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高达70%中共国制造口罩不符合美国进口标准 【中英对照翻译】

新闻来源:The National Pulse《国家脉动》;作者:Natalie Winters;发布时间:September 25, 2020 / 2020年9月25日

翻译/简评:X-Wing;校对:1818;审核:海阔天空 ;Page:拱卒

简评:

美国最大的患者安全组织、独立的医疗设备评估机构ECRI发布报告,宣称将近70%的从中国进口到美国的口罩是劣质品。这不仅无法有效遏制疫情的扩散,患者和一线医护人员也可能面临感染的风险。

中共国社会道德沦丧,假冒伪劣产品泛滥,因这次疫情而仓促上马大量口罩和个人防护设备生产厂家,在长期行业监管的缺乏和标准指定不符实际情况下,部分产品的品质低劣可想而知。但因为中共国提前买光了这些产品,导致美国医疗保健机构没有选择,不得不从中共国进口。ECRI的报告为美国机构和消费者及患者敲响警钟,与中共脱钩出于安全因素考虑也是势在必行!

原文翻译:

Up To 70% Of Chinese-Made Masks Imported To U.S. Identified As Faulty

将近70%的从中共国进口到美国的口罩是劣质品

FILE PHOTO:MASKS ARE SEEN ON A PRODUCTION LINE MANUFACTURING MASKS AT A FACTORY IN SHANGHAI, CHINA JANUARY 31, 2020. REUTERS/ALY SONG/FILE PHOTO 资料图片:2020年1月31日,在中共国上海的一家口罩工厂生产线上出产的口罩。路透社/ ALY SONG /文件照片

ANALYSIS FROM THE NATION’S LARGEST PATIENT SAFETY ORGANIZATION REVEALED THAT UP TO 70 PERCENT OF KN95 CHINA-MADE MASKS DO NOT MEET U.S. STANDARDS FOR EFFECTIVENESS.

来自美国最大的患者安全组织的分析表明,中共国制造的KN95口罩中高达70%不符合美国的有效标准。

Researchers at ECRI, a not-for-profit organization that for decades has advised hospitals, government organizations, and other healthcare stakeholders on product safety, found that 60 to 70 percent of imported KN95 masks do not filter 95 percent of aerosol particulates, contrary to what their name suggests.

ECRI是一家非营利性组织,数十年来一直向医院、政府组织和其他医疗保健利益相关者提供产品安全方面的建议,他们的研究人员发现60%至70%的进口KN95口罩不能过滤95%的气溶胶颗粒,这与其产品名称所暗示的意思不符。

Early indication from ECRI’s testing of nearly 200 masks, reflecting 15 different manufacturer models purchased by some of the largest health systems, raised alarms for ECRI, which issued a high priority hazard alert. The testing was done according to rigorous product testing protocols, conducted by ECRI’s quality assurance researchers at the organization’s independent medical device laboratory.

ECRI对近200个口罩进行测试的早期迹象表明,某些最大的卫生系统购买了15种不同的制造商型号,从而为ECRI发出了警报,并发出了高度优先的危险警报。测试是由ECRI的质量保证研究人员依照严格的产品测试规程,在该组织的独立医疗设备实验室进行。

“Because of the dire situation, U.S. hospitals bought hundreds of thousands of masks produced in China over the past six months and we’re finding that many aren’t safe and effective against the spread of COVID-19,” said Marcus Schabacker, MD, PhD, ECRI’s president and chief executive officer. “Using masks that don’t meet U.S. standards puts patients and frontline healthcare workers at risk of infection. As ECRI research shows, we strongly recommend that healthcare providers going forward do more due diligence before purchasing masks that aren’t made or certified in America, and we’re here to help them.”

具有医师和医学博士资格的ECRI总裁兼首席执行官马库斯·沙贝克(Marcus Schabacker)表示:“由于严峻的形势,美国医院在过去六个月中购买了数十万只在中国生产的口罩,我们发现许多口罩对防止COVID-19的传播并不安全有效。”“使用不符合美国标准的口罩会使患者和一线医护人员面临感染的风险。正如ECRI研究显示的那样,我们强烈建议医疗保健提供商在购买未在美国制造或认证的口罩之前,应进行更多的尽职调查,我们会在这里为他们提供帮助。”

As U.S. healthcare providers felt forced to fend for themselves in the early days of the pandemic amidst a massive shortage of personal protective equipment (PPE) for their workers, they turned to thousands of companies newly registered in China to manufacture KN95 masks. Despite a recent increase in government-supported PPE production in the United States, including manufacturing N95 masks, hospitals and health systems continue to report widespread shortages on quantities that can be purchased, causing providers to keep purchasing imported KN95 masks that do not meet U.S. regulatory standards. Hospitals report significant challenges ordering American-made masks, with some believing they are competing with the U.S. government as it seeks to replenish its PPE stockpile.

在中共病毒大流行初期,由于美国医疗保健提供者的雇员的个人防护设备(PPE)严重短缺,被迫要自食其力,便求助于成千上万在中国新注册的口罩生产公司来提供KN95口罩。尽管最近美国政府支持的PPE生产增加,包括制造N95口罩,但是医院和卫生系统继续报告可购买数量普遍短缺,导致提供商继续购买不符合美国法规标准的进口KN95口罩。医院报告,订购美国制造的口罩面临重大挑战,有些人认为海外厂家正在与美国政府竞争,以寻求补充美国PPE库存。

Although the majority of imported KN95 masks do not meet the U.S. National Institute for Occupational Safety and Health (NIOSH) N95 standard, ECRI researchers say the KN95s can be used in lieu of surgical or procedure masks for activities that involve limited contact with bodily fluids (because KN95s are not intended for fluid repellency), and they may provide superior respiratory protection. ECRI warns U.S. healthcare organizations, however, to use KN95s or other non-NIOSH-certified masks only as a last resort when treating known or suspected COVID-19 patients.

尽管大多数进口的KN95口罩均不符合“美国国家职业安全与健康研究院”(U.S. National Institute for Occupational Safety and Health,NIOSH)N95标准,但ECRI研究人员表示,KN95可以代替涉及体液接触有限的活动的外科或手术口罩使用( 因为KN95并不适用于液体排斥性),它们可以提供出色的呼吸防护,但ECRI警告美国医疗保健组织,在治疗已知或疑似COVID-19患者时, KN95或其他未经NIOSH认证的口罩应作为最后选项。

“KN95 masks that don’t meet U.S. regulatory standards still generally provide more respiratory protection than surgical or cloth masks and can be used in certain clinical settings,” said Michael Argentieri, vice president for technology and safety at ECRI. “Hospitals and staff who treat suspected COVID-19 patients should be aware that imported masks may not meet current U.S. regulatory standards despite marketing that says otherwise.”

ECRI技术与安全副总裁Michael Argentieri表示:“不符合美国监管标准的KN95口罩通常仍比外科或布口罩提供更多的呼吸保护,并且可以在某些临床环境中使用。治疗可疑COVID-19病人的医院和员工应注意,进口口罩可能不符合美国现行监管标准,尽管市场营销如此说明。”

While not providing 95 percent protection, ECRI researchers say many non-certified masks that have head and neck straps, as opposed to masks with ear loops, better conform to and seal against the wearer's face, ensuring that air being breathed is filtered.

ECRI研究人员表示,虽然没有提供95%的保护,但许多未经认证的带有头带和颈带的口罩,而不是带有耳环的口罩,可以更好地贴合并密封佩戴者的面部,确保呼吸的空气得以过滤。

For more information about ECRI’s testing of KN95 masks and other personal protective equipment (PPE), or to request ECRI’s high priority hazard report, visit ecri.org, or e-mail communications@ecri.org.

有关ECRI对KN95口罩和其他个人防护设备(PPE)进行测试的更多信息,或索取ECRI的高优先级危害报告,请访问ecri.org,或发送电子邮件至communications@ecri.org 。

About ECRI

关于ECRI

ECRI is an independent, nonprofit organization improving the safety, quality, and cost-effectiveness of care across all healthcare settings. With a focus on patient safety, evidence-based medicine, and health technology decision solutions, ECRI is respected and trusted by healthcare leaders and agencies worldwide. Over the past fifty years, ECRI has built its reputation on integrity and disciplined rigor, with an unwavering commitment to independence and strict conflict-of-interest rules.

ECRI是一间独立的非营利组织,致力于提高所有医疗机构的护理安全性、品质和成本效益。 ECRI专注于患者安全,循证医学和健康技术决策解决方案,受到全球医疗保健领导者和机构的尊重和信任。在过去的五十年中,ECRI凭借诚信和纪律严谨建立了声誉,坚守独立性和严格的利益冲突规则。

ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality. ECRI and the Institute for Safe Medication Practices PSO is a federally certified Patient Safety Organization as designated by the U.S. Department of Health and Human Services. The Institute for Safe Medication Practices (ISMP) formally became an ECRI Affiliate in 2020.

ECRI是全球唯一一家对医疗器械进行独立评估的组织,其实验室位于北美和亚太地区。ECRI被美国医疗保健研究与质量局指定为循证实践中心。ECRI和安全用药实践研究所PSO是由美国卫生与公共服务部指定的联邦认证的患者安全组织。安全用药实践研究所(ISMP)于2020年正式成为ECRI会员。

编辑:【喜马拉雅战鹰团】Edited by:【Himalaya Hawk Squad】