FDAnews Device Daily Bulletin

REPROCESSORS RESPOND TO DEVICE REUSE INVESTIGATION

Dec. 13, 2005
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The Association of Medical Device Reprocessors (AMDR) is challenging the results of a Washington Post investigation into reuse of medical devices, arguing that the series of articles misinforms readers by intimating that reprocessing presents a heightened health risk.

According to AMDR's release, the investigation found no evidence of a link between reprocessed devices and an increase in risk. In the Washington Post series the paper examined a number of instances where flaws in reprocessed devices led to adverse events such as death or serious physical harm.

However, the group alleges that the newspaper's report was "irresponsible" in focusing on a few anecdotal reports to intimate that reprocessed devices are more dangerous. These examples took place either overseas where FDA regulations do not apply or before agency regulations governing reprocessed devices were in place, the group said. There is no demonstrated link between reprocessed devices and increased risk, AMDR added.

"The problem with the Post article is that it seeks to alarm readers by exaggerating the risks associated with reprocessed devices. The fact is that there are far more problems reported for new devices than there are for reprocessed devices," AMDR said.

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