It is imperative that every single step and detail in the reprocessing/sterilization process is performed precisely in accordance with the medical device and equipment manufacturers’ instruction for use (IFU). There are absolutely no short cuts in the sterilization process. All policies and procedures must be followed for cleaning, disinfection, inspection, assembly, instrument positioning, packaging, loading sterilizer, sterilizer operation, cycle settings, monitoring, documentation, and adherence to aseptic techniques.

Clearly, sterilization is a complex and very precise process and one that cannot be rushed. For that reason all professional entities agree and recommend that the use of IUSS be reserved for true emergency and/or unanticipated events. Having inadequate instrumentation to meet surgical case load needs is not considered an emergency or unanticipated event. Surveyors from CMS, TJC, and other accrediting bodies will be looking at the efficacy of the entire sterilization process, not merely how many IUSS cycles are run. They will also assess your adherence to professional guidelines and standards relative to managing and monitoring all sterilization processing, including IUSS.

As a quality improvement initiative, you may want to consider benchmarking your own IUSS cycle rates against themselves to demonstrate that you are managing the process and implementing measures to reserve the use of IUSS to the unanticipated events. Calculate your IUSS rates by dividing the number of IUSS cycles per month by the number of procedures per month.

QIs it essential to sanitize all soiled items returned to CS, or is decontamination/disinfection sufficient prior to sterilization?

Sanitization is suitable for easily-killed microorganisms and can reduce the number of microbial contaminants on an inanimate surface to a relatively safe level. Following thorough cleaning, the objects are rinsed in hot water or steam-purged for a designated period of time depending on method used. Examples of sanitizing equipment include cart washes, steam guns, and dishwashers. Sanitization is adequate for items that only come in contact with the surface of unbroken skin. Disinfection provides a higher level of safety and can be used on work surfaces, medical devices and equipment that have come in contact with highly contaminated substances, body fluids and blood. The disinfection process may be accomplished either by a thermal or chemical exposure. Pasteurization is an example of a thermal disinfection process. It involves exposing an object to a hot water bath at between 150 and 170 degrees Fahrenheit for 30 minutes. Contact with water at or above 180 to 205 degrees Fahrenheit for one minute can provide an intermediate level of disinfection. This is the process used in automated instrument washers during the final rinse.

Chemical disinfection processes employ various liquid chemicals that contain agents such as quaternary ammonium compounds, iodophors, hydrogen peroxide, phenolics, chlorine compounds and glutaraldehydes. Chemical disinfection can be a complicated process, and careful selection of the appropriate chemical for each medical device or piece of equipment is imperative. Labeling will identify a chemical’s active ingredients and concentrations and provide the scope and spectrum of microbicidal activity. Directions for use must be followed precisely, including required contact time and temperature. It is essential to follow the device manufacturer’s IFU for proper cleaning and disinfection.