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医械创新资讯
医械创新资讯

新品 可高压灭菌插管防护罩获批EUA

日期:2020-05-13
NN采用PSU推出插管防护罩高压灭菌



本文摘译自MASSDEVICE 2020年5月8日评论

以下为详文

NN公司(NSDQ:NNBR)宣布,COVID-19大流行期间,其Paragon Medical部门推出插管防护罩,用于为医疗工作者提供防护。


NN公司网站截图


在插管和拔管过程中,插管防护罩为医护人员和患者之间提供了一道屏障,从而减少了空气悬浮污染物的暴露。


Paragon与佐治亚州Alpharetta的Solvay Specialty Polymers公司合作,防护罩采用医用级材料设计生产,可承受全面清洗、消毒和反复高压灭菌。


solvay公司网站截图


NN的设计师与苏威紧密合作,选择Udel P-1700聚砜(PSU),这是一种ISO 10993生物相容性透明聚合物,可以反复消毒和消毒。


上周,由于担心COVID-19在患者护理期间的传播,FDA发布了防护屏障罩的紧急使用授权(EUA)。由于防护屏障罩在个人防护设备(PPE)之上可提供额外的保护层,该授权涵盖了在医疗保健环境中对COVID-19患者(或潜在患者)进行护理或执行医疗程序时使用Paragon防护罩之类的设备。






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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