Joint Commission issues new Sentinel Event Alert on managing risks of direct oral anticoagulants
Editor's Note In response to an increase in adverse events related to direct oral anticoagulants (DOACs), the Joint Commission, on July 31, issued a new Sentinel Event Alert on managing DOAC risks. The alert: provides guidance for safe use and management of DOACs stresses understanding the risks, benefits, side effects,…
FDA issues final guidance for drug-device combo products
Editor's Note The Food & Drug Administration (FDA) on July 22 issued a final guidance for makers of products that combine devices and drugs or biologics. The guidance clarifies how manufacturers should comply with recordkeeping requirements and how they should submit safety reports and avoid duplication.
FDA issues draft guidance on initiating voluntary recalls
Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls. The guidance includes recommendations in three areas: proper training of personnel thorough and organized record keeping written recall initiation procedures. The guidance…
ECRI Institute launches new web-based clinical practice guidelines repository with open access
Editor's Note ECRI Institute recently launched ECRI Guidelines Trust, a publicly available web-based repository of evidence-based national and international clinical guidelines as well as Guideline Briefs with TRUST Scorecards. The healthcare community has free access to the repository, which was created after funding cuts forced the Agency for Healthcare Research…
SHEA issues new guidance on infection control in anesthesiology
Editor's Note The Society for Healthcare Epidemiology of America (SHEA) on December 11 published a new expert guidance on “Infection prevention in the operating room anesthesia work area.” Key recommendations of the guidance to improve infection prevention include: Increased hand hygiene performed, at a minimum, before aseptic tasks, after removing…
Research backs changes to AORN's Guideline for Sterilization
AORN’s updated Guideline for Sterilization is based on a recent review of evidence in peer-reviewed journals and regulations from 2012 to 2017. In addition to guidance for sterilizing reusable medical devices to be used in perioperative and procedural settings, the updated guideline points to findings that substantiate current practices, and…
FDA guidance updates UDI compliance policy
Editor's Note The Food & Drug Administration on November 5 released the guidance, “Unique Device Identification: Policy Regarding Compliance dates for Class I and Unclassified devices and Certain Devices Requiring Direct Marking,” which takes effect immediately. The new guidance includes updated Unique Device Identification (UDI) direct mark requirements and supersedes…
SASM issues guideline on intraop management of adults with OSA
Editor's Note The Society of Anesthesia and Sleep Medicine (SASM) has issued a new guideline on Intraoperative Management of Adult Patients with Obstructive Sleep Apnea (OSA). Specific aims of the guideline are to: evaluate considerations of difficult airway management in patients with OSA assess the impact of anesthesia-related drugs and…
Johns Hopkins panel develops opioid prescribing guidelines for 20 surgical procedures
Editor's Note Led by Martin A. Makary, MD, MPH, a Johns Hopkins panel of experts developed the nation’s first set of opioid prescribing guidelines for 20 common surgical procedures in 8 surgical specialties. The guidelines are based on the premise that opioid prescribing should be based on the surgical procedure…
Joint Commission, AHA offer cardiovascular certification program
Editor's Note The Joint Commission and American Heart Association (AHA) on July 25 announced a new jointly offered hospital cardiovascular certification program. The “Advanced Certification for Heart Failure” program is the first of multiple, jointly offered cardiac certifications that will be available to hospitals. Organizations must meet the following criteria:…
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