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    FDA Orders Manufacturers to Study Duodenoscope Reprocessing

    Healthcare facilities consistently seek ways to improve patient care, limit infections and reduce capital spending.

    The transmission of several fatal infections of Carbapenem-Resistant Enterobacteriaceae (CRE) has been linked to unclean duodenoscopes across the nation over the last two years. Healthcare facilities have since placed greater importance on the proper care and handling of endoscopic equipment. In October, the FDA mandated that three U.S. manufacturers investigate how their scopes are handled in hospitals and if the instrument-specific protocols are enough to thwart spreading patient-to-patient infections in the future.

    “While the overwhelming proportion of procedures with these devices are carried out safely and effectively, the FDA takes the risk of infection very seriously and is working intensively to address it,” according to the federal agency’s website. More than half a million duodenoscopes are used annually in the United States, according to the FDA.

    Duodenoscopes are used in procedures to identify and treat obstructions in the pancreas and bile ducts. The illuminated tube is passed via the mouth through to the small intestines to visualize the area and treat the medical issue. There is no alternative medical device available.

    Duodenoscope Reprocessing

    The complex design of the ERCP endoscopes may contribute to the difficulty in disinfecting the devices, even after a thorough cleaning. In response to these designs, the recommendations associated with effective duodenoscope reprocessing are complex and highly technical in nature. Failure to adhere to any one of the many required steps will often render a scope contaminated, leading to a potential for a hospital acquired infection (HAI).

    One example is a recommendation for a visual inspection of the elevator mechanism in the raised/lowered position as well as ensuring the elevator mechanism is completely dried prior to storage. Failure to adhere to either of these steps puts the sterility of the device into question and opens the door for increased patient to patient disease transmission.

    It is essential to precisely follow the manufacturer’s instructions for duodenoscope reprocessing for the make and model of the instrument, which explains the FDA’s intensive study into current manufacturer recommendations and reprocessing procedures within healthcare facilities.

    Important questions being considered include:

    1. Are the technician resources, such as manuals and quick-reference material, adequate enough to guarantee proper reprocessing?
    2. After cleaning and decontamination of scopes utilizing the manufacturer’s guidelines, how many remain polluted?
    3. What causes the contagion to manifest and how can it be prevented?

    Supplemental Measures

    In addition to the FDA, the Center for Disease Control issued an official health alert, advising that personnel with expertise in duodenoscope reprocessing should evaluate techniques to confirm it is being done correctly and thoroughly. The CDC recommended specialized training for personnel who reprocess these instruments, either prior to hire or as a provision of hire and at least once a year thereafter.

    Training, the CDC says, should be required whenever new instrument models or reprocessing procedures are handed down, including any updated instructions from the manufacturer.

    Additionally, the FDA believes microbiological culturing, ethylene oxide sterilization, and repeating high-level disinfection, in conjunction with copious attention to duodenoscope reprocessing directions from the manufacturer will diminish the possibility of infectious transmissions from patient-to-patient. For the FDA’s complete recommendations, click here.

    PREZIO Health

    Training and auxiliary protocols are only part of the solution to decrease bacterial infections between patients. Endoscopes must be properly maintained in good working condition and removed from service at the earliest detection of malfunction. To diminish these threats and improve patient care, contact PREZIO Health about its Endoscopy Equipment Repair and Maintenance Services. Our expert service can get your equipment back in service, while helping identify repair trends that point to potential failures in reprocessing. PREZIO is an ISO-certified provider of up-to-the-minute endoscopic equipment repair tracking through its client portal.


    By westwood | January 04, 2016 | NEWS | 0 Comments

    About the Author: westwood

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