Don’t Erode Medical Device Trust with Right to Repair

When you walk into a doctor’s office or a hospital, you don’t even think twice about the machines that your healthcare professionals are using to treat you. It’s an inherent trust that wherever you seek your care, the equipment works properly and will protect your well-being.

Doctors have also bought into this sentiment of trust in the efficacy of the medical devices they use. They must have full confidence that their equipment will carry out its necessary job.

But what if the effectiveness of the medical equipment that serves both patients and doctors was suddenly not guaranteed? Not only would this widen the disparities already existent in the healthcare community, but it could also open these devices to inherent risks that will put patient safety on the line. Unfortunately, this could become reality if policymakers decide to include medical devices in the so-called right to repair legislation.

There have been several states that are looking to expand their residents’ ability to fix the products they own — either by themselves or by taking it to an independent repair business. However, the right to repair discussion expands beyond personal devices — like your cell phone — to include commercial products like medical devices. But medical devices are a completely different type of product and opening the door to more unregulated repairs could create a significant risk to patient safety.

Patients need more safeguards on the lifesaving equipment that they are treated with, not less. If anything, we need to find ways to enhance oversight for third-party repairs and encourage access by trained technicians.

First, it’s important to note that medical devices are highly regulated, especially the aftermarket repairs conducted on them. The U.S. Food and Drug Administration (FDA) exists to ensure the safety, efficacy, and security of medical devices. There are more than 20,000 different kinds of products used to treat patients, all with varying levels of risk. By its very nature, an MRI machine is very different from your cell phone. There needs to be standards for safety and efficacy and is exactly what FDA regulations ensure.

For example, the FDA has stringent guidelines and a system of reporting setup to keep repairs transparent and the people who conduct servicing accountable. But not third parties. In fact, they are not required to adhere to the FDA’s standards and importantly do not report adverse repair events, potentially exposing patients to poorly serviced or malfunctioning medical devices.

By enforcing these standards, the FDA helps doctors and healthcare professionals do their jobs and uphold the trust between medical professionals and patients. The FDA has said that “proper servicing [of medical devices] is critical to their continued safe and effective use.” But the right to repair could undermine the FDA’s repair regulations and introduce unnecessary risks to an industry where patient safety is the most important priority. 

In Latino and underrepresented communities, trust in the healthcare system has largely wavered, with many already finding themselves wary of any care they receive. If medical devices are included in the right to repair legislation, this distrust could grow larger and the willingness for these populations to visit the doctor’s office could drop dramatically. We know firsthand that individuals in underserved regions encounter significant barriers to accessing quality healthcare. These obstacles include inadequate transportation, insufficient infrastructure, and a scarcity of care facilities. Additionally, a lack of confidence in the healthcare system can severely impact their long-term health outcomes.

Aside from the increased distrust, medical devices would also become more susceptible to cybersecurity attacks and infringements through open access. In 2023, the healthcare industry set records with the most reported data breaches and the most breached records, with 725 data breaches exposing more than 133 million records. If the right to repair worms its way into the industry, this number is only destined to increase.

Thankfully, medical device exemptions — or “carve-outs” — have already been included in the right to repair legislation passed in some statehouses. This ensures medical devices are not susceptible to unregulated repairs.

Doctors deserve the confidence to know that each piece of equipment they pick up will be able to perform to its maximum capacity. And patients shouldn’t have to question their health professionals. Bottom line: right to repair would undermine the FDA’s regulations and introduce unnecessary risk into the healthcare industry, threatening the high-quality care that doctors provide patients. 

Ensuring that medical device repairs are performed by certified professionals is crucial to maintaining the highest standards of patient care. So, for now, keeping medical devices out of the so-called right to repair policies will help establish that necessary guardrail. For medical devices, keep prioritizing safety over convenience.

Photo: Besjunior, Getty Images

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