Forensic Engineering Analysis of Medical Device Accidents.

The approach to forensic investigation of a medical device related accident differs from that for consumer products, industrial equipment, and vehicles. Techniques for investigating and providing case assistance related to suspected medical device incidents are presented, including essential elements of the investigation, investigative techniques, and information resources on device failures and standards. User error versus design defect is discussed, along with the causes of medical device-related incident and the mechanisms by which they cause injury and death. Since a patient is a variable biological system, it must also be considered that the alleged cause of the incident was not attributable to the medical device. [ABSTRACT FROM AUTHOR]