Perhaps the chemical indicator in the package of instruments didn't change, or the biological indicator in the sterilizer chamber with a load of trays came out positive. Maybe the autoclave printout reported that the just-completed cycle didn't meet the time, temperature and steam pressure parameters required to ensure instrument sterilization. Whatever the reason, the signs are clear: You have a sterilization failure on your hands, a situation that demands immediate action.

Read and react
The first step is paying attention to the indicators that will signal a process failure. Make sure each employee who operates a sterilizer understands the measures it must meet and reviews and signs every load receipt at the end of each cycle (see "Can You Read a Sterilizer Load Receipt?" June, page 14). Just as importantly, make sure that sterile processing department personnel routinely deploy the right combination of chemical and biological indicators with each load and each processed package.

Don't confine the ability to interpret the results of chemical and biological indicators to just your sterile processing technicians. Train your OR staff to be vigilant in observing the indicators when they open instrument trays or packages for procedures. By reading indicators before the items are placed on the back table or before the implant is put into the patient, your surgical staff may even catch a failed load before your reprocessing techs do.

If these steps are integrated into routine practice, you'll be able to detect potential errors or malfunctions and take corrective action relatively quickly.

Maintain a paper (or paperless) trail
The sooner you react to a sterilization process failure, the better the eventual outcome. Once you've been alerted to a sterilization process failure, you'll have to quarantine the items that came out of that unsuccessful cycle. But if your subsequent investigation of the cause and extent of the incident reveals that previous cycles also failed to meet sterilization standards, you'll have to recall previously repro-cessed items. That's where tracking is essential.

If your center's budget can accommodate it, an automated tracking system makes the job quick and precise. Bar-coded trays and packages are scanned at every point throughout the use and reprocessing process, from pulling for a case to arriving in the sterile processing department and from loading into the autoclave to returning to storage. Automated systems may also be able to record your reprocessing equipment's cycle data and indicator results.

If you've not gone electronic with your tracking, you should still accurately log every load and label each package to let your investigators, in the event of a process failure, trace reprocessed items back to the sterilizers in which they were treated and the cases in which they were used.

Drafting a recall policy that assigns personnel and delegates responsibility to expedite instrument and device retrieval in the event of a sterile processing failure can also prepare your staff to act on manufacturers' recalls of faulty devices and supplies.

Causes for concern
How you respond to a sterilization process failure is largely dictated by necessity: quarantining and perhaps recalling items, locking equipment out of service, notifying relevant personnel, documenting findings and corrective actions. In its "Comprehensive Guide to Steam Sterilization and Sterility Assurance in Health Care Facilities," the Association for the Advancement of Medical Instrumentation presents the steps as a decision-making flowchart.

Identifying the cause of the failure in order to correct it, however, can require some legwork. You'll examine the incident, the equipment and the available information with your sterile processing techs as well as with your maintenance engineer or the manufacturer's service representative. You'll investigate all the variables at hand. It may be that your sterilizer remains perfectly operational, and a sterile processing tech's error caused the failure. A sterilizer that was improperly loaded, items that were incorrectly packaged, an inappropriate cycle or unheeded manufacturers' directions can all lead to substandard outcomes. Fortunately, they're often easily identified and resolved through education and reprocessing the failed items or load.

The cause of such mechanical malfunctions as a sterilizer that doesn't create a proper vacuum, doesn't reach the prescribed temperature, doesn't maintain that temperature for a long enough span of time and doesn't adequately dry its contents may be more difficult to pin down. These issues generally require the help of the manufacturer's service rep. It should be noted, though, that autoclave gaskets are known to wear out over time, so it may be worthwhile to keep a spare around and see to it that someone on site knows how to replace them.

If items coming out of a steam sterilizer are still damp, or you're wiping down the chamber more often due to the appearance of mineral deposits, your water source or steam generator could be the culprit. Lab water testing can tell you whether filtration is required. A break in a steam line, steam generator malfunctions or even some boiler repairs can affect the quality of the steam piped in.

Don't discount the possibility of a false positive in testing, either. Occasionally a chemical indicator lot is accidentally exposed to light, rendering them useless, or faulty biological indicators are recalled.

Trained to respond
Regardless of whether operator error is to blame for a sterilization process failure, conducting occasional in-services to retrain your sterile processing techs can ensure that their practices are consistent. AORN's "Recommend-ed Practices for Sterilization in the Perioperative Practice Setting" suggests establishing a quality control and improvement program that continually evaluates the effectiveness of the sterile processing department to ensure patient safety. Among its recommendations are: Always check a sterilizer's load receipt when it's completed a cycle to verify that it met its required times, temperatures and pressures; make sure that your staff is qualified to interpret indicator results; and thoroughly document and immediately report process failures and corrective actions.

Lastly, don't neglect preventive maintenance of your sterile processing equipment. The manufacturer's service representative should visit at least once a year to calibrate the devices. If you employ an in-house maintenance engineer and the manufacturer offers a repair training course, you might also consider budgeting the funds and the time for your employee to learn the basics. That way he may be able to make minor repairs and get a malfunctioning sterilizer, arguably the linchpin of your surgical operations, back into service sooner.

Damage control
Whether it's the result of human error, a mechanical malfunction or environmental factors, a breach in your instrument sterilization process puts your patient safety, your surgical care and your business reputation at risk. Vigilant preparation and an immediate, thorough response can help you to minimize or even avoid the resulting damage.