Knowledge for Clinical Practice WWW.DENTALLEARNING.NET A PEER-REVIEWED PUBLICATION D ENTAL L EARNING Instrument Processing for Infection Prevention Fiona M. Collins, BDS, MBA, MA Inside earn 3 CE Credits Written for dentists, hygienists and assistants Integrated Media Solutions Inc./DentalLearning.net is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. Integrated Media Solutions Inc./Dental Learning.net designates this activity for 3 continuing education credits. Approved PACE Program Provider FAGD/MAGD Credit Approval does not imply acceptance by a state or provincial board of dentistry or AGD endorsement. 2/1/2016 - 1/31/2020 Provider ID: # 346890 AGD Subject Code: 148 Dental Learning, LLC is a Dental Board of California CE Provider. The California Provider # is RP5062. All of the information contained on this certificate is truthful and accurate. Completion of this course does not constitute authorization for the attendee to perform any ser- vices that he or she is not legally authorized to perform based on his or her license or permit type. This course meets the Dental Board of California’s requirements for 3 units of continuing education. CA course code is 03-5062-15029
Transcript
Knowledge for Clinical Practice
WWW.DENTALLEARNING.NET
A PEER-REVIEWED PUBLICATION
DENTAL LEARNING
Instrument Processing for Infection PreventionFiona M. Collins, BDS, MBA, MA
Inside earn
3 CE CreditsWritten for dentists, hygienists and assistants
Integrated Media Solutions Inc./DentalLearning.net is an ADA CERP Recognized Provider. ADA CERP is a service of the American Dental Association to assist dental professionals in identifying quality providers of continuing dental education. ADA CERP does not approve or endorse individual courses or instructors, nor does it imply acceptance of credit hours by boards of dentistry. Concerns or complaints about a CE provider may be directed to the provider or to ADA CERP at www.ada.org/cerp. Integrated Media Solutions Inc./Dental Learning.net designates this activity for 3 continuing education credits.
Approved PACE Program Provider FAGD/MAGD Credit Approval does not imply acceptance by a state or provincial board of dentistry or AGD endorsement.2/1/2016 - 1/31/2020Provider ID: # 346890AGD Subject Code: 148
Dental Learning, LLC is a Dental Board of California CE Provider. The California Provider # is RP5062. All of the information contained on this certificate is truthful and accurate. Completion of this course does not constitute authorization for the attendee to perform any ser-vices that he or she is not legally authorized to perform based on his or her license or permit type. This course meets the Dental Board of California’s requirements for 3 units of continuing education. CA course code is 03-5062-15029
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DENTAL LEARNING
EDUCATIONAL OBJECTIVES
The overall objective of this article is to provide the reader with information on instrument processing. On completing this article, the reader will be able to do the following:
1. Define the elements of the chain of infection;
2. Delineate and describe the differences in the processing of critical, semicritical and noncritical instruments;
3. Review the use of presoaks and cleaning of instruments;
4. List and describe heat sterilization options and appropriate sterilization packaging; and,
5. Review the uses and purposes of chemical and biological indicators.
Safe and effective instrument processing is a key element of the infection prevention cycle. This process must meet CDC guide-lines and OSHA requirements. The steps in instrument processing include cleaning and sterilizing the instruments. Their treatment depends on whether they are critical, semicritical or noncritical. Critical and heat-resistant critical instruments must be heat-sterilized, and handpieces must be autoclaved. Prior to heat sterilization, instruments are wrapped in appropriate FDA-cleared sterilization packaging, which must include chemical indicators. Sterilization processes must be tested for sterility assurance and all sterilization records maintained.
ABSTRACT
3JUNE 2012
Introduction
Infection prevention is one of the key mandates in the dental office, required to protect clinicians and other dental healthcare workers, patients, dental laboratory
personnel and, at a macrolevel, the community. In order to prevent cross-contamination and disease transmission, the chain of infection must be broken and a rigorous infec-tion prevention protocol followed. The chain of infection consists of five elements: the presence of a pathogen at a sufficiently high concentration to cause disease, a source/reservoir for that pathogen, a mode of transmission, an entry portal in the host and a susceptible host. (Figure 1) The tenet “Do no harm” is as applicable to the infection prevention cycle as to any other aspect of clinical care. This cycle consists of steps repeated sequentially during the day – prior to individual patient care, during patient care, im-mediately following patient care and at the end of the day after the last patient has been seen. Examples include the use of protective barriers on clinical contact surfaces and donning of personal protective equipment prior to patient care, and the use of single-use disposables and instrument cassettes during patient care. The focus of this article is on instrument processing and the associated protocols that must be followed.
Instrument Processing Instrument processing is a key component of the infec-
tion prevention cycle, addressed in the Centers for Disease Control and Prevention (CDC) 2003 guidelines for infec-tion control in dental healthcare settings.1 Although the CDC later expanded the standard precautions in its isola-tion guidelines for healthcare settings to address highly transmissible diseases and specific pathogens,2 this did not introduce any additional procedures with respect to instru-ment processing in the dental setting.3
The overall goal of instrument processing is to provide sterile instruments for all patient care. Used instruments
are relevant to every element of the chain of infection. They may contain a sufficiently high level of a given patho-gen to transmit disease, serve as sources/reservoirs for pathogens, offer multiple modes of transmission through indirect and direct contact, are relevant to several portals of entry and then only require a susceptible host to com-plete the chain. Inadequately processed instruments place patients, dental professionals and other dental healthcare workers at risk.
Instrument processing involves a number of pre-scribed, systematic steps that consider occupational safety, types of instruments, required instrument process-ing equipment and supplies, sterilization assurance, and instrument inventory management. Instrument process-ing should occur in a specific location that is segregated into “dirty” and “clean” areas, with instruments being received in the dirty area and moving unidirectionally as
Instrument Processing for Infection Prevention
Figure 1. Chain of infection
The Chain of Infection
Reservoir (source)
Pathogen at a Sufficient
Level
Susceptible Host
Portal of Entry
Mode of Transmission
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they are processed. Designating dirty and clean areas with a unidirectional flow avoids the risk of confusing sterile and contaminated instruments, which could result in recontamination of sterile instruments by newly received contaminated instruments and/or the use of contaminated instruments that had not been processed.
Safe Instrument ProcessingOccupational safety must be ensured during instrument
processing to protect the operator from the risk of sharps injuries and contact with contaminated instruments, spat-ter and chemicals. Wearing heavy-duty utility gloves,4 a face mask and protective eyewear is required during opera-tory cleanup and instrument processing. (Figure 2) Medi-cal and surgical gloves are never indicated for instrument processing; the person performing this must remove and discard any medical or surgical gloves worn, perform hand hygiene and don heavy-duty utility gloves to reduce the risk of injury.
Sharps disposalDisposing of sharps chairside, prior to transporting
instruments in closed cassettes/trays to the process-ing area, reduces the risk of sharps injuries, which is
well-documented.5 The sharps container must be color-coded and puncture-resistant, have a rigid base and walls, and be capable of being securely closed.6 Capped syringe needles, disposable all-in-one syringes, dispos-able scalpels, blades, suture needles and broken glass carpules should all be placed in the sharps container. The container should be closed, sealed and disposed of in accordance with the Occupational Safety and Health Administration (OSHA), state, local and municipal regulations.
Figure 2. Use of heavy-duty utility gloves
Attributes of safe instrument processing
• Use of heavy-duty utility gloves, masks and protective eyewear
• Disposal of sharps chairside
• Use of a sharps container
• Use of closed cassettes and instrument cages
• Separate dirty and clean processing areas
• Use of automated cleaning devices and ultrasonic baths
Figure 3. Perforated cassette and sterilization cages for instruments
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Using closed cassettes - safety and transport Using closed instrument cassettes contributes to the safe-
ty of patient care and instrument processing. Contaminated instruments transported in closed cassettes to the instru-ment processing area pose less risk of sharps injury than do instruments transported while loose on a tray.7 In addition, closed perforated cassettes can be placed in presoaks and ultrasonic cleaners or washers/disinfectors prior to packag-ing and sterilization, further reducing the risk of injury and disease transmission. Closed cassettes used for instrument processing must be perforated (Figure 3) if they are being used in an autoclave or chemclave, to allow the sterilant to penetrate the cassette and reach the instruments.
Using automated cleaning devices and ultrasonic bathsUsing automated cleaning devices and ultrasonic baths
increases safety during instrument processing compared with manual scrubbing.
Effective Instrument ProcessingThe sequential steps involved in instrument process-
ing must be properly executed each time.1 These steps are: 1) disposal of sharps; 2) transportation of contaminated instruments/cassettes/trays to the dirty receiving area of the instrument processing location; 3) sorting of instru-ments and devices; and 4) further processing of different categories of instruments, for which the process involves presoaking, cleaning, preparation/packaging, sterilization and storage.1,8
Disposal The disposal of single-use items such as disposable air/
water syringes, bibs and bib holders, and saliva ejectors and the disposal of waste may occur chairside or in the instrument processing area. Regulated medical waste (hazardous waste) must be discarded separately (or, if appropriate, first treated to render it nonhazardous), in
Figure 4. Sequential steps in effective instrument processing
Handpieces:
Remove burs, wipe exterior of
handpiece. Pre-sterilization
cleaning and maintenance.
Follow manufacturer’s instructions.**
Pouch handpieces and autoclave
Remove damaged instruments from
service
High-level liquid disinfectant/
sterilant for semi-critical
heat-sensitive instruments.*
Store in dry, closed area
Dispose of sharps chairside; dispose of single-use items
Transport multiple use instruments to the processing area
Segregate instruments by category, heat-resistant, heat-sensitive and handpieces
Presoak instruments as required (except handpieces)
Clean and inspect instruments; if visible debris, clean again
Pouch/package critical, and semi-critical heat-resistant, instruments
Heat-sterilize
Store, unopened, in a dry storage area until next use
* Noncritical instruments maybe treated with an EPA-registered disinfectant. If blood or OPIM is visible an EPA-registered disinfectant with a TB claim must be used. Noncritical heat-resistant instruments may also be heat-sterilized.
**Make sure to follow the manufacturer’s specific instructions. The above are general recommendations, specifics vary for a given handpiece.
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keeping with OSHA, state, local and municipal regulations.
Transport precautions Impressions and other materials that will be trans-
ported to the dental laboratory must first be disinfected ac-cording to the material involved and following the manu-facturer’s recommendations. Instructions regarding how long a chemical disinfectant should be in contact with a set impression should be carefully followed to avoid the risk of altering the surface characteristics of the impression.9
Sorting and SoakingContaminated cassettes/trays with instruments are
sorted on arrival in the instrument processing area, and handpieces are removed for separate preparation, accord-ing to the sterilization procedure (see page 9). Instruments that will remain in the processing area for a period of time prior to cleaning and sterilization should be presoaked in a presoak solution or spray to help prevent debris from drying on the instruments, which would make its removal more difficult during cleaning.10
If debris has already dried on by the time instruments are received from the operatory, these instruments should also be soaked before cleaning. Do not presoak hand-pieces.
The closed perforated cassettes (or loose instruments) should first be placed in a soak container and then the presoak solution or enzymatic spray added to fully coat the instruments. If a foam product is being used, suffi-cient foam must be sprayed over the instruments to allow for complete coverage after shrinkage of the foam. In addition to preventing debris from drying on and wetting (softening) debris that has already dried on, enzymatic foam sprays begin dissolving blood, protein, carbohy-drates, fat and other organic tissue, and help to break down bioburden. Some foams that are marketed as non-enzymatic have a near-neutral pH (slightly alkaline), and are formulated to also break down bioburden. In general, however, nonenzymatic foams and solutions do not help to break down bioburden. If necessary, check with the manufacturer. Foams are easier to use than solutions, are less likely to result in spillage, and obviate the need to store bulky solutions or dilute liquid concentrates. On the other hand, liquid solutions do not dissipate. Solutions and foams are now available that help to remove debris and bioburden but with less wear on instruments.
Liquid solutions are available that can be used as presoaks, in ultrasonic cleaners and instrument wash-ers/disinfectors, and for evacuation lines. In deciding what to use, factors to consider include whether a presoak product is able to break down bioburden, how
Figure 5a. Presoaking in container with foam
Figure 5b. Pre-soak tub
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instrument-friendly (i.e., nonaggressive) it is, whether it is a concentrate or ready to use (consider inventory requirements, storage space, and risk of spillage and chemical exposure), ease of use, pH and, specifically for foam, how quickly it will dissipate and whether it will maintain coverage over instruments. Presoaking togeth-er with ultrasonic cleaning was found in one series of tests to result in more effective cleaning than ultrasonic cleaning alone. Presoaking should be relatively brief and the manufacturer’s instructions followed to reduce the possibility of corrosion/rusting of non-stainless steel metal instruments (e.g., burs).
Cleaning InstrumentsInstruments must be cleaned prior to sterilization.1 The
objective is to remove debris and bioburden prior to prepa-ration/packaging of instruments for sterilization; debris can act as a barrier that protects microorganisms and thereby prevents sterilization. The available options are manual cleaning or mechanical cleaning (i.e., the use of ultrasonic cleaners, instrument washers or washers/disinfectors). The CDC recommends using an automated cleaner. Mechani-cal cleaning by ultrasonic cleaners and instrument washers or washers/disinfectors is superior to manual cleaning for debris removal and reduces handling.11,12 Manual cleaning/scrubbing of contaminated instruments should be avoided where possible to reduce the risk of the operator sustaining percutaneous injuries or being exposed to splash/splatter that could result in disease transmission. If manual scrub-bing is required – for example, if debris remains on an instrument following mechanical cleaning – this should be performed at arm’s length, low in the sink using a long-han-dled brush and underwater (and while wearing heavy-duty utility gloves, a mask and protective eyewear).
Ultrasonic cleaningUltrasonic cleaning requires the use of an ultrasonic
cleaning machine and solution. During cleaning, the machine generates sound waves which are introduced into the solution, causing it to bubble. The action of the
bubbles imploding against the surfaces of the instru-ments cleans them. This is called cavitation. Ultrasonic machines with intermittent sound waves are considered superior to those with continuous sound waves and offer more consistent activity throughout the cleaning solution. Other factors in choosing cleaning machines include their volume (size) and design, which will be based on the anticipated size of instrument loads, processing-area space requirements, and whether the space is countertop or under the counter. Additional factors are the cleaner’s power and noise levels, test-ing and reliability, and ease of use — i.e., whether the cleaning solution must be emptied manually (requiring user handling) or can be drained through a hose. All manufacturer’s instructions must be followed for a given ultrasonic cleaner.
Closed, perforated cassettes should be placed on a tray or rack inside the machine and not placed in con-tact with the bottom of the ultrasonic cleaner. Similarly, loose instruments should be placed in a basket and not be loose or bundled in contact with the bottom of the ultrasonic cleaner. Only one or two layers should be stacked in the ultrasonic cleaner; failure to load the cleaner appropriately can result in areas of instruments not being cleaned because imploding bubbles may be unable to reach some areas. After loading the ultrasonic cleaner, the lid should be closed before the cleaner is turned on to ensure no ultrasonic solution sprays out into the surrounding environment. Instruments should not be added to batches of instruments already being ultrasonically cleaned. After treatment, cleaned instru-ments are removed and rinsed under running water to remove the cleaning solution (prevents instrument spotting, staining and pitting) and then allowed to dry before being prepared/packaged for sterilization.
Ultrasonic cleaning solutionsUltrasonic cleaning solutions or dissolving ultrasonic
tablets are essential. Water is not an ultrasonic cleaning solution. Both enzymatic and nonenzymatic options are
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available for instrument processing. As with presoaks, preferred ultrasonic cleaning solutions are those that help to break down bioburden and can help remove organic tissue, blood and material debris such as plaster and oxides stuck to instruments. A solution’s cleaning abil-ity and instrument compatibility are important. Anti-corrosive ultrasonic cleaners help protect non-stainless steel metal instruments and increase their useful life, while noncorrosive products will not damage them. Other factors to consider are the form of the solution
(i.e., concentrate versus a prepared solution or tablets), cost-effectiveness and scent. It is essential that ultrasonic solutions are discarded and replaced at least once a day. If bacterial loads are higher due to more heavily contami-nated instruments or heavier/more-frequent instrument loads, then the solution must be changed more frequently. Ultrasonic solutions should not under any circumstances be topped off in lieu of full replacement of the solution.
Instrument washers and washers/disinfectorsInstrument washers and washers/disinfectors are more
automated compared with ultrasonic cleaners, requiring less handling of contaminated instruments and therefore reducing exposure to contamination and the risk of injury. Both washer and washer/disinfector cycles provide for cleaning, rinsing and drying. The difference lies in the use of high-temperature water and disinfectants in washers/disinfectors compared with the hot water and detergent used in washers, which results in cleaned and disinfected instruments with less debris. The detergent/disinfectant recommended by the manufacturer should be used and the manufacturer’s instructions followed. Note that these cleaners are medical devices regulated by the FDA; regular dishwashers are not regulated as medical devices and are not a suitable substitute for an instrument washer or wash-er/disinfector. After cleaning, rinsing and drying, instru-ments are ready for inspection to ensure that they are free of damage and debris before entering the next phase of instrument processing. For cleaning endodontic files, ultra-sonic cleaners have been found to be superior to washers/disinfectors, which may have been due to the shape of the instrument holder or complexity of the file’s surface area.13
Instrument SterilizationThe sterilization process for instruments is based on
their classification. Spaulding’s classification categorizes instruments as critical, semicritical or noncritical. Critical instruments are those that penetrate soft tissues (e.g., oral mucosa) and contact or enter bone and other normally sterile tissues. Semicritical instruments contact mucous
Tips for Effective Ultrasonic Cleaning
• Place cassettes on a tray or rack in the machine
• Place loose instruments in a basket
• Place only one or two layers of cassettes in the ultrasonic cleaner
• Avoid overloading the ultrasonic cleaner
• Use an ultrasonic cleaning foam or solution that is gentle on instruments while being able to reduce bioburden
• Keep the lid on the ultrasonic cleaner while it is in use
• Rinse all cleaned instruments under running water and allow to dry
• Discard and replace ultrasonic cleaning solution at least daily and more often if bacterial loads are high or if visibly dirty
• Do not add instruments to others already being cleaned
• Do not place cassettes or loose instruments in the base of the ultrasonic bath
• Never top off ultrasonic cleaning solutions
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membrane or nonintact (i.e., broken) skin but do not penetrate these or contact or penetrate other tissues. Lastly, noncritical instruments are those that contact only intact skin and do not penetrate tissues. Instruments in each of these categories are treated differently. (Table 1)
All critical instruments, and semicritical instruments that are heat-resistant, as well as handpieces, must be heat-sterilized. Semicritical instruments that are heat-sensitive – with the exception of handpieces – may be sterilized with a high-level sterilant/disinfectant.1,8 Noncritical instru-ments may be treated with an EPA-registered disinfectant. If blood or OPIM is visible an EPA-registered disinfectant with a TB claim must be used. A high-level disinfectant sterilant may also be used. Noncritical heat-resistant instruments may also be heat-sterilized. The majority of in-struments in service today are heat-tolerant (and therefore can be heat-sterilized), or are single-use disposable which means they may not be reprocessed and must be disposed of after a single use. In fact, recent studies have shown that, even after precleaning and sterilization, sterilization of complex-surface instruments such as dental burs and endodontic files was not always successful, with failure ranging from 15% (bur set) to 58% (endodontic files).14 The CDC recommends the use of single-use disposable items whenever possible.
With more advanced devices being used chairside, it is critical to understand which instruments can undergo
mechanical cleaning, tolerate use of disinfectant/sterilant or need to be disassembled for processing. For example, autoclaving was found to result in significantly less change in the transmitted light intensity of curing lights in one study of 2,100 sterilization cycles when compared with use of a 2% glutaraldehyde liquid disinfectant/sterilant for curing light tips.15 Another example is lasers, some of which have been designed with fully autoclavable tips, spools and sleeves, while others may have disposable tips and other components that are autoclavable. These attri-butes are considerations when purchasing equipment, and the protocol for an instrument must be known to ensure appropriate processing.
HandpiecesFor handpieces, the burs should be removed and
the external surface of the handpiece wiped to remove debris. Since the exact protocol used for processing var-ies by handpiece type, it is essential to read and follow the manufacturer’s instructions. Handpieces must not be immersed in solution or placed in an ultrasonic bath, as doing so would damage the bearings and result in premature failure. After cleaning, handpieces must be heat-sterilized in accordance with the processing de-scribed below. Handpieces that cannot be heat-sterilized must be removed from service.1 Although handpieces were highly vulnerable to heat associated with steriliza-
Semi-critical Contact mucous membranes, nonintact skinDo not penetrate hard or soft tissues
Heat-sterilize if heat-resistantHeat-sterilize handpieces If heat-sensitive: High-level disinfectant/sterilant
Noncritical Contact intact skinEPA-registered disinfectant or high-level disinfectant or heat-sterilized (if heat-resistant)
Sources: Guidelines for infection control in dental healthcare settings—2003 (CDC); Guidelinefor disinfection and sterilization in healthcare facilities—2008 (CDC).
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tion when heat-sterilization first became a requirement, developments in O-rings and turbines have resulted in a significant improvement in the life of heat-sterilized handpieces. In one study assessing high-speed air tur-bine handpieces after 300 cycles, no abnormalities were noted in the turbines’ ball bearings.16 A newly com-pleted study found that tested turbines failed after 560 cycles, with longevity influenced by lubrication, corro-sion protection and maintaining usage at low loads. It was concluded that although autoclaving reduces the life of handpieces, lubrication increases their life, and the greatest negative influence on the turbines was run-ning at high load.17 In addition to following the CDC guidelines, it is essential to follow the handpiece manu-facturer’s instructions for cleaning, sterilization and lubrication.
Heat-Sensitive Semicritical and Noncritical Instruments
For heat-sensitive semicritical instruments (except hand-pieces) and noncritical instruments, high-level disinfectants/sterilants (not surface disinfectants) may be used instead of heat sterilization. High-level disinfectants/sterilants are germicidal chemicals that have been cleared by the FDA for this use and can destroy all microorganisms (including spores) in a given length of time. Soaking trays are also available for use with high-level disinfectants/sterilants. A number of chemicals meet the requirements of a high-level disinfectant/sterilant, including 7.5% hydrogen peroxide solution (sterilizes in six hours of immersion) and 3.4% buffered glutaraldehyde solution (sterilizes in 10 hours at 77°F). Other chemicals include phenol solutions and 8% periacetic acid. The manufacturer’s instructions must be followed and compatibility with instrument materials veri-fied. Sterilized instruments should be dried, segregated and stored in a dry, enclosed area. Note that tests cannot be performed to assure sterility with high-level disinfectants/sterilants. Tests are however available for some high-level disinfectant/sterilants that show whether the solution is still active and above the minimum effective concentration.
Heat-Sterilization: Instrument and Closed- Cassette Sterilization Packaging
Cleaned, dry instruments and closed cassettes should be packaged before being heat-sterilized. In all situations, only FDA-cleared sterilization packaging may be used. Properly packaging instruments and cassettes prior to sterilization serves several functions: 1) packaging has external and inter-nal indicators that verify sterilization parameters (see below); 2) the risk of confusing contaminated with sterilized instru-ments is removed; and 3) sterile instruments will remain un-contaminated in intact packaging post-sterilization, provided they are handled and stored correctly, until they are again used chairside.18 In contrast, unpackaged loose instruments are handled immediately after sterilization and therefore are subject to contamination from then onward.
Sterilization packaging must be strong enough for routine use without tearing, must allow penetration of the sterilant and must remain intact post-sterilization during storage to prevent contamination.19 The choice of packaging depends on what type of heat sterilizer will be used,20 what is being pack-aged and personal preference. Options include FDA-cleared paper wrap, paper pouches, paper/plastic pouches, plastic pouches and tubing. Paper wrap is used routinely for cas-settes, with an internal indicator and heat-sensitive tape for closure. Note that staples, pins and other objects that close the packaging by piercing it may not be used because they compromise the packaging and permit recontamination of processed instruments once they have been removed from the sterilizer. Plastic and plastic/paper pouches and plastic tubing are used for cassettes, instruments and handpieces. These en-able identification of both the contents and the status of inter-nal indicators. Self-sealing pouches are also available, offering ease of use. The seal on any packaging must be adequate and not compromised.
Paper and paper/plastic pouches are contraindicated for sharp instruments that are not contained in cassettes, because the points of the instruments can pierce these. In addition, plastic/paper pouches may separate, scorch or melt during exposure to the high temperatures reached in dry-heat sterilizers and are therefore contraindicated for
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that purpose.21 If dry-heat sterilization is being performed, packaging that is FDA-cleared specifically for this purpose must be used. If in doubt, check with the manufacturer on the intended use of specific sterilization packaging.
All sterilization packaging must include an internal in-dicator; if the internal indicator is not visible (for example, in a paper wrap), then an external indicator must also be used. Sterilization packaging should have FDA clearance, use medical-grade paper and/or plastic, be easy to use (e.g., self-sealing), be reliable and be available in multiple sizes.
Chemical indicatorsThere are six classes of chemical indicators used with ster-
ilization packaging/processing. These indicate whether mal-functioning occurred during sterilization (including as a result of operator error); they do not indicate if sterilization was achieved. Class I and II indicators are external indicators. A Class I indicator is required if an internal indicator is present but not visible. It indicates only that the package was exposed to the process. Class II indicators are required specifically for dynamic air removal (Class B) sterilizers. This is the Bowie-Dick (air-removal) test and must be performed in a test pack at the beginning of each day in an otherwise-empty sterilizer, in conformance with standards.22
Class III, IV, V and VI indicators are internal. The Class VI, known as an emulating indicator, reacts to all variables (time, temperature and presence of saturated steam) for a specific sterilization cycle and verifies the cycle; Class V in-tegrating indicators react to all variables (time, temperature and presence of saturated steam) over a range of tempera-tures. The main difference between a Class III and Class IV internal indicator is that the Class IV is designed to react to two or more variables rather than to only one, at stated values for the given variables. These also meet the packag-ing internal indicator requirement and are built into some sterilization pouches. Sterilization packaging with built-in indicators saves time and inventory and avoids the risk that placement of an indicator may be forgotten. If any in-use in-dicator fails, the load must be repackaged and reprocessed. When using internal indicators, these should be placed next to the instruments to ensure that they are measuring the pa-rameters where the instruments are located. This is especial-ly important for larger sterilization packages. No chemical indicators indicate sterility has been achieved, rather, that the process met the parameters being measured.
Heat SterilizationHeat sterilization of dental instruments is achieved by au-
toclaving, dry-heat sterilization or chemical sterilization using a chemclave. All are effective at killing microorganisms when used correctly, and cycle times vary depending on the method of sterilization, cycle selected and the specific sterilizer. Instru-ment loads placed in sterilizers should not be placed on top
Figure 6a. Sterilization packaging
Figure 6b. Sterilization packaging over cassette
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of, in contact with or overlapping one another. They must be placed with sufficient space between them to allow sterilant contact and penetration of the sterilant through sterilization packaging. The sterilizer must not be overloaded, and the manufacturer’s instructions must be followed.
AutoclavesAutoclaves use a combination of heat and pressure to
generate steam that penetrates the sterilization packaging to sterilize instruments. Sterilization occurs by denatur-ation of microbes’ proteins. Cassette racks are available for horizontal or vertical loading, thereby helping to pre-vent overloading. All autoclaves require the use of distilled water to prevent potential spotting on instruments or cassettes and the buildup of mineral deposits from regular tap water – including calcium – on the autoclave chamber and in its pipes.
Autoclaves operate in two distinct ways, using dynamic air-removal or gravity displacement. Dynamic air-removal autoclaves (vacuum autoclaves) work by first removing air using a vacuum pump or a valve that is controlled elec-tronically, after which steam enters the chamber. Com-pared with the gravity displacement autoclave, this process removes more air and improves the steam’s penetration into the turbines of dental handpieces.23 With the gravity displacement autoclave, steam enters the chamber from the sides and top of the chamber and pushes air out of the chamber through the base using a vent.
After autoclaving, the load must remain in the auto-clave with the door still closed until depressurization and drying of the packaging has been completed. Packaging removed prematurely from an autoclave while still damp can wick and become contaminated, at which point instru-ment processing must begin anew for that load. Typical cycle times and temperatures for gravity displacement and dynamic air-removal autoclaves are, respectively, 15 to 30 minutes at 250°F (121°C) and 3.5 to 10 minutes at 270°F (132°C). This does not include warm-up pressurization time or the time required for depressurization and the drying cycle.
Dry-heat sterilizersDry-heat static and convection (forced-air) sterilizers
utilize higher temperatures compared with autoclaves to achieve sterilization. As with autoclaves, the cycle time var-ies, ranging from six minutes to up to two hours. Unlike with autoclaves, the packaged instruments are then ready for removal and storage since no drying cycle is necessary. Typical cycle times and temperatures for static and convec-tion dry-heat sterilizers are, respectively, 60 to 120 minutes at 320°F (160°C) and 6 to 12 minutes at 375°F (190°C).
ChemclavesChemclaves use temperatures similar to those used
in autoclaves. They have a fast cycle time of around 20 minutes, and the instruments are dry after the cycle. Chemclaves use proprietary formaldehyde-alcohol-based chemicals. Although chemclaves are faster than autoclaves and use lower temperatures than those used in dry-heat sterilization, their use of chemicals reduces their attractive-ness and increases exposure to chemicals in the office. The typical cycle time and temperature for chemclaves are 20 minutes at 270°F (132°C).
Each category of heat sterilizer has advantages and disadvantages. Autoclaving can result in corrosion/pitting of non-stainless steel metals – carbon-steel instruments/devices can be treated with rust inhibitors to help prevent this. In comparison, chemclaves reduce the risk of corro-sion/pitting, and dry-heat sterilization eliminates the risk completely (because only dry heat is used) and reduces dulling of the instruments. On the other hand, dry-heat sterilizers utilize the highest temperatures and are more likely than autoclaves to damage instrument O-rings (con-tained in dental handpiece turbines) and other plastics and lead to their deterioration.
All sterilizers are medical devices regulated by the FDA, and all must pass rigorous testing before being cleared as medical devices. Mechanical indicators on sterilizers confirm that a specific parameter was reached. These may be mechanical gauges or electronically controlled gauges. Examples of mechanical indicators include the gauges on
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autoclaves indicating that a given temperature or pres-sure has been reached in the chamber. In some devices, these parameters can be printed; when this capability is present, the printout for each cycle should be kept in the sterilization log. Mechanical indicators provide immediate feedback; however, even if all parameters are met, they in-dicate only that the sterilizer was functioning, not whether sterilization has occurred.
Biological indicators (spore tests)Only biological indicators give any assurance that steril-
ity has actually been achieved. The necessity of performing biological indicator tests (spore tests) is highlighted by results from several studies in Europe and North America demon-strating fail rates ranging from 2.3% up to 33% when spore tests were performed in autoclaves.24-28 Biological indicators must be used at least weekly and every time an implantable device is being sterilized before implantation.8
Spores are tested because they are the most resistant – if they are killed by sterilization, then so are all microorgan-isms, which are less resistant. To ensure that a successful test result stems from sterilization having actually occurred rather than from spores that were not viable even without sterilization, both test and control biological indicators are used. The test indicator is placed inside the sterilizer, while the control one is left outside the sterilizer. The test is deemed valid if the spores outside the sterilizer are still alive and the sterilized ones are not.
Spore tests differ in the type of spore they use for differ-ent modes of heat sterilization: Geobacillus stearothermophi-lus for autoclaves and chemclaves, and Bacillus subtilis for dry-heat sterilization. Spore tests may be performed in-office using standard kits that include the spore test vials and incubators, or the spore test can be sent to a laboratory for verification of sterility assurance following its use in the sterilizer. Regardless of which method is used, all data must first be recorded before the spore test is performed, including the load number, sterilizer number and processing date. This data should be placed on the spore test vial label as well as in the record book, together with the results of the test.
Control and failed spore tests (live spores) must be autoclaved at 250°F/121°C for at least 30 minutes prior to disposal. For failed tests, a repeat test should be per-formed before using the sterilizer again for instrument processing. The loads that were treated at the time of the first failed test must also be reprocessed, as must implant-able devices (which must always be accompanied by a spore test in the sterilizer). If the sterilizer fails to inac-tivate spores in a second (repeat) test, then the sterilizer must be examined by a specialist before being used again. After such an examination, for a dynamic air-removal autoclave the Bowie-Dick test must be run in three con-secutive cycles, together with CI and BI tests. The CI and BI tests are also required in three consecutive cycles for gravity displacement autoclaves.
StorageRegardless of which heat-sterilization technique is used,
sterilized instruments and devices should be stored in their unopened sterilization packaging in a dry, dust-free storage area until needed. One study found no contamination of test groups of autoclaved or dry-heat-sterilized instruments that had been stored for six months in intact packaging in a closed, dry area post-sterilization. Contamination oc-curred where packaging had lost its integrity (was torn), increasing with time.29 Another study that ended at 124 days found no post-sterilization contamination of instru-ments stored in their intact, unopened sterilization packag-ing during the duration of the study.30
SummaryInstrument processing is a key element of the infec-
tion prevention cycle. Its success depends on following a standard protocol that meets the CDC guidelines and OSHA requirements. The protocol must be reliable and repeatable, and FDA-cleared devices and supplies, as well as personal protective equipment, must be used appropri-ately to ensure safe and effective instrument processing for the protection of dental personnel, patients and the general public.
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References1. CDC. Guidelines for infection control in dental health-care set-tings—2003. MMWR 2003;52(RR-17):1-66.
2. Siegel JD, Rhinehart E, Jackson M, Chiarello L; Health Care Infection Control Practices Advisory Committee. 2007 Guideline for isolation precautions: preventing transmission of infectious agents in health care settings. Am J Infect Control. 2007;35(10 suppl 2):S65-S164.
3. Harte JA. Standard and Transmission-Based Precautions: An Update for Dentistry. J Am Dent Assoc. 2010;141;572-581. www.osha.gov/SLTC/dentistry/index.html.
4. Cleveland JL, Barker LK, Cuny EJ, Panlilio AL. National Surveillance System for Health Care Workers Group.
Preventing percutaneous injuries among dental health care personnel. J Am Dent Assoc. 2007 Feb;138(2):169-178.
5. OSHA. Bloodborne pathogens standard. Available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.
6. Harte JA, Molinari JA. Instrument cassettes for office safety and infec-tion control. Compendium. November 2007;28(11):596-601.
7. Rutala WA, Weber DJ, Healthcare Infection Control Practices Advi-sory Committee. Guideline for disinfection and sterilization in health-care facilities. CDC—2008. Available at: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf
8. Blalock JS, Cooper JR, Rueggeberg FA. The effect of chlorine-based disinfectant on wettability of a vinyl polysiloxane impression material. J Prosthet Dent. 2010 Nov;104(5):333-341.
9. Miller CH. Cleaning, sterilisation and disinfection: basics of microbial kill-ing for infection control. J Am Dent Assoc. 1993;124:48-56.
10. Miller CH, Riggen SD, Sheldrake MA, Neeb JM. The presence of microorganisms in used ultrasonic cleaning solutions. Am J Dent. 1993;6:27-31.
11. Miller CH, Palenik CJ. Infection Control & Management of Hazard-ous Materials for the Dental Team. 3rd Edition, Elsevier Mosby, St. Louis, Mo., 2005.
12. Perakaki K, Mellor AC, Qualtrough AJ. Comparison of an ultrasonic cleaner and a washer disinfector in the cleaning of endodontic files. J Hosp Infect. 2007 Dec;67(4):355-359. Epub 2007 Nov 19.
13. Morrison A, Conrod S. Dental burs and endodontic files: are routine sterilization procedures effective? J Can Dent Assoc. 2009 Feb;75(1):39.
14. Kakaboura A, Tzoutzas J, Pitsinigos D, Vougiouklakis G. The effect of sterilization methods on the light transmission characteristics and structure of light-curing tips. J Oral Rehabil. 2004 Sep;31(9):918-923.
15. Nagai M, Takakuda K. Influence of number of dental autoclave treatment cycles on rotational performance of commercially available air-turbine handpieces. J Med Dent Sci. 2006 Jun;53(2):93-101.
16. We M, Dyson J, Darvell B. Factors affecting dental air-turbine hand-piece bearing failure. Oper Dent. 2012 Feb 16. [Epub ahead of print]
17. ADA Council on Scientific Affairs and ADA Council on Dental Prac-tice. Infection control recommendations for the dental office and the
dental laboratory. J Am Dent Assoc. 1996;127:672-680.
18. Dunkelberg H, Fleitmann-Glende F. Measurement of the microbial barrier effectiveness of sterilization containers in terms of the log reduc-tion value for prevention of nosocomial infections. Am J Infect Control. 2006;34:285-289.
19. Association for the Advancement of Medical Instrumentation, American National Standards Institute. Good hospital practice: steam sterilization and sterility assurance. ANSI/AAMI ST46-1993. Arlington, VA: Association for the Advancement of Medical Instrumentation, 1993.
20. Rutala WA, Weber DJ. Choosing a sterilization wrap for surgical packs. Infect Cont Today. 2000;4:64-70.
21. OSAP. Infection Control in Practice. 2008;7(4):1-8.
22. Association for the Advancement of Medical Instrumentation. ANSI/AAMI.2006;ST79-2006;A1,A2.
23. Andersen HK, Fiehn NE, Larsen T. Effect of steam sterilization inside the turbine chambers of dental turbines. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999;87(2):184-188.
24. Palenik CJ, King TN, Newton CW, Miller CH, Koerber LG. A survey of sterilisation practices in selected endodontic offices. J Endod. 1986;12:206-209.
25. Simonsen RJ, Schachtele CF, Joos RW. An evaluation of sterilisation by autoclave in dental offices. J Dent Res. 1979;58:400.
26. Engelhardt FP, Fisvatin H. Hygiene in der Zahnartzpraxis—Wunsch und Wirklichkeit. Dtsch Zahnarzd Z 1976; 31:277-281.
27. Scheutz F, Reinholdt J. Outcome of sterilisation by steam autoclaves in Danish dental offices. Scand J Dent Res. 1988; 96:167-170.
28. Burke FJT, Coulter WA, Cheung SW, Palenik CJ. Autoclave perfor-mance in and practitioner knowledge of autoclave use: a survey of selected UK practices. Quintessence Int. 1998;29:231-238.
29. Rosa AC, Brusca MI, Manto MC, Mosca CO, Nastri N. Effects of han-dling and storage on sterile dental instruments. Acta Odontol Latinoam. 2001;14(1-2):35-39.
30. Barker CS, Soro V, Dymock D, Fulford M, Sandy JR, Ireland AJ. Time-dependent recontamination rates of sterilised dental instruments. Br Dent J. 2011 Oct 21;211(8):E17.
WebliographyCenters for Disease Control and Prevention. Guidelines for infection control in dental health-care settings—2003. MMWR 2003;52(RR-17):1-66. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/rr5217a1.htm.
OSHA. Bloodborne pathogens standard. Available at: http://www.osha.gov/pls/oshaweb/owadisp.show_document?p_table=STANDARDS&p_id=10051.
Rutala WA, Weber DJ, Healthcare Infection Control Practices Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. CDC—2008. Available at: http://www.cdc.gov/hicpac/pdf/guidelines/Disinfection_Nov_2008.pdf.
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1. The chain of infection consists of __________ elements. a. one b. three c. five d. seven
2. The CDC guidelines for infection control in dental healthcare settings were published in __________. a. 1993b. 1998c. 2003d. 2008
3. The isolation guidelines for healthcare settings from the CDC address __________. a. specific pathogens b. all pathogens c. highly-transmissible diseases d. a and c
4. The overall goal of instrument processing is to provide _______. a. a clean clinical setting b. sterile instruments c. an OSHA-compliant office d. all of the above
5. Instrument processing should occur in a specific location that is segregated into __________. a. ‘dirty’ and ‘clean’ areas b. ‘cold’ and ‘hot’ areas c. the most convenient location d. all of the above
6. The wearing of heavy-duty utility gloves, a face mask and pro-tective eyewear is necessary during __________. a. operatory clean-up b. transportation of instruments c. instrument processing d. all of the above
7. Closed perforated cassettes __________. a. can be placed in pre-soaks b. can be placed in ultrasonic cleaners or washer/disinfectors c. reduce the risk of injury d. all of the above
8. __________ should be placed in the sharps container. a. Suture needles and capped syringe needles b. Disposables blades, scalpels and all-in-one syringes c. Broken glass carpules d. all of the above
9. __________, state, local and municipal regulations must be followed when disposing of sharps containers. a. FDAb. OSHAc. AGDd. all of the above
10. Medical and surgical gloves are __________ indicated for instrument processing. a. sometimes b. never c. always d. none of the above
11. Using automated cleaning devices and ultrasonic baths increases safety during instrument processing compared with __________. a. manual scrubbingb. mechanical brushingc. chemical scavengingd. all of the above
12. Disposing of sharps chairside, prior to transporting instruments in closed cassettes/trays to the processing area, __________. a. is compulsory b. is essential c. reduces the risk of sharps injuries d. all of the above
13. Non-perforated closed cassettes __________used for autoclaving of instruments. a. must not be b. may be c. must be d. none of the above
14. Impressions and other materials that will be transported to the dental laboratory must first be disinfected according to __________. a. the material involved b. the time available c. the manufacturer’s recommendations d. a and b
15. Instruments are segregated by __________ after being transported to the instrument processing area. a. sizeb. purpose c. whether or not they are heat-resistant or handpiecesd. a and b
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16. Instruments that will remain in the processing area for a period of time prior to cleaning and sterilization should be __________ to help prevent debris from drying on to the instruments. a. pre-soaked b. ultrasonically treated c. treated with high-level sterilants instead of heat sterilization d. a and c
17. If debris has dried on instruments while being used in the operatory, they must be __________ before cleaning. a. dunked in hot waterb. placed in a pre-soakc. placed in a vibrator to loosen the debrisd. none of the above
18. If a foam product is being used as a pre-soak, sufficient foam must be sprayed over the cassette/loose instruments to allow for complete coverage __________. a. after removal of the instruments b. after shrinkage of the foam c. over the bottom layer of instruments d. none of the above
19. Solutions and foams are now available that __________. a. are less aggressive on instruments b. help remove debris c. help remove bioburden d. all the above
20. Presoaking together with ultrasonic cleaning was found in one series of tests to result in __________ cleaning than ultrasonic cleaning alone. a. less effective b. more effective c. unnecessary d. none of the above
21. If manual scrubbing of instruments is required, this should be performed __________. a. at arm’s lengthb. low in the sink and underwaterc. while wearing gloves, a mask and protective eyeweard. all of the above
22. Instruments and cassettes should never be placed in contact with the bottom of the ultrasonic bath as __________. a. imploding bubbles may then not be able to reach all areas of
the instruments b. this can result in inadequate cleaning of instruments c. this will result in a high-pitched whine d. a and b
23 Anti-corrosive ultrasonic cleaners help protect and increase the useful life of __________. a. stainless steel metal instruments b. non-stainless steel metal instruments c. plastic instruments d. all of the above
24. If instruments are not rinsed with water after being in an ultrasonic cleaning solution, this can result in instrument __________. a. spottingb. staining c. pitting d. all of the above
25. If there is no longer enough ultrasonic cleaning solution present, this can be __________. a. topped upb. replaced with waterc. diluted with salined. none of the above
26. Instruments washer/disinfectors use __________. a. cold water and sterilantb. hot water and detergentc. high-temperature water and disinfectantd. none of the above
27. Mechanical cleaning by ultrasonic cleaners and instruments washers or washer/disinfectors is __________ to manual cleaning for debris removal. a. inferior to b. superior to c. the same as d. none of the above
28. For processing of handpieces, __________. a. the bur should be removed b. the external surface of the handpiece should be wiped c. the handpiece must be autoclaved d. all of the above
29. __________ classification categorizes instruments as critical, semi-critical or non-critical. a. Spelling’s b. Spaulding’s c. Sporeman’s d. none of the above
30. __________ must be heat-sterilized. a. All critical instruments b. All handpieces c. Semi-critical instruments that are heat-resistant d. all of the above
31. Precleaning and sterilization of complex-surface instruments is __________ successful. a. never b. not always c. always d. extremely
32. High-level disinfectants/sterilants can __________ curing lights. a. reduce the light transmission intensity ofb. improve the functioning ofc. soften d. all of the above
CE QUIZ
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17JUNE 2012
33. High-level disinfectants/sterilants __________. a. can destroy all microorganisms in almost no time b. have been cleared by the FDA for use c. are germiphobic chemicals d. all of the above
34. 7.5% hydrogen peroxide solution sterilizes instruments after __________ hours of immersion. a. twob. four c. six d. eight
35. Tests can be performed on high-level disinfectant/sterilants that __________. a. assure sterilityb. measure whether it is at the minimum effective concentrationc. take the place of indicatorsd. none of the above
36. Paper and paper/plastic sterilization pouches __________. a. are contraindicated for sharp instruments that are not contained
in cassettesb. may separate during exposure to the high temperatures reached
in dry heat sterilizers c. must be FDA-cleared for this use d. all of the above
37. Paper wrap is used for cassettes, with __________. a. heat-sensitive tape b. an internal indicator c. a biological indicator d. a and b
38. All sterilization packaging must include use of __________. a. an external indicator b. an internal indicator c. a biological indicator d. none of the above
39. Sterilization packaging must __________. a. be strong enough for routine use b. allow penetration of the sterilant through it c. remain intact post-sterilization during storage d. all of the above
40. A __________ indicates only that the package was exposed to the process. a. Class I indicator b. Class III indicator c. Class VI indicator d. all of the above
41. The main difference between a Class III and Class IV internal indicator is that the Class IV is designed to react to __________. a. single variables b. multiple variables c. specific instruments d. b and c
42. Heat sterilization of dental instruments is achieved by __________. a. autoclavingb. dry-heat sterilizationc. chemical sterilizationd. all of the above
43. Instrument loads placed in sterilizers should not be placed __________. a. on top of each other b. in contact with each other c. overlapping each other d. all of the above
44. Autoclaves __________. a. use a combination of heat and pressureb. denature microbes’ proteinsc. can be gravity displacement or dynamic air-removal
autoclavesd. all of the above
45. After autoclaving, the load must remain in the autoclave with the door still closed until __________. a. depressurization has occurred b. drying of the packaging has been completed c. repressurization has occurred d. a and b
46. Chemclaves are __________ than autoclaves. a. slowerb. fasterc. less effective d. b and c
47. Dry-heat sterilization __________. a. eliminates the risk of instrument corrosionb. increases the potential for damage to O-ringsc. reduces the dulling of instrumentsd. all of the above
48. Mechanical indicators __________. a. indicate if parameters were metb. indicate whether sterilization occurredc. indicate the weight of the instrument loadd. all of the above
49. Only __________ indicators give any assurance that sterility was actually achieved. a. external indicators b. biological indicators c. internal indicators d. none of the above
50. Sterilized instruments and devices should be stored in their unopened sterilization packaging __________. a. above the autoclaveb. in the processing areac. in a dry, dust-free storage aread. none of the above
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EDUCATIONAL OBJECTIVES• Define the elements of the chain of infection;• Delineate and describe the differences in the processing of critical, semicritical and noncritical instruments;• Review the use of presoaks and cleaning of instruments;• List and describe heat sterilization options and appropriate sterilization packaging; and• Review the uses and purposes of chemical and biological indicators.
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