This is not a time for companies that make medical devices to be secretive and possessive with their repair manuals. And yet, nearly 92 percent of biomedical repair technicians reported recently that they had been recently denied access to service information for critical equipment, including defibrillators and ventilators, according to U.S. PIRG.
That’s why Sen. Ron Wyden of Oregon and Representative Yvette D. Clark of New York introduced Senate and House bills to make it easier for technicians and hospitals to fix medical devices during the COVID-19 pandemic. Wyden and Clark’s Senate ad House bills will be the first introduction of Right to Repair laws at the federal level in the U.S.
Under the Critical Medical Infrastructure Right-to-Repair Act of 2020, medical manufacturers must share service information and sell parts to biomedical technicians trying to keep machines working during a pandemic. The Act would also prevent medical device manufacturers from enforcing strict service agreements that forbid medical techs from working on devices themselves. And the usual copyright, patent, and legal restrictions that make the copying or sharing of service manuals illegal would be suspended while dealing with COVID-19 is a priority.
“There is no reason we should tolerate manufacturers putting their own proprietary concerns over patient safety—especially during the pandemic,” wrote Kevin O’Reilly, a Right to Repair advocate with U.S. PIRG, in a statement regarding the legislation. “Passing this bill is an easy, common-sense way for the Senate to help hospitals in their time of need, and a terrific first step towards a permanent solution.”
There’s also a forward-looking aspect to the pandemic-focused bills. The Federal Trade Commission is tasked with enforcing the act, but would also deliver a study one year after it takes effect. The FTC would then report to Congress on the effectiveness of suspending business as usual when it comes to repair.
The need for quick repairs to devices with locked-down manuals was apparent in the early days of the pandemic. A lack of access to ventilator service information spurred iFixit into action in early March; that project later swelled into a general medical repair database. Our goal was to build a free, open database for biomedical technicians, compiled from the manuals they’ve amassed over the years, hosted in continuity by our company. But unfortunately our repository can’t do anything to prevent companies from restricting their manuals in the first place.
Along with U.S. PIRG, the medical right to repair bills have the support of the Electronic Frontier Foundation, the American College of Clinical Engineering, and others. Sens. Elizabeth Warren and Bernie Sanders both included some form of right to repair in their platforms when they ran for president in 2020. We’re eager to see this bill enter the national debate.