The 2008 “Guideline for Disinfection and Sterilization in Healthcare Facilities,” authored by William Rutala, PhD, MPH, David Weber, MD, MPH, and the Healthcare Infection Control Practices Advisory Committee (HICPAC), was finally issued in November following a significant delay caused by disagreement over several issues, including the recommended exposure time for achieving high-level disinfection with greater than 2 percent glutaraldehyde.
“This delay has occurred even though the Centers for Disease Control and Prevention (CDC) guidelines are evidence-based and there are greater than 30 peer-reviewed publications that demonstrate the effectiveness of greater than 2 percent glutaraldehyde at 20 minutes and 20 degrees Celsius provided cleaning precedes disinfection,” says Rutala. “In addition, all professional organizations such as SHEA, APIC, ASGE, ACG, AGA, SGNA, AORN, and The Joint Commission that have a recommendation on this subject, recommend 20 minutes and 20 degrees C for greater than 2 percent glutaraldehyde.”
Rutala explains that HICPAC accepted the guideline for publication in February 2003; however, the Food and Drug Administration (FDA) had not cleared the guideline because it makes a recommendation that is contrary to an FDA-cleared label claim (45 minutes at 25 degrees C for greater than 2 percent glutaraldehyde). “This disagreement persists even though the guideline states that if the user selects exposure conditions that differ from those in the FDA-cleared labeling for high-level disinfection, the user assumes liability for any injuries resulting from off-label use. In addition, because the FDA-cleared label claim is based on a test that does not allow cleaning, is conducted in the presence of horse serum (i.e., protein load), and uses an extremely high number of mycobacteria (100,000 to 1,000,000), an extended immersion time and elevated temperature are necessary to inactivate 100 percent of the mycobacteria. When cleaning is performed, the time to achieve high-level disinfection is reduced. While this issue of glutaraldehyde use at 20/20 was supposed to have been resolved on several occasions it remained why the guideline was not published.”