National adverse event reporting for medical devices in Israel, 2013-2024.

Abstract

Background: Post-market surveillance systems are essential for identifying medical device-related adverse events and ensuring patient safety. In Israel, the Ministry of Health has operated a national medical device reporting system for decades. The system is modeled on United States and European regulatory frameworks, although the Medical Devices Act has not yet entered into force.

Methods: Following formal approval, anonymized aggregate data were obtained from the Ministry of Health Medical Device Division for reports submitted between 2013 and 2024. The dataset included annual reporting volumes, report classification as adverse events or Field Safety Notices, reporting source, and event type (death, injury, or malfunction), where available. Availability varied across the study period; analyses were therefore restricted to years in which the relevant variables were recorded.

Results: Overall reporting volumes increased over time, from 406 in 2013 to 874 in 2024. Non-linear trends were observed, with declines in 2017, 2020, 2022, and 2024. Since 2019, adverse events accounted for approximately 61.9-75.5% of reports annually, while Field Safety Notices comprised 21.4-33.3%. From 2022 onward, most adverse events were classified as injuries, increasing from 87.1% in 2022 to 89.8% in 2023 and remaining high at 89.1% in 2024. Malfunctions accounted for 10.3% of adverse events in 2022, 7.9% in 2023, and 8.5% in 2024, whereas deaths remained relatively stable at 2.2-2.5%. Reporting was dominated by registration holders (70-80%), primarily importers and distributors, followed by manufacturers, with consistently limited contributions from healthcare institutions and voluntary reporters.

Conclusions: This analysis of Israel's national medical device reporting database provides an empirical baseline for assessing the structure and functioning of the country's post-market surveillance system. Increasing reporting activity and improved event classification indicate system maturation. The predominance of reports from registration holders, alongside more limited participation by healthcare institutions and voluntary reporters, points to areas for continued development. The following measures would strengthen post-market surveillance in Israel: full implementation of the legal framework; clearer reporting responsibilities and pathways: targeted guidance and training; electronic reporting and analytical tools; improved event documentation; and structured feedback and transparency mechanisms.