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FDA warns public not to use unapproved oruncleared medical devices to help assess or diagnose a concussion

FDA提醒公众不要使用未经批准或未经许可的医疗设备来帮助评估或诊断脑震荡

Today, the U.S. Food and Drug Administration is warning the public not to use medical devices marketed to consumers that claim to help assess, diagnose or manage head injury, including concussion, traumatic brain injury (TBI) or mild TBI. In a new safety communication, the FDA warned that such tools — such as apps on a smartphone marketed to coaches or parents for use during sporting events — have not been reviewed by the FDA for safety and efficacy and could result in an incorrect diagnosis, potentially leading to a person with a serious head injury returning to their normal activities instead of getting medical care.

今日，美国食品药品监督管理局提醒公众不要使用声称可以帮助评估、诊断或者处理头部损伤的医疗设备（包括脑震荡，创伤性脑损伤（TBI）或轻度TBI）。在新的安全通信中,FDA警告称，这类产品-比如面向教练或家长销售的用于体育赛事期间使用的智能手机应用程序——没有经过FDA的安全性和有效性审查，从而导致错误的诊断，可能致使头部严重受伤的人没有及时就医，而继续正常活动。

To date, there are a limited number of medical devices that have been cleared or approved by theFDA to aid in the diagnosis, treatment, or management of concussion, and all ofthem require an evaluation by a health care professional.

迄今为止，只有为数不多的医疗设备通过了FDA的审核或批准，可以用于脑震荡的诊断、治疗或管理，而且所有这些设备都需要经过专业医疗人员的评估。

“I want to be clear, there are currently no devices to aid in assessing concussion that should be used by consumers on their own. Using such devices can result in an incorrect diagnosis after a head injury that could lead a person with a serious injury to return to their normal activities instead of seeking critical medical care, putting them at greater danger,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “Products being marketed for the assessment, diagnosis, or management of a head injury, including concussion that have not been approved or cleared by the FDA are in violation of the law.The FDA routinely monitors the medical device market and became aware of violative products being marketed to consumers. The FDA has alerted companies to our concerns and asked them to remove such claims. “We will continue to monitor the market place for devices making these unsubstantiated claims and are prepared to take further action if necessary.”

“我想说明的是，目前还没有消费者可以自己操作用于评估脑震荡的设备。使用这种设备可能导致头部受伤后的错误诊断，这可能导致严重受伤的人继续正常生活，而不及时就医，使他们处于更大的危险之中，”FDA)设备和放射卫生中心主任，法学，医学博士杰弗里舒伦(Jeffrey Shuren)说。“在市场上销售的用于评估、诊断或治疗头部损伤(包括脑震荡)的产品，未经FDA批准或批准，都是违法的。FDA定期监测医疗器械市场，并意识到市场上存在向消费者销售的违规产品的现象。FDA已经提醒相关公司，并要求他们删除此类声明。”我们将继续监测作出这些未经证实的声明的设备的市场，并准备在必要时采取进一步行动。”

In the safety communication issued today, the FDA explains that the products of concern include those that claim to assess and diagnose any changes in brain function by having an injured person perform tests on a smartphone or tablet-based app to determine a change in physical or mental (cognitive) status including vision, concentration,memory, balance and speech.

在今天发布的安全通信中，FDA解释说, 令人担忧的产品包括那些声称能通过伤者在智能手机或平板电脑的应用程序上的测试，来评估和诊断大脑功能的任何变化，以确定身体或心理(认知)状态的变化，包括视力、注意力、记忆力、平衡感和说话能力。

The FDA’s recommendations for consumers, parents, caregivers and athletic coaches note that individuals should seek treatment right away from a health care professional if any head injury, including concussion, is suspected.

FDA对消费者、家长、护理人员和运动教练建议，如果怀疑有任何头部损伤，包括脑震荡，应立即寻求医疗专业人士的治疗。

The FDA will continue to monitor promotional materials and claims about uses of these and similar products and contact companies when we see violative practices. If the agency’s concerns are not addressed, the FDA will consider what additional actions, including potential enforcement actions, are appropriate. The FDA will continueto monitor complaints and adverse event reports from patients, caregivers,health care providers and industry.

FDA将继续监测宣传材料和关于使用这些类似产品的声明，发现违规将联系公司。如果违规行为没有得到解决，FDA将考虑采取额外措施，包括起诉。FDA将继续监测来自患者、护理人员、卫生保健提供者和行业的投诉和不良事件报告。

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

美国食品药品监督管理局（FDA）是美国卫生和公众服务部的一个机构，它通过确保人类和兽药、疫苗和其他供人类使用的生物制品以及医疗器械的安全性、有效性和安全性来保护公众健康。该机构还负责我国食品供应、化妆品、膳食补充剂、散发电子辐射的产品的安全和保障，并负责监管烟草产品。

本文内容取自 FDA

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