Safe design of surgical robots - a systematic approach to comprehensive hazard identification.

Abstract

Objectives: Since the 1980s, robotic arms have been transferred from industrial applications to orthopaedic surgical robotics. Adverse events are frequent and often associated with the adopted powerful and oversized anthropomorphic arms. The FDA's 510(k) pathway encourages building on such systems, leading to the adoption of hazards, which is known as "predicate creep". Additionally, the methodology of hazard identification for medical device development needs improvement.

Methods: We present an approach to enhance general hazard identification and prevent hazards of predicate creep by using the integrative, scenario-based and multi-perspective Point-of-View (PoV) approach. We also present the Catalogue of Hazards (CoH) as an approach for collecting and systematising hazards for future risk analysis and robot development.

Results: We applied seven predefined PoVs to the use case of robotic laminectomy and identified 133 hazards, mainly coming from HMI analysis and literature. By analysing the MAUDE and recalls databases of the FDA, we were able to classify historical hazards and adopt them into the use case.

Conclusions: The combination of PoV approach and CoH is suitable for integrating multiple established hazard identification methods, increasing comprehensiveness, and supporting the systematic and hazard-based development of surgical robots.