September 10, 2020 at 5:00 am ET
Over the past several months, we have seen the COVID-19 pandemic place never-before-seen strains on the American health care system. Demand for life-saving medical devices such as ventilators, dialysis machines, portable ultrasound and patient monitors on the front lines of the pandemic has surged.
The medical technology industry has stepped up to meet these demands, working 24/7, adding extra shifts and repurposing manufacturing lines to boost already record-level production. Ventilator companies, for example, boosted production from approximately 700 devices a week, pre-pandemic, to nearly 10,000 a week within a few short months.
While the production of vital medical technologies is skyrocketing, manufacturers are also taking essential steps to ensure these highly complex devices continue to be properly serviced and repaired. This is crucial, as a patient’s life and well-being often hinge on a properly functioning diagnostic or treatment device.
Original equipment manufacturers of medical devices develop comprehensive servicing plans from the outset of the product’s design phase. Also, OEMs and their authorized servicers must follow strict Food and Drug Administration regulations and are subject to FDA inspection to ensure their devices are properly maintained and continue to meet the agency’s gold standard of safety and effectiveness. Unfortunately, this is not the case for unregulated third-party servicers, who are independent and often have no affiliation with the manufacturer and, as a result, lack the knowledge, training and expertise to properly service complex medical devices, putting patients, clinicians and other device users at risk.
Instead of mandating that these third-party servicers follow the same regulatory requirements as everyone else — requirements that would ensure the devices they service continue to meet FDA high standards of safety and effectiveness — the so-called “Right to Repair” movement aims to further loosen regulations on these independent operators, in effect giving free rein to unregulated third-party servicers of complex medical devices.
Although well-intentioned, this is not in the best interests of patients and could lead to increased patient harm. Before the COVID-19 emergency, in 2018, the FDA found that there had been more than 4,300 adverse incidents involving medical devices, including 40 deaths and 294 serious injuries, that involved third-party servicers. There have even been accounts of parts being lodged in patients, imaging equipment repaired with aluminum foil and one report of a 90-pound piece of equipment striking an operator associated with third-party servicing. These avoidable mishaps expose patients to dangerous risks — including concussions, fractures, burns or even overexposure to radiation.
FDA regulations are there for good reason: to ensure that serviced and repaired devices continue to be safe and effective. This helps prevent patient harm and ensures that all imaging, therapeutic devices, patient monitors, infusion pumps, and other essential equipment needed both during the current health care crisis and beyond remain in service.
Some unregulated, third-party servicers argue their previous work for an OEM servicing earlier models of devices qualifies them to work on all models of a device. But the pace of medical technology innovation is so rapid that these technicians’ expertise can quickly become obsolete, rendering their work on newer-model devices potentially dangerous to patients and other device users.
Furthermore, there is no evidence that hospitals are having any difficulty finding properly trained servicers for their devices, either from the original manufacturer or their authorized repair technicians. These authorized servicers are conducting on-site repairs, providing remote technical assistance and delivering necessary replacement parts without interruption to patient care. Medical technology companies are successfully working hand-in-glove with hospitals, clinics, and other health care institutions to service, repair, and maintain crucial medical devices.
To ensure patient safety, third-party service providers need more than just access to a repair manual to properly fix and maintain these sophisticated, life-saving medical technologies. They need the same knowledge, training, and expertise the OEMs and their authorized reps have. Even one minor miscalculation could lead to catastrophic injury — to the patient or the device user. Until there is evidence of an actual shortage of properly trained service technicians, the movement to lower medical device repair standards remains a solution in search of a problem.
Scott Whitaker is the president and CEO of AdvaMed. Patrick Hope is the executive director of the Medical Imaging & Technology Alliance.
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