Standardized Terminologies for Reporting Medical Device Component Issues

The International Medical Device Research Foundation (IMDRF) has released Annex G, a standardized list of terms and codes for reporting adverse events related to medical device components.

Key Details:

• Covers components such as headphones, electronic parts, cables, sensors, fasteners, and medical equipment (e.g., catheters, cannulas, sutures).

• Headphones are used for private listening and communication, while electronic components handle current, data transfer, and signal processing.

Recent Updates:

• Added two new terms (G0201208, G02041).

• Modified three existing terms (G07, G07002, G07003).

• The terms apply only to components, not standalone devices.

This update ensures consistency in reporting medical device incidents globally.

Source: https://www.imdrf.org/documents/terminologies-categorized-adverse-event-reporting-aer-terms-terminology-and-codes

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