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Creating a Master Harms List Using Standard Codes
Build a solid foundation for your risk management process by creating a standardized Master Harms List.
WHY
Ensure consistency in defining potential harm terms using standardization.
WHAT
Learn about harmonized codes and terms used by FDA for regulatory purposes.
HOW
A case study example to help you create a standardized Master Harms List.
Using standardized terms helps you avoid confusion and inaccuracies in risk estimation
Surprising fact: You are already using standard terms for adverse events reporting, but not in risk management.
A common practice in the medical device industry is to use non-standard complaint codes in risk management files to define device failures and patient harms.
It leads to inconsistency and confusion. Frequently, it also results in errors during risk estimation.
Plus, it leads to difficulties in analyzing post-market data, including publicly available adverse event data, when reviewing occurrence rates of device failures and patient harms.
Did you know that FDA and other regulatory authorities already require the use of IMDRF codes to report adverse events? Why not use the same codes in your risk management file?
Standardization will help you ensure consistency and avoid mistakes in risk estimation.
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Lean how to create a Master Harms List using standard terms and codes.
