FDAnews Device Daily Bulletin

STATEMENT FROM THE ASSOCIATION OF MEDICAL DEVICE REPROCESSORS

Dec. 13, 2005
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A year-long Washington Post investigation into the widely used practice of reprocessing of medical devices, found no evidence that patients are put at an increased risk from the practice. The article was irresponsible in avoiding a basic fact: that no surgery is without risk, and that hundreds of surgical incident reports are filed every year as a result of new or original equipment. A simple review of FDA's adverse event reporting database will uncover many times more examples of adverse events using original equipment than reprocessed equipment.

The Washington Post (http://www.washingtonpost.com/wp-dyn/content/article/2005/12/11/AR2005121101197.html)