IMDRF Opens Consultation on Annex Related to Adverse Event Terminology
Posted 15 July 2019 | By
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
IMDRF also proposes revisions, which include three new terms and certain editorial changes, for the first annex to its technical document on adverse events. The new terms are “unexpected color,” “undercorrection” and “erratic results” and fall under calibration problem, chemical problem and output problem, respectively. A Level 2 or 3 definition is proposed for each term. A finalized version of Annex A will mark the third edition of the list of problem terms and codes.
IMDRF is accepting comments on Annex G and the revised Annex A until 10 September 2019.
The new Annex G and the revised Annex A form part of recent work on the adverse events technical document. At the March meeting of the IMDRF management committee meeting, the first editions of Annex E and Annex F were approved. These cover clinical signs, symptoms and conditions associated with the adverse events as well as the resulting impacts on patient health.
CDRH recently began rolling out
changes to its Global Unique Device Identification Database of medical device adverse events in support of harmonization with the IMDRF system, which will likely lead to a reduction in submissions. The EU will require
the IMDRF adverse event coding/terminology in the new version of the medical device incident report from January 2020.
In addition to the adverse events annexes, two other public consultations were opened after the March meeting. IMDRF opened a consultation on regulatory pathways for personalized medical devices
in April, followed by a consultation to revise clinical evaluation documents
. The latter will seek to inform a mechanism for satisfying clinical evaluation requirements across IMDRF jurisdictions. This would be similar to the Medical Device Single Audit Program and the forthcoming
medical device single review program, which has yet to be officially named.
Other recently finalized and revised
IMDRF documents relate to unique device identification, device labeling principles, standard operating procedures as well as the Table of Contents format. A CDRH proposal on standard development organizations received
approval as well.
IMDRF terminologies for categorized Adverse Event Reporting (AER): terms, terminology structure and codes (Edition 4) - Annex А (Edition 3), G