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NEWS & INFORMATION
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Source To Surgery - November 2000, Vol. 8 Issue 3
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A Review of International Regulatory & Standards Actions Regarding Latex Allergy
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Russell Thompson, Editor
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In this issue of Source to Surgery we review the efforts to promulgate various initiatives in Finland, UK, Europe, Japan and Malaysia. Many of the standards being developed for latex protein content are being combined with other barrier and quality issues surrounding the use of medical and industrial gloves. Of particular note is Japan's slow response to the entire medical device regulatory effort. Many readers may be interested in the associated article by Dr. Ritsuko Hayakawa of Nagoya University, Japan, where researchers are discovering allergic reactions to polyvinyl chloride (PVC) gloves which have been proposed as an alternative to natural rubber latex (NRL). Malaysia, the world's largest producer of NRL gloves has instituted minimum standard specifications for all latex gloves produced. Many of the global educational and awareness efforts can be contributed to the work of Dr. Timo Palosuo and colleagues who began their effort in 1994 and have been successful in reducing the number of high-allergen content gloves marketed in Finland as well as influencing the initiatives in many other countries. Major regulatory efforts are underway in both the UK and Europe in order to reduce the risk and provide consistent quality of products used in barrier protection.
Previous issues of Source to Surgery have reported on the continuing efforts of the USA FDA to develop standards for gloves.
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