H E A LT H C A R E E P I D E M I O L O G Y INVITED ARTICLE

Robert A. Weinstein, Section Editor

Disinfection and Sterilization in Health Care Facilities:

What Clinicians Need to Know
William A. Rutala and David J. Weber

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Hospital Epidemiology, University of North Carolina Health Care System, and Division of Infectious Diseases, University of North Carolina School of Medicine,
Chapel Hill

All invasive procedures involve contact between a medical device or surgical instrument and a patient’s sterile tissue or
mucous membranes. A major risk of all such procedures is the introduction of pathogenic microbes that could lead to
infection. Failure to properly disinfect or sterilize reusable medical equipment carries a risk associated with breach of the
host barriers. The level of disinfection or sterilization is dependent on the intended use of the object: critical items (such as
surgical instruments, which contact sterile tissue), semicritical items (such as endoscopes, which contact mucous membranes),
and noncritical items (such as stethoscopes, which contact only intact skin) require sterilization, high-level disinfection, and
low-level disinfection, respectively. Cleaning must always precede high-level disinfection and sterilization. Users must consider
the advantages and disadvantages of specific methods when choosing a disinfection or sterilization process. Adherence to
these recommendations should improve disinfection and sterilization practices in health care facilities, thereby reducing
infections associated with contaminated patient-care items.

In 1996 in the United States, ∼46,500,000 surgical procedures of compliance with established guidelines for disinfection and
and an even larger number of invasive medical procedures were sterilization [2, 3]. Failure to comply with scientifically based
performed [1]. For example, ∼5 million gastrointestinal en- guidelines has led to numerous outbreaks of infection [3–7].
doscopies are performed per year [1]. Each of these procedures In this article, a pragmatic approach to the judicious selection
involves contact by a medical device or surgical instrument and proper use of disinfection and sterilization processes is
with a patient’s sterile tissue or mucous membranes. A major presented that is based on the results of well-designed studies
risk of all such procedures is the introduction of pathogenic assessing the efficacy (via laboratory investigations) and effec-
microbes, which can lead to infection. For example, failure to tiveness (via clinical studies) of disinfection and sterilization
properly disinfect or sterilize equipment may lead to person- procedures.
to-person transmission via contaminated devices (e.g., Myco-
bacterium tuberculosis–contaminated bronchoscopes). A RATIONAL APPROACH TO DISINFECTION
Achieving disinfection and sterilization through the use of AND STERILIZATION
disinfectants and sterilization practices is essential for ensuring
More than 35 years ago, Spaulding [8] devised a rational ap-
that medical and surgical instruments do not transmit infec-
proach to disinfection and sterilization of patient-care items or
tious pathogens to patients. Because it is not necessary to ster-
equipment. This classification scheme is so clear and logical
ilize all patient-care items, health care policies must identify
that it has been retained, refined, and successfully used by in-
whether cleaning, disinfection, or sterilization is indicated, pri-
fection-control professionals and others when planning meth-
marily on the basis of each item’s intended use.
ods for disinfection or sterilization [9–15]. Spaulding believed
Multiple studies in many countries have documented lack
that the nature of disinfection could be understood more read-
ily if instruments and items for patient care were divided into
Received 15 March 2004; accepted 5 May 2004; electronically published 12 August 2004.
Reprints or correspondence: Dr. William A. Rutala, Div. of Infectious Diseases, 130 Mason
3 categories—namely, critical, semicritical, and noncritical—
Farm Rd., Bioinformatics, University of North Carolina at Chapel Hill, Chapel Hill, NC 27599- on the basis of the degree of risk of infection involved in the
7030 ([email protected]).
use of the items. This terminology is employed by the Centers
Clinical Infectious Diseases 2004; 39:702–9
 2004 by the Infectious Diseases Society of America. All rights reserved.
for Disease Control and Prevention (CDC) in the documents
1058-4838/2004/3905-0015$15.00 “Guidelines for Environmental Infection Control in Health-

702 • CID 2004:39 (1 September) • HEALTHCARE EPIDEMIOLOGY

Care Facilities” [16] and “Guideline for Disinfection and Ster- 1.93% phenol/phenate, 7.5% stabilized hydrogen peroxide,
ilization in Healthcare Facilities” [14]. 7.35% hydrogen peroxide with 0.23% peracetic acid, ⭓0.2%
Critical items. Critical items are those associated with a peracetic acid, and 1.0% hydrogen peroxide with 0.08% per-
high risk of infection if the item is contaminated with any acetic acid. The indicated exposure times are within the range
microorganism, including bacterial spores. Thus, sterilization 3–12 h, with the exception of ⭓0.2% peracetic acid (sporicidal
of objects that enter sterile tissue or the vascular system is time of 12 min at 50C–56C) [19]. Use of liquid chemical
critical, because any microbial contamination could result in sterilants is a reliable method of sterilization only if cleaning
disease transmission. This category includes surgical instru- precedes treatment, which eliminates organic and inorganic
ments, cardiac and urinary catheters, implants, and ultrasound material, and if the proper guidelines for concentration, contact
probes used in sterile body cavities. The items in this category time, temperature, and pH are followed. Another limitation to
should be purchased as sterile or should be sterilized by steam sterilization of devices with liquid chemical sterilants is that the

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sterilization, if possible. If the item is heat sensitive, it may be devices cannot be wrapped during processing in the liquid
treated with ethylene oxide (ETO) or hydrogen peroxide gas chemical sterilant; thus, maintaining sterility after processing
plasma or with liquid chemical sterilants if other methods are and during storage is impossible. Furthermore, after exposure
unsuitable. Tables 1 and 2 list several germicides that are cat- to the liquid chemical sterilant, devices may require rinsing
egorized as chemical sterilants. These include ⭓2.4% glutar- with water that, in general, is not sterile. Therefore, because of
aldehyde–based formulations, 1.12% glutaraldehyde with the inherent limitations of the use of liquid chemical sterilants

Table 1. Methods for disinfection and sterilization of patient-care items and environmental surfaces.

Process, method Level of microbial inactivation Example(s) (processing time) Health care application (example)
Sterilization
High temperature Destroys all microorganisms, Steam (∼40 min) and dry heat (1–6 h, Heat-tolerant critical (surgical instru-
including bacterial spores depending on temperature) ments) and semicritical patient-care
items
Low temperature Destroys all microorganisms, ETO gas (∼15 h) and hydrogen perox- Heat-sensitive critical and semicritical
including bacterial spores ide gas plasma (∼50 min) patient-care items
a
Liquid immersion Destroys all microorganisms, Chemical sterilants: ⭓2.4% glut (∼10 Heat-sensitive critical and semicritical
including bacterial spores h), 1.12% glut and 1.93% phenol patient-care items that can be
(12 h), 7.35% HP and 0.23% PA (3 immersed
h), 7.5% HP (6 h), 1.0% HP and
0.08% PA (8 h), and ⭓0.2% PA
(∼50 min at 50C–56C)
High-level disinfection
Heat automated Destroys all microorganisms except Pasteurization (∼50 min) Heat-sensitive semicritical patient-
high numbers of bacterial spores care items (respiratory-therapy
equipment)
Liquid immersion Destroys all microorganisms except Chemical sterilants or high-level disin- Heat-sensitive semicritical patient-
a
high numbers of bacterial spores fectants: 12% glut (20–45 min), care items (GI endoscopes and
0.55% OPA (12 min), 1.12% glut bronchoscopes)
and 1.93% phenol (20 min), 7.35%
HP and 0.23% PA (15 min), 7.5%
HP (30 min), 1.0% HP and 0.08%
PA (25 min), and 650–675 ppm
chlorine (10 min)
Intermediate-level disinfection, Destroys vegetative bacteria, myco- EPA-registered hospital disinfectants Noncritical patient-care items (blood-
liquid contact bacteria, most viruses, and most with label claiming tuberculocidal pressure cuff) or surfaces (bedside
fungi but not bacterial spores activity, such as chlorine-based table), with visible blood
products and phenolics (at least 60
s)
Low-level disinfection, Destroys vegetative bacteria and EPA-registered hospital disinfectants Noncritical patient-care items (blood-
liquid contact some fungi and viruses but not with no tuberculocidal claim, such pressure cuff) or surfaces (bedside
mycobacteria or spores as chlorine-based products, phenol- table), with no visible blood
ics, and quaternary ammonium
compounds (at least 60 s), or 70%–
90% alcohol

NOTE. Modified from [13], [14], and [17]. AER, automated endoscope reprocessing; EPA, Environmental Protection Agency; ETO, ethylene oxide; FDA,
US Food and Drug Administration; GI, gastrointestinal; glut, glutaraldehyde; HP, hydrogen peroxide; PA, peracetic acid; OPA, ortho-phthalaldehyde.
a
Consult FDA-cleared package inserts for information about FDA-cleared contact time and temperature; see text for discussion of why one product (2%
glut) is used at reduced exposure (20 min at 20C). Increasing the temperature by using AER will reduce the contact time (e.g., for OPA, 12 min at 20C, but
5 min at 25C in AER). Tubing must be completely filled for high-level disinfection and liquid chemical sterilization. Compatibility of material should be investigated
when appropriate (e.g., HP and HP with PA will cause functional damage to endoscopes).

HEALTHCARE EPIDEMIOLOGY • CID 2004:39 (1 September) • 703

Table 2. Summary of advantages and disadvantages of chemical agents used as chemical sterilants or as high-level disinfectants.

Sterilization method Advantages Disadvantages

Peracetic acid and No activation required Concerns regarding compatibility with materials (lead,
hydrogen peroxide Odor or irritation not significant brass, copper, and zinc) and both cosmetic and
functional damage
Limited clinical use
Potential for eye and skin damage
Glutaraldehyde Numerous published studies of use Respiratory irritation from glutaraldehyde vapor
Relatively inexpensive Pungent and irritating odor
Excellent compatibility with materials Relatively slow mycobactericidal activity
Coagulates blood and fixes tissue to surfaces
Allergic contact dermatitis
Hydrogen peroxide No activation required Concerns regarding compatibility with materials (brass,

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May enhance removal of organic material and organisms zinc, copper, and nickel/silver plating) and both
No disposal issues cosmetic and functional damage
No odor or irritation issues Serious eye damage with contact
Does not coagulate blood or fix tissues to surfaces
Inactivates Cryptosporidium
Published studies of use
Ortho-phthalaldehyde Fast-acting high-level disinfectant Stains protein gray (e.g., skin, mucous membranes,
No activation required clothing, and environmental surfaces)
Odor not significant Limited clinical use
Claim of excellent compatibility with materials More expensive than glutaraldehyde
Claim of not coagulating blood or fixing tissues to Eye irritation with contact
surfaces Slow sporicidal activity
Repeated exposure may result in hypersensitivity in
some patients with bladder cancer
Peracetic acid Rapid sterilization cycle time (30–45 min) Potential incompatibility with materials (e.g., aluminum
Low-temperature (50C–55C) liquid-immersion anodized coating becomes dull)
sterilization Used for immersible instruments only
Environmentally friendly by-products (acetic acid, O2, and Biological indicator may not be suitable for routine
H2O) monitoring
Fully automated Only one scope or a small number of instruments can
Single-use system eliminates need for concentration be processed in a cycle
testing More expensive (endoscope repairs, operating costs, and
Standardized cycle purchase costs) than high-level disinfection
May enhance removal of organic material and endotoxin Serious eye and skin damage (concentrated solution)
No adverse health effects to operators, under normal with contact
operating conditions Point-of-use system; no sterile storage
Compatible with many materials and instruments
Does not coagulate blood or fix tissues to surfaces
Sterilant flows through scope, facilitating salt, protein,
and microbe removal
Rapidly sporicidal
Provides procedure standardization (constant dilution,
perfusion of channel, temperatures, and exposure)

NOTE. Modified from [18]. All products are effective in the presence of organic soil, are relatively easy to use, and have a broad spectrum of antimicrobial
activity (bacteria, fungi, viruses, bacterial spores, and mycobacteria). The above characteristics are documented in the literature; contact the manufacturer of the
instrument and sterilant for additional information. All products listed have been cleared by the US Food and Drug Administration (FDA) as chemical sterilants,
except for ortho-phthalaldehyde, which is an FDA-cleared high-level disinfectant.

in a nonautomated reprocessor, their use should be restricted common bacterial spores but are susceptible to other organ-
to reprocessing critical devices that are heat sensitive and in- isms, such as bacteria, mycobacteria, and viruses. The mini-
compatible with other sterilization methods. mum requirement for semicritical items is high-level disinfec-
Semicritical items. Semicritical items are those that come tion using chemical disinfectants. Glutaraldehyde, hydrogen
in contact with mucous membranes or nonintact skin. Respi- peroxide, ortho-phthalaldehyde (OPA), peracetic acid with hy-
ratory-therapy and anesthesia equipment, some endoscopes, drogen peroxide, and chlorine have been cleared by the US
laryngoscope blades, esophageal manometry probes, anorectal Food and Drug Administration (FDA) [19] and are dependable
manometry catheters, and diaphragm-fitting rings are included high-level disinfectants when guidelines for effective germicidal
in this category. These medical devices should be free of all procedures are followed (tables 1 and 2). The exposure time
microorganisms (i.e., mycobacteria, fungi, viruses, and bacte- for most high-level disinfectants varies from 10 to 45 min, at
ria), although small numbers of bacterial spores may be present. 20C–25C. Outbreaks of infection continue to occur when
In general, intact mucous membranes, such as those of the ineffective disinfectants, including iodophor, alcohol, and over-
lungs or the gastrointestinal tract, are resistant to infection by diluted glutaraldehyde [5], are used for so-called high-level

704 • CID 2004:39 (1 September) • HEALTHCARE EPIDEMIOLOGY

disinfection. When a disinfectant is selected for use with certain million procedures) [24], more health care–associated out-
patient-care items, the chemical compatibility after extended breaks of infection have been linked to contaminated endo-
use with the items to be disinfected must also be considered. scopes than to any other medical device [3–5]. To prevent the
For example, compatibility testing by Olympus America of spread of health care–associated infection, all heat-sensitive en-
7.5% hydrogen peroxide showed cosmetic and functional doscopes (e.g., gastrointestinal endoscopes, bronchoscopes, and
changes in the tested endoscopes (Olympus America, personal nasopharyngoscopes) must be properly cleaned and, at a min-
communication). Similarly, Olympus America does not endorse imum, subjected to high-level disinfection after each use. High-
the use of products containing hydrogen peroxide with pera- level disinfection can be expected to destroy all microorganisms,
cetic acid, because of cosmetic and functional damage (Olym- although a few bacterial spores may survive when high numbers
pus America, personal communication). of spores are present.
Semicritical items that will have contact with the mucous Recommendations for the cleaning and disinfection of en-

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membranes of the respiratory or gastrointestinal tract should doscopic equipment have been published and should be strictly
be rinsed with sterile water, filtered water, or tap water, followed followed [14, 20]. Unfortunately, audits have shown that per-
by an alcohol rinse [14, 20, 21]. An alcohol rinse and forced- sonnel do not adhere to guidelines on reprocessing [25–27]
air drying markedly reduces the likelihood of contamination and that outbreaks of infection continue to occur [28, 29]. To
of the instrument (e.g., endoscopes), most likely by eliminating ensure that the personnel responsible for reprocessing are prop-
the wet environment favorable to bacterial growth [21]. After erly trained, initial and annual competency testing should be
rinsing, items should be dried and then stored in a manner required for each individual who is involved in reprocessing
that protects them from damage or contamination. There is endoscopic instruments [14, 20, 21, 30].
no recommendation to use sterile or filtered water, rather than In general, endoscope disinfection or sterilization with a liq-
tap water, for rinsing semicritical equipment that will have uid chemical sterilant or high-level disinfectant involves the
contact with the mucous membranes of the rectum (e.g., rectal following 5 steps, which should be performed after leak testing:
probes or anoscopes) or vagina (e.g., vaginal probes) [14]. (1) clean: mechanically clean internal and external surfaces,
Noncritical items. Noncritical items are those that come including brushing internal channels and flushing each internal
in contact with intact skin but not mucous membranes. Intact channel with water and an enzymatic cleaner; (2) disinfect:
skin acts as an effective barrier to most microorganisms; there- immerse endoscope in high-level disinfectant (or chemical ster-
fore, the sterility of items coming in contact with intact skin ilant), perfuse disinfectant (which eliminates air pockets and
is “not critical.” Examples of noncritical items are bedpans, ensures contact of the germicide with the internal channels)
blood-pressure cuffs, crutches, bed rails, linens, bedside tables, into all accessible channels, such as the suction/biopsy channel
patient furniture, and floors. In contrast to critical and some
and the air/water channel, and expose endoscope for the time
semicritical items, most noncritical reusable items may be de-
recommended for specific products; (3) rinse: rinse the en-
contaminated where they are used and do not need to be trans-
doscope and all channels with sterile water, filtered water (com-
ported to a central processing area. There is virtually no doc-
monly used with automated endoscope reprocessors), or tap
umented risk of transmitting infectious agents to patients via
water; (4) dry: rinse the insertion tube and inner channels with
noncritical items [22] when they are used as noncritical items
alcohol and dry with forced air, after disinfection and before
and do not contact nonintact skin and/or mucous membranes.
storage; and (5) store: store the endoscope in a way that
However, these items (e.g., bedside tables or bed rails) could
prevents recontamination and promotes drying (e.g., hung
potentially contribute to secondary transmission, by contam-
vertically).
inating the hands of health care workers or by contact with
Unfortunately, there is poor compliance with the recom-
medical equipment that will subsequently come in contact with
mendations for reprocessing endoscopes. In addition, in rare
patients [23]. Table 1 lists several low-level disinfectants that
instances, the scientific literature and recommendations from
may be used for noncritical items. The exposure times for these
professional organizations regarding the use of disinfectants
disinfectants are 60 s or longer.
and sterilants may differ from claims on the manufacturer’s
label. One example is the contact time used to achieve high-
CURRENT ISSUES IN DISINFECTION
level disinfection with 2% glutaraldehyde. On the basis of FDA
AND STERILIZATION
requirements (the FDA regulates liquid sterilants and high-level
Reprocessing of endoscopes. Physicians use endoscopes to disinfectants used on critical and semicritical medical devices),
diagnose and treat numerous medical disorders. Although en- manufacturers test the efficacy of their germicide formulations
doscopes are a valuable diagnostic and therapeutic tool in mod- under worst-case conditions (i.e., minimum recommended
ern medicine and although the incidence of infection associated concentration of the active ingredient) and in the presence of
with their use has been reported to be very low (∼1 in 1.8 organic soil (typically, 5% serum). The soil represents the or-

HEALTHCARE EPIDEMIOLOGY • CID 2004:39 (1 September) • 705

ganic loading to which the device is exposed during actual use (e.g., immerse in 1N NaOH for 1 h, remove and rinse in water,
and that would remain on the device in the absence of cleaning. and then transfer to an open pan for autoclaving for 1 h [at
These stringent test conditions are designed to provide a margin 121C in a gravity displacement sterilizer or at 134C in a
of safety, by assuring that the contact conditions for the ger- porous or prevacuum sterilizer]); autoclaving for 18 min at
micide provide complete elimination of the test bacteria (e.g., 134C in a prevacuum sterilizer; or autoclaving for 1 h at 132C
105–106 cfu M. tuberculosis in organic soil and dried on a scope) in a gravity displacement sterilizer) [14, 37]. The temperature
if inoculated into the most difficult areas for the disinfectant should not exceed 134C, because the effectiveness of auto-
to penetrate and in the absence of cleaning. However, the sci- claving may decline as the temperature is increased (e.g., to
entific data demonstrate that M. tuberculosis levels can be re- 136C or 138C) [38]. Prion-contaminated medical devices that
duced by at least 8 log10 cfu with cleaning (reduction of 4 log10 are impossible or difficult to clean should be discarded. Flash
cfu) followed by chemical disinfection for 20 min at 20C (re- sterilization (i.e., steam sterilization of an unwrapped item for

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duction of 4–6 log10 cfu) [14, 15, 19, 20, 31]. Because of these 3 min at 132C) should not be used for reprocessing. To min-
data, professional organizations (at least 14 worldwide) that imize environmental contamination, noncritical environmental
have endorsed an endoscope-reprocessing guideline recom- surfaces should be covered with plastic-backed paper; when
mend contact with 2% glutaraldehyde for 20 min (or !20 min contaminated with high-risk tissues, the paper should be prop-
outside the United States) at 20C to achieve high-level dis- erly discarded. Noncritical environmental surfaces (e.g., labo-
infection, which differs from the recommendation given on the ratory surfaces) contaminated with high-risk tissues should be
manufacturer’s label [20, 32–34]. cleaned and then spot decontaminated with a 1:10 dilution of
It is important to emphasize that the FDA tests do not in- hypochlorite solution [37].
clude cleaning, a critical component of the disinfection process. Emerging pathogens, antibiotic-resistant bacteria, and bio-
When cleaning has been included in the test methodology, terrorism agents. Emerging pathogens are of growing con-
contact with 2% glutaraldehyde for 20 min has been demon- cern to the general public and infection-control professionals.
strated to be effective in eliminating all vegetative bacteria. Relevant pathogens include Cryptosporidium parvum, Helico-
Inactivation of Creutzfeldt-Jakob disease (CJD) agent. bacter pylori, Escherichia coli O157:H7, HIV, hepatitis C virus,
CJD is a degenerative neurologic disorder in humans, with an rotavirus, multidrug-resistant M. tuberculosis, human papillo-
incidence in the United States of ∼1 case/million population/ mavirus, and nontuberculosis mycobacteria (e.g., Mycobacte-
year [35]. CJD is thought to be caused by a proteinaceous rium chelonae). Similarly, recent publications have highlighted
infectious agent, or prion. CJD is related to other human trans- concern about the potential for biological terrorism [39]. The
missible spongiform encephalopathies (TSEs), such as kuru CDC has categorized several agents as “high priority” because
(now eradicated), Gertsmann-Straussler-Sheinker syndrome (1 they can be easily disseminated or transmitted by person-to-
case/40 million population/year), and fatal insomnia syndrome person contact, can cause high mortality, and are likely to cause
(!1 case/40 million population/year). The agents of CJD and public panic and social disruption [40]. These agents include
other TSEs exhibit an unusual resistance to conventional chem- Bacillus anthracis (anthrax), Yersinia pestis (plague), variola
ical and physical decontamination methods. Because the CJD major (smallpox), Francisella tularensis (tularemia), filoviruses
agent is not readily inactivated by conventional disinfection (Ebola and Marburg [hemorrhagic fever]), and arenaviruses
and sterilization procedures and because of the invariably fatal (Lassa [Lassa fever] and Junin [Argentine hemorrhagic fever])
outcome of CJD, the procedures for disinfection and sterili- and related viruses [40].
zation of the CJD prion have been both conservative and con- With rare exceptions (e.g., human papillomavirus), the sus-
troversial for many years. ceptibility of each of these pathogens to chemical disinfectants
The current recommendations consider inactivation data but or sterilants has been studied, and all of these pathogens (or
also use epidemiological studies of prion transmission, infec- surrogate microbes, such as feline calicivirus for Norwalk virus,
tivity of human tissues, and efficacy of removing proteins by vaccinia for variola [41], and Bacillus atrophaeus [formerly Ba-
cleaning. On the basis of scientific data, only critical devices cillus subtilis] for B. anthracis) have been found to be susceptible
(e.g., surgical instruments) and semicritical devices contami- to currently available chemical disinfectants or sterilants [42].
nated with high-risk tissue (i.e., brain, spinal cord, or eye tissue) Standard sterilization and disinfection procedures for patient-
from high-risk patients (e.g., known or suspected infection with care equipment (as recommended in this article) are adequate
CJD or other prion disease) require special prion reprocessing. for sterilization or disinfection of instruments or devices con-
When high-risk tissues, high-risk patients, and critical or sem- taminated with blood or other body fluids from persons in-
icritical medical devices are involved, one of the following fected with bloodborne pathogens, emerging pathogens, or
methods should be used: cleaning of the device and sterilization bioterrorism agents, with the exception of prions (see previous
using a combination of sodium hydroxide and autoclaving [36] section). No changes in procedures for cleaning, disinfecting,

706 • CID 2004:39 (1 September) • HEALTHCARE EPIDEMIOLOGY

Table 3. Summary of advantages and disadvantages of commonly used sterilization technologies.

Sterilization method Advantages Disadvantages

Steam Nontoxic to patient, staff, and environment Deleterious for heat-sensitive instruments
Cycle is easy to control and monitor Microsurgical instruments damaged by repeated
Rapidly microbicidal exposure
Least affected by organic/inorganic soils, among steriliza- May leave instruments wet, causing them to rust
tion processes listed Potential for burns
Rapid cycle time
Penetrates medical packing and device lumens
Hydrogen peroxide gas plasma Safe for the environment Cellulose (paper), linens, and liquids cannot be processed
Leaves no toxic residuals Sterilization chamber is small (∼3.5–7.3 ft3)
Cycle time is 45–73 min, and no aeration is necessary Endoscope or medical-device restrictions based on lu-
Used for heat- and moisture-sensitive items, because men internal diameter and length (see manufacturer’s
process temperature is !50C recommendations)

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Equipment is simple to operate, install (208 V outlet), Requires synthetic packaging (polypropylene wraps or
and monitor polyolefin pouches) or special container tray
Compatible with most medical devices Hydrogen peroxide may be toxic at levels 11 ppm TWA
Equipment requires electrical outlet only
100% ETO Penetrates packaging materials and device lumens Requires aeration time to remove ETO residue
Single-dose cartridge and negative-pressure chamber Sterilization chamber is small (∼4–8.8 ft3)
minimizes the potential for gas leak and ETO exposure ETO is toxic, a carcinogen, and flammable
Equipment is simple to operate and monitor ETO emission regulated by states, but catalytic cell re-
Compatible with most medical materials moves 99.9% of ETO and converts it to CO2 and H2O
ETO cartridges should be stored in flammable liquid–
storage cabinet
Lengthy cycle and aeration time
a
ETO mixture Penetrates medical packaging and many plastics Some states (e.g., CA, NY, and MI) require ETO-emission
Compatible with most medical materials reduction of 90%–99.9%
Cycle is easy to control and monitor CFC (inert gas that eliminates explosion hazard) banned
in 1995
Potential hazards to staff and patients
Lengthy cycle and aeration time
ETO is toxic, a carcinogen, and flammable
Peracetic acid Rapid cycle time (30–45 min) Point-of-use system; no sterile storage
Low-temperature (50C–55C) liquid-immersion Biological indicator may not be suitable for routine
sterilization monitoring
Environmentally friendly by-products Used for immersible instruments only
Sterilant flows through endoscope, which facilitates salt, Some incompatibility with materials (e.g., aluminum
protein, and microbe removal anodized coating becomes dull)
Only 1 scope or a small number of instruments
processed in a cycle
Potential for serious eye and skin damage (concentrated
solution) with contact
Must use connector between system and scope to
ensure infusion of sterilant to all channels

NOTE. Modified from [46]. CFC, chlorofluorocarbon; ETO, ethylene oxide; HCFC, hydrochlorofluorocarbon; TWA, time-weighted average.
a
8.6% ETO and 91.4% HCFC; 10% ETO and 90% HCFC; or 8.5% ETO and 91.5% CO2.

or sterilizing need to be made [14, 15]. In addition, there are log10 in 5 min), when compared with glutaraldehyde. The ad-
no data to show that antibiotic-resistant bacteria (e.g., meth- vantages, disadvantages, and characteristics of OPA are listed
icillin-resistant Staphylococcus aureus, vancomycin-resistant En- in table 2 [15].
terococcus faecium, and multidrug-resistant M. tuberculosis) are The FDA recently cleared a liquid high-level disinfectant (su-
less sensitive to liquid chemical germicides than are antibiotic- peroxidized water) that contains 650–675 ppm free chlorine
sensitive bacteria at currently used germicide contact conditions and a new sterilization system using ozone. Because there are
and concentrations [15, 43, 44]. limited data in the scientific literature for assessing the anti-
Advances in disinfection and sterilization methods. In microbial activity or material compatibility of these processes,
the past several years, new methods of disinfection and ster- they have not yet been integrated into clinical practice in the
ilization have been introduced in health care settings. OPA is United States [14].
a chemical sterilant that received FDA clearance in October Several methods are used to sterilize patient-care items in
1999. It contains 0.55% 1,2-benzenedicarboxaldehyde. In vitro health care, including steam sterilization, ETO, hydrogen per-
studies have demonstrated excellent microbicidal activity [14, oxide gas plasma, and a peracetic acid–immersion system. The
15]. For example, Gregory et al. [45] demonstrated that OPA advantages and disadvantages of these systems are listed in table
has shown superior mycobactericidal activity (reduction of 5 3 [14].

HEALTHCARE EPIDEMIOLOGY • CID 2004:39 (1 September) • 707

 New sterilization technology based on plasma was patented 7. Lowry PW, Jarvis WR, Oberle AD, et al. Mycobacterium chelonae caus-
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