基于YY/T 0316的风险评价矩阵在医疗器械质量监督抽查检验项目中的应用研究

Application of Risk Evaluation Matrix Based on YY/T 0316 in Inspection Items of Medical Device Quality Supervision Sampling

目的:通过对医疗器械监督抽查检验项目进行风险评价并划分风险等级,基于风险的思维开展抽检工作,进一步提升抽检工作的科学性和公正性。方法:基于YY/T 0316-2016《医疗器械风险管理对医疗器械的应用》给出的风险评价矩阵,进一步细化评价医疗器械质量监督抽查检验项目不合格所对应的风险等级。结果与结论:基于YY/T 0316-2016的风险评价矩阵可应用于医疗器械质量监督抽查检验的方案拟定,提升抽检的靶向性,亦可用于评价抽检不合格项目的潜在风险等级,供行政处罚中行使自由裁量权参考使用。

Objective: To further improve the scientifi cness and fairness of the sampling inspection work, the risk assessment and risk classifi cation of the sampling inspection items of medical devices supervision were carried out based on the risk thinking. Methods: Based on the risk evaluation matrix given by YY/T 0316-2016 “Medical Devices--Application of Risk Management to Medical Devices” the risk levels corresponding to unqualified inspection items of medical device quality supervision and random inspection were further refi ned and evaluated.Results and Conclusion: The risk assessment matrix based on YY/T 0316-2016 can be applied to the formulation of the program of random inspection of medical device quality supervision, improve the targeting of random inspection, and could also be used to evaluate the potential risk level of unqualifi ed items in random inspection,which could be used for reference in the exercise of administrative punishment discretion.