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PVC Safety Concerns Reflected Too Broadly In FDA Guidance, Industry Asserts

This article was originally published in The Gray Sheet

Executive Summary

FDA's draft guidance on DEHP-plasticized polyvinyl chloride is incompatible with the agency's safety assessment and should be withdrawn, health product manufacturers contend

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DEHP risk elevated in Germany

Federal Risk Assessment Institute challenges evaluation that average daily intake of plasticizer is within tolerable dose range, asserts daily intake "may be far higher than assumed up to now." New study data from the University of Erlangen could lead to exposure-reducing measures, the institute says Aug. 13, emphasizing DEHP use in the production of PVC-containing devices such as dialysis tubes. In the U.S., industry groups claim CDRH reacted hastily to an unestablished link between DEHP and developmental difficulties (1"The Gray Sheet" Dec. 9, 2002, p. 9)...

DEHP risk elevated in Germany

Federal Risk Assessment Institute challenges evaluation that average daily intake of plasticizer is within tolerable dose range, asserts daily intake "may be far higher than assumed up to now." New study data from the University of Erlangen could lead to exposure-reducing measures, the institute says Aug. 13, emphasizing DEHP use in the production of PVC-containing devices such as dialysis tubes. In the U.S., industry groups claim CDRH reacted hastily to an unestablished link between DEHP and developmental difficulties (1"The Gray Sheet" Dec. 9, 2002, p. 9)...

California, Massachusetts Bills Propose Ban On DEHP In Medical Devices

C.R. Bard and Kendall Healthcare's lines of Foley urinary catheters may receive increased exposure in California and Massachusetts if the states pass legislation banning the use of DEHP, a chemical used to soften polyvinyl chloride (PVC) plastic, in medical devices

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