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Stop using the sterilizer, notify the supervisor and infection-control lead, and quarantine every implantable item from the affected load. Preserve the cycle records, check the operating conditions and indicator handling, and repeat the biological-indicator test under the applicable protocol. A single positive steam indicator does not automatically require recall of every non-implantable item under general U.S. CDC guidance, but persistent positives or a confirmed process defect require affected supplies to be treated as nonsterile, recalled when possible, reprocessed, and kept out of service until verification testing passes.
Immediate actions after a positive result
A positive biological indicator (BI) is a process alarm, not a result to dismiss while instruments continue circulating. Use this sequence immediately; your facility policy, sterilizer instructions, indicator labeling, and local requirements may add steps.
- Take the sterilizer out of service. Label it clearly so no one starts another production load. CDC’s Table 12 protocol states: “Take the sterilizer out of service. Notify area supervisor and infection control department.”
- Notify the responsible people. Contact the area supervisor and infection-prevention or infection-control department. Include sterile-processing leadership, dental-clinic leadership, or surgical-services management as appropriate.
- Quarantine implantable items. Do not release or use implants from the positive load while the investigation is open. CDC recommends a BI for every load containing implantables and, when possible, holding those items until the BI is negative.
- Secure records and identify affected loads. Preserve the sterilizer printout or electronic record, load number, contents, operator, exposure time, temperature and pressure, chemical-indicator results, BI lot and expiration information, and the dates of the last acceptable negative and subsequent cycles.
- Repeat the BI promptly. CDC dental guidance calls for an immediate repeat using the same cycle that produced the positive result. CDC’s general steam protocol also describes BI testing in three consecutive sterilizer cycles as soon as possible. These are related but distinct instructions: follow the pathway that matches your sterilizer, setting, and written policy.
Decide what happens to processed items
Disposition depends on two questions: whether the item is implantable and whether the result is an isolated positive or part of a persistent failure or confirmed defect.
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|---|---|---|
| Implantable item in the affected load | Quarantine and do not use until the BI is negative and the applicable release process is complete. | Implantables remain in the patient for an extended period, so CDC recommends BI testing for every implant load and holding items whenever possible. |
| One positive steam BI; no confirmed equipment or procedure defect; non-implantable items | Investigate immediately and repeat testing. Do not automatically recall every item solely because of one positive test under CDC’s general recommendation. | A positive may reflect testing, handling, or indicator problems, but it must be investigated before the sterilizer is returned to routine use. |
| Additional positive tests, or a confirmed sterilizer, procedure, or cycle-setting defect | Treat supplies processed since the last acceptable negative BI as nonsterile; recall and reprocess suspect loads when possible. Keep the sterilizer out of service. | Persistent evidence changes the risk assessment from an isolated signal to a likely process failure. |
| Dental setting with a repeat positive | Follow the dental protocol and facility policy to recall, rewrap, and resterilize suspect items dating back to the last negative BI when possible. | CDC dental guidance uses this operational approach while still requiring local-policy implementation. |
Do not infer that every positive steam test automatically makes every non-implantable item unusable. Conversely, do not release an implant load simply because mechanical gauges looked normal or because a second test has not yet finished.
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If an item was already used
Sometimes a package has been opened or an instrument has been used before the BI result is known. If the item cannot be retrieved, involve the infection-control professional, central processing, surgical services, and risk-management staff. Assess the specific load rather than making a blanket assumption.
- Review mechanical parameters and the sterilizer’s cycle record.
- Check internal and external chemical indicators.
- Confirm that instruments were thoroughly cleaned before sterilization.
- Determine whether the target temperature and exposure time were achieved.
- Identify the load contents, patient procedure, date, and whether other loads share the same suspected failure.
CDC describes the margin of safety in steam sterilization as sufficiently large that infection risk is minimal when instruments were properly cleaned and the required temperature was achieved. CDC also reports no published studies documenting disease transmission through a nonretrieved surgical instrument after a positive BI cycle. This evidence informs a documented risk assessment; it is not permission to ignore the failed test or skip corrective action.
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Investigate the sterilizer and the test
Work through both process causes and indicator causes. A BI should not be labeled a “false positive” until the entire process has been examined.
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- Compare the selected cycle with the load and the sterilizer’s instructions.
- Check programmed exposure time, temperature, pressure, drying time, and any delayed-start or abbreviated settings.
- Review the printout for temperature or pressure excursions, aborted cycles, alarms, or an incomplete exposure phase.
- Confirm that packs were arranged to permit steam contact and that the chamber was not overloaded.
Check steam and utilities
CDC’s steam protocol calls out electrical irregularities and changes in steam supply. For standard steam, it specifies steam that is at least 97% steam and less than 3% moisture. Ask maintenance to evaluate the steam source, supply lines, water quality, electrical service, drains, door gasket, sensors, valves, and chamber condition. Report abnormalities to the sterilizer manufacturer or authorized service organization rather than attempting an undocumented adjustment.
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Confirm the BI and its handling
- Use a BI cleared for the sterilizer type and cycle and follow its labeling exactly.
- Check expiration date, lot number, storage temperature and humidity, transport conditions, and package integrity.
- Confirm that the correct incubation temperature, time, media, and reader were used.
- Review whether the BI was contaminated during handling or incubated with an incorrect control.
- Consider paired indicators from a different manufacturer when product performance is suspected, while keeping the primary investigation focused on the sterilizer and process.
Steam BIs contain resistant spores of Geobacillus stearothermophilus, formerly called Bacillus stearothermophilus. Their growth indicates that the biological challenge survived the process. Chemical indicators show exposure to one or more conditions; they do not replace a BI.
Repeat testing and return-to-service pathways
The number and type of challenge cycles depend on the applicable CDC pathway, sterilizer design, and facility policy. Document which protocol you are following instead of combining instructions from different contexts.
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Immediate repeat after the first positive
- Use the same sterilizer cycle that generated the positive result, with a properly prepared BI and the required controls.
- Run the cycle according to the manufacturer’s full operating instructions.
- Record mechanical and chemical results with the BI identification and incubation outcome.
- Keep the sterilizer restricted while the repeat is processed and reviewed.
A negative repeat does not erase the need to evaluate how the first positive occurred. Review records, indicator handling, loading practices, and any maintenance issue before deciding disposition.
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When repeat tests remain positive, request equipment inspection, check steam supply lines, discuss the abnormality with the manufacturer, and consider a BI from another manufacturer. If the problem is not resolved, close the sterilizer until the manufacturer or qualified service personnel can assure proper operation.
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CDC dental guidance describes re-challenging a repaired or persistently positive sterilizer in three consecutive fully loaded chamber cycles. CDC’s general cycle-verification description separately specifies three consecutive empty steam cycles with BIs and chemical indicators in an appropriate test pack or tray. Test each type of cycle separately; a sterilizer with multiple cycle types must be challenged for each relevant type.
Prevacuum sterilizers and Bowie-Dick testing
For a dynamic-air-removal or prevacuum sterilizer, CDC also describes three consecutive Bowie-Dick tests during verification. A Bowie-Dick test evaluates air removal and steam penetration in the chamber. It is not a BI and cannot substitute for a BI challenge. Do not return the sterilizer to service until the required BIs are negative and chemical indicators show the correct endpoint.
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| Monitoring method | Question answered | Typical use |
|---|---|---|
| Mechanical | Did the cycle reach the programmed time, temperature, and pressure? | Review for every load using gauges, printouts, or electronic records. |
| Chemical indicator | Was the indicator exposed to one or more specified process conditions? | Use with every load, including internal indicators in packages as required by policy. |
| Biological indicator | Did a standardized population of resistant spores survive? | At least weekly with an FDA-cleared preparation intended for the sterilizer and cycle; every implant load is recommended by CDC. |
| Bowie-Dick test | Was air removed effectively and replaced by steam in a dynamic-air-removal sterilizer? | Use only for applicable prevacuum or dynamic-air-removal equipment; it is not a BI. |
When can the sterilizer return to service?
Return-to-service approval should be documented by the person designated in your policy, generally infection prevention together with sterile-processing leadership and maintenance or the manufacturer. Before release, confirm all of the following:
- The cause of the positive result was investigated and corrective action completed.
- Required repairs, utility corrections, or operator retraining are documented.
- The applicable BI challenge cycles are negative.
- Chemical indicators reach the specified endpoint in the verification cycles.
- Required Bowie-Dick tests pass for a prevacuum sterilizer.
- Cycle records, load configuration, and test results are retained.
- Staff know the revised procedure and any temporary restrictions.
If any required test is positive, any chemical endpoint is incorrect, or the manufacturer cannot assure proper operation, keep the sterilizer out of service and escalate.
Quick Recap
Preventing another failed cycle
- Maintain a complete record for every cycle: sterilizer and cycle, load identification and contents, exposure parameters, operator, and mechanical, chemical, and biological results.
- Train staff to select the correct cycle, avoid overloading, position packages for steam contact, and interpret indicators according to labeling.
- Follow scheduled preventive maintenance and promptly report electrical, steam, drainage, or door-seal abnormalities.
- Use only indicators and incubators compatible with the sterilizer and cycle; a compatible incubator is needed when the indicator system requires incubation.
- Keep implantable items on hold until the BI result and release criteria are complete whenever workflow allows.
- Review local policy regularly against current CDC guidance, manufacturer instructions, and applicable jurisdictional requirements.
A practical decision checklist
- Was the sterilizer stopped and the supervisor and infection-control team notified?
- Are implantable items quarantined and clearly identified?
- Are all records preserved back to the last acceptable negative BI?
- Was the immediate repeat performed using the correct cycle and BI system?
- Were settings, loading, cleaning, steam supply, utilities, maintenance, and indicator handling checked?
- Is this an isolated positive, or are there repeat positives or a confirmed defect?
- Have suspect items been recalled and reprocessed when the applicable protocol requires it?
- Were repaired or persistently positive units challenged in the required consecutive cycles, with chemical indicators and Bowie-Dick testing where applicable?
- Has an authorized person documented the decision to return the sterilizer to service?
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