Sterilization Indicators Shine Light on Equipment, Human Errors


Sterilization Indicators Shine Light on Equipment, Human Errors

By Kelli M. Donley

CentralSterile departments tend to be hidden from the rest of the hospital, carefullytucked away on the bottom floor, with few signs pointing out their existence topassing patients. Similarly, chemical and biological indicators are subtly slidinto sterilization loads, away from the hustle and bustle of other events takingplace in the busy department. While obscure and perhaps unappreciated, both CSand indicators are a top priority in an efficacious healthcare center. Withoutsterile instruments, shown to be ready for use by indicators, a hospital isimmobilized.

Biological indicators (BIs) consist of resistant microorganism spores. Thesebacteria die at a slow rate and should be killed within a normal sterilizationprocess. BIs are the only method of confirming that the sterilization processwas successful in killing microbial spores.1

Chris Dwyer, director of marketing at Raven Biological Laboratories in Omaha,Neb., said BIs consist of the most difficult bacteria to kill, ensuring thesterilization process is efficacious.

"At their core, BIs are fairly simple--they're tough bugs," Dwyersays. "We grow different species of nonpathogenic, spore-forming bacillus,chosen for their resistance to specific sterilization process. We concentratethem, calibrate them, and provide a growth medium suitable for recoveringinjured but surviving microorganisms," he adds. "Using a concentrated,calibrate life challenge offers the user a high level of assurance that theirsterilizer is functioning correctly."

BIs should be used daily in a steam sterilizer, and with every loadcontaining an implantable medical device. Implantable device loads processedwith ethylene oxide should also have a BI. These devices should not be re-useduntil the BI demonstrates the equipment was processed correctly.

"AORN guidelines for steam sterilization indicate that a processindicator should be inside each package. If not visible from the outside, thenan additional process indicator should be placed on the outside of thepackage," Dwyer said. "The guideline indicates the BIs should be usedat least weekly, preferably daily, and in each load where an implantable deviceis being sterilized."

It has also been written that it is more cost effective to monitor each loadwith a BI rapid readout than to have to quarantine a system if a weekly ormonthly report indicates there has been a system failure. The cost of using BIsdaily is less than the money that would be spent on potential lawsuits involvedwith nosocomial infections and patient harm.1

Chemical indicators (CIs) should monitor multiple or all parameters of thesterilization process. Integrated CIs, those that determine if all chemicals inthe process are functioning properly, were created to determine the response ofBIs to the process. The difference is CIs do not contain spores.

Using CIs in each load, along with BIs ensures that local problems-human ormechanical errors-can be determined. Individual packages within a load can alsobe specifically isolated if an indicator shows the group of instruments was notproperly sterilized. This could be from sterilization error, or perhaps thepackage was packed too tightly. Other problems that could occur include airpockets or small leaks in a steam sterilizer, packs that are too denselywrapped, and low humidity in the area.1

Without CIs present, there is a significant risk that sterilization errorswill go undetected.

"How critical is it that the items being processed become sterile? If itcould endanger patient safety, then I would use BIs and CIs in every load,"Dwyer said.

Dwyer says that in today's uncertain political climate, healthcare workers (HCWs)should be more prepared to handle the unexpected. This includes be ready tosterilize equipment efficiently every time. He says BIs and CIs only aid thisprocess and provide peace of mind.

"In light of recent events, it is more important than ever for HCWs tounderstand the sterilization process and be up to date on current practices andproducts. With instant news and instant messaging, there is greater opportunityfor instant misinformation," he said. "Those involved in sterilizationneed to be able to make informed decisions regarding their facility's use of BIsand CIs to ensure patient and employee safety. How to load the sterilizer, whereto place the BIs and CIs, how many, and how often are all questions that canonly be adequately addressed by well informed professionals."

CS managers who are interested in more information about these tools shouldcontact a company representative. This person will walk through the departmentand will be able to properly match sterilization systems with BIs and CIs. Also,managers can prepare a frequently asked questions list with the representativeand use the information as an educational tool for staff members.

Indicator Manufacturers

The following companies produce both biological and chemical indicators:

Allegiance Healthcare Corp,  

Anderson Medical Products Inc, 

Becton Dickinson Microbiology Systems, 

Getinge/Castle Inc.,

Kern Medical Products Corp,

Propper Manufacturing Company,

Raven Biological Laboratories,

SPS Medical Supply Corp,


3M Heath Care,

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