Did CMS revise guidelines addressing flash sterilization?
Flash steam sterilization was originally defined by Underwood and Perkins as sterilization of an unwrapped object at 132 degrees C for 3 minutes at 27-28 lbs. of pressure in a gravity displacement sterilizer. Currently, the time required for flash sterilization depends on the type of sterilizer and the type of item (i.e., porous vs. non-porous items).
The CDC published Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. In this document flash sterilization is addressed. The CDC states:
- Flash sterilization is considered acceptable for processing cleaned patient-care items that cannot be packaged, sterilized, and stored before use.
- It also is used when there is insufficient time to sterilize an item by the preferred package method.
- Flash sterilization should not be used for reasons of convenience, as an alternative to purchasing additional instrument sets, or to save time.
- Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body); however, flash sterilization may be unavoidable for some devices (e.g., orthopedic screw, plates).
- If flash sterilization of an implantable device is unavoidable, recordkeeping (i.e., load identification, patient's name/hospital identifier, and biological indicator result) is essential for epidemiological tracking (e.g., of surgical site infection, tracing results of biological indicators to patients who received the item to document sterility), and for an assessment of the reliability of the sterilization process (e.g., evaluation of biological monitoring records and sterilization maintenance records noting preventive maintenance and repairs with dates).
- The standard biological indicator used for monitoring full-cycle steam sterilizers does not provide reliable monitoring flash sterilizers. Biological indicators specifically designed for monitoring flash sterilization are now available
- Do not flash sterilize implanted surgical devices unless doing so is unavoidable.
- Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time.
- When using flash sterilization, make sure the following parameters are met:
- Clean the item before placing it in the sterilizing container (that are FDA cleared for use with flash sterilization) or tray;
- Prevent exogenous contamination of the item during transport from the sterilizer to the patient; and
- Monitor sterilizer function with mechanical, chemical, and biologic monitors.
- Do not use packaging materials and containers in flash sterilization cycles unless the sterilizer and the packaging material/container are designed for this use.
- When necessary, use flash sterilization for patient-care items that will be used immediately (e.g., to reprocess an inadvertently dropped instrument).
- When necessary, use flash sterilization for processing patient-care items that cannot be packaged, sterilized, and stored before use.
AORN is in line with CDC recommendations with the following additional recommendations:
- When using flash sterilization the manufacturer's instructions for the item to be flash sterilized should be followed; cycle type, exposure times, temperature settings, drying times
- Items are to be fully taken a part and thoroughly cleaned with an approved detergent
- Lumens are brushed and flushed according to policy and procedure before flash sterilization
- Items should be placed in a closed container or tray that is approved for flash sterilization
- A flash sterilization log should be maintained. Information to be logged includes patient name and identifying information, date and time of the cycle, item flash sterilized, cycle information, monitoring results, reason for flash sterilization and individual's name who is flash sterilizing the item.
CMS Conditions of Participation state under the Infection Control Regulations:
- The hospital's program for prevention, control and investigation of infections and communicable diseases should be conducted in accordance with nationally recognized infection control practices or guidelines, as well as applicable regulations of other federal or state agencies. Examples of organizations that promulgate nationally recognized infection and communicable disease control guidelines, and/or recommendations include: the Centers for Disease Control and Prevention (CDC), the Association for Professionals in Infection Control and Epidemiology (APIC), the Society for Healthcare Epidemiology of America (SHEA), and the Association of periOperative Registered Nurses (AORN).
Healthcare organizations can expect accreditation surveyors to observe the sterilization process including flash sterilization.
CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008, William A. Rutala, Ph.D., M.P.H., David J. Weber, M.D., M.P.H., and the Healthcare Infection Control Practices Advisory Committee (HICPAC), http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_Nov_2008.pdf
AORN, Peri-operative Standards and Recommended Practices, 2009 Edition
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