The recent scientific article “Validation of CORE-MD PMS Support Tool: A Novel Strategy for Aggregating Information from Notices of Failures to Support Medical Devices’ Post-Market Surveillance” discusses the validation of a support tool called CORE-MD PMS. The tool is designed to aggregate public information from national authority websites about notices of failures (NoF) of medical devices (MD) in order to support post-market surveillance (PMS). The study aimed to validate this tool, developed by the group of Prof. Caiani at Politecnico di Milano, by comparing its results with manual analysis of the same information. The results showed that the tool was effective in accurately categorizing the information, re-attributing to each MD the proper MD category, based on the European Medical Device Nomenclature (EMDN), as a first step to data aggregation, thus demonstrating its potential usefulness in supporting post-market surveillance of medical devices.
The article provides valuable insights into the field of medical device post-market surveillance (PMS). PMS is a critical process for monitoring the performance of medical devices once they are in use by patients, and the CORE-MD PMS Support Tool offers a new approach to collecting and analyzing data aggregated for categories of MD to support PMS activities, as well as the activity of the Expert Panels in the process of certification of new MD.
The tool is based on Natural Language Processing techniques to cope with possible information incompleteness in order to assign the proper EMDN code, and its graphical interface is designed to be user-friendly and accessible to a wide range of stakeholders, including MD manufacturers, regulators, and healthcare providers. It was initially tested on data from the Italian Ministry of Health, relevant to the Italian market of MD, thus providing a first positive demonstration of the underlying framework.
In conclusion, the “Validation of CORE-MD PMS Support Tool” article provides important contributions to the field of medical device PMS. The CORE-MD PMS Support Tool offers a novel strategy for aggregating information from notices of failures to support PMS activities, and its validation study demonstrates its effectiveness and potential to enhance the efficiency and effectiveness of Post-market surveillance.
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