April 20th, 2020, the International Medical Device Regulators Forum (IMDRF) posted the 4th edition of the documentation supporting harmonized terminology for reporting adverse events related to medical devices including in-vitro diagnostics (IVDs).
The IMDRF coding/ terminology defined in the Annexes are of import in Manufacturer Incident Reporting.
- Annex A of the document provides a comprehensive list of medical device problem terms and codes.
- Annex B explains the kind of review that should be conducted to find an adverse event’s root cause (Cause Investigation – Type of Investigation Terms and Codes).
- Annex C contains words and codes to describe the findings of an adverse event (Cause Investigation – Investigation Findings Terms and Codes).
- Annex D supplies phrases explaining conclusions regarding the root cause of the event (Cause Investigation – Investigation Conclusion Terms and Codes).
- Annexes E and F, respectively, present terminology to capture clinical signs and symptoms, and ultimate health impacts (Health Effect – Clinical Signs, Symptoms and Conditions Terms and Codes and Health Impact Terms and Codes).
- Annex G provides terms that allow the identification of the specific part or component of the medical device which was involved in the incident (Medical Device Parts and Component Terms and Codes).
What does this mean to you?
As these codes have been incorporated into the Manufacturer Incident Reporting form it is vital that you as a company have set-up your systems to allow the correct assignment of the various codes.
Should you want to discuss this more in depth with one of our consultants, please do not hesitate to get in touch with us.