Hospitals, independent device repairers, public health groups oppose changes that would undermine medical Right to Repair

WASHINGTON — The U.S. Public Interest Research Group (PIRG) and the International Association of Medical Equipment Remarketers and Servicers (IAMERS) delivered a letter to the House Energy & Commerce committee Tuesday opposing a manufacturer-backed amendment to the Medical Device User Fees Amendment (MDUFA), a must-pass piece of legislation.

The letter—signed by leaders from health networks representing 253 hospitals across 26 states, the country’s top independent service organizations (ISOs) and other repair and public health advocates—states that the changes to the definition of “remanufacturing” suggested by Rep. Scott Peters’ (CA) H.R.7253 could severely reduce competition in the medical device repair industry. PIRG and IAMERS also delivered a similar letter signed by 100 biomedical repair technicians, aka biomeds, who work on our healthcare system’s frontlines to maintain and service medical devices.

“The pandemic exposed how manufacturer repair restrictions cause service delays that hurt clinicians’ ability to give patients life-saving care,” said Kevin O’Reilly, U.S. PIRG’s Right to Repair campaign director. “This bill would worsen patient safety and drive up healthcare costs.”

H.R.7253, the “Clarifying Remanufacturing to Protect Patient Safety Act,” would expand the definition of “remanufacturing” beyond the recommendation issued by the Food and Drug Administration (FDA) in draft guidance in June 2021. If revised, the definition would include activities that have long been considered routine maintenance. As a result, many hospital biomed departments and ISOs could have to register with the FDA as manufacturers—bringing potentially overwhelming costs and regulatory burdens—to continue providing the equipment maintenance services that a 2018 FDA Report described as “critical to the functioning of the U.S. healthcare system.”

The FDA has engaged more than 80 stakeholders from across the device-servicing community and solicited public comment to establish a definition of remanufacturing that would satisfy all parties and appropriately address the problem. Congress would bypass this process by accepting the amendment laid out in H.R.7253.

“This legislation would do more to confuse than it would to clarify as it defines as remanufacturing any acts which ‘could’ significantly change performance. How is a term like ‘could’ an improved legislative clarification of what activities are servicing and what activities are remanufacturing?” said IAMERS General Counsel Robert Kerwin. “It is all the more ill-timed as we await the FDA’s final guidance on remanufacturing, which has been designed by FDA as an ‘A’ list priority for this year after several years of consultation with industry. Congress should welcome this deliberative process as a means to reach results for the industry and for patients.”

While the issue of repair restrictions is not new, the COVID-19 pandemic exposed the extent of the problem. As ventilators were pressed into around-the-clock use, repair and maintenance issues became more pronounced. A U.S. PIRG survey of biomeds conducted between December 2020 and February 2021 found that 80% had equipment they could not service because of restrictions on critical repair materials.  

“I manage ventilator repair for a dozen hospitals across the state of Colorado. When our equipment beaks, we need to be able to fix it, STAT,” said Leticia Reynolds, president of the Colorado Association of Biomedical Equipment Technicians. “Our team of clinical engineers and biomeds is world-class, but there’s nothing they can do to fix critical equipment when we can’t access needed repair materials. We already face too many delays waiting for manufacturer-branded technicians to show up on site. This bill would only make our job harder.”

Efforts to enact medical Right to Repair, which would provide qualified biomeds with access to everything they need to fix modern medical equipment have gained steam in the wake of the COVID-19 pandemic. Sen. Ron Wyden (OR) and Rep. Yvette Clarke (NY) introduced the Critical Medical Infrastructure Right-to-Repair Act of 2020, and states from Hawaii to California to Arkansas have considered similar legislation. The issue was also included in President Joe Biden’s Executive Order on Promoting Competition in the American Economy. Special Assistant to the President Tim Wu stated in a town hall that the issue is a “confluence of a lot of really important priority policies for the Biden Administration.”

H.R.7253 was not included in the House Committee on Energy & Commerce’s initial MDUFA package, which goes to markup in the Health Subcommittee on Wednesday. The language could still be added in a manager’s amendment before Wednesday, or during the ensuing markup.

“Leaders in Congress should know one thing: this change is too controversial to be included in a package that is meant to be bipartisan and popular,” O’Reilly said. “We need Congress to promote competition that will deliver patients the best care possible, not pass industry-backed efforts to squash it. H.R.7253 misses that mark.”