FDA發出呼吁

本文摘譯自MASSDEVICE 2020年5月26日評論

以下為詳文

因為全國冠狀病毒大流行的蔓延，FDA發出呼吁，要求制造商生產更多的非手術服和其他個人防護用品(PPE)。

MASSDEVICE截圖

周五發布的緊急使用授權還列出了導電鞋及鞋套、手術室鞋及鞋套、手術頭盔和帽子以及其他手術配件。

FDA表示，它發布EUA，是為了回應醫務人員用的手術服和其他醫護服的短缺顧慮。在本月初，醫療衛生機構就已經告知了，一些分銷商可能是基于衛生系統以前的使用情況而不是按計劃用途來分配PPE的。

PPE的短缺，促使《柳葉刀》最近發表了一篇文章，這篇文章是根據GetUsPPE的研究撰寫的，GetUsPPE是一個在COVID-19大流行期間把醫務人員與PPE的供應連接起來的志愿者機構。

THELANCET截圖

該文章表示，通過GetUsPPE提出申請PPE的6169家醫院、醫療衛生機構和其他機構(包括療養院)中，大多數需求N95防護口罩(74%)、外科口罩(64%)、防護服(61%)和面罩(60%)。

大都市地區的申請數占了5416(88%)，縣區的申請數占了3990(65%)。數據顯示，PPE 可獲得性和收入水平之間存在顯著差異。

在申請PPE的設施類型列表中，醫院居首位，占27%；門診部占15%；熟練護理設施占9%。南部提出的設施申請為最多，占32%；西部次之，為26%；東北部為23%；中西部為16%。

GetUsPPE機構呼吁要大幅增長PPE制造業。

本月初，FDA發布了手術服的保護策略，包括：

◤可重復使用的手術服，而不用一次性的、單次性使用的手術服；

◤無菌手術隔離服，用于中等至高污染風險的手術/侵入性手術；

◤非無菌手術服；

◤隔離服，用于疑似或確診感染COVID-19的患者提供常規護理。

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.