The Report on medical device surveillance activities contains an analysis of data for the year 2019 on 
accidents with medical devices, collected in the database of the surveillance system on reports from healthcare professionals and manufacturers.
The Ministry carries out a constant monitoring activity on the accidents that occur with medical devices after their placing on the market, also thanks to the collaboration with all the stakeholders involved in the system, collecting and analyzing all the data that flow into the surveillance system.
The 2019 Report
The Report presents numerous additional insights compared to the previous one and also includes an assessment of the accidents involving i in vitro devices (IVDs).
The publication is divided into two sections:
- the first concerns the description of data on incidents that occurred in 2019, and pays particular attention to the categories of medical devices that have had a higher frequency of accidents
- the second provides insights on some issues of particular interest in the context of supervisory activities.
The surveillance system of the Ministry of Health recorded, in 2019, 6,421 accident reports with medical devices; 435 reports concern in vitro diagnostic medical devices (IVD).
The analysis of the accident reports in reference to the Region in which the event occurred highlights a strong territorial lack of homogeneity, suggesting more or less marked phenomena of under-reporting.
The second section includes an overview of insights on the subject of very broad supervision of breast implants, health equipment and related components and accessories, medical devices in the cardiovascular sector, the cardiovascular sector and the orthopedic sector, devices for administration, sampling and collection. An in-depth study is dedicated, among the supervisory activities, to the fight against counterfeiting.
For further information consult:
- the Medical Devices > page The surveillance system
- Medical Device Supervisory Activity Report 2019
