The Medical Imaging & Technology Alliance (MITA) has expressed strong opposition to the Critical Medical Infrastructure Right-to-Repair Act of 2020 introduced by U.S. Senator Ron Wyden (D-Ore.) and Congresswoman Yvette Clarke (D-NY). According to the manufacturer lobbying group, 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.”
“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,” adds 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 an article in Vice upon the bill’s introduction, Sen. Wyden’s office said: “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.”
“That argument, however, fails to recognize that third-party services are not currently required to be compliant with FDA regulations,” Hope says. “What ‘standards’ does the legislation ensure third-party servicers will be compliant with?”
MITA also asserted that there has been no evidence of any shortage of qualified technicians servicing medical devices. Moreover, allowing unfettered access to software raises serious cybersecurity risks, officials for the manufacturer lobbying group say.
“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 says.
What are your thoughts on MITA’s opposition? Comment below and let us know.
There is a bit of common sense that BMET’s have that is being ignored with this opposing argument. BMET or HTM company or Technician would not work on a piece of equipment that they are not able to work on because of knowledge or test equipment needed to repair the equipment. Yes, there are those who think can fix anything, those will be weeded out by their own incompetence. If I am correct there are certain requirements in the bill that mandate technicians need to have the required knowledge or training to service the equipment.
Some companies treat all there equipment as proprietary right down to the footswitches that can be purchased for $600 but, the company’s internal service group charges $1200 to repair. Cost is the MAJOR reason for the Right to Repair.
No BMET or HTM wants a death cause by equipment they worked on even if it was not caused by or related to the equipment.
It doesn’t matter if you are a 3rd party repair svc, In House Biomed/Clinical engineering, or manufacturer field service. The Health Care organization is held to CMS and usually Joint Commission standards for testing and repair, that is, “Manufacturer recommended procedures” are followed. The argument that there is a different set of service standards for one or the other is irrelevant.