FDA updates endoscope cleaning guidelines after deadly superbug outbreaks

(Reuters) — Hospitals that can afford it should take steps beyond those recommended by the manufacturer to clean and disinfect a type of device at the center of a recent superbug outbreak in the U.S., health regulators said yesterday. Healthcare facilities that use duodenoscopes should meticulously follow the manufacturer’s cleaning instructions, the agency said in a safety update. Those with resources should also take several other measures to reduce the risk of infection. Duodenoscopes are flexible, lighted tubes inserted down the throat during a procedure called endoscopic retrograde cholangiopancreatography (ERCP) used to drain fluids from blocked pancreatic and biliary ducts. The reusable device is a more complex instrument than other endoscopes and must be properly cleaned and disinfected after use so that pathogens are not transferred from 1 patient to another. Seven patients at the Ronald Reagan UCLA Medical Center were exposed to antibiotic-resistant bacteria from such devices between October and January. Two died. In March Olympus (TYO:7733), the biggest maker of the devices, issued new cleaning instructions to replace those on the original label. The FDA recommended at the time that any facilities using the TJF-Q180V device should train staff on the new instructions and implement them as soon as possible. In its latest safety update the FDA recommended hospitals also consider microbiological culturing to identify any bacterial contamination that may be p...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regulatory/Compliance Arthroscopic Source Type: news