August 06, 2020

Wyden and Clarke Introduce Bill to Eliminate Barriers to Fixing Critical Medical Equipment During the Pandemic

Restrictions Can Prevent Medical Providers from Repairing Ventilators and Other Essential Equipment, Worsening Shortages; The Critical Medical Infrastructure Right-to-Repair Act Will Allow Emergency Repairs During COVID-19 Crisis

Washington, D.C. – Sen. Ron Wyden, D-Ore., and Rep. Yvette D. Clarke, D-N.Y., today introduced legislation to allow trained experts to maintain and repair essential medical equipment during the COVID-19 pandemic, and temporarily suspend restrictions that are blocking needed repairs. 

The Critical Medical Infrastructure Right-to-Repair Act of 2020 would allow trained repair technicians to more easily access information and tools required to complete maintenance and repair of critical medical infrastructure in preparation for and as part of a response to the current COVID-19 crisis.

“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,” Wyden said. “It is just common sense to say that qualified technicians should be allowed to make emergency repairs or do preventative maintenance, and not have their hands tied by overly restrictive contracts and copyright laws, until this crisis is over.”

“As America grapples with this lethal pandemic, we are also experiencing unprecedented shortages of medical equipment,” Rep. Clarke said. “This narrowly-tailored, common-sense, and time-limited bill will ensure critical medical items like ventilators do not go to waste due to maintenance restrictions that have no nexus to safety. During this health crisis, we must do everything in our power to expand access to life-saving devices.”

Specifically, the bill would:

  • Protect equipment owners, lessees, and servicers from liability under federal copyright law for creating an incidental copy of service materials or for breaking a digital lock during the course of equipment repair in response to COVID-19;
  • Allow equipment owners or lessees to fabricate patented parts on a non-commercial basis and as needed for repair or maintenance in response to COVID-19;
  • Invalidate provisions in equipment contracts to the extent that they prohibit or restrict the repair or maintenance of critical medical infrastructure in response to COVID-19; 
  • Require manufacturers to provide, on fair and reasonable terms, access to information and tools used to diagnose problems and service, maintain, or repair equipment; and
  • Require the Federal Trade Commission to evaluate the bill’s impact and effectiveness on innovation and competition in the critical medical infrastructure market.

Rural health care and public interest advocates praised the bill today:

“As COVID-19 surges across rural America, rural providers must have the rapid ability to maintain effective and operational equipment. This common-sense approach will enable rural providers caring for COVID patients to keep lifesaving equipment operating during this pandemic,” said Alan Morgan, CEO of the National Rural Health Association.

“I've talked to over a hundred professional medical device repairers -- all they want is to be able to fix broken equipment and protect the patients in their hospitals. COVID-19 is making all they do harder, and this bill helps them get their job done. 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 towards a permanent solution,” said Kevin O’Reilly, of the U.S. Public Interest Research Group.

"Since the onset of the COVID-19 pandemic in the United States, Color Of Change has pushed ventilator manufacturers to dial-back their dangerous, counterproductive repair restrictions, which have put an unnecessary strain on our medical providers’ ability to tackle the virus. For Black people especially, Senator Wyden and Representative Clarke’s bill would be a necessary protection against medical rationing in a system that has consistently neglected and harmed our communities. We commend Senator Wyden for introducing this bill and shining a light on the critical role that medical equipment manufacturers should play in the outcome of this pandemic," said Color Of Change Vice President Arisha Michelle Hatch.

The Critical Medical Infrastructure Right-to-Repair Act has been endorsed by a wide range of health care, engineering and civil society groups:

  • American College of Clinical Engineering (ACCE)
  • Association of Medical Service Providers (AMSP)
  • National Rural Health Association (NRHA)
  • National Association of Rural Health Clinics (NARHC)
  • International Association of Medical Equipment Remarketers and Servicers (IAMERS)
  • Alliance for Quality Medical Device Servicing (AQMDS)
  • ISS Solutions Healthcare Technology Management
  • U.S. Public Interest Research Group (U.S. PIRG)
  • The Repair Association
  • Electronic Frontier Foundation (EFF)
  • Color of Change
  • Public Knowledge
  • R Street Institute
  • Re:Create
  • Lincoln Network
  • Niskanen Center
  • Colorado Association of Biomedical Equipment Technicians (CABET)
  • MaineGeneral Medical Center
  • Pennsylvania Public Interest Research Group (PennPIRG)
  • Center for Democracy & Technology (CDT)

The full bill text is available here.