Qualitative Application of Operation and Support Hazard Analysis for Syringe Infusion Pumps

In this paper, we provide a qualitative analysis with an experimental viewpoint for the Operation and Support Hazard Analysis O&SHA process applied to syringe infusion pumps as a cheap and accurate way of contributing with the mitigation of the safety problem in these devices. The proposed model takes as quality criteria the compliance within safety requirements defined by the Foods and Drugs Administration FDA initiative Generic Patient Controlled Analgesia Pump GPCA. We apply the results directly to the assessment of syringe infusion pumps available on the market and for improving new solutions under development in the NUTES project.