Prospective Failure Mode and Effects Analysis to Support Implementation Readiness for a New Hyperbaric Oxygen Therapy...

Launching a clinical service is a vulnerable phase in which latent risks may emerge before care processes stabilize. Hyperbaric oxygen therapy (HBOT) is a high-risk, technology-intensive service requiring infrastructure, equipment control, procedures, emergency preparedness, and cross-departmental coordination. The role of failure mode and effects analysis (FMEA) in supporting pre-launch implementation readiness has been less clearly described.

The authors conducted a prospective, multidisciplinary patient safety improvement project during pre-implementation of a hospital-based HBOT service in northern Israel. FMEA linked risk identification with mitigation planning, accountability, operational controls, readiness activities, and early post-launch review.

The FMEA mapped 13 process stages and identified 114 failure modes. High-priority risks extended beyond in-chamber treatment to maintenance, patient preparation and transfer, discharge planning, equipment control, and fire and electrical safety. The highest risk priority number (RPN) was 504 for use of a non-approved external electrical device; RPNs were prioritization aids rather than precise risk estimates. Of the 10 highest-priority failure modes, mitigation actions for 7 were implemented before launch, while 3 underwent additional reinforcement during early follow-up. All core launch-facing staff completed preparation, and three operational checklists were deployed. By February 2026, 347 treatment sessions had been completed, with no patient harm events identified in the reviewed top-risk categories. This was treated as an early operational observation, not evidence of reduced harm.

Prospective multidisciplinary FMEA helped structure implementation readiness by linking risk identification with mitigation ownership, operational controls, readiness review, and early post-launch learning. This single-center project did not evaluate whether FMEA reduced patient harm or improved clinical outcomes. FMEA or a comparable prospective hazard-assessment method may be considered in pre-launch planning for selected high-risk clinical services.