Regulations/Legal
FDA: Class I recall of certain SD BioSensor Pilot COVID-19 At-Home Tests
Editor's Note The Food and Drug Administration (FDA), on May 25, identified the recall by SD BioSensor, Inc, of certain Pilot COVID-19 At-Home Tests as Class I, the most serious. The recall was initiated because the liquid solution in the test kit may be contaminated with bacteria such as Enterococcus,…
SHEA: Strategies to prevent SSIs updated
Editor's Note The Society for Healthcare Epidemiology of America (SHEA) has updated the Strategies to Prevent Surgical Site Infection in Acute Care Hospitals, which was published in 2014. The update highlights practical recommendations designed to assist acute-care hospitals in implementing and prioritizing their surgical site infection (SSI) prevention efforts. Among…
FDA: Class I recall of Draeger Medical’s Seattle PAP Plus, breathing circuit/anesthesia kits
Editor's Note The Food and Drug Administration (FDA), on May 24, identified the recall by Draeger Medical of the Seattle PAP Plus as well as VentStar and other breathing circuit/anesthesia kits as Class I, the most serious. The recall was initiated after finding that glued connections may loosen before or…
The Joint Commission seeking comments on proposed new infection control requirements for hospitals, critical access hospitals
Editor's Note The Joint Commission, on May 24, announced that it is seeking comments on new infection control (IC) requirements for hospitals and critical access hospitals on preparedness for high-consequence diseases or special pathogens. These new requirements will replace the current standard IC.01.06.01 on preparing for an influx of potentially…
The Joint Commission: Licensed independent practitioner term eliminated from AHC, OBS accreditation programs
Editor's Note The Joint Commission, on May 24, announced that it was eliminating the term licensed independent practitioner from its Ambulatory Health Care and Office-Based Surgery accreditation programs, beginning August 27. The revisions are consistent with terminology used by the Centers for Medicare and Medicaid Services’ Conditions for Coverage and…
FDA: Class I recall of certain ICU Medical infusion system batteries
Editor's Note The Food and Drug Administration (FDA), on May 22, identified the recall by ICU Medical of replacement batteries for its Plum 360, Plum A+, and Plum A+3 infusions systems as Class I, the most serious. The recall was initiated because a manufacturing defect substantially diminished how long the…
AAMI releases updated protective barriers standard
The Association for the Advancement of Medical Instrumentation (AAMI) has revised the ANSI/AAMI PB70 Liquid barrier performance and classification of protective apparel and drapes intended for use in healthcare facilities. This revised standard provides healthcare professionals with a better understanding of the barrier protection properties of available protective apparel. The…
Effect of COVID-19 precautions on postop SSIs
Editor's Note This study from the Mayo Clinic finds that perioperative COVID-19 precautions did not significantly reduce the risk of surgical site infections (SSIs). The analysis included 29,904 patients who had colorectal, hysterectomy, hip, and knee prosthesis procedures at the Mayo Clinic’s multicenter institution between January 1, 2018 and December…
FDA finalizes recommendations for blood donations
Editor's Note The Food and Drug Administration (FDA), on May 11, finalized its recommendations for assessing blood donor eligibility, which uses individual risk-based questions to reduce the risk of transmitting HIV. The questions will be the same for all donors, regardless of sexual orientation, sex, or gender. The new policy…
Heightened focus on cybersecurity amid ransomware attacks, data breaches
Editor's Note Cybersecurity remains a top concern and potential hazard for patient data. In February, Lehigh Valley Health Network in Allentown, Pennsylvania, was attacked by a ransomware gang BlackCat, which has ties to Russia, Becker’s Health IT reports. The health system has since notified 627 individuals and will continue to…
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