Legislation Raises Patient Safety Concerns as Non-Regulated Servicers Do Not Have FDA-Regulated Quality Control Management Systems
Washington, D.C – The Medical Imaging & Technology Alliance (MITA) today expressed strong opposition to the Critical Medical Infrastructure Right-to-Repair Act of 2020 introduced by U.S. Senator Ron Wyden (D-OR) and Congresswoman Yvette Clarke (D-NY). The legislation would give unregulated, third-party medical device service companies unfettered access to proprietary service materials and tools to maintain and repair sophisticated, highly regulated medical devices during the COVID-19 emergency. Further, the proposed legislation does not require that those servicers be held accountable to any U.S. Food and Drug Administration (FDA) regulations, such as adopting the quality management systems and safety standards that original equipment manufacturer (OEM) servicers must follow.
“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. “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.”
According to a story in Vice upon the bill’s introduction, Sen. Wyden’s office said: “nothing in this bill would exempt health care providers or technicians from compliance with the safety standards set forth by the FDA or other relevant agencies.”
“That argument, however, fails to recognize that third-party services are not currently required to be compliant with FDA regulations. What “standards” does the legislation ensure third-party servicers will be compliant with?” Hope asked.
MITA also pointed out there has been zero evidence of any shortage of qualified technicians servicing medical devices. Moreover, allowing unfettered access to software raises serious cybersecurity risks.
“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.