FMEA in preventing medical accidents

摘要

A management system capable of fostering quality improvement in an organization such as a health-systems pharmacy must have a firm foundation. A firm foundation consists of consistent policies, procedures and processes and their documentation. An organization must understand how these activities are carried out in the present reality in order to improve them to create a new, improved future reality. ISO 9001:2000 provides guidance for the creation of a firm foundation of a high quality management system, itself capable of fostering quality improvement throughout the organization. One of the processes operating in healthcare delivery systems is that of medicating. Reducing medication errors is one of our nation's current hot topics and will require healthcare delivery systems to document and then improve those processes that allow such errors to occur. Medication errors or accidents represent a subset of adverse drug affects and account for more than 10% of medical errors. Humans have a propensity to commit errors; medication accidents occur when errors occur and latent system faults are present. Much has been written and reported on the causes of and most effective ways to prevent medication errors. Despite this wealth of research, medication errors continue to plague healthcare systems. Methods to error proof critical processes in ordering, preparing, dispensing and administrating medications have themselves been subject to error. Manufacturing, aerospace, chemical and other industries have been successful in error proofing their processes and creating workplace safety. A specific tool to achieve comprehensive and rapid improvement in safety in non-healthcare industries has been the application of Failure Modes and Effects Analysis, sometimes referred to as Failure Mode Effects and Criticality Analysis. This tool is commonly known as FMEA. FMEA examines all potential causes or modes of failure, of critical processes and of methods designed to prevent failure of those processes. Each mode is studied for potential effects. Three measures are made of each mode and effect: severity, ease of detection and rate of occurrence. The resulting Criticality Scores can be used to identify those modes most in need of further error proofing and, when tracked, serve as proxies of effectiveness of medication error prevention. FMEA provides health-system pharmacies an opportunity to apply and study a manufacturing industry tool in the prevention of medication errors.