“For decades, doctors reassured patients about the safety of medical scopes with a single statistic. But the statistic is 22 years old. And even then it was wrong.”
“Infection experts have been warning for years in speeches and research papers that many types of endoscopes can remain dirty after cleaning — only to have their concerns mostly ignored by doctors performing the procedures.”
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.
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.”
“Hospitals don’t have a legal obligation to tell patients about the presence of pathogens — even antibiotic-resistant bacteria. Recent outbreaks, linked to contaminated endoscopes at UCLA and other hospitals, are bringing this policy gap to the fore.”
“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.”
Last week, various news outlets reported on a superbug outbreak at UCLA hospital linked to two patient deaths and nearly 180 possibly infected.
An outbreak of an antibiotic resistant bacteria (CRE) occurred at UCLA’s Ronald Reagan Medical Center infecting almost 180 patients. The culprit was a medical device, an duodenoscope which is like an endoscope and inserted in the throat.
Health Watch USA makes the news! “CRE is very dangerous. It is almost totally resistant to antibiotics,” said Dr. Kevin Kavanagh, an infection-control activist who leads the Somerset, Ky.-based watchdog group Health Watch USA.”