Safe Medical Device Act Reporting (Clinician)

This course covers the Safe Medical Device Act reporting requirements as they apply to “user facilities,” which are clinicians and organizations outside of the physician office setting per the regulation. Learners will review the U.S. Food and Drug Administration’s mission related to medical devices and how their role in medical device reporting impacts patient safety.
Objectives:
  • Explain the FDA’s mission as related to medical devices.
  • Identify three common medical device reporting situations.
  • List three key data elements required in a medical device report.
A smiling woman with a stethoscope around her neck and a clipboard in her hand appears in a medical setting. She wears a peach-colored medical uniform and has her dark hair pulled back. The background is blurred with a noticeable red clipboard or folder.

   English

   Audio Included

   CE Credit Hours: 0.5

   Length: 0.5

   Approvers: ANCC

Safe Medical Device Act Reporting (Clinician)

A smiling woman with a stethoscope around her neck and a clipboard in her hand appears in a medical setting. She wears a peach-colored medical uniform and has her dark hair pulled back. The background is blurred with a noticeable red clipboard or folder.

   English

   Audio Included

   CE Credit Hours: 0.5

   Length: 0.5

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Get Unlimited Access to the Entire Activated Insights Training Course Library
Talk with one of our program experts to learn how you can provide your care staff with valuable online training at their fingertips.