IMDA eNews 050223
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
Needed: Innovation in Pediatric Devices
The current state of pediatric medical device innovation represents a significant health inequity, with the majority of device development targeting adults, argue authors in JAMA Pediatrics. The U.S. Congress and FDA have introduced several legislative and regulatory actions to expand pediatric-specific medical device innovation and development. But strategies to promote pediatric medical device innovation have been insufficient to stimulate substantial industry investment. The authors recommend that the FDA’s data systems be modernized to improve the ability to track pediatric device approvals and study requirements and to evaluate the consequences of policies for pediatric device development.
Elective surgeries down, and jobs follow
A downturn in elective surgeries due to staffing shortages is the reason 3M cited in its decision to cut a further 6,000 jobs, reports MedTech Dive. First-quarter elective healthcare procedure volumes were approximately 90% of pre-COVID levels as nurse labor shortages and strained hospital budgets continue to impact the pace of recovery, Monish Patolawala, chief financial and transformation officer, was quoted as saying on a call with investors. 3M, which said in January it would eliminate 2,500 manufacturing positions, expects the additional 6,000 job cuts to lead to an annual pre-tax savings of as much as $900 million.
New cross-country health system formed
Kaiser Foundation Hospitals and Geisinger Health announced the launch of Risant Health and a definitive agreement to make Geisinger the first health system to join Risant Health. Upon regulatory approval, Geisinger will become part of the new organization through acquisition. Risant Health will operate separately from Kaiser Permanente’s core integrated care and coverage model.
FDA seeking solutions to EtO problem
The FDA is encouraging sterilization providers to find alternatives to gamma radiation and ethylene oxide, reports Medical Device and Diagnostic Industry. The agency announced the opening of its radiation sterilization Master File Pilot Program in which nine eligible sterilization providers that use gamma radiation or EtO will submit a master file to change methods, including the reduction of gamma radiation dose or use of non-gamma radiation sources such as X-ray or electron beam. The program is currently only directed toward PMA-approved products, excluding medical devices cleared under the 510(k) pathway. A pilot program specifically for 510(k) holders is currently underway to help companies move away from EtO if other ways to sterilize devices are possible.
Ventilation, tachycardia linked, in severe COVID patients
Patients with severe COVID-19 requiring mechanical ventilation are 16 times more likely to develop ventricular tachycardia – a life-threatening heart rhythm disturbance — within six months compared to peers without severe infection, according to research presented at EHRA 2023, a scientific congress of the European Society of Cardiology (ESC). Risks of other heart rhythm disorders were also elevated.
FDA to manufacturers: ‘Report device modifications’
Medical device manufacturers with products on the U.S. market need to check in with the FDA when significantly modifying a previously cleared device, reports Medical Device and Diagnostic Industry. Case in point: London, England-based Medivance Instruments holds a 510(k) clearance for its Velopex Aquacut Fluid Abrasion Unit, intended for use in a range of dental procedures. However, according to a recent FDA warning letter to the company, the device has been significantly modified since it was cleared in 2003, including the incorporation of a new air regulator and changes to the materials used in the powder tubing/valves. According to the FDA, Medivance was required to submit a new premarket notification submission at least 90 days before the company proposed to begin marketing the modified Valopex devices.
Hibernating bears offer clues to DVT
Why do people who are temporarily immobilized due to surgery or an injury develop deep vein thrombosis, while those who are chronically immobilized after a spinal cord injury or stroke do not? A team of scientists in Europe found clues among hibernating bears, and they suggest that a protein – HSP47 — that is downregulated on platelets during extended periods of little movement (not just in bears, but in people and pigs) could be a key factor, reports JAMA. For researchers, the next steps are identifying binding sites on the protein that small molecule drugs or antibodies could target, and studying the potential adverse effects of blocking HSP47 with such agents. The Centers for Disease Control and Prevention estimates that in the United States, DVT and pulmonary embolism affect as many as 900,000 people every year and cause 60,000 to 100, 000 annual deaths.
It's Orlando in March for 2023-2024 conference
It’s Orlando in
March for 2023-2024 conference Rosen Shingle Creek in Orlando, Florida, will be the site of the 2024 IMDA/HIRA Conference. Golfers will tee off Monday morning, March 4, and the conference will begin that afternoon. We’ll finish at noon on Wednesday, March 6. And in between? Networking, business and market information, Manufacturers Forum, great food. So get smart! Make plans to attend the IMDA/HIRA Conference in March 2024. Details will follow. |
