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System Factors in the OR: Measurement and intervention with the OR Black Box

Robert C Adams-McGavin, B, Eng1, James J Jung, MD1, Anne H van Dalen, MD, BSc2, Marlies P Schijven, MD, PhD, MHSc2, Teodor P Grantcharov, MD, PhD1. 1International Centre for Surgical Safety, Li Ka Shing Knowledge Institute of St. Michael’s Hospital, Toronto, ON, 2Dept of surgery, Amsterdam Gastroenterology and Metabolism, Amsterdam UMC, University of Amsterdam, the Netherlands

Adverse events occur commonly in the operating room (OR) and may result in significant patient morbidity and mortality. Intraoperative events often result from system factors, a term describing the complex interactions within the system including communication, teamwork, organizational policies, tools and technology, and the physical environment. Understanding how system factors contribute to intraoperative events is therefore critical to improving surgical quality. Analysis of system factors, however, often occurs retrospectively and is limited by recall bias, poor compliance, and insufficient detail. Other studies utilize intraoperative observers which are resource intensive and can be disruptive to the system. The OR Black Box® was developed to provide standardized monitoring of several aspects of intraoperative events including the systems factor influencing patient safety. Data from the OR Black Box© can be utilized to develop targeted interventions that reduce intraoperative events and mitigate their impact.

The OR Black Box captures and synchronizes intraoperative data from several sources including the laparoscopic camera, panoramic room cameras, audio capturing devices, anesthesia monitors, and other sensors. It is installed in unobtrusive locations to allow for assessment of systems factors in the OR without an observer. The data is encrypted and sent to a centralized center where trained surgical analysts evaluate the procedure. Intraoperative system factors are identified and coded using a standardized framework developed inductively by our group. Each event was classified as either a safety threat, which increases the risk of harm to a patient, or a resilience support, which prevents or mitigates harm. They were also categorized into one of the 6 components of the OR environment based on the Systems Engineering Initiative for Patient Safety (SEIPS) model: (1) person, (2) tasks, (3) tools and technology, (4) physical environment, (5) organization, and (6) external environment. The findings were then used in an educational intervention to help translate knowledge and improve safety. Audiovisual clips of events of were anonymized and packaged into a video report for each case. This was promptly provided to the surgical team to facilitate a debriefing session.

A study of 24 laparoscopic general surgery cases identified a median of 14 safety threats (IQR 11-16) and 12 resilience supports (IQR 11-16) per case. Safety threats were most prevalent in the person, organization, and tools and technology categories. The majority of resilience support was contributed by clinicians’ preventative actions or responses to unexpected events. Debriefs performed using the video reports allowed structured discussions around safety threats, such as medication errors, tool malfunctions, and teamwork and communication breakdowns. Changes in practice were observed after debriefs were performed, including mindful practices to prevent a break in sterility when handling devices.

The OR Black Box allows for retrospective evaluation of system factors and their impact on intraoperative events with minimal disruption to the OR environment. In the future, we plan to refine our framework and apply it to a larger series of cases. The effect of intraoperative events and interventions on patient outcomes will also be studied.


Presented at the SAGES 2017 Annual Meeting in Houston, TX.

Abstract ID: 98791

Program Number: ETP737

Presentation Session: Emerging Technology Poster Session (Non CME)

Presentation Type: Poster

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