Methodology to assess medical processes based on a Failure Mode and Effects Analysis (FMEA)

Risk is always present in every activity and several methodologies are often used to reduce or mitigate situations where risk is unacceptable. Founded on this assumption, the present paper has the objective to propose a methodology to assess critical medical processes based on a Failure Mode and Effects Analysis (FMEA), identifying and making a hierarchy of the inherent activities belonging to those processes using a quantified Risk Priority Number (RPN). Thus, based in that knowledge, it is possible to recommend actions with the purpose of lowering risk by acting on the most important failure modes. The methodology proposed will be described for medical processes and all steps to apply the methodology are sufficiently detailed for a broad comprehension in a field where such methodology is not so often applied. An intravenous medication process by infusion pump is analyzed just to demonstrate the applicability of the proposed methodology, reaching to results that are suitable to be considered and evaluated to improve a process that is widely used in hospitals and similar installations. This work brings the opportunity to experts and professional in the field to use the approach proposed for every process where safety is a priority and where undesirable situations must be avoided.