FDA: Class I recall of Miller and Fogarty Atrioseptostomy Dilation Catheters
Editor's Note The Food & Drug Administration (FDA) on April 26 identified the recall of Edwards Lifesciences' Miller and Fogarty Atrioseptostomy Dilation Catheters as Class I, the most serious. The recall was initiated because of reports of difficulty in balloon deflation after deployment, which may lead to balloon fragmentation or…
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[Free Webinar] Is Your Operating Room Ready for the Supply Chain of the Future?
Is Your Operating Room Ready for the Supply Chain of the Future? Thursday, June 6, 2019 | 12:00 p.m. โ 1:00 p.m. ET | 1 CE Join this free webinar to learn how to prepare your teams for the supply chain of the future. Understand why evolution of the supply…
Improving hand hygiene compliance among anesthesia providers
Editor's Note Education and monitoring of hand hygiene among anesthesia providers in the OR improved hand hygiene compliance in this study from the Duke University School of Nursing, Durham, North Carolina. Anesthesia providers were educated on the World Health Organizationโs five indications for hand hygiene, and their access to hand…
FDA issues Safety Communication for Stryker Wingspan Stent System
Editor's Note The Food and Drug Administration (FDA) on April 25 issued a Safety Communication on use of the Stryker Wingspan Stent System outside of approved indications. The Wingspan Stent System is used to open narrowed arteries in the brains of patients with intracranial stenosis who are experiencing repeated strokes.…
Transplanting hearts, lungs from HCV-infected donors into recipients without HCV infection
Editor's Note In patients without HCV infection who received a heart or lung transplant from HCV-infected donors, treatment with a 4-week antiviral regimen prevented establishment of HCV infection, this study finds. Of 44 patients enrolled in the study, 36 received lung transplants and 8 received heart transplants. All of the…
FDA issues draft guidance on initiating voluntary recalls
Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls.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…
Increased duration of surgical antimicrobial prophylaxis linked to adverse events
Editor's Note In this multi-center study, longer durations of surgical prophylaxis did not result in further reductions in surgical site infections (SSIs) but were associated with increasing adverse events. Of 79,058 surgical patients in the VA healthcare system, SSI was not associated with duration of prophylaxis, but odds of acute…
Joint Commission announces updates to E-dition
Editor's Note The Joint Commission on April 24 announced that it will be posting spring 2019 updates to the E-ditionยฎ of its accreditation and certification manuals in May. The changes, which can be viewed on an organizationโs Joint Commission Connectยฎ extranet site, will go into effect July 1 unless otherwise…
Off-label use of simethicone, lubricants, and tissue glue contributes to endoscope reprocessing failures
Editor's Note The off-label use of defoaming agents, lubricants, and tissue glue is common, and these insoluable substances are not removed during reprocessing, this study finds. Of 69 fully reprocessed endoscopes examined in four hospitals, microbial cultures were positive for 50% or more. The researchers, led by Cori Ofstead, MSPH,…