Mar 8, 2023 | Business
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.
Jul 18, 2022 | Business
Harris County Public Library (HCPL) announced its slate of author talks for the expanded 2022 edition of its Authorama series. This year, for the first time, Authorama will feature in-person appearances by two nationally known authors with ties to the Houston area, in addition to virtual visits. Award-winning poet Van G. Garrett will host story times featuring his debut children’s picture book, Kicks, and Young Adult author J. Elle will share her unique and inspirational path to the New York Times bestseller list. On the virtual side, Authorama will live stream appearances by Preeti Chhibber, super fan and author of Disney’s new release Spider-Man’s Social Dilemma, the duo who make up the pseudonymous fantasy author M.A. Carrick (The Mask of Mirrors, The Liar’s Knot), and novelist, children’s book author and Houston’s first poet laureate Gwendolyn Zepeda who will discuss her work editing the acclaimed anthology Houston Noir.
Expanding in Scope, but Staying True to its Roots
HCPL’s Authorama was born during the depths of the pandemic out of the library’s need to provide compelling and entertaining content for audiences stuck at home. This year, HCPL’s Authorama is pivoting to a mix of virtual and in-person author talks. “We really wanted to put these authors inside our libraries to give audiences a chance to meet and interact with them in person,” says Jennifer Schwartz, Programming Services Manager for HCPL, “but our past Authorama virtual events have been wildly successful and have the potential to reach more people. Authorama 2022 is the best of both worlds.”
Authorama Goes Year-Round with Authorama365
Coinciding with the end-of-summer Authorama events, HCPL is launching a new partnership with the Library Speakers Consortium (LSC) called Authorama365. Authorama365 will bring bestselling authors and thought leaders to readers all year long. “Because LSC has many library partners across the country, it is able bring in authors who might not be accessible to individual libraries,” says Schwartz, “They book a wonderful mix of bestselling fiction writers and writers who will appeal to entrepreneurs and business people who are looking for thought-provoking, actionable insight to grow their careers and businesses.” Authorama365 events are online and free to the public. Audience members can submit questions to the authors prior to the livestreams, and can browse and watch past events at any time.
Authorama 2022 Live and In-Person
Kicks: A Special Story Time with Author Van G. Garrett – Award-winning poet Van G. Garrett will read from his debut children’s picture book, Kicks.
Katy Branch Library
Wednesday, July 27, 10:30 AM
Spring Branch Memorial Branch Library
Thursday, August 4, 10:30 AM
An Afternoon with J. Elle – YA Author J. Elle will talk about the second book in her Wings of Ebony series, Ashes of Gold, and share her improbable and inspiring journey to the bestseller list.
Maud Smith Marks Branch Library
Thursday, July 28, 4:30 PM
Authorama 2022 Live Streams: @harriscountypl on YouTube and Facebook Live.
Authors’ Insight with Alyc Helms & Marie Brennan – Two amazing writers who together make up the bestselling pseudonymous fantasy author M. A. Carrick (The Mask of Mirrors, The Liars Knot). They will join the HCPL Writes crew to discuss their writing process, collaboration and more.
YouTube and Facebook Live: @harriscountypl
Tuesday, July 26, 6:30 PM
Preeti Chhibber: Spider-Man Super Fan and Author – Preeti will talk about fandom and her books: the just-released Spider-Man’s Social Dilemma and the Avengers Assembly series, X-Change Students 101 coming in September. Q&A follows.
YouTube and Facebook Live: @harriscountypl
Live Viewing Party: La Porte Branch Library
Monday, August 1, 3:00 PM
Gwendolyn Zepeda on Anthologies – HCPL Writes takes a deep dive into anthologies. Learn what they are and how they work from Gwen Zepeda, novelist, children’s book author, and Houston’s first poet laureate, as well as editor of the acclaimed anthology Houston Noir.
YouTube and Facebook Live: @harriscountypl
Tuesday, August 9 at 6:30 PM
All Authorama365 programs are free. Visit www.libraryc.org/hcpl for more information, to register and to view more upcoming events.
About Harris County Public Library:
The Harris County Public Library (HCPL) mission is to provide information and resources to enrich lives and strengthen communities through innovative services within and beyond our walls. The library has an annual circulation of over 10 million items and is a network of 26 community-focused branch libraries and is committed to providing excellent customer service, strong collections, and cutting-edge information technology.
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