Nearly eight months into the COVID-19 pandemic, American hospitals and our health care workers are under incredible stress. In Utah, almost three-quarters of ICU beds were full on Oct. 8. As the crisis continues, concerns about the maintenance of critical medical equipment, including X-ray machines, dialysis machines, and ventilators, are growing.
Even before the pandemic, hospitals faced a shortage of licensed repair technicians. But pandemic-induced patient loads are exacerbating that problem. Many of these devices are in heavy use, increasing the frequency of required maintenance and causing a spike in demand for repairs. Yet, because of the novel coronavirus, many manufacturers are restricting travel for their repair technicians.
Rural hospitals, which are stretched thin in the best of circumstances, face some of the biggest challenges. A medical system in Colorado and Kansas reported that one of the few authorized repair technicians in its state was sidelined for weeks after being exposed to COVID-19.
The result: Too many hospitals face long waits for authorized technicians to repair life-saving machines. In a survey published in July by the U.S. PIRG Education Fund, almost one-third of biomedical repair technicians said some equipment at their facilities could not be used because repairs were unavailable. To be clear, it isn’t just equipment needed for coronavirus treatment that’s impacted—preventative maintenance on all kinds of devices has fallen behind because manufacturer certified technicians were unavailable. Everything from imaging equipment like MRI, CT X-ray, and ultrasound machines, to anesthesia machines, heart-lung machines, and other surgical equipment were affected.
As an example, at the facility where Ilir works, electrosurgical units were recalled in April due to major cybersecurity concerns, but the manufacturer couldn’t send its repair technician. It took more than eight weeks of back-and-forth, but eventually the manufacturer gave his team permission to address the recall—which simply required installing new software.
It doesn’t have to be this way. As the president of American College of Clinical Engineering and the top Democrat on the Senate committee with oversight of Medicare and most federal health care spending, we know there’s a solution to alleviate this impending equipment shortage crisis.
Many hospitals already have repair experts on-site (like the ones in the survey who said they had equipment they couldn’t use). But manufacturers often require restrictive licensing agreements and use copyright law to prevent hospitals from diagnosing and fixing their own equipment. Rather than fixing the broken ventilators, technicians are spending hours on the phone pleading for parts, or manuals, or passwords. In July, Vice reported that some repair technicians have resorted to buying what amount to hacking tools from Poland just to be able to fix ventilators. A recent study shows that an overwhelming majority of repair technicians have been blocked from making critical repairs as a result of manufacturer restrictions.
Lifesaving equipment is being left to gather dust in a closet, as patients have to wait for something called a “manufacturer authorized technician,” which is simply the person the manufacturers allows to fix the equipment. Often, the authorized technician has the same exact qualifications as those who the manufacturer refuses to provide necessary information to. And newer devices have even more advanced technologies to shut out technicians who haven’t paid a manufacturer for the privilege of entering a passcode in order to do routine maintenance.
U.S. PIRG Education Fund’s report found that 48.8 percent of medical equipment repair professionals report they have been denied access to “critical repair information, parts or service keys” during the pandemic. Denying sick people access to life-saving equipment over a repair manual is about as short-sighted as it gets.
That’s why we are urging Congress to pass Sen. Wyden’s Critical Medical Infrastructure Right-to-Repair Act, as part of the next COVID-19 relief package, whenever election-season gridlock ends. This commonsense legislation would allow trained repair technicians to more easily access the information and tools they need to fix and maintain critical medical infrastructure during the COVID-19 crisis. The legislation has been endorsed by rural doctors and health care providers, as well as repair technicians across the country—from the Colorado Association of Biomedical Equipment Technicians, to MaineGeneral Medical Center.
So why hasn’t Congress already made this slap-your-forehead obvious change? The main criticism by device manufacturers has been that a right to repair would somehow make patients less safe. We want to be clear: This bill wouldn’t change a single safety requirement or standard for equipment. The Food and Drug Administration, the Centers for Medicare and Medicaid Studies, and other federal agencies would continue to enforce those rules.
And we already know that the right to repair is safe. A 2018 FDA study found that across millions of equipment reports, there was no evidence that manufacturers are more safe than in-house technicians or third-party repair companies.
While this bill is focused on addressing the pandemic-induced emergency facing medical infrastructure, Americans should always have the right to repair the vehicles, tools, and devices they own. If a farmer’s tractor breaks down, they should have the right to go to any qualified mechanic, instead of being locked-in to paying higher prices at dealerships. Americans should be able to buy generic-brand replacement printer cartridges or go to independent phone repair technicians. Our hope that this legislation serves as the first step toward establishing a new balance that strikes down unnecessary obstacles to home repair—everything from tractors to electronics—while continuing to allow manufacturers to innovate and thrive.