REUTERS: An unnamed hospital in Oklahoma used contaminated gastroscopes in procedures performed on nearly a thousand patients in recent months, device maker Pentax Medical told U.S. regulators last month, putting the patients at risk of exposure to bacteria that can cause infections.
The FDA echoed Pentax’s assessment and said regulators"have determined that the manufacturer’s reprocessing instructions were not followed." The agency said it is continuing to discuss the incident with Pentax and the hospital to learn more details. Researchers say the intricate design of many endoscopes, with narrow channels and tiny crevices, hinders cleaning and those problems are compounded when health workers skip steps or ignore basic protocols in a rush to get scopes ready for the next patient.
In its filing to the FDA, Pentax said the"forward water jet channel" was not properly cleaned on three of the gastroscopes and a"foreign liquid was evacuated from at least one of the devices upon flushing" that channel. After discovering the problem, the hospital took the scopes out of service and returned them to Pentax.
In 2015, the FDA ordered Pentax and two other scope manufacturers – Olympus Corp and Fujifilm Holdings Corp – to conduct surveillance studies after the spread of antibiotic-resistant"superbugs" at U.S. and European hospitals from contaminated duodenoscopes. Those gastrointestinal scopes are put down a patient’s throat to diagnose and treat problems such as gallstones, cancers and blockages in the bile duct.
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