OBJECTIVES : Field safety corrective actions (FSCA), communicated through field safety notices (FSN), are actions taken by manufacturers to reduce risk of death or serious deterioration in the state of health associated with use of medical devices (MD) that are already placed on the market. These may include return of the MD to manufacturer or its representative. As the European Medical Device Regulation has tightened up requirements to effectively guarantee safety after marketing, there is a need to identify a methodology to estimate administrative and clinical costs borne by healthcare providers and healthcare systems in case of MDs recalls. The goal of this work was to identify standard methods to use for this purpose.

METHODS : We conducted a review of scientific literature and court sentences. We interviewed Italian regional and hospital MDs vigilance managers asking (i) how FSCA are managed and FSN are collected by public providers; (ii) how the various actors (competent authority, regions, healthcare providers, and manufacturers) communicate and share information; (iii) whether, and according to which methodologies, expenses incurred by providers, as a consequence of MDs recalls, are estimated and refunded.

RESULTS : MDs post-marketing surveillance appeared as fragmented across the country, with Northern regions characterized by higher maturity and capacity of implementing best practices to manage FSN. All respondents, instead, underlined a weak attitude to report adverse events by physicians due to scarce culture of FSN. No standardized methods to deal with FSCA legal and economic implications have been identified in the literature or in the jurisprudence. Italian regions and hospitals have never quantified the amount of administrative costs related to MDs recalls nor developed a structured methodology to estimate them.

CONCLUSIONS : A theoretical framework, based on time-driven activity-based costing, to estimate costs related to MDs recalls is under development. Empirical analyses, collaboration among stakeholders and training of healthcare professionals are warranted.