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

Journal: Biomedizinische Technik. Biomedical engineering
Published Date: Oct 14, 2022

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.

Authors

  • Lukas Theisgen
    Chair of Medical Engineering, Helmholtz Institute for Biomedical Engineering, RWTH Aachen University, Pauwelsstraße 20, 52074, Aachen, Germany.
  • Florian Strauch
    Chair of Medical Engineering, RWTH Aachen University, Aachen, Germany.
  • Matías de la Fuente Klein
    Chair of Medical Engineering, RWTH Aachen University, Aachen, Germany.
  • Klaus Radermacher
    Chair of Medical Engineering, RWTH Aachen.

Keywords

External Resources

Popular Topics
Recent Journals