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醫(yī)療器械創(chuàng)新網(wǎng)

新品 可高壓滅菌插管防護(hù)罩獲批EUA

日期:2020-05-13
NN采用PSU推出插管防護(hù)罩復(fù)高壓滅菌



本文摘譯自MASSDEVICE 2020年5月8日評論

以下為詳文

NN公司(NSDQ:NNBR)宣布,COVID-19大流行期間,其Paragon Medical部門推出插管防護(hù)罩,用于為醫(yī)療工作者提供防護(hù)。


NN公司網(wǎng)站截圖


在插管和拔管過程中,插管防護(hù)罩為醫(yī)護(hù)人員和患者之間提供了一道屏障,從而減少了空氣懸浮污染物的暴露。


Paragon與佐治亞州Alpharetta的Solvay Specialty Polymers公司合作,防護(hù)罩采用醫(yī)用級材料設(shè)計生產(chǎn),可承受全面清洗、消毒和反復(fù)高壓滅菌。


solvay公司網(wǎng)站截圖


NN的設(shè)計師與蘇威緊密合作,選擇Udel P-1700聚砜(PSU),這是一種ISO 10993生物相容性透明聚合物,可以反復(fù)消毒和消毒。


上周,由于擔(dān)心COVID-19在患者護(hù)理期間的傳播,F(xiàn)DA發(fā)布了防護(hù)屏障罩的緊急使用授權(quán)(EUA)。由于防護(hù)屏障罩在個人防護(hù)設(shè)備(PPE)之上可提供額外的保護(hù)層,該授權(quán)涵蓋了在醫(yī)療保健環(huán)境中對COVID-19患者(或潛在患者)進(jìn)行護(hù)理或執(zhí)行醫(yī)療程序時使用Paragon防護(hù)罩之類的設(shè)備。






原文:



NN’s Paragon Medical launches intubation shield


MAY 8, 2020 BY SEAN WHOOLEY LEAVE A COMMENT


NN Inc. (NSDQ:NNBR) announced that its Paragon Medical division launched an intubation shield for healthcare workers amid the COVID-19 pandemic.


The intubation shield provides a barrier between the healthcare professional and the patient during the intubation and extubation processes, reducing exposure to aerosolized airborne contaminants.


Paragon collaborated with Solvay Specialty Polymers in Alpharetta, Ga., to produce the shields with medical-grade materials designed to withstand full cleaning, disinfection and repeated autoclaving.


“I am extremely proud of the team who worked on the project. To have developed a product that contributes to the safety of the clinicians who are risking so much during this tough time is something that we take a lot of pride in,” NN life sciences group VP Rick Stetler said in a news release. “Our designers worked closely with Solvay on the selection of Udel P-1700 polysulfone (PSU), an ISO 10993 biocompatible, transparent polymer that can be repeatedly disinfected and sterilized. With their technical support and expedited lead-times on the material, the project went from concept to release in under two weeks. We are already receiving positive feedback from the field and facilities who are requesting more.”


Last week, the FDA issued emergency use authorization (EUA) for protective barrier enclosures amid concerns over transmission of COVID-19 during patient care. The authorization covers the use of devices like Paragon’s shield when caring for or performing medical procedures on COVID-19 patients (or potential patients) in healthcare settings, as it offers an extra layer of protection on top of personal protective equipment (PPE).

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