The International Medical Device Regulators Forum (IMDRF) proposed a new annex to its adverse event terminology technical document to include medical device parts and components.
Annex G proposes the terminology on medical device parts and components using the same Excel spreadsheet format as Annexes A through F. The proposed document seeks to harmonize definitions for a range of parts, including materials, and components including accessories.
“The terms allow capturing of the specific part or component of the medical device which was involved in the incident,” IMDRF says. The component terms fall under the categories of “biological and chemical,” “electrical and magnetic,” “measurement,” “mechanical,” “optical”, “safety” or “others.”
For cases where more detail of the adverse event is necessary, the sections capture terms and definitions under a second level, where appropriate. As part of IMDRF’s hierarchical coding structure, each additional level adds granularity to the description of the incident. IMDRF says that “with an increasing number of levels, the resolution and descriptive power of the hierarchical system grows.” The coding structure makes it easier for users to identify the terms they need to know.
The move to include adverse event terminology/coding specific to medical device parts and components coincides with the US Food and Drug Administration’s Center for Devices and Radiological Health’s (CDRH) recent campaign on materials…