Friday, September 11, 2015

CDC HAN Advisory On Cleaning, Disinfecting & Sterilization Of Reusable Medical Devices


# 10,513


The past year we’ve seen a renewed focus on HAIs (Hospital Acquired Infections) due to improperly cleaned, disinfected, or sterilized reusable medical devices. Today the CDC and the FDA are jointly issuing a HAN Advisory for all healthcare facilities to review their procedures for the disinfection of these reusable devices


The CDC’s Health Alert Network (HAN) is designed to ensure that communities, agencies, health care professionals, and the general public are able to receive timely information on important public health issues.


I've only excerpted a portion of today's advisory.  Follow the link to read it in its entirety.


Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices

This is an official


Distributed via the CDC Health Alert Network
September 11, 2015, 12:15 EDT (12:15 PM EDT)



The Centers for Disease Control and Prevention (CDC) and U.S. Food and Drug Administration (FDA) are alerting healthcare providers and facilities about the public health need to properly maintain, clean, and disinfect or sterilize reusable medical devices. Recent infection control lapses due to non-compliance with recommended reprocessing procedures highlight a critical gap in patient safety. Healthcare facilities (e.g., hospitals, ambulatory surgical centers, clinics, and doctors’ offices) that utilize reusable medical devices are urged to immediately review current reprocessing practices at their facility to ensure they (1) are complying with all steps as directed by the device manufacturers, and (2) have in place appropriate policies and procedures that are consistent with current standards and guidelines.



Recent media reports describe instances of patients being notified that they may be at increased risk for infection due to lapses in basic cleaning, disinfection, and sterilization of medical devices. These events involved failures to follow manufacturers’ reprocessing instructions for critical[1] and semi-critical[2] items and highlight the need for healthcare facilities to review policies and procedures that protect patients.



Healthcare facilities should arrange for a healthcare professional with expertise in device reprocessing to immediately assess their reprocessing procedures. This assessment should ensure that reprocessing is done correctly, including allowing enough time for reprocessing personnel to follow all steps recommended by the device manufacturer. The following actions should be performed:



  • Healthcare facilities should provide training to all personnel who reprocess medical devices.
    • Training should be required and provided:
      • Upon hire or prior to provision of services at the facility
      • At least once a year
      • When new devices or protocols are introduced, including changes in the manufacturer’s instructions for use during the device’s life cycle
    • Personnel should be required to demonstrate competency with device reprocessing (i.e., trainer observes correct technique) prior to being allowed to perform reprocessing independently.
    • Healthcare facilities should maintain current documentation of trainings and competencies.
    • If the healthcare facility hires a contractor for device reprocessing, the facility should verify that the contractor has an appropriate training program and that the training program includes the specific devices the healthcare facility uses.
    • Copies of manufacturers’ instructions for operating and reprocessing each type of reusable device should be readily available to staff and inspectors. This file should include instructions for use of chemical disinfectants.

(Continue . . .)

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