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目的运用行业标准YY/T0316-2008中有关风险分析的基本概念及医疗器械产品相关风险的基本评价方法和评估手段,分析持续气道正压通气机产品的安全性特征和主要危害,探讨产品设计开发和上市准入时的风险关注点及控制措施。方法依据行业标准YY/T0316-2008附录C中与产品有关的安全性特征判定表以及附录E中危害、可预见的事件序列和危害处境判断表,逐一分析持续气道正压通气机产品所具有的安全性特征和主要危害,从技术审评角度对该类产品设计开发和上市准入时应考虑并采取的风险控制措施提出建议。结果该类产品不用于生命支持,但考虑其主要用于家庭使用且为长期使用,产品的工作压力、通气量等性能指标的准确性、稳定性及受干扰后的恢复性能和仪器内部压力、温度等监控系统的可靠性等都会影响到产品的安全性、有效性及产品的整体性能,该类产品仍属于中度风险类产品。结论在产品的设计开发以及技术审评过程中都应关注和识别产品的主要风险点,可采取改进设计获取固有安全性、在产品结构中增加防护措施以及将剩余风险和警示说明等安全性信息在用户手册中充分说明等各种方式规避风险。
Objective To analyze the safety characteristics and main hazards of continuous positive airway pressure positive airway ventilator by using the basic concepts of risk analysis and the basic evaluation methods and evaluation methods of the related risks of medical equipment products in industry standard YY / T0316-2008, and to discuss the product design Risks and control measures in the development and listing of access. Methods According to the industry-standard YY / T0316-2008 Appendix C product-related safety characteristics of the decision table and Appendix E of the hazard, the sequence of events and hazardous situation judgment table, one by one continuous positive airway pressure ventilator products have The safety features and major hazards from the technical review point of view of such products in the design and development and listing access should take into account and take risk control measures to make recommendations. The results of such products are not used for life support, but considering its mainly for domestic use and for long-term use, product pressure, ventilation and other performance indicators of accuracy, stability and interference after the recovery performance and pressure inside the instrument, Temperature and other monitoring system reliability will affect the product’s safety, effectiveness and overall product performance, these products are still classified as moderate risk products. Conclusions The main risk points of products should be paid attention to and identified in the process of product design and development and technical review. Improved design can be adopted to acquire intrinsic safety, protective measures can be added to the product structure, and safety information such as residual risk and warning instructions In the user manual full description and other ways to avoid risks.