James J Jung1,2, Arash Kashfi3, Sahil Sharma4, Teodor Grantcharov3,4. 1. Department of Surgery, University of Toronto, Toronto, Canada. jungj@smh.ca. 2. International Centre for Surgical Safety, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada. jungj@smh.ca. 3. Department of Surgery, University of Toronto, Toronto, Canada. 4. International Centre for Surgical Safety, Li Ka Shing Knowledge Institute, St. Michael's Hospital, Toronto, Canada.
Abstract
BACKGROUND: The burden of device-related interruptions is expected to increase as modern surgical practices adopt complex minimally invasive surgery devices. Currently, there is a paucity of empiric data that examined the nature of device-related interruptions using comprehensive intraoperative data. METHODS: We performed a cross-sectional study of consecutive elective laparoscopic general surgery cases performed in one operating room (OR) at a referral center between April 2014 and April 2016. The included cases were directly observed using a comprehensive multiport data recorder called the OR Black Box. The data were synchronized, encrypted, and reviewed by expert surgeon assessors. The assessors characterized device-related interruptions that occurred during operations. The prevalence of the cases with device-related interruptions was calculated. Device-related interruptions were classified into a priori categories of (1) absent/wrong device; (2) improper assembly; (3) loss of sterility; (4) disconnection; and (5) device failure. RESULTS: In a cohort of 210 cases, 64 (30%) had at least one device-related interruption. Sleeve gastrectomy (52%) and oncologic gastrectomy (43%) procedures experienced the highest prevalence of device-related interruptions. Device failure was the most frequently chosen category with laparoscopic staplers implicated in more than half of these failures. Three failure modes were described for laparoscopic stapler, of which stapler malfunction (46%) was the most common. CONCLUSIONS: Device-related interruptions occurred frequently in the OR and could be characterized into one of the five categories. Understanding the nature of the device-related interruptions can help guide implementation of safety interventions and user training in the future.
BACKGROUND: The burden of device-related interruptions is expected to increase as modern surgical practices adopt complex minimally invasive surgery devices. Currently, there is a paucity of empiric data that examined the nature of device-related interruptions using comprehensive intraoperative data. METHODS: We performed a cross-sectional study of consecutive elective laparoscopic general surgery cases performed in one operating room (OR) at a referral center between April 2014 and April 2016. The included cases were directly observed using a comprehensive multiport data recorder called the OR Black Box. The data were synchronized, encrypted, and reviewed by expert surgeon assessors. The assessors characterized device-related interruptions that occurred during operations. The prevalence of the cases with device-related interruptions was calculated. Device-related interruptions were classified into a priori categories of (1) absent/wrong device; (2) improper assembly; (3) loss of sterility; (4) disconnection; and (5) device failure. RESULTS: In a cohort of 210 cases, 64 (30%) had at least one device-related interruption. Sleeve gastrectomy (52%) and oncologic gastrectomy (43%) procedures experienced the highest prevalence of device-related interruptions. Device failure was the most frequently chosen category with laparoscopic staplers implicated in more than half of these failures. Three failure modes were described for laparoscopic stapler, of which stapler malfunction (46%) was the most common. CONCLUSIONS: Device-related interruptions occurred frequently in the OR and could be characterized into one of the five categories. Understanding the nature of the device-related interruptions can help guide implementation of safety interventions and user training in the future.
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