Sterilization Technology

Basics of Steam Sterilization

TO FLASH OR NOT TO FLASH?
terilization is the complete destruction of all microbial life by physical or chemical procedures. There are several methods of sterilization available today, but steam sterilization continues to be the preferred method to destroy microorganisms. The process is non-toxic, safe, sporicidal and relatively inexpensive. Further, it rapidly heats and penetrates all fabrics. Other sterilization methods are only used when the item being sterilized cannot withstand the heat and/or moisture of steam sterilization. The sterile processing department prepares instrument trays for surgical procedures by assuring that they are decontaminated, inspected, assembled, wrapped and sterilized prior to patient use. However, there may be times when the instruments are not yet sterile and are needed

by Carol Petro, RN, BSN, CRCST

in the operating room immediately. This is when flash steam sterilizers come into play. Virtually all operating rooms have flash sterilizers available adjacent to the operating room suites. These sterilizers provide for the sterilization of instruments that have been dropped on the floor or contaminated during the surgical procedure. In addition, these flash sterilizers can be used to sterilize instruments that were not anticipated and subsequently not prepared in advance.

Types of Steam Sterilizers

There are four basic types of steam sterilizers: gravity air displacement, dynamic air removal, washer-sterilizer and flash sterilizer. Gravity air displacement sterilizers use gravity to remove air from their chambers. Steam introduced into the chamber creates a layer above the air, which increases until the air is pushed down through a drain at the bottom of the unit. After air is removed, steam temperature and pressure builds, and exposure time begins when the sterilization temperature is reached. Gravity sterilizers are used to sterilize surgical instrumentation, liquids and linen. Dynamic air removal sterilizers (also called prevacuum or prevac steam sterilizers) were created to overcome a problem that can occur when using saturated steam in gravity cycles: air can be trapped in the chamber, and cool air pockets may form and hinder sterilization. PreVac sterilizers use a pump to remove air from the chamber before steam is introduced. Dynamic air removal units are, therefore, more efficient than gravity air displacement sterilizers since air is pumped out before steam enters the chamber, and the steam can immediately penetrate packages. A Bowie Dick test should be used daily with these sterilizers to determine if there is residual air in the chamber, which can prevent steam from reaching all surfaces of the items. Washer-sterilizers are usually located in areas next or close to operating room suites. These combination units wash and sterilize instruments; however, gross contamination must be removed and rinsed from instruments before they are processed. These units use a mechanical cycle to wash and rinse away debris before the sterilization cycle begins. While this processing does not provide terminal

Flash sterilizers are located close to operating room suites so dropped instruments can be sterilized quickly.

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sterilization for patient use, it does render the instruments safe for handling after the operation. Flash sterilizers are typically located near operating room suites. They are used to quickly sterilize dropped instruments using cycles with minimum exposure times and temperatures for unwrapped items. Sterilized items must be transferred immediately from the flash sterilizer to the operating room using aseptic technique to minimize recontamination from pathogenic organisms. There is considerable risk that flashsterilized items can be contaminated during transport to the point of use. The decision to use a flash sterilizer requires that the benefit of having these instruments is greater than the risks associated with the process of flash sterilizing and transporting these instruments.

The Basics of the Steam Sterilization Process

Steam, by itself, is inadequate to achieve sterilization. Pressure that is greater than the atmosphere is required to increase the

temperature of steam to kill microorganisms. Microbes die when steam under pressure creates changes in cell structure, and when cell protein coagulates (thickens into a mass). The first steps in sterilization involve proper cleaning (the removal of visible and invisible soil) and decontamination (the removal or reduction of infectious organisms or other harmful substances). Failure to adequately prepare an item for sterilization hinders the direct steam contact needed to destroy microorganisms. Operating rooms run on a tight schedule, but proper decontamination of instruments is mandatory. The concern with flash sterilization is that in order to accommodate the surgeon and schedule, the operating room staff will be pressured to eliminate steps, therefore proper decontamination may not occur between surgical procedures. The Association for the Advancement of Medical Instrumentation (AAMI) states that flash sterilization should only be considered if work practices ensure proper cleaning, decontamination, inspection and arrangement of instruments into the

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recommended sterilizing trays or other containment devices before sterilization.1 There are four critical parameters to steam sterilization: steam, temperature, pressure and time. Steam must be of high quality and contain no more than 3 percent moisture and a relative humidity (the amount of water vapor) of 97 percent. The temperature depends upon the type of sterilizer used. Gravity air displacement sterilizers require a temperature of 250F (121C). Dynamic air removal, washer sterilizers, and flash sterilizers require a temperature of 270-275F degrees (132C-134C). To achieve these temperatures, the pressure must reach 15 pounds per square inch (psi) for the 250F (121C) setting, and 27 psi to sterilize at 270F. Exposure times depend upon the sterilizer manufacturers recommendations based upon load contents. Flash sterilization times usually vary from three minutes to 10 minutes. If the load consists of a single instrument comprised of metal (nonporous) and without lumens, a three minute cycle should be used. If the load includes multiple instruments or instruments with lumens, a 10 minute cycle should be used.2 The intense heat of flash sterilization can shorten the life of power equipment (drills and saws) and batteries. Frequently, when the flash cycle is complete, batteries are not immediately removed from the sterilizer; hence the batteries sit longer in the extreme heat than they should. The condensation that is formed inside the power equipment can increase the chance of corrosion and damage to the internal components, therefore an additional eight minute drying time may be added to help dry the water droplets that have been created in the device. Precautions must be taken when items are loaded into the sterilizer to ensure that steam will contact all items to

be sterilized. All instruments should be opened and disassembled to allow the steam to completely contact items during sterilization. The sterilizer should not be overloaded and items should not be allowed to contact the sterilizers chamber walls.

Monitoring Sterilization Cycles

Sterility should never be taken for granted. Sterilization cycles should be routinely monitored using mechanical, chemical and biological indicators. Mechanical indicators are indicators that come from the sterilizer itself to indicate how it has functioned. This may include thermometers, timers, gauges, recorders and/or other devices that monitor its function. At the end of every cycle, the sterilizer printout tape should be checked for: Start time and date; Operators initials; Sterilizer parameters selected (Was the correct cycle and time selected?); Sterilizer parameters met (time, pressure, minimum temperature). Chemical indicators are indicators that verify exposure to a sterilization process by changing color. Chemical indicators or integrators can be used in flash sterilizers. They will change color when the exposure or parameters have been met. The chemical indicators/integrators should be placed in each tray among the instruments with every cycle. Biological indicators (BI) monitor the adequacy of the sterilization process and the destruction of microorganisms. They consist of an inoculated carrier (Geobacillus stearothermophilus for steam sterilization) that provides a defined resistance to the sterilization process in which they will be used. Sterilizer operators should verify that the date on the BI has not expired, and should be placed in the middle of the sterilizer above the drain. AAMI recommends that a biological test be performed at least weekly, preferably every day that the sterilizer is used. A positive result for growth would indicate that the sterilizer did not function appropriately. The sterilizer must be taken out of service immediately and the instruments must be re-sterilized. In fact, all items that were processed in that sterilizer since the last negative BI are considered non-sterile. This is why documentation of all flash sterilization cycles must be traceable to a patient.

Concerns
AAMI and the Centers for Disease Control and Prevention (CDC) warn against flash sterilizing of implantables. AAMI states that implantables should not be flash-sterilized. The possible consequences to the patient from placing even a minimally contaminated device in an essentially avascular environment and leaving it there at the conclusion of the procedure are potentially severe.3 In addition, implants should be quarantined until the results of the BI are known.

Printout tape from the sterilizer verifies that parameters have been met.

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When the sterilization cycle is completed, the contents should be removed immediately for use. Items are considered sterile when necessary conditions have been met during a sterilization process. The circulating nurse should assure that

Scrub nurses need to verify color change on chemical indicators.

all parameters have been met before releasing the load. The scrub nurse should visually inspect the chemical indicator for color change. Biological indicators need to be processed and read in a timely manner according to manufacturers instructions. Attention should be made to avoid heat injuries when unloading the sterilizer. The instrument(s) must be removed and transported using aseptic technique. Transferring the sterilized item to the sterile field is difficult without contaminating it. The scrub nurse needs to pay attention to how they reach into the sterilizer to remove the contents and not touch the edges of the sterilizer. The circulator should escort the scrub nurse to the flash sterilizer eliminating traffic or opening of doors from the inner core during transportation of the sterile instruments. The risk of contamination increase if transported through areas where personnel are scrubbing or washing their hands, creating splashing or aerosolization.4 The work area should be arranged so that it ensures direct delivery of sterilized items to point of use without physical hazards and possible contamination. Another concern of flash sterilization is being able to assure that all items are allowed to cool before using. To meet the

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demands of the surgical procedure, scrub nurses frequently try to cool the instruments by immersing them in cool sterile water or wrap in sterile wet towels. Depending on the item, this cooling process can cause harm to the instrument. For example, if attempting to cool autoclavable scopes too quickly, it can crack the lenses inside the scope. Cooling power equipment (drills/saws) quickly can cause more condensation to form on the inside. Most importantly, the hot instruments can cause injury to the patient and/or physician. Depending on the thickness of the metal, the scrub nurse might think it is cool enough to use, but instead it heats up in the surgeons hands or while on the patient. Some retractors are thick and the heat continues to leech out during the case. Burns may not be noticed until the retractor is removed from the incision site. We must remember that while the patient is under anesthesia and unable to alert the staff to undesirable conditions, we must act as their advocate and prevent these accidents from happening. Lets not forget the danger to the employees themselves. When carrying hot and heavy instruments from the flash sterilizer, poor body mechanics are frequently used in holding the hot items out and away from their body to prevent burning. These poor body mechanics lead to the straining of the lower back and arms.

not used on the procedure, the documentation must be completed for that particular cycle. Accountability for each load must be maintained. Sterilization records are considered legal documents and, since the length of time they must be kept varies, each healthcare facility must develop recordretention policies based upon state and local regulations and legal considerations.

Sterilizer Maintenance
Sterilizer maintenance is important. Sediment screens should be removed and cleaned daily because clogged strainers prevent air from being removed from the unit. Chamber interiors should be cleaned weekly with a mild detergent. Note: Sterilizers must be allowed to cool for eight hours before cleaning. Maintenance requirements differ depending on the model used, and the sterilizer manufacturers instructions should always be followed.

Documentation
Documentation of the flash sterilization process should be consistent with requirements for sterilizing wrapped items. However, flash sterilized items require documentation linking the patient. The following information should be documented for each flash sterilization cycle: Date; Sterilizer number and sterilizer load number; Sterilizer operator; Chemical indicator; Contents of load (including BI if used); Patient information; Reason for flash sterilization; Initialed printout tape of cycle parameters. Effective documentation ensures that the sterilization process is monitored as it occurs, that required cycle parameters have been met, and that accountability is established. At the end of each day, each sterilizer should have complete documentation for each load. A common problem with flash sterilization is incomplete documentation. Operating room employees are overwhelmed with the other duties and tasks pertaining to their job and sterilization records take a low priority. Chemical control cards or integrators are lost; contents of the load are not documented and/or patient information not included. Even if the instruments were

Sediment screens need to be checked daily for proper maintenance.

Ongoing Considerations
To flash or not to flash, that is the question. According to the Association for periOperative Registered Nurses (AORN), it states that flash sterilization should be minimized. It should only be used in selected clinical situations and in a controlled manner.5 It should not be used as a substitute for not having enough instrumentation. Scheduling of cases in a manner that does not require back-to-back usage of the same instrument trays needs to be addressed. Managers who have budget constraints often end up with insufficient instrument inventory. However, purchasing of additional instruments to maintain the daily caseload should be a priority. Enforcing policies to have on time arrivals of vendor pans, brought in the day before surgery, is critical for providing the best care for the patient.

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Reader Service No. 40

Alternatives need to be created for the doctors specials that are carried from the operating room of one hospital to another. Can we evaluate what is contained in these special instrument sets and provide them in one of our existing sets, so that they are sterile prior to the procedure? Operating room personnel must maintain high standards of sterile technique. Every individual is accountable for their role in infection control. Work practices need to ensure that proper cleaning and decontamination is performed and that procedures are developed and followed in regard to flash sterilization.

References
1. 2. 3. 4. 5. ANSI/AAMI ST79:2006. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA.2006, page 2-3. International Association of Healthcare Central Service and Materiel Management. Central Service Technical Manual. Seventh Edition. 2007. Point of Use Processing, chapter 14, page 269. ANSI/AAMI ST79:2006. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA.2006, page 3. ANSI/AAMI ST79:2006. Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities. Arlington, VA.2006, page 2. Association of PeriOperative Registered Nurses (AORN). Standards, Recommended Practices, and Guidelines. Denver, CO. 2007, page 675.

Carol Petro, RN, BSN, CRCST, is the clinical educator for Clarian Health sterile processing departments at Methodist Hospital, University Hospital and Riley Hospital for Children in Indianapolis. She has worked in the sterile processing department for two years and the surgery department for 25 years. She has a Bachelor of Science Degree in Nursing from University of Indianapolis. She received her technical training as a Certified Registered Central Service Technician (CRCST) from IAHCSMM in 2006. Previous positions held at Clarian included Oral/ Maxillofacial/Ophthalmology Specialty Coordinator from 1992 to 2001 and Special Projects Coordinator/SurgiNet Informatics Project Leader from 2001 to 2005. She may be reached at cpetro@clarian.org.

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