Original Title: État des connaissances - Modalités de suivi des dispositifs médicaux implantables

Authors' objectives: Implantable medical devices (IMDs) are commonly used to manage a variety of medical conditions, but the risks associated with their use can be serious. The Ministère de la Santé et des Services sociaux (MSSS) mandated INESSS to produce a state-of-knowledge report on existing IMD tracking methods in order to inform potential modalities for instituting a tracking strategy in Québec.

Authors' results and conclusions: RESULTS: Three monitoring objectives emerged from the analysis and structure this report: traceability, surveillance and evaluation. First, traceability refers to the ability to track a device from its site of manufacture to its implantation in a patient and, if applicable, to its removal. Generally, few data are required to set up a traceability system, and the development of the unique device identifier (UDI) in some countries has been recognized as a facilitator for optimizing tracking systems. Second, postapproval or postcommercial surveillance of devices involves gathering and analyzing safety data in real-world contexts to identify any noncompliance issues or defective devices. To this end, there are so-called reactive materiovigilance mechanisms, which rely on the voluntary reporting of incidents by different stakeholders. Other, more proactive methods, such as targeted observational studies and the automated detection of safety signals, are also being explored in several countries. Lastly, evaluation in real-world contexts allows for continuous improvement in the quality of care and practices and supports decisionmaking regarding access to public coverage for the devices under evaluation. Registries and real-world evidence studies are generally used to support evaluation in clinical contexts. Operationalizing these objectives involves several considerations, some of which are common to several methods. They are grouped into five categories: management, governance and organization; data collection, oversight and security; technological and technical aspects; stakeholder participation; and ethical and legal aspects. CONCLUSION: This state-of-knowledge report identifies three main IMD tracking objectives and associated methods in Canada and abroad and draws out certain lessons that can guide decision-making in Québec. Determining the desired objective for a tracking system through consultative processes appears to be an essential preliminary step. Moreover, defining information needs early in the process enables decision-makers to develop and implement relevant methods, whose benefits would be proportional to the investment in terms of time and resources.

Authors' methods: The methodology is centred on a review of the scientific and grey literature to answer two main assessment questions concerning 1) the types of tracking systems currently in operation in Canada and elsewhere in the world, and 2) the operational and ethical considerations affecting the implementation of these systems. The state-of-knowledge report gives an overview of existing systems for information purposes only and does not suggest any recommendations as to which tracking method is best suited for Quebec.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/modalites-de-suivi-des-dispositifs-medicaux-implantables.html

Year Published: 2023

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/modalites-de-suivi-des-dispositifs-medicaux-implantables.html

English language abstract: An English language summary is available

Publication Type: Other

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: L'Institut national d'excellence en sante et en services sociaux (INESSS)