No matter how long an infection preventionist has worked alongside a sterile processing department (SPD) manager, it pays to review the basics relating to best practices for the SPD to ensure compliance and to fight healthcare-acquired infections (HAIs).
In her presentation at the 2010 ICT Conference on Professional Development in February, Nancy Chobin, RN, AAS, ACSP, CSPDM, a sterile processing educator and consultant, emphasized the importance of the SPD as the guardian against the spread of infection via medical devices and equipment. And consultant Rose Seavey, RN, BS, MBA, CNOR, CRCST, CSPDT, during a talk at the 57th annual AORN Congress in March, noted that upholding patient safety is the No. 1 goal for the SPD.
The complexity of the SPD’s role has increased and evolved with the times, Chobin says, as well as the fact that medical device sophistication has dramatically increased over the past 20 years. With manufacturers’ instructions varying from device to device and numerous new disinfection and sterilization methodologies available today, the SPD is challenged to stay current. Chobin explains that SPD personnel must be knowledgeable in all aspects of the job with competencies verified, and that SPD staff members’ job descriptions must be upgraded to include qualifications that reflect these technology changes. Because of the complexity of technology and the seriousness of the role in the operative process, Seavey says that SPD personnel should become certified to help ensure competencies and to elevate the profession.
Seavey advises SPD personnel to keep on top of current standards from the Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN) and recommendations outlined in the disinfection and sterilization guideline from the Centers for Disease Control and Prevention (CDC). One of the most critical documents with which SPD personnel must be familiar is AAMI Standard 79, which in 2006 combined five separate standards, and was amended in 2008 and 2009. ST79 is available at www.aami.org.
Chobin says that the main areas of impact in the SPD include: Transport of soiled devices; decontamination; preparation/assembly; sterilization; sterile storage; and transport of sterile product. Some basics to bear in mind:
• SPD attire: The appropriate personal protective equipment (PPE) must be worn by anyone working in the SPD, and its use should be monitored to ensure compliance. Proper hand hygiene should also be implemented.
• SPD design: The design of the department should be adequate for the cleaning, decontamination and sterilization tasks performed. There should be proper ventilation in general and a negative air flow at the decontamination area (department temperature should be within 60 to 65 degrees F with a humidity of 30 percent to 60 percent; 10 air exchanges/hour). Water quality, which minimizes the risk for infection and prolongs the use of instruments, must be ensured. The proper traffic pattern of going from dirty to clean must be observed by staff, and a handwashing sink must be present in both clean and dirty areas of the SPD.
• Reusable devices: Manufacturers’ recommendations for processing instruments and devices must be readily available and must provide instruction for the cleaning, disassembling, handling, assembling, sterilization and packaging these devices. The SPD staff must have the appropriate tools with which to perform their cleaning and decontamination duties.
• Cleaning and decontamination: The cardinal rule is that if it cannot be cleaned, it cannot be sterilized, so thorough and proper cleaning is essential. The proper detergents and decontaminants must be utilized in conjunction with appropriate cleaning mechanics and solutions should be tested daily or with each use. All instruments and devices should be treated as though they are contaminated with infectious pathogens and standard precautions should be followed.
• Sterilization: Sterilization machines must be loaded properly, with heavier objects on the bottom and lighter objects at the top. Sufficient space between items must be ensured so that air/sterilant can circulate properly. Items must be cool to the touch after being sterilized, and they must not be placed under an AC vent to avoid possible condensation that can create wet packs. Biological and chemical indicators must be used properly to maintain sterility assurance.
• Inspection: All surgical instruments must be inspected and tested for cleanliness, functionality and safety, and all multi-component instruments should be checked to ensure all part are present.
• Packaging: Manufacturer’s instructions should be available for all devices, as well as a wide variety of packaging materials and sizes to accommodate all devices. Because packaging materials can affect sterility, SPD staff must use proper application and closure methods for devices to prevent contamination from particulates and microorganisms. Instrument sets must weigh 25 pounds or less including the container; peel packages should only be used for light-weight or small items and should not be placed inside any other tray/set or container.
• Transport: If this step is not performed correctly, contamination can occur, so all items must be confined and contained during the journey from the SPD to the operating room. Closed or covered carts should be used for transport, and soiled instruments should not be transported back to the SPD while they are soaking in solution to prevent spills that could contaminate staff and the environment.
• Sterile storage: Sterilized items should be properly stored in a segregated, protected area to prevent contamination. The temperature of the area should be between 68 degrees F and 75 degrees F, with humidity between 35 percent and 75 percent and with four air exchanges/hour with positive pressure flow. Sterile items should not be stacked haphazardly, as rips and tears in the packaging can result, leading to contamination. Items should be kept 8 to 10 inches off the floor and at least 2 inches from an outside wall.
Finally, Chobin says that a system of process improvement monitoring must be in place to ensure compliance with all stated policies and procedures in the SPD. Identified deficiencies should be remedied and the infection preventionist and the SPD director should make observational rounds to monitor processes.