Medical Device Failures:

Lessons Learned and Impact on Regulatory Policy and Culture

Daniel J. Chwirut, MS, PE

CardioMed Device Consultants

Rockville, Maryland

Since 1976, the Food & Drug Administration has been responsible for regulating the sale of medical devices in the United States.  The engineering and epidemiologic analyses of several high-visibility device failures, involving scores of patient deaths, have led to significant changes to not only the technical requirements for the devices, but also to the laws and policies by which they are regulated.  Details of several of these failure analyses and their impact will be reviewed.