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