IMDA eNews 080823
The latest news affecting you and your customers…
from the Independent Medical Specialty Dealers Association
Vendor sells products without FDA signoff
A Philadelphia-area man pleaded guilty for his role in distributing medical devices without U.S. Food and Drug Administration (FDA) clearance, the Department of Justice announced. Peter Stoll III, 34, pleaded guilty to causing the introduction of misbranded and adulterated medical devices into interstate commerce. Stoll was a regulatory affairs specialist at a medical device manufacturer located in the Eastern District of Pennsylvania [reported to be B. Braun Aesculap] and was responsible for making submissions to the FDA that were required before the company could sell its medical devices. Stoll was responsible for shepherding two of the company’s devices through the FDA’s 510(k) clearance process: the ELAN-4 Air Drill, a high-speed surgical drill used for bone cutting, sawing, and drilling; and the JS Series SterilContainer S2, a reusable sterilization container for medical instruments.
Gun violence in medical settings
Word spread one day last month through Legacy Good Samaritan Medical Center in Portland, Oregon, that a visitor was causing trouble in the maternity ward, and nurses were warned the man might try to abduct his partner’s newborn, reports Associated Press. Hours later, the visitor opened fire, killing a security guard. The shooting was part of a wave of gun violence sweeping through U.S. hospitals and medical centers. Last year, a man killed two workers at a Dallas hospital while there to watch his child’s birth. In May 2023, a man opened fire in a medical center waiting room in Atlanta, killing one woman and wounding four. In late July, a man shot and wounded a doctor at a health center in Dallas. In June 2022, a gunman killed his surgeon and three other people at a Tulsa, Oklahoma, medical office because he blamed the doctor for his continuing pain after an operation. It’s not just deadly shootings: Healthcare workers racked up 73% of all nonfatal workplace violence injuries in 2018, the most recent year for which figures are available, according to the U.S. Bureau of Labor Statistics.
Cyberattack Shutters Medical Facilities
Hospitals and outpatient facilities in at least three states at press time were still working to restore their computer systems after a cyberattack hit their parent company, according to Axios. Prospect Medical Holdings, a Los Angeles-based private equity company, which operates 16 hospitals and 165 outpatient facilities across California, Texas, Connecticut, Rhode Island and Pennsylvania, announced it sustained an attack on Aug. 3. The attack shuttered several emergency departments and required ambulances to be diverted from some hospitals, while health providers reverted to pen and paper. On Sunday, Aug. 6, Eastern Connecticut Health Network still reported closures of multiple services, including urgent care and elective surgeries.
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