Editor's Note The Food & Drug Administration on August 12 identified the recall by Fresenius Kabi (Bad Homburg, Germany) of its Volumat MC Agilia Infusion System and Vigilant Drug Library as Class I, the most serious. The recall was initiated because of a “Low Priority,” “Keep Vein Open,” “End of…
Editor's Note In this study, human performance deficiencies were identified in more than half of surgical adverse events, and they were most commonly associated with cognitive errors. Of 5,365 surgical procedures analyzed, adverse events occurred in 188 patients. A total of 106 adverse events (56.4%) were because of human error,…
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,…
Editor's Note The “July Effect”−the idea that more errors occur in July because of the influx of new interns and residents starting their in-hospital training−does not apply to cardiac surgery, this study finds. For more than 470,000 cardiac procedures analyzed (coronary bypass, aortic valve, mitral valve, thoracic aortic aneurysm), in-hospital…
Editor's Note The Food & Drug Administration’s General and Plastic Surgery Devices Advisory Committee on May 30 recommended that surgical staplers be reclassified from Class I to Class II devices. This would add premarket review and special controls to the devices. The Committee said Class II regulation would offer a…
Editor's Note A study published May 15 by the Leapfrog Group finds that more than 160,000 preventable deaths occur in US hospitals annually, a decline of about 56,000 from 3 years ago. The Leapfrog Group uses hospital performance on 16 patient safety measures to assign hospital grades. Of the 2,620…
Several never events at The Medical Center of Aurora (TMCA) in Aurora, Colorado, over a 1-year period prompted leaders there to launch patient safety first (PSF) initiatives. Part 1 of this series discussed how these initiatives were identified and implemented, and the importance of evidence-based communication tools (OR Manager, March…
Editor's Note The Joint Commission on March 13 released its sentinel event statistics for 2018, the majority of which were voluntarily reported by an accredited or certified organization. Of the 10 most frequently reported events, falls and unintended retention of a foreign body were at the top with 111 reports…
Communication breakdowns in the perioperative environment are a factor in 70% of events that adversely affect patients. Sometimes those breakdowns occur because OR staff are reluctant to voice their concerns in an environment that is hierarchical and intimidating. However, when an organization adopts patient safety first (PSF) initiatives, adverse outcomes…
Editor's Note A new blog post featured in the Joint Commission’s "High Reliability Healthcare" examines four essential steps for developing a reporting culture and why they are important. The steps are: Establish trust: Leaders should help create personal responsibility by establishing clear performance expectations for employees in an environment where…