New Olympus Duodenoscope Infection Outbreak Identified at Huntington Memorial Hospital in L.A.
Another California hospital is reporting a possible outbreak of antibiotic-resistant “superbug” infections linked to Olympus duodenoscopes, which may have caused the spread of disease between patients even after the manufacturer cleaning instructions were followed.
Huntington Memorial Hospital in Pasadena is warning that there may be a potential link between pseudomonas bacteria infections among some of its patients and the duodenoscopes. At least three patients have been diagnosed with the infections and the hospital says the patients had all recently underwent procedures involving the endoscopic medical devices.
The hospital is now testing the duodenoscopes themselves to see if the bacteria is present. It is unclear at this time how many other patients may have been exposed to the devices. The hospital has refused to release a number, citing patient privacy laws.
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Duodenoscopes are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures, but difficulties cleaning the devices between patients have resulted in a number of recent outbreaks of antibiotic-resistant hospital-acquired infections in recent years.
This lastest outbreak comes after a number of duodenoscope hospital infection outbreaks were reported earlier this year, including an outbreak of carbapenem-resistant enterobacteriaceae (CRE) that was revealed in February by UCLA’s Ronald Reagan Medical Center. The outbreak caused at least seven infections, two deaths, and raised concerns that nearly 200 other patients had been placed at risk by duodenoscopes manufactured by Olympus Corp.
The infections have been linked to problems with the “reprocessing” instructions used to clean the devices for use by another patient. FDA reviewers determined that the instructions sent out at the time were inadequate and that even if the recommended steps were followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.
On August 17, the FDA posted a warning letter to Olympus, indicating that the company had failed to report links between the company’s devices and serious patient infections, injuries and deaths. Two other duodenoscope manufacturers, Pentax and Fujifilm, also received FDA warning letters.
The letters, issued on August 12, suggest that duodenoscope makers knew for years that their devices were linked to infection outbreaks, but failed to warn the FDA or address the problem. The companies are also currently under investigation by the Department of Justice.
In May, an FDA advisory committee determined that the devices “do not provide a reasonable assurance of safety and effectiveness” due to the difficulty cleaning them. The panel said that manual cleaning is still important and needs to continue, but also recommended that the FDA reclassify duodenoscopes from semi-critical medical devices to critical medical devices and said reprocessing needs to be taken from “high level disinfection” processes to full sterilization.
Despite the concerns, the panel also determined that the benefits provided by ERCP procedures still outweigh the risks associated with the use of duodenoscopes. They called on the FDA to develop a guide of best practices to make sure that manufacturer instructions are followed, in addition to the need for better instructions overall.
Earlier this month, the FDA issued a safety communication expanding cleaning instructions for duodenoscopes used in ERCP procedures. Olympus Corp. issued expanded cleaning instructions which were approved by the FDA earlier this year.
Several duodenoscope infection lawsuits have already been filed against Olympus over the infections linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.
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