OBJECTIVES : The global investigation known as “Implant Files” has recently reignited the debate on how medical devices (MDs) are approved, marketed and monitored. This study maps MDs recalls occurred in Italy from 2009 till 2018, with the specific aims of understanding i) what is the median time-on-market and how risk-class and MD category impact on this variable, ii) what is the prevalence of recalls by MD category.

METHODS : A database of recalls was manually created based on publicly available Field Safety Notices (FSN) between 2009 and 2018. Additional information was derived via cross-link with the National MD repertoire (BD/RDM). Kaplan-Maier curves were drawn to estimate the mean and median time since registration in the BD/RDM till recall for different risk classes and MD category according to National Device Classification (CND). Prevalence of recalls by CND category was derived together with Clopper-Pearson confidence intervals for small proportions.

RESULTS : Overall, 1445 FSNs were issued over the observed time period, corresponding to 3725 MDs recalled from the market, of which 1666 (45%) in Risk Class III, 827 (22%) in IIb, 999 (27%) in IIa and the remainder in Class I. More than 42% of these recalls were in CND category P (implantable prosthetic devices and osteosynthesis products). Together with CND category C (device for cardiovascular system), these make 64.5% of all recalls. Overall, mean survival time is 4.7 years and median survival time is 3.7 years across MD classes. There is evidence of higher survival time for higher risk classes (p<0.0001) and difference across CND categories (p<0.0001). The highest prevalence of recalls was 0.018 (95% CI: 0.017 to 0.019) in CND category C.

CONCLUSIONS : These findings provide useful evidence to inform the debate on the post-marketing surveillance, total product life-cycle management and upcoming MD Regulation that will enter into force in 2020.