The Spaulding Classification categorizes medical devices based on their risk of infection to help determine what level of disinfection or sterilization is required to render them safe for reuse. The American Society for Gastrointestinal Endoscopy’s (ASGE) Multisociety guideline on reprocessing flexible GI endoscopes: 2016 update describes the three classes as critical, semi-critical, and non-critical. While healthcare has followed the Spaulding classification system to determine the required level of processing for medical devices for decades, infection outbreaks related to contaminated devices, most notably endoscopes, have prompted hospitals, manufacturers, regulators and industry associations to reevaluate the processing of reusable medical equipment.
ClorDiSys Solutions’ Brand Manager, Emily Lorcheim, was asked by Healthcare Purchasing News when, why and how to choose high-level disinfection or sterilization. Her response was “Issues on determining whether high-level disinfection or sterilization is appropriate are many times based off the intended application. Disinfection is defined as a 99.99% to 99.999% level of kill, whereas sterilization is the elimination of all organisms and results in a 99.9999%, or 6-log sporicidal reduction. Sterilization is required in healthcare for applications such as implantable medical devices, or if there is a major occurrence of a significant disease.” Emily added “High-level disinfection is key on items that should be rid of organisms often, due to frequent human contact and therefore potential contamination. These items can include cell phones, tablets, office supplies, remotes, etc. Another opportunity where measures of high-level disinfection can be utilized is on external medical equipment that either cannot be easily cleaned due to size restraints or being fixed in position, or cannot be treated with certain sterilizing chemicals or conditions. Methods may cause material damages, especially liquid methods, which may be corrosive or leave residues.”
Most healthcare facilities use an array of processes to clean, disinfect and sterilize surgical equipment and instrumentation. Emily points out “many times sterilization methods require long exposure times, harsh chemicals, sealing spaces off or separate chambers… many of these methods are not conducive to the fast-paced environment of the healthcare setting. High-level disinfection can be applied in a variety of methods, quickly, easily and effectively to maintain a safe healthcare environment.” Regardless of the modality, high-level disinfection or sterilization, a device won’t be safe for use unless it has been properly cleaned according to the manufacturer’s IFU. Attention must be dedicated to the training, certification and competencies for individuals performing these cleaning activities, because as Damien Berg, Regional Manager of Sterile Processing at UCHealth, stated “We don’t ever want to say no to a product that could save a life, but we also don’t want to hurt a life by agreeing to a product that is too challenging to clean or for which we don’t have the necessary technology to process.”
Click here to read Kara Nadeau’s “Disinfection by Degrees” article in its entirety.
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