Pharmaceutical

Olympus issues new cleaning instructions for duodenoscopes

ucm434882 Olympus issues new cleaning instructions for duodenoscopesOlympus, makers of the specialized endoscopes called duodenoscopes targeted by lawsuits tied to the superbug outbreak at UCLA Ronald Reagan Medical Center, has issued new manual reprocessing instructions for medical facilities charged with cleaning and disinfecting the duodenoscopes in an effort to curb the number of patient-to-patient infections caused by the devices.

The new, validated manual reprocessing instructions are specifically for the TJF-Q180V duodenoscope and are designed to replace those provided in the original labeling. The Food and Drug Administration (FDA) has reviewed the new reprocessing instructions and validated data as part of its ongoing review of the device. Any facilities using the specialized endoscopes are advised to train staff on the new instructions and implement them as soon as possible.

Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. The FDA is closely monitoring the possible link between reprocessed duodenoscopes and the transmission of infectious agents, including the multidrug resistant bacterial infections caused by Carbapenem-Resistant Enterobacteriaceae, or CRE, such as Klebsiella species and Escherichia coli.

It was determined that these bacteria can harbor in the small crevasses in the duodenoscopes even after the devices are cleaned following the previous disinfecting processes.

Duodenoscopes are fed down patients’ throats during procedures to treat or diagnose various gastrointestinal conditions. About a half million duodenoscope procedures are performed each year. The devices have been linked to outbreaks of antibiotic-resistant bacterial infections, including CRE, which kills up to 50 percent of patients it infects.

At least five lawsuits have been filed against Olympus by patients and their family members who were sickened after undergoing procedures with the Olympus duodenoscopes.

Source: FDA