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N95 呼吸器/外科口罩超过制造商规定的保质期进行库存放行:法国的经验。

Stockpiled N95 respirator/surgical mask release beyond manufacturer-designated shelf-life: a French experience.

机构信息

Service Central de la Qualité et de l'Information Pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Marseille, France; Aix-Marseille Université, CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Equipe de Pharmaco-Chimie Radicalaire, Marseille, France.

Service Central de la Qualité et de l'Information Pharmaceutiques (SCQIP), Pharmacy Department, AP-HM, Marseille, France; Aix-Marseille Université, CNRS, Institut de Chimie Radicalaire ICR, UMR 7273, Equipe de Pharmaco-Chimie Radicalaire, Marseille, France.

出版信息

J Hosp Infect. 2020 Oct;106(2):258-263. doi: 10.1016/j.jhin.2020.07.032. Epub 2020 Aug 1.

Abstract

BACKGROUND

To reduce the shortage of N95 respirators and surgical masks during the COVID-19 pandemic, stockpiled equipment beyond its expiry date could be released.

AIM

Centralized testing of batches of expired surgical masks and N95 for safe distribution to hospital departments saving users time.

METHODS

Tests of compliance with health authority directives were developed and carried out on 175 batches of N95 masks and 31 batches of surgical masks from 12 March 2020 to 16 April 2020. Five quality-control tests were performed on batch samples to check: packaging integrity, mask appearance, breaking strength of elastic ties and strength of nose clip test, and face-fit.

FINDINGS

Forty-nine per cent of FFP2 mask batches were compliant with directives, 32% of batches were compliant but with some concerns and 19% of batches were non-compliant. For surgical masks, 58% of batches were compliant, 39% of batches compliant but with concerns and 3% of batches were non-compliant.

CONCLUSION

The main areas of non-compliance were the breaking strength of the elastic ties and the nose clip but these alone were not considered to make the masks unacceptable. Only mask appearance and face-fit results were decisive non-compliance criteria.

摘要

背景

为了减少 COVID-19 大流行期间 N95 口罩和外科口罩的短缺,可以释放超出保质期的库存设备。

目的

集中测试过期外科口罩和 N95 的批次,以安全分发给医院科室,为使用者节省时间。

方法

开发并于 2020 年 3 月 12 日至 2020 年 4 月 16 日期间对 175 批 N95 口罩和 31 批外科口罩进行了符合卫生当局指令的测试。对批次样品进行了五项质量控制测试,以检查:包装完整性、口罩外观、弹性系带的断裂强度和鼻夹测试强度以及面部贴合度。

结果

49%的 FFP2 口罩批次符合指令要求,32%的批次符合要求,但存在一些问题,19%的批次不符合要求。对于外科口罩,58%的批次符合要求,39%的批次符合要求,但存在问题,3%的批次不符合要求。

结论

主要的不合规领域是弹性系带和鼻夹的断裂强度,但仅凭这些并不认为口罩不可接受。只有口罩外观和面部贴合度的结果才是决定性的不合规标准。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4c58/7395218/9707854042b2/gr1_lrg.jpg

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