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  1. Home
  3. Hospital Medical Device Quality And Safety Monitoring Using Real-world Data From Friuli Venezia Giulia Regional Health Coordination Agency.
  1. Home
  3. Hospital Medical Device Quality And Safety Monitoring Using Real-world Data From Friuli Venezia Giulia Regional Health Coordination Agency.

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Hospital medical device quality and safety monitoring using real-world data from Friuli Venezia Giulia regional

Anna Flamigni1, Marta Paulina Trojniak1, Laura Distefano2

  • 1Pharmacy Unit, Institute for Maternal and Child Health - IRCCS "Burlo Garofolo" - Trieste, Italy.

Expert Review of Medical Devices
|March 5, 2025

View abstract on PubMed

Summary
This summary is machine-generated.

Analyzing medical device reports in Italy revealed a need for better reporting and training. Improving these areas enhances patient safety and hospital efficiency.

Keywords:
Device vigilanceEU MDRmedical deviceproactive monitoringreactive monitoringreal-world data

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Area of Science:

  • Medical device safety and regulatory science.
  • Healthcare quality improvement and patient safety.

Background:

  • The medical device and in vitro diagnostic industries are rapidly innovating.
  • New European regulations aim to foster a sustainable and innovation-friendly regulatory environment for medical devices.

Purpose of the Study:

  • To proactively and reactively monitor the quality and safety of hospital medical devices.
  • To analyze reported complaints and incidents to identify areas for improvement in medical device management.

Main Methods:

  • Retrospective analysis of 132 complaints and incidents reported in 2023.
  • Involved 101 different medical devices in the Friuli Venezia Giulia region, Italy.
  • Utilized safety and usability metrics for monitoring.

Main Results:

  • Identified 132 reports (57 incidents, 75 complaints), with 24 complaints misclassified as incidents.
  • Risk class IIA and European Medical Device Nomenclature (EMDN) class A devices were most frequently reported.
  • Highlighted needs for improved reporting compliance, proactive post-market surveillance, and enhanced training.

Conclusions:

  • Proactive and reactive surveillance of medical devices is crucial for improving real-world safety and effectiveness.
  • Refining local reporting practices and enhancing user education are key to improving patient safety, outcomes, and hospital expenditure.