Guideline for high-level disinfection
The AORN Guideline for High-Level Disinfection provides guidance for the safe and effective high-level disinfection (HLD) of reusable instruments and equipment in perioperative and procedural settings. It is designed for areas such as operating rooms, ambulatory surgery centers, physician offices, endoscopy suites, radiology departments, and other locations where invasive procedures are performed.
A central principle is the Spaulding classification system, which categorizes devices as critical, semicritical, or noncritical based on how they are used. Critical items require sterilization, semicritical items require at least high-level disinfection, and noncritical items generally require intermediate- or low-level disinfection or cleaning.
The guideline strongly emphasizes that thorough cleaning must occur before HLD. Blood, tissue, organic debris, and biofilm can interfere with disinfectant effectiveness, making immediate and meticulous cleaning an essential part of preventing disease transmission. Complex devices with lumens, joints, ports, and channels require particular attention.
HLD may be achieved through thermal methods such as pasteurization or through FDA-cleared chemical disinfectants. Chemical agents should be selected based on effectiveness, material compatibility, concentration, temperature, exposure time, and manufacturer instructions. Devices must be completely immersed, with lumens and channels filled so that all surfaces contact the disinfectant.
The document also places significant emphasis on worker safety. Personnel handling disinfectants should use appropriate PPE, work in properly ventilated environments, and follow safe chemical handling and disposal procedures because some HLD agents can cause respiratory, skin, eye, or allergic reactions.
Personnel performing HLD should receive initial and ongoing education, training, and competency validation, including instruction on decontamination, chemical use, PPE, equipment, and device-specific procedures. Detailed processing records should also be maintained to support traceability, regulatory compliance, and investigation of adverse events.
Finally, the guideline recommends formal policies, procedures, and quality-control programs covering equipment testing, solution concentration, competency, documentation, adverse-event investigation, and continuous performance improvement.
In short: the guideline provides a structured approach to HLD that focuses on proper device classification, meticulous cleaning, correct disinfectant use, worker protection, staff competency, documentation, and quality assurance to reduce the risk of infection and reprocessing failures.