Reporting Root Causes of Medical Device Use Error

INTRODUCTION In Chapter 12, we describe root causes of many different types of use errors. Such root causes are usually reported to regulatory authorities (FDA in parti cular) in a broader context that includes the following elements:

modes and effects analysis) line item related to the use error. ª Risk priority number, and possibly the use error’s likelihood and the

severity ratings from which it is derived. ª Potential harms that result from the use error, which may be

extracted from the risk analysis. Note that some regulators have

a sentence or phrase).