Overview of Failure Mode and Effects Analysis (FMEA): A Patient Safety Tool.

Patient safety has become a strategic pillar in healthcare organizations, requiring significant resources to avoid accidents during the hospital stay. Patient care processes are documented precisely in detailed policy and procedure manuals. The expectation has been that competent healthcare providers, acting per defined policies and procedures, will create a safe environment for patients. This expectation, although laudable, has proven to be unrealistic. Safety studies in healthcare and other socio-technological industries have repeatedly demonstrated that human error is the cause of many accidents in complex systems. Because the error is inherent to human nature, its consequences must be minimized. Healthcare may create risks, and patient safety is the most important care quality objective. The importance of patient safety, or protecting patients from harm incurred in medical care, is a topic of much discussion, which has been demonstrated in various international and national publications since the late 1990s. Most reporting systems concentrate on analyzing adverse events; this means that injury has already occurred. More progressive systems also concentrate on analyzing close calls, which facilitates learning from an event that did not result in injury or harm to a patient. Systems also permit proactive evaluation of vulnerabilities before close calls occur.