The Report on supervisory activities on medical devices 2021-2022 provides a description of the supervisory activities that the Ministry of Health, as the Competent Authority, carries out on medical devices and in vitro diagnostic medical devices.
The Report, the fourth on the subject of supervision of medical devices and the third on in vitro diagnostic medical devices, collects an analysis of the data present in the NSIS-Dispovigilance database relating to the years 2021-2022.
The publication is aimed at all stakeholders involved in the device sector, manufacturers, healthcare professionals, patient associations, local and central institutions interested in the purchase and management of medical devices and in vitro diagnostic medical devices.
Data on accidents and safety alerts, insights into certain sectors
The Report consists of an introductory part, in which a overview of the surveillance system on medical devices and in vitro diagnostic medical devices, of innovations introduced by the European Regulations on supervision and the structure and operational aspects of the supervisory system by analyzing both the European and national levels, with particular detail to national surveillance device network.
The Report on supervisory activities is divided into two sections:
the Description of accident data and safety alerts occurred in the years 2021-2022, with particular attention to some specific categories of devices
insights into some topics of particular interest emerged during the years 2021 and 2022.
The in-depth analyzes are specific to some sectors involving medical devices: devices in the orthopedic sector, administration, sampling and collection devices, devices in the cardiovascular and cardiovascular sector, devices in the gynecological sector, breast prostheses and healthcare and related components and accessories.
A chapter is, in consideration of the pandemic context that continued to characterize the years 2021 and 2022, dedicated to the impact of the pandemic on the surveillance activity of medical devices and in vitro diagnostic medical devices.
There is also an in-depth analysis of the issue of the company supplying the device sterilization service (SterilMilano) and the problem of safety warnings regarding the degradation of the sound-absorbing foam of CPAP, PAP/BiPAP devices and mechanical ventilators of the manufacturer Respironics Inc.
The Report aims to disseminate the results of the analyzes deriving from the supervisory activity, in a transparent manner and with informative purposes.
Greater sensitization and awareness of all the actors involved in the surveillance system and transparent and shared information represent one of the priorities of the Ministry of Health, as a starting point for a active vigilance it’s at protection of public health.
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