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Residual ethylene oxide varies in medical devices and device material

Published in Medical Letter on the CDC and FDA, September 28th, 2003

The amount of residual ethylene oxide varies in medical devices and device material.

"Ethylene oxide (EO) gas is commonly used to sterilize medical devices. The amount of residual EO remaining in a device depends partly on the type and size of polymeric material. A major concern is the amount of residue that may be available in the body," scientists in the United States report.

"With the use of the method described by AAMI for headspace analysis of EO residues, different polymers and medical devices subjected to different numbers of sterilization cycles were examined," said Anne D. Lucas and colleagues at the Food and Drug Administration. "Next, the...

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