CSPT Sterilization

Tyvek

A brand of flashspun high-density polyethylene fibers, a synthetic material. The name is a registered trademark of DuPont. The material is very strong, it is difficult to tear but can easily be cut with scissors or a knife.

Ethylene chlorohydrin

A byproduct produced when EO reacts with saline or body fluids.

Ethylene glycol (antifreeze)

A byproduct produced when EO reacts with water. Characterized by the presence of a brown oily film that is poisonous and toxic.

Table-top steam sterilizer

A compact steam sterilizer with a chamber volume no more than two cubic feet that generates its own steam when distilled or deionized water is added by the user.

Maximum, small

A failed ___-load test indicates the sterilization process was not adequate, a failed ___-load test indicates inadequate steam penetration or air removal.

Exception form

A form documenting the premature release of implants before the BI result is known.

Implant load

A load that requires a BI PCD containing a Class 5 integrating indicator and that is quarantined until the BI test results are known.

Wet pack

A package that has visible moisture on the outside, inside, on the instruments, or visible water in the set. It must be completely reprocessed.

Low-temperature gas plasma (LTGP)

A quick, low-temperature process using a combination of hydrogen peroxide vapor and gas plasma to sterilize packaged devices. An alternative to EO gas without the hazards or extended aeration times. A.k.a. STERRAD sterilizers.

Low-temperature hydrogen peroxide (LTHP)

A quick, low-temperature sterilization process that uses vaporized hydrogen peroxide without plasma. It is an oxidizing agent that can be corrosive to device surfaces.

Small-load test

A test that assesses the steam sterilizer's ability to sterilize under worst-case conditions. One test container is placed on the sterilization cart over the drain with no other additional items.

Maximum-load test

A test that assesses the sterilizer's ability to sterilize under actual use conditions. Two test containers are placed on each shelf of the sterilizer cart along with other containers or packaged items.

Polyethylene

A tough, light, flexible synthetic resin made by polymerizing ethylene, chiefly used for plastic bags, food containers, and other packaging.

Process indicators Class 1

Also referred to as external CIs. Indicators used to differentiate between packages that have and have not been sterilized. Contains a chemical that reacts to the sterilization process with a color change (e.g. indicator tape).

Control BI

An unsterilized BI that is tested in an incubator. Used to verify that the spores are viable before being sterilized, that the incubator can promote growth of test spores, that storage conditions are correct, and that the proper temperature was used for incubation.

Humidity level

Because microorganisms must be hydrated for EO to penetrate the cell walls, the ___ is critical in EO sterilization.

700ppm

Concentration of EO in the air where it can be detected by odor.

48-72, 4

Conventional BI indicators for EO require ___ hours while enzyme-based early-readout indicators require ___ hours for incubation.

113-131

Depending on the model, cycle temperatures for LTGP sterilizers range from ___°F.

Chemical indicator (CI)

Device used to monitor one or more of the sterilization parameters required for the sterilization process.

3

During a recall, if the sterilization process failure was caused by a sterilizer, it should be rechallenged with a BI PCD in ___ consecutive empty-chamber cycles in the shortest cycle time. Repeat with a Bowie-Dick test afterwards for prevacuum sterilizers.

Prevacuum sterilizer

Dynamic-air-removal sterilizer that removes air by drawing a series of vacuums with an injection of steam between each vacuum pull.

Steam-flush pressure-pulse (SFPP) sterilizer

Dynamic-air-removal sterilizer that uses a sequence of steam injections and pressure at or above atmospheric pressure to remove air. No vacuum required.

Lot control number

Enables each sterilized device to be tracked, and includes the sterilizer number, the cycle or load number, and the date of sterilization.

Process challenge device (PCD)

Formerly called a "test pack", designed for sterilization monitoring. It contains a BI and/or CI and is designed to be representative of a load.

Neoprene, butyl rubber, nitrile rubber

Glove materials that are EO resistant.

EO

Hydrochlorofluorocarbon (HCFC) and carbon dioxide (CO2) are often mixed with ___ to reduce it's potential for fire or explosion.

97-100%

Ideal range of incoming steam's relative dryness.

Negative, positive

If the color of a BI is unchanged or shown no fluorescence after testing, it is considered a ___ test. If it is yellow or shows fluorescence it is a ___ test.

Upper, lower

In a mixed load of textile items and metal goods, textile packs or paper-plastic pouches should be placed on the ___ shelfs while metal instruments, basins, and other metal items should be placed on the ___ shelves.

Higher, shorter

In a steam sterilizer; the higher the temperature, the ___ the pressure. The higher the temperature, the ___ the time.

131-140, 24

Incubation of a BI for LTGP and LTHP is at ___°F for at least ___ hours.

Emulating indicators Class 6

Indicators designed to react to all critical variables of a specified sterilization cycle (e.g. an indicator labeled for use in only prevacuum, express, 270°F, 4-minute cycles).

Integrating indicators Class 5

Indicators designed to react to all of the critical variables of the sterilization process. These parallel the performance of BIs, but should not be used as a substitute.

Multi-variable indicators Class 4

Indicators designed to react to two or more variables of the sterilization process. Most show an acceptable endpoint by a color change.

Single-variable indicators Class 3

Indicators designed to respond to only one variable of the sterilization process (e.g. glass ampule containing a chemical that melts when sterilization temperature is achieved).

Specific test indicators Class 2

Indicators used in certain test procedures, such as the Bowie-Dick test for air-removal performance of prevacuum sterilizers.

LTGP

Items sterilized in ___ sterilizers must be packaged in non-cellulose materials. Cloth, paper-plastic pouches, and cotton can not be used. Tyvek all-plastic pouches and polypropylene-based wraps are compatible materials.

Superheated steam

Saturated steam subjected to higher temperatures, occurring when heat is added to dry steam in the absence of water. The steam is "dried out".

Denaturing/coagulating

Saturated steam under pressure kills microorganisms by ___ the protein.

Action level

Set at 0.5ppm as an 8 hour TWA. The level at which additional monitoring and/or other actions must be taken regarding EO exposure.

Excursion limit (EL)

Set at 5ppm as a 15 minute TWA. EO levels measured over 15 minute periods while performing specific activities.

Gravity-displacement liquids cycle

Steam cycle used to sterilize liquids. Uses a slow exhaust to prevent rupture of the liquid container.

Steam sterilization

Sterilization as a product of heat plus moisture, where heat is given up by the process of condensation.

Dynamic-air-removal cycle

Sterilization cycle used in prevacuum and SFPP sterilizers.

Gravity-displacement cycle

Sterilization cycle where incoming steam displaces residual air through the drain at the bottom of the sterilizer chamber. No mechanical air removal.

Immediate-use steam sterilization (IUSS)

Sterilization method used in emergency situations, formerly known as "flash sterilization".

Physical monitoring

Sterilization monitoring process involving the observation of charts, gauges, and printouts.

Chemical monitoring

Sterilization monitoring process involving the use of external and internal chemical indicators, and for prevacuum sterilizers, a Bowie-Dick test pack.

Biological monitoring

Sterilization monitoring process used to verify that the sterilization conditions in the load are adequate to kill bacterial spores.

Administrative monitoring

Sterilization monitoring process using policies and procedures.

Biological indicator (BI)

Sterilization process monitoring device consisting of a standardized, viable population of microorganisms (10-6 or one million spores) known to be resistant to the mode of sterilization being monitored.

Gravity-displacement

Table-top sterilizers usually have a limited number of cycles, most with "locked-in" cycles, using ___ steam sterilization.

PCD with conventional BI

The BI in this PCD must be incubated for 48 hours after sterilization. Used with 270-275°F dynamic-air-removal and 250°F gravity-displacement cycles.

Permissible exposure limit (PEL)

The amount of airborne EO or H2O2 which personnel are exposed to may not exceed 1ppm as an 8 hour TWA.

Sterilizer access area

The area behind the steam (and sometimes EO) sterilizers, needed by service representatives to gain access to the equipment for repairs.

Time-weighted average (TWA)

The average exposure level over an entire shift of an employee.

Steam jacket

The component of a steam sterilizer that insulates the chamber, provides heat to prevent condensation on the walls, and holds the steam until cycle initiation.

Drain line

The coolest part of the steam sterilizer chamber, also where the thermometer is located.

Fluorescence

The emission of radiation, especially of visible light, by a substance during exposure to external radiation, as light or x-rays.

Vacuum, injection, diffusion, plasma, vent

The five phases of a LTGP sterilizer (phases 2-4 are repeated a second time).

Gas concentration, exposure time, humidity, temperature, (pressure)

The four (or five for EO mixtures) parameters of EO sterilization.

Condition, exposure, exhaust, dry

The four phases of a steam sterilization cycle.

Administrative, physical, chemical, biological

The four types of monitoring of the sterilization process.

Sterility assurance level (SAL)

The level of sterility defined by log reduction, i.e. 10-6 equals a 99.9999 % reduction of bacteria, or a one-in-a-million chance a viable microorganism survived.

4, 270, 28-30, 3, 275, 28-30

The minimum parameters for dynamic-air-removal cycles: ___ minutes, ___°F and ___psi, or ___ minutes, ___°F and ___psi.

30, 250, 15, 15-25, 270, 27, 10, 275, 30

The minimum parameters for gravity-displacement cycles: ___ minutes, ___°F and ___psi, ___ minutes, ___°F and ___psi, or ___ minutes, ___°F and ___psi.

Ethylene oxide (EO)

The most stable low-temperature sterilant for heat, pressure, and moisture-sensitive items. It has no restrictions on its use with lumens, complex devices, or packaging materials. Kills microorganisms by an alkylation process.

PCD with enzyme-based early-readout BI

The original version of this BI PCD provides a final reading 3 hours after sterilization, based on the detection of fluorescence. A new type uses the same technology with a final reading only 1 hour after sterilization. Used with 270-275°F dynamic-air-removal and 250°F gravity-displacement cycles.

Conditioning phase

The phase of a steam sterilization cycle where air is removed from the chamber and steam is injected, and the packs in the sterilizer are gradually heated by steam.

Drying phase

The phase of a steam sterilization cycle where filtered air is drawn into the chamber, or the chamber walls are heated in order to evaporate the moisture.

Exhaust phase

The phase of a steam sterilization cycle where steam is exhausted from the sterilizer through the drain.

Sterilization/exposure phase

The phase of a steam sterilization cycle where the exposure temperature is maintained for the prescribed amount of time.

60-80 psi

The pressure range required in a steam sterilizer.

75-85, 10

The recommended temperature range of the sterilizer access area is ___°F, with recommended ventilation at ___ air exchanges per minute under negative air pressure.

Alkylation

The removal of hydrogen from the chemical structure of a microorganism. The process used by EO sterilization.

Bacillus atrophaeus

The spore used in BI monitoring of EO and dry heat sterilization.

Geobacillus stearothermophilus

The spore used in the BI monitoring of large and table-top steam sterilizers, as well as LTGP, LTHP, and ozone sterilizers.

99

The temperature for incubation of EO BIs is typically ___°F.

68-73, 30-60, 50, 35-60, 50, 10

The temperature of the sterilization area should be between ___°F with relative humidity at ___%, ideally at ___%. If sterilization is performed within the prep & pack area, then humidity range should be ___% with ideal at ___%. ___ air exchanges per hour.

Time, temperature, hydrogen peroxide gas plasma

The three parameters for LTGP sterilization.

Saturated steam under pressure, time, temperature

The three parameters for steam sterilization.

Routinely, implant loads, qualification testing

The three times a BI should be used in monitoring steam sterilization.

PEL, action level, EL

The three types of limits on employee exposure to EO.

Qualification testing

The type of testing performed when a sterilizer is installed, relocated, malfunctions, or when the sterilizer or its utilities have a major repair.

6

There are ___ classes of chemical indicators.

1

There should be a ___ inch space between each container as well as the chamber wall to permit air removal and steam penetration, and to prevent scorching of packaging material.

Wick

To absorb or draw off liquid by capillary action.

270-275, 3, 4, 3, 10

Typical IUSS cycles are ___°F and either ___ or ___ minutes for dynamic-air-removal or ___ or ___ for gravity-displacement.

122, 12, 130, 10, 140, 8

Typical minimum aeration times and temperatures for EO sterilization are ___°F for ___ hours, ___°F for ___ hours, or ___°F for ___ hours.

131-140

Typical temperature range (Fahrenheit) for incubation of BIs.

EO

Polyester, polyvinylchloride (PVC), styrofoam, and nylon packaging materials are not recommended for ___ sterilization.

Bowie-Dick test

Used to detect air leaks, inadequate air removal, inadequate steam penetration, and the presence of non-condensable gases. Performed daily for dynamic-air-removal cycles of prevacuum sterilizers.

Wet load

When multiple wet packs are found in the same load. May be cause for recalling entire load.

18, 273, 60, 250

When processing instruments used on suspected CJD patients, AAMI recommends a minimum prevacuum cycle of ___ minutes at ___°F, or a gravity-displacement cycle of ___ minutes at ___°F.

Plasma phase

Phase in a LTGP cycle where the chamber pressure is reduced by vacuum and radiofrequency energy is radiated within the chamber from the electrode screen. H2O2 is ionized into gas plasma, leading to the formation of oxygen and water.

Diffusion phase

Phase in a LTGP cycle where the chamber returns to atmospheric pressure and H2O2 vapor is driven into the small crevices and lumens of the devices. Inactivation of microorganisms is initiated.

Injection phase

Phase in a LTGP cycle where a premeasured amount of concentrated (59%) H2O2 is pumped from the cassette into the vaporizer bowl, then vaporized into the chamber.

Vacuum phase

Phase in a LTGP cycle where air is removed from the chamber until the pressure is reduced below atmospheric pressure.

Vent phase

Phase in a LTGP cycle where radiofrequency energy is turned off and air is vented into the chamber through HEPA filters, returning it to atmospheric pressure.