Strategies for Successful Device Investigations Involving Vendors

October 1, 2013 | Health System Risk Management


ECRI Institute's Accident and Forensic Investigation (AFI) Group provides specialized services to investigate, analyze, and prevent incidents, injuries, and deaths related to medical device failures and organization systems and processes. This column draws from the AFI Group's broad experience to discuss the risk management implications of medical-device-related incidents.

Should a healthcare facility involve vendors in a medical device accident investigation? ECRI Institute's AFI Group is often asked this question, but the answer is not always a simple yes or no.

Vendors that may have an interest in device investigations include medical device manufacturers and distributors, as well as third-party providers that service equipment. Sometimes multiple manufacturers may be involved in one investigation. For example, an anesthesia-related event could potentially affect the manufacturers of the anesthesia...

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