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.
Flash sterilization has always been a controversial topic. Because of abuse, lack of knowledge and poor habits, flash sterilization is often discussed in a negative context, and is frequently mentioned in the headlines of many healthcare publications.
Sterile is Sterile, Period
Sterilization is an absolute. A product or piece of equipment is either sterile or it is not. There is no "almost" or "close enough" when it comes to sterilization. Smaller autoclaves designed for flashing are as efficient as the larger autoclaves found in the sterile processing department (SPD) designed for terminal sterilization. The real difference with flashing is the lack of drying time and the requirement to use the devices immediately.
The issues and concerns focus on what happens before the devices go into the sterilizer (the disassembly, pre-cleaning, and packaging of the instrumentation), and what happens after they come out (the transportation of the sterilized items to the point of use). These are the extremely important steps that often get missed during flash sterilization. Even when attempted, these steps may be improperly completed due to the demand for "quick turnarounds." Another common error with flash sterilization is using the wrong type of sterilization cycle (either gravity, prevacuum, or steam-flush pressure-pulse), the wrong temperature, or an insufficient amount of exposure time to ensure sterility.
Cycle Selection
In the past, flash sterilization was defined by Underwood and Perkins as a sterilization cycle of an unwrapped object at 132oC (270oF) for 3 minutes at 27-28 lbs. of pressure in a gravity displacement sterilizer.[1] Today's instrumentation is more technologically advanced with complex designs that make sterilization much more challenging. As a result, these sophisticated devices require specific cleaning and sterilization instructions. Current published recommended practices and guidelines tell us the manufacturers' recommendations must be followed or sterilization cannot be assured.[2, 3]
The Joint Commission Update
In the summer of 2009, the Joint Commission (TJC) announced their updated position on steam sterilization. In this update, they describe how the surveyors were now going to evaluate or review sterilization practices to include a close observation of all critical aspects of the sterilization method and process-related issues. Rather than referring to flash sterilization, TJC described this process as "less than a full sterilization cycle."[4] This statement caused some confusion and misunderstanding among healthcare professionals concerning the safe performance of flash (or immediate-use) sterilization cycles.
CMS Surveys
In the fall of 2009, the Centers for Medicare and Medicaid Services (CMS) declared that state survey agencies had experienced challenges evaluating the use of "flash sterilization." The CMS memorandum described how to distinguish appropriate from inappropriate use of flash sterilization in ambulatory surgery centers (ASCs). To help surveyors review appropriateness of the sterilization process, CMS developed a list of questions for the surveyors to use during the survey.[5] CMS used the term "short cycles" in reference to flash sterilization. The variety of terms (flashing, short cycle, less than full cycle, immediate use) has added to the confusion among healthcare providers.
AORN and AAMI
The Association of periOperative Registered Nurses (AORN) and the Association for the Advancement of Medical Instrumentation (AAMI) develop published guidelines and recommendations on sterilization. Perioperative and sterile processing department (SPD) professionals use these guidelines when developing policies regarding sterilization.
AORN and AAMI describe flash sterilization as a process designed for the steam sterilization of patient care items for immediate use.[2,3]
Need for Consensus and Collaboration
Due to the ongoing confusion and to help clarify recommendations, in April 2010, AAMI organized a meeting with professional organizations and regulatory agencies to discuss the sterilization of items intended for immediate use. Representatives from the Food and Drug Administration, Centers for Disease Control and Prevention (CDC), TJC, CMS, American Dental Association, AORN, APIC, International Association of Healthcare Central Service Materiel Management, American Society of Cataract and Refractive Surgery, American Association for Accreditation for Ambulatory Surgery Facilities, Inc., and Accreditation Association for Ambulatory Healthcare attended the April meeting and a subsequent conference call held in August 2010.
During the collaborative meeting, attendees reviewed the various guidelines and position statements of each organization with the intent to draft a multi-society position statement addressing flash sterilization. Reaching consensus with so many organizations and agencies is a long and difficult process. The group is working on a draft position statement at this time. Once a consensus is achieved on the draft, it will be presented to the leadership of the various organizations for endorsement. The group hopes to see the final multi-society position paper published later in 2010 or in early 2011.
"Flash" – An Outdated Term
As the work toward a new consensus is progressing, it is important to remember that "flash sterilization" is an outdated term and no longer reflects the current definition of the abbreviated sterilization cycles used in today's healthcare environments. Today there is no single standard "flash" cycle for all devices. To ensure effective sterilization processes, multiple factors must be evaluated, including the device manufacturers' recommendations for cycle type, exposure time, the load composition, and container manufacturer's directions for use.
Sterilization cycles with little or no dry time are available, safe, and efficacious when done correctly and when only used to process instruments intended for immediate use. For this reason, "immediate-use sterilization" is a term that more accurately describes the recommended sterilization process for items not intended to have a shelf life.[6]
The Real Issues with Immediate-Use Sterilization
If all the steps are not performed properly, immediate-use sterilization may increase the risk of infection. Therefore, "immediate use-sterilization" should be kept to a minimum and only used when there is insufficient time to process by the preferred terminal sterilization method. "Immediate-use sterilization" should not be a result of insufficient instrument inventory.[2]
Devices sterilized for immediate use should have the same level of cleaning and preparation as instruments being terminally sterilized. The most current AORN recommendations state: "Immediate-use sterilization" should be performed only if all of the following conditions are met:
- "The device manufacturer's written instructions on cycle type, exposure times, temperature setting, and drying times (if recommended) are available and followed.
- Items are disassembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats, and other substances.
- Lumens are brushed and flushed under water with a cleaning solution and rinsed thoroughly.
- Items are placed in a closed sterilization container or tray, validated for flash sterilization, in a manner that allows steam to contact all instrument surfaces.
- Measures are taken to prevent contamination during transfer to the sterile field."[2]
TJC and CMS also require that instruments be protected from sterilizer to point of use during transportation.[4,5]
Documentation
To ensure the sterilization process is monitored, the cycle parameters have been met, and to establish accountability, documentation of the sterilization process is necessary.
The following information must 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 and;
- Results of the sterilization process monitors (i.e., Physical, CI, BI).[2,3]
The process of "immediate-use sterilization" is efficacious, if and only if, all of the critical steps of cleaning, decontamination, and aseptic transportation accompany the sterilization cycle.
Published Resources
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.
AORN's newest edition of Perioperative Standards and Recommended Practices 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 CDC's Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008 is another resource for valuable information and can be downloaded for free at http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_ Nov_2008.pdf.
References
1. Rutala, WA, Weber DJ. Healthcare Infection Control Practices Advisory Committee. Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008. http://www.cdc.gov/ncidod/dhqp/pdf/guidelines/Disinfection_ Nov_2008.pdf Accessed 8/20/2010.
2. Recommended Practices for Sterilization in the Perioperative Practice setting. In: Association of peri-Operative Registered Nurses (AORN). Perioperative Standards and Recommended Practices. Denver: Association of peri-Operative Registered Nurses, 2010: 457-480.
3. Association for the Advancement of Medical Instrumentation (AAMI) (ST79:2006, A1:2008 and A1:2009). Comprehensive guide to steam sterilization and sterility assurance in health care facilities. Arlington: Association of the Advancement of Medical Instrumentation.
4. Update: The Joint Commission's Position on Steam Sterilization. In: The Joint Commission Perspective, July 2009, Vol. 29, Number 7; p. 8,11.
5. Centers for Medicaid and State Operations/Survey & Certification Group. State Operations Manual (SOM) Appendix L, Ambulatory Surgical Centers (ASC) Comprehensive Revision. In: Memorandum to State Survey Agency Directors. Available at: http://www.cms.gov/SurveyCertificationGenInfo/downloads/SCLetter09_ 37.pdf. Accessed 8/23/2010.
6. Stanton, C. Gathering consensus on steam sterilization. AORN Connections; June 2010. Available at: http://www.aorn.org/News/June2010News/Flash. Accessed 8/20/2010.
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