FDA medical device Class 1 recalls trend upward
Editor's Note The number of US Food and Drug Administration (FDA) Class 1 recalls—the most serious classification—for medical devices has been trending upwards. Regulatory News, a publication of the Regulatory Affairs Professional Society (RAPS), reported the news April 25. According to the report, Anne Reid, program director of the Office…
Data cast doubt on recommendation to delay weight-loss meds prior to surgery
Editor's Note A recent analysis of insurance claims data suggests weight-loss medications like Ozempic (semaglutide), Trulicity (dulaglutide), and other glucagon-like peptide-1 (GLP-1) receptor agonists do not increase risks associated with undergoing anesthesia. As reported April 22 in MedPage Today, these finding that contradicts a June 2023 recommendation from the American Society of…
Surgical site infections often caused by preexisting bacteria
Editor's Note Most healthcare-associated surgical site infections are not caused by pathogens acquired in the hospital, but by previously harmless bacteria already present on patients’ skin prior to being admitted, according to a study published April 10 in Science Translational Medicine. Surgical site infections account for the highest annual costs…
The Joint Commission launches new telehealth accreditation program
Editor's Note Effective July 1, telehealth providers can apply for a new Joint Commission accreditation designed to ensure safe, high-quality care. Announced April 23 by The Joint Commission, the new Telehealth Accreditation Program is designed for organizations that exclusively provide care, treatment and services via telehealth. Hospitals and other healthcare…
FDA announces class 1 recall for disposable biopsy needle kit
Editor's Note Microscopic stainless steel debris on the insides of biopsy needles prompted the FDA to issue a class 1 recall—indicating risk of death or serious injury—for Elekta Instrument’s Disposable Biopsy Needle Kit, which is used with the Leksell Stereotactic System for brain tissue sampling during neurosurgery, the disposable biopsy…
Death, hospital readmission less likely for women treated by female doctors
Editor's Note A new study showing women treated by female doctors are less likely to die or be readmitted to the hospital adds to the growing body of evidence that women and minorities tend to receive worse medical care than men and white patients, NBC News reported April 22. Published…
FDA announces class 1 recalls for infusion pumps, anesthesia workstation
Editor's Note Reports of spontaneous backup battery failure in Dreager Inc.’s Perseus A500 anesthesia workstation and multiple failures in InfuTronix, LLC’s Nimbus infusion pump systems prompted the FDA to classify manufacturer recalls as class 1, the most serious categorization indicating risk of serious harm or death. According to an April…
Joint replacement manufacturer recalls products after FDA packaging warning
Editor's Note A January complaint about inefficient packaging for joint replacement products has prompted the manufacturer to recall certain knee and shoulder system devices after initially declining to take the products off the market, according to an April 23 report in Health Exec. The manufacturer, Exactech, is now recalling a…
Catheter sterility concerns prompt Class 1 FDA recall for surgery trays
Editor's Note The US Food and Drug Administration has designated DeRoyal Industries’ recall of GeoMed custom tracecarts a class 1, the most serious type of recall indicating a risk of serious injury or death. According to the April 24 FDA notice, the recall is due to sterility concerns with the…
Large amounts of personal data possibly stolen in Change Healthcare cyberattack
Editor's Note Personal information about a “substantial portion of people in America” could be at risk from the February 21 cyberattack on UnitedHealth’s Change Healthcare division, The Associated Press reported April 23. Although the company reports no signs of full medical histories or charts were released, notifying all who were…
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