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

Soo Jeong Choi1,2, Sooin Choi3,4, Songhyeon Park5

  • 1Division of Nephrology, Department of Internal Medicine, Soonchunhyang University College of Medicine, 170, Jomaru-Ro, Bucheon, 14584, Republic of Korea. crystal@schmc.ac.kr.

BMC Health Services Research
|November 15, 2024
PubMed
Abstract

Insights

Medical device adverse event (MDAE) reporting shows varied code application among regulators. Most participants used broad codes, indicating a need for improved standardization in post-market surveillance.

Area of Science:

  • Regulatory Science
  • Medical Device Safety
  • Post-Market Surveillance

Background:

  • Adverse event reporting is crucial for medical device (MD) post-market surveillance and safety signal detection.
  • Standardized codes for medical device adverse events (MDAE) were implemented by international regulators due to global occurrences and public health crises.
  • This study evaluates the practical application of MDAE terminology and coding systems.

Purpose of the Study:

  • To assess the application of International Medical Device Regulators Forum (IMDRF) adverse event terminology and codes.
  • To identify patterns and variations in code selection during medical device adverse event reporting.

Main Methods:

  • An online survey was administered to participants of the MD Training Program for Regulatory Authorities.
  • The survey included six virtual medical device adverse event (MDAE) cases for participants to code.
  • Participants' code selections were analyzed for patterns and variations.

Main Results:

  • Regulators predominantly selected broad (Level 1) codes over detailed (Level 2 or 3) codes for MDAE reporting.
  • While code selection varied, over 50% of responders selected intended codes for a specific case (Case 6).
  • Codes related to device problem, components, and health effects were frequently chosen for cause investigation.

Conclusions:

  • Diversification in terminology and code selection was observed in medical device adverse event (MDAE) reporting.
  • Findings suggest potential challenges in consistent application of standardized MDAE coding systems.
  • Further refinement or training may be needed to enhance uniformity in MDAE reporting.
Keywords:
Adverse eventIMDRFInternational medical device regulators forumMedical devicesPost-market surveillanceSafety management

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