The Medical Imaging & Technology Alliance said it opposes legislation introduced Thursday that gives third-party service companies expanded access to repair medical devices during the ongoing pandemic.
Under the Critical Medical Infrastructure Right-to-Repair Act of 2020, unregulated organizations would have “unfettered” access to proprietary tools to maintain highly regulated devices, including imaging modalities. MITA, however, says the legislation doesn't hold these companies accountable to abide by any federal regulations.
MITA further added that the legislation—introduced by U.S. Senator Ron Wyden, D-Ore., and Congresswoman Yvette Clarke, D-N.Y.—puts patients in harm’s way.
“While the intention of the bill’s sponsors is to protect patients, the unintended consequences of this legislation would increase the risk to patient safety,” said Patrick Hope, executive director of MITA, in a statement. “Especially during the pandemic, we should want the most qualified, trained experts servicing essential medical equipment, not third-party servicers unknown to the FDA who are not held to any requirements.”
In its statement, MITA pointed to a recent story in Vice that quoted Sen. Wyden’s office as saying: “nothing in this bill would exempt healthcare providers or technicians from compliance with the safety standards set forth by the FDA or other relevant agencies.”
Meanwhile, Hope said this “fails to recognize” that third-party services aren’t required to comply with FDA regulations and questioned what “standards” the bill will hold these companies to be compliant with?
Furthermore, Hope said there is “zero” evidence that there’s a shortage of currently qualified technicians.
“The issue at hand is not that that independent servicers do not and should not have a ‘right-to-repair’ complex medical imaging systems, but rather with that right comes an inherent responsibility to have a well-implemented quality management system, file Medical Device Reports, and register with the FDA.” Hope concluded in the statement.