Models and methods of failure analysis and risk assessment during medical treatment

BACKGROUND: Medical risks are all unsafe events or that damage to the patient during medical services. Present medical risk management is mainly qualitative experience, and lacks of regular failure analysis and risk assessment for established medical treatment. OBJECTIVE: To construct models of medical process failure analysis and risk assessment, find possible risks during medical treatment, and propose effective measures to eliminate or decrease above risks. METHODS: Failure mode and effects analysis during reliability engineering were used in production. That was, risk assessment was conducted in the possible technical failure modes, causes and all impacts on the product during each process. Improvement measures were made for weak link during the process. The risk could reach an acceptable level. In accordance with failure mode and effects analysis during production, the procedure of medical process failure analysis and risk assessment could be made to analyze the potential failures during medical treatment. Moreover, the improvement measures were proposed for weak link with high risks so as to prevent the occurrence of risk of significant adverse effects on patients. RESULTS AND CONCLUSION: The methods and basic procedures of medical process failure analysis and risk assessment were established by using the experience of failure mode and effects analysis. Taking the rescue process of myocardial infarction in the emergency of a hospital as an example, the analysis of failures, reasons and impacts was performed taking “chewing 300 mg aspirin” in the rescue steps as a key. The improvement measures and suggestions were proposed for unacceptable failures and reasons. Seen from the analysis results, proposed improvement measures and suggestions can obviously decrease the risks of failures caused by this step to patients. Therefore, the application of failure mode and effects analysis in medical treatment has a strong practical value.