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.
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