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骨科植入物产品在流程和使用过程中的质量可控性是患者正常康复的重要环节和保障,对于产品质量的可追溯性管理和抽验是药品监管部门监督执法的一种重要手段。以北京市平谷区为例,近几年医疗机构在规模和业务水平上有了很大提升,药品监督管理部门如何加强对此类产品的有效监管,确保产品使用过程中的安全有效值得探讨。本文通过对辖区内医疗机构进行深入调研分析,为如何针对高风险骨科植入物产品的监管方式提供新思路。
The quality control of the orthopedic implants during the process and use of the orthopedic implants is an important link and guarantee for the normal rehabilitation of the patients. The traceability management and sampling of product quality are an important measure for supervising and enforcing the law by the drug regulators. Take Pinggu District of Beijing as an example. In recent years, medical institutions have greatly improved in terms of scale and operational level. How the drug regulatory authorities can strengthen the effective supervision of such products and ensure the safe and effective use of the products is worth discussing. This article through the area of medical institutions in-depth investigation and analysis of how to provide high-risk orthopedic implant products to provide new ways of regulation.