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
manufacturer’s label on the high-level disinfectants and chem-
ical 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 high-
level 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.

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Test Questions medical devices. The Food and Drug Administration (FDA)
True or False has regulations governing medical device high-level
1. Pre-cleaning of medical devices is recommended for disinfection and sterilization. All HLDs, LCSs and GSs, as
some high-level disinfectants (HLDs) and liquid chemical well as equipment that may use HLD and LCS products,
sterilants (LCSs). exist in the regulatory domain of the FDA. In order for
2. Safe use and handling requirements of chemicals are HLDs, LCSs and GSs to be used on medical devices, they
the same for all HLDs and LCSs. must meet strict requirements for approval by the FDA.
3. Some HLDs and LCSs require activation prior to being used. Such requirements are necessary to determine that these
4. All chemical disinfectants can be classified as sterilants. products meet basic criteria against which all such medical
5. Personal protective equipment (PPE) is the only required safety devices are compared.1 Meeting standard test conditions
feature recommended for use of HLDs, LCSs and GSs. assures that, with proper use and handling, the HLD, LCS
6. Once the medical device is disinfected or sterilized, PPE is and GS will provide the indicated performance required for
no longer necessary. cleaning and disinfecting of equipment being treated.
7. Room ventilation at a rate of 10 air exchanges per hour is the Equally important as the approval of these products
most common facility requirement to minimize indirect HLD by the FDA is that the recommended practices for their use be
or LCS exposure. consistently followed to ensure that expected disinfection
8. An appropriate test strip or chemical monitoring device performance is achieved and that the safety of the healthcare
should be used to test the minimum recommended professionals is assured. Since HLDs, LCSs and GSs vary
concentration (MRC) or minimum effective concentration widely in their safe and recommended use patterns, the
(MEC) of an HLD or LCS before each use. Association for the Advancement of Medical Instrumentation
9. Gaseous chemical sterilants should be tested with a biological (AAMI) has developed a new unified standard for
indicator in a process challenge device (PCD or test pack) at recommended practices and safe use of chemical HLDs,
least daily and preferable in each load. LCSs and GSs to reenforce this imperative.2 Close attention
10. Reusable HLDs and LCSs can be used repeatedly as long as to the specific product being used is important since the
the expiration date has not been reached. nature of the chemistry, the associated equipment being used
for a given type of chemical product, and safe handling
High-Level Disinfectants (HLD), Liquid Chemical methods for each of the devices can vary considerably.
Sterilants (LCS) and Gaseous Chemical Sterilants Factors such as available personal protective equipment
(GS) Application Scope (PPE), environmental limitations of a medical facility, types
The objectives of this article are to introduce the new of monitoring devices, work practices, annual training and
ANSI/AAMI ST58:2005 standard Chemical Sterilization and recommended disposal procedures are all highly specific for
High-level Disinfection in Health Care Facilities; provide a any particular HLD, LCS or GS. The new ANSI/AAMI
summary of the topics covered by this new standard; and high- ST58:2005 Chemical Sterilization and High-level Disinfection
light the recommended practices for high-level disinfectants in Health Care Facilities standard is written to address these
(HLD), liquid chemical sterilants (LCS), and gaseous chemical issues. It details the appropriate requirements and procedures
sterilants (GS). Training questions are provided that cover to provide the healthcare professional with a solid foundation
specific topics reviewed in this article. These questions are for in-service use of these products and a concise resource to
included to emphasize the key points about the topics being address concerns or questions regarding these issues.
covered and to allow readers to reflect on their understanding of The FDA provides the regulatory parameters and device
these topics relative to their specific work settings. intended use definitions to guide manufacturers and healthcare
Reuse of medical devices is a necessity in all healthcare professionals in determining the level of decontamination
facilities. As technology drives the invention of more sophisti- required for a particular medical device and the criteria for
cated medical devices, cost control measures increasingly add the defined levels of disinfection and sterilization.3
pressure for the repeated use of these medical tools. Fortunately, “A liquid chemical sterilant or high-level
technical innovations are also creating new products to facilitate disinfectant is a germicide that is intended for use
the cleaning and decontamination of these tools. Prior to as the terminal step in processing critical and
reuse, medical devices contaminated by potentially pathogenic semicritical medical devices prior to patient use.
organisms such as bacteria or viruses must first be disinfected Critical devices make contact with normally
or sterilized. The level of decontamination required depends on sterile tissue or body spaces during use.
the intended use of the medical device. This intended use is Semicritical devices make contact during use with
divided into three categories: noncritical, semicritical and critical mucous membranes or nonintact skin.

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“High Level Disinfectant: A germicide that AAMI has previously standardized the recommended
inactivates all microbial pathogens, except large practices for these devices in two separate documents.4,5
numbers of bacterial endospores, when used In ANSI/AAMI ST58:2005 Chemical Sterilization and
according to labeling (Rutala, 1990; Spaulding, High-level Disinfection in Health Care Facilities, these
1970). The FDA further defines a high level disin - standards present comprehensive coverage of all the approved
fectant as a sterilant used under the same contact HLD or LCS chemistries and gaseous chemical sterilants used
conditions except for a shorter contact time. in a sterilizing device, including revised recommendations
“Sterilant: An agent that destroys all viable for safe use, quality control technology, training assessments,
forms of microbial life.” in-service training qualifications, regulatory recommendations,
and chemical material and compatibility recommendations.
AAMI provides a clearer definition of the criteria Additional guidelines are provided for the safe handling
and conditions necessary for disinfection or sterilization, and stewardship of these chemicals, an essential element
and helps in our understanding of these criteria by of the in-service document because it emphasizes both the
defining the type of organisms used in the certification safety of the healthcare professionals working with these
testing and evaluation of HLDs, or chemical sterilants devices and the safety of the patient services being provided by
(LCS or GS). these devices.
“The conditions given on the product label
for high-level disinfection or sterilization are Examples of FDA-Cleared HLDs, LCSs and GSs
determined by the manufacture r. The labeled There are currently eight general HLD, LCS or GS
conditions for high-level disinfection are the time chemical categories that have clearance for use as a HLD, LCS
and temperature re q u i red to achieve a six-log or GS (Table 1). The basis for this categorization is linked to the
reduction of an appropriate Mycobacterium species, specific chemical type for these products. It is important
such as M. bovis BCG or M. terrae, that has to understand that the use requirements of individual products
resistance characteristics similar to those of the within the same chemical category may vary. It may be helpful
human strain of M. tuberculosis under the conditions to remember that manufacturers of each product within each
specified in the recommended test protocol. chemical category strive to differentiate their products from
“For most FDA-cleared sterilants or HLDs, the the others. Ease of use, treatment conditions, cycling time,
labeled contact conditions for sterilization are the stability, safety and costs are all considerations that manufacturers
contact conditions required to pass the AOAC are trying to optimize. These product differences need to be
Sporicidal Activity Test as a sterilant (i.e., to pass recognized and understood to ensure that the selected HLD, LCS
the test with no failures).”2 or GS product is used both on the appropriate medical device and
in the appropriate manner.
These two definitions emphasize that sterilants and Examples of these product differences include product
HLDs are products tested to assure complete and safe activation requirements, storage conditions, reusable lifetimes
removal of microbial contamination in a manner that is and neutralization requirements prior to disposal. Chemical
matched to the intended use of a given medical device d i fferences between the different HLDs, LCSs and GSs can
(semicritical or critical). have very different and sometimes deleterious effects on the
In addition, for FDA approval, these devices need to materials (stainless steel, glass, etc.) of medical devices being
pass a series of evaluations under certified laboratory treated. In addition, the required treatment conditions or device
conditions to demonstrate their safety and effectiveness.1 preparation (wrapped or unwrapped, heat sensitivity, etc.) can
Once done, it becomes the healthcare professional’s respon- vary significantly for different HLD or LCS with specific
sibility to assure compliance with the manufacturer’s medical devices.
recommended use instructions. These instructions can be The details of the product categories covered in Table 1 on
obtained for any HLD, LCS or GS from the manufacturer page 87 are listed in ANSI/AAMI ST58:2005 Chemical
and are also included on the labels of products intended for Sterilization and High-level Disinfection in Health Care
this use. Additional in-service details of the products and Facilities, but specific details for a given product’s use and
their safe and effective use may not be provided by the limitations must be determined from the manufacturer’s product
manufacturer, which is why AAMI has established its own label. Also, as identified in Table 1, some of the chemical
in-service document to address these issues. AAMI has products may be listed as an HLD (for treatment of semicritical
created a uniform list of recommendations covering the devices), as a sterilant (for treatment of semicritical or critical
safety, necessary competence and specific use consideration medical devices), or both. Products listed as both an HLD and
that are necessary for all HLDs or LCSs and GSs. a sterilant will require different treatment conditions for the

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Table 1. Current FDA-Cleared High-Level Disinfectants respective level of decontamination to be

and Sterilants achieved. The manufacturer’s label is the best
source for the most current information. Also
Number of High-level
Registered Sterilization
listed in Table 1 are the relative numbers of
Device Type Disinfection
Products* products currently registered for each device
type along with their intended use profile as a
Glutaraldehyde Solutions 9 X X
sterilant and/or HLD. A range of products are
Hydrogen Peroxide Solutions1 3 X X readily available for use in small and large
Ortho-phthaladehyde 3 X facilities, and the number of such registered
Solutions devices provides a perspective on the number
Peracetic Acid and or 2 X X of chemical variants being employed for
Hydrogen Peroxide Solutions2 high-level disinfection and sterilization use.
Sodium Hypochlorite 1 X This table does not define the numerous
Solutions application types associated with the different
Chemical Vapor with 1 X
chemical categories. In general, many of
Formaldehyde the products listed can be used in a manual
Hydrogen Peroxide 1 X
solution bath or in appropriate automated
Gas Plasma equipment, but prior to this use it must be
determined that the intended product is
Ozone Gas 1 X
approved for a selected application.

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An advantage for many solution chemistries is the relative glutaraldehyde formulations, but the open bottle reuse
low cost for implementation due to the low hardware duration as defined by the manufacturer must be followed.
requirements and, for some of the solutions, their general Sodium hypochlorite is an active disinfectant that has
medical device component compatibility. There are several the longest history as a general disinfectant. Technology is
solution chemistries that are commonly used for high- now being applied to allow for the use of common salt
level disinfection and/or sterilization. Glutaraldehyde-based solutions to create the active ingredient hypochlorous acid,
solutions are the most prevalent and have a long history of use bridging new technology development with older chemistries
as HLD and LCS products. Peracetic acid and hydrogen for liquid chemical sterilization of solid, heat-sensitive
peroxide solutions (or mixtures thereof) and aldehyde materials and equipment. Other related technologies include
(glutaraldehyde or ortho-phthaladehyde) based products can hydrogen peroxide ionization and gaseous sterilants (GS)
be used as in-bath solutions or in automated reprocessing by ozone gas generation. Each of these devices generates
equipment. A key benefit of either peracetic acid or hydrogen the active chemical sterilant within the automated device
peroxide is that disposal concerns are relatively minimal. from other materials (H 2O 2 or O 2 respectively) as the
For all of these product formulations, the range of compatible processing cycle initiates.
materials must be closely monitored because the proportions Irrespective of the chemical selected or the sophistication
of the active ingredients in a chemical formulation can vary of the equipment, successful processing relies on the
significantly. Some formulations require activation prior healthcare provider to manage appropriate use of the HLD,
to their use and once activated can be reused for only a LCS and GS by ensuring the compatibility of the medical
predetermined period of time. Other formulations may not equipment and to employ the proper precleaning and
require activation, such as ortho-phthaladehyde and some process verification.

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Minimizing Exposure, Maximizing Safety chemical exposure (from splashes or droplets), and physical
In an attempt to address the growing challenge of hazards (burns) for face, eyes and skin. Standard protective
improving safety recommendations, while recognizing equipment includes chemical goggles, face shields and gloves.
and balancing in-service realities, ANSI/AAMI ST58:2005 PPE is also designed to protect the healthcare professional
document provides a clear plan for minimizing exposure to from potentially biohazardous material derived from contaminated
HLDs, LCSs and GSs through recommended practices and the medical devices. Safe use of HLDs, LCSs and GSs requires an
use of appropriate personal protective equipment (PPE). All evaluation of the exposure and duration conditions prior to
manufacturers of HLDs, LCSs and GSs recommend the use use. Recommended PPE is listed in Table 2 on page 92 for
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, Standard protective
vapor or fumes can be released from these products such that
proper ventilation of the assigned rooms used for performing equipment includes
disinfection or sterilization processes or tasks is recommended.
PPE is intended to be the primary barrier that protects chemical goggles,
individuals through the handling and processing of the face shields and gloves.
contaminated medical equipment, including the decontamination
steps performed by manual application of an HLD or LCS.
The PPE represents a barrier between potentially harmful

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routine exposure conditions. It must be noted that if nonroutine and emergency treatment in case of accidental exposure.
exposure conditions occur (such as for handling spills, new Equally important topics include the types and appropriate
types of equipment, or sharps), additional precautions are application of different PPE materials such as glove construction
warranted.6 Importantly, PPE is also intended to protect the (recommending nitrile and butyl rubber as opposed to latex),
healthcare provider from any residual material or hazards and the safe use conditions for a given type of PPE.
present on or in a processed medical device. Prior to thorough Recommended use conditions for several of the HLDs
rinsing or neutralization, the presence of residual HLD/LCS and LCSs utilize open tray or other types of open containers.
chemistry is very likely, both on the outside of the device and Although properly used PPE will protect the healthcare
also potentially residing within the luminal spaces of the professional from direct contact from these chemicals, indirect
medical equipment, such as found in endoscope equipment. exposure and the hazards of indirect exposure must be
Proper PPE must be worn during all phases of the medical minimized in a safe work environment. All manufacturers
device cleaning. of HLDs and LCSs used either in an open tray system or
Identification of the proper PPE is only part of the in enclosed automated equipment recommend operation
challenge for the healthcare providers using HLD, LCS or GS of these devices in a well-ventilated environment. ANSI/
products and equipment. The ANSI/AAMI ST58:2005 standard AAMI ST58:2005 Chemical Sterilization and High-level
addresses these challenges by recommending procedures for Disinfection in Health Care Facilities recommends a minimum
when and how to effectively use this equipment. It identifies ventilation of 10 air volume changes per hour, but additional
the specific issues associated with a particular hazard, the optimizations are also recommended (such as overhead fume
appropriate PPE types, and situational issues such as nonroutine hoods) pertaining to each of the specific HLD or LCS devices.
spill containment, safe disposal, HLD or LCS neutralization, In addition, exposure limits such as the threshold limit value

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Table 2. Recommended Personal Protective Equipment (PPE)*

Minimum PPE Ventilation Vapor PPE

Device Type Recommended Recommended Monitoring Recommended Note
[1] [2] Recommended Operations [3]

Glutaraldehyde G, E, F X X A, P, I, T, S, R, H Minimize splashing

Solutions Rinse thoroughly

Hydrogen Peroxide G, E, F X X P, I, T, S, R, H Minimize splashing

Solutions Rinse thoroughly

Hydrogen Peroxide - G, E, or F X X P, I, T, S, R, H Minimize splashing

Peracetic Acid Solutions Rinse thoroughly

Ortho-phthaladehyde G, E, or F X P, I, T, S, R, H Minimize splashing

Solutions Rinse thoroughly

Peracetic Acid G, E, or F X X P, I, T, S, R, H Minimize splashing

Solutions Rinse thoroughly

Sodium Hypochlorite G, L, E, or F X P, I, T, S, R, H Minimize splashing

Solutions Rinse thoroughly

Chemical Vapor with G, E, or F X P, H Read applicable sterilizer cautions

Formaldehyde

Hydrogen Peroxide Gas G, E X P, H Read applicable sterilizer cautions

Plasma

Ozone Gas X Read applicable sterilizer cautions

* Recommended when following manufacturer’s label guidelines for routine use. 3. Legend: Activation of disinfection solutions (A), Pouring solutions or
1. Legend7: Gloves (G), Splash proof eye protection (E), Face shield (F), Laboratory addition to equipment (P), Immersing devices to be disinfected (I), Rinsing
coat or other protective clothing (L) disinfected items (R), Transporting solutions (T), Storing opened solutions
2. Automated devices have regulated exhaust and or exhaust through filter apparatus (S), Handling sterilized devices from automated equipment (H)

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(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

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decreases over time, it is recommended that no replenishment solution fails to meet the MRC/MEC, this solution should not
take place. If a minimum volume for use is reached, it is be used, and additional verification measures should be taken
recommended that the entire contents of the bottle be discarded to determine that subsequent HLD or LCS solutions meet the
and replaced with a fresh bottle. So-called “topping-off” of necessary specifications. Appropriate test strips or chemical
reusable HLD or LSC solutions is not recommended.8 monitoring devices (CIs) that indicate the MRC/MEC are the
Finally, the MRC/MEC value itself can be informative to recommended method for verification that a chemical product
distinguish if a solution can be safely used. If a new or nonexpired has the required level of the active ingredients recommended.9

Table 3. High-Level Disinfection and Sterilization Process Verification

Device Type Recommended Routine Verification CI [1] BI [2] PCD [3] Measurement

-Physical monitor verification

Glutaraldehyde CI should be used before each use X -CI test results
Solutions -Open bottle expiration date
-Shelf life

-Physical monitor verification

Hydrogen Peroxide CI should be used before each use X -CI test results
Solutions -Open bottle expiration date
-Shelf life

-Physical monitor verification

Ortho-phthaladehyde CI should be used before each use X -CI test results
Solutions -Open bottle expiration date
-Shelf life

-Physical monitor verification

Hydrogen Peroxide CI should be used before each use X -CI test results
Solutions -Open bottle expiration date
-Shelf life

-Physical monitor verification

Peracetic Acid CI should be used before each use X -CI test results
Solutions -Open bottle expiration date
-Shelf life

-Physical monitor verification

Peracetic Acid CI and BI as recommended X X -CI test results
Automated by manufacturer -Open bottle expiration date
-Shelf life

-Physical monitor verification

Sodium Hypochlorite CI should be used before each use X -CI test results
Solutions -Open bottle expiration date
-Shelf life

Chemical Vapor CI as recommended by manufacturer -Physical monitor verification

with Formaldehyde BI- should use at least daily and X X X -CI test results
preferable each load in a PCD -BI automated cycle verification

Hydrogen Peroxide CI as recommended by manufacturer -Physical monitor verification

Gas Plasma BI should use at least daily and X X X -CI test results
preferable each load in a PCD. -BI automated cycle verification

CI-as recommended by manufacturer -Physical monitor verification

Ozone Gas BI-Should use at least daily and X X X -CI test results
preferable each load in a PCD -BI automated cycle validation

1. Chemical Indicator (CI)—An FDA-approved test strip or reagent chemical monitoring 3. Process Challenge Device (PCD)—An FDA-approved
device that evaluates the active concentration of a HLD, LCS or GS product. device used to mimic standard devices sterilized by this
process that contains a BI. Their use is recommended as part
2. Biological Indicator (BI)—An FDA-approved device containing viable microorganisms of a routine quality verification program, in conjunction with
used to determine the effectiveness of the HLD, or LCS or GS process. a CI.

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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.

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Summary
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
Regular training overview of the recommended practices for use of all chemical HLD
and LCS products and gaseous sterilization devices. It must be said
and process that the ANSI/AAMI ST58:2005 recommended practice on Chemical
Sterilization and High-level Disinfection in Health Care Facilities
verification is a series of v o l u n t a ry recommended practices. The in-service
recommendations cover a broad range of topics, including not only the
is essential. 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. Content and Format of Pre-market Notification [510(k)] Submissions for Liquid
Chemical Sterilants or High Level Disinfectants. FDA, January 3, 2000.
2. Association for the Advancement of Medical Instrumentation. Chemical
sterilization and high-level disinfection in health care facilities. ANSI/AAMI
ST58:2005.
3. Code of Federal Regulations. 21 CFR § 880.6885.
4. Association for the Advancement of Medical Instrumentation. Safe use and
handling of glutaraldehyde-based products in health care facilities. ANSI/AAMI
ST58:1996.
5. Association for the Advancement of Medical Instrumentation. Chemical
sterilants and high-level disinfectants: A guide to selection and use. AAMI
TIR7:2000.
6. 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.

96 MANAGING INFECTION CONTROL June 2006

 Education & Training

Reprint with permission from Workhorse Publishing L.L.C.

Copyright©2006/Workhorse Publishing L.L.C./All Rights Reseved.
7. Determine material recommendations
for personal protective equipment (PPE)
devices for each respective products Sterile Process and Distribution CEU Information
listed in Association for the Advancement
of Medical Instrumentation. Chemical CEU Applicant Name ______________________________________________
sterilization and high-level disinfection Address_____________________________________________ _ _ _ ________
in health care facilities. ANSI/AAMI
ST58:2005. City____________________________________________________________
8. Guideline for the Use of High-Level
Disinfectants and Sterilants for State_________________________ Zip Code ______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___
Reprocessing of Flexible Gastrointestinal
Endoscopes. Society of Gastroenterology
Nurses and Associates, Inc., 2004.
The CBSPD (Certification Board for Sterile Processing and Distribution)
9. Association for the Advancement of has preapproved this inservice for one (1) contact hour for a period of five
Medical Instrumentation. Sterilization years from the date of publication and to be used once in a recertification period.
of health care products-Chemical Successful completion of the lesson and post test must be documented by
indicators-Part 1: General require-
ments. ANSI/AAMI ST60:1996. facility management and those records maintained by the individuals until
10. Association for the Advancement re-certification is required. DO NOT SEND LESSON OR TEST TO CBSPD.
of Medical Instrumentation. Process For additional information regarding Certification, contact: CBSPD,
challenge devices/test packs for use
2 Industrial Park Road, Suite 3, Alpha, NJ 08865 or call 908-454-9555 or visit
in health care facilities. A A M I
TIR31:2003. www.sterileprocessing.org.
11. Sections 9.3, 9.4, 9.5 listed in Association
for the Advancement of Medical IAHCSMM has awarded one and one-half (1.5) contact point for completion
Instrumentation. Chemical sterilization of this continuing education lesson toward IAHCSMM recertification.
and high-level disinfection in health
care facilities. ANSI/AAMI ST58:2005

Nursing CEU Application Form

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
Donald P. Satchell, Ph.D., is years from the date of publication.
a Dow Chemical Company Senior 1. Make a photocopy of this form.
Research Biochemist and is the Global 2. Print your name, address and daytime phone number and position/title.
Technical Specialist for disinfection and 3. Add your social security number or your nursing license number.
HLD products. As a researcher with Dow 4. Date the application and sign.
Biocides he developed TauNovate™ 5. Answer the CE questions.
6. Submit this form and the answer sheet to:
technology for testing antimicro b i a l
Workhorse Publishing
disinfectant and preservative efficacy,
Managing Infection Control
a high-throughput technology that is
PO Box 25310, Scottsdale, AZ 85255-9998
used for new biocide discovery and for
7. Participants who score at least 70% will receive a certificate of completion
performance evaluation of biocide
within 30 days of Managing Infection Control’s receipt of the application.
formulations. With more than eight years
of experience studying antimicro b i a l Application
agents, he has published several papers Please print or type.
on the discovery and characterization
Name______________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ _ _ _ _ ____________ _ ___
of novel antimicrobial agents and
their applications. Mailing Address________________________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
City, State, Country, Zip ___________________________________________
Daytime phone ( )___________________ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __ _ _ __
ANSWERS Position/Title___________________________________________________
1. F 6. F
Social Security or Nursing License Number _______ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ ___
2. F 7. T
3. T 8. T Date application submitted _________________________ _ _ _ _ _ _ _ _ _ _ ______
4. F 9. T Signature _______________________________________________________
5. F 10. F Offer expires June 2011

70-2009-7383-5

June 2006 MANAGING INFECTION CONTROL 97