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Use an FDA-cleared biological indicator (BI) made for steam sterilization, expose it to the specified cycle with a matching control from the same lot, and incubate or read it exactly as the BI manufacturer directs. Place the challenge according to the product and sterilizer instructions, review mechanical and chemical monitoring, and follow a documented escalation procedure for any positive result.
What a biological indicator tests
A biological indicator is a standardized preparation of highly resistant microorganisms used to challenge a sterilization process. In steam sterilization, the Centers for Disease Control and Prevention (CDC) identifies Geobacillus stearothermophilus spores as the appropriate challenge organism. The spores are exposed to the cycle and then assessed for survival using the BI system’s specified incubation, color, fluorescence, or other readout method.
This is different from the other monitoring layers used in a sterilization program:
- Mechanical monitoring records the sterilizer’s physical conditions, such as time, temperature, and pressure, from the cycle display or printout.
- Chemical indicators respond to one or more process conditions and show that the indicator was exposed to the specified environment. They do not demonstrate that resistant spores were killed.
- Biological indicators directly challenge microbial inactivation with resistant spores.
Use all applicable layers rather than treating one result as a substitute for the others. CDC’s summary recommendations state that biological monitoring is part of a broader monitoring program and that unacceptable mechanical or chemical results mean the processed items should not be used.
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A BI is evidence about the sterilization challenge it experienced; it is not a certificate that every item in a load is sterile. The CDC glossary states: “A negative biologic indicator does not prove that all items in the load are sterile or that they were all exposed to adequate sterilization conditions.”
Choose a BI that matches the sterilizer and cycle
Verify the sterilization technology
Buy a commercial BI specifically cleared and labeled for steam sterilizers. Do not substitute a strip, self-contained vial, test pack, or rapid-read system intended for another technology, such as dry heat, ethylene oxide, hydrogen peroxide, or another low-temperature process. Even within steam sterilization, the product must be intended for the cycle parameters you are running.
Before opening the package, compare the BI labeling with the sterilizer’s instructions for use. Confirm the sterilizer type, cycle name, exposure temperature, exposure time, load configuration, and any required test pack. The CDC recommendation calls for an FDA-cleared commercial spore preparation intended specifically for the sterilizer type and cycle parameters; see recommendation 16.d.
Check the challenge configuration
Some BIs are used as self-contained units, while others are supplied as spore strips or incorporated into a process challenge device or test pack. The challenge configuration affects where the indicator is placed and how it is processed. Use the exact configuration named on the current label, not a generic “hardest spot” rule copied from another product.
Plan for a control
Use a matching control from the same BI lot when the product instructions require one. CDC dental guidance specifically recommends a biological indicator and control from the same lot number. The control verifies that the spores and the incubation or detection system can produce the expected growth or positive signal. Follow the product directions for whether the control is processed, when it is activated, how it is incubated, and how its result is recorded. The dental guidance is available at Best Practices for Sterilization Monitoring in Dental Settings.
Compare practical product requirements
| Selection point | What to verify on the label or instructions | Why it matters |
|---|---|---|
| Intended technology | Steam sterilization, not another sterilization method | Spore resistance and exposure conditions differ among technologies. |
| Cycle parameters | Compatible temperature, exposure time, cycle type, and sterilizer configuration | A BI validated for one cycle may not represent another cycle. |
| Regulatory status | Current FDA clearance and stated intended use | Clearance supports use for the labeled application; marketplace descriptions are not a substitute for labeling. |
| Challenge device | Required test pack, process challenge device, or self-contained format | The device determines how the challenge is exposed and where it belongs. |
| Control | Same-lot control requirement and control-handling steps | Controls help distinguish a true negative from a failed test system. |
| Readout system | Incubator or reader, incubation temperature, reading interval, and endpoint | There is no universal incubation time or readout procedure. |
| Storage and handling | Temperature, humidity, expiration date, transport limits, and activation steps | Improper storage or activation can invalidate a result. |
| Documentation | Lot number, cycle identification, result format, and retention instructions | Complete records connect the BI result to the specific load. |
Set the monitoring schedule
CDC recommends biological monitoring of sterilizers at least weekly. A facility that runs a sterilizer frequently may choose daily BI testing to identify a problem sooner. Every load containing implantable items should receive biological monitoring, and those items should be quarantined whenever possible until the BI result is negative. The recommendation appears in CDC’s sterilization monitoring guidance.
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| Situation | Minimum action described by CDC guidance | Handling implication |
|---|---|---|
| Routine operation | Run a BI at least weekly | Keep the schedule in the facility’s written monitoring program. |
| Frequently used sterilizer | Daily BI use can help detect problems sooner | Adopt a daily schedule when the facility’s risk assessment and workflow support it. |
| Any load with implantable items | Monitor every load biologically | Quarantine implantable items whenever possible until the BI is negative. |
| Any cycle with unacceptable mechanical or chemical results | Do not use the processed items | Investigate the cycle and follow the facility’s release and reprocessing policy. |
How to run a steam BI: the operational workflow
1. Confirm that the test applies
Identify the sterilizer, cycle, and load before preparing the indicator. Check that the BI is within its expiration date, has been stored as labeled, and is intended for that exact steam process. Read both the BI instructions and the sterilizer manufacturer’s instructions. If either document requires a particular test pack, challenge location, or cycle, use that requirement.
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Assign or obtain the load identification number and record the sterilizer and cycle type. Note the contents, intended exposure temperature and time, operator, and any other fields required by the facility’s record system. Recording the information before the cycle prevents a later result from becoming detached from the load that produced it.
3. Prepare the BI and control
Handle the BI exactly as its instructions describe. If the system uses a self-contained vial, do not activate or crush it early. If it uses a spore strip or test pack, assemble the challenge device in the labeled configuration. Prepare the same-lot control according to the control instructions; some systems require a control to be incubated without sterilization, while others specify a different sequence. Do not infer the control procedure from another brand or format.
4. Place the challenge as directed
There is no single placement location that applies to every steam sterilizer and BI. Placement depends on the BI system, the sterilizer configuration, the cycle, and any validated test pack. Follow the BI manufacturer’s placement directions and the sterilizer instructions. Do not move the BI to a convenient location, tape it to an item, or open a test pack unless the instructions authorize that arrangement. CDC’s dental monitoring FAQ directs users to follow the manufacturer’s directions for BI placement.
5. Run the specified cycle
Load the sterilizer in the normal validated arrangement for that cycle, leaving the BI in its prescribed challenge position. Start the cycle and retain the printout, electronic record, or other mechanical record. Do not shorten the exposure, change the temperature, or interrupt the cycle merely to obtain a faster test.
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6. Check mechanical and chemical evidence
After the cycle, review the recorded time, temperature, pressure, and other displayed parameters against the cycle requirements. Check the external and internal chemical indicators required for the load or test pack. If a mechanical reading is outside the acceptance range or a required chemical indicator is unacceptable, hold the load and follow the facility’s nonconforming-load procedure; do not release it because the BI appears negative.
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7. Incubate or read the BI exactly as labeled
Activate, incubate, and read the processed BI using the temperature, equipment, timing, and endpoint specified by the current product instructions. Rapid fluorescent systems, color-change self-contained units, and spore strips do not necessarily share the same incubation conditions or result terminology. The CDC pages do not establish one universal temperature or reading time, so use the product’s instructions rather than a generic interval. Process and read the same-lot control as directed.
8. Document and release only under policy
Enter the BI lot number, control result, processed BI result, reader or incubator identification if applicable, reading time, operator, cycle record, and any deviations into the sterilization log. Release the load only when the facility’s policy and all required monitoring results permit release. Implantable items should remain quarantined whenever possible until the BI is negative.
How to interpret a negative result
A negative BI means the indicator’s spores did not produce the positive signal defined by that product’s instructions under the stated readout conditions. It supports the conclusion that the challenge was inactivated, provided the control behaved as required and the BI was handled correctly.
It does not prove that every package, lumen, instrument, or other item in the load was sterile. Items may have been shielded, overloaded, wrapped incorrectly, exposed to trapped air, or otherwise prevented from receiving the required conditions. A negative BI also cannot repair an unacceptable mechanical record, failed chemical indicator, incorrect cycle selection, broken packaging, wet load, or other process deviation.
Use the BI result alongside the cycle record, chemical indicators, packaging inspection, and load-release criteria. If any required evidence is unacceptable, keep the load out of service and investigate rather than relying on the negative BI alone.
What to do after a positive steam BI
Treat a positive BI as a process signal requiring immediate investigation, not as a result to ignore or simply file. CDC’s suggested protocol for management of a positive biological indicator in a steam sterilizer was updated December 20, 2023. Apply the protocol together with local regulations, accreditation requirements, and the facility’s written policy.
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Immediate response
- Take the sterilizer out of service. Do not run routine loads for use while the positive result is being evaluated.
- Notify responsible personnel. Inform the area supervisor and infection-control department or equivalent responsible authority.
- Secure the records and affected load information. Identify the positive BI, its lot and control, the cycle, the load contents, the operator, and the mechanical and chemical monitoring results.
- Check for test or use errors. Verify that the BI matched the sterilizer and cycle, was placed and activated correctly, was incubated or read at the correct settings, and had a valid same-lot control. Confirm the sterilizer’s time and temperature settings and review loading, packaging, water quality, and other facility-specific factors.
Repeat testing over three consecutive cycles
After the initial checks, repeat BI testing in three consecutive cycles using the procedure and controls specified for the BI. Keep the sterilizer out of routine service while the repeat tests are interpreted. Record each cycle and result separately; do not combine three indicators into one undocumented conclusion.
If all three repeat BIs are negative
CDC’s suggested protocol allows the sterilizer to return to service when the problem has been resolved and all three repeat BIs are negative. Document the cause, corrective action, repeat results, and authorization to return the unit to service. If a mechanical or chemical result remains unacceptable, continue to hold the affected load even if the repeat BI is negative.
If repeat BIs remain positive
Persistent positive results indicate that the process may not be reliably sterilizing. Consider the implicated items nonsterile, recall and reprocess relevant loads under the facility’s recall procedure, and involve qualified maintenance personnel and the sterilizer manufacturer. Determine the time period and loads covered by the investigation from the records rather than assuming that only the last cycle was affected.
How a single positive affects nonimplant loads
For steam sterilization, CDC guidance says nonimplant items do not need to be recalled solely because of one positive BI when no sterilizer or process defect has been identified. That exception is specific to the circumstances described in the CDC protocol; it does not authorize release when other monitoring or equipment evidence is unacceptable, and it should not be generalized to other sterilization modalities.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.Do not confuse BI testing with the Bowie-Dick test
A Bowie-Dick test is a separate air-removal test for dynamic-air-removal steam sterilizers. It evaluates whether the sterilizer removes air and permits steam penetration as required by the test system. A failed Bowie-Dick test is not a substitute for biological monitoring, and a BI does not replace the daily air-removal test where that test is required.
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A free scan shows the junk files, broken settings and background clutter dragging Windows down - then fixes them in one click.Free scan · Windows 10 & 11Follow the applicable daily Bowie-Dick procedure and failure response in the CDC’s steam sterilization guidance and the sterilizer manufacturer’s instructions. Keep a failed air-removal test and a BI result as separate findings in the record.
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Special handling for implantable items
Implantable devices create a stricter release decision because an implant may remain in the patient. CDC recommends biological monitoring for every load containing implantable items and recommends quarantining those items whenever possible until the BI is negative. Plan the workflow so the implant can be held without being issued accidentally, and ensure that the load identification links the implant to the BI result.
If an implant load is released before the BI result is available because of an urgent clinical need, follow the facility’s documented exception process and applicable jurisdictional requirements. Do not treat that exception as ordinary release practice.
Documentation that makes a BI result useful
CDC recommends retaining enough information to reconstruct the cycle and evaluate a failure. At minimum, the record should connect the following fields:
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- sterilizer identification and cycle type;
- load identification number;
- load contents, including implantable items when present;
- exposure parameters such as time and temperature;
- operator name or initials;
- mechanical monitoring results;
- chemical-indicator results;
- BI manufacturer, lot number, expiration date, and result;
- same-lot control identification and result;
- incubation or reader information and the time the result was obtained;
- deviations, corrective actions, notifications, and final release or recall decision.
Use the facility’s approved electronic or paper record system and follow applicable retention rules. A result without the cycle, lot, control, and operator information cannot reliably identify which loads are affected if a problem is discovered later.
Common mistakes and the safer alternative
| Mistake | Why it is unsafe | Safer alternative |
|---|---|---|
| Using a BI intended for another sterilization method | The organism, resistance, and exposure validation may not match steam. | Select a cleared BI labeled for the sterilizer and cycle. |
| Choosing a placement location from a generic checklist | Challenge locations differ by BI format, test pack, and sterilizer. | Use the current BI and sterilizer instructions. |
| Skipping the same-lot control | A negative processed BI may be uninterpretable if the test system failed. | Use and handle the matching control as labeled. |
| Releasing a load because the BI is negative | Negative BI results do not prove every item received adequate conditions. | Review mechanical, chemical, packaging, and load-release criteria together. |
| Using a universal incubation time | Readout systems have different temperatures, endpoints, and times. | Follow the current product instructions and reader requirements. |
| Running another routine load after a positive BI | A process problem could continue and expand the affected population. | Remove the sterilizer from service and begin the escalation protocol. |
| Recalling every item after one positive result without investigation | CDC’s steam-specific protocol distinguishes a single positive from persistent positives when no defect is found. | Follow the CDC protocol and local policy, documenting the investigation. |
| Treating a Bowie-Dick result as a BI result | The tests answer different process questions. | Run and record each required test separately. |
How much confidence should a BI provide?
The BI is the most direct of the three monitoring layers because it challenges the process with resistant spores, but its evidence is limited to the indicator’s exposure and the validity of the test procedure. A negative result cannot compensate for poor loading, blocked lumens, damaged packaging, inadequate drying, wrong cycle selection, or an incomplete record.
CDC’s sterilizing-practices guidance has cited an estimate of about 1% steam-sterilization failure. That figure comes from an older underlying reference and is not a current universal failure rate or a prediction for a particular facility. Use current monitoring results and local quality data rather than treating that estimate as a performance benchmark.
Keeping the procedure current
CDC’s steam recommendations trace to its 2008 guideline, while the positive-indicator protocol page identifies a December 20, 2023 update. Product labeling, sterilizer software, local regulations, and facility policies can change independently. Review the live CDC pages, the current BI instructions, the sterilizer instructions for use, and jurisdictional requirements before changing a monitoring program.
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The safest routine is therefore procedural: select a correctly matched BI, use the specified control and placement, run the intended cycle, review every monitoring layer, read the indicator exactly as labeled, document the complete chain of evidence, and stop and investigate when the result is positive or any other release criterion fails.
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