CDC Issues Health Alert
Advisory on IFUs

The September 11, 2015 Health Alert Advisory (HAN00323) from the CDC states:

“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.”

In view of this new Alert from the CDC, healthcare facilities should ask their current instrument representatives/suppliers for a copy of their cleaning IFUs that have been validated by an independent laboratory using AAMI and ANSI validation protocols.

When it comes to requesting validated IFUs from instrument manufacturers, Linda Clement, a consultant in sterile processing for STERIS Corporation warns hospital personnel, “Be sure the manufacturer understands you are asking for more than just cleaning instructions (IFUs). You must have the independent laboratory verification that those instructions actually work for cleaning the instrument.”

The IFUs for all AIM Clear Flush® instruments have been validated by independent laboratory testing* using AAMI and ANSI testing protocols to ensure clean, sterile, moisture-free instruments for every patient, every time!

*Nelson Laboratories and Midbrook Biomedical Cleaning Validation reports