Cleaning, Disinfection, and Sterilization Flashcards
Process of appraisal that considers the value and significance of quality, cost, safety, and practitioner choice for product selection
Product evaluation
What are the benefits of product evaluation
- Systematic product review and value analysis
- Inventory control
- Product standardization
- Cost control through competitive pricing
- Influencing purchasing agreements
What is the joint commission’s infection prevention requirement for product evaluation
Facility must limit transmission of infections associated with the use of medical equipment devices and supplies and the infection preventionist must participate in product evaluation
How can IPs get the information needed to review products?
Attend conferences
Review evidence-based practices in the literature
Review product materials
Network with colleagues
Review current guidelines
Critically evaluate clinical studies
What is the primary objective for product evaluation programs
To select and purchase products that meet specific performance criteria, contributes a good patient outcomes, meet safety requirements, and are cost effective
What is the process for product evaluation
- Need for a product is identified
- Develop functional product specifications
- Research the product
- Review potential safety and IP implications
- Develop product trial protocol
- Conduct product trial
- Evaluate trial results
- Present to PEC for final decision
Describe training and competence of new products
- ensure appropriate training and personnel with all products and equipment- conduct post implementation surveillance to ensure ongoing competence, proper use, and intended outcomes
Application of a product for a purpose that’s not included in approved device labeling
Off label use
What is the FDA review and approval structure for medical devices?
Pre-market approval (PMA) + pre-market notification (510k) = FDA designates labeled or indicated use of product
What is one common off label product use?
Reprocessing single use devices
What organization oversees reprocessing of single use devices?
FDA
What is the process for reprocessing a single-use device so that it can be patient ready?
Decontamination
Functional testing
Repackaging
Relabeling
Sterilizing
A device intended for one use on a single patient during a single procedure
Single use device
Who determines if a product should be labeled as single use?
The manufacturer
What class of devices presents the lowest potential risk to the patient and carries the least regulation?
Class I
What class of medical device poses the greatest potential risk and requires the greatest regulation?
Class III
What typically prompts consideration of reprocessing and reuse of single-use devices?
Cost
Who should be involved in decisions to reprocess single-use devices?
Infection prevention
Hospital administration
Supply chain administrator
Liability insurance carrier
Should healthcare facilities reprocess single-use devices on site?
No CMS recommends using a third party because most of their facilities do not have what is needed to reprocess single use devices to regulatory standards of the FDA
How should IP be involved with selecting the third party reprocessor for single use devices
- review FDA approval of the 510k application
- conducting on-site visit to review policies and observe cleaning and decontamination inspection testing and sterilization
- review quality control records
The process of removing visible dirt, organic material, and debris from surfaces and objects
Cleaning
The process of killing or inctivating microorganisms on surfaces and objects
Disinfection
Destroys all microorganisms including bacterial spores
Sterilization
What are the three categories of medical equipment under the Spaulding classification system
- Critical
- Semi-critical
- Non-critical
What did AAMI add as the fourth category for classifying medical equipment?
Environmental surfaces
Spalding classification in which the medical equipment enters tissue and must be sterile
Critical
Spalding classification in which the medical equipment contacts mucous membranes and requires high level disinfection
Semi- critical
Spalding classification in which medical equipment comes in contact with intact skin and requires low level disinfection
Non-critical
What are examples of critical medical equipment in the Spaulding classification?
Surgical instruments
Cardiac and urinary catheters
Implants
Ultrasound probes used in sterile body cavities
What is the minimum reprocessing requirement for critical equipment?
Sterilization
What are examples of semi critical equipment?
Respiratory therapy and anesthesia equipment
Scopes
Esophageal manometry probes
What is the minimum reprocessing requirement for semi critical equipment
High level disinfection
What are examples of non-critical medical equipment items?
Blood pressure cuff
Stethoscope
What is the minimum reprocessing requirement for non-critical items?
Low level disinfection
What is always required before disinfection and or sterilization?
Cleaning
Where does cleaning begin
Point of use
What is the first step to cleaning?
Remove gross debris and keep the medical equipment moist prior to transport
Is open but unused equipment contaminated?
Yes, it needs to be reprocessed
How should reusable items be transported from the point of use to the reprocessing area?
In closable, puncture resistant, leak proof containers that are properly marked as biohazard
This reduces the bioburden and removes foreign material such as organic residue and inorganic salts that interfere with the sterilization process by acting as a barrier to the sterilization agent
Cleaning
What is used to clean with friction?
Brushes based on the manufacturers instruction for use
This is used to remove soil and debris from internal channels after brushing and when the design does not allow the passage of a brush through a channel
Fluidics
How to load medical equipment into washers
Open hinged instruments
Do not stack
Disassemble as much as possible
Where are contaminated items cleaned?
Decontamination area
What is used to clean and decontaminate equipment?
Water and detergents or enzymatic cleaners
Brushes
Type of cleaning used when the area does not have a mechanical unit or for fragile or difficult to clean instruments
Manual cleaning
What cleaning methods are important for manual cleaning?
Friction and fluidics
Fluids under pressure to clean
Fluidics
If using automated washers what steps are still needed before loading the equipment?
Pre-cleaning and decontamination
What are the types of automated washers?
- Ultrasonic cleaners
- Washer decontaminators
- Washer disinfectors
- Washer sterilizers
This automated washer cleans by cavitation
Ultrasonic cleaner
This automated washer cleans like a dishwasher
Washer decontaminator
This automated washer is computer controlled
Washer disinfectors
This automated washer is a modified steam sterilizer
Washer sterilizers
When using a washer disinfector, care should be taken as to the method of.. ?
Loading instruments
What PH is best choice for cleaning instruments?
Neutral or near neutral pH detergent solution
Adding_____ assist in the removal of organic material
Enzymes
These cleaning agents maybe used because they dissolve protein and fat residues
Alkaline based cleaning agents
This is a non-enzyme option that’s just as effective as enzymatic cleaners
Hydrogen peroxide
What are some special considerations for using enzymatic cleaning solutions?
-they are not disinfectants and may be inactivated by germicides
- they must be rinsed from equipment or adverse reactions could result
- used in accordance with manufacturers instructions
What is the best solution option for a cleaning solution for delicate medical instruments, especially flexible endoscopes?
Neutral pH detergent solutions that contain enzymes
What is the concern with alkaline based cleaning agents?
They are corrosive
Process for keeping away disease-producing microorganisms
Asepsis
Use of sterile technique to prevent the transfer of any organisms from one person to another or from one body site to antoher
Surgical asepsis
Practice interventions that reduce the number of microorganisms
Medical asepsis
Practices aimed at reducing the microbial flora on the hands
Hand hygiene
Antimicrobial substance applied to the skin to reduce microbial flora
Antiseptic agent
Practices designed to render and maintain objects maximally free from microoganisms
aseptic technique
When should aseptic technique always be used?
When placing invasive devices
What types of barriers are used in aseptic technique?
sterile gloves
Sterile gowns
Masks
Sterile drapes
Practices designed to reduce the number of microorganisms
Clean technique
When is clean technique used?
Wound care
Placement of IV devices (such as peripheral venous catheters)
Respiratory suctioning
What type of gloves may be used for clean technique?
Clean gloves
What type of glove should always be worn for sterile dressing applications
sterile gloves
What is the best technique to dress a wound?
No touch dressing technique
Glove type for wound cleaning
Clean glove
Supplies/ Instrumentation for wound cleaning
-Normal saline or prepared sterile wound cleaner
-Irrigation sterile device with clean technique
Glove type for dressing change without debridement
Clean
Supplies/ instrumentation for wound cleaning without debridement
-Sterile supplies with clean technique
Glove type for dressing change with debridement
Clean gloves
Supplies/ instrumentation for dressing change with debridement
sterile supplies with clean technique
Type of glove for dressing change with sharp, conservative bedside debridement
Sterile
Supplies/ instrumentation for dressing change with sharp, conservative bedside debridement
-sterile supplies and sterile technique
Glove type for central line dressing change
Sterile for removing and new sterile for placement
Supplies and instrumentation for central line dressing change
sterile dressing change kit
Sterile technique
Surgeon mask
Glove type for trachestomy care or suctioning within a closed sheath
Clean
Supplies/ instrumentation for tracheostomy care or suctioning within a closed sheath
sterile supplies with clean technique
glove type for tracheal suctioning not within a closed sheath
Sterile
Supplies/ instrumentation for tracheal suctioning not within a closed sheath
Sterile suction
Environmental control strategies for surgical asepsis outside of the OR: Room specicic
- Use special treatment or operating room
- keep doors closed
- use ventilation
- use barriers
Environmental control strategies for surgical asepsis outside of the OR: related to activity around the setting
- manage activity to reduce airborne transmission of bedside procedures
- Divert traffic in open units
- Exclude visitors and unnecessary personnel
- avoid cleaning activities in the area
Area surrounding site of the incision or perforation into tissue, or the site of introduction of an instrument into a body orifice that has been prepared for an invasive procedure
Sterile field
Methods to maintain sterile field in the OR- sterile items
-sterile drapes and drape accessories to cover items in the field
- sterile gloves
- sterile gowns
- sterile attire for staff
Maintaining sterile field in the Or: related to ventilation
- Higher air exchanges
- positive pressure room
- air duct filters with routine changes
- temp + humidity control
OR Attire
- freshly laundered scrubs
- head and facial hair covering
- Clean shoes
- Masks
- impervious or fluid-resistant barriers
- may also need face and eye protection
When is hand hygiene performed in ORs?
- before donning sterile gloves
What should be used for HH in ORs?
Antiseptic or antiseptic soap
Goal of this is to remove soil and microorganisms living on the patient’s skin before surgery
Surgical skin antisepsis
How to use antiseptic agents
Follow the manufactuers directions for use
What are examples of skin antiseptics?
Chlorhexidine gluconate
povidone iodine in alcoholic or acqeous solutions
Sterile packages should always:
- maintain sterile packaging/ container integrity
- inspect before use and inspect for signs of contamination
How to transfer sterile equipment into sterile field
aseptically
Areas responsible for reprocessing instrumentation and other resuable medical devices
sterile processing
Includes handling, collecting, transporting, sorting, dissassembling, cleaning, disinfecting, inspecting, packaging, sterilization, sorting, and distributing equipment and supplies
Sterile processing
Goal of this is to provide safe, functional and sterile instruments and medical devices to reduce the risk for HAIs
Sterile processing
Organizations involved with regulations, guidelines, and standards of sterile processing
- OSHA
-EPA
-FDA
-HICPAC
-TIR (Tech Info Reports)
-AORN (perioperative nurses)
-Society of gastroenterology nurses and ass - facilities guideline institutes
Where does reprocessing begin?
Point of use
What is the point of use end user responsible to do for sterile processing?
Remove gross soil and debris and discard of soaking liquids using PPE
Container needed for transport of soiled equipment to sterile processing
puncture resistant
leakproof
sealable
Labeled biohazard
What agency regulates transport of contaminated material to an off-site sterile processing center?
US Department of Transportation
+ state regs
Physical environment of sterile processing: floors, walls, ceiling
nonparticulate or nonfibrous shedding material
Physical environment of sterile processing: ceilings
Flush surface with enclosed fixtures
Physical environment of sterile processing: work surfaces
Covered with nonporous material
Physical environment of sterile processing: Eyewash/ shower equipment
available with 10 seconds travel time
Physical environment of sterile processing: Physical barrier
between the decontamination area and work area where clean or sterilization procedures are carried out
Safety requirements for Sterile Processing staff- what to wear and not to wear
- wear surgical attire (scrubs) and dedicated shoes
- cover head and facial hair
- no jewelry on hands or wrists
- no nail polish or artificial nails
- Proper use of PPE
What does effectiveness of cleaning used items depend on?
- appropriate detergent or enzymatic cleaner
- acceptable washing method
- proper rinsing and drying
- correct use of mechanical cleaning equipment
- operator performance
What should personnel follow when completing the cleaning process for sterile processing?
Always follow manufactuerer’s written IFUs
the sterile processing physical environment should be as clean as the ___
OR
What do AAMI and AORN recommend about the location/ locations of sterile processing?
centralize to one location
Things to consider for the size of the central processing area
- volume
- processes
- types of services provided
- amount of equip needed
What does the decontamination area need to have in sterile processing?
decontamination area
? Mistake
What are the sink requirements for sterile processing?
36 inches from the floor
8-10 inches deep
What are the air requirements for central processing?
Move from clean side to the decontamination side
What are the temperature and humidity requirements for sterile processing?
Follow ANSI/ ASHRAE/ ASHE Standard 170
when is manual cleaning recommended?
- delicate medical devices
What do you need to do the instruments before manual cleaning
open and disassemble all instruments
Details about brushes for manual cleaning methods
use brushes of the appropriate type, size, and bristle material
What does selection of the proper cleaning solution depend on:
- type of debris or soil left on items
- length of time between use and cleaning
- compatibility of cleaning product with the item being cleaned
- point at which the product makes items safe for handling
Manual cleaning solution specifics: measure
use a measuring device to ensure appropriate dilution calculated for the volume of the sink
Manual cleaning solution specifics: temp
Record the temperature of the soaking solution and the time instruments are soaked
Manual cleaning solution specifics: when to change cleaning solution
After every use
Manual cleaning solution specifics: rinse
Rinse with tap water to remove residue
Manual cleaning solution specifics: final rinse
Final rinse for semi-critical and critical items is with critical water
Who makes the specs for critical water?
AAMI TIR34
What is more consistent and reliable: mechanical or manual cleaning?
Mechanical
Where should equipment for automated or semi-automated cleaning and rinsing processes be located?
Decontamination area
When using mechanical cleaning methods, it’s important to follow the IFUs for both…
cleaning equipment and cleaning for each specific device
___________ equipment is essential and should be thoroughly documented
Monitoring
These cleaners use sound waves to remove particles
Ultrasonic cleaners
What are ultrasonic cleaners meant for?
Fine cleaning
How often do ultrasonic cleaners need to be emptied, cleaned, disinfected, rinsed and dried?
At least daily
How often should the cleaning solution be changed for ultrasonic cleaners?
After each use
How often are cavitation and soil tests to assess the equipments performance carried out?
Daily
These cleaners make automated processes that combine all the steps of cleaning and disinfection into one
Washer-disinfectors and washer-decontaminators
These automated cleaners destroy microorganisms so that instruments are decontaminated and safe to handle OR for patient care
Washer disinfectors/ washer decontaminators
When can equipment from washer disinfectors/ washer decontamintors be used?
Immediately depending on intended use and the manufacturer’s IFU
How often should equipment performance be tested for washer-disinfectors/ washer-decontaminators?
each day it’s used and all results should be recorded
These automated cleaners are designed to clean and provide low-to-intermediate level thermal disinfection
Cart washer-disinfectors
What does the cart-washer disinfector cycle consist of?
Wash
thermal rinse
Drying phase
These two items on a cart-washer-disinfector should be checked at this interval
Sprayers and drain screens
daily
disinfection process using contact with hot water for at least 30 minutes
Pasteurization
What is an alternative disinfection method for respiratory therapy and anesthesia equipment
Washer-pasteurizer
What should be monitored in the washer-pasteurizer?
Temperature of final rinse
Designed to clean and/or disinfect endoscopes and components
Automatic endoscope reprocessors (AER)
What kind of solution do automatic endoscope reprocessors use?
liquid chemical sterilant or high-level disinfection solution
Liquid chemical sterilant in automatic endoscope reprocessors (AER) provides…
Microbial kill
These reduce the risk that users will be exposed to toxic substances through endoscope
Automatic Endoscope Reprocessors
Automatic endoscope reprocessors allow for more ____ and _____ disinfection
Automatic endoscope reprocessors
MISTaKE card
How often should testing devices be used on automatic endoscope reprocessors
At least weekly
How often should the minimum recommended or minimum effective concentration of disinfectant for AERs be tested?
Before each use
How often should the AER cycle parameters be checked?
Beginning and end of each cycle
What is the final step in the manual or mechanical cleaning process?
cleaning verification
What is a resource for cleaning verification and soil markers?
ANSI/ AAMI ST7 D.3
What needs to be established for cleaning verification?
- cleaning benchmarks
- Cleaning policies
- procedures for verification of cleaning efficacy
Where should inspection of equipment occur for cleaning verification?
Decontamination area or in packaging and assembly area
What to look for during inspection of equipment
Proper function
Defects
All soil removed
Issues to resolve for release: cutting surfaces
Sharpness
Issues to resolve for release: powered equipment
Functionality
Issues to resolve for release: gaskets, latching mechanisms, mechanical valve function, sealed rivets, and screws in sterilization containers
integrity
Issues to resolve for release: woven and nonwoven wraps and peel pouches
Defects and debris
HLD in SP: Documentation: lot number
document assigned lot number of the soaking container or processor
HLD in SP: Documentation: contents
Document contents of lot (quantity, department, and description of items)
HLD in SP: Documentation: patient info
Patient’s name and record # if available
HLD in SP: Documentation: HCP info
Procedure
Physician
Serial # or item identifyer
HLD in SP: Documentation: Solution
HLD solution specifics
HLD in SP: Documentation: exposure phase
Date/ time cycle
Exposure time and temp
chemical concentration
HLD in SP: Documentation: operator
Initials
HLD in SP: Documentation: test strip
results of solution test strip
Any inconclusive or nonresponsive solution test strip testing
How often do AAMI and AORN recommend the appropriate solution test strip or other FDA- cleared device be used to test the concentration of the HLD solution?
Before each use
When to discard solution
If test strip indicated inadequate concentration of active ingredient
if inspection shows precipitates
How to monitor manual cleaning processes?
Thermometer and timer
After decontamination, this happens and should be physically separated from decontamination area
preparation and packaging
What type of airflow should be used in preparation and packaging?
Down-draft airflow
How to reduce lint accumulation in preparation and packaging area
-enclosed,separate space
-Air flows downward
- enough air exchanges per hour
when are peel pouches recommended?
When visibility of the packaged item is important
Types of packaging material
Sterilization wraps (woven or nonwoven)
When packaging materials the correct ___ and ______ of folds and the ____ of wraps are critical
order* and direction* of folds
number of wraps
What may be used on wrapped packs or trays for impervious protection?
Sterility maintenance covers
When selecting a peel pouch, the product should be specific for the type of _____ used
Sterilant
These contain a known number of microorganisms, of known resistance to the mode of sterilization
Biological indicator (BI) process challenge device (PCD)
This is used routinely to monitor sterilizer efficacy and perform qualification testing of sterilizers
process challenge device
What should each sterile package label contain?
- sterilizer ID number
-cycle and lot numbers - date of processing
-Expiration date
ANSI and AAMI standards dictate this about sterile product traceability
Able to trace the implant or reprocessed device to specific patients based on load records
Guidelines for sterilization area design
ANSI/ AAMI ST79
This organization regulates control of occupational exposure to ethylene oxide, formaldehyde, and other contaminants in sterile processing
OSHA
What determines the selection of the sterilization method?
- turnaround needs
- volume
- Equipment compatibility with sterilization method
- space
When can immediate use steam sterilization be used?
urgent clinical situation and only if recommended on manufacturer’s IFU
What are the different ways to monitor the sterilization process?
- Physical monitors
- chemical indicators
- biological indicators
- process challenge devices
- documentation of results
Why monitor every load for sterilization?
- detect operator errors
- ensure each cycle type and implant loads are monitored
- simplify staff training
- provide universal standard for pt care
These are the first step in verification of the sterilization process and are used to monitor and document each load’s parameters
Physical monitors
The indicators are used to detect potential sterilization process failures and there are 6 types
Chemical indicators
What is the type 1 chemical indicator?
process indicator
What is the type 2 chemical indicator?
Bowie Dick
What is the type 3 chemical indicator?
Single critical process
What is the type 4 chemical indicator?
Multicritical process
What is the type 5 chemical indicator?
Integrating indicators
What is the type 6 chemical indicator?
Emulating indicators
This chemical indicator ensures that all air is removed from the sterilizer and there are no air leaks in the system
Bowie-Dick-Testing
These chemical indicators check whether a package has been processed or exposed to the sterilization process
external chemical indicators
This chemical indicator is used for pack control to determine that the sterilant penetrated
Internal chemical indicator
These indicators directly monitor the lethality of a given sterilization process
Biological indicator
How do biological indicators work?
Each day that a test BI is incubated, a positive control BI from same lot number as the test BI should be used in each incubator or autoreader
Product recall process if the processing failure is confined to one load or one item in the load
Correct the cause of the failure
Reprocess the load or the item
Product recall if the error is not immediately identifiable
- Recall all items since the last negative BI
Guidelines for action to take with BIs, CIs, or Physical monitors indicate failure
ANSI/ AAMI ST79 13.7.5
Where should sterile equipment storage area be located?
Adjacent to sterilization area
What are the specs for storing sterile items?
- 18 inches below ceiling/ sprinkler head
- 8-10 inches above floor
- at least 2 inches from outside walls
- only on designated shelving, counters, or carts
- on closed or covered shelving to minimize dust
-restricted
How long are items considered sterile?
sterile unless integrity of the packaging is compromised
What conditions can alter the integrity of the sterile packaging?
- Env sources of contamination
- barrier properties of packaging materials
- storage and distribution processes
- stacking sterile items
-inventory control - freq of handling
what should sterile devices be transported on?
Completely enclosed storage compartment, separated from contaminated items
