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    Two Federal Agency Alerts Address Medical Device Reprocessing Challenges

    Endoscopes, bronchoscopes, mini cameras and other equipment used for medical diagnoses are wonderful tools, but they must be completely sterilized prior to re-use.

    The U.S. Food and Drug Administration (FDA) and the Center for Disease Control and Prevention (CDC) have recently issued warnings and concerns over proper device reprocessing. Both organizations are urging health care services using endoscopic and related equipment to carefully review their procedures for sterilizing and disinfecting all devices.

    Endoscopes and other invasive devices that are not sterilized and disinfected can spread bacterial infections. Certain protocols have been established for device reprocessing and they must be followed by hospitals and outpatient clinics in the perioperative environment.

    Manufacturer recommendations for proper care and handling should be followed alongside hospital policy and in concordance with AAMI recommendations to prevent the spread of infections. According to the FDA, all healthcare facilities should follow certain policies and procedures for cleaning these reusable instruments.

    Some recommended infection control procedures

    • All instruments must be carefully treated, dried, stored and transported in compliance with the manufacturer's instructions for proper cleaning and handling.
    • Adequate time must be scheduled between the uses of the instruments to allow them to be properly sterilized and disinfected.
    • Healthcare facilities should train all personnel working with reprocessed devices on disinfecting procedures.
    • Personnel responsible for sterilizing services should carefully inspect all devices and assess their condition. They should be able to point out errors and indicate how and why the items are not ready for use.
    • Comprehensive documentation should be kept of the use of endoscopes and other equipment that can spread infection. This must include when they were last sterilized.
    • Documentation should be easy to access by anyone using the equipment. This information should be audited on a regular basis to insure compliance with cleaning and reprocessing procedures.

    Device reprocessing services

    PREZIO Health is a leading repair service provider for flexible and rigid endoscopic equipment. Our expertise includes experience repairing and refurbishing cameras, fiber-optic cables, Phaco hand probes, pneumatic and electric hand pieces and much more!

    In addition to our National Repair Center and our Endoscopic Repair Lap, PREZIO Health has mobile repair units that serve healthcare facilities throughout the United States. Our trained technicians possess the expertise necessary to extend the useful life of surgical and endoscopic equipment, while maintaining the strictest standards of patient safety.

    PREZIO Health also offers education support for healthcare personnel involved with reprocessing medical devices. Through PREZIO Health University, technicians can prepare for certification and obtain continuing education containing the most up-to-date information in the industry.

    Contact PREZIO Health for more information on ensuring adherence to FDA and CDC regulations and recommendations.


    By westwood | December 20, 2015 | NEWS | 0 Comments

    About the Author: westwood

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