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www.fdanews.com/articles/89786-ban-on-reuse-of-semi-and-noncritical-suds-delayed-in-australia

BAN ON REUSE OF SEMI- AND NONCRITICAL SUDS DELAYED IN AUSTRALIA

December 27, 2006

Australia's Therapeutic Goods Administration (TGA) extended the Dec. 1 deadline for companies remanufacturing semi-critical and noncritical single-use devices (SUDs) for reuse to comply with a ban on reused medical devices labeled for single use. The new deadline is July 1, 2007.

In announcing the delay, the TGA cited concerns raised by a working group of the National Coordinating Committee on Therapeutic Goods that the original deadline did not give hospitals enough time to adjust to the change and that certain aspects of the regulation need to be clarified.

The initiative to eliminate the reuse of SUDs by unapproved institutions was launched in 2003 and was originally set to take effect in December 2005. That date has since been changed several times to accommodate concerns of hospitals and other healthcare facilities that they needed more time to determine what they would use instead of reprocessed devices.

(http://www.fdanews.com/imdrm/14_12/)