重庆市场医疗设备应对公共卫生事件的能力

Ziyue Sheng
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引用次数: 0

摘要

背景与目的:从此次新冠肺炎疫情中可以发现,现有的制度还不能满足公共卫生等突发事件的需要。有必要从法律法规层面做好药品和医疗器械可及性的制度储备。这需要进行梳理,实现无障碍通行。要完善现有法规制度,满足公共卫生等突发事件中医疗器械使用的需要。然而,由于研发和检验周期长、适用标准广、生产能力不足、审查程序繁琐等因素,医疗器械不能完全满足临床需求。在突发公共卫生事件中,作为辅助或直接治疗的医疗器械起着至关重要的作用,发挥着不可或缺的作用。因此,医疗器械能否安全有效地发挥作用成为决定性原则。通过对 2022 年突发公共卫生事件中的特定医疗器械进行程序性检测,可以更加清晰直观地分析此类医疗器械的合格状况,以及不合格医疗器械存在的具体问题,并根据获得的数据对这些医疗器械在此期间的使用情况进行分析:采用中国国家标准对 8 起公共卫生事件中使用的医疗器械进行安全性检测:结果:87%的样品符合国家标准并通过检验:结论:法律法规有待完善,监管存在隐患,监管队伍能力有待提高,医疗器械企业存在问题,医疗器械应严格遵循国家标准,公众应积极参与医疗器械监管。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Capabilities of Medical Equipment to Response in Public Health Events at Chongqing Market
Background and Aim: From this new crown pneumonia epidemic, it can be found that the existing system is still unable to meet the needs of emergencies such as public health. It is necessary to do a good job of system reserves for the accessibility of drugs and medical devices from the level of laws and regulations. This needs to be sorted out to achieve accessibility. The existing regulations and systems should be improved to meet the needs of medical device use in public health and other emergencies. However, medical devices cannot fully meet clinical needs due to factors such as long research and development and inspection cycles, wide applicable standards, insufficient production capacity, and cumbersome review processes. In public health emergencies, medical devices that serve as auxiliary or direct treatment play a crucial role and play an indispensable role. Therefore, whether medical devices can function safely and effectively has become a determining principle. By conducting procedural testing on a specific medical device in public health emergencies in 2022, the qualification status of such medical devices can be more clearly and intuitively analyzed, And the specific problems with unqualified medical devices, and these medical devices during this period based on the obtained data. Materials and Methods: Safety testing of medical devices used in 8 public health events using Chinese national standards Results: 87% of the samples meet national standards and pass the inspection Conclusion: Laws and regulations need to be improved, there are hidden dangers in regulation, the ability of regulatory teams needs to be improved, medical device enterprises have problems, medical devices should strictly follow national standards, and the public should actively participate in medical device regulation
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