IMDRF Offers New Guideline on Adverse Event Reporting
April 11, 2017
As a way to improve the accuracy and capture of medical device adverse events, the International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, on Monday published a new final guideline on a harmonized terminology for reporting such events.
"Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory agencies," IMDRF’s adverse event working group explained.
The 14-page guideline offers IMDRF terms, definitions and alpha-numerical codes to be used for pre- and post-market adverse event reporting for medical devices and in vitro diagnostics.
To ease the use of these terminologies, particularly in databases, and to reduce possible ambiguities, each term in the guideline is uniquely identified by an alpha-numerical code and is further explained by a definition and, in some cases, examples. The terminologies are based on what's currently available and have been reviewed, improved, and as appropriate, either expanded or simplified.
Notably, the guideline says the term "adverse event" in the context of clinical trials (i.e. in the pre-market space) has a more restricted meaning than in the post-market space, and depending on jurisdictions, the term adverse event (in its post-market meaning) and incident can typically be used interchangeably.
However, the guideline notes that "it is important that changes to the AE terminology should be restricted to the absolute necessary, i.e. mainly reserved for adaptation to technical progress (new terms as new devices, designs and materials emerge). Frequent changes to the terminology are not anticipated. Any change for involved parties and end users will require re-programming of existing coding systems at the level of industry, healthcare facilities and regulators alike so needs to be managed with this in mind."
International Medical Device Regulators Forum (IMDRF), a voluntary and global group of device regulators, published a new final guideline on a harmonized terminology for reporting medical device adverse events.