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5PSQ-101 Medical devices incident reports: an Italian experience
  1. G Guarnieri,
  2. C Zero,
  3. M Dall’aglio,
  4. G Mangoni,
  5. L Cervi
  1. Asst Grande Ospedale Metropolitano Niguarda, Pharmacy, Milan, Italy


Background and Importance Dispovigilance is the Italian Ministry of Health’s database that supports the National Vigilance Device Network since October 2022. It is an essential tool in the reporting system for serious, non-serious incidents and safety actions related to medical and in vitro diagnostic devices (MDs and IVDs).

The National Classification of Medical Devices (CND) groups MDs into homogeneous categories of products for similar diagnostic and/or therapeutic intervention.

The European Medical Device Nomenclature (EMDN), Regulations 2017/745 and 2017/746, is based on the Italian CND. The Regulations also classify MDs into different classes according to risk management.

Aim and Objectives The purpose was to investigate MDs involved in incidents occurred at an Italian hospital, to provide real world evidence.

Material and Methods This study was performed on incident reports collected through Dispovigilance between January 2022 and September 2023. CND, risk class (I, IIA, IIB, III) and reporter were analysed.

Results A total of 42 reports were collected; of these, 17 (40%) during 2022 and 25 (60%) in the first nine months of 2023. According to CND, the most frequently reported DMs belonged to ‘C, Cardiocirculatory System Devices’ (20 cases, 23%); ‘P, Implantable Prosthetic and Osteosynthesis Devices’ (8 cases, 19%) and ‘A, Devices for Administration, Withdrawal and Collection’ (7 cases, 16%). Based on the class of risk, 1 MD referred to class I, 15 to class IIA, 13 to class IIB, 13 to class III. Most accidents were reported by clinicians (25 cases), followed by pharmacists (7 cases) and nurses (7 cases).

Conclusion and Relevance The analysis shows an increasing reporting trend in 2023 compared to 2022, probably due to the advent of Dispovigilance, although underreporting is still present especially for low-risk devices. Most reports refer to medium and high-risk devices.

Based on CND, C and P are frequently notified; the reason could be the greater attention on these high-risk devices. According to our results, clinicians are the predominant reporters, together with pharmacists and other healthcare professionals since they are directly involved in the management and use of DMs.

This study highlights the essential role of vigilance of medical devices.

Conflict of Interest No conflict of interest.

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