When a smartphone, computer, router, GPS, or any of the connected devices we use in our day-to-day lives malfunctions, there are frustrations. Maybe some family photos are lost or that time spent preparing an important presentation is squandered. Headaches, certainly, but usually minor ones.
But when a patient goes under the scalpel in an operating room, there is an expectation—a trust—that the necessary equipment will work as it should. It’s often a matter of life or death.
The presumption that medical devices will operate properly is fundamental. Like any modern technology, such important and finely calibrated equipment requires regular preventative maintenance and repair. It’s the Food and Drug Administration (FDA), that’s responsible for ensuring the safety, effectiveness, and quality of medical devices. And as the agency notes, “proper servicing is critical to their continued safe and effective use.”
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While such a statement may seem obvious, the current direction of the right to repair policies sweeping the nation could very well end up unintentionally undermining the regulations that ensure the integrity of sophisticated 21st century healthcare technologies.
On the surface, the idea behind right to repair seems innocuous enough. Policymakers want to require electronics manufacturers to make proprietary parts and schematics public, so they don’t have a monopoly on repairs. Consumers, in theory, would enjoy lower costs not having to take a broken phone, laptop, or tablet to the original manufacturer for repairs.
While this rationale may work for personal-use technologies, it doesn’t hold water when it comes to medical devices such as defibrillators, CAT Scans and MRI machines. Even a minor mistake, miscalculation or service error can result in catastrophic results – including the death of a patient. To make matters worse, in our increasingly interconnected world, a simple coding error could expose personal data to hackers. No patient or physician should have to worry about these dystopian scenarios.
It’s obvious that such healthcare devices must be exempted from general right to repair legislation; they are in a completely different class than common electronics. Who would feel comfortable having a potentially inexperienced third-party servicer repair a ventilator or a surgical robotics system? Who’s to ensure that a non-FDA compliant vendor has the experience, training and knowhow to fix and recalibrate a highly specialized piece of equipment? Few people would probably trust the adage, “Anybody can do it.”
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It is imperative that lawmakers know where to draw the legislative line. Last year, nearly 30 states introduced some version of right to repair legislation, demonstrating how pervasive this idea has become. And there’s no guarantee that state officials will have the good sense to carve out protections for sensitive technology, like medical devices. Diligence is required. Patient lives are at stake.
Not surprisingly, tort lawyers are pushing hard to pass sprawling right to repair laws that include sensitive, FDA-regulated medical technologies. Where the FDA fears diluted oversight, lawyers see a new and potentially lucrative opportunity to sink their claws of litigation into the pocketbooks of device manufacturers at the expense of patients.
And then there’s the very real threat of compromised cybersecurity. The FDA acknowledges cybersecurity is a “widespread issue affecting medical devices,” which more and more are connected to the Internet. Here again, the wrong person working on healthcare devices could cause adverse outcomes—namely, cyber criminals gaining access to sensitive data, which can be used to exploit unsuspecting patients, their families, and employers.
Major electronics manufacturers like Apple and John Deere support right-to-repair, but that doesn’t make it right for highly complicated, lifesaving healthcare technologies. Lawmakers should keep medical devices in the hands of the FDA and the professionals who understand their many nuances. Right to repair legislation mustn’t be allowed to put patient safety at risk.
Photo: Vadim Sazhniev, Getty Images
Peter J. Pitts is President and co-founder of the Center for Medicine in the Public Interest. He also serves as a Visiting Professor at University of Paris School of Medicine. Professor Pitts is a former member of the United States Senior Executive Service and Associate Commissioner of the US Food & Drug Administration where he served as senior communications and policy adviser to the Commissioner. He supervised FDA's Office of Public Affairs, Office of the Ombudsman, Office of Special Health Issues, Office of Executive Secretariat, and Advisory Committee Oversight and Management.
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