Organizations Email Urges Right to Repair Action
Mon May 09 2022
The letter below was emailed to HTM professionals regarding the Right to Repair.
“In late March, I reached out to warn of a rumored effort by medical device manufacturers to change the FDA’s definition of “remanufacturing” in a way that would include many activities that have long been considered standard service, repair or refurbishing.
A bill has now been introduced that would have huge impacts on the ability of hospital and ISO biomeds like you to continue servicing medical equipment. It would undermine all of the progress we have made on Medical Right to Repair over the past couple years.
The manufacturer lobby has shopped this bill as a “non-controversial” clarification. In fact, it introduces more confusion by making any act that “could” change performance or safety specifications, including changes to the design of a piece of equipment, remanufacturing. It comes just a month before the FDA is due to release the final guidance around which the agency engaged more than 80 stakeholders and the public in order to come to an appropriate solution.
Along with our allies at IAMERs and the Alliance for Quality Medical Device Servicing, we have been meeting with members of Congress to tell them that this is in fact a controversial bill that would have a detrimental impact on competition in the medical device servicing space, leading to worse patient care and higher healthcare costs. But our decision-makers in DC need to hear from you—the hard-working professionals on the frontlines that this would affect most—before the House Energy & Commerce Health Subcommittee meets early next week.
Thank you for all of the important work that you do. We’ll keep working to make sure that our leaders in Congress hear your voice.
Director, PIRG Campaign for the Right to Repair”