Question 1

Which biological indicator (spore) is used to test Steam sterilization cycles?

Accepted Answer

Geobacillus stearothermophilus is the spore most resistant to steam sterilization. If these spores are killed, the cycle is considered effective.

Question 2

Which biological indicator is used for Ethylene Oxide (EtO) and Dry Heat sterilization?

Accepted Answer

Bacillus atrophaeus is the specific spore used to challenge EtO and Dry Heat cycles due to its high resistance to dry/chemical sterilization.

Question 3

A Bowie-Dick test is designed to check for:

Accepted Answer

The Bowie-Dick test is a Class 2 Chemical Indicator used daily to verify that the vacuum system effectively removes air from the chamber. It does NOT prove sterilization.

Question 4

When should the Bowie-Dick test be run?

Accepted Answer

The test must be run in an empty chamber (to maximize the challenge to the vacuum system) at the beginning of each day of use.

Question 5

A Class 5 Chemical Integrator:

Accepted Answer

Class 5 Integrators are internal indicators designed to mimic the response of a biological indicator by reacting to time, temperature, and steam quality.

Question 6

Where should the Process Challenge Device (PCD) containing the Biological Indicator be placed in a steam sterilizer?

Accepted Answer

The area over the drain is the 'coldest point' in the sterilizer because air and condensate gravitate there. Placing the PCD here presents the greatest challenge to the cycle.

Question 7

Which Class of FDA Product Recall is the most serious, indicating a reasonable probability of serious health problems or death?

Accepted Answer

Class I recalls involve products that could cause serious injury or death. Class II involves temporary/reversible health issues. Class III is unlikely to cause adverse health consequences.

Question 8

Validation vs. Verification: Who performs 'Validation' of a sterilization process?

Accepted Answer

Validation is performed by the manufacturer to prove their instructions work. Verification is performed by the end-user (CS tech) to confirm they are following those instructions correctly.

Question 9

According to AAMI ST79, how often should a Biological Indicator (BI) test be run for steam sterilizers?

Accepted Answer

Weekly is the absolute minimum requirement, but daily (plus every implant load) is the recommended best practice for patient safety.

Question 10

If a biological indicator test is positive, what is the first action the technician should take?

Accepted Answer

A positive BI means sterilization failed (spores grew). All items processed since the last confirmed 'good' cycle are suspect and must be recalled/quarantined.

Question 11

Which Chemical Indicator is used to differentiate between processed and unprocessed items (external indicator)?

Accepted Answer

Class 1 Process Indicators (like autoclave tape) change color to show the item has been exposed to the sterilization process, preventing unprocessed items from being used.

Question 12

What information does a 'Load Control Label' provide?

Accepted Answer

Load labels (Lot numbers) provide the traceability needed to recall specific items if a sterilization failure occurs.

Question 13

When incubating a Biological Indicator, what is the purpose of the 'Control' vial?

Accepted Answer

The control vial is not sterilized. It MUST grow bacteria (turn yellow/positive). If the control doesn't grow, the test is invalid because the spores might have been dead to begin with.

Question 14

Implantable devices should not be released for use until:

Accepted Answer

Because implants remain in the body, the risk of infection is higher. Loads containing implants should be quarantined until the BI confirms sterilization success.

Question 15

A Class 6 'Emulating Indicator' verifies:

Accepted Answer

Class 6 indicators are cycle-specific. They emulate the performance of the specific cycle they are designed for (temperature/time) with a high degree of precision.

Question 16

Testing the sharpness of scissors or the alignment of hemostats is a form of:

Accepted Answer

Inspection and functional testing ensure the device will perform as intended. Sending up a broken instrument is a quality failure.

Question 17

Which organization develops the nationally recognized standards (like ST79) for sterilization?

Accepted Answer

AAMI sets the consensus standards for sterilization processing. OSHA regulates safety; FDA regulates device manufacturing/sales.

Question 18

Temperature and humidity logs in the sterile storage area should be checked and recorded:

Accepted Answer

Daily monitoring ensures environmental conditions remain within safe limits to maintain sterility.

Question 19

During a recall, the first step is to:

Accepted Answer

Traceability is key. Use the lot numbers to find exactly which items were in the failed load and retrieve them.

Question 20

Which test is used to verify the efficacy of the mechanical washer's cleaning ability (cavitation or impingement)?

Accepted Answer

Cleaning verification tests like TOSI (dried blood soil simulation) or aluminum foil tests verify that the washing equipment is actually removing soil.

Question 21

Sterilization records (printouts, BI results) must be retained for how long?

Accepted Answer

Retention requirements vary by state, but records are typically kept for several years to align with statutes of limitations for lawsuits.

Question 22

If the physical monitor (printer) on the sterilizer indicates a failure (e.g., temperature dropped), but the chemical indicator passed, what should be done?

Accepted Answer

The physical monitor is the first and most critical indicator. If the printout shows parameters were not met, the load is unsterile, regardless of what the CIs say.

Question 23

Using a rigid container that has not been validated for use in your specific sterilizer cycle is an example of:

Accepted Answer

Using a device in a manner not approved by the manufacturer (IFU) is 'off-label' and creates liability/safety risks.

Question 24

Which of the following is considered a 'Sentinel Event' in sterilization?

Accepted Answer

A sentinel event is an unexpected occurrence involving death or serious physical injury. Using non-sterile instruments on a patient fits this criteria (Joint Commission).

Question 25

The recommended incubation temperature for Geobacillus stearothermophilus is:

Accepted Answer

Geobacillus stearothermophilus is a thermophile (heat-loving). It requires high incubation temperatures (55-60°C) to grow.

Question 26

A chemical indicator placed inside a rigid container is called an:

Accepted Answer

Internal indicators verify that the sterilant penetrated the barrier (container) and reached the instruments inside.

Question 27

If wet packs are frequently found in a specific sterilizer, the first step in troubleshooting should be:

Accepted Answer

Most wet packs are caused by operator error (improper loading). Verify procedures before assuming equipment failure.

Question 28

Which agency requires Safety Data Sheets (SDS) be available for all chemicals used in the department?

Accepted Answer

OSHA's Hazard Communication Standard ('Right to Know') mandates access to SDS for employee safety.

Question 29

Product quality assurance testing of a rigid sterilization container includes checking the:

Accepted Answer

Routine inspection must verify the gasket seals tight and the filter retention mechanism is not bent or loose, ensuring a sterile barrier.

Question 30

For quality assurance, a Process Challenge Device (PCD) for EtO sterilization should contain:

Accepted Answer

EtO PCDs typically contain a BI (B. atrophaeus), a CI, and materials (like a syringe or tubing) that create a resistance challenge similar to the load.

Question 31

Failure to remove soil from the box lock of a hemostat during cleaning is a failure of:

Accepted Answer

Cleaning is the core of decontamination. If soil remains, sterility cannot be achieved.

Question 32

A rapid-readout Biological Indicator uses what technology to detect spores?

Accepted Answer

Rapid-readout BIs (1-3 hours) detect fluorescence produced by enzymes released by living spores, providing results much faster than visual pH color change (24-48 hours).

Question 33

What is the correct placement for a Bowie-Dick test pack?

Accepted Answer

The test pack must be placed in the most challenging area (over the drain) in an empty chamber to accurately test the vacuum system's ability to remove air.

Question 34

Verification of the ultrasonic cleaner's cavitation energy should be performed:

Accepted Answer

Routine verification (weekly/daily) ensures the transducers are functioning and cleaning is effective.

Question 35

Which document is the ultimate authority on how to process a specific medical device?

Accepted Answer

The Manufacturer's IFU is the primary source of truth. Validated instructions must be followed to ensure safety and efficacy.

Question 36

A load record indicates that a 'Control' Biological Indicator was NOT run with the daily BI test. The test BI came back negative (growth). What is the status of the sterilizer?

Accepted Answer

Without a positive Control BI, you cannot prove the spores were alive to begin with or that the incubator is working. A negative test result is meaningless (invalid) without a positive control for comparison.

Question 37

Which scenario represents a 'sentinel event'?

Accepted Answer

A sentinel event is an unexpected occurrence involving death or serious physical/psychological injury. A severe infection from dirty instruments qualifies.

Question 38

When testing a rigid sterilization container, a technician places a biological indicator inside but forgets the chemical indicator. The BI is negative (pass). Can the tray be used?

Accepted Answer

Every package must contain an internal chemical indicator (Class 3, 4, 5, or 6) to verify that sterilant penetrated the package. Without it, the package is considered non-compliant/unsterile.

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