含天然胶乳医疗器械产品的过敏风险管控策略

Strategy of allergy risk management and control for products of medical devices with NRL

目的:基于控制含天然胶乳医疗器械产品的过敏风险,探讨监管过敏风险管控策略。方法:回顾疏理美国和欧盟对含天然胶乳医疗器械产品引发过敏风险的研究思路和监管措施,结合我国此类产品的现状和监管要求,疏理我国已颁布的相应国家标准和行业标准等指导文件,以及目前含天然胶乳医疗器械种类多样、风险等级和致敏原暴露存在较大差异等情况。结果:通过加强标准修订、制定相关指导原则和细化产品说明书与标签要求3方面完善,并为天然胶乳材料上市前的管理类别、原材料状态、适用范围及生产工艺等9方面提出合理化建议,管控含天然胶乳医疗器械产品的过敏风险。结论:含天然胶乳医疗器械产品容易引发过敏反应,合理的管控有助于降低过敏风险。

Objective: To investigate strategy of supervising management and control of allergy risk based on controlling allergy risk of products of medical devices with natural rubber latex (NRL). Methods: By retrospectively sorted the research strategies and supervising measures for allergy risk caused by NRL of medical devices in the United States and European Union, and combined with the current situation and supervising requirement of this kind of products in China, the issued guidance document included corresponding national standards and industrial standards of our country were sorted further. And the current situations of medical devices with NRL included various species, the existing larger differences in risk grade and sensitinogen exposure and so on were also sorted. Results: The management can be improved from the following three areas: 1. Enhanced standards revising, 2. Formulated relevant guidance principle of risk management of medical devices with NRL, 3. Refined product description and labeling statements so as to reduce residual risk. Besides, the rational suggestions about 9 aspects included management class, the situation of raw material, the range of application and manufacturing technique and others before the products with NRL went into market were provided. And the allergy risks of medical devices with NRL were further managed and controlled. Conclusion: The products of medical devices contained NRL are prone to cause allergic reactions. Reasonable measurement of management and control can contribute to reduce the risk of allergies.