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

Statement

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.

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)
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
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)

Source