Surgical instruments and other reusable devices must be effectively reprocessed so they are safe and functional for patient use. Before an instrument can go through sterilization or high-level disinfection, it must be cleaned. To ensure quality outcomes for the patient, the cleaning process requires consistency and standardization.
Before reviewing the details of the process, it's important to understand the distinction between "cleaning" and "disinfection." Here are a few key definitions to know:
Next, let's review the steps in reprocessing surgical instruments starting from point-of-use to manual cleaning and finally automated cleaning using a washer/disinfector or ultrasonic cleaner.
The first step in cleaning a surgical instrument is to initiate pre-treatment. Instrument transport gels, like Pre-Klenz™ Point of Use Preprocessing Gel, help initiate the cleaning process of surgical, endoscopic, and robotic instruments immediately after use. Instrument transport gels prevent the drying of bioburden, which can decrease the time needed to manually clean at the sink, as well as loosen soils.
After point-of-use pre-cleaning, instruments are transported to the decontamination area of the Sterile Processing Department (SPD) to begin manual cleaning. Manual cleaning should be performed on all instruments but may be recommended as the preferred method of cleaning for delicate or complex devices, such as endoscopes or microsurgical instruments. Devices must be removed from the transportation container and disassembled to expose all the surfaces to the cleaning process. Always follow the device's Instructions for Use (IFU) for comprehensive instructions for cleaning and disassembly.
For manual cleaning, a three bay sink configuration is recommended. When using a three bay configuration:
After manual cleaning, most devices are then processed through automated cleaning technologies such as ultrasonic cleaning systems and washer/disinfectors.
Ultrasonic cleaning is used for fine cleaning of instruments with hard-to-reach areas like crevices, hinges, and lumens. After manual cleaning, the devices should be sorted based on metal to prevent damage. For example, aluminum instruments can react with stainless steel if immersed together, causing etching, or replating to the devices.
Ultrasonic cleaners work through cavitation where high-frequency sonic waves create tiny bubbles on the surfaces of the instruments which eventually implode. The implosion of these bubbles helps to dislodge soil from the surface of the device. Low-foaming enzymatic cleaners can be used in ultrasonic cleaners, assuming the foam does not interfere with the cavitation process. After the ultrasonic cleaning process, the instruments must be thoroughly rinsed with either deionized or softened water.
Advantages of ultrasonic cleaning include a reduction of time spent to clean complex instruments and removal of residual soil, however not all materials or devices are compatible with this type of cleaning.
The mechanical cleaning action of washer/disinfectors relies on spray arm technology with pressurized water to help clean surgical instruments or other reusable devices. The load inside a washer/disinfector is exposed to a specific water temperature, chemical concentration, and flow rate. The thermal rinse phase in a washer/disinfector provides a level of disinfection. An optional drying phase can be added to reduce manual drying.
Successful cleaning using washer/disinfectors depends on four parameters within the cycle:
• When enzymatic cleaning chemistries are used in washer/disinfectors, they typically work best between 100-140 F/32-60 C with detergents typically being used in ranges between 122-180 F/50-82 C. This can vary by manufacturer.
Washer/disinfector cleaning offers consistency and productivity, as parameter control is easier. Staff must be properly trained on device loading to ensure effective use.
If after manual and mechanical cleaning soil is still present, this can present several risks, with the most severe being the risk of transmission to patients. In addition, residual soils left on devices can damage the device's surfaces or ability to function correctly.
If soils are left on surgical instruments or reusable devices after cleaning, common causes could be:
After cleaning, all devices should be visually inspected thoroughly with a lighted magnifying glass. In addition to routine visual inspection, there are several methods that can be used to test cleaning efficacy:
There are a variety of standards surrounding cleaning surgical instruments and medical devices. Governing agencies, including AAMI/ANSI, FDA, and AORN release guidelines for cleaning and disinfection. Specific device IFUs should always be followed to ensure the device is reprocessed according to the manufacturer. The specific standards/guidelines around cleaning are spread throughout many standards, but the most common ones are:
Cleaning is an important step in the reprocessing of a reusable device or surgical instrument. Both manual and automated cleaning can be used and the methods will vary based on the device. Cleaning reusable devices is important to prevent what we can see – including device damage – as well as what we can't see like pathogenic microorganisms or transmissible proteins. If devices are not clean, they cannot be properly sterilized, or high-level disinfected.