The following FDA Report for Safer Medical Products for Healthcare Providers educates healthcare providers (HCP) on how to report medical device malfunctions, serious injuries, or deaths associated with medical devices to the FDA. Since December 13, 1984, the FDA Medical Device Reporting (MDR) regulations have obliged companies that have received complaints about device malfunctions, significant injuries, or deaths caused by medical devices to notify the FDA. The following course outlines the Medical Device Reporting Regulation and its importance in healthcare.
What you will learn:
- Introduction to Medical Device Reporting
- Summary of MDR Regulation
- Reporting Requirements
- Mandatory vs voluntary MDR requirements
- Reporting Guidelines
- How to report a medical device problem
Details
Course length: 45 minutes. CME: 0.75
Languages: American English
Key features: Audio narration, learning activity, and post-assessment.
American Medical Compliance is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing education to physicians. Our Continuing Medical Education (CME) program is committed to enhancing the knowledge, skills, and professional performance of healthcare providers to improve healthcare outcomes. Through high-quality educational activities, we aim to address the identified educational gaps to support the continuous professional development of our medical community. American Medical Compliance designates this activity for a maximum of 0.75 AMA PRA Category 1 Credits. Physicians should only claim this credit for their complete participation in this activity.
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How to Report a Medical Device Problem
There are different requirements for those reporting issues with medical devices, all of which are outlined in the course. However, it is important to note that manufacturers, importers, and the user facility all must report malfunctions with medical devices to the FDA. This could be for the purpose of monitoring number of deaths associated with that specific medical device. Or it could simply just be a malfunction. Also, the graph within the course properly outlines who must report specific incidents to the specific party if necessary.
Additionally, complaint files are linked to MDR event files. This is because reviewing complaints is important in determining if it is a reportable adverse occurrence. Furthermore, a complaint is any written, electronic, or spoken statement that asserts flaws in a product’s identity, quality, durability, dependability, safety, efficacy, or performance after it has been released for distribution. To learn more about medical devices, their potential issues, and linkage to the FDA, click the button below.
