Proactive steps paramount for greater surgical stapler safety
Internal surgical staplers made headline news in 2019. Reports discussed the little-known US Food and Drug Administration database housing tens of thousands of stapler-related problem reports and covered the agency’s recent proposal to reclassify staplers as Class II devices, instead of the more lightly regulated Class I. ECRI Institute named…
ECRI Institute’s Top 10 Health Technology Hazards for 2020
Editor's Note The ECRI Institute on October 7 released its annual safety report identifying the top 10 device hazards in hospitals, medical practices, and homecare for 2020. Topping the list was surgical stapler misuse and malfunction that can lead to patient harm. Third on the list is sterile processing errors…
How mistakes shape physicians’ perceptions of learning
Editor's Note Using a learning culture perspective that acknowledges blame and responsibility can facilitate learning from mistakes, this Canadian study finds. A total of 19 physicians were interviewed on their experiences in learning from medical errors. Memories of mistakes from residence training stood out, and participants expressed feeling both responsible…
Joint Commission releases new sentinel event stats
Editor's Note The Joint Commission on August 14 released new sentinel event statistics for the first half of 2019. The latest data also introduce new categories for describing sentinel events, including suicide-related events, surgical or invasive procedure events, anesthesia-related events, and product or device events. The top five most frequently…
FDA: Class I recall of Volumat MC Agilia Infusion System, Vigilant Drug Library
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…
Deficiencies in human performance linked to surgical adverse events
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,…
Joint Commission issues new Sentinel Event Alert on managing risks of direct oral anticoagulants
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,…
Study debunks ‘July Effect’ in cardiac surgery
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…
FDA panel recommends reclassification of surgical staplers to Class II
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…
Leapfrog Group: More than 160,000 preventable deaths occur in hospitals each year
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…
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