CNOR Infection Prevention and Control of Environment, Instrumentation, and Supplies pt 2 Flashcards
Packaging materials should be compatible with what?
different types of sterilization methdos
What 3 things disqualify a package from being used?
- broken seals
- evidence of loss of package integrity (the condition of a sterilized package)
- evidence of moisture penetration
What 2 things should be inspected on an instrument prior to being packaged?
- cleanliness
- function
instruments should be what prior to packaging?
dry
Instruments with multiple parts should be what?
disassembled if possible
instruments with locks should be what?
processed in the open position
What should not be placed in sterilization containers unless required by the manufacturer’s IFU?
towels
What is used to prevent microbial migration?
sequential wrapping with 3 single wraps or a single wrap with 2 layers
What should be followed when placing one pouch inside another?
IFU
If recommended by the manufacturer, pouches should be placed how?
paper side to paper side
To allow sterilant contact and drying during sterilization, pouches should be what?
properly spaced and positioned on edge
package labels should be what? so that what?
should be secured so that they do not become dislodged during processing, storage, and movement to the point of use
peel pouches should not be placed where?
in instrument sets
What is the weight limit for instrument pans and their contents?
a 25 lb weight limit
Why is their a weight limit for instrument pans?
allows for adequate drying of contents and decreases the risk of injury to the staff handling the sets
Before placing the contents of a rigid container, OR personnel should check what 3 things?
- check the filters for defects and determine whether the valve is functional
- ensure that no moisture is present
- determine whether the indicator has turned
What should OR personnel check wrapped containers for?
check for perforations and moisture and whether the indicator has turned
Where should personnel label a peel pack?
on the plastic side
What can writing on the paper side of a peel pack do?
may cause the ink to leach through and compromise the integrity of the package
discovery of a wet pack involves what?
a multidisciplinary approach to determine and correct the problem
Who will be involved if a wet pack is discovered?
- infection preventionist
- perioperative and sterile processing staff and managers
- facility manager
What are the subsequent events if a wet pack is discovered?
- load in question should be quarantined according to lot number
- surgeons should be notified
- the sterilizer should be repaired if needed
Documentation on the package label should include what 5 things?
- the sterilizer identifier
- the cycle or load number
- the date of sterilization
- a description of the contents
- assembler identification information
New, repaired, refurbished, or loaned instruments need to be what before use?
cleaned, decontaminated, inspected, and sterilized
What does single use mean?
that personnel must use that item only one time
single-use istruments that are reprocessed must meet what?
FDA guidelines for reprocessing, which includes policies, procedures, competencies, and education
Items that are not clean cannot be what?
sterilized
What can be used to sterilize heat- and moisture-stable items?
saturated steam under pressure
what is the critical step in steam sterilization?
the removal of air from the chamber
How can the removal of air from the chamber be achieved?
via gravity displacement or through a dynamic air removal process (prevacuum)
What are the 4 parameters of steam sterilization?
- pressure
- temperature
- time
- moisture
what are the first 3 parameter that are captured as part of the sterilizer monitoring log or record?
pressure, temperature, time
What are examples of items that can be sterilized with saturated steam?
stainless steel instruments, glass, and towels
What may you also use saturated steam with but may require longer exposure or drying times?
some powered instruments, specialty orthopedic instruments and devices, and neurosurgery
Both terminal sterilization and immediate-use steam sterilization follow what?
the manufacturer’s written guidelines for required cycles for different devices and load configurations
immediate-use steam sterilization follows the same what?
process as that for saturated steam under pressure without the dry cycle
Why should IUSS not be used frequently?
increased risk of infection secondary to inconsistent cleaning practices in the OR and the transfer of the item from the sterilizer to the point of use
IUSS should only be used when?
in specific situations when there is not enough time for a full cycle
What should definitely not be sterilized through IUSS?
implants; except in the case of a defined emergency in which no other option is available
If an implant is processed via IUSS, what needs to be run with the load?
a biological indicator and a type V integrating chemical indicator
Records for IUSS should include what?
- the item sterilized
- the patient’s name
- the sterilizer number
- the cycle paramaters - temperature, duration of cycle
- monitoring results
- the date and time the cycle was run
- the name of the cycle operator
- the reason for IUSS
what provides a monitoring system for quality assurance with IUSS?
routine follow up audits
what is ethylene oxide sterilization?
a low temperature sterilization method used for moisture- and heat-sensitive devices (fiberoptic cords, lensed instruments, flexible endoscopes)
EO is very effective but what 4 features make it less than ideal choice?
- EO is a known carcinogen
- the extensive time required for aeration (up to 8 hours) makes EO an impractical choice for many operating rooms
- EO is explosive and flammable
- Sterilizer installation must meet National Institute for Occupational Safety and Health (NIOSH) and EPA standards for exhaust of flumes
items must be what before placement in the chamber for EO?
must be dry
what is imperative in EO and why?
correct loading of the baskets or cart is imperative to allow for EO circulation and penetration.
EO-sterilized items must be what to prevent burns to staff or patients?
must be aerated at the endy of the cycle
Peronnel must wear what with EO?
must wear EO monitoring badges during exposure
low-temperature hydrogen peroxide methods (vapor, gas plasma combination, ozone combination) can be used when?
to sterilize items that cannot tolerate high temperatures and humidity (i.e. some plastics, electical devices, and corrosion-susceptible metal alloys
Why is low-temperature hydrogen peroxide desirable?
packages do not require aeration
What are the risks that accompany low-temperature hydrogen peroxide methods?
it may cause burns, upper airway irritation, and, in cases of severe exposure, permanent lung damage
what cannot be used in low-temperature hydrogen peroxide methods?
liquid and cellulose-based paper
instruments should be evaluated for what with low-temperature hydrogen peroxide methods?
for acceptable lumen diameter and length
what needs to be specially designed and designated for low-temperature hydrogen peroxide sterilization?
trays, mats, and containers AND cleared by the FDA
What can ozone sterilization be used for?
to sterilize moisture- and heat-sensitive items according to the manufactuerers’ IFU
What has the FDA approved the use of ozone sterilization for?
for use with metal and plastic surgical instruments
what does ozone sterilized use?
uses only oxygen and water in the sterilizer chamber
personnel should first determine what before using ozone sterilization?
lumen diameter and length
What cannot be used with ozone sterilization?
cellulose-based paper
What can be used with ozone sterilization?
FDA approved rigid containers and nonwoven packages
When is dry heat sterilization used?
for materials that are impenetrable to moist heat and can withstand high temperatures
What are examples of items that can tolerate high, dry heat?
dental instruments, oils, and heat-stable powders
What usually cannot withstand the high temperatures associated with dry heat sterilization?
most types of type
what kind of containers should be used for dry heat? and why?
small containers to allow for the lowest possible package density
What should personnel use to prevent burns with dry heat?
proper PPE - insulated gloves, handles
At the end of the cycle, personnel should what with dry heat sterilization?
should not touch the sterilizer chamber or items in the chamber. allow things to cool before handling
What is paracetic acid liquid sterilization?
a low-temperature sterilant that should not be used for devices that are heat sensitve, can be immersed, are approved for this process, and cannot be sterilized using steam sterilization methods
In FDA-cleared formulated prodcuts, paracetic acid liquid is effective even when what is present?
organic matter
What is really important for paracetic acid liquid with use?
since the processed item is wet and the container is not sealed, the item should be transported to the point of use to be used immediately, not stored for later use
Paracetic has what kind of implications for staff?
health implications, include skin and eye irritation, burns, and toxic effects to internal organs
glutaraldehyde and ortho-phthalaldehyde are used as what?
high-level disinfectants or chemical sterilants
To use chemical sterilants, the device must be able to be what?
be immersed in the disinfectant bath
What is the advantage of glutaraldehyde?
it has a noncorrosive action on endoscopic equipment, thermometers, rubber, anesthesia equipment, respiratory equipment, and plastic
What are health concerns associated with glutaraldehyde?
include respiraotry irritation from the vapor and contact dermatitis
where should the glutaraldehyde bath be located?
in a well-ventilated area that has 7 to 15 air exchanges per hour to prevent toxic fume buildup
what should be checked prior to each glutaraldehyde load?
concentration and temperature of the solution
If a glutaraldehyde solution is not within acceptable parameters what should eb done?
the solution must be discarded
what should the container being processed with glutaraldehyde and ortho-phthalaldehyde have?
a tight fitting lid
In order to avoid diluting the glutaraldehyde and ortho-phthalaldehyde solutions, items must be what?
dry
thorough cleaning of the instrument prior to placement in the bath is important why?
HLDs may fix blood and organic material to the surface of the instrument
At the end of a cycle with glutaraldehyde and ortho-phthalaldehyde, instruments must be what?
thoroughly rinsed and lumens flushed at the end of the cycle
what does working with glutaraldehyde, hydrogen peroxide, and ortho-phthalaldehyde require?
that perioperative nurses wear protective attire, which may include chemical-resistant gloves, protective eyewear, and an impervious gown or apron
the process of sterilization requires what?
properly functioning devices
what does monitoring of both packages and sterilizers provide?
provides verification that the recommended parameters for sterilization have been met
What 3 things should be used to monitor the sterilization process?
physical, chemical, and biological indicators
What are physical monitors that are reviewed by staff at the end of each cycle to ensure that paramaters for meeting sterility have been met?
- temperature, time, pressure, humidity, sterilant concentration
Where are physical monitors results recorded?
in logs, digital readings, printouts, graphs, or gauges
What should documentation of sterilization process incorprated into?
the facility’s quality assurance plan
If physical parameters are not met, or if the sterilizer has been moved, cleaned, or repaired, what must happen?
a biological indicator must be negative for 3 consecutive cycles (empty chamber) before the sterilizer is returned to service
what are chemical indicators used for?
to immediately verify that the package has been exposed to the sterilization process
chemical indicators do not establish what?
sterility of the content
biological indicators are used to monitor what?
sterilizer efficacy
when should biological testing for steam sterilizers be performed?
at least weekly, although most facilities choose to test their sterilizers daily to allow for earlier discovery of equipment malfunction or errors
all loads containing implants should contain what?
a BI and be quarantined until the BI results are known
Storing sterilized items in a controlled environment helps to ensure what?
the integrity of the product and decreases the risk for contamination through dust, moisture, heat, or excessive handling of the packaging
Shelf life is related to what rather than what?
related to event (amount of handling, exposure to humidity) rather than to the length of the time the package sits on the shelf or the date it was sterilized
What 3 environmental conditions help assure sterility of stored packages?
- the temperature does not exceed 75 degrees fahrenheit
- there are 4 total air exhanges per hour
- the relative humidity is between 20% and 60% and no higher than 70%
personnel should place chemical indicators where in the package?
in the package area that offers the most challenge for air removal and sterilant contact
Storage areas for sterilized instruments and supplies and shelves, racks, bins, and containers must be what? and kept?
in compliance with fire codes and kept clean and dry
sterile supplies must be how many inches above the floor?
8-10 inches above the floor
sterile supplies must be how many inches from the outside walls?
2 inches
sterile supples must be how many inches from the ceiling or sprinkler heads to support adequate air circulation and cleaning?
18 inches
sterile supplies must never be stored where?
under sinks or other areas where moisture or vermin can compromise the integrity of the packaging
sterile items stored outside a designed sterile storage room should be kept where?
in closed cabinets or carts
sterile storage rooms may contain either?
closed or open shelves or racks
the bottom of an open shelving unit must be what?
solid
Flexible endoscopes should be stored how?
vertically in a drying cabinet or closed cabinet with high-efficiency particulate air (HEPA) filtered air that provides positive pressure to promote drying and discourage bacterial growth
Is there a standard for maximum storage time of flexible endoscopes?
no
A multidisciplinary team should establish what for endoscopes?
a policy for the length of time an endoscope may be stored before reprocessing is required
What is the description of a chemical indicator CLASS I?
process. place externally (i.e. tape)
What is the purpose of a chemical indicator CLASS I?
immediately verifies exposure to the sterilization process
What is the description of a chemical indicator CLASS II?
speciality (i.e. bowie-dick air removal test sheet/pack)
What is the purpose of a chemical indicator CLASS II?
tests for the precence of air in the sterilizer chamber of a prevacuum steam sterilizer
What is the description of a chemical indicator CLASS III?
single parameter (i.e. time or pressure)
What is the purpose of a chemical indicator CLASS III?
reacts to 1 critical process parameter
What is the description of a chemical indicator CLASS IV?
multi-paramter (time, temperature, and pressure)
What is the purpose of a chemical indicator CLASS IV?
reacts to 2 or more critical process parameters
What is the description of a chemical indicator CLASS 5?
integrating. place internally. multilayered trays may require an indicator on each layer
What is the purpose of a chemical indicator CLASS 5?
reacts to all critical process parameters. used for all implantable devices
What is the description of a chemical indicator CLASS 6?
emulating. place internally.
What is the purpose of a chemical indicator CLASS 6?
reacts to all the critical parameters of a specialized sterilization cycle
A health care facility plan for receiving and using loaned instrumentation includes what?
tracking and maintaining quality controls
A health care facility plan for receiving and using loaned instrumentation must describe what?
appropriate decontamination and sterilization processes for the loaned items
A health care facility plan for receiving and using loaned instrumentation should most importantly include what 3 thingS?
- details about how to acquire instruments and implants
- written manufacturer’s instructions for cleaning, assembly, and sterilization
- requirements to limit instrument set weight to no more than 25 pounds
requests for loaned instrument use should include what?
quantities and the time of use, return, and restocking to prevent the need for IUSS
Sterile processing manager should maintain what for loaned instruments?
should maintain the documentation of loaned transactions in a central location and give a copy to the industry representative
What must be removed before loaned items are transported to the sterile processing area?
external shipping containers
sterile processing personnel should inspect what upon receipt? and then do what?
should inspect rigid instrument containers upon receipt and then clean and decontaminate the containers
sterile processing personnel should inventory what?
inventory the instruments and implants and then clean, decontaminate, and sterilize the loaned instruments before sending them to the point of use
true or false; presterilized loaned instruments do not need to be reprocessed
false; they do to ensure sterility and prevent cross-contamination from another facility or during transport to the receiving facility
At the completion of the procedure, sterile processing personnel should what what before returning loaned instruments to an industry representative?
clean, decontaminate, inventory, and inspect the instruments
What helps ensure that instruments have been returned in good repair and are safe to handle?
documentation
steam sterilizer (include IUSS) has what biological indicator?
geobacillus stearothermophilus
What is the timing of testing for steam sterilizers and biological indicators?
at least weekly, preferably daily
steam sterilizer, dynamic air displacement has what biological indicator?
bowie dick
What is the timing of testing for steam sterilizer, dynamic air displacement and biological indicators?
empty the chamber at the beginning of each day the sterilizer is used
EO has what biological indicator?
bacillus atrophaeus
What is the timing of testing for EO and biological indicators?
every load
low-temp hydrogen plasma has what biological indicator?
geobacillus stearothermophilus
What is the timing of testing for low-temp hydrogen plasma and biological indicators?
at least daily
ozone has what biological indicator?
geobacillus stearothermophilus
What is the timing of testing for ozone and biological indicators?
at least daily
dry heat has what biological indicator?
bacillus atrophaeus
What is the timing of testing for dry heat and biological indicators?
at least daily
paracetic acid has what biological indicator?
no fda-cleared biologic indicator is available currently
