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FDA

Published On July 20, 2021

POLICY

Who Has the Right to Repair Medical Equipment?

If a simple latch breaks, a lifesaving device could be down for months. Should hospitals be allowed to fix their machines themselves?

In early 2020 during the first surge of COVID-19, J. Scot Mackeil was helping the state of Massachusetts evaluate some ventilators it had received from the federal government stockpile. Mackeil, a senior biomedical electronics technician for Massachusetts General Hospital, found that one of the machine’s DC power connectors had been crushed during shipment.

Mackeil called the manufacturer and told them, “I’m working for my state’s emergency management agency and I just need a part for a minor repair.” The company’s representative wouldn’t provide the support or sell him parts, saying that Mackeil hadn’t attended the manufacturer’s technical training program. They insisted the ventilator be shipped to the factory for the repair—a basic repair, says Mackeil, that any technician might easily have done.

It has become common practice for manufacturers to clamp down on user repairs, a practice that extends not only to consumer cell phones and laptops but medical equipment. The purchasers may own these devices, but an estimated 80% of original equipment manufacturers deny hospitals access to critical information, such as diagnostic software and factory service manuals, or refuse to send parts and materials. Instead, manufacturers may favor their own divisions and insist that the work only be performed by factory service technicians.

Representatives of the medical equipment industry, in particular, insist that these policies are a measure to ensure patient safety. But a landmark U.S. Food and Drug Administration report in 2018 found little evidence of “widespread public health concern relating to servicing … of medical devices.”

Nathan Proctor, who leads the Right to Repair campaign for the U.S. Public Interest Research Group, believes that even when hospitals are allowed to repair their own equipment, “the existing regulatory environment works to protect patient health.” The ECRI Institute, a nonprofit that conducts medical device evaluations, sifted through 10 years of FDA data and more than two million reported device failures. In only 96 of those failures, or 0.005%, the problem stemmed from maintenance issues or botched repairs—some of which were the result of the manufacturers’ own technicians. “Any reasonable assessment would indicate that it’s safe for trained hospital biomedical technicians, independent service organizations and manufacturers to fix medical equipment,” Proctor says.

The move to allow repairs for medical devices mirrors a wider trend. In May 2021, the U.S. Federal Trade Commission released a report, “Nixing the Fix.” It called for more rules to “ensure that consumers have choices when they need to repair products that they purchase and own.” The report focuses largely on mobile devices, consumer electronics, tractors and cars, but it also touches on medical equipment—acknowledging the argument of manufacturers, that the risks of “improperly repaired machinery are especially acute.” But the report also cites research from the International Association of Medical Equipment Remarketers and Servicers Inc., a medical trade organization, which found “no significant safety problem related to servicing maintenance and repair by independent services.”

That’s also the experience of those working day-to-day with these devices. Mackeil notes that a clinician recently brought his team a broken device used in cancer surgeries. The only damage was to a small plastic latch on the battery door, the kind you might see on a TV remote. Repairing it was straightforward and it didn’t fundamentally alter the device or its effectiveness. The manufacturer quoted an inflated cost for parts and labor, and then, after a mostly one-sided discussion, Mackeil had to agree to ship the entire device back to the company for the repair. That took an important tool used in breast cancer surgeries out of play for about two weeks.

In normal times, says Jarone Lee, medical director of an intensive care unit at MGH, the politics of repair happens in the background. “COVID changed that,” he says. Ventilators and hemodialysis machines were pressed into service around the clock, and physicians saw the crucial need for hospitals to fix devices as they broke down. In April, Lee and several MGH colleagues published “The medical right to repair: the right to save lives” in The Lancet, noting in the paper that the COVID-19 pandemic underscored “the longstanding refusal by manufacturers to provide information for repairing medical equipment.”

One solution to the problem is legislative. The paper’s authors applaud the bill put forward by Senator Ron Wyden of Oregon, the Critical Medical Infrastructure Right-to-Repair Act of 2020. It would give trained repair technicians like Mackeil better access to information and tools, and in the senator’s words, “qualified technicians should be allowed to make emergency repairs or do preventative maintenance, and not have their hands tied…until this crisis is over.” Though the bill never received a vote, a sweeping executive order issued in July called for a crackdown on “unfair anticompetitive restrictions on third-party repair or self-repair of items.” The order did not specifically cite medical device repair but signals that the issue is now on the national radar—and perhaps the momentum for change in the medical sphere will grow.