Sound the Alarm! CDC and FDA Alert on Reprocessing in Healthcare Facilities





On September 11, 2015, the Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) distributed a Health Alert to all healthcare faculties that reprocess reusable medical devices. This includes hospitals, ambulatory surgery centers, clinics, and doctors’ offices that utilize reusable medical devices. The alert is a response to the recent non-compliance with current standards and manufacturers’ instruction for use (IFU) causing a critical gap in patient safety.

The CDC and FDA recommend, “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 regulatory agencies cited recent reports 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. They recommend the following actions to be performed by a device reprocessing subject matter expert.


Healthcare facilities should provide training to all personnel who reprocess medical devices,

  • Training upon hire and at least once a year thereafter, and when new devices or protocols are introduced
  • Demonstrated competency must be required before being allowed to perform any steps in reprocessing independently
  • Training and competencies must be documented and maintained
  • Manufacturers’ IFUs for each type of reusable device and chemical disinfectants should be readily available to staff and inspectors

Audit and Feedback

Monitored and documented audits should be preformed to evaluate adherence to cleaning, disinfection, sterilization, and device storage procedures. Audits should assess all reprocessing steps and be conducted in all areas of the facility where reprocessing occurs. Feedback should be provided to personnel regarding their adherence to cleaning, disinfection, and sterilization procedures.

Infection Control Policies and Procedures

Healthcare facilities should:

  • Allow adequate time for reprocessing to ensure adherence to all steps recommended by the device manufacturers’ IFU including drying, proper storage, and transport of reprocessed devices
  • Consider scheduling of procedures and supply of devices to ensure adequate time is allotted for reprocessing
  • Have policies and procedures outlining facility response in the event of a recognized reprocessing error or failure
  • Maintain documentation of reprocessing activities, including maintenance records for reprocessing equipment and records verifying high-level disinfectants were tested and replaced appropriately
  • Follow manufacturer recommendations for maintenance and repair of medical devices

As a professional who has spent her entire professional career in the Operating Room and Sterile Processing, I say it is about time regulatory agencies publicly highlight the need for explicit focus and additional resources necessary for reprocessing reusable medical devices for patient and public safety. I personally hope that this latest Healthcare Advisory Alert will garner additional resources (products, time and subject matter experts) so desperately needed for safely reprocessing reusable medical devices.





  1. Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfection, and Sterilizing Reusable Medical Devices. CDC Health Alert Network. Sept. 11, 2015 Available at: Accessed 10/12/2015.
  2. CDC/FDA Helaht Update about the Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfection, and Sterilizing Reusable Medical Devices. CDC Health Alert Network. Oct 2, 2015. Available at: Accessed 10/12/2015.

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