Benchmarking failure mode and effects analysis of electronic brachytherapy with data from incident learning systems.

PURPOSE

Failure modes and effects analysis (FMEA) is a prospective risk assessment tool for identifying failure modes in equipment or processes and informing the design of quality control systems. This work aims to benchmark the performance of FMEAs for electronic brachytherapy (eBT) of the skin and for breast by comparing predicted versus actual failure modes reported in multiple incident learning systems (ILS).

METHODS AND MATERIALS

Two public and our institution's internal ILS were queried for Xoft Axxent eBT-related events over 9 years. The failure modes and Risk Priority Numbers (RPNs) were taken from FMEAs previously performed for Xoft eBT of nonmelanoma skin cancer and breast intraoperative radiation therapy (IORT). For each event, the treatment site and primary failure mode was compared with the failure modes and RPNs from that site's FMEA.

RESULTS

49 events involving Xoft eBT were identified. Thirty-one (63.3%) involved breast IORT, and 18 (36.7%) involved the skin. Three events could not be linked to an FMEA failure mode. In 87.7% of events, the primary failure mode ranked in the FMEA top 10 by RPNs. In 83.3% of skin events, the failure modes ranked in the top 10 by RPN or severity. In 90.3% of IORT events, the failure modes ranked within the top 10 by RPN or severity.

CONCLUSIONS

Evaluating FMEA failure modes against ILS data demonstrates that FMEA is effective at predicting failure modes but can be dependent on user experience. ILS data can improve FMEA by identifying potential failure modes and suggesting realistic occurrence, detectability, and severity values.