restoration of legislative power. This may be because, on the surface, the concept is expected to bring significant benefits. But, like many good ideas, the evidence for pudding is in diet.
als, as HL Mencken puts it, “For every complex question, there is a clear, simple and wrong answer.” The extensive implementation of the maintenance rights presents many challenges that need careful consideration. From browsing complex intellectual property laws to ensuring compliance with the safety standards of the normative products, many obstacles must be addressed before the sport can truly deliver on its commitments.
So, as state legislatures across the country try to secure victory by granting greater autonomy to consumers, legislators must develop these policies with a prudent and precise attitude. Too broad language can inadvertently undermine key safety standards for basic products that the public relies on, such as complex medical devices.
Welcome to Minecraft. As a former deputy specialist at the U.S. Food and Drug Administration (FDA), we oversee regulations on health technologies and quality standards that help manufacturers bring safe and innovative technologies to the market and ensure they are safe and effective. Importantly, maintaining patient safety is crucial in a time when technology plays a key role in healthcare delivery and outcomes.
But it's friction.
Manufacturers who require medical equipment follow the highest standards – third-party repair shops are not. In fact, unregulated service providers are not obliged to report any adverse events arising from their work because they are not subject to the FDA's jurisdiction. Therefore, not only does there be a dangerous regulatory gap, but it creates the right to legal maintenance rights in this field, but it also creates life-threatening loopholes. This is an invisible one.
While the rights to repair laws vary across states, many proposed bills cover all types of digital electronic products extensively. Such a broad policy unintentionally allows unregulated repairs to endanger the safety of patients. Therefore, legislators are routinely called on to create special exemptions for medical device technology. This is a wise move.
But now, some states have strangely adopted the right to deliberately focus on pairing direct repairs with medical devices. Cui Bono? Not a patient.
In February, Vermont introduced a repair bill for specific medical devices, which would encourage third-party service personnel to perform equipment repairs in hospitals without the need for reviewed training programs, regulatory oversight or regular reporting requirements. In March, North Carolina proposed a similar policy that required original manufacturers to provide their own proprietary repair information and manuals to unregulated service providers. This is the secret to disaster.
The question we have to ask is how doctors and patients are confident that suppliers are totally unaware that the FDA’s repair and reporting process can properly recalibrate life-saving machines? This is really the right place to argue “Can anyone do it?”
Worse, these legislations are often confused with the rights to try the law that allow patients to access experimental drugs that have not yet been approved by the FDA. The right to try is supported by federal law. It is different from the right to repair. Not even closed.
As the legislative session continues, lawmakers must consider the serious risks of repair policies related to dangerous broad rights and ensure implementation of medical devices before it is too late. Patient safety must always be the first to come. No exception.
Photo: Vadim Sazhniev, Getty Images
Peter J. Pitts is a visiting professor at the School of Medicine in the Public Good and the University of Paris Medical.
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