Sponsored by SELF-STUDY SERIES
prions, which cause Creutzfeldt-Jakob Dis- sterilization process concludes with its use as are more resistant than the bioburden found
ease (CJD), are the most difficult. a sterilant for “materials and devices that can- on medical devices.”
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When using disinfectants and sterilants, it’s not tolerate high temperatures and humid- The actual recommendations for disinfec-
important to consider the effect of physical ity, such as some plastics, electrical devices, tion and sterilization can be found toward the
and chemical factors. For example, is the ef- and corrosion-susceptible metal alloys.”
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Dis- end of the guideline. To help the reader ap-
ficacy of a particular disinfectant sensitive to advantages of this process are the tendency preciate the strength of the recommendations,
pH? Is your ethylene oxide sterilizer de- of the cycle to abort because of failure to they are categorized according to the avail-
signed to provide adequate in-chamber rela- achieve vacuum if any moisture is present, ability of supporting science, theoretical ra-
tive humidity (RH), as RH is a critical factor and the concern about hydrogen peroxide tionale, or relevant government regulation as
influencing the activity of ethylene oxide. penetration into long or narrow lumens. Per- explained in the table below. The comprehen-
The guideline reinforces the importance of acetic acid is described as “a highly biocidal sive recommendations are divided into sec-
meticulous cleaning prior to sterilization by oxidizer that maintains its efficacy in the pres- tions. Some of the sections of particular inter-
discussing the negative impact both organic ence of organic soil.”
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The guideline reminds est to Sterile Processing Departments are:
and inorganic matter have on the process, the reader that the appropriate channel con- • Occupational Health and Exposure
whether by reacting with the active agent or nector must be connected to lumened • Cleaning of Patient-Care Devices
acting as a physical barrier to shield micro- endoscopes processed in the automated pro- • Indications for Sterilization, High-Level Dis-
organisms. cessor to ensure that peracetic acid has direct infection, and Low-Level Disinfection
contact with the lumen. • High-Level Disinfection of Endoscopes
Sterilization methods and One of the features of the guideline is the • Flash Sterilization
sterilizing practices extensive bibliography. For example, the • Methods of Sterilization
Have you ever wondered how steam kills mi- reader learns that studies investigating the • Packaging
croorganisms or how many microorganisms microbial load present on used instruments • Monitoring of Sterilizers
typically contaminate a reusable surgical in- have found a relatively low level of organ- • Quality Control
strument when it arrives in decontam? The isms. A variety of studies are referenced to • Reuse of Single-Use Medical Devices
guideline provides an overview of methods facilitate further research on this topic. Let’s look at a short sampling from some of
of sterilization (steam, flash, ethylene oxide, While bioburden may be relatively low, these categories to get a flavor for the type
hydrogen peroxide and peracetic acid), in- other studies have determined that con- and specificity of the recommendations. The
cluding a discussion of the microbicidal ac- taminating salts and serum can negatively Occupational Health and Exposure section in-
tivity, mode of action, and uses of each impact the efficacy of sterilization, reinforc- cludes a recommendation, rated as Category
method. ing the need for meticulous cleaning before IC and Category II, to “educate health-care
The guideline states that steam sterilization sterilization. A theme stressed throughout workers in the selection and proper use of
is the preferred method for heat resistant items the guideline is that healthcare facilities personal protective equipment (PPE).” The
“because it has the largest margin of safety should develop protocols for adequate High-Level Disinfection of Endoscopes section
due to its reliability, consistency, and lethal- cleaning of contaminated devices, includ- includes a Category 1A recommendation that
ity.”
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Microorganisms are destroyed during ing narrow-lumened devices, to ensure the the endoscope be meticulously cleaned with
exposure to moist heat “by the irreversible co- sterilization process is not compromised. a compatible enzymatic cleaner immediately
agulation and denaturation of enzymes and As would be expected, the guideline com- after use. A Category 1B recommendation in
structural proteins.”
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ments on sterilization monitoring. Consistent the Flash Sterilization section states “Do not
A detailed discussion of low-temperature with AAMI and AORN recommended prac- flash sterilize implanted surgical devices un-
sterilization methods is included in the guide- tices, the guideline states that sterilization pro- less doing so is unavoidable.”
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line and a table summarizing the advantages cesses “should be monitored routinely by us- In the Methods of Sterilization section, there
and disadvantages of sterilization methods is ing a combination of mechanical, chemical, are recommendations reminding the reader
a helpful reference. The discussion about eth- and biological indicators to evaluate the ster- that “steam is the preferred method for steril-
ylene oxide (EO), used to “sterilize critical ilization conditions and indirectly the micro- izing critical medical and surgical instruments
items (and sometimes semicritical items) that biologic status of the processed items.”
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Pro- that are not damaged by heat, steam pressure,
are moisture or heat sensitive and cannot be viding rationale to support the use of biologi- or moisture” (Category IA), to completely
sterilized by steam sterilization”
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includes a cal indicators, the guideline goes on to state: aerate items that have been ethylene oxide
review of both 100% EO and the various EO “Biological indicators are the only process in- sterilized (Category IB), and to use items that
gas mixtures, along with reminders about the dicators that directly monitor the lethality of have been sterilized by the peracetic acid im-
toxicity of EO and the need for aeration to re- a given sterilization process. Spores used to mersion process immediately (Category II).
move residual EO from sterilized items. A de- monitor a sterilization process have demon- In the Monitoring of Sterilizers section, the
scription of the hydrogen peroxide gas plasma strated resistance to the sterilizing agent and use of BIs in every load containing implant-
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See SELF-STUDY on page 28
Recommendations - CDC system for categorizing recommendations
Category IA Category IB Category IC Category II
Strongly recommended for Strongly recommended for implementation Required by state or federal Suggested for implementation and
implementation and strongly supported and strongly supported by some experimental, regulations. supported by suggestive clinical or
by well-designed experimental, clinical, clinical, or epidemiologic studies, and by a epidemiologic studies or by a theoretical
or epidemiologic studies. strong theoretical rationale. rationale.
No recommendation
Unresolved issue. These include practices for which insufficient evidence or no consensus exists regarding efficacy.
est Answers: 1. A, 2. A, 3. B, 4. A, 5. A, 6. A, 7. B, 8. A, 9. A, 10. A Self-T
www.hpnonline.com • HEALTHCARE PURCHASING NEWS August 2009 27
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