FDA Safety Alert on Absorb GT1 Bioresorbable Vascular Scaffold
Editor's Note The Food and Drug Administration (FDA) on March 18 issued a Safety Alert for Abbott Vascular’s (Santa Clara, California) Absorb GT1 Bioresorbable Vascular Scaffold (BVS). The alert was issued to inform healthcare providers of an increased rate of major adverse cardiac events in patients receiving the BVS, when…
Automated harm trigger system IDs patients at risk
Editor's Note In this study, an automated harm trigger system developed by the Adventist Health System Patient Safety Organization (Altamonte Springs, Florida) enabled the identification of patients who may have been harmed or at risk for harm. Nurse reviewers analyzed electronic health records of current patients with positive triggers to…
Penn Patient Safety Authority reviews RSI events, guidelines
Editor's Note In this advisory, the Pennsylvania Patient Safety Authority reviews retained surgical item (RSI) events in Pennsylvania hospitals and RSI guidelines from various organizations. Analysis of events reported to the Pennsylvania Patient Safety Authority from 2014 to 2015 reveals 112 RSIs that met the definitions of the National Quality…
AHRQ data show drop in hospital-acquired conditions
Editor's Note There were about 3.1 million fewer hospital-acquired conditions (HACs) between 2010 and 2015, according to a newly released report from the Agency for healthcare Research and Quality (AHRQ). Most of the decline was because of a: 42% reduction in adverse drug events 23% drop in pressure ulcers 15%…
Impact of intraop adverse events on readmissions
Editor's Note In this study from the Massachusetts General Hospital, Boston, major intraoperative adverse events were independently associated with a two-fold increase in readmissions. Of 9,274 surgical procedures analyzed, 921 resulted in readmission. Of these, 183 had confirmed intraoperative adverse events, 73 of which were major events. Procedures with major…
Joint Commission updates sentinel event stats
Editor's Note The Joint Commission announced February 22 that it had updated its sentinel event statistics through the end of 2016. Of 824 events reviewed, unintended retention of a foreign object topped the list at 120. Wrong-patient, wrong-site, or wrong-procedure was second at 104 events, and operative/postoperative complication was seventh…
Harvard study assesses surgeon as second victim
Editor's Note Intraoperative adverse events (iAEs) occur often and have a significant negative impact on surgeons’ wellbeing, this study finds. Barriers to transparency include fear of litigation and absence of a well-defined reporting system. A survey was conducted of all surgeons at three major teaching hospitals connected with the Harvard…
Plan B: Managing surgical equipment failure
With safety and quality now tied to reimbursement as part of value-based purchasing (VBP), hospitals must meet benchmarks for patient satisfaction, clinical outcomes, and readmissions to avoid financial penalties imposed by the Centers for Medicare & Medicaid Services. The VBP program added the Patient Safety Indicator, or PSI 90, metric…
ECRI Institute provides Executive Brief on Top 10 Health Technology Hazards for 2017
Editor's Note ECRI Institute announced December 15 that it is providing an abridged version of its 2017 Top 10 list of health technology hazards as a free public service to inform healthcare facilities about important safety issues involving the use of medical devices and systems. Among the hazards are: inadequate…
FDA issues final rule on adverse event reporting for manufacturers
Editor's Note The Food and Drug Administration (FDA) on November 8 published its final rule on the requirements for reporting adverse events by medical device companies, the November 14 Medical Design & Outsourcing reports. The final rule walks back much of the burden for contract manufacturers that was in the…
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