Cleaning, Disinfection, and Sterilization Flashcards
(224 cards)
1
Q
Process of appraisal that considers the value and significance of quality, cost, safety, and practitioner choice for product selection
A
Product evaluation
2
Q
What are the benefits of product evaluation
A
- Systematic product review and value analysis
- Inventory control
- Product standardization
- Cost control through competitive pricing
- Influencing purchasing agreements
3
Q
What is the joint commission’s infection prevention requirement for product evaluation
A
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
4
Q
How can IPs get the information needed to review products?
A
Attend conferences
Review evidence-based practices in the literature
Review product materials
Network with colleagues
Review current guidelines
Critically evaluate clinical studies
5
Q
What is the primary objective for product evaluation programs
A
To select and purchase products that meet specific performance criteria, contributes a good patient outcomes, meet safety requirements, and are cost effective
6
Q
What is the process for product evaluation
A
- 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
7
Q
Describe training and competence of new products
A
- ensure appropriate training and personnel with all products and equipment- conduct post implementation surveillance to ensure ongoing competence, proper use, and intended outcomes
8
Q
Application of a product for a purpose that’s not included in approved device labeling
A
Off label use
9
Q
What is the FDA review and approval structure for medical devices?
A
Pre-market approval (PMA) + pre-market notification (510k) = FDA designates labeled or indicated use of product
10
Q
What is one common off label product use?
A
Reprocessing single use devices
11
Q
What organization oversees reprocessing of single use devices?
A
FDA
12
Q
What is the process for reprocessing a single-use device so that it can be patient ready?
A
Decontamination
Functional testing
Repackaging
Relabeling
Sterilizing
13
Q
A device intended for one use on a single patient during a single procedure
A
Single use device
14
Q
Who determines if a product should be labeled as single use?
A
The manufacturer
15
Q
What class of devices presents the lowest potential risk to the patient and carries the least regulation?
A
Class I
16
Q
What class of medical device poses the greatest potential risk and requires the greatest regulation?
A
Class III
17
Q
What typically prompts consideration of reprocessing and reuse of single-use devices?
A
Cost
18
Q
Who should be involved in decisions to reprocess single-use devices?
A
Infection prevention
Hospital administration
Supply chain administrator
Liability insurance carrier
19
Q
Should healthcare facilities reprocess single-use devices on site?
A
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
20
Q
How should IP be involved with selecting the third party reprocessor for single use devices
A
- 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
21
Q
The process of removing visible dirt, organic material, and debris from surfaces and objects
A
Cleaning
22
Q
The process of killing or inctivating microorganisms on surfaces and objects
A
Disinfection
23
Q
Destroys all microorganisms including bacterial spores
A
Sterilization
24
Q
What are the three categories of medical equipment under the Spaulding classification system
A
- Critical
- Semi-critical
- Non-critical
25
What did AAMI add as the fourth category for classifying medical equipment?
Environmental surfaces
26
Spalding classification in which the medical equipment enters tissue and must be sterile
Critical
27
Spalding classification in which the medical equipment contacts mucous membranes and requires high level disinfection
Semi- critical
28
Spalding classification in which medical equipment comes in contact with intact skin and requires low level disinfection
Non-critical
29
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
30
What is the minimum reprocessing requirement for critical equipment?
Sterilization
31
What are examples of semi critical equipment?
Respiratory therapy and anesthesia equipment
Scopes
Esophageal manometry probes
32
What is the minimum reprocessing requirement for semi critical equipment
High level disinfection
33
What are examples of non-critical medical equipment items?
Blood pressure cuff
Stethoscope
34
What is the minimum reprocessing requirement for non-critical items?
Low level disinfection
35
What is always required before disinfection and or sterilization?
Cleaning
36
Where does cleaning begin
Point of use
37
What is the first step to cleaning?
Remove gross debris and keep the medical equipment moist prior to transport
38
Is open but unused equipment contaminated?
Yes, it needs to be reprocessed
39
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
40
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
41
What is used to clean with friction?
Brushes based on the manufacturers instruction for use
42
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
43
How to load medical equipment into washers
Open hinged instruments
Do not stack
Disassemble as much as possible
44
Where are contaminated items cleaned?
Decontamination area
45
What is used to clean and decontaminate equipment?
Water and detergents or enzymatic cleaners
Brushes
46
Type of cleaning used when the area does not have a mechanical unit or for fragile or difficult to clean instruments
Manual cleaning
47
What cleaning methods are important for manual cleaning?
Friction and fluidics
48
Fluids under pressure to clean
Fluidics
49
If using automated washers what steps are still needed before loading the equipment?
Pre-cleaning and decontamination
50
What are the types of automated washers?
1. Ultrasonic cleaners
2. Washer decontaminators
3. Washer disinfectors
4. Washer sterilizers
51
This automated washer cleans by cavitation
Ultrasonic cleaner
52
This automated washer cleans like a dishwasher
Washer decontaminator
53
This automated washer is computer controlled
Washer disinfectors
54
This automated washer is a modified steam sterilizer
Washer sterilizers
55
When using a washer disinfector, care should be taken as to the method of.. ?
Loading instruments
56
What PH is best choice for cleaning instruments?
Neutral or near neutral pH detergent solution
57
Adding_____ assist in the removal of organic material
Enzymes
58
These cleaning agents maybe used because they dissolve protein and fat residues
Alkaline based cleaning agents
59
This is a non-enzyme option that's just as effective as enzymatic cleaners
Hydrogen peroxide
60
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
61
What is the best solution option for a cleaning solution for delicate medical instruments, especially flexible endoscopes?
Neutral pH detergent solutions that contain enzymes
62
What is the concern with alkaline based cleaning agents?
They are corrosive
63
Process for keeping away disease-producing microorganisms
Asepsis
64
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
65
Practice interventions that reduce the number of microorganisms
Medical asepsis
66
Practices aimed at reducing the microbial flora on the hands
Hand hygiene
67
Antimicrobial substance applied to the skin to reduce microbial flora
Antiseptic agent
68
Practices designed to render and maintain objects maximally free from microoganisms
aseptic technique
69
When should aseptic technique always be used?
When placing invasive devices
70
What types of barriers are used in aseptic technique?
sterile gloves
Sterile gowns
Masks
Sterile drapes
71
Practices designed to reduce the number of microorganisms
Clean technique
72
When is clean technique used?
Wound care
Placement of IV devices (such as peripheral venous catheters)
Respiratory suctioning
73
What type of gloves may be used for clean technique?
Clean gloves
73
What type of glove should always be worn for sterile dressing applications
sterile gloves
74
What is the best technique to dress a wound?
No touch dressing technique
75
Glove type for wound cleaning
Clean glove
76
Supplies/ Instrumentation for wound cleaning
-Normal saline or prepared sterile wound cleaner
-Irrigation sterile device with clean technique
77
Glove type for dressing change without debridement
Clean
78
Supplies/ instrumentation for wound cleaning without debridement
-Sterile supplies with clean technique
79
Glove type for dressing change with debridement
Clean gloves
80
Supplies/ instrumentation for dressing change with debridement
sterile supplies with clean technique
81
Type of glove for dressing change with sharp, conservative bedside debridement
Sterile
82
Supplies/ instrumentation for dressing change with sharp, conservative bedside debridement
-sterile supplies and sterile technique
83
Glove type for central line dressing change
Sterile for removing and new sterile for placement
84
Supplies and instrumentation for central line dressing change
sterile dressing change kit
Sterile technique
Surgeon mask
85
Glove type for trachestomy care or suctioning within a closed sheath
Clean
86
Supplies/ instrumentation for tracheostomy care or suctioning within a closed sheath
sterile supplies with clean technique
87
glove type for tracheal suctioning not within a closed sheath
Sterile
88
Supplies/ instrumentation for tracheal suctioning not within a closed sheath
Sterile suction
89
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
90
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
91
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
92
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
93
Maintaining sterile field in the Or: related to ventilation
- Higher air exchanges
- positive pressure room
- air duct filters with routine changes
- temp + humidity control
94
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
95
When is hand hygiene performed in ORs?
- before donning sterile gloves
96
What should be used for HH in ORs?
Antiseptic or antiseptic soap
97
Goal of this is to remove soil and microorganisms living on the patient's skin before surgery
Surgical skin antisepsis
98
How to use antiseptic agents
Follow the manufactuers directions for use
99
What are examples of skin antiseptics?
Chlorhexidine gluconate
povidone iodine in alcoholic or acqeous solutions
100
Sterile packages should always:
- maintain sterile packaging/ container integrity
- inspect before use and inspect for signs of contamination
101
How to transfer sterile equipment into sterile field
aseptically
102
Areas responsible for reprocessing instrumentation and other resuable medical devices
sterile processing
103
Includes handling, collecting, transporting, sorting, dissassembling, cleaning, disinfecting, inspecting, packaging, sterilization, sorting, and distributing equipment and supplies
Sterile processing
104
Goal of this is to provide safe, functional and sterile instruments and medical devices to reduce the risk for HAIs
Sterile processing
105
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
106
Where does reprocessing begin?
Point of use
107
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
108
Container needed for transport of soiled equipment to sterile processing
puncture resistant
leakproof
sealable
Labeled biohazard
109
What agency regulates transport of contaminated material to an off-site sterile processing center?
US Department of Transportation
+ state regs
110
Physical environment of sterile processing: floors, walls, ceiling
nonparticulate or nonfibrous shedding material
111
Physical environment of sterile processing: ceilings
Flush surface with enclosed fixtures
112
Physical environment of sterile processing: work surfaces
Covered with nonporous material
113
Physical environment of sterile processing: Eyewash/ shower equipment
available with 10 seconds travel time
114
Physical environment of sterile processing: Physical barrier
between the decontamination area and work area where clean or sterilization procedures are carried out
115
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
116
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
117
What should personnel follow when completing the cleaning process for sterile processing?
Always follow manufactuerer's written IFUs
118
the sterile processing physical environment should be as clean as the ___
OR
119
What do AAMI and AORN recommend about the location/ locations of sterile processing?
centralize to one location
120
Things to consider for the size of the central processing area
- volume
- processes
- types of services provided
- amount of equip needed
121
What does the decontamination area need to have in sterile processing?
decontamination area
? Mistake
122
What are the sink requirements for sterile processing?
36 inches from the floor
8-10 inches deep
123
What are the air requirements for central processing?
Move from clean side to the decontamination side
124
What are the temperature and humidity requirements for sterile processing?
Follow ANSI/ ASHRAE/ ASHE Standard 170
125
when is manual cleaning recommended?
- delicate medical devices
126
What do you need to do the instruments before manual cleaning
open and disassemble all instruments
127
Details about brushes for manual cleaning methods
use brushes of the appropriate type, size, and bristle material
128
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
129
Manual cleaning solution specifics: measure
use a measuring device to ensure appropriate dilution calculated for the volume of the sink
130
Manual cleaning solution specifics: temp
Record the temperature of the soaking solution and the time instruments are soaked
131
Manual cleaning solution specifics: when to change cleaning solution
After every use
132
Manual cleaning solution specifics: rinse
Rinse with tap water to remove residue
133
Manual cleaning solution specifics: final rinse
Final rinse for semi-critical and critical items is with critical water
134
Who makes the specs for critical water?
AAMI TIR34
135
What is more consistent and reliable: mechanical or manual cleaning?
Mechanical
136
Where should equipment for automated or semi-automated cleaning and rinsing processes be located?
Decontamination area
137
When using mechanical cleaning methods, it's important to follow the IFUs for both...
cleaning equipment and cleaning for each specific device
138
___________ equipment is essential and should be thoroughly documented
Monitoring
139
These cleaners use sound waves to remove particles
Ultrasonic cleaners
140
What are ultrasonic cleaners meant for?
Fine cleaning
141
How often do ultrasonic cleaners need to be emptied, cleaned, disinfected, rinsed and dried?
At least daily
142
How often should the cleaning solution be changed for ultrasonic cleaners?
After each use
143
How often are cavitation and soil tests to assess the equipments performance carried out?
Daily
144
These cleaners make automated processes that combine all the steps of cleaning and disinfection into one
Washer-disinfectors and washer-decontaminators
145
These automated cleaners destroy microorganisms so that instruments are decontaminated and safe to handle OR for patient care
Washer disinfectors/ washer decontaminators
146
When can equipment from washer disinfectors/ washer decontamintors be used?
Immediately depending on intended use and the manufacturer's IFU
147
How often should equipment performance be tested for washer-disinfectors/ washer-decontaminators?
each day it's used and all results should be recorded
148
These automated cleaners are designed to clean and provide low-to-intermediate level thermal disinfection
Cart washer-disinfectors
149
What does the cart-washer disinfector cycle consist of?
Wash
thermal rinse
Drying phase
150
These two items on a cart-washer-disinfector should be checked at this interval
Sprayers and drain screens
daily
151
disinfection process using contact with hot water for at least 30 minutes
Pasteurization
152
What is an alternative disinfection method for respiratory therapy and anesthesia equipment
Washer-pasteurizer
153
What should be monitored in the washer-pasteurizer?
Temperature of final rinse
154
Designed to clean and/or disinfect endoscopes and components
Automatic endoscope reprocessors (AER)
155
What kind of solution do automatic endoscope reprocessors use?
liquid chemical sterilant or high-level disinfection solution
156
Liquid chemical sterilant in automatic endoscope reprocessors (AER) provides...
Microbial kill
157
These reduce the risk that users will be exposed to toxic substances through endoscope
Automatic Endoscope Reprocessors
158
Automatic endoscope reprocessors allow for more ____ and _____ disinfection
Automatic endoscope reprocessors
MISTaKE card
159
How often should testing devices be used on automatic endoscope reprocessors
At least weekly
160
How often should the minimum recommended or minimum effective concentration of disinfectant for AERs be tested?
Before each use
161
How often should the AER cycle parameters be checked?
Beginning and end of each cycle
162
What is the final step in the manual or mechanical cleaning process?
cleaning verification
163
What is a resource for cleaning verification and soil markers?
ANSI/ AAMI ST7 D.3
164
What needs to be established for cleaning verification?
1. cleaning benchmarks
2. Cleaning policies
3. procedures for verification of cleaning efficacy
165
Where should inspection of equipment occur for cleaning verification?
Decontamination area or in packaging and assembly area
166
What to look for during inspection of equipment
Proper function
Defects
All soil removed
167
Issues to resolve for release: cutting surfaces
Sharpness
168
169
Issues to resolve for release: powered equipment
Functionality
170
Issues to resolve for release: gaskets, latching mechanisms, mechanical valve function, sealed rivets, and screws in sterilization containers
integrity
171
Issues to resolve for release: woven and nonwoven wraps and peel pouches
Defects and debris
172
HLD in SP: Documentation: lot number
document assigned lot number of the soaking container or processor
173
HLD in SP: Documentation: contents
Document contents of lot (quantity, department, and description of items)
174
HLD in SP: Documentation: patient info
Patient's name and record # if available
175
HLD in SP: Documentation: HCP info
Procedure
Physician
Serial # or item identifyer
176
HLD in SP: Documentation: Solution
HLD solution specifics
177
HLD in SP: Documentation: exposure phase
Date/ time cycle
Exposure time and temp
chemical concentration
178
HLD in SP: Documentation: operator
Initials
179
HLD in SP: Documentation: test strip
results of solution test strip
Any inconclusive or nonresponsive solution test strip testing
180
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
181
When to discard solution
If test strip indicated inadequate concentration of active ingredient
if inspection shows precipitates
182
How to monitor manual cleaning processes?
Thermometer and timer
183
After decontamination, this happens and should be physically separated from decontamination area
preparation and packaging
184
What type of airflow should be used in preparation and packaging?
Down-draft airflow
185
How to reduce lint accumulation in preparation and packaging area
-enclosed,separate space
-Air flows downward
- enough air exchanges per hour
186
when are peel pouches recommended?
When visibility of the packaged item is important
187
Types of packaging material
Sterilization wraps (woven or nonwoven)
188
When packaging materials the correct ___ and ______ of folds and the ____ of wraps are critical
order* and direction* of folds
number of wraps
189
What may be used on wrapped packs or trays for impervious protection?
Sterility maintenance covers
190
When selecting a peel pouch, the product should be specific for the type of _____ used
Sterilant
191
These contain a known number of microorganisms, of known resistance to the mode of sterilization
Biological indicator (BI) process challenge device (PCD)
192
This is used routinely to monitor sterilizer efficacy and perform qualification testing of sterilizers
process challenge device
193
What should each sterile package label contain?
- sterilizer ID number
-cycle and lot numbers
- date of processing
-Expiration date
194
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
195
Guidelines for sterilization area design
ANSI/ AAMI ST79
196
This organization regulates control of occupational exposure to ethylene oxide, formaldehyde, and other contaminants in sterile processing
OSHA
197
What determines the selection of the sterilization method?
- turnaround needs
- volume
- Equipment compatibility with sterilization method
- space
198
When can immediate use steam sterilization be used?
urgent clinical situation and only if recommended on manufacturer's IFU
199
What are the different ways to monitor the sterilization process?
- Physical monitors
- chemical indicators
- biological indicators
- process challenge devices
- documentation of results
200
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
201
These are the first step in verification of the sterilization process and are used to monitor and document each load's parameters
Physical monitors
202
The indicators are used to detect potential sterilization process failures and there are 6 types
Chemical indicators
203
What is the type 1 chemical indicator?
process indicator
204
What is the type 2 chemical indicator?
Bowie Dick
205
What is the type 3 chemical indicator?
Single critical process
206
What is the type 4 chemical indicator?
Multicritical process
207
What is the type 5 chemical indicator?
Integrating indicators
208
What is the type 6 chemical indicator?
Emulating indicators
209
This chemical indicator ensures that all air is removed from the sterilizer and there are no air leaks in the system
Bowie-Dick-Testing
210
These chemical indicators check whether a package has been processed or exposed to the sterilization process
external chemical indicators
211
This chemical indicator is used for pack control to determine that the sterilant penetrated
Internal chemical indicator
212
These indicators directly monitor the lethality of a given sterilization process
Biological indicator
213
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
214
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
215
Product recall if the error is not immediately identifiable
- Recall all items since the last negative BI
216
Guidelines for action to take with BIs, CIs, or Physical monitors indicate failure
ANSI/ AAMI ST79 13.7.5
217
Where should sterile equipment storage area be located?
Adjacent to sterilization area
218
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
219
How long are items considered sterile?
sterile unless integrity of the packaging is compromised
220
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
221
what should sterile devices be transported on?
Completely enclosed storage compartment, separated from contaminated items
222
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