This system of filing these (MDR) reports is the only thing in place that can tell us that devices are having problems, (and) … it often puts the interests of (device) manufacturers and the hospitals ahead of the public,” says Lisa McGiffert, who heads the Safe Patient Project at Consumers Union, the publisher of Consumer Reports. “It’s a pretty weak system.”
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“This problem has been known since at least 1987,” said Allen, the president of the American Gastroenterological Association. “It certainly is disturbing that a fundamental design issue with these scopes would cause problems for this long.”
More than 600,000 such surgeries were performed in 2012, compared with about 250,000 just 15 years ago.
“It’s unacceptable that we make money when we have more complications,” said Virginia Mason’s CEO Dr. Gary Kaplan.
As the FTC evaluates the proposed merger of manufacturers Zimmer and Biomet, the group sent a letter to regulators urging the preservation of existing warranties.
The FDA has been criticized for approving medical devices through the 510K (fast track) approval requiring no clinical trials. But there’s another way-read on.