The following article was originally published in Preventing Infection in Ambulatory Care, the quarterly e-publication from the Association for Professionals in Infection Control and Epidemiology (APIC). To learn more about receiving this resource and joining APIC, visit www.apic.org/ambulatorynewsletter. To learn more about APIC, visit www.apic.org.
The Sterile Processing Department (SPD) plays a major role in minimizing the risk of surgical site infections (SSI). The responsibility of reprocessing medical instruments and supplies takes knowledgeable and accountable people and a workplace that facilitates effective and efficient processing. It is critical that Infection Preventionists (IP) understand and support the roles and responsibilities of SPD.
PUBLISHED RESOURCES
The three major resources for standards and recommended practices for SPD are The Association for the Advancement of Medical Instrumentation (AAMI), The Association of periOperative Registered Nurses (AORN) and the Guidelines for Disinfection and Sterilization in Healthcare Facilities, 2008 by William Rutala, Ph.D, M.P.H., David Weber, M.D., M.P.H and the Healthcare Infection Control Practices Advisory Committee (HICPAC).
AAMI's Comprehensive guide to steam sterilization and sterility assurance in health care facilities (ANSI/AAMI ST79:2006 and ANSI/AAMI/A1:2008/A2:2009) is a complete guideline for all steam sterilization activities. AAMI has combined five recommended practices into this one standard. No matter what the size of the facility or the size of the sterilizer, this is a "must-have" resource that every SPD, Operating Room (OR) and IP should have readily available.
The five recommended practices incorporated into ST79 are:
- ANSI/AAMI ST46, Steam sterilization and sterility assurance in health care facilities
- ANSI/AAMI ST42, Steam sterilization and sterility assurance using table-top sterilizers in office-based, ambulatory-care medical, surgical, and dental facilities
- ANSI/AAMI ST37, Flash sterilization: Steam sterilization of patient care items for immediate use
- ANSI/AAMI ST35, Safe handling and biological decontamination of medical devices in health care facilities and in non-clinical settings
- ANSI/AAMI ST33, Guidelines for the selection and use of reusable rigid sterilization container systems for ethylene oxide sterilization and steam sterilization in health care facilities.
AORN's newest Edition of Perioperative Standards and Recommended Practices (RP) is another "must-have" resource. This document contains many recommended practices related to SPD such as High-Level Disinfection, Cleaning and Processing of Endoscopes, Cleaning and Care of Instruments and Powered Equipment, Selection and Use of Packaging Systems, and Sterilization in the Perioperative Practice Setting.
The HICPAC guideline discusses evidence based recommendations on the preferred methods for cleaning, disinfection and sterilization.
Manufacturers' written recommendations for reprocessing surgical instruments and medical devices should always be on file available to all staff and consistently followed. (1,2,3)
STAFFING CONSIDERATIONS
Responsibility for performing sterilization processes should only be assigned to personnel that are competent in all aspects of disinfection and sterilization procedures as well as safety precautions. Staff should have documented competencies in:
- all phases of decontamination: sorting, disassembly/reassembly, manual and mechanical cleaning methods, microbicidal processes, equipment operation, standard/transmission-based precautions, and engineering and work-practice controls
- the operation of all sterilizing systems
- the principles of sterilization and infectious disease transmission; infection control, and all aspects of sterilization and
- staff safety related to medical device processing and sterilization
"It is recommended that all personnel performing sterile processing activities be certified as a condition of employment. At a minimum, all such personnel should successfully complete a central service certification examination within two years of employment and should maintain that certification throughout their employment." (1)
Personnel assigned to supervisory functions of SPD should be prepared for this responsibility by education, training and experience. At the very least the supervisor should:
- be certified as a Sterile Processing Manager or Supervisor
- demonstrate current knowledge and relevant experience
- demonstrate comprehensive understanding of relevant state and federal regulations, particularly Occupational Safety and Health Administration (OSHA) blood borne pathogens exposure control plan and engineering and work-practice controls (1)
In addition, managers/supervisors should actively participate in health care committees such as infection control, risk management, quality improvement, safety, product evaluation, and standardization. (1)
ATTIRE
General considerations (Section 4.5.1) Uniforms (usually known as scrubs) should be provided by and donned at the health care facilities and worn by all personnel entering the decontamination, preparation, sterilization, and sterile storage areas. Scrubs should be changed daily or more often as required (i.e. when wet, grossly soiled, or visibly contaminated with blood or body fluids). Visibly contaminated scrubs must be laundered in the facility's laundry.
Head and facial hair (except for eyebrows and eyelashes) should be completely covered with a surgical-type hair covering. Jewelry including wristwatches should not be worn in the decontamination, preparation, or sterilization area. (1)
PPE
Personnel protective equipment (PPE) should include a fluid-resistant face mask and eye protection. PPE used to protect the eyes from splash or splatter could include goggles, full-length face shields or other devices that prevent splash exposure from any angle. (1)
General-purpose heavy duty utility gloves and a liquid-resistant covering with long sleeves backless gown, jumpsuit, or surgical gown should be worn when working in the decontamination area. (1)
Upon leaving the decontamination area, all protective attire should be removed, being careful not to contaminate the clothing beneath or their skin. After removal of PPE hands should be thoroughly washed. (1) Used face masks are considered contaminated and should not be worn hanging around the neck, stuffed into a pocket or perched on the forehead. (4)
PHYSICAL DESIGN
Instrument processing functions should be performed in one central department for safety and cost-effectiveness. If the facility cannot centralize all sterilization, processing should be managed by the same person, and consistent policies and procedures should be followed.
There should be a physical separation of where items are decontaminated and where clean items are packaged, sterilized and stored. Mechanical decontamination equipment that processes items and then automatically unloads them into the clean side is recommended.
A pass-thru window, between the decontamination area and the clean area is recommended to progressively move items from being contaminated to being safe to handle.
Floors and walls should be constructed of materials that will withstand everyday cleaning with chemical agents. Carpet is not appropriate in any work areas.
Ceilings should be flush with recessed, enclosed pipes and fixtures and constructed of materials that are not of particulate-or fiber-shedding material. Sterilization, preparation, packaging and sterile storage are considered clean areas and should have positive airflow ventilation. Soiled and decontamination areas should be under negative pressure. Each area should have a minimum of 10 air exchanges per hour. (1)
Work areas should be between 20°C and 23°C (68°F and 73°F). Because of the need to wear PPE, temperature in the decontamination area should be between 16°C and 18°C (60°F and 65°F).
The relative humidity should be maintained between 30% and 60% in all areas. (1)
SPD should receive the same housekeeping procedures as the operating room to ensure a high level of cleanliness at all times.
WATER QUALITY
Water quality supplied to each piece of equipment should meet the manufacturers' requirements. Water quality is key to prolonging the life of medical instrumentals, and more importantly, minimize the risk of patient infection resulting from contaminated medical devices. (5)
CLEANING AND DISINFECTION
Any instruments opened in the OR should be decontaminated even if they have not been used. (6)
Instruments should not be decontaminated in scrub or hand sinks. (1)
SPD should follow all surgical instrument and medical device manufacturers written validated instructions regarding types of cleaning methods (automatic or manual), cleaning agents, and disassembly procedures. (6) To avoid the possibility of aerosolization of microorganisms, brushing lumens and other items should only occur under water. (1)
INSTRUMENT SET WEIGHTS
Due to ergonomic, sterilization and drying issues, packages should not weigh more than 25 pounds, including the wrap or container. (1, 3)
CONTAINMENT DEVICES
Paper-plastic pouches should not be placed within wrapped sets or containment devices. The pouches cannot be positioned to ensure adequate air removal, sterilant contact, and drying. Small perforated, mesh-bottom baskets, absorbent, single-layer flat wrap, medical grade all paper bags or appropriate foam products may be used if they have been validated by the manufacture for this use. (1, 2)
STERILIZATION MONITORING
Sterilization should be monitored by using physical indicators, chemical indicators (CI) and biological indicators (BI) monitors.
Sterilizer graphs, gauges and printouts are considered physical monitors. They provide real-time evaluation of the sterilization conditions and result in permanent records. After cycle completion but before items are removed from the sterilizer, the operator should examine and interpret the chart or printout to verify that all cycle parameters were met and then write their initials on this physical monitor. (1)
CIs are intended to react to one or more of the parameters required for the specific sterilization process. The use of Class 5 CI integrating indicators is strongly recommended because it monitors all the parameters for the cycle, not just one or two. (7)
BIs provide evidence of efficacy by challenging the sterilizer with a large number of highly resistant bacterial spores. Biological monitoring provides a direct measure of the lethality of a sterilization cycle. BI for steam should be run weekly, preferably every day, and in every load containing an implant. (1, 3)
Many facilities are choosing to monitor sterilizer efficacy with every load to eliminate the need to recall in case of a positive BI.
DOCUMENTATION
The following information should be recorded for each sterilization cycle:
- Sterilizer identification
- Type of sterilizer and cycle used
- Lot control number
- Load contents
- Critical parameters for specific sterilization method
- Operator's name
- Results of the sterilization process monitors (i.e., Physical, CI, BI). (1,6)
Sterilization records should be maintained for a time specified by the facility's policies and in compliance with the local, state and federal regulations. (1, 3)
FLASH STERILIZATION
Flash sterilization may increase the risk of infection to patients due to the additional pressure placed on staff to skip steps in the cleaning and sterilization process. Therefore, flash sterilization should be kept to a minimum and only used when there is insufficient time to process by the preferred wrapped method. Flash sterilization should not be the result of insufficient instrument inventory. (3)
Implants are foreign bodies that enhance the risk of surgical site infection; therefore, flash sterilization is not appropriate for implantable devices. (3)
If flash sterilization is unavoidable due to a documented emergency, a rapid-action biological monitoring device should be used along with a class 5 CI. The implant should be quarantined on the back table until the rapid-action indicator provides a negative result.(3)
STERILE STORAGE
The recommended temperature for all sterile storage areas is 24°C (75°F). These areas require at least 4 air exchanges per hour, in a controlled relative humidity that does not exceed 70%. (1)
Sterile items should be stored on or in designated shelving, counters or containers.
Sterile items should be stored:
- 18" below the ceiling (or level of sprinkler head) because adequate space is needed for air circulation and to ensure the effectiveness of sprinkler systems
- 8-10" above the floor to prevent contamination during cleaning and
- 2" for outside walls because of condensation that may form on • interior surfaces of outside walls (1, 3)
The bottom shelf should be solid or contain a physical barrier between the shelf and the floor.
Heavy instruments packages should not be stacked due to the possibility of compression. (1)
Outside shipping containers and corrugated cardboard boxes are exposed to unknown and potentially high microbial contamination and should never be allowed in the sterile storage area. (1, 3)
TRANSPORTATION
Sterile items should be transported in covered or enclosed carts with solid-bottom shelves. If transported by hand, sterile packages that contain instrumentation should be kept parallel to the floor. (1)
Contaminated items should be contained and transported to the decontamination area or soiled utility area in containers, devices or carts labeled as biohazard as soon as possible. Dirty items should be separated from the clean and sterile supplies. (1, 3)
Items should be kept moist in the transport container by adding a moist towel (water, not saline) or using a foam, spray or gel product, specifically intended for this use. (1)
Transport vehicles used for off-site transportation, (motorized or manual) should be totally enclosed and leak free and constructed of material that allows for proper decontamination processes. (1)
TRAFFIC CONTROL
Traffic control practices are necessary to minimize the potential for contamination in the processing area and to protect personnel and visitors from the microorganisms present on contaminated items in the decontamination area. Only authorized personnel in appropriate attire should be allowed in decontamination, preparation and packaging, sterilization processing and sterile storage areas. (1)
LOANER INSTRUMENTATION PROGRAM
The management of loaner instrumentation and implants is recognized as a major concern by many healthcare professionals.
All instruments including those packaged and sterilized by another healthcare facility should be reprocessed according to the manufacturers' written recommendations by the receiving health care facility before use. Managing loaner instrumentation entails planning. The SPD needs time to inventory, inspect, clean, package and sterilize loaner instrumentation. In addition, if there are implants, they must be quarantined until the BI reads negative. As with all sterilized items, loaner items should be traceable to the patient. A well written policy with controls for enforcement and consequence should be developed and routinely followed. (1,3,8)
SUMMARY
The IP should be familiar with current best practices in SPD. The information in this article will help the IP to assess the SPD for compliance with best practices.
References
1. The Association for the Advancement of Medical Instrumentation. Comprehensive guide to steam sterilization and sterility assurance in health care facilities. ANSI/AAMI ST79:2006 and ANSI/AAMI/A1:2008/ A2:2009
2. Recommended Practices for Selection and Use of Packaging Systems. Association of periOperative Registered Nurses. AORN Standards and Recommended Practices 2009.
3. Recommended Practices for Sterilization in the Perioperative Practice Setting, Association of periOperative Registered Nurses. AORN Standards and Recommended Practices 2009.
4. Recommended Practices for Surgical Attire. Association of periOperative Registered Nurses. AORN Standards and Recommended Practices 2009.
5. The Association for the Advancement of Medical Instrumentation. Water for the reprocessing of medical devices. AAMI TIR34:2007.
6. Recommended Practices for Cleaning and Care of Surgical Instruments and Powered Equipment, Association of periOperative Registered Nurses. AORN Standards and Recommended Practices 2009.
7. Spry, C. Using Steam Sterilization Monitors. Managing Infection Control, June, 2008 Volume Eight Issue 6.
8. Seavey, Rose. Loaner Instrumentation-Keeping Patient Safety First! Managing Infection Control. April 2007.
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