Battery Issues Prompt Medtronic Insulin Pump Recall
Medtronic has initiated a recall of its MiniMed 600 and 700 series insulin pumps after customer reports of shortened battery life. A comprehensive analysis, according to Medtronic, found that pumps that have been “dropped, bumped, or experienced physical impact even once” may have a shortened battery life due to damage to internal electrical components.
This issue can cause battery alerts to occur when there is less battery life remaining than otherwise indicated in the user guide. Medtronic says this could result in the pump stopping insulin delivery significantly sooner than expected, potentially leading to hyperglycemia or diabetic ketoacidosis.
Medtronic received 170 reports of hyperglycemia and 11 reports of diabetic ketoacidosis from January 2023 to September 2024 in the US, which the company says are potentially related to this problem.
The FDA has classified this action as a class I recall.
Medtronic has provided updates for customers to address these issues.
ARPA-H Awards $110 Million To Accelerate New Discoveries and Innovation In Women’s Health
First Lady Jill Biden recently announced $110 million in awards from the Advanced Research Projects Agency for Health (ARPA-H) to accelerate transformative research and development in women’s health. Companies in the devices and diagnostics space that received grants include Aspira Women’s Health Inc., which is developing a blood test to diagnose endometriosis; Gravidas Diagnostics, Inc., which is creating the first at-home test for serious pregnancy complication pre-eclampsia; and Boston’s Beth Israel Deaconess Medical Center, which is researching a technique to detect Alzheimer’s in women through the use of a non-invasive MRI biomarker.
President Biden established ARPA-H, a new research and development funding agency, with bipartisan Congressional support to generate high-impact biomedical and health breakthroughs.
Earlier this year, Biden signed an executive order ensuring women’s health is integrated and prioritized across the federal government.
CDC Awards Quest With Contracts To Develop Diagnostics For Emerging Viruses
The US Centers for Disease Control and Prevention has tapped Quest Diagnostics to help fight two emerging infectious diseases the government says require rapid response.
The government contracts will support Quest in developing diagnostics to detect H5 avian influenza — or bird flu — and the Oropouche virus, an emerging virus in the Americas spread by infected biting midges and some mosquito species.
The contracts, according to Quest, also provide funding to enable the company to maintain testing readiness, such as for adequate supplies of certain equipment and chemical reagents used to perform the tests on a sustained basis.
According to the CDC, avian influenza is currently widespread in wild birds worldwide and is causing outbreaks in US poultry and dairy cows with recent sporadic human cases primarily among farm workers exposed to infected animals.
“While the threat of avian influenza and Oropouche virus to the public remains low, we applaud CDC for its forward-thinking approach to ensuring commercial laboratories are prepared to quickly mobilize should a serious threat to human health emerge,” said Elizabeth Marlowe, executive scientific director at Quest Diagnostics.
FDA Approves Companion Diagnostic From Thermo Fisher For Patients With Brain Tumors
The US FDA has approved the Ion Torrent Oncomine Dx Target Test, a companion diagnostic from Thermo Fisher Scientific that is designed to identify patients that might benefit from Voranigo (vorasidenib) tablets. Voranagio is used to treat grade 2 IDH mutant glioma, a relentless and incurable type of brain cancer that hasn’t seen treatment advances in nearly 25 years, according to David Lee, CEO of drug manufacturer Servier Pharmaceuticals.
Gliomas are the most common malignant primary brain tumor in adults, around 81%. Of those, about 20% harbor an IDH mutation, making testing for these mutations essential for accurate treatment decisions. The National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend IDH mutation testing in all patients with a glioma, noting its impact on diagnosis and prognosis of gliomas.
Survey Finds Reprocessed Devices Saved Hospitals $465M Last Year
Health care facilities saved $465m in 2023 through the use of reprocessed devices, a survey from the Association of Medical Device Reprocessors has found.
In addition to the cost savings, the survey also found that use of reprocessed devices prevented the release of 98 million pounds of greenhouse gas emissions – the equivalent, AMDR says, of “7.5 Olympic swimming pools filled with gasoline.”
AMDR says that reprocessed devices like lateral transfer mats, pulse oximeters, and EP catheters and cables are used in every US health system except that run by the Veterans’ Administration. Facilities purchased 30.9 million sterilized devices last year, which kept 3.7 million pounds of medical waste out of landfills.
“AMDR members partner with hospitals to dramatically reduce cost, waste, and greenhouse gas emissions by using regulated, reprocessed SUDs,” said AMDR president and CEO Daniel Vukelich. “While these numbers are record setting and robust, they represent only a small fraction of the reprocessed devices that hospitals could use.”
CHAI’s Health AI ‘Nutrition Labels’ Move Ahead
The Coalition for Health AI (CHAI) is moving forward with its proposal to certify independent quality assurance labs for evaluating health AI models for performance, bias, localized considerations, and ongoing monitoring.
The group issued draft frameworks on 18 October and plans to make its certification process and model card design available by the end of April 2025, after review by CHAI members, partners, and the public.
CHAI worked with the ANSI National Accreditation Board and several emerging quality assurance labs to develop its draft certification program, which makes use of international testing laboratory standard ISO 17025. The Office of the National Coordinator for Health Information Technology (ONC) used the same standard for its Electronic Health Record (EHR) certification program. Additionally, CHAI says the certification program will integrate FDA guidelines on the use of real-world data and align with the National Academy of Medicine’s AI Code of Conduct.
The “nutrition labels” will include details such as a product’s developer, intended uses, targeted patient populations, AI model type, data types, key performance metrics, security and compliance accreditations, maintenance requirements, known risks and out-of-scope uses, known bias, ethical considerations and third-party information such as relevant clinical studies.
“As a 35-year medtech industry veteran, I have experienced years of frustration at the gaps in product development and governance practices between health delivery organizations and medtech companies,” said Eric Henry, an advisor in the FDA and Life Sciences practice of King & Spalding. “I am encouraged by CHAI’s commitment to map its quality assurance laboratory guidelines to internationally recognized consensus medical device and healthcare standards. This effort will lead to a more harmonized view of what ‘good’ looks like in the evaluation of AI-enabled health technology across these two critical players in the health care ecosystem.”
FDA Warns Against Use Of BioZorb Markers
Providers and facilities should not use BioZorb Markers and BioZorb LP Markers from Hologic Inc. due to major safety issues, the FDA announced on 25 October.
The markers are implantable devices used for radiographic marking of sites in soft tissue that need to be marked for future medical procedures. They were commonly used in breast cancer patients.
According to Hologic, the recall follows 399 complaints about the markers, of which 188 were associated with adverse events as of 16 October. Known complications include pain, infection and fluid buildup, as well as the device moving out of position or breaking through the skin. In some instances, the markers had to be surgically removed.
Hologic conducted a smaller class I recall of the product in May.
The agency recommends that facilities quarantine all lots of BioZorb markers for return to Hologic and continue to monitor patients who have been implanted with the devices.
Shuren To Receive Reagan-Udall Foundation Leadership Award
The Reagan-Udall Foundation for the FDA will present its Leadership Award to Jeff Shuren, who stepped down as director of the agency’s Center for Devices and Radiological Health (CDRH) in July.
Michelle Tarver has been named the center’s new director.
The foundation said its honoring Shuren for achieving “significant milestones” during his 15 years running the device center, including a five-fold increase in new medical device authorizations, establishment of key programs like the Breakthrough Devices Program and the Digital Health Center of Excellence, and significant contributions to the Medical Device Innovation Consortium and the International Medical Device Regulators Forum.
The foundation will also present its Advocacy/Policy Award to Steven Grossman, co-founder of the Alliance for a Stronger FDA, and its Innovation Award to the Real-World Evidence (RWE) Collaborative, convened by the Duke-Margolis Institute for Health Policy.
The foundation will hold the awards ceremony and dinner on 10 December at the Willard InterContinental Hotel in Washington.
Registration for the event is available here.