By Trish L. Stoutzenberger
Immediate-use steam sterilization, formally referred to as flash sterilization, is currently a topic getting much attention by operating room and sterile processing personnel across the country. As a sterile processing manager of a large facility, I am keenly aware of the challenges involved with following best practices and guidelines to perform the complex procedure of sterilizing instruments for immediate use. The Joint Commission received intense training in the entire process just last year and the surveyors will be certain to visit the operating room sub-sterile during their annual survey.
When performed correctly and when deemed appropriate, immediate-use steam sterilization is an effective and safe way to sterilize critical medical devices for a surgical procedure (CDC, 2008). However, this process is complex and requires a facility to consistently follow all the necessary steps each time to ensure the sterility of the instruments to the point of use. There can be no margin of error. Improper technique can result in the use of contaminated instruments in surgery resulting in serious consequences including surgical site infections (SSI). It is because of this risk that all operating rooms should reduce their reliance and use of this process. Facilities should take action and increase their surgical instrument inventory, employ a scheduling conflict mechanism, improve communications between the operating room and sterile processing personnel, and educate all those involved with immediate-use steam sterilization.
Issues and Concerns
The serious consequence of an SSI is the No. 1 concern of improper use of immediate-use steam sterilization. According to the CDC, SSIs affect 2 percent to 5 percent of all patients undergoing surgery. That is equal to about 300,000 patients each year. Patients with an SSI have a 3 percent mortality rate. In addition, SSIs can increase of hospital length of stay for up to seven to 10 days. The increase hospital stay equates to increase costs of $3,000 to $29,000 per SSI with upwards of $10 billion annually (CDC, 2011). There are many causes of SSIs, and proper sterilization is just one factor of prevention. Nonetheless, it is an important factor as facilities continue to strive to reduce its number of hospital acquired infections.
The obstacle for facilities to reduce risk of SSIs is lack of education and understanding of current processes. In early 2011, a multi-society position statement addressing immediate-use steam sterilization of surgical instruments was released by American Association for the Advancement of Medical Instrumentation (AAMI), the Association of periOperative Registered Nurses (AORN), and several other national organizations. This statement stressed the importance of education for the personnel directly involved in reprocessing of surgical instruments to the point of use. Furthermore, surgical and sterile processing personnel should be knowledgeable regarding the different types of steam sterilization cycles, standards and practices, cleaning, decontamination and rinsing processes, and correct aseptic transfer from the sterilizer to the point of use (AORN, 2011a).
The last major concern, which is also addressed in the position statement, is manufacturers instructions for use. The world of surgery is now more technologically advanced. That new technology introduces more complex instruments and more complex manufacturers instructions. A facility is required to follow those instructions as the manufacturers perform the quality testing of their instruments and they determine which steam cycles are successful. The problem is that their instructions do not always match the cycles available of a flash sterilizer in an operating room. If a facility chooses to sterilize an instrument tray without following these instructions, the sterility of the instruments is in question and they are putting their patients at risk.
Standards and Guidelines
Although standards are voluntary, facilities should strive for best practice. AORN and AAMI standards are written as achievable practices for most facilities. According to AORN standards, immediate-use steam sterilization should only be used in selected clinical situations. Those situations include the following:
When a one-of-a-kind instrument has been contaminated and needs to be replaced to the sterile field immediately.
When an item has dropped on the floor and is needed to continue a surgical procedure.
When specific instruments are needed for an emergency procedure.
When there is no other sterilization alternative (AORN, 2011b).
AAMI ST 79 is a comprehensive document covering recommended practices for steam sterilization. The document states that immediate-use steam sterilization can be performed when deemed appropriate and when all of the following conditions are met:
The device manufacturers written instructions on cycle times, exposure times, temperature settings and dry times are followed.
Items are dissembled and thoroughly cleaned with detergent and water to remove soil, blood, body fats and other substances.
Lumens are brushed and flushed under the water with cleaning solution and rinsed thoroughly.
Items are placed in a closed sterilization container or tray, validated for immediate-use sterilization, in a manner that allows steam contact and aseptic transfer to the operating room (American National Standard, 2010).
In addition, the multi-society position statement addresses the instances when immediate-use steam sterilization should never be performed. Immediate-use sterilization should not be performed on the following devices:
Implants, except in a documented emergency situation when no other option is available.
Post-procedure decontamination of instruments used on patients who may have Creutzfeldt-Jakob disease (CJD) or similar disorders.
Devices or loads that have not been validated with the specific cycle employed.
Devices that are sold sterile and intended for single-use only (AORN, 2011a).
Immediate-use steam sterilization can be a safe and effective process if used correctly. However, it should not be used as a matter of convenience. Steps should be taken to reduce the reliance and use of this process. The first appropriate response is to increase the surgical instrument inventory to levels that match the case load. Inadequate inventory is not an excuse for excessive use of immediate-use sterilization. However, as capital budgets are decreasing, this may not be an option for many facilities. A better and more efficient model would be to improve asset management and use the conflict scheduling mechanism. Facilities should not simply over-ride scheduling conflicts and manage resources on the day of surgery. In addition, there needs to be adequate turn over time built into the system in order for the sterile processing department (SPD) to terminally process the instruments.
The most important function of any high-level operation in the hospital is communication. Teams should be communicating and planning for the unexpected. No two days are alike in surgery, and the teams in the operating room (OR) and SPD must communicate with each other to ensure the patients needs are met. The OR must inform the SPD if their surgeries are advancing ahead of schedule so together they can plan for the quick turnover of instrument resources. SPD staff must then communicate whether the turnover expectations can truly be delivered.
The final and most important solution to avoid excessive use is through education. Physicians, nurses, surgical technologists and management should understand the correct processes and the associated risks involved with immediate-use steam sterilization. Physicians are charged with the responsibility to do no harm, and nurses protect the rights as well as the dignity of their patients. They cannot do their job without the correct information.
Immediate-use steam sterilization is a critical aspect of delivering care to the patient during surgery. The serious consequences of SSIs can result from improper sterilized instruments used on patients. The best ways to deliver sterile instruments to patients every time are to know when to use the process, follow the correct procedures with well educated staff, and to ensure the availability of instruments before the need to use the sterilizer in the operating room. The teams in the OR and SPD should work together to address these issues and do what is ultimately safe for the patient.
Trish L. Stoutzenberger, ST, CRCST, CHL, is sterile processing manager for Lancaster General Hospital in Lancaster, Pa.
American National Standard. (2010). ANSI/AAMI ST79 Comprehensive guide to steam sterilization and sterility assurance in healthcare facilities. Arlington: Association for the Advancement of Medical Instrumentation.
Association of periOperative Registered Nurses. (2011a). Immediate-use steam sterilization. Retrieved Oct. 7, 2011, from www.aorn.org: http://www.aorn.org/docs/assets/DD40EB03-0ABC-B900-242EB48CBFD7C55A/ImmediateUseSteamSterilization.pdf
Association of periOperative Registered Nurses. (2011b). Perioperative standards and recommended practices. Denver: AORN.
Centers for Disease Control and Prevention. (2011, July 12). Healthcare-associated infections (HAIs) surgical site infections. Retrieved Oct. 7, 2011, from www.cdc.gov: http://www.cdc.gov/HAI/ssi/ssi.html
Centers for Disease Control and Prevention. (2008). Guideline for disinfection and sterlization in healthcare facilities. Retrieved Oct. 7, 2011, from http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf