Why medical device repair should stay in the hands of regulated professionals | Opinion
As state policymakers, like those in Delaware, consider Right to Repair legislation it’s critically important that they recognize the potential dangers of untrained, unregulated technicians servicing medical equipment. Advancements in medical technology bring hope to patients around the world. From outpatient clinics to emergency rooms, medical devices and equipment provide doctors and surgeons with the tools they need to appropriately diagnose, triage, and care for individuals in their moment of need.
As a trauma surgeon and critical care physician, I have to trust that the precision instruments we use in a pre-hospital setting, the emergency room, operating room and post-op, are always functioning in optimal condition. Patients’ lives depend on it. As a consequence, any repairperson tasked with servicing these highly technical medical machines must be well qualified and operate in a manner consistent with Food and Drug Administration regulations for medical device servicing and remanufacturing.
Who is qualified to service medical equipment, and how device service is performed is being debated in some circles as the so-called “right to repair” movement is growing. Right to repair supporters claim that allowing any repairperson free access to proprietary digital information, tools and technologies developed by the manufacturer would lower costs and cut waste. Indeed, their advocates have found some success in repairing electronic devices — like mobile phones — and some farm equipment. But ask any patient going in for heart surgery — the margin for error with their surgeon’s cardiopulmonary bypass equipment is much lower than what they’d allow for farm equipment or cell phones. Patients and doctors know that errors associated with cutting corners — even to save money — would risk much more than an inconvenience, it could be the difference between life and death.
Today, the FDA requires original equipment manufacturers to uphold “mandatory Quality System/Current Good Manufacturing Practices to ensure that device software updates, patches, and more comprehensive repair jobs are done correctly.” In fact, advancements in medical device hardware and software components mean that “the cybersecurity consequences of even a slightly imprecise or careless maintenance job have become increasingly stark.”
In a sense, medical device repair personnel are just as critical as anyone in the room during an operation, because if the equipment fails — or is simply miscalibrated — a patient is at risk.
As doctors, our Hippocratic oath compels us to always consider patient safety. But unfortunately, the move to give more access to unregulated, untrained repair people servicing life-saving medical devices could undermine these quality and safety standards. In fact, a 2018 study “showed 4,300+ reports of adverse events–including 40 deaths, 294 serious injuries–from devices repaired, replaced, or maintained by third-party servicers.”
Moreover, this report likely doesn’t even begin to capture the full picture of adverse events that are happening. That’s because, unlike manufacturers and device-user facilities, unauthorized servicers are not required to report an adverse event. In fact, the number of times a device serviced by a third-party may have caused or contributed to a death or serious injury is likely much larger. But in the absence of enforcement of regulation on the third-parties servicing these machines, we end up with a lack of transparency — and data — that is terrifying in an industry where precision is paramount.
It's clear that the risks are far too severe to entertain the idea of “Right to Repair” when it comes to medical devices. It is essential to the health and safety of those we have the privilege to care for that the complex instrumentation on are always serviced by specially trained technicians under the watchful eye of the FDA.
Too many people rely on these life-saving devices to introduce an unnecessary risk that could jeopardize their functionality. There may be a place for “Right to Repair” with household appliances and telecom equipment, but it’s not in the operating room, the emergency room, or the doctor’s office.
Richard H. Carmona, M.D., M.P.H., F.A.C.S. was the 17th Surgeon General of the United States.
This article originally appeared on Delaware News Journal: Delaware medical device repair should stay regulated
