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Manufacturers should label PVC devices made with DEHP.(polyvinyl chloride plastic; di-2-ethylhexyl-phthalate)
2002 NOV 7 - (NewsRx.com & NewsRx.net) -- The U.S. Food and Drug Administration is recommending that manufacturers label medical devices made with di-2- ethylhexyl-phthalate (DEHP), a chemical linked to birth defects and other illnesses that is used to soften polyvinyl chloride (PVC) plastic.
DEHP can leach from the plastic and pose a risk to some patients, particularly developing boys, the FDA said.
The FDA's draft "Guidance for Industry" document issued in September 2002 also recommends that medical device manufacturers consider replacing PVC containing DEHP with alternative materials. Devices used in Neonatal Intensive Care Units (NICUs) should be a primary focus, FDA said.
"The FDA is moving in the right direction, but has fallen far short of what is necessary to protect patients because they are recommending, rather than requiring, labeling of DEHP-containing products. How can healthcare providers protect their patients from this toxic chemical without a uniform way for them to know whether a medical device ...
- FDA DEHP guidance comment period ends; 'anti' voices grow.
- Newspaper article from: Medical Device Daily December 11, 2002 700+ words
FDA DEHP guidance comment period...the total impact of the DEHP problem. One department of the FDA issuing a warning, she...will not universally label DEHP containing devices in the absence of an FDA requirement. HCWH proposes...
- Industry ahead of FDA on DEHP/device alternatives?
- Newspaper article from: Medical Device Daily July 18, 2002 700+ words
Industry ahead of FDA on DEHP/device alternatives? By KEVIN...products have or do not have DEHP in them, Last fall, the FDA issued a safety assessment concluding...and accurate information from FDA on DEHP-plasticized medical devices...
- Activists claim FDA's DEHP warning confirms product dangers. (Products &...
- Magazine article from: Healthcare Purchasing News Shields, Todd November 1, 2001 700+ words
...Washington, D.C. "The FDA has not before weighed in on the toxicity of DEHP as a chemical that...statement, calling the FDA's proclamation its...to understand how DEHP data found in the...Specifically, the FDA says DEHP might be harmful to...
- FDA pushes labeling of medical devices that contain DEHP.(Brief Article)
- Magazine article from: Chemical Market Reporter September 16, 2002 700+ words
...should be a primary focus, the FDA says. DEHP can leach from the plastic and...alternatives or coatings. If DEHP is retained, the FDA recommends that the manufacturer...associated with exposure to DEHP," the FDA says. The phthalate esters...
- AMA Asks FDA to Expedite DEHP Evaluation. (Markets).(risks of use of...
- Magazine article from: Chemical Market Reporter December 10, 2001 700+ words
...noted the significance of the FDA assessment on DEHP," says Charlotte Brody...vulnerable patients' exposure to DEHP," Ms. Brody says. FDA'S assessment found that DEHP...risk of harmful effects from DEHP. FDA'S finding was based on the...
- FDA recommends DEHP alternatives. (Phthalates).(Brief Article)
- Magazine article from: Chemical Week Franz, Neil September 18, 2002 700+ words
...the products contain DEHP, FDA says. The recommendations follow a 2001 FDA safety assessment of DEHP in medical devices...phthalate esters panel says FDA's assessment overstates the risks of DEHP. There has been an estimated...
- Agency letter on DEHP risk a 'good case study showing' FDA's approach, CBER...
- Newspaper article from: Validation Times Pickett, Joseph December 1, 2005 700+ words
...biopharmaceuticals has caused FDA to face head-on the...ethylhexl) phthalate (DEHP) released from polyvinyl...s sensitivity to DEHP, and the dose received. FDA has found that the...http://www.fda.gov/cdrh/safety/dehp.pdf.
- FDA Study Concludes DEHP May Pose Risks to Infants.(di(2-ethyihexyl) phthalate...
- Magazine article from: Chemical Week SISSELL, KARA September 12, 2001 700+ words
...ANTICIPATED U.S. FDA SAFETY assessment concludes...ethyihexyl) phthalate (DEHP) may pose a risk to...laboratory animals. The FDA launched the DEHP safety assessment to...warning labels about DEHP's risks. "FDA expressed little to no...
Source: HighBeam Research, Manufacturers should label PVC devices made with DEHP.(polyvinyl...