The application study of harmonization code in medical device adverse event reporting.

ABSTRACT:

Background

The reporting of adverse events in medical devices (MD) is a starting point of post-market surveillance and the most common source of initial safety signals. Because MD adverse events (AE) occur globally and involve high-profile international public health crises, international regulators implanted standard codes for MDAE reporting. This study aimed to assess the application of MDAE terminology and codes by providing examples of virtual events.

Methods

An online survey was conducted among participants of the MD Training Program for Regulatory Authorities which provide International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes, and six virtual MDAE cases.

Results

All 29 of the 72 participants were regulators. In all cases, most

SUBMITTER: Choi SJ 

PROVIDER: S-EPMC11562707 | biostudies-literature | 2024 Nov

REPOSITORIES: biostudies-literature