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…
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 Organization’s five indications for hand hygiene, and their access to hand…
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.…
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…
Editor's Note The Food and Drug Administration (FDA) on April 23 issued a new draft guidance to help manufacturers avoid delays in preparing, planning, and executing voluntary recalls.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…
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…
Editor's Note The Joint Commission on April 24 announced that it will be posting spring 2019 updates to the E-dition® of its accreditation and certification manuals in May. The changes, which can be viewed on an organization’s Joint Commission Connect® extranet site, will go into effect July 1 unless otherwise…
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,…
Editor's Note The Food & Drug Administration on April 16 announced it is considering additional regulatory actions, including consulting with federal health experts for guidance, to reduce the risks of contamination and infections associated with duodenoscopes. The FDA is also working with manufacturers of disposable duodenoscopes that would make reprocessing…
Editor's Note Compared with preoperative independent functional status, preoperative dependent functional status was independently associated with worse outcomes after primary total hip arthroplasty in this study. Of 43,179 patients analyzed, those who were less able to care for themselves: were 2 to 3 times more likely to have surgical complications…