Background: Recent safety issues involving medical devices have highlighted the need for better safety surveillance of medical devices. Proactive approaches are becoming more necessary as regulators increase the scrutiny of device safety. This thesis aims to describe the current safety system of medical devices, and how it may be enhanced from a technical and a regulatory perspective. Methods: We used literature reviews and descriptive analysis of FDA MAUDE data to discuss the following topics associated with safety surveillance of medical devices: identification of key data sources, challenges associated with the process and recommendations to address them, new safety evaluation tools, proposal to improve safety signal detection, and potential applications of blockchain technology. Results: Completeness and standardization of the collected safety data for medical devices can be improved. Certain features of the drug safety surveillance process could, if adopted and adapted for medical devices, address some of the current challenges and lead to a more proactive surveillance system. One of the new safety surveillance tools for medical devices is the PMS plan. It is our suggestion that the PMS plan should consist of a PMS plan Core and a PMS plan Supplement. The PMS plan Core document will describe the PMS system, and the PMS plan Supplement will outline the specific activities performed by the manufacturer for a particular medical device. A modular approach to structure the contents of the PMS plan will help to consistently update other PMS information. Data source harmonization, the development of gold standard signal detection methodologies and the standardization of coding dictionaries are amongst the recommendations to support the implementation of a new proactive approach to safety surveillance. This new approach can be supported by a secured PMS data permissioned blockchain with a proof-of-authority consensus mechanism. Blockchain has the potential to support the establishment of a more proactive safety surveillance system that could allow real time identification of safety issues, and address some of the challenges associated with safety surveillance of medical devices. Conclusions: There is a need for regulatory and technical standardization that, together with the creation of big PMS distributed data networks, will support the early detection of potential safety issues associated with medical devices.

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M.C.J.M. Sturkenboom (Miriam)
Erasmus University Rotterdam
Department of Medical Informatics

Pané Salvadó, J.M. (2021, December 14). Recommendations for the safety surveillance of medical devices. Erasmus University Rotterdam. Retrieved from