Sen. Ron Wyden (Ore.) introduced the Critical Medical Infrastructure Right-to-Repair Act in an online press conference with U.S. PIRG on Thursday. The bill would remove manufacturer-imposed barriers to fixing medical equipment during the COVID-19 pandemic, providing much-needed help to HTM professionals, or biomeds, advocates say.
“There is no excuse for leaving hospitals and patients stranded without necessary equipment during the most widespread pandemic to hit the U.S. in 100 years,” Sen. Wyden said. “It is just common sense to say that qualified technicians should be allowed to make emergency repairs or do preventative maintenance—without having their hands tied by overly restrictive contracts and copyright laws—at least until this crisis is over.”
When a ventilator or dialysis machine goes down, coronavirus patients don’t have much time to wait. But some manufacturers of medical devices refuse to provide hospital biomeds with what they need to fix these machines. That means onsite biomeds who could make the repair in minutes to hours have to wait hours to weeks for an “authorized” technician to travel to the hospital.
“I’ve talked to more than a hundred biomeds since the start of the crisis. All they want is to be able to fix broken equipment and protect the patients in their hospitals. By giving these frontline workers access to service materials, Sen. Wyden’s bill helps them get their job done,” said U.S. PIRG Right to Repair Advocate Kevin O’Reilly.
After pressure from U.S. PIRG and other advocates, some medical device manufacturers have opened up access to repair materials such as manuals and training modules. But problems persist: A recent U.S. PIRG Education Fund report found that 48.8% of biomeds surveyed had been denied access to “critical repair information, parts or service keys for medical equipment,” since the coronavirus first swept the country in March.
“We continue to hear during the pandemic that manufacturers of imaging equipment have declined to cooperate fully in providing service access information. Regional and rural hospitals depend upon independent servicers when their equipment is in need of repair. We are hoping this legislation will cause greater cooperation,” says Robert Kerwin, general counsel, the International Association of Medical Equipment Remarketers and Servicers.
“We believe that every organization that purchases or services medical equipment should have the right to get trained and be able to procure parts to repair the equipment they own,” adds Ilir Kullolli, president of the American College of Clinical Engineering. “This will make healthcare delivery better, faster, and safer—especially during this pandemic.”
“During the pandemic, I have run into problems getting what I need to fix ventilators in my hospital, leading to delays of two to three weeks. That cannot be an acceptable outcome,” adds Leticia Reynolds, president of the Colorado Association of Biomedical Equipment Technicians. “This bill would make sure that this does not happen to me or any other biomed for the remainder of the emergency.”
Right to Repair campaigns around the country, such as PennPIRG’s efforts in Pennsylvania, are advancing reforms that improve access to parts and service information for medical equipment. This bill’s introduction in Congress represents growing national support for reforms that address unnecessary repair barriers across multiple industries.
“There is no reason we should tolerate manufacturers putting their own proprietary concerns over patient safety — especially during the pandemic. 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 toward a long-term solution to manufacturer-imposed barriers to repair,” says O’Reilly.
The bill has attracted support from a wide range of medical and policy groups, including:
- American College of Clinical Engineering
- National Rural Health Association
- National Association of Rural Health Clinics
- International Association of Medical Equipment Remarketers and Servicers (IAMERS)
- Alliance for Quality Medical Device Servicing
- ISS Solutions Healthcare Technology Management
- The Repair Association
- Electronic Frontier Foundation
- Color of Change
- Public Knowledge
- R Street Institute
- Lincoln Network
- Niskanen Center
- Colorado Association of Biomedical Equipment Technicians (CABMET)
- MaineGeneral Medical Center