Regulators Put Healthcare Facilities on Notice

Immediate Need to Review Reprocessing Procedures for Reusable Medical Devices

By Phenelle Segal, RN, CIC, Infection Control Consultant and President of Infection Control Consulting Services

During the past several months, numerous healthcare facilities have reported issues with cleaning, disinfection and sterilization of medical devices, particularly duodenoscopes, which feature a complex design that creates challenges for first-step cleaning and subsequent high-level disinfection.

Several deaths have occurred as a result of highly resistant bacteria that were transmitted from patient to patient, primarily during a procedure known as endoscopic retrograde cholangiography (ERCP).

The Centers for Disease Control and Prevention (CDC) and the U.S. Food and Drug Administration (FDA) have been actively involved in working with facilities and medical device manufacturers to improve reprocessing procedures for the benefit of patient safety.

On September 11, the CDC issued an official Health Advisory to healthcare facilities, such as hospitals, ambulatory surgery centers, clinics and doctors’ offices that utilize reusable medical devices urging them 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."

In addition, the Advisory encourages facilities to "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 are some of the critical tasks that should be performed as soon as possible:

  • Training of all personnel who reprocess medical devices upon hire or prior to provision of services at the facility; at least once a year; and when new devices or protocols are introduced, including changes in the manufacturer’s instructions for use during the device’s life cycle.
  • Audits (monitor and document) of adherence to cleaning, disinfection, sterilization and device storage procedures.
  • Audits in all areas of the facility where reprocessing occurs.
  • Development of appropriate infection prevention and control policies and procedures. These policies should replace or provide an addendum to current reprocessing policies which focus not only on the cleaning/disinfection and sterilization steps, but also drying, proper storage and transport of the reprocessed devices.
  • Development of protocols to ensure healthcare personnel can readily identify devices that have been properly reprocessed and are ready for patient use (e.g., tagging system, storage in a designated area).
  • Feedback from audits provided to personnel regarding their adherence to cleaning, disinfection and sterilization procedures.

To view the CDC Health Advisory, click here.

Need Help?

If you have any questions about the actions surveyors expect your facility to perform to ensure patient safety and compliance with maintaining, cleaning and disinfecting sterilize reusable medical devices, contact Infection Control Consulting Services (ICCS). ICCS specializes in provide comprehensive infection prevention and infection control assistance to a wide variety of healthcare organizations, including hospitals, ambulatory surgery centers, outpatient care facilities, clinics and physicians' offices. Contact ICCS by filling out the form here, emailing or calling (215) 692-3485.