基于灾害脆弱性分析构建医疗设备风险评估体系

摘要

目的:探讨灾害脆弱性分析(HVA)在医疗设备风险评估中的应用.方法:对医疗设备风险评估工具进行改革,突出事故后果严重性的风险、加入内部缓解措施等因素,制定故障风险、发生频率、临床功能、对业务的影响、预防性维护作用、异常事件临床响应、异常事件设备科响应以及应急响应8个维度的量化评估指标体系,对瑞安市人民医院医疗设备进行风险分析调查.根据设备的风险水平进一步改进技术保障措施,同时监控风险控制的有效性.结果:2015年处于50%以上重大风险的设备有除颤仪(占50%)、婴儿暖箱(占54%)、人工心肺机(占57%)、血液透析机(占54%)、呼吸机(占54%)、微量注射泵(占50%)和保暖台(占54%)7类设备.通过改进风险控制措施,2016年对7类设备的风险评估结果表明,重大风险设备减少到仅为血液透析机与人工心肺机两类.结论:风险评估不仅有助于制定设备的维护周期,更可针对风险点开展技术培训及演习;定期对风险评估进行调整,增进质量管理,确保医疗安全.%Objective:To explore the application of hazard vulnerability analysis(HVA) on the risk assessment system of medical equipment.Methods: The risk assessment tool was reformed, the risk of the severity for accident consequence was emphasized, and joined in the interior relieved measurement and so on. And drawn up quantifiable evaluation criteria, and then to investigate and analyze the medical equipment of Rui'an people's hospital by using HVA.Results: The risk assessment survey indicated that the equipments with more than 50% major risk were, respectively, defibrillator(50%), infant incubator(54%), the heart-lung machine(57%), hemodialysis machine(54%), ventilator(54%), trace injection pump(50%) and warm platform (54%).Conclusion: Risk assessment not only can determine maintenance period of equipment, but also can improve the risk have been found. To carry out exercises and training for risk point, and adjust the risk assessment on regular intervals so as to ensure medical safety.