FDA发出呼吁

生产更多的防护用品包括鞋盔罩

本文摘译自MASSDEVICE 2020年5月26日评论

以下为详文

因为全国冠状病毒大流行的蔓延，FDA发出呼吁，要求制造商生产更多的非手术服和其他个人防护用品(PPE)。

MASSDEVICE截图

周五发布的紧急使用授权还列出了导电鞋及鞋套、手术室鞋及鞋套、手术头盔和帽子以及其他手术配件。

FDA表示，它发布EUA，是为了回应医务人员用的手术服和其他医护服的短缺顾虑。在本月初，医疗卫生机构就已经告知了，一些分销商可能是基于卫生系统以前的使用情况而不是按计划用途来分配PPE的。

PPE的短缺，促使《柳叶刀》最近发表了一篇文章，这篇文章是根据GetUsPPE的研究撰写的，GetUsPPE是一个在COVID-19大流行期间把医务人员与PPE的供应连接起来的志愿者机构。

THELANCET截图

该文章表示，通过GetUsPPE提出申请PPE的6169家医院、医疗卫生机构和其他机构(包括疗养院)中，大多数需求N95防护口罩(74%)、外科口罩(64%)、防护服(61%)和面罩(60%)。

大都市地区的申请数占了5416(88%)，县区的申请数占了3990(65%)。数据显示，PPE 可获得性和收入水平之间存在显著差异。

在申请PPE的设施类型列表中，医院居首位，占27%；门诊部占15%；熟练护理设施占9%。南部提出的设施申请为最多，占32%；西部次之，为26%；东北部为23%；中西部为16%。

GetUsPPE机构呼吁要大幅增长PPE制造业。

本月初，FDA发布了手术服的保护策略，包括：

◤可重复使用的手术服，而不用一次性的、单次性使用的手术服；

◤无菌手术隔离服，用于中等至高污染风险的手术/侵入性手术；

◤非无菌手术服；

◤隔离服，用于疑似或确诊感染COVID-19的患者提供常规护理。

---

原文：

FDA signals PPE shortage, issues EUA for more

MAY 26, 2020 BY NANCY CROTTI LEAVE A COMMENT

The FDA has issued a call for manufacturers to produce more non-surgical gowns and other personal protective equipment (PPE) as the coronavirus pandemic makes its way across the country.

The emergency use authorization issued Friday also listed conductive shoes and shoe covers, operating room shoes and shoe covers, surgical helmets and caps and other surgical accessories.

The FDA said it issued the EUA in response to concerns about shortages of gowns and other apparel for use by healthcare personnel. Earlier this month, the agency said that healthcare organizations had informed the agency that some distributors may be allocating PPE basing on a health system’s previous use rather than its projected use.

Shortages of PPE prompted a recent article in The Lancet, based on a study by GetUsPPE, a volunteer organization connecting healthcare providers with supplies of PPE during the COVID-19 pandemic.

That study showed that most of the 6,169 hospitals, healthcare and other facilities — including nursing homes — that made PPE requests through GetUsPPE asked for N95 respirators (74%), surgical masks (64%), gowns (61%), and face shields (60%).

Metropolitan areas comprised 5,416 (88%) of the requests. The data show significant disparities between PPE availability and income levels, with requests equaling 3,990 (65%) coming from counties with the highest quartile of median income. This may be because requesters in those areas are more aware of the GetUsPPE Demand Data Hub, the organization said.

Hospitals topped the list of facility types requesting PPE at 27%, with outpatient clinics at 15% and skilled nursing facilities at 9%. Facilities in the South made the most requests at 32%, followed by the West at 26%, the Northeast at 23%, and the Midwest at 16%. The organization called for a significant increase in PPE manufacturing.

Earlier this month, the FDA issued conservation strategies for gowns, including using:

Reusable gowns instead of disposable, single-use gowns.

Sterile surgical isolation gowns for surgery/invasive procedures with a medium to high risk of contamination.

Non-sterile gowns.

Isolation gowns for routine care of patients that are suspected or confirmed to be infected with COVID-19.