IMDRF Guideline Seeks To Unify Adverse Event Terminology, Coding
By Jof Enriquez,
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The International Medical Device Regulators Forum (IMDRF), a voluntary group of international medical device regulators, has released a final document containing harmonized terminology for reporting adverse events, with matching alpha-numeric codes and examples for medical devices and in vitro diagnostics (IVDs) in both premarket and postmarket settings.
The set of terminologies is intended for use by device manufacturers, healthcare providers, and other entities obligated to report adverse events, as well as regulatory authorities, national competent authorities (NCAs), and supranational bodies charged with monitoring adverse events to protect public health.
"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," stated IMDRF.
The group says common terms, definitions, and codes help medical device companies report adverse events to multiple jurisdictions, while regulatory authorities will benefit from increased accuracy and reliability of information exchanged about adverse events between counterpart authorities around the world, and faster detection of “emerging signals” of safety concerns. Also, a harmonized system can make adverse event reporting more efficient for healthcare facilities, and protects patients who will benefit from swifter response from authorities when safety issues arise.
In order to facilitate the use of these harmonized terminologies (in particular in databases), and make them less ambiguous in meaning, each term is uniquely identified by an alphanumerical code and is further explained by a definition and, in some cases, examples. IMDRF’s set of terminologies makes use of existing terminologies, some of which were either simplified or expanded when appropriate.
According to RAPS, the guideline says the term "adverse event," in the context of clinical trials (i.e., in the premarket space), has a more restricted meaning than in the postmarket space, and depending on jurisdictions, the term adverse event (in its postmarket meaning) and the term “incident” can typically be used interchangeably.
IMDRF referenced existing standardization documents from the International Organization for Standardization (ISO), the U.S. Food and Drug Administration (FDA), and several guidance materials from IMDRF's predecessor organization, the Global Harmonization Task Force (GHTF).
Due to the evolving nature of the medical device industry and new technologies, materials, designs, and procedures, IMDRF says the terminologies and codes should be updated periodically, but not so frequently, as this will require overhauling the existing coding systems long used by healthcare facilities, industry, and government. Terminologies must be changed only when absolutely necessary, for example, when new terms for devices, designs and materials emerge, according to IMDRF.