Failure Analysis of Medical Devices

Bearing in mind the three-legged stool approach of device design/manufacturing, patient factors, and surgical technique, this article aims to inform the failure analyst of the metallurgical and materials engineering aspects of a medical device failure investigation. It focuses on the device "failures" that include fracture, wear, and corrosion. The article first discusses failure modes of long-term orthopedic and cardiovascular implants. The article then focuses on short-term implants, typically bone screws and plates. Lastly, failure modes of surgical tools are discussed. The conclusion of this article presents several case studies illustrating the various failure modes discussed throughout.

Emergencies in the clinical environment

Managing adverse incidents1110 Fire safety1112 Missing and absconding patients1113 Major incidents1114 Medical device failure1115 Utility failure1116 Violent and aggressive patients1118 Violent and aggressive relatives1120 Control of Substances Hazardous to Health (COSHH)1121 This refers to any event that produces unexpected or unwanted effects involving the safety of a person or the loss or damage of property. Incidents may be clinical, health and safety, security, assaults, or accidents....