“Sterile Processing” is both a place and a process. Today, we will focus on the process. The primary goal of sterile processing is to eliminate all forms of microbial life from the surfaces of surgical devices and instruments. This includes, but is not limited to bacteria, viruses, fungi, and many other microorganisms. Sterile processing is the decontamination, cleaning, rinsing, inspection, repair or replacement of damaged instruments, packaging, sterilization, and preparation of surgical instruments, devices and equipment for safe use in the care of patients in hospitals, ambulatory surgery centers (ASCs), and other healthcare facilities. These processes are carried out by Sterile Processing Technicians, the front-line warriors, hidden in a behind-the-scenes lair that is often ignored and unseen until there is a problem identified in the operating room. The critical role of sterile processing in healthcare is to ensure patient safety and infection prevention and control, through attention to detail throughout every step of the reprocessing cycle. Sterile processing employs the use of a variety of chemical agents including, detergents, disinfectants, sterilants, and other cleaners. The use of the correct chemical for the job is critical for removing all bioburden and microorganisms before using the instruments on or in another patient. They must also use the correct dosage of each chemical, so as to not leave residue on any surfaces or do damage to the device they are cleaning. Adhering to the established industry standards and following the instructions for use (IFUs) to the letter protects patients and staff and leads to a longer useful life for the instruments. Taking shortcuts can lead to negative patient outcomes and early deterioration of surgical instruments and containers. The critical tasks of sterile processing are carried out in four strategically defined areas of the Sterile Processing Department (SPD).
The first of these task areas is Decontamination. Cleaning is the critical first step and should actually begin at the point of use, in the operating room. Gross soil should be removed at the point of use and a multi-enzymatic pre-soak spray should be applied, to keep instruments moist until processed in the decontamination area. This will prevent bioburden from drying on the instruments and biofilms from forming. The quicker the contaminated instrumentation can be cleaned, following the surgical procedure, the better. The use of a liquid multi-enzymatic pre-soak cleaner can speed up the cleaning process by beginning the breakdown of bioburden at the point of use, increasing productivity in Decontamination and reducing turnaround time. Only detergents, meeting all the ANSI/AAMI: ST79 guidelines for a quality detergent, should be used. For additional safety, Decontamination staff should also watch for the “Safer Choice” label, for cleaners certified by the U.S. EPA. The decontamination process involves disassembling all instruments for cleaning in accordance with the manufacturer’s instructions. Proper disassembly is essential to ensure thorough cleaning, whether performed manually at the sink using sponges and brushes, or with ultrasonic cleaners and automated washers. Failure to disassemble instruments correctly can result in incomplete cleaning, which may compromise subsequent disinfection or sterilization procedures. This will interfere with subsequent disinfection or sterilization. Whether cleaning manually or mechanically, a thorough rinse under the flow of water is critical for removing bioburden and leaving no detergent residue. There should always be a thorough rinse after every step of the cleaning and decontamination process.
After Decontamination, the next area in sterile processing is Inspection, Assembly and Packaging. Every instrument should be inspected after each use, during the set assembly process. They should be inspected for proper function, damage, missing parts, and any bioburden or detergent residue. Rigid sterilization containers are also inspected for physical and surface damage. The lid and base should fit securely, gaskets should be intact, latches should be fully functional, and filter retention plates should be flat, lock onto the positioning pins, and hold filters in place over vents in the containers. Physical properties such as surface integrity should also be inspected. Following Inspection, each instrument is placed into the proper set by using a count sheet of instruments for each set. Completing this process from memory, without a countsheet, leads to errors. After Assembly, the basket of set contents is packaged, with the appropriate filters and chemical indicators, into appropriately sized rigid sterilization containers or are wrapped in polypropylene wraps.
From the Packaging area, the instrument set moves to the Sterilization area where a variety of sterilants and equipment are used to sterilize the instruments, depending on the instruments or devices being sterilized. The instrument manufacturer always provides written instruction for use that must be followed exactly, so instruments are properly and fully cleaned, while at the same time not doing any damage to the device itself. The most commonly used method of sterilization is by the use of steam in an autoclave. Another commonly used method includes low temperature sterilizers, like STERRAD and V-Pro, which use hydrogen peroxide instead of steam. Other sterilization methods include Ethylene Oxide (EtO), Nitrogen Oxide (NO2) and dry heat. Non-steam sterilization is used for instruments and devices that are heat sensitive and/or are extremely delicate in construction. High-level disinfection is used for items that don’t need to be sterilized or when it is impractical because of how the devices are used. Some instruments can only be high-level disinfected, through the use of liquid sterilants.
The last task area in sterile processing is Storage and Distribution. After the instrument sets are sterilized and properly cooled, they are placed on shelving or in carts in a sterile storage area. They are stored in this area until needed for the next surgical procedure. The instrument sets are kept in this area, where sterility can be monitored and maintained. They are not removed from this area until needed for patient care.
Sterile processing is the science of reprocessing surgical instruments and other medical devices for safe reuse in healthcare facilities. It is the process of rendering surgical instruments functional, safe and sterilized or high level disinfected for use on the next patient. Sterile processing is an extremely detailed scientific process that intentionally strives to provide patient safety and infection prevention and control, while maintaining the longest possible life for the instruments and devices they process.
