Enhancing Surgical Safety and Efficiency: Systematic Review and Single-Arm Meta-Analysis of Surgical Data Recorders

Abstract

Background: Recently, surgical data recorders that are comparable to flight data recorders, also known as black boxes in the aviation industry, have been developed to improve patient safety and performance in surgery. These devices allow for unique insights in the operating room by providing new data capture capabilities. No systematic review has been carried out to evaluate the areas of application of surgical data recorders to date.

Objective: This systematic review and single-arm meta-analysis aims to assess the aspects of the operating theater environment for which surgical data recorders are used and to make a preliminary assessment of the quantifiable data that can be collected, compared to traditional collection methods.

Methods: This systematic review followed the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines. Medline, Embase, and Web of Science databases were lastly systematically searched for papers that focused on a clinical use case for surgical data recorders on February 10, 2025. In particular, not relevant papers focusing on implementation of surgical data recorders were excluded. Title, abstract, and full-text screening were completed to identify relevant articles. The included studies were analyzed descriptively using data extraction forms. Where possible, quantifiable data was also analyzed. Risk of bias was assessed using the Risk Of Bias In Non-Randomized Studies of Exposure (ROBINS-E) tool.

Results: In total, 70 studies were screened, and a total of 17 studies were included. A total of 10 of the 17 studies had a low overall risk of bias; however, confounding, selection bias, small sample sizes, short study periods, and potential Hawthorne effects were the notable limitations. Only 2 studies were assessed to have publication bias. Use cases could be grouped into 4 categories: economic, safety, behavior in the operating room, and technical skill assessment. A single-arm meta-analysis focusing on adverse events and distractions in the operating theater could be conducted, demonstrating accurate reporting of distractions in line with the existing literature.

Conclusions: Surgical data recorders provide an unobstructed view of various aspects of the operating theatre. Most published papers present preliminary studies on surgical data recorders, indicating the potential for further, larger-scale studies with enhanced methodological quality.

Keywords: healthcare technology; intraoperative monitoring; medical error reduction; meta-analysis; operating room; outcome assessment; patient safety; safety behavior; surgical data recorders; surgical performance.

Figure 1.. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow chart (study identification and screening process).

Figure 2.. Distractions per minute. Values show scatter. Overall, about one distraction per minute was noted [4,10,19,20,21].

Figure 3.. Errors per minute. Values show scatter. Overall, about 1 distraction per 6 minutes was noted [10,20,24].