MEDICAL DEVICE ASSEMBLY: Failure Modes Analysis Aids Design of Medical Devices

摘要

In 2011, the U.S. Food and Drug Administration received more than 400,000 reports of adverse events related to medical devices. More than 12 percent of those events resulted in hospitalization. When an adverse event occurs, the manufacturer is required to look into what went wrong. The FDA requires the manufacturer to report how it conducted the evaluation, the results of the investigation, and what conclusions it may have reached. However, the FDA does not provide guidance on how to conduct such evaluations.