FDA: Class I recall of Alaris Infusion Pump Module 8100
Editor's Note The Food and Drug Administration, on April 30, identified the recall of the Alaris Infusion Pump Module 8100 as Class I, the most serious. The Pacific Medical Group (DBA Avante Health Solutions) is recalling the infusion pump because the front bezel components may crack or separate, leading to…
Emotional outcomes of intraoperative deaths on surgical teams
Editor's Note This study from Cedars-Sinai Medical Center, Los Angeles, finds that intraoperative deaths negatively affect surgical team members, with a considerable number experiencing feelings of anger and depression. Of 120 OR team members completing a survey, 82 (68.3%) said they had prior experience with intraoperative deaths, referencing more than…
FDA: Class I recall of Cordis Precise PRO Rx US Carotid System
Editor's Note The Food and Drug Administration (FDA), on April 26, identified the recall by Cordis Corporation of its Precise PRO Rx US Carotid System as Class I, the most serious. The Carotid System is being recalled due to a risk of separation of the atraumatic distal tip of the…
The Joint Commission releases 2020 sentinel event statistics
Editor's Note The Joint Commission, on March 24, released its sentinel event statistics for 2020, which totaled 794. The top five most frequently reported events were: Falls: 170 Unintended retention of a foreign object: 106 Suicide: 81 Delay in treatment: 76 Wrong-site surgery: 68. The Joint Commission’s Office of Quality…
Importance of critical event debriefs cannot be overstated
During the COVID-19 pandemic, healthcare workers nationwide have experienced patient deaths on a scale like never before. Whether from COVID-19 or other complications, surgical services staff sometimes lose patients despite their best efforts, and these failures to rescue can leave lasting psychological or emotional scars. Many healthcare facilities have ramped…
FDA: Class I recall of Medtronic's HVAD Pump Implant Kits
Editor's Note The Food and Drug Administration (FDA) on March 1 identified the recall by Medtronic of its HeartWare Ventricular Assist Device (HVAD) Pump Implant Kits as Class I, the most serious. The kit is part of the HeartWare HVAD System, which is used to help the heart pump blood…
ECRI Institute, ISMP launch new Patient Safety Organization
Editor's Note In an August 17 news release, the ECRI Institute and its affiliate, the Institute for Safe Medication Practices (ISMP), announced that they had launched a new Patient Safety Organization (PSO). The PSO is an important step in making medication, medical devices, and healthcare practices safer for patients across…
Joint Commission releases sentinel event stats for first half of 2020
Editor's Note The Joint Commission on August 12 released its sentinel event statistics for the first half of 2020. From January 1 through June 30, the Joint Commission reviewed 437 sentinel events. The most frequently reported events were in the following categories: Care management, 165 Surgical or invasive procedures, 131…
Lancet, NEJM retract COVID-19 treatment studies
Editor's Note The Lancet and New England Journal of Medicine (NEJM) have both retracted COVID-19 treatment studies because of concerns about the validity of the data and how the research was conducted by Chicago-based Surgisphere Corp, the June 4 Medscape Medical News reports. Authors of the Lancet study, which was…
COVID-19: Randomized, double-blind, placebo-controlled, multicenter trial of remdesivir
Editor's Note In this randomized, double-blind, placebo-controlled, multicenter trial of remdesivir for the treatment of COVID-19, remdesivir was not associated with statistically significant clinical benefits. For the analysis, 237 patients were randomly assigned to either a treatment group with remdesivir (158 patients) or placebo (79 patients). Remdesivir use was not…
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