DOJ cracking down on AI tools for clinical decision-making
Editor's Note: The U.S. Justice Department is investigating how the healthcare industry is using artificial intelligence (AI) tools to analyze and make decisions using patients’ electronic health records (EHRs), Bloomberg Law reported January 29. So far, DOJ has served subpoenas related to EHRs to at least three major pharma companies:…
Surgeons design implant coating to combat infections
Editor's Note: A point-of-care, antimicrobial coating for orthopedic implants could soon make implant-associated infections a problem of the past, UCLA Health reported on January 3. Developed by two UCLA surgeons, the coating is designed to kill or slow the spread of micro-organisms in order to prevent post-surgical infections. According to…
Managing immediate use steam sterilization
Immediate use steam sterilization (IUSS, a standard steam sterilization cycle with little to no dry time) is considered safe for patient care when the processes recommended in Association for the Advancement of Medical Instrumentation (AAMI) standards and AORN guidelines are followed. IUSS is a valuable option in an emergency. Lack…
Biorobotic heart shows promise for research, surgical training
Editor's Note: Surgeons successfully tested three fixes for a leaky heart valve on a biological pig heart fitted with a silicone robotic pump, HealthDay reported on January 11. According to the article, the biorobotic heart offers significant advantages over existing heart simulators. These include a longer shelf life, greater ability…
Superpotency concerns spur recall of IV bags for vancomycin, phenylephrine, and fentanyl
Editor's Note: Englewood, Colo,-based Leiters Health is voluntarily recalling 33 lots of vancomycin, phenylephrine, and fentanyl IV bags due to concerns that they may contain twice the labeled amount of drug, according to a January 8 safety alert from the US Food and Drug Administration (FDA). “The semi-automated IV bag…
FDA issues statements on VHP sterilization; hip surgery device safety
Editor's Note Recent announcements from The US Food and Drug Administration (FDA) validate vaporized hydrogen peroxide (VHP) as an established device sterilization method and warn against the use of the Synovo Total Hip Replacement system. Issued January 8, the announcement about VHP is part of the agency’s multi-pronged approach to…
Investigation reveals medical device safety testing concerns
Editor's Note Published December 21, a year-long investigation by KFF Health News into medical device malfunctions found that the FDA allows the sale of most medical devices, including many implants, without requiring tests for safety or effectiveness. Instead, manufacturers need to show only that they have “substantial equivalence” to an…
Brain stimulation improves surgeon dexterity with robotic tools
Editor's Note Mild electric stimulation to the back of surgeons’ heads could enhance robotic surgery accuracy and precision, according to findings published in the journal Scientific Reports on December 20. The study tasked 36 participants – approximately half male, half female, none of whom had experience with robotic surgery –…
Burns prompt recalls of airway scopes, electrosurgical pads
Editor's Note Reports of burn injuries have prompted two medical device recalls: one for Megadyne patient return electrodes and one for Olympus bronchofiberscopes and bronchovideoscopes. According to a December 21 notice from AORN, the former recall is a voluntary correction on the part of Megadyne Medical Products, Inc. Following reports…
First hospital joins FDA’s medical device information sharing and analysis initiative
Editor’s Note Charlotte, North Carolina-based Atrium Health is the first hospital to join the Medical Device Information Analysis and Sharing (MDIAS) public-private partnership (PPP) between the Food and Drug Administration (FDA) and private sector stakeholders. The news was announced December 12 by Mitre, a nonprofit research organization and the independent…
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