Chemical Sterilants and High-Level Disinfectants: Managing Practical, Safe and Effective Use

Education & Training
Chemical Sterilants and

High-Level Disinfectants:
Managing Practical, Safe
and Effective Use
by Donald P. Satchell, Ph.D.
Objectives
After completion of this self-study activity, the learner will be
able to:
1. Understand the importance of reading and understanding the
manufacturers label on the high-level disinfectants and chemical sterilants (liquid and gas) being used in their facility.
2. Wear the appropriate personal protective equipment (PPE) for
routine protection.
3. Write a policy and procedure for routine monitoring of highlevel disinfectants (HLD), liquid chemical sterilants (LCS) and
gaseous chemical sterilants (GS).
4. Understand the purpose of manual verification tools used for
liquid and gaseous chemical sterilants and high-level disinfectants
discussed in the new Association for the Advancement of
Medical Instrumentation standard, Chemical Sterilization and
High-level Disinfection in Health Care Facilities ST58:2005.
Many thanks to the team at 3M Health Care for

working with Managing Infection Control to provide the
following accredited course. IAHCSMM has awarded one
and one-half (1.5) contact points for completion of this
continuing education lesson toward IAHCSMM recertification.
The CBSPD has pre a p p roved this inservice for one (1)
contact hour for a period of five (5) years from the date of
publication, and to be used only once in a recertification
period. This inservice is 3M Health Care Provider approved
by the California Board of Registered Nurses, CEP 5770 for
one (1) contact hour. This form is valid up to five (5) years
from the date of publication. Instructions for submitting
results are on page 97.
Managing Infection Control and 3M Health Care will
be working collaboratively to provide continuing education
courses in monthly editions of Managing Infection Control.
82
MANAGING INFECTION CONTROL
June 2006
Test Questions
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
True or False
Pre-cleaning of medical devices is recommended for
some high-level disinfectants (HLDs) and liquid chemical
sterilants (LCSs).
Safe use and handling requirements of chemicals are
the same for all HLDs and LCSs.
Some HLDs and LCSs require activation prior to being used.
All chemical disinfectants can be classified as sterilants.
Personal protective equipment (PPE) is the only required safety
feature recommended for use of HLDs, LCSs and GSs.
Once the medical device is disinfected or sterilized, PPE is
no longer necessary.
Room ventilation at a rate of 10 air exchanges per hour is the
most common facility requirement to minimize indirect HLD
or LCS exposure.
An appropriate test strip or chemical monitoring device
should be used to test the minimum recommended
concentration (MRC) or minimum effective concentration
(MEC) of an HLD or LCS before each use.
Gaseous chemical sterilants should be tested with a biological
indicator in a process challenge device (PCD or test pack) at
least daily and preferable in each load.
Reusable HLDs and LCSs can be used repeatedly as long as
the expiration date has not been reached.
High-Level Disinfectants (HLD), Liquid Chemical

Sterilants (LCS) and Gaseous Chemical Sterilants
(GS) Application Scope
The objectives of this article are to introduce the new
ANSI/AAMI ST58:2005 standard Chemical Sterilization and
High-level Disinfection in Health Care Facilities; provide a
summary of the topics covered by this new standard; and highlight the recommended practices for high-level disinfectants
(HLD), liquid chemical sterilants (LCS), and gaseous chemical
sterilants (GS). Training questions are provided that cover
specific topics reviewed in this article. These questions are
included to emphasize the key points about the topics being
covered and to allow readers to reflect on their understanding of
these topics relative to their specific work settings.
Reuse of medical devices is a necessity in all healthcare
facilities. As technology drives the invention of more sophisticated medical devices, cost control measures increasingly add
pressure for the repeated use of these medical tools. Fortunately,
technical innovations are also creating new products to facilitate
the cleaning and decontamination of these tools. Prior to
reuse, medical devices contaminated by potentially pathogenic
organisms such as bacteria or viruses must first be disinfected
or sterilized. The level of decontamination required depends on
the intended use of the medical device. This intended use is
divided into three categories: noncritical, semicritical and critical
84
medical devices. The Food and Drug Administration (FDA)

has regulations governing medical device high-level
disinfection and sterilization. All HLDs, LCSs and GSs, as
well as equipment that may use HLD and LCS products,
exist in the regulatory domain of the FDA. In order for
HLDs, LCSs and GSs to be used on medical devices, they
must meet strict requirements for approval by the FDA.
Such requirements are necessary to determine that these
products meet basic criteria against which all such medical
devices are compared.1 Meeting standard test conditions
assures that, with proper use and handling, the HLD, LCS
and GS will provide the indicated performance required for
cleaning and disinfecting of equipment being treated.
Equally important as the approval of these products
by the FDA is that the recommended practices for their use be
consistently followed to ensure that expected disinfection
performance is achieved and that the safety of the healthcare
professionals is assured. Since HLDs, LCSs and GSs vary
widely in their safe and recommended use patterns, the
Association for the Advancement of Medical Instrumentation
(AAMI) has developed a new unified standard for
recommended practices and safe use of chemical HLDs,
LCSs and GSs to reenforce this imperative.2 Close attention
to the specific product being used is important since the
nature of the chemistry, the associated equipment being used
for a given type of chemical product, and safe handling
methods for each of the devices can vary considerably.
Factors such as available personal protective equipment
(PPE), environmental limitations of a medical facility, types
of monitoring devices, work practices, annual training and
recommended disposal procedures are all highly specific for
any particular HLD, LCS or GS. The new ANSI/AAMI
ST58:2005 Chemical Sterilization and High-level Disinfection
in Health Care Facilities standard is written to address these
issues. It details the appropriate requirements and procedures
to provide the healthcare professional with a solid foundation
for in-service use of these products and a concise resource to
address concerns or questions regarding these issues.
The FDA provides the regulatory parameters and device
intended use definitions to guide manufacturers and healthcare
professionals in determining the level of decontamination
required for a particular medical device and the criteria for
the defined levels of disinfection and sterilization.3
A liquid chemical sterilant or high-level
disinfectant is a germicide that is intended for use
as the terminal step in processing critical and
semicritical medical devices prior to patient use.
Critical devices make contact with normally
sterile tissue or body spaces during use.
Semicritical devices make contact during use with
mucous membranes or nonintact skin.
June 2006
High Level Disinfectant: A germicide that

inactivates all microbial pathogens, except large
numbers of bacterial endospores, when used
according to labeling (Rutala, 1990; Spaulding,
1970). The FDA further defines a high level disin fectant as a sterilant used under the same contact
conditions except for a shorter contact time.
Sterilant: An agent that destroys all viable
forms of microbial life.
AAMI provides a clearer definition of the criteria
and conditions necessary for disinfection or sterilization,
and helps in our understanding of these criteria by
defining the type of organisms used in the certification
testing and evaluation of HLDs, or chemical sterilants
(LCS or GS).
The conditions given on the product label
for high-level disinfection or sterilization are
determined by the manufacture r. The labeled
conditions for high-level disinfection are the time
and temperature re q u i red to achieve a six-log
reduction of an appropriate Mycobacterium species,
such as M. bovis BCG or M. terrae, that has
resistance characteristics similar to those of the
human strain of M. tuberculosis under the conditions
specified in the recommended test protocol.
For most FDA-cleared sterilants or HLDs, the
labeled contact conditions for sterilization are the
contact conditions required to pass the AOAC
Sporicidal Activity Test as a sterilant (i.e., to pass
the test with no failures).2
These two definitions emphasize that sterilants and
HLDs are products tested to assure complete and safe
removal of microbial contamination in a manner that is
matched to the intended use of a given medical device
(semicritical or critical).
In addition, for FDA approval, these devices need to
pass a series of evaluations under certified laboratory
conditions to demonstrate their safety and effectiveness.1
Once done, it becomes the healthcare professionals responsibility to assure compliance with the manufacturers
recommended use instructions. These instructions can be
obtained for any HLD, LCS or GS from the manufacturer
and are also included on the labels of products intended for
this use. Additional in-service details of the products and
their safe and effective use may not be provided by the
manufacturer, which is why AAMI has established its own
in-service document to address these issues. AAMI has
created a uniform list of recommendations covering the
safety, necessary competence and specific use consideration
that are necessary for all HLDs or LCSs and GSs.
June 2006
AAMI has previously standardized the recommended

practices for these devices in two separate documents.4,5
In ANSI/AAMI ST58:2005 Chemical Sterilization and
High-level Disinfection in Health Care Facilities, these
standards present comprehensive coverage of all the approved
HLD or LCS chemistries and gaseous chemical sterilants used
in a sterilizing device, including revised recommendations
for safe use, quality control technology, training assessments,
in-service training qualifications, regulatory recommendations,
and chemical material and compatibility recommendations.
Additional guidelines are provided for the safe handling
and stewardship of these chemicals, an essential element
of the in-service document because it emphasizes both the
safety of the healthcare professionals working with these
devices and the safety of the patient services being provided by
these devices.
Examples of FDA-Cleared HLDs, LCSs and GSs

There are currently eight general HLD, LCS or GS
chemical categories that have clearance for use as a HLD, LCS
or GS (Table 1). The basis for this categorization is linked to the
specific chemical type for these products. It is important
to understand that the use requirements of individual products
within the same chemical category may vary. It may be helpful
to remember that manufacturers of each product within each
chemical category strive to differentiate their products from
the others. Ease of use, treatment conditions, cycling time,
stability, safety and costs are all considerations that manufacturers
are trying to optimize. These product differences need to be
recognized and understood to ensure that the selected HLD, LCS
or GS product is used both on the appropriate medical device and
in the appropriate manner.
Examples of these product differences include product
activation requirements, storage conditions, reusable lifetimes
and neutralization requirements prior to disposal. Chemical
d i fferences between the different HLDs, LCSs and GSs can
have very different and sometimes deleterious effects on the
materials (stainless steel, glass, etc.) of medical devices being
treated. In addition, the required treatment conditions or device
preparation (wrapped or unwrapped, heat sensitivity, etc.) can
vary significantly for different HLD or LCS with specific
medical devices.
The details of the product categories covered in Table 1 on
page 87 are listed in ANSI/AAMI ST58:2005 Chemical
Sterilization and High-level Disinfection in Health Care
Facilities, but specific details for a given products use and
limitations must be determined from the manufacturers product
label. Also, as identified in Table 1, some of the chemical
products may be listed as an HLD (for treatment of semicritical
devices), as a sterilant (for treatment of semicritical or critical
medical devices), or both. Products listed as both an HLD and
a sterilant will require different treatment conditions for the
85
Table 1.
Current FDA-Cleared High-Level Disinfectants

and Sterilants
Number of
Registered
Products*
Sterilization
High-level
Disinfection
Glutaraldehyde Solutions
Hydrogen Peroxide Solutions1
Ortho-phthaladehyde
Solutions
Peracetic Acid and or

Hydrogen Peroxide Solutions2
Sodium Hypochlorite
Solutions
Chemical Vapor with

Formaldehyde
Hydrogen Peroxide
Gas Plasma
Ozone Gas
Device Type
86
X
X
respective level of decontamination to be

achieved. The manufacturers label is the best
source for the most current information. Also
listed in Table 1 are the relative numbers of
products currently registered for each device
type along with their intended use profile as a
sterilant and/or HLD. A range of products are
readily available for use in small and large
facilities, and the number of such registered
devices provides a perspective on the number
of chemical variants being employed for
high-level disinfection and sterilization use.
This table does not define the numerous
application types associated with the different
chemical categories. In general, many of
the products listed can be used in a manual
solution bath or in appropriate automated
equipment, but prior to this use it must be
determined that the intended product is
approved for a selected application.
June 2006
An advantage for many solution chemistries is the relative

low cost for implementation due to the low hardware
requirements and, for some of the solutions, their general
medical device component compatibility. There are several
solution chemistries that are commonly used for highlevel disinfection and/or sterilization. Glutaraldehyde-based
solutions are the most prevalent and have a long history of use
as HLD and LCS products. Peracetic acid and hydrogen
peroxide solutions (or mixtures thereof) and aldehyde
(glutaraldehyde or ortho-phthaladehyde) based products can
be used as in-bath solutions or in automated reprocessing
equipment. A key benefit of either peracetic acid or hydrogen
peroxide is that disposal concerns are relatively minimal.
For all of these product formulations, the range of compatible
materials must be closely monitored because the proportions
of the active ingredients in a chemical formulation can vary
significantly. Some formulations require activation prior
to their use and once activated can be reused for only a
predetermined period of time. Other formulations may not
require activation, such as ortho-phthaladehyde and some
88
glutaraldehyde formulations, but the open bottle reuse

duration as defined by the manufacturer must be followed.
Sodium hypochlorite is an active disinfectant that has
the longest history as a general disinfectant. Technology is
now being applied to allow for the use of common salt
solutions to create the active ingredient hypochlorous acid,
bridging new technology development with older chemistries
for liquid chemical sterilization of solid, heat-sensitive
materials and equipment. Other related technologies include
hydrogen peroxide ionization and gaseous sterilants (GS)
by ozone gas generation. Each of these devices generates
the active chemical sterilant within the automated device
from other materials (H 2O 2 or O 2 respectively) as the
processing cycle initiates.
Irrespective of the chemical selected or the sophistication
of the equipment, successful processing relies on the
healthcare provider to manage appropriate use of the HLD,
LCS and GS by ensuring the compatibility of the medical
equipment and to employ the proper precleaning and
process verification.
June 2006
Minimizing Exposure, Maximizing Safety

In an attempt to address the growing challenge of
improving safety recommendations, while recognizing
and balancing in-service realities, ANSI/AAMI ST58:2005
document provides a clear plan for minimizing exposure to
HLDs, LCSs and GSs through recommended practices and the
use of appropriate personal protective equipment (PPE). All
manufacturers of HLDs, LCSs and GSs recommend the use
of PPE and, as may be expected, different types of chemical
products and disinfecting equipment may require different
types of PPE (Table 2 on page 92) or PPE made of specific
types of material. In addition to direct exposure concerns,
vapor or fumes can be released from these products such that
proper ventilation of the assigned rooms used for performing
disinfection or sterilization processes or tasks is recommended.
PPE is intended to be the primary barrier that protects
individuals through the handling and processing of the
contaminated medical equipment, including the decontamination
steps performed by manual application of an HLD or LCS.
The PPE represents a barrier between potentially harmful
90
chemical exposure (from splashes or droplets), and physical

hazards (burns) for face, eyes and skin. Standard protective
equipment includes chemical goggles, face shields and gloves.
PPE is also designed to protect the healthcare professional
from potentially biohazardous material derived from contaminated
medical devices. Safe use of HLDs, LCSs and GSs requires an
evaluation of the exposure and duration conditions prior to
use. Recommended PPE is listed in Table 2 on page 92 for
Standard protective
equipment includes
chemical goggles,
face shields and gloves.
June 2006
routine exposure conditions. It must be noted that if nonroutine

exposure conditions occur (such as for handling spills, new
types of equipment, or sharps), additional precautions are
warranted.6 Importantly, PPE is also intended to protect the
healthcare provider from any residual material or hazards
present on or in a processed medical device. Prior to thorough
rinsing or neutralization, the presence of residual HLD/LCS
chemistry is very likely, both on the outside of the device and
also potentially residing within the luminal spaces of the
medical equipment, such as found in endoscope equipment.
Proper PPE must be worn during all phases of the medical
device cleaning.
Identification of the proper PPE is only part of the
challenge for the healthcare providers using HLD, LCS or GS
products and equipment. The ANSI/AAMI ST58:2005 standard
addresses these challenges by recommending procedures for
when and how to effectively use this equipment. It identifies
the specific issues associated with a particular hazard, the
appropriate PPE types, and situational issues such as nonroutine
spill containment, safe disposal, HLD or LCS neutralization,
June 2006
and emergency treatment in case of accidental exposure.

Equally important topics include the types and appropriate
application of different PPE materials such as glove construction
(recommending nitrile and butyl rubber as opposed to latex),
and the safe use conditions for a given type of PPE.
Recommended use conditions for several of the HLDs
and LCSs utilize open tray or other types of open containers.
Although properly used PPE will protect the healthcare
professional from direct contact from these chemicals, indirect
exposure and the hazards of indirect exposure must be
minimized in a safe work environment. All manufacturers
of HLDs and LCSs used either in an open tray system or
in enclosed automated equipment recommend operation
of these devices in a well-ventilated environment. ANSI/
AAMI ST58:2005 Chemical Sterilization and High-level
Disinfection in Health Care Facilities recommends a minimum
ventilation of 10 air volume changes per hour, but additional
optimizations are also recommended (such as overhead fume
hoods) pertaining to each of the specific HLD or LCS devices.
In addition, exposure limits such as the threshold limit value
91
Table 2. Recommended Personal Protective Equipment (PPE)*
Minimum PPE
Recommended
[1]
Ventilation
Recommended
[2]
Vapor
Monitoring
Recommended
PPE
Recommended
Operations [3]
Glutaraldehyde
Solutions
G, E, F
A, P, I, T, S, R, H
Minimize splashing
Rinse thoroughly
Hydrogen Peroxide
Solutions
G, E, F
P, I, T, S, R, H
Minimize splashing
Rinse thoroughly
Hydrogen Peroxide Peracetic Acid Solutions
G, E, or F
P, I, T, S, R, H
Minimize splashing
Rinse thoroughly
Ortho-phthaladehyde
Solutions
G, E, or F
P, I, T, S, R, H
Minimize splashing
Rinse thoroughly
Peracetic Acid
Solutions
G, E, or F
P, I, T, S, R, H
Minimize splashing
Rinse thoroughly
Sodium Hypochlorite
Solutions
G, L, E, or F
P, I, T, S, R, H
Minimize splashing
Rinse thoroughly
Chemical Vapor with

Formaldehyde
G, E, or F
P, H
Read applicable sterilizer cautions
G, E
P, H
Device Type
Hydrogen Peroxide Gas

Plasma
Ozone Gas
* Recommended when following manufacturers label guidelines for routine use.

1. Legend7: Gloves (G), Splash proof eye protection (E), Face shield (F), Laboratory
coat or other protective clothing (L)
2. Automated devices have regulated exhaust and or exhaust through filter apparatus
92
Note

3. Legend: Activation of disinfection solutions (A), Pouring solutions or
addition to equipment (P), Immersing devices to be disinfected (I), Rinsing
disinfected items (R), Transporting solutions (T), Storing opened solutions
(S), Handling sterilized devices from automated equipment (H)
June 2006
(TLV) [both the short term exposure limits (STEL) and time-weighted
average (TWA) values, if applicable] are defined for some of HLDs and LCSs.
These safety considerations are critical components of the recommended
procedures for all stages of the medical device HLD/LCS/GS process
cycle. The beginning of the cycle includes handling of the contaminated
medical equipment and using cleaning aids and/or scrubbing of the
equipment to remove soil residue. Intermediate steps in the cycle include
p u rging small lumens in the equipment or wrapping of the equipment
in appropriate materials. The disinfection stage of the cycle is when the
medical devices are submersed into a chemical reservoir, attachment to
the automated equipment or placed within an open chamber sterilizer. The
final stage involves removing the treated equipment from the HLD/LCS/GS
environment and final rinsing and/or drying. The recommended practices
covered by the ANSI/AAMI ST58:2005 document are in place to protect the
healthcare professional from exposure to these important but potentially
hazardous materials and to ensure safe and effective processing of the
medical devices.
Process Verification
As the technology for HLDs, LCSs and GSs improves, it would be
expected to have subsequent improvements in the quality assurance for the
different medical device sterilizing equipment. These improvements include
recent invention of sophisticated automated reprocessing equipment.
However, the reality of new medical device sterilizers executing a complete
cycle with automated verification has yet to be fully realized. Currently,
the most automated devices will only measure the chemical and system
variables of a process cycle. Indeed, the majority of HLD or LCS users are
required to manually handle the contaminated equipment and the HLD or
LCS solutions at some or all stages of the medical device decontamination.
In addition, external variables that could affect successful processing, such as
the bio-burden present on the medical equipment or device packing, must be
evaluated by visual inspection (Table 3 on page 94).2
A second important issue relevant to both automated and manual
processing of HLD or LCS systems is the reuse of the HLD or LCS chemical.
Manufacturers supply shelf-life expiration dates, reuse-life (open bottle)
expiration dates, and minimum recommended concentration (MRC) or
minimum effective concentration (MEC) information with each of their
products. Understanding these values and their implication for the use of a
product is critical to safe and effective product use.
Manufacturer shelf-life recommendations should be clearly marked on
each product package. The shelf-life value is established for a given product
to verify that material stored appropriately will meet or exceed the MRC/MEC
for use as a HLD or LCS. If the shelf life is exceeded, this solution must be
discarded whether or not the solution meets the MRC/MEC.
Once the container is opened, reuse-life or the open-bottle expiration date
must be followed. This value represents the reuse period for a product under
defined use conditions. These conditions include the temperature of the
system being used as well as any storage variables. Typical ranges for reusable
products are 14 to 28 days. Within this reuse period, the user of this material
must continually verify that the MRC/MEC for the product is met prior to
each HLD or LCS process. As the solution is being used and the volume
June 2006
93
decreases over time, it is recommended that no replenishment

take place. If a minimum volume for use is reached, it is
recommended that the entire contents of the bottle be discarded
and replaced with a fresh bottle. So-called topping-off of
reusable HLD or LSC solutions is not recommended.8
Finally, the MRC/MEC value itself can be informative to
distinguish if a solution can be safely used. If a new or nonexpired
solution fails to meet the MRC/MEC, this solution should not

be used, and additional verification measures should be taken
to determine that subsequent HLD or LCS solutions meet the
necessary specifications. Appropriate test strips or chemical
monitoring devices (CIs) that indicate the MRC/MEC are the
recommended method for verification that a chemical product
has the required level of the active ingredients recommended.9
Table 3. High-Level Disinfection and Sterilization Process Verification

Device Type
CI [1]
BI [2]
PCD [3]
Measurement
-Physical monitor verification
-CI test results
-Open bottle expiration date
-Shelf life
Glutaraldehyde
Solutions
CI should be used before each use
Hydrogen Peroxide
Solutions
Ortho-phthaladehyde
Solutions
Hydrogen Peroxide
Solutions
Peracetic Acid
Solutions
Peracetic Acid
Automated
CI and BI as recommended
by manufacturer
Sodium Hypochlorite
Solutions
Chemical Vapor
with Formaldehyde
CI as recommended by manufacturer
BI- should use at least daily and
preferable each load in a PCD

-CI test results
-BI automated cycle verification
Hydrogen Peroxide
Gas Plasma
CI as recommended by manufacturer
BI should use at least daily and
preferable each load in a PCD.

-CI test results
-BI automated cycle verification
CI-as recommended by manufacturer

BI-Should use at least daily and
preferable each load in a PCD

-CI test results
-BI automated cycle validation
Ozone Gas
94
Recommended Routine Verification
1.
Chemical Indicator (CI)An FDA-approved test strip or reagent chemical monitoring

device that evaluates the active concentration of a HLD, LCS or GS product.
2.
Biological Indicator (BI)An FDA-approved device containing viable microorganisms

used to determine the effectiveness of the HLD, or LCS or GS process.

-CI test results
-Shelf life
-CI test results
-Shelf life
-CI test results
-Shelf life
-CI test results
-Shelf life
-CI test results
-Shelf life

-CI test results
-Shelf life
3.
Process Challenge Device (PCD)An FDA-approved

device used to mimic standard devices sterilized by this
process that contains a BI. Their use is recommended as part
of a routine quality verification program, in conjunction with
a CI.
June 2006
Manufacturer recommendations
for specific test strips or CIs
should be followed.
The CIs should be used prior to every HLD, LCS or GS process as part of
the routine verification for both manual and automated procedures. Products
from different manufacturers that contain the same chemical active ingredient,
such as glutaraldehyde, may have different MRC/MEC values because of
different concentrations or other components in the product formulation and
therefore may require a different series of test strips or CIs to perform the
verification. Manufacturer recommendations for specific test strips or CIs
should be followed.
Additional verification procedures applying to the automated LCS and
GS devices include the use of biological indicators (BI). These indicators
contain test organisms that are used to determine the effectiveness of the
sterilization process. They are typically spore-contaminating carriers that are
placed in simulated devices known as process challenge devices (PCD),
within packages or open trays in the processing equipment.10 Once the
sterilization process is completed these indicators are incubated in a growth
medium selective for that organism type. Verification of the sterilization
process requires that no growth occurs from any of the BIs placed in the
equipment (e.g. indicating that the spores were killed).
It is clear that continual improvement in the automation of HLD and
LCS cycle verification is being made. The range of HLD and LCS cycle
verification includes manual test indicators and some automated measurements
made internally by the equipment. Regardless of the sophistication of the
equipment, other factors such as material types, packaging and packing
density can affect the quality of the process cycle. Therefore, the current
recommended practices for HLD and LCS cycle verification are that chemical
and biological indicators be utilized as routine practice to ensure quality
and safety. Tracking logs should be maintained to record processing
dates, times, solution temperatures, cycle parameters, and CI and BI indicator
results (positive, negative or inconclusive). The ANSI/AAMI ST58:2005
Chemical Sterilization and High-level Disinfection in Health Care Facilities
recommends very specific actions to be taken in the event of a positive BI
result.11 These and additional recommendations made in the ANSI/AAMI
ST58:2005 standard are part of a process for continual improvement. Quality
process improvement strives to ensure both the safety of the healthcare
professionals working with the equipment and the patients receiving the
medical care. The object of any process improvement program is to provide
assurance that recommended procedures are being followed, that expected
results are being met and, most importantly, that deficiencies are quickly
identified and corrected.
June 2006
95
Summary
Regular training
and process
verification
is essential.
As the number and types of medical devices and their requisite

cleaning and disinfecting material increase, so do the competencies
for adequate training and experience. Each topic in this in-service
document is designed to highlight and simplify the relative complexity
of these issues. The essence of this document is to provide a solid
overview of the recommended practices for use of all chemical HLD
and LCS products and gaseous sterilization devices. It must be said
that the ANSI/AAMI ST58:2005 recommended practice on Chemical
Sterilization and High-level Disinfection in Health Care Facilities
is a series of voluntary recommended practices. The in-service
recommendations cover a broad range of topics, including not only the
subject of HLDs or LCS and GS products, but also operation and use
of these products within a healthcare facility. Providing these
guidelines to healthcare professionals should emphasize the need for
regular training and process verification. It is incumbent on the user of
these devices to have read the manufacturing label on the device, to be
familiar with the safe working requirements of the products, and to be
aware of the resources that are available to them for further education
on the safe and effective use of these devices.
Medical device HLDs or LCSs and GSs require a high degree of
attention and understanding to ensure they are being used safely and
effectively. Their use potentially affects all semicritical and critical
medical devices being used in a healthcare setting. While many of these
materials are hazardous, adopting a standardized decontamination
process and understanding the appropriate device applications will
facilitate their safe use and allow the verification of their effectiveness.
The new standard has successfully combined into a single document
recommended safe and effective use procedures and implementation
plans for all chemical and gaseous sterilization and high-level disinfection
devices and represents a key source for acquiring this information.
AAMI documents can be purchased through AAMI by credit card
using the following four options:
1. Internet: http://marketplace.aami.org/eseries/ScriptContent/ Index.cfm
2. Call: 800.332.2264, ext 217 or 703.525.4890, ext 217
3. Fax: 703.525.1424
4. Mail: AAMI, Customer Service Center, 1100 N. Glebe Road, Suite
220, Arlington, VA 22201-5762
References
1.
2.
3.
4.
5.
6.
96
Content and Format of Pre-market Notification [510(k)] Submissions for Liquid

Chemical Sterilants or High Level Disinfectants. FDA, January 3, 2000.
Association for the Advancement of Medical Instrumentation. Chemical
sterilization and high-level disinfection in health care facilities. ANSI/AAMI
ST58:2005.
Code of Federal Regulations. 21 CFR 880.6885.
Association for the Advancement of Medical Instrumentation. Safe use and
handling of glutaraldehyde-based products in health care facilities. ANSI/AAMI
ST58:1996.
Association for the Advancement of Medical Instrumentation. Chemical
sterilants and high-level disinfectants: A guide to selection and use. AAMI
TIR7:2000.
Respiratory selection requires training prior to use. Refer to section 4.4.4
in Association for the Advancement of Medical Instrumentation. Chemical
sterilization and high-level disinfection in health care facilities; ANSI/AAMI
ST58:2005.
June 2006

Reprint with permission from Workhorse Publishing L.L.C.
Copyright2006/Workhorse Publishing L.L.C./All Rights Reseved.
7.
Determine material recommendations

for personal protective equipment (PPE)
devices for each respective products
listed in Association for the Advancement
of Medical Instrumentation. Chemical
sterilization and high-level disinfection
in health care facilities. ANSI/AAMI
ST58:2005.
8. Guideline for the Use of High-Level
Disinfectants and Sterilants for
Reprocessing of Flexible Gastrointestinal
Endoscopes. Society of Gastroenterology
Nurses and Associates, Inc., 2004.
9. Association for the Advancement of
Medical Instrumentation. Sterilization
of health care products-Chemical
indicators-Part 1: General requirements. ANSI/AAMI ST60:1996.
10. Association for the Advancement
of Medical Instrumentation. Process
challenge devices/test packs for use
in health care facilities. A A M I
TIR31:2003.
11. Sections 9.3, 9.4, 9.5 listed in Association
for the Advancement of Medical
Instrumentation. Chemical sterilization
and high-level disinfection in health
care facilities. ANSI/AAMI ST58:2005
Sterile Process and Distribution CEU Information

CEU Applicant Name ______________________________________________
Address_____________________________________________ _ _ _ ________
City____________________________________________________________
State_________________________ Zip Code ______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___
The CBSPD (Certification Board for Sterile Processing and Distribution)
has preapproved this inservice for one (1) contact hour for a period of five
years from the date of publication and to be used once in a recertification period.
Successful completion of the lesson and post test must be documented by
facility management and those records maintained by the individuals until
re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD.
For additional information regarding Certification, contact: CBSPD,
2 Industrial Park Road, Suite 3, Alpha, NJ 08865 or call 908-454-9555 or visit
www.sterileprocessing.org.
IAHCSMM has awarded one and one-half (1.5) contact point for completion
of this continuing education lesson toward IAHCSMM recertification.
Nursing CEU Application Form
Donald P. Satchell, Ph.D., is

a Dow Chemical Company Senior
Research Biochemist and is the Global
Technical Specialist for disinfection and
HLD products. As a researcher with Dow
Biocides he developed TauNovate
technology for testing antimicro b i a l
disinfectant and preservative efficacy,
a high-throughput technology that is
used for new biocide discovery and for
performance evaluation of biocide
formulations. With more than eight years
of experience studying antimicro b i a l
agents, he has published several papers
on the discovery and characterization
of novel antimicrobial agents and
their applications.
This inservice is 3M Health Care Provider approved by the California Board

of Registered Nurses, CEP 5770 for (1) contact hour. This form is valid up to five
years from the date of publication.
1. Make a photocopy of this form.
2. Print your name, address and daytime phone number and position/title.
3. Add your social security number or your nursing license number.
4. Date the application and sign.
5. Answer the CE questions.
6. Submit this form and the answer sheet to:
Workhorse Publishing
Managing Infection Control
PO Box 25310, Scottsdale, AZ 85255-9998
7. Participants who score at least 70% will receive a certificate of completion
within 30 days of Managing Infection Controls receipt of the application.
Application
Please print or type.
Name______________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ ____________ _ ___
Mailing Address________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
City, State, Country, Zip ___________________________________________
Daytime phone (
ANSWERS
1.
2.
3.
4.
5.
F
F
T
F
F
6.
7.
8.
9.
10.
F
T
T
T
F
)___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ __
Position/Title___________________________________________________
Social Security or Nursing License Number _______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___
Date application submitted _________________________ _ _ _ _ _ _ _ _ _ _ ______
Signature _______________________________________________________
Offer expires June 2011
70-2009-7383-5
June 2006
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