ALL111 - Medical Device Reporting (1.0 HR)

Purpose:

This course is designed to provide employees of user facilities with pertinent information regarding the reporting requirements for medical device malfunctions.

Objectives:

1. Define “medical device.”
2. Discuss the rationale for medical device reporting requirements.
3. Explain how user facilities are required to report medical device adverse events to the FDA.
4. Explain the difference between mandatory and voluntary MDR.
5. Discuss required recordkeeping.
6. Describe procedures for complying with FDA medical device recall actions.

Continuing Education Credits: 1.0 contact hours Iowa BON #335; 1.0 contact hours CA Board of Nursing CEP 14033; 1.0 contact hours CE Broker # 50-4572 Florida and District of Columbia; 0 contact hours for Social Work State of Illinois Department of Financial and Professional Regulation. License No. 159.001315; 0 contact hours for Physical Therapy State of Illinois Department of Financial and Professional Regulation. License No. 216.000284; 0 contact hours for Occupational Therapy State of Illinois Department of Financial and Professional Regulation. License No. 224.000164; 1.0 CE hours for certified nursing assistants; long term care department heads; and other health care disciplines.