Bio-monitoring sterilization a pointless practice?
It may be time for parametric release’
Editor: Has the time come to formally consider the practice of constantly biologically monitoring sterilization cycles as pointless?
In most health care institutions in the United States, the biological indicator continues to be a primary indicator of successful sterilization, and relied upon for quality assurance and sterilization record keeping purposes. Generally, a sterilization cycle is not deemed sterile until the biological indicator confirms sterilization. Ideally, biological monitor results would occur at the same time as mechanical parameters are met in a sterilization cycle, but with the exception of the one-hour rapid readout biological for steam sterilization, this has not occurred.
In the last few years, new low-temperature sterilization technologies have shortened the turnaround time for sterilization but lengthened the dwell time for biological incubation. This has presented a dilemma for the sterilizer user and made it impractical to follow policies that dictate recall of sterilized products in the event of a positive biological indicator. Short sterilization cycles coupled with long incubation periods therefore do not make a good marriage in sterilization.
Because of this, should not the inevitable conclusion to the use of biological indicators in a rapid sterilizer with rapid turnover of instruments and no quarantine of instruments be that the biological indicator is no more than equivocal to other sterilization parameters such as time, temperature and pressure variables, and therefore viewed as such? It seems that the immediate usefulness of biologically testing rapid sterilization methods has lost any value. The probability of recalling a non-sterile item is low and getting lower.
What is left for the operator of the new technologies, or the consumer of the items sterilized in the new technologies, is a chemical indicator and the device printout demonstrating that known parameters leading to sterilization have occurred. As a result of our acceptance of these shortcomings, should we not accept this as a new policy and thereby confess that new practice has pioneered a new confidence? I know of no greater reason to promote the concept of parametric release meeting specific sterilization parameters for standard load configurations without dependence upon the use of a biological indicator.
Submitted by: Richard Easterling, RN
Materials Management Department
University of Washington Medical Center, Seattle
[Editor’s note: Letters to the editor are welcomed. They should be no longer than 500 words and are subject to editing for length, style, and clarity. Send letters to Editor, Hospital Infection Control, P.O. Box 680, Winterville, GA 30683 or fax them to (706) 742-2516. Please include your name, title, and a daytime telephone number. Unsigned letters cannot be published.]
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