Hidden Errors in IVF: From Reported Incidents to Electronic Witnessing and Proactive Risk Detection

Abstract

Background: Errors involving gametes and embryos are uncommon but can have irreversible clinical, psychological, ethical, and legal consequences. Conventional incident reporting captures only events that are recognized and reported, whereas electronic witnessing systems (EWS) can also reveal mismatch conditions and near misses during routine laboratory work. To review the spectrum of reported IVF laboratory errors and non-conformances, summarize published data generated by IVF laboratories using electronic witnessing and structured risk-analysis systems, and examine how automation can shift safety practice from retrospective incident review toward prospective risk detection.

Methods: Narrative review of peer-reviewed studies, contemporary professional guidance, and regulatory data addressing IVF laboratory non-conformances, traceability, witnessing, mismatch events, and electronic witnessing. No unpublished or institution-specific data are included.

Results: In a 12-year Boston IVF series, 360 graded andrology/embryology non-conformances were identified across 36,654 cycles and at least 181,899 laboratory procedures; moderate and significant non-conformances together occurred in 0.23% of cycles and 0.045% of procedures, with no major events. A 10-year Brussels IVF EWS analysis included 109,655 cycles and 849,650 witnessing points: 2,132 mismatches (0.251% per witnessing point), including 144 critical mis-matches, with a yearly mean critical mismatch rate of 0.017%. At Fertility North, 73,719 witnessing points from 11,210 cycles yielded 138 mismatches (0.19%) and 16 critical mismatches (0.02%); risk varied by time of day, procedure, and operator. FMEA studies show that structured traceability and EWS implementation can substantially reduce modeled mismatch risk. UK HFEA data for 2024/25 recorded 792 reported incidents across more than 100,000 cycles and 68 near misses, while more than 99% of cycles were completed without a reported incident.

Conclusion: Serious IVF identification errors are rare, but measurable upstream mismatch conditions persist even in mature laboratories. EWS should be viewed not merely as a substitute for manual double witnessing but as a real-time safety barrier, a source of near-miss intelligence and a component of a broader quality-management system.