FDA updates Safety Alert for Cortrak 2 Enteral Access System
Editor's Note The Food & Drug Administration (FDA) on January 12 updated a Safety Alert about pneumothorax events associated with feeding tube placement procedures using the Cortrak 2 Enteral Access System (EAS) by Corpak Medsystems (Buffalo Grove, Illinois). Several of the events were associated with cardiopulmonary arrest, and there were…
Patient preference for surgery, antibiotics to treat appendicitis
Editor's Note In this survey, most respondents chose surgical rather than nonsurgical treatment for acute appendicitis. Of 1,728 respondents, 85.8% chose laparoscopic appendectomy, 4.9% chose open appendectomy, and 9.4% chose antibiotics alone as treatments for themselves. For their child, 79.4% chose laparoscopic appendectomy, 6.1% chose open appendectomy, and 14.5% chose…
CMS proposes coverage change for MRI with implanted cardiac devices
Editor's Note The Centers for Medicare & Medicaid Services on January 11 issued a proposal to modify its national coverage determination for magnetic resonance imaging (MRI) to include patients who have implanted cardiac devices. Proposed changes include the expansion of coverage for patients with cardiac devices that are approved or…
FDA delays UDI compliance dates for class I, unclassified devices
Editor's Note The Food and Drug Administration (FDA) on January 12 announced a delay in enforcement of unique device identification (UDI) requirements for class I and unclassified devices until September 24, 2020. The FDA also will not enforce direct mark requirements for these devices until September 24, 2022. The guidance…
Education brochure helps surgical patients improve opioid disposal
Editor's Note Dissemination of low-cost patient education brochures improved disposal of unused opioids after surgery, this study finds. The study involved 334 patients−164 who did not receive the brochure and 170 who did receive it. Patients who received the brochure informing them of appropriate methods for disposal were twice as…
CDC updates data on HAIs
Editor's Note The Centers for Disease Control and Prevention (CDC) on January 5 updated its data on healthcare-associated infections (HAIs). Central line-associated bloodstream infections (CLABSIs) have dropped 50% since 2008. Catheter-associated urinary tract infections (CAUTIs) have had consistent year-to-year decreases, especially since those caused by yeast were deleted from the…
FDA: Class I recall of Certitude Delivery System
Editor's Note The Food and Drug Administration (FDA) on January 11 classified the recall by Edwards LifeSciences (Irvine, California) of its Certitude Delivery System as Class I, the most serious. The system is used for delivery of the Edwards SAPIEN 3 transcatheter aortic heart valve. The recall was issued because…
CMS announces new voluntary bundled payment model
Editor's Note The Centers for Medicare and Medicaid Services (CMS) on January 9 announced a new voluntary bundled payment model called, “Bundled Payments for Care Improvement Advanced” (BPCI Advanced). Participants in BPCI Advanced will receive payments for performance on 32 (29 inpatient, 3 outpatient) different clinical episodes. The first cohort…
AHRQ: New toolkit for ambulatory care transitions
Editor's Note The Agency for Healthcare Research and Quality (AHRQ) on January 9 announced a new “Safe Transitions Toolkit” for clinical staff working in ambulatory care settings. The toolkit is designed to help staff actively engage patients and their care partners to prevent errors during care transitions. The toolkit includes…
Intraop handover of anesthesia care linked to adverse outcomes
Editor's Note Complete handover of intraoperative anesthesia care was significantly linked to adverse postoperative outcomes in this Canadian study. In this analysis of 313,066 adult patients having major surgery, complete intraoperative handover of anesthesia care, compared with no handover, was significantly associated with a higher risk of a composite of…