Transcript Document

Best Practices for
High-Level Disinfection
(HLD)
Presented by Crosstex/SPSmedical
Chuck Hughes, VP of Infection Prevention & Consulting
Objectives
At the end of this program, participants will be able to:
• Explain the Spaulding Classification System for the
reprocessing of reusable medical devices
• Understand the importance of effective cleaning and
decontamination prior to HLD
• Identify commonly used agents for HLD
• Discuss SGNA recommended steps for the HLD of
flexible endoscopes
Spaulding Classification System
• In 1968, Dr. Earle Spaulding devised a rational
approach to disinfection and sterilization that is
still in use today
• He believed that instruments and equipment should be
reprocessed according to the nature of the item and the
level of risk associated with their intended use
• This is referred to as Spaulding's Classification System
and it has been refined and retained over the years,
because it is so clear and logical
• The three (3) categories he described were critical,
semi-critical and non-critical
Spaulding Classification System
• Critical items are medical devices that enter sterile tissue or the
vascular system
• These items should be sterile when used
• Examples include, but are not limited to:
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surgical instruments
cutting endoscopic accessories that break the mucosal barrier
endoscopes used in sterile body cavities
cardiac, vascular or urinary catheters
implants, needles and ultrasound probes used in the sterile body cavities
Spaulding Classification System
• Semi-critical items are medical devices that come into contact
with non-intact skin or mucous membranes
• These items should be high level disinfected when used
• Examples include, but are not limited to:
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vaginal and rectal probes
anesthesia equipment
Laryngoscopes
Bronchoscopes
Gastrointestinal endoscopes (and accessories)
Spaulding Classification System
• Non-critical items are medical devices that come into contact
with only intact skin
• These items should receive intermediate level disinfection, lowlevel disinfection or cleaning
• Intact skin is considered an effective barrier to most organisms
• Examples of non-critical items include, but are not limited to:
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Tourniquets
Blood pressure cuffs
Linens
Bed pans
Stethoscopes
Three Levels of Disinfection
The terminology adopted by the CDC and widely used,
describes disinfectants in terms of their activity as set out
below. This program will focus on high-level disinfection
(HLD).
• High-level disinfectants are chemical sterilants, which when
used for a shorter exposure period than would be required
for sterilization, kill all microorganisms with the exception
of high numbers of bacterial spores.
• Intermediate-level disinfectants may kill mycobacteria,
vegetative bacteria, most viruses, and most fungi but do not
necessarily kill bacterial spores
• Low-level disinfectants may kill most vegetative bacteria,
some fungi, and some viruses.
Cleaning and Decontamination
• Pre-cleaning must occur at point of use in order to keep
blood and other organic material from drying
– Blood and body fluids, as well as saline, are highly corrosive
and can damage instruments
– Dried blood and debris is difficult, if not impossible to clean
during decontamination, which can cause disinfection or
sterilization not to be achieved
• Surgical instruments should be wiped as needed with
sterile surgical sponges moistened with sterile water
during the procedure to remove gross soil
– Instruments with lumens should be irrigated with sterile water
Cleaning and Decontamination
Flexible endoscopes used on the sterile field should be
pre-cleaned to the following recommended steps:
1. Wipe external surfaces with a lint-free cloth saturated
with sterile water
2. Alternate suctioning the channels with sterile water
and air
3. Hand the endoscope and accessories to the circulator
as soon as possible, so he/she may pre-clean (follow
the steps on the next slide)
Cleaning and Decontamination
Flexible endoscopes used in GI/Endoscopy Centers should be pre-cleaned in the Procedure
Room wearing appropriate PPE and using the following recommended steps:
1.
2.
3.
4.
5.
6.
7.
External surface of insertion tube should be cleaned with a soft cloth or sponge and an
enzymatic detergent
Internal suction/biopsy channels cleaned by suctioning copious amounts of enzymatic
detergent and air
Air/water channels flushed with enzymatic solution, then flushed using low-pressure
compressed air or a syringe if air is not available
Complex design components or channels should be flushed or purged with water
and/or enzymatic detergent solution per the MFG’s IFU
The tip of the endoscope should be inspected for damage to any surface and any
working part, and for cleanliness
The video protective cap (if applicable) should be attached after removing the
endoscope from the light source and suction
Remove all detachable parts and immerse in enzymatic detergent solution until
transport.
Cleaning and Decontamination
Flexible endoscopes are some
of the most complex devices
for health care workers to
reprocess, due to their unique
design and multiple reprocessing
steps.
Strict adherence to the scope
MFG’s validated instructions
for use (IFU) is required.
Transport
• After pre-cleaning at point of use
– contaminated items should be immediately transported to the
decontamination area before any remaining organic material dries on the
surface, box lock, crevices or channels of the instruments.
– Surgical instruments should be covered with a wet towel or treated with an
instrument cleaner prior to transport.
• Contaminated items can expose health care workers and can
contaminate the environment during transport
– A sealed container should be used to avoid contaminating the environment
or exposure to health care workers
– Per OSHA, the transport container must be labeled to indicate biohazardous
contents.
Cleaning and Decontamination
• Meticulous cleaning and decontamination must proceed
HLD or sterilization
– Medical device manufacturers are required to provide
healthcare facilities with validated reprocessing instructions for
use (IFU)
• It is important to have and follow each device MFG’s
IFU to ensure worker and patient safety
– This is especially true for complex devices with multiple pieces
that have joints, crevices, lumens, ports and channels
– Proper PPE is required for all cleaning and decontamination
steps.
Heat HLD
• Pasteurization is a heat-automated HLD process that uses time and
heat (i.e. 160-170°F/21.7-25°C) for 30 minutes for HLD of heatsensitive semi-critical devices
• Medical washer/pasteurizers have wash, rinse and pasteurization
cycles
• Some pasteurizers offer quality assurance data recorders that
document the temperature and cycle time
Chemical HLD
• For chemical HLD, health care facilities must purchase
FDA cleared HLD products as listed on the FDA website
– Products selected should be compatible and efficacious with
the materials or items to be disinfected
• The use of incompatible chemicals can damage the
surfaces of the instrument, causing corrosion, scratches
and other surface irregularities
– Such damage can be a challenge for cleaning, HLD, interfere
with proper function, and reduce the life and cosmetic
appearance of the device
FDA-cleared Chemical sterilants and HLDs
Device Type
# of Registered
Products
Chemical
Sterilization
High Level
Disinfection
Glutaraldehyde
17
X
X
Hydrogen Peroxide
4
X
X
Ortho-phthaldehyde
(OPA)
3
Peracetic Acid
2
Sodium Hypochlorite
1
Chemical Vapor
w/Formaldehyde
2
X
Hydrogen Peroxide Gas
Plasma
1
X
Hydrogen Peroxide
without Plasma
1
X
Ozone Gas
1
X
X
X
X
X
Source: www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofSingle-UseDevices/ucm133514.htm
Chemical HLD
• HLD requires appropriate temperature, contact time, and
length of use following solution activation
• MFG’s IFU should be followed when preparing
disinfectant solutions, calculating expirations dates, and
labeling solution soaking containers
Update with McKesson branded
products
Chemical HLD
• Glutaraldehyde has been widely used for a long time in
health care facilities as a HLD for reusable medical
devices
• Most solutions are acidic and must be activated to become
sporicidal. There are a variety of brand names available in
a variety of concentrations, with and without surfactants
HLD and Steriliant requires no
mixing or activation
Chemical HLD
• Ortho-phthaladehyde (OPA) has demonstrated superior
mycobactericidal activity compared to glutaraldehyde and requires
no mixing or activation
• OPA has been shown to last longer before reaching its MEC and
the concentration of the active ingredient does not decrease with
age alone
Chemical HLD
• Other solutions FDA-cleared for HLD include hydrogen peroxide,
peracetic acid and sodium hypochlorite in a variety of
concentrations and combinations
• The FDA website has a listing of manufacturers, active ingredients
and contact conditions for each cleared solution
Chemical HLD
• Because most HLDs are reused, they must be tested and
recorded prior to each use to assure that they remain
above their MRC
– If the test strip fails, the HLD solution should not be used,
even if it’s within the reuse life
Reprocessing of Flexible Endoscopes
• Chemical HLD is recognized as the standard for the
reprocessing of flexible gastrointestinal endoscopes
by SGNA, ASGE, ACG, AGA, APIC and AST
• The CDC and The Joint Commission recognize HLD
as appropriate for gastrointestinal endoscopes
Standards of Infection Control in
Reprocessing of Flexible
Gastrointestinal Endoscopes
Are you following the updated 2012 SGNA Standards?
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
After the necessary Pre-Cleaning, Leak Testing, Manual
Cleaning and Rinsing steps; this SGNA Standard details
both manual and AER HLD starting with Step 5
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
5. Manual HLD:
1. Completely immerse the endoscope and all
removable parts in a basin of HLD
a. The basin must be of a size to accommodate the endoscope
without undue coiling, and must have a tight-fitting lid to contain
the chemical vapors
b. To prevent damage, the endoscope should be not be soaked with
other sharp instruments
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
5. Manual HLD
2. Flush disinfectant into all
channels of the endoscope until it can
be seen exiting the opposite end of
each channel. Take care that all
channels are filled with the chemical,
and that no air pockets remain within
the channels
a.
b.
Complete microbial destruction cannot occur unless all surfaces
are in complete contact with the chemical
Since internal contact cannot be visually confirmed because of
scope design, purging until a steady flow of solution observed
is necessary.
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
5A. Manual HLD:
3. Cover the soaking basin with a tight-fitting lid
to minimize chemical vapor exposure
Note that:
a. Exposure to chemical vapors may present a
health hazard
b. The reprocessing area should have engineering
controls to ensure good air quality
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
5A. Manual HLD:
4. Soak the endoscope in the HLD solution for
the time/temperature required to achieve HLD.
Use a timer to verify soaking time
5. Purge all channels completely with air before
removing the endoscope from the HLD solution.
Note that purging the channels preserves the
concentration and volume of the chemical, and
prevents exposure from dripping and spilling
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
5A. Manual HLD:
6. RINSE (same as after Manual Cleaning)
a. Thoroughly rinse the endoscope and all removable parts
with clean water to remove residual debris and detergent
b. Purge water from all channels using forced air. Dry the
exterior of the endoscope with a soft, lint-free cloth to
prevent dilution of the liquid chemical germicide used in
subsequent steps
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
6. Drying:
a. Purge all channels with air until dry
Note that:
a. Bacteria such as Pseudomonas aeruginosa have been
identified in both tap and filtered water, and may multiply
in a moist environment
b. Avoid the use of excessively high air pressure which can
damage the internal channels of flexible endoscopes
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
6. Drying:
b) Flush all channels, including accessory channels, with alcohol until the
alcohol can be seen exiting the opposite end of each channel
a. 70% isopropyl alcohol is used to assist in drying the interior channel surfaces
b. It must be properly stored in a closed container between uses, because when exposed to
air, it rapidly evaporates, and if less than recommended % level, cannot be relied upon
to assist in the drying process
c. Alcohol flushes should be used even when sterile water is used for rinsing
c)
d)
e)
f)
Purge all channels with air. Note that alcohol mixes with the remaining
water on the channel surfaces and acts to encourage evaporation of the
residual water as air flows through the channel
Remove all channel adapters
Dry the exterior of the endoscope with a soft, clean lint-free towel
Thoroughly rinse and dry all removable parts. Do not attach removable parts (e.g.
valves, etc.) to the endoscope during storage as this can trap liquid inside
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
7. Storage:
Hang the endoscope in a vertical position to facilitate
drying (with caps, valves, and other detachable components
removed, per MFG’s IFU)
a. The storage area should be clean, well
ventilated and dust free
b. Correct storage will prevent damage
c. The interval of storage before use has
limited investigations and warrants further
data
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
Automated HLD:
Automated Endoscope Reprocessors (AERs)
standardize the disinfection process and decrease
personnel exposure to HLDs
NOTE:
It is necessary to follow
all steps for the manual
cleaning prior to using
an AER.
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
Automated HLD:
An AER should have the following features:
1.
2.
3.
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5.
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7.
Circulate fluids through all endoscope channels at an equal pressure without
trapping air. Channel flow sensors provide an added measure of compliance
Detergent and disinfectant cycles should be followed by thorough rinse cycles
and forced air to remove all used solutions
Disinfectant should not be diluted with any fluids
Machine should be self-disinfecting
No residual water should remain in hoses and reservoirs
Cycles for alcohol flushing and forced air drying are desirable
Should also feature a self-contained or external water filtration system
In addition, a method to automatically store or print data verification of
cycle completion, is desirable
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
To use an AER:
1. Follow steps for manual cleaning of endoscope
2. Prepare the AER according to the MFG’s guidelines
3. Place the endoscope in the AER and attach all channel adapters
according to the MFG’s IFU
a. The elevator channel of a duodenoscope has a very small
lumen. Since most AERs cannot generate pressure required to force
fluid through the lumen, a 2-5 ml syringe must be used to manually
reprocess (all steps) the elevator channel unless the AER is
validated to perfuse this channel
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
To use an AER:
4. Place valves and other removable parts into the soaking
basin of the AER. Unless the AER has a dedicated space for
accessories, reprocess these items separately
5. If the AER has a cycle that uses enzymatic detergent, it
should be a product that is compatible with the AER and the
endoscope
6. Set the AER for the appropriate time and temperature
depending on the chemical used
7. Start the AER and allow it to complete all cycles or phases
8. Note that if cycles or phases are interrupted, HLD cannot be
ensured and the full cycle must be repeated
SGNA Standards of Infection Control
in Reprocessing of Flexible Endoscopes
To use an AER:
8. If AER does not include a final alcohol rinse,
this step should be done manually followed by
purging all the channels with air until dry
The ERCP elevator and elevator channel must
be manually perfused and dried per MFG’s
instructions
9. Drying and storage procedures are the same as
described in the manual disinfection section
To get a free copy of the complete SGNA
document, go to: www.sgna.org
Chemical HLD Safety
• Healthcare facilities are responsible for providing a safe
work and patient care environment
• Patients, visitors, and health care workers should be
protected from injuries or illnesses caused by hazardous
chemicals
• When handling HLDs, personnel should wear protective
apparel that may include, but is not limited to:
• 100% nitrile rubber or 100% butyl rubber gloves when
handling glutaraldehyde
• PVC gloves should not be worn because they absorb
glutaraldehyde
• Protective eye wear, face mask, and impervious gown
Chemical HLD Safety
• Glutaraldehyde should only be used in well ventilated
areas or in freestanding or vented chemical fume hoods
• Vapor generated from glutaraldehyde can may aggravate
preexisting respiratory conditions
AAMI describes adequate ventilation as:
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Room large enough to ensure adequate dilution of vapors
10 air exchanges per hour
Exhaust located at the source of the discharge of vapors
Fresh air return at ceiling level across room from exhaust vents
Routine maintenance and surveillance of system
Elimination of cross draft effects
Air must not be recirculated
Chemical HLD Safety
• Glutaraldehyde can be absorbed by inhalation, ingestion
and through the skin
• It has a detectable odor at 0.04 parts per million volume
(ppmv) and is irritating to skin and mucous membranes
at 0.3 ppmv
• Vapors are released whenever solutions are disturbed and
the surface tension is broken
– mixing, adding and removing equipment, or disposing of a
glutaraldehyde solution can cause a break in the surface tension
– Whenever the glutaraldehyde solution is not being accessed, it
should be covered with a tight-fitting lid
Chemical HLD Safety
• Glutaraldehyde vapor monitoring is important per
The
American Conference of Governmental Industrial Hygienists
(ACGIH) which recommends a ceiling limit of 0.05 ppm for
occupational exposure
• OSHA has not established exposure limits; however, OSHA can
regulate exposure and has recommended
following the ACGIH limit
Chemical HLD
• To avoid these glutaraldehyde issues, many health care facilities
have switched to using an OPA for HLD
• McKesson OPA/28 features:
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The fastest manual disinfection time
Twice the reuse period of other OPA brands
Guaranteed materials compatibility
100% Satisfaction Guarantee
NEW
Chemical HLD Safety
• Exposure monitoring is not required; however, OPA is still a
potential irritant of eyes, skin, nose and other tissues resulting in
symptoms such as stinging, excessive tearing, coughing, and
sneezing
• Like glutaraldehyde, OPA fixes proteins, allows for biofilm
formation and exposure causes staining on linen, skin, instruments
and AERs
Update with
McKesson
branded product
Training and Education
• Personnel should receive initial training and competency
validation on procedures, chemicals used, and PPE and should
receive additional training when new equipment, instruments,
supplies, or procedures are introduced
• Employers must provide:
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Written hazard communication program
Hazard evaluation
Hazardous materials inventory
Safety Data Sheets
Labels on all containers of hazardous chemicals
Employee training.
Quality Control Program
• A quality control program should be established in all
areas where HLD is used
• Quality control programs should be documented and
should include, but not be limited to:
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Orientation programs
Competency assurance
Continuing education
Quality control checks
Investigation of adverse events
Monitoring of solution replacement intervals
Quality Control Program
• Surfaces of complex instruments require meticulous cleaning in
order to minimize infection control risks to patients and staff
• Inadequate cleaning can potentially leave residual protein on a
surface
• Quality control checks, such as
ATP systems and VERiFIND™
Protein Detection Kit, provide
rapid and easy to read
cleaning verification
CONCLUSION
• Health care workers responsible for HLD must maintain the
technical skills needed to establish and maintain a safe practice
environment for patients, visitors and peers
• Administrative personnel must ensure competency validation of
personnel participating in decontamination and HLD of reusable
medical devices
• The validation of competencies should include all types of devices
the individual is authorized to reprocess
Sponsored by
McKesson
website: www.SPSmedical.com
Educational Program was presented by SPSmedical Supply Corp. To request 1 CE
through IAHCSMM, CBPSD or California Board of Registered Nurses (CBRN), please
contact SPSmedical at 800-722-1529 or [email protected]
© 2013, SPSmedical Supply Corp.
References & Resources
Association for the Advancement of Medical Instrumentation. (2010). Chemical sterilization and
high level disinfection in health care facilities (ANSI/AAMI ST58:2005/(R) 2010). Arlington, VA.
Association of periOperative Registered Nurses. (2013 Edition). Recommended Practices for
High-Level Disinfection.
Society of Gastroenterology Nurses and Association, Inc. (2007) Guideline for High-Level
Disinfectants & Sterilants for Reprocessing Flexible Gastrointestinal Endoscopes.
Society of Gastroenterology Nurses and Association, Inc. (2012) Standards of Infection Control
in Reprocessing of Flexible Gastrointestinal Endoscopes.
Occupational Health and Safety Administration (OSHA). (2012). Hazardous waste and emergency
response. www.osha.gov
Rutala, W. A., Weber, D. J., & the Healthcare Infection Control Practices Advisory Committee
(HICPAC). (2008). Guideline for Disinfection and Sterilization in Healthcare Facilities.