The Centers for Disease Control and Prevention (CDA) consider laryngoscope blades and LMAs to be semi-critical equipment under the Spaulding Classification. According to CDC and Association for Professionals in Infection Control and Epidemiology (APIC), this equipment must be either sterilized or high-level disinfected (HLD) per the manufacture’s instructions for use (IFUs) because they come into contact with the patient’s mucous membranes of the respiratory tract. QUAD A recently posted guidance for its accredited facilities indicating that surveyors will review compliance with this requirement.
Furthermore, “[l]aryngoscope blades and LMAs must be stored to maintain a level of cleanliness, not sterility. They do not need to be sterilized in a peel pouch. The use of either sterilization or HLD is acceptable depending upon the IFUs for the individual item.” For reusable LMAs, a tracking system must be implemented that comports with the IFUs, showing the maximum number of times they may be resterilized, which typically is 10 sterilization cycles.
QUAD A surveyors will:
- evaluate whether the equipment is sanitized for the next patient in accordance with these requirements.
- verify the number of times the reusable LMA has been resterilized.
- Issue citations if laryngoscope blades are on the anesthesia cart with no identification of having been sanitized with HLD, at a minimum.