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Recent Changes in Disinfection/Sterilization
Reflected in the 2008 Guidelines
- Formaldehyde-alcohol has been deleted as a recommended
chemical sterilant or high-level disinfectant because it
is irritating and toxic and not commonly used.
- Several new chemical sterilants have been added, including
hydrogen peroxide, peracetic acid and peracetic acid and
hydrogen peroxide in combination.
- Three percent phenolics and iodophors have been deleted
as high-level disinfectants because of their unproven efficacy
against bacterial spores, M. tuberculosis, and/or some fungi.
- Isopropyl alcohol and ethyl alcohol have been excluded
as high-level disinfectants 15 because of their inability
to inactivate bacterial spores and because of the inability
of isopropyl alcohol to inactivate hydrophilic viruses (i.e.,
poliovirus, coxsackie virus).
- Reiteration/clarification of the need to high-level disinfect
items such as vaginal endoscopes and ENT scopes between
each patient use even if a protective sheath is used.
- A 1:16 dilution of 2.0% glutaraldehyde-7.05% phenol-1.20%
sodium phenate (which contained 0.125% glutaraldehyde, 0.440%
phenol, and 0.075% sodium phenate when diluted) has been
deleted as a high-level disinfectant because this product
was removed from the marketplace in December 1991 because
of a lack of bactericidal activity in the presence of organic
matter; a lack of fungicidal, tuberculocidal and sporicidal
activity; and reduced virucidal activity.
- The exposure time required to achieve high-level disinfection
has been changed from 10-30 minutes to 12 minutes or more
depending on the FDA-cleared label claim and the scientific
literature. A glutaraldehyde and an ortho-phthalaldehyde
have an FDA-cleared label claim of 5 minutes when used at
35 degrees C and 25 degreesC, respectively, in an automated
endoscope reprocessor with FDA-cleared capability to maintain
the solution at the appropriate temperature.
- Many new subjects have been added to the 2008 Guideline.
These include inactivation of emerging pathogens, bioterrorist
agents, and bloodborne pathogens; toxicologic, environmental,
and occupational concerns associated with disinfection and
sterilization practices; disinfection of patient-care equipment
used in ambulatory and home care; inactivation of antibiotic-resistant
bacteria; new sterilization processes, such as hydrogen
peroxide gas plasma and liquid peracetic acid; and disinfection
of complex medical instruments (e.g., endoscopes).
OSHA's Bloodborne Pathogens Standard
OSHA's Bloodborne Pathogens
Standard is aimed at eliminating or minimizing
occupational exposure to bloodborne pathogens. One component
of Standard is that all equipment and environmental and working
surfaces be cleaned and decontaminated with an appropriate
disinfectant after contact with blood or other potentially
infectious materials. Even though the OSHA standard does not
specify the type of disinfectant or procedure, the OSHA original
compliance document suggested that a germicide must be tuberculocidal
to kill the HBV. To follow the OSHA compliance document a
tuberculocidal disinfectant (e.g., phenolic, and chlorine)
would be needed to clean a blood spill. However, in February
1997, OSHA amended its policy and stated that EPA-registered
disinfectants labeled as effective against HIV and HBV would
be considered as appropriate disinfectants ". . . provided
such surfaces have not become contaminated with agent(s) or
volumes of or concentrations of agent(s) for which higher
level disinfection is recommended."
When bloodborne pathogens other than HBV or HIV are of concern,
OSHA continues to require use of EPA-registered tuberculocidal
disinfectants or hypochlorite solution (diluted 1:10 or 1:100
with water). Studies demonstrate that, in the presence of
large blood spills, a 1:10 final dilution of EPA-registered
hypochlorite solution initially should be used to inactivate
bloodborne viruses to minimize risk for infection to healthcare
personnel from percutaneous injury during cleanup.
Potential for contamination is dependent upon:
- Type of instrument, medical device, equipment, or environmental
surface.
- Potential for external contamination (e.g., presence of
hinges, crevices).
- Potential for internal contamination (e.g., presence of
lumens).
- Physical composition, design, or configuration of the
instrument, medical device, equipment, or environmental
surface.
- Frequency of hand contact with instrument medical device,
equipment, or environmental surface. Potential for contamination
with body substances or environmental sources of microorganisms.
Level of contamination is dependent upon:
- Types of microorganisms
- Number of microorganisms
- Potential for cross-contamination
Cleaning and Disinfecting Strategies
for Environmental Surfaces in Patient-Care Areas
- Select EPA-registered disinfectants, if available, and
use them in accordance with the manufacturer's instructions.
- Do not use high-level disinfectants/liquid chemical sterilants
for disinfection of either noncritical instruments and devices
or any environmental surfaces; such use is counter to label
instructions for these toxic chemicals.
- Follow manufacturers' instructions for cleaning and maintaining
noncritical medical equipment.
- In the absence of a manufacturer's cleaning instructions,
follow certain procedures:
- Clean noncritical medical equipment surfaces with
a detergent/disinfectant. This may be followed by an
application of an EPA-registered hospital disinfectant
with or without a tuberculocidal claim (depending on
the nature of the surface and the degree of contamination),
in accordance with germicide label instructions.
- Do not use alcohol to disinfect large environmental
surfaces.
- When using a pre-moistened/pre-mixed detergent/disinfectant
wipe, use enough sheets to ensure that the surface area
remains visibly wet for the contact time required for
that product.
- Use barrier protective coverings as appropriate for
noncritical surfaces that are:
- touched frequently with gloved hands during the
delivery of patient care;
- likely to become contaminated with blood or body
substances; or
- difficult to clean (e.g., computer keyboards).
- Keep housekeeping surfaces (e.g., floors, walls, tabletops)
visibly clean on a regular basis and clean up spills promptly.
- Use a one-step process and an EPA-registered hospital
detergent/ disinfectant designed for general housekeeping
purposes in patient-care areas where:
- Uncertainty exists as to the nature of the soil
on the surfaces (e.g., blood or body fluid contamination
versus routine dust or dirt); or
- Uncertainty exists regarding the presence of multidrug
resistant organisms on such surfaces.
- Detergent and water are adequate for cleaning surfaces
in nonpatient-care areas (e.g., administrative offices).
- Clean and disinfect high-touch surfaces (e.g., doorknobs,
bed rails, light switches, and surfaces in and around
toilets in patients' rooms) on a more frequent schedule
than minimal-touch housekeeping surfaces.
- Clean walls, blinds, and window curtains in patient-care
areas when they are visibly dusty or soiled.
- Do not perform disinfectant fogging in patient-care areas.
- Avoid large-surface cleaning methods that produce mists
or aerosols, or disperse dust in patient-care areas.
- Follow proper procedures for effective uses of mops,
cloths, and solutions:
- Prepare cleaning solutions daily or as needed, and
replace with fresh solution frequently according to
facility policies and procedures.
- Change the mop head at the beginning of each day
and also as required by facility policy, or after cleaning
up large spills of blood or other body substances.
- Clean mops and cloths after use and allow to dry before
reuse; or use single-use, disposable mop heads and cloths.
- After the last surgical procedure of the day or night,
wet vacuum or mop operating room floors with a single-use
mop and an EPA-registered hospital disinfectant.
- Do not use mats with tacky surfaces at the entrances
to operating rooms or infection-control suites.
- Use appropriate dusting methods for patient-care areas
designated for immunocompromised patients (e.g., HSCT patients).
- Wet-dust horizontal surfaces daily by moistening
a cloth with a small amount of an EPA-registered hospital
detergent/disinfectant.
- Avoid dusting methods that disperse dust (e.g., feather-dusting).
- Keep vacuums in good repair and equip vacuums with HEPA
filters for use areas with patients at risk.
- Close the doors of immunocompromised patients' rooms
when vacuuming, waxing, or buffing corridor floors to minimize
exposure to airborne dust.
- When performing low- or intermediate-level disinfection
of environmental surfaces in nurseries and neonatal units,
avoid unnecessary exposure of neonates to disinfectant residues
on these surfaces by using EPA-registered germicides in
accordance with manufacturers' instructions and safety advisories.
- Do not use phenolics or any other chemical germicide
to disinfect bassinets or incubators during an infant's
stay.
- Rinse disinfectant-treated surfaces, especially those
treated with phenolics, with water.
- When using phenolic disinfectants in neonatal units,
prepare solutions to correct concentrations in accordance
with manufacturers' instructions, or use premixed formulations.
Reprocessing
Universal Principles
Instruments, medical devices and equipment should be managed
and reprocessed according to recommended/appropriate methods
regardless of a patient's diagnosis except for cases of suspected
prion disease.
Special procedures are required for handling brain, spinal,
or nerve tissue from patients with known or suspected prion
disease (e.g., Creutzfeldt-Jakob disease [CJD]). Consultation
with infection control experts prior to performing procedures
on such patients is warranted.
Industry guidelines as well as equipment and chemical manufacturer
recommendations should be used to develop and update reprocessing
policies and procedures.
Written instructions should be available for each instrument,
medical device, and equipment reprocessed.
Steps of Reprocessing
- Pre-cleaning Removes soil, debris, lubricants from internal
and external surfaces; to be done as soon as possible after
use
- Cleaning
- Manual (e.g., scrubbing with brushes)
- Mechanical (e.g., automated washers) " Appropriate
use and reprocessing of cleaning equipment (e. g., do
not reuse disposable cleaning equipment)
- Frequency of solution changes
- Disinfection- requires sufficient contact time with chemical
solution
- Sterilization- requires sufficient exposure time to heat,
chemicals, or gases
Choice/Level of reprocessing sequence
- Based on intended use (see Definitions):
- Critical instruments and medical devices require sterilization.
- Semi critical instruments and medical devices minimally
require high level disinfection.
- Noncritical instruments and medical devices minimally
require cleaning and low level disinfection.
- Based on manufacturer's recommendations
- Compatibility among equipment components, materials,
and chemicals used
- Equipment heat and pressure tolerance
- Time and temperature requirements for reprocessing
The effectiveness of reprocessing instruments, medical
devices and equipment is dependent on:
- Cleaning prior to disinfection
- Disinfection
- Selection and use of disinfectants-use of surface
products or immersion products
- Presence of organic matter
- Presence of biofilms
- Monitoring, including activity and stability of disinfectant,
contact time with internal and external components,
record keeping/tracking of instrument usage and reprocessing
- Post-disinfection handling and storage
- Sterilization
- Selection and use of methods
- Monitoring - biologic monitors, process monitors
(tape, indicator strips, etc.), physical monitors (pressure,
temperature gauges), record keeping and recall/tracking
system for each sterilization processing batch/item
- Post-sterilization handling, packaging and storage
(event-related criteria)
It is important to recognize potential sources of cross-contamination
in the healthcare environment:
- Surfaces or equipment which require cleaning between
patient procedures/treatments
- Practices that contribute to hand contamination and the
potential for cross-contamination
- Consequences of reuse of single-use/disposable instruments,
medical devices or equipment
At any point in reprocessing or handling, breaks in infection
control practices can compromise the integrity of instruments,
medical devices or equipment. Some specific factors have contributed
to contamination in reported cases of disease transmission
include:
- Failure to reprocess or dispose of items between patients
" Inadequate cleaning "
- Inadequate disinfection or sterilization
- Contamination of disinfectant or rinse solutions
- Improper packaging, storage and handling
- Inadequate/inaccurate record keeping of reprocessing
requirements
Provider Practice Setting and Need
for Detailed Reprocessing Information
The individual healthcare provider's area of professional
practice setting and scope of responsibilities determines
the need for more information regarding infection control
and disinfection/sterilization.
For professionals who practice in settings where handling,
cleaning, and reprocessing equipment, instruments or medical
devices is performed elsewhere (e.g., in a dedicated Sterile
Processing Department), it is important to understand core
concepts and principles of infection control, including:
- Standard and Universal Precautions (e.g., wearing of personal
protective equipment);
- Cleaning, disinfection, and sterilization described in
Sections III and IV above;
- Appropriate application of safe practices for handling
instruments, medical devices and equipment in the area of
professional practice;
- Designation and physical separation of patient care areas
from cleaning and reprocessing areas is strongly recommended
by NYSDOH;
- Verify with those responsible for reprocessing what steps
are necessary prior to submission regarding pre-cleaning,
soaking, etc.
For professionals who have primary or supervisory responsibilities
for equipment, instruments or medical device reprocessing
(e.g., Sterile Processing Department staff or clinics and
physician practices where medical equipment is reprocessed
on-site):
- Understand core concepts and principles
- Standard and Universal Precautions
- Cleaning, disinfection, and sterilization described
in Sections III and IV above
- Appropriate application of safe practices for handling
instruments, medical devices, and equipment in the area
of professional practice
- Designation and physical separation of patient care
areas from cleaning and reprocessing areas is strongly
recommended by NYSDOH.
- Determine appropriate reprocessing practices and the
selection of appropriate methods, taking into consideration:
- Antimicrobial efficacy
- Time constraints and requirements for various methods
- Compatibility among equipment/materials, including
factors such as corrosiveness, penetrability, leaching,
disintegration, heat tolerance and moisture sensitivity.
- Toxicity, including occupational health risks, environmental
hazards, abatement methods, monitoring exposures, potential
for patient toxicity/allergy
- Residual effect, including antibacterial residual,
patient toxicity/allergy
- Ease of use, is there a need for specialized equipment
or are there special training requirements
- Stability, concentration, potency, efficacy of use,
rffect of organic material
- Odor
- Cost
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