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

Area of Science:

• Surgical Innovation
• Medical Device Technology
• Patient Safety Research

Background:

• Surgical data recorders (SDRs), akin to aviation black boxes, are emerging tools for enhancing surgical patient safety and performance.
• These devices capture novel data within the operating room, offering unique insights.
• No prior systematic review has comprehensively evaluated the application areas of SDRs.

Purpose of the Study:

• To systematically review the application areas of surgical data recorders in the operating theater environment.
• To conduct a preliminary assessment of the quantifiable data that can be collected using SDRs compared to traditional methods.

Main Methods:

• Systematic review and single-arm meta-analysis adhering to PRISMA guidelines.
• Searched Medline, Embase, and Web of Science databases for clinical use cases of SDRs, excluding implementation-focused papers.
• Included 17 studies after screening 70; assessed risk of bias using ROBINS-E tool and analyzed data descriptively and quantitatively where possible.

Main Results:

• Seventeen studies were included, with 10 showing a low risk of bias. Key limitations included confounding, bias, small sample sizes, and Hawthorne effects.
• Identified four main use case categories: economic, safety, operating room behavior, and technical skill assessment.
• A meta-analysis confirmed accurate reporting of distractions, aligning with existing literature.

Conclusions:

• Surgical data recorders provide comprehensive, unobstructed views of operating theater activities.
• The majority of published studies are preliminary, highlighting the need for larger-scale research with improved methodology.
• Further investigation into SDRs holds significant potential for advancing surgical practice and patient outcomes.