The new era of flash sterilization

AORN Journal,  July, 2007  by Arlene Carlo

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Flash sterilization was designed for use in the OR for emergent and immediate use of a forgotten or unanticipated instrument or one that was accidentally dropped on the floor. Historically, it was common practice for instruments to be flash sterilized in an unwrapped tray in a small, gravity-displacement steam sterilizer. The minimal parameters ranged from three- to 10-minute exposures at 270 [degrees] F (132 [degrees] C), depending on the type of devices being flash sterilized (ie, nonporous, porous) and whether a prevacuum or gravity-displacement sterilization method was used. Typically, there was no drying time.

The biological indicator (BI) used to test the efficacy of the sterilizer to kill microbial spores required a 24- to 48-hour incubation before the results were available. If the BI results were positive, a 24-to 48-hour period had elapsed before the recall process could be initiated. The recall process involved identifying all loads processed since the last negative BI results were identified, tracing affected items used for surgery to individual patients, notifying each patient's physician and the infection control practitioner, and initiating appropriate antibiotic prophylaxis as necessary.

Today, state-of-the-art products and equipment, including sealed containers that have been designed for flash sterilization cycles to protect instruments during transport to the point of use, have helped to address some of the challenges historically associated with the flash sterilization process. Prevacuum sterilizers with efficient vacuum-assisted, air-removal systems and enzyme-based BIs with a rapid one- or three-hour readout that now typically are used to monitor the flash sterilization cycle provide more timely results than the conventional biological readout.

When performed correctly, flash sterilization is safe and effective for sterilizing medical devices. Performing flash sterilization correctly, however, is a complex process contingent on the control of many variables. According to the American National Standards Institute (ANSI)/Association for the Advancement of Medical Instrumentation's (AAMI's) ST79:2006 Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities,

   The delivery of sterile health care products for
   use in patient care depends not only on the efficacy
   of the sterilization process itself but also on
   the following factors: efficient facility design,
   proper training of staff, good infection control
   practices, effective quality control and documentation,
   and process improvement systems. (1(p1))

Safe and effective flash sterilization requires that all steps in the multistep process be done properly each and every time to achieve sterilization and maintain sterility of instruments and instrument sets to the point of use. There is no room for error, no room for shortcuts, and no room for being lax. Improperly sterilized or contaminated instruments used in a surgical procedure can result in serious consequences, from surgical site infections (SSIs) to increased costs and legal liability.

ISSUES, CONCERNS, AND RISKS

Postoperative infection is a major cause of patient injury and increased health care costs. Statistics published by the Centers for Disease Control and Prevention indicate that an estimated 30 million surgical procedures are performed annually in US acute care facilities. (2) An estimated 500,000 SSIs occur each year, which represents one quarter of the estimated two million health care-associated infections. (2) An SSI increases the patient's hospital stay by an average of seven days and can add more than $3,000 in charges. (2) Treating postoperative infections costs billions of dollars annually and, ultimately, increases the overall cost of health care to all. (2)

That flash sterilization may be overused to compensate for insufficient inventory of instruments, to save time, and for reasons of convenience is an issue of concern. Increased use also may be driven by factors such as changes in reimbursement systems, budgetary restraints, in creased surgical volume, and quick turnover demands. The Centers for Disease Control and Prevention (CDC), (3) the Joint Commission, (4) and AORN (5) all state that flash sterilization should be kept to a minimum and should not be used as an alternative to purchasing additional instruments, to save time, or for convenience.

AORN states that "flash sterilization may be associated with increased risk of infection to patients because of pressure on personnel to eliminate one or more steps in the cleaning and sterilization process." (5(p676)) Adequate cleaning is the first step in the decontamination and sterilization process. Failure to adequately clean and rinse instruments before flash sterilization may result in ineffective sterilization and increase the patient's risk of infection.

Pertinent information also is needed to ensure full traceability of loads. Insufficient documentation may not permit traceability of loads to patients regarding instruments or instrument sets used. Flash sterilization records are necessary if there is a recall of items flash sterilized or if these records are subpoenaed for a lawsuit.