New Harris Poll: FDA Should Regulate All Medical Device Service and Repair

 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.

Patients Rising Now
Sarah Shelson
610-844-8366
www.patientsrisingnow.org

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  • Medical & Health

Registrars Should be Actively Engaged with Enrollment Management and Student Engagement Efforts, According to Research from Modern Campus and AACRAO

 Seventy-nine percent of respondents agreed registrars should be actively involved in student engagement across the student life cycle, and 88 percent indicated the same for strategic-enrollment management efforts. This according to results from the “Perceptions of and Expectations for the Role of the Registrar” 60-Second Survey by the American Association of Collegiate Registrars and Admissions Officers (AACRAO), in participation with Modern Campus, the higher education industry’s leading modern learner engagement platform. These responses imply the role of the modern registrar centers around the concept of student centricity.

The 60-Second Survey invited registrars and enrollment management professionals from colleges and universities across North America to provide their perspectives on what the role of the registrar should be at their institution. Particular attention was paid to what the role of the registrar should be for student engagement and enrollment management. The data from the survey was used to shape a roundtable discussion in July 2022 and a subsequent white paper by AACRAO and Modern Campus titled, “The Modern Registrar: Reflections from the Field,” which launched today.

“A successful registrar is much more than a record gatekeeper – the registrar’s portfolio is central to an institution and engaged in aspects of academic affairs, financial aid, data and technology, compliance and records management. Through this portfolio they create, maintain and are continuously engaged in improving the student experience and student success,” said Dr. Wendy Kilgore, senior director of research at AACRAO.

The registrar has the unique ability to simultaneously influence institution-wide policies and practices related to both academic affairs and student success. They have access to, and an understanding of, a broad set of data. A modern registrar uses this data to identify pitfalls and areas of success, and to advocate for data-driven student-centric policy, practice and the application of technology. The roundtable participants contributed further to the understanding of what it means to be student centric by sharing their institutional and professional perspectives on the topic. Themes in their collective responses included, but are not limited to, the following:

· Placing the student at the center of decision-making around policy, practice and the use of technology

· Being aware of the use of profession-specific terminology

· Understanding the registrar’s role as an educator

· Using of empathy to understand a student’s perspectives

· Leveraging data to inform student-centric policy and practice

· Highlighting understanding that there is no “one-size-fits-all” student experience in higher education

“More and more, we are seeing the role of the registrar shift from being more systems and process focused to more student focused,” said Amrit Ahluwalia, senior director of strategic insights at Modern Campus. “By spending less time on records management and more time focused on becoming student centric – helping support student needs on a daily basis – will ultimately help students attain their goal of degree completion.”

Methodology

As part of ongoing efforts to understand the role of the modern registrar in higher education, AACRAO deployed its 60-Second Survey, which launched in June 2022, inviting members of the AACRAO community to provide their perspectives on what the role of the registrar should be at their institution. 922 responses were received, representing 731 institutions or systems of higher education in eight countries. Subsequently, 250 respondents volunteered to be a part of a roundtable discussions on the role of the modern registrar. Of those, nine volunteers were selected to impart their understanding of what it means to be student centric by sharing their institutional and professional perspectives on the topic.

AACRAO intends to continue engaging the higher-education community as a whole in discussing the role of the modern registrar as part of its goal to support a community centered on learner success driven by professional excellence and leadership in enrollment and academic services. More specifically, AACRAO aims to advance the knowledge and understanding of the professions engaged in enrollment and academic services, of which the registrar position is part, to help those who are not yet viewed within their institution as a nexus and a resource to fulfill this role.

Modern Campus

Angela Tuzzo

732-758-1100

www.moderncampus.com

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  • College & University