Prospective risk analysis of health care processes: a systematic evaluation of the use of HFMEA in Dutch health care.

The aim of this study was to evaluate the use of Healthcare Failure Mode and Effect Analysis (HFMEA) in Dutch health care by means of user feedback. Thirteen HFMEA analyses of various health care processes were successfully concluded and on average took 69 person-hours (excluding reporting). These results show that HFMEA can successfully be applied in Dutch health care. However, the user feedback also uncovered several perceived drawbacks, such as the fact that HFMEA is very time-consuming and that, particularly, the risk assessment part of HFMEA is difficult to carry out. Moreover, a lack of guidance with regard to the identification of failure mode causes and effective actions might influence the quality of the outcomes of an HFMEA analysis. Several suggestions are put forward to improve the perceived utility and acceptance of HFMEA. Nevertheless, future research is necessary to evaluate the actual effects of these recommendations. Error modelling and risk analysis, and their contribution to explaining human performance in socio-technical systems, traditionally belong to the field of ergonomics. The user feedback on HFMEA and the suggestions that are put forward may also be useful for (H)FMEA and hazard analysis and critical control point applications in sectors other than health care.