The Fall Out of the 2017 European Medical Device Regulation for Tracheal Occlusion.

Abstract

Objective: The use of the Balt Goldbal-balloon and Baltacci-catheter in Fetoscopic Endoluminal Tracheal Occlusion is affected by the 2017-European Medical Device Regulation, which necessitates recertification even for devices long considered safe. This regulation has led the manufacturer to stop distributing these devices in Europe. We alert fetal surgery centers to these challenges and regulators to the broader impact on the availability of fetal therapy devices in Europe.

Methods: We surveyed 50 fetal surgery centers worldwide and communicated directly with the manufacturer. Additionally, we provide updates on a new device under evaluation.

Results: The response rate among 39 balloon users was 95% (n = 37). Currently, all balloons in Europe are expired. Supply issues exist in Australasia and South-America, with some distributors reporting discontinuation despite the manufacturer's communications on its sustained availability. Some centers manage shortages by importing from other countries. Balt has agreed to supply devices to European centers that obtain derogation by the national competent authorities, for which we cannot provide a generic procedure. An alternative device is unlikely to be marketed before 2026.

Conclusion: This scenario highlights the unintended consequences of stringent medical device regulations, leading to their unavailability for beneficial procedures or complicated administrative processes, even as these devices remain available outside the EU.