Rapid response to medical device recalls: an organized patient-centered team effort.

As more patients depend upon mechanical or electronic technologies for treatment, medical device recalls-like the recent recall of common positive airway pressure treatment devices-impact millions of patients, often causing significant anxiety, extra costs, and interruption of care for patients. When recalls require health care and/durable medical equipment providers to be part of the solution, the burden on practices and businesses can be significant, creating strains on access for new patients and on limited medical supplies. We have observed that having an established and well-organized medical device recall plan in place allows for a rapid response, decreased practice burden, and reduced provider stress. Coupling the organized response with proactive, empathic, and clear communication with patients reduces their anxiety, provides clear directions for how to address the issue constructively, and reduces reactive communications. We share what we believe are key components of a medical device and produce recall procedure as we describe our institutions response in hopes that others can build on these basics as they design their own response plans. CITATION: Morgenthaler TI, Linginfelter EA, Gay PC, et al. Rapid response to medical device recalls: an organized patient-centered team effort. J Clin Sleep Med. 2022;18(2):663-667.

Avoiding Retained Surgical Items at an Academic Medical Center: Sustainability of a Surgical Quality Improvement Project.

Unintentionally retained surgical items (RSIs) are a serious complication representing a surgical "Never" event. The authors previously reported the process and significant improvement over a 3-year multiphased quality improvement RSI reduction effort that included sponge-counting technology. Herein, they report the sustainability of that effort over the decade following the formal quality improvement project conclusion. This retrospective analysis includes descriptive and qualitative data collected during RSI event root cause analysis. Between January 2009 and December 2019, 640 889 operations were performed with 24 RSIs reported. The resulting RSI rate of 1 per 26 704 operations represent a 486% performance improvement compared to the preintervention rate of 1 per 5500 operations. The interval, in days, between RSI events increased to 160 from 26 during the preintervention phase. Cotton sponges were the most retained RSI despite the use of sponge-counting technology. A significant and sustained reduction in RSI is possible after designing a sustainable comprehensive multidisciplinary effort.

Surgical never events and contributing human factors.

INTRODUCTION: We report the first prospective analysis of human factors elements contributing to invasive procedural never events by using a validated Human Factors Analysis and Classification System (HFACS). METHODS: From August 2009 to August 2014, operative and invasive procedural "Never Events" (retained foreign object, wrong site/side procedure, wrong implant, wrong procedure) underwent systematic causation analysis promptly after the event. Contributing human factors were categorized using the 4 levels of error causation described by Reason and 161 HFACS subcategories (nano-codes). RESULTS: During the study, approximately 1.5 million procedures were performed, during which 69 never events were identified. A total of 628 contributing human factors nano-codes were identified. Action-based errors (n = 260) and preconditions to actions (n = 296) accounted for the majority of the nano-codes across all 4 types of events, with individual cognitive factors contributing one half of the nano-codes. The most common action nano-codes were confirmation bias (n = 36) and failed to understand (n = 36). The most common precondition nano-codes were channeled attention on a single issue (n = 33) and inadequate communication (n = 30). CONCLUSION: Targeting quality and interventions in system improvement addressing cognitive factors and team resource management as well as perceptual biases may decrease errors and further improve patient safety. These results delineate targets to further decrease never events from our health care system.