Editor's Note In this study of low-risk patients with severe aortic stenosis, outcomes were significantly better at 1 year follow-up with transcatheter aortic-valve replacement (TAVR) than surgical aortic-valve replacement. In 1,000 patients at 71 centers who were randomized to undergo either TAVR or surgical aortic-valve replacement, the rate of the…
Editor's Note Becton, Dickinson and Company (BD) announced on April 30 that it had received Food & Drug Administration (FDA) approval for BD ChloraPrep skin preparation with sterile solution. This new product is the only fully sterile chlorhexidine gluconate (CHG) antiseptic skin preparation commercially available in the US. The FDA’s…
Editor's Note Patients with diabetes who had low blood glucose values during the last day of hospitalization had higher rates of 30-day readmission and post discharge mortality, this study finds. Examining 843,978 admissions to the VA health care system over a 14-year period, researchers found that patients with diabetes who…
Editor's Note The Department of Health and Human Services (HHS) on April 26 announced it is lowering the maximum civil penalty for healthcare providers, health plans, and business associates who violate the Health Insurance Portability and Accountability Act (HIPPA), based on the level of culpability. A 2013 rule created four…
Editor's Note Physician burnout has reached a critically high level, fueled by regulatory, compliance, and technology demands, but health system leaders at the Massachusetts General Hospital in Boston are working to address and relieve burnout and bring the joy back to the practice of medicine with centrally and locally designed…
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…