FDA發(fā)出呼吁

本文摘譯自MASSDEVICE 2020年5月26日評(píng)論

以下為詳文

因?yàn)槿珖?guó)冠狀病毒大流行的蔓延，F(xiàn)DA發(fā)出呼吁，要求制造商生產(chǎn)更多的非手術(shù)服和其他個(gè)人防護(hù)用品(PPE)。

MASSDEVICE截圖

周五發(fā)布的緊急使用授權(quán)還列出了導(dǎo)電鞋及鞋套、手術(shù)室鞋及鞋套、手術(shù)頭盔和帽子以及其他手術(shù)配件。

FDA表示，它發(fā)布EUA，是為了回應(yīng)醫(yī)務(wù)人員用的手術(shù)服和其他醫(yī)護(hù)服的短缺顧慮。在本月初，醫(yī)療衛(wèi)生機(jī)構(gòu)就已經(jīng)告知了，一些分銷(xiāo)商可能是基于衛(wèi)生系統(tǒng)以前的使用情況而不是按計(jì)劃用途來(lái)分配PPE的。

PPE的短缺，促使《柳葉刀》最近發(fā)表了一篇文章，這篇文章是根據(jù)GetUsPPE的研究撰寫(xiě)的，GetUsPPE是一個(gè)在COVID-19大流行期間把醫(yī)務(wù)人員與PPE的供應(yīng)連接起來(lái)的志愿者機(jī)構(gòu)。

THELANCET截圖

該文章表示，通過(guò)GetUsPPE提出申請(qǐng)PPE的6169家醫(yī)院、醫(yī)療衛(wèi)生機(jī)構(gòu)和其他機(jī)構(gòu)(包括療養(yǎng)院)中，大多數(shù)需求N95防護(hù)口罩(74%)、外科口罩(64%)、防護(hù)服(61%)和面罩(60%)。

大都市地區(qū)的申請(qǐng)數(shù)占了5416(88%)，縣區(qū)的申請(qǐng)數(shù)占了3990(65%)。數(shù)據(jù)顯示，PPE 可獲得性和收入水平之間存在顯著差異。

在申請(qǐng)PPE的設(shè)施類(lèi)型列表中，醫(yī)院居首位，占27%；門(mén)診部占15%；熟練護(hù)理設(shè)施占9%。南部提出的設(shè)施申請(qǐng)為最多，占32%；西部次之，為26%；東北部為23%；中西部為16%。

GetUsPPE機(jī)構(gòu)呼吁要大幅增長(zhǎng)PPE制造業(yè)。

本月初，F(xiàn)DA發(fā)布了手術(shù)服的保護(hù)策略，包括：

◤可重復(fù)使用的手術(shù)服，而不用一次性的、單次性使用的手術(shù)服；

◤無(wú)菌手術(shù)隔離服，用于中等至高污染風(fēng)險(xiǎn)的手術(shù)/侵入性手術(shù)；

◤非無(wú)菌手術(shù)服；

◤隔離服，用于疑似或確診感染COVID-19的患者提供常規(guī)護(hù)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.