在美国的指定设施中实施脊髓灰质炎病毒制,2017-2024年
Christy Ottendorfer1, Patrick Vander Kelen1, Cecelia A Sanders1
1Centers for Disease Control and Prevention, Office of Readiness and Response, U.S. National Authority for Containment of Poliovirus, Atlanta, GA 30329, USA.
Pathogens (Basel, Switzerland)
|December 31, 2025
概括
有效制脊髓灰质炎病毒对于全球根除至关重要. 美国国家控制局 (NAC) 发现了改进,但发现了主要保障措施的漏洞,阻止了指定设施的全面认证.
科学领域:
- 公共卫生 公共卫生
- 传染病控制和控制传染病
- 生物安全是生物安全.
背景情况:
- 全球野生脊髓灰质炎病毒的根除需要强有力的制措施来防止重新引入.
- 美国成立了国家控制局 (NAC) 管理脊髓灰质炎病毒材料和设施监督.
- 指定设施需要初级,二级和三级安全措施来进行封闭认证.
研究的目的:
- 评估美国脊髓灰质炎病毒制措施的有效性.
- 评估设施是否符合国家封闭标准.
- 识别初级保障实施中的差距.
主要方法:
- 国家审计委员会在2017年至2024年期间进行了16次审计 (差距评估,第一阶段,第二阶段).
- 审计遵循ISO基于风险的过程进行初级保障评估.
- 使用标准化工具收集数据,并使用SAS和R软件进行分析.
主要成果:
- 在所有审计类别 (p < 0.0001) 中,对制标准的整体符合性得到改善.
- 2024年的审计显示,在风险评估,个人防护设备,事故/事故程序和消毒方面存在持续的缺陷.
- 设施显示符合二级和三级保护措施,但与主要封闭元件扎.
结论:
- 虽然制工作取得了进展,但主要保障措施的缺陷阻碍了美国指定的脊髓灰质炎设施的全面认证.
- 持续改进风险评估和程序要素对于实现完全制至关重要.
- 保持无脊髓灰质炎状态需要持续保持警,并遵守严格的制协议.
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