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【medical-news】【动态版】FDA采取措施改善隐形眼镜的安全性

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super19830102

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FDA Taking Steps to Improve Contact Lens Safety
The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness.

To support proper cleaning and storage, the FDA has developed a new video on contact lens safety, which can be found on the FDA’s Web site (www.fda.gov), along with an in-depth Consumer Update article. The video and the article stress the importance of emptying the solution out of the contact lens case after each use and using the rub-and-rinse method for added effectiveness. Other important lens care tips include:

• Do not top off or reuse lens cleaning solution;
• Use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use;
• Do not expose contact lenses or lens storage cases to any type of water or other non-sterile solutions.

In early 2009, the FDA convened a workshop called “Microbiological Testing of Contact Lens Care Products," in collaboration with several eye care professional groups, to develop consensus on test methods for evaluating contact lens solutions. Based on discussions from this workshop and from a 2008 meeting of the agency’s advisory panel for ophthalmic devices, the FDA is developing manufacturer guidance on potential labeling improvements for these products.

In its June 2008 meeting, the advisory panel for ophthalmic devices made specific recommendations for contact lens product labeling and directions for use, including adding a discard date on their products, in addition to the usual expiration date. The discard date is the date the solution should be thrown out after opening.

On May 19, 2009, the FDA’s Center for Devices and Radiological Health issued a letter to manufacturers of contact lens multipurpose solution products that include an option for cleaning without a step for rubbing the lenses. This letter informed these manufacturers of the panel's conclusion that there is improvement in lens care when using a rub-and-rinse regimen as compared to a rinse-alone regimen, which omits the rubbing step. The direction to rub and rinse lenses, based on the advice of an eye care professional, has always been part of the labeling for multipurpose contact lens care products
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm167187.htm

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2009-06-17 08:38 浏览 : 1241 回复 : 6

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本人已认领本文翻译，48小时未提交，请其他战友继续认领。

2009-06-17 13:50

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FDA Taking Steps to Improve Contact Lens Safety
FAD采取措施改善隐形眼镜的安全
The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness.
美国食品药品管理局将通过采取提醒消费者正确清洁和保存隐形眼镜的重要性来改善隐形眼镜的安全。购买的消费者不遵循隐形眼镜说明的护理和使用将增加他们患严重的眼转播疾病的危险，甚至可以导致失明。
To support proper cleaning and storage, the FDA has developed a new video on contact lens safety, which can be found on the FDA’s Web site (www.fda.gov), along with an in-depth Consumer Update article. The video and the article stress the importance of emptying the solution out of the contact lens case after each use and using the rub-and-rinse method for added effectiveness. Other important lens care tips include:
为了正确的清洁和保存，FAD发布了关于隐形眼镜安全的新视频，在FAD的官方网站上就可以找到(www.fda.gov)，视频与致消费者的修正文章在一起。视频和文章强调在使用结束后清空隐形眼镜盒内溶液和使用摩擦清洁来增加效力的重要性。其他重要的关于隐形眼镜护理的方法包括：
• Do not top off or reuse lens cleaning solution;
• Use a contact lens solution to clean, rinse, and then air dry contact lens cases after each use;
• Do not expose contact lenses or lens storage cases to any type of water or other non-sterile solutions.
不要top off重新使用用过的隐形眼镜清洗液。
使用隐形眼镜的清洗液清洗，冲净，在使用时空气干燥隐形眼镜盒。
不要使隐形眼镜或者其保存盒暴露于任何水或者是其他未消毒的溶液中。

In early 2009, the FDA convened a workshop called “Microbiological Testing of Contact Lens Care Products," in collaboration with several eye care professional groups, to develop consensus on test methods for evaluating contact lens solutions. Based on discussions from this workshop and from a 2008 meeting of the agency’s advisory panel for ophthalmic devices, the FDA is developing manufacturer guidance on potential labeling improvements for these products.
2009年初，FAD召集工厂称之为“隐形眼镜护理产品微生物检测”与其他数个眼部专业护理组合作，来提高评估隐形眼镜护理液检测方法的一致性。讨论基于这个工厂和2008年眼部设备顾问团的会议，FAD通过发展人为指导潜在标识来提高那些产品。
In its June 2008 meeting, the advisory panel for ophthalmic devices made specific recommendations for contact lens product labeling and directions for use, including adding a discard date on their products, in addition to the usual expiration date. The discard date is the date the solution should be thrown out after opening.
在这次2008 6月的会议上，眼部设备顾问团做了关于隐形眼镜生产标识和指导使用详细而精确的建议，包括在正常的使用时间之外，增加使用产品的报废日期，报废的日期是护理液在开封后应该在某个日期被丢弃的时间。

On May 19, 2009, the FDA’s Center for Devices and Radiological Health issued a letter to manufacturers of contact lens multipurpose solution products that include an option for cleaning without a step for rubbing the lenses. This letter informed these manufacturers of the panel's conclusion that there is improvement in lens care when using a rub-and-rinse regimen as compared to a rinse-alone regimen, which omits the rubbing step. The direction to rub and rinse lenses, based on the advice of an eye care professional, has always been part of the labeling for multipurpose contact lens care products
在2009年5月19日，FAD的设备及放射卫生中心发行了一封致隐形眼镜多功能护理液产品包括选择无摩擦的清洗液生产厂家的文章。文章告知那些生产厂家的顾问团，结论是当使用摩擦清洗方法与仅使用清洗的方法而忽略了摩擦这一步的方法相比，可以提高隐形眼镜的护理。直接的摩擦和清洗隐形眼镜，是基于眼部护理专业人员的建议，应当作为多功能隐形眼镜护理产品标识的一部分。

编译：
FAD采取措施改善隐形眼镜的安全
美国食品药品管理局将通过采取提醒消费者正确清洁和保存隐形眼镜的重要性来改善隐形眼镜的安全。购买的消费者不遵循隐形眼镜说明的护理和使用将增加他们患严重的眼转播疾病的危险，甚至可以导致失明。
为了正确的清洁和保存，FAD发布了关于隐形眼镜安全的新视频，在FAD的官方网站上就可以找到(www.fda.gov)，视频与致消费者的修正文章在一起。视频和文章强调在使用结束后清空隐形眼镜盒内溶液和使用摩擦清洁来增加效力的重要性。其他重要的关于隐形眼镜护理的方法包括：
不要top off重新使用用过的隐形眼镜清洗液。
使用隐形眼镜的清洗液清洗，冲净，在使用时空气干燥隐形眼镜盒。
不要使隐形眼镜或者其保存盒暴露于任何水或者是其他未消毒的溶液中。
2009年初，FAD召集工厂称之为“隐形眼镜护理产品微生物检测”与其他数个眼部专业护理组合作，来提高评估隐形眼镜护理液检测方法的一致性。讨论基于这个工厂和2008年眼部设备顾问团的会议，FAD通过发展人为指导潜在标识来提高那些产品。
在这次2008 6月的会议上，眼部设备顾问团做了关于隐形眼镜生产标识和指导使用详细而精确的建议，包括在正常的使用时间之外，增加使用产品的报废日期，报废的日期是护理液在开封后应该在某个日期被丢弃的时间。
在2009年5月19日，FAD的设备及放射卫生中心发行了一封致隐形眼镜多功能护理液产品包括选择无摩擦的清洗液生产厂家的文章。文章告知那些生产厂家的顾问团，结论是当使用摩擦清洗方法与仅使用清洗的方法而忽略了摩擦这一步的方法相比，可以提高隐形眼镜的护理。直接的摩擦和清洗隐形眼镜，是基于眼部护理专业人员的建议，应当作为多功能隐形眼镜护理产品标识的一部分。

请各位前辈指点批评，谢谢！

2009-06-18 22:01

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2009-06-19 00:20

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