| 李晓,张欣涛,郝擎,朱炯,袁瑶.2021年国家医疗器械抽检经营使用环节质量状况分析[J].中国药事,2022,36(12):1369-1376 |
| 2021年国家医疗器械抽检经营使用环节质量状况分析 |
| Analysis on the Quality Status of the Links in the Operation and Use of National Medical Device Supervision and Inspection in 2021 |
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| DOI：10.16153/j.1002-7777.2022.12.006 |
| 中文关键词: 抽检 经营使用环节 质量状况 |
| 英文关键词: supervision and inspection links in the operation and use quality status |
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| 中文摘要: |
| 目的：对医疗器械流通企业及监管措施提出建议，进一步提高医疗器械流通环节质量，保障公众用械安全有效。方法：根据2021年国家医疗器械抽检经营使用环节检验结果，总结医疗器械流通环节质量状况，归纳分析产生问题的原因并提出针对性的建议。结果：2021年国家医疗器械抽检结果显示，多数经营使用环节不合格检出率低于生产环节，但仍发现4个品种的经营使用环节不合格检出率高于生产环节。其中，合成树脂牙经营环节不合格检出率为13.33%；软性接触镜经营环节不合格检出率为 3.13%；手术衣使用环节不合格检出率为18.87%；一次性使用人体静脉血样采集针使用环节不合格检出率为3.57%。不合格原因，一是因运输导致的样品零部件掉落，二是经营使用单位缺乏产品技术认知， 反映出经营使用单位缺乏质量管理意识。结论：建议企业加强主体责任意识，建立全过程的质量管理制度及控制措施，严格控制采购和销售环节的资质审核，确保医疗器械的合法流通，并且主动配合监管部门开展的监管工作。同时，建议监管部门加强监督检查，丰富管理手段，加大法规宣贯力度。 |
| 英文摘要: |
| Objective: To put forward suggestions on medical device circulation enterprisess and supervision measures, so as to further improve the quality of medical device circulation and ensure the safe and eff ective use of medical device. Methods: Based on the inspection results of the links in the operation and use of national medical device sampling inspection in 2021, the quality status of the circulation links of medical device was summarized, and the causes of the problems were summarized and analyzed, and targeted suggestions were put forward. Results: In 2021, the national medical device sampling results showed that the unqualifi ed detection rate of most links in the operation and use was lower than that links in the production, but it was still found that the four varieties of the links in the operation and use were higher than that in the production. Among them, the unqualifi ed detection rates of synthetic resin teeth and soft contact lenses in the links of the operation were 13.33% and 3.13%. The unqualifi ed detection rates of surgical clothing and single-use needles for human venous blood specimen collection in the links of the use were 18.87% and 3.57%. The reasons for the unqualifi ed are as follows: fi rst, due to transportation, the parts and components fell; second, the operating and using enterprises lack product technology awareness, which reflects the weak quality management awareness of the operating and using enterprises. Conclusion: It is suggested that the enterprises should strengthen the awareness of main responsibility, establish the whole process quality management system and control measures, control the qualifi cation audit of procurement and sales strictly, ensure the medical device legitimate circulation, and actively cooperate with the regulatory authorities to carry out the supervision work. At the same time, it is suggested that the regulatory authorities should strengthen supervision and inspection, enrich management means, and enlarge the publicity and implementation of laws and regulations. |
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