Description:
Adverse Medical Device Events involve incidents where a patient or employee experience a serious injury or death that involved a medical device. In this program you will learn about the origin and the key points of the Safe Medical Device Act; the definition and types of medical devices; reporting requirements; and, when and what to report.

Objectives:

• Participant will define adverse medical device events
• Participant will name at least three conditions that must be present for an event to qualify as an adverse medical device event
• Participant will explain what an employee needs to do if he/she witnesses or discovers an incident resulting in death or serious injury that may have been caused or contributed by a medical device

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