A topic that emerges whenever problems occur on implantable medical devices, is the need for national registries, an essential tool to protect patients’ health and safety.
That is why a specific article (art.108) has been included in the European Regulation 2017/745 on medical devices in which Member States are asked to take “All appropriate measures to encourage the establishment of registers and databanks for specific types of devices setting common principles to collect comparable information. Such registers and databanks shall contribute to the independent evaluation of the long-term safety and performance of devices, or the traceability of implantable devices, or all of such characteristics”.
Similarly, in Italy, in 2012, with the decree-law 179, converted into Law 221, the legislator created the framework that currently supports the implementation of surveillance systems and registers of particular concern for public health, identified with the Prime Minister’s Decree on 03/03/2017. These surveillance systems and registers, whose filling by regions and healthcare professional has been made mandatory with Law 145 of 31/12/2018 (paragraph 558), are formally established once approved by the regulation sets by the Prime Minister’s Decree.
Among these surveillance systems and registers, there are the Register of implantable prostheses (The Italian Implantable Prostheses Registry, RIPI) and the National Breast Implants Register (RNPM), headed respectively by the Italian National Institute of Health (Iss) and the Ministry of Health.
An implantable devices registry is a systematic data collection of all the implantable device replacements procedures (joint replacements, spinal implants, cardiac devices, artificial heart valves) performed in a defined geographic area (a national registry collects data at a national level).
The aims of the registry are, firstly, to facilitate recalling patients in case of implantable devices’ failures and, secondly, to analyse collected data for statistics and survival analysis, to measure how long an implant lasts. These analyses are a very powerful tool for early detection of any problems which, otherwise, could compromise patient’s health.
RIPI will allow, as in other countries, to have an efficient tool for patients’ health protection. In fact, with the data produced by the Registry it will be possible to support the Ministry of Health in its surveillance and supervision activities on medical devices. Furthermore, the results of the survival analysis will be a useful reference for manufacturers to monitor the quality of their products, allowing them to participate in the prostheses’ international benchmarking, contributing to the early reporting of any adverse events.
RIPI is organized as a cross coordination structure of individual registries of implantable devices divided by subject: