Investigation into the CRE outbreak at UCLA underscores the need for increased scrutiny of medical devices by the FDA before approving them for use on patients.
“The 21st Century Cures Act, which would lower standards for the approval of many medical products and potentially place patients at unnecessary risk.”
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.”
How dirty medical devices expose patients to infection
Duodenoscopes have contributed to deadly CRE infection outbreaks across the country. Learn how to protect yourself.
“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.