More than three-quarters percent of American consumers (77%) say the U.S. Food and Drug Administration (FDA) should regulate medical device service and repair conducted by either original equipment manufacturers (OEM) or independent third-party companies, according to a new poll among 2061 U.S. adults conducted by The Harris Poll for Patients Rising Now.
Currently, the FDA only regulates service conducted by an equipment manufacturer but does not regulate the remainder of the approximately 20,000 service and repair entities operating in the United States. According to the poll, consumers overwhelmingly support regulatory parity, says Patients Rising Now, which commissioned the poll.
“Knowing that someone repairing a CT or MRI machine doesn’t have to follow FDA rules is shocking,” said Terry Wilcox, Co-founder and CEO of Patients Rising Now, a leading patient advocacy organization. “Sophisticated medical devices are highly regulated by the FDA – from clearance to repair – except if the repair is done by an independent repair shop. That makes no sense and only serves to increase risks for patients at an incredibly vulnerable time.”
The lack of FDA oversight on independent service and repair has become a focal point in the medical device right to repair debate. Unregulated repair shops are pushing Congress, state legislators and the Federal Trade Commission to force manufacturers to publish intellectual property in the form of service manuals, passwords and training materials making sensitive information available to anyone with an internet connection anywhere in the world. Manufacturers contend that compelling the transfer of intellectual property raises serious safety concerns for patients and providers. Equipment manufacturers also say handing over intellectual property to independent servicers increases cyber security vulnerabilities for hospitals and physician offices.
The poll, which was conducted February 14-16, also demonstrates deep support for excluding medical devices from right to repair legislative efforts federally, and at the state level. According to The Harris Poll, nearly three in five Americans (59%) would be more likely to vote for a member of Congress or state legislator if they supported efforts to not include medical devices in right to repair legislation.
“Legislators take notice: By a sizable majority, consumers say they’re more likely to vote for an elected official if they support efforts to exclude medical devices from right to repair legislation,” Wilcox said. “Thankfully, in New York and other states, legislators are already heeding their constituents call by excluding medical devices from the right to repair debate. We urge any state considering right to repair to exclude FDA-regulated medical devices.”
Last year, Patients Rising Now spearheaded a 24-member strong patient group coalition that urged state legislators to oppose right to repair for medical devices. Wilcox says the recent Harris Poll is evidence that consumers share the same concerns as patient groups. She says Patients Rising Now will continue to sound the alarm about the inherent patient safety concerns associated with handing over intellectual property to unregulated medical device repair companies.
About the Poll
This survey was conducted online within the United States by The Harris Poll on behalf of Patients Rising Now from February 14-16, 2023 among 2,061 U.S. adults ages 18 and older. The sampling precision of Harris online polls is measured by using a Bayesian credible interval. For this study, the sample data is accurate to within +/- 2.8 percentage points using a 95% confidence level. For complete survey methodology, including weighting variables and subgroup sample sizes, please contact Sarah Shelson, sshelson@riesterpublicaffairs.com.
About Patients Rising Now
Patients Rising NOW works with patients to advocate for access to the treatments, innovations and care they need. Its programming efforts focus on educating patients about the legislative process and empowering them to advocate for reforms to advance patient access, affordability, and transparency in healthcare.
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