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Cancellation/Refund Policy: Any participant who is not 100% satisfied with this course can request a full refund by contacting PennWell in writing. Instrument Processing, Work Flow and Sterility Assurance
A Peer-Reviewed Publication
Written by Eve Cuny, MS and Fiona M. Collins, BDS, MBA, MA
Educational Objectives
The overall goal of this article is to provide the reader with information on instrument processing requirements and the methods for instrument processing. Upon completion of this course, the reader will be able to do the following:
1. List and describe the CDC guidelines for instrument pro-
cessing in the dental office setting
2. List and describe the flow of instrument processing, as well
as the considerations involved
3. List and describe the types of sterilizers available for use
in the dental office, the use of cassettes during instru-ment processing, and the considerations involved in selecting these.
4. List and describe the purpose of sterility assurance and
the tests required to monitor and document sterility as-surance.
Abstract
Government agencies regulate and make recommendations on instrument processing and occupational safety. There are a number of requirements and necessary steps involved in instrument processing, including preparation, cleaning and packaging of instruments for sterilization. The use of cassettes reduces the risk of exposure injuries for the operator, while simplifying and streamlining the process. There is a variety of instrument sterilizers for dental office settings including steam sterilizers (autoclaves), chemiclaves and dry heat sterilizers. Each has different features, advantages and disadvantages that must be considered when selecting sterilization equip-ment for your practice. Monitoring sterilization processes for sterility assurance requires the regular use of mechanical, chemical and biological indicators to assure that these pro-cesses and the equipment are providing effective sterilization. Sterility assurance monitoring must be documented to show compliance with regulations governing your practice. Instrument Processing Requirements Instrument processing is a critical aspect of patient safety and one of the few areas of dental patient care in which the patient has no direct involvement and is not normally present to observe. Incomplete or inappropriate instru-ment processing has the potential to cause harm to both patients and health care workers involved in the process.
A systematic approach is useful in work processes where standardization is important to achieve a consistent out-come. A system for instrument processing should include, at a minimum:
1. Following existing standards and recommendations
2. Consideration of physical work flow
3. Occupational safety
4. Selection of equipment
5. Necessary supportive materials
6. Quality assurance
7. Instrument inventory management
These elements should be brought together in a system that is safe, repeatable and learnable using step-by-step pro-cedures. This will discourage those shortcuts that can lead to errors in the sterilization process. Several governmental and regulatory agencies provide regulations, guidelines and recom-mendations related to infection control in healthcare settings. Regulatory and Government Agencies Occupational Safety and Health Administration The Occupational Safety and Health Administration (OSHA) is an agency within the U.S. Department of Labor whose charge is to protect the health and safety of working men and women in the United States. Among the many regulations OSHA administers is the Bloodborne Pathogens Rule. This standard is designed to reduce the risk of occupational expo-sure to bloodborne pathogens. The regulations define how healthcare workers may handle contaminated instruments and waste, as well as how contaminated waste should be disposed of. Instrument processing is not directly addressed in the rule, although certain aspects of the process will trigger some of the standard’s requirements. One example is the use of personal protective equipment (PPE) including protective eyewear, surgical masks, gowns and heavy-duty utility gloves, when handling and cleaning used, contaminated instruments.1
U.S. Food and Drug Administration
The Food and Drug Administration (FDA) Medical Device and Radiological Health branch regulates the claims that manufacturers may make regarding the performance of medi-cal devices and certain products used in health care.2 Some of the devices used in instrument processing that are regulated by the FDA include sterilizers of all types, instrument wash-er/thermal disinfectors and high-level disinfectants. In order for a manufacturer to sell these devices in the U.S., it must submit data to the FDA supporting the claims it makes and explaining the instructions for use.3 For example, manufac-turers of autoclaves or dry heat sterilizers must meet specific standards for showing that sterilization will be achieved using the cycles identified in their instructions for use.2 Centers for Disease Control and Prevention Although a government agency, the Centers for Disease Control and Prevention (CDC) is not a regulatory authority. As part of the U.S. Public Health Service, however, the CDC performs many activities. One of these is the development of evidence-based recommendations for infection control. The recommendations for instrument processing have been well addressed in both the Guidelines for Infection Control in Dental Health-Care Settings—20034 and the more recent Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008.5
Many state dental licensing boards require licensees to adhere to the infection control recommendations of the CDC. Some states incorporate these recommendations by reference,
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while other states have specific language for minimum stan-dards for infection control. In addition, some states require a minimum number of hours in infection control continuing education for relicensure. These boards of licensure vary in the specifics of their regulations, and the individual boards need to be consulted to determine the state requirements.
Protocol Development
A protocol is necessary for instrument processing to ensure that instruments are consistently processed in an appropriate manner for safe and effective infection control. The protocol should provide step-by-step procedures involved in instru-ment processing in a manner consistent with agency regula-tions, guidelines and recommendations.
Preparation
The first step in developing the protocol for instrument pro-cessing is to evaluate the manner in which items are used, their ability to withstand the cleaning and sterilization processes, and the availability of adequate resources. These resources include instruments and devices that need processing after patient use, cleaning devices and sterilizers, and the necessary ancillary items such as cassettes; sterilization wrap; pouches; indicators, chemical integrators and biological indicators; and personnel time to complete the process.
Critical, Semicritical and Noncritical Instruments For purposes of selecting the appropriate process, the in-struments may be divided into three broad categories: criti-cal, semicritical and noncritical (Table 1).
Table 1. Infection-control categories of patient-care instruments *Although dental handpieces are considered semicritical items, they must always be heat-sterilized between uses and not high-level disinfected. If they cannot be heat sterilized, they must be removed from service.
Sources: Guidelines for Infection Control in Dental Health-Care Settings—2003 (CDC); Guide-line for disinfection and sterilization in healthcare facilities —2008 (CDC).
In today’s dental practice, most items that fall into the critical and semicritical categories either can withstand the heat sterilization process or are available as a single-use disposable
(SUD) product. SUD items should never be reprocessed for use on more than one patient.4,5
Figure 1. Instrument processing flow
Noncritical;semicritical
heat-sensitive
sorting of disinfectant/protected area
Handpieces
heat-resistant instruments
heat/chemiclave;
dry, protected area
cleaning and Mechanical
cleaning of Transportation
Use of Cassettes
Instrument cassettes allow procedural sets of instruments to
remain intact through all parts of the use, transportation, clean-ing, sterilization, and storage processes. Instrument cassettes are a tool for instrument management, providing a means by which to organize, protect and contain instruments (Figure 1). The use of locked instrument cassettes also aids transportation of instruments, reducing the risk of accidental injury to person-nel transporting the used instruments as well as reducing the risk of damaging or losing instruments during processing and saving time.6 The holes in the cassettes permit adequate pene-tration for cleaning and sterilization. In addition to instrument cassettes, accessory boxes can be used during sterilization. Procedural tubs may be used to organize and store disposables used during dental procedures, including composites, cotton, etc. The use of an instrument cassette does not replace the need for packaging: semicritical and critical instruments should be packaged after cleaning and prior to sterilization.4Figure 2. Cassettes and accessory boxes
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Instrument Processing Area and Work Flow
The instrument processing work flow must follow the CDC guidelines, with the following sequential steps: disposal of sharps; transportation; disposal of single-use disposable instruments and waste; sorting of instruments and handpieces; cleaning; sterilization and storage.4,5 The instrument processing area should be centrally lo-cated and must be designed for this work flow and traffic pattern. The area set aside for cleaning and sterilization of dental instruments should promote a one-directional work flow to avoid the risk of cross-contamination of sterilized items via contact with contaminated items and equipment. It is useful to designate separate areas (spaces) within the sterilization room for receiving, de-contamination, cleaning, drying, inspection, packaging, sterilization and storage, to help maintain one-directional flow during instrument processing.
Transporting
Instruments should be transported from the patient treatment area to the sterilization area after disposable sharps have been placed in an appropriate sharps container. OSHA requires the transport of used sharp instruments in rigid puncture-proof containers with rigid sides and bottom. Handling of contami-nated instruments should be minimized during transportation to the instrument processing area. Personnel should wear heavy-duty utility gloves when handling used sharp items during the removal, transport, cleaning and packaging pro-cesses, to help prevent accidental puncture injury during these processes. 1,5 Biohazardous waste must be disposed of in an ap-propriate receptacle in accordance with state and local medical waste regulations.
Figure 3. Use of heavy-duty utility gloves
Receiving, Sorting and Cleaning
If instruments cannot be cleaned immediately after use, it may be beneficial to use an instrument presoak or enzymatic spray to prevent drying of debris. Handpieces should be wiped externally to remove any debris and the burs re-moved prior to packaging and sterilization. For all other devices and instruments, cleaning can be carried out using ultrasonic baths and/or instrument washer/disin-fectors that hold instrument cassettes or baskets of loose
instruments. After cleaning, whether in an ultrasonic bath or instrument washer/disinfector, instruments should be visually inspected for any remaining debris or damage and if necessary cleaned again or, if damage is present, disposed of. If an ultrasonic cleaner was used, the instruments must be rinsed with clean water and must be dry prior to packaging. Hand washing/cleaning of instruments should be avoided and minimized to avoid the risk of exposure to contaminated instruments.
Preparation and Packaging
Whether the practitioner is using instrument cassettes or sets of loose instruments, items should be packaged in a pouch or wrap made of material intended for the particu-lar type of sterilization process.5 According to the CDC’s Guideline for Disinfection and Sterilization in Healthcare Facilities 2008, wrap or packaging for instruments may con-sist of “peel-open pouches (e.g., self-sealed or heat-sealed plastic and paper pouches), roll stock or reels (i.e., paper-plastic combinations of tubing designed to allow the user to cut and seal the ends to form a pouch), and sterilization wraps (woven and nonwoven).” The packaging material must allow penetration of the sterilant, prevent contamina-tion during handling, provide an effective barrier to micro-bial penetration and maintain the sterility of the processed item after sterilization.7 When loading packages into the sterilizer, correct loading is required for sterilization to oc-cur and packages must remain intact without being pierced or damaged during loading. In accordance with the CDC Guidelines, a chemical indicator should be placed inside each wrapped package. If this indicator cannot be seen from the outside of the package, another indicator (e.g., indicator tape) should be placed on the outside of the package.
Sterilization
Sterilizing contaminated instruments is an essential component of an effective infection-control program to protect the patient and staff. There is a variety of steril-ization methods available for use in reprocessing instru-ments depending on needs and the type of instruments being processed. In the dental practice setting, the most commonly used and recommended sterilization method is steam (autoclaving). Other options include dry heat steril-izers, and chemiclaves using chemical vapor sterilization.
Storage
Sterile pouches or wrap will maintain asepsis of instruments for prolonged periods, provided they are not compromised by becoming wet or torn. Studies have indicated that dental instruments remain sterile in packs for prolonged periods, but may show signs of contamination if not handled properly.8 Therefore, there is no evidence to suggest that packs of dental instruments should be routinely resterilized solely based on the length of time in storage. The event-related shelf-life prac-
tice, as described in the 2008 CDC guideline, recognizes this and the fact that packs will remain sterile unless compromised.
Instruments must only be removed from the sterilizer after completion of the full sterilization cycle and, if wet dur-ing sterilization, after the packaging is dry. Storage should be away from sources of moisture and areas subject to excessive dust. Covering packages or storing them in enclosed cabinets or drawers will help maintain their sterility. All of the items in packs that become torn or remaining items in packs that have been opened to remove one or more items in the pack should be reprocessed, beginning with the cleaning step of the process. It is neither necessary nor recommended that sterile packs be routinely resterilized on an arbitrary time schedule.4,5,8 Steam Sterilizers
Pressurization and high temperature are required to produce the saturated steam environment in the sterilizer chamber needed to kill resistant microorganisms. Distilled water is used to generate the steam, thereby preventing mineral buildup in the water reservoir and autoclave chamber. The result is rapid sterilization of packaged (or pouched) items, and rapid and effective penetration of fabrics and steriliza-tion packaging by the sterilant (steam). One disadvantage of autoclaves is the potential over time for corrosion and pitting of metals and damage to materials such as rubbers, plastics and o-rings; this potential can be reduced by closely adhering to the device manufacturer’s instructions. Hand-pieces should be cleaned and prepared for sterilization in accordance with the handpiece manufacturer’s instructions and recommendations. To achieve optimal steam steriliza-tion conditions inside the sterilizer chamber, it is necessary to eliminate any air trapped in the chamber and load after the door is closed. Steam sterilizers are classified by the general method used to remove this air.
Gravity Displacement Autoclaves
Gravity displacement steam sterilizers use the oldest tech-nology and as their name suggests, they rely on the force of gravity to displace the trapped air – steam entering the sterilizer from the top and sides of the chamber displaces the air and forces it out through a drain vent in the base of the chamber. A small amount of trapped air is frequently retained in gravity displacement autoclaves; thus, steam penetration into wrapped loads and lumened devices is not as good as with other types of steam sterilizers, limiting their application. Sterilization cycles for gravity displace-ment steam sterilizers range from 3 to 30 minutes at 121°C (250°F) to 132°C (270°C).
Dynamic Air Removal Steam Sterilizers Dynamic air removal steam sterilizers are the other clas-sification and these sterilizers use either an electronically controlled air valve or a vacuum pump to eliminate the trapped air. The first type of dynamic air removal steril-izer is the Steam Flush Pressure Pulse (SFPP) type which removes the trapped air from the sterilizer chamber and load by opening an electronically controlled valve as re-quired, based on chamber conditions, to create pressure pulses which purge the chamber and load of air. The second type of dynamic air removal sterilizer is the pre/ post vacuum type (sometimes referred to as Class B) which uses a vacuum pump to draw the trapped air from the chamber through a series of vacuum and pressure pulses. The vacuum pump is also used to help draw the moisture from the chamber during the drying phase in this type sterilizer. Dynamic air removal steam sterilizers maximize air removal and thus provide better steam pen-etration into wrapped loads and lumened devices. Thus, these sterilizers are capable of sterilizing a broader range of devices. Sterilization cycles for dynamic air removal steam sterilizers range from 3 to 30 minutes at 121°C (250°F) to 132°C (270°F). One study found a vacuum autoclave offered more reliable sterilization of the internal aspects of dental handpieces than did non-vacuum autoclaves.9 The most recent tabletop autoclaves are highly auto-mated and have been designed with a push-button to start the automated cycle as well as offering the option of shorter cycles at a higher temperature or longer cycles at a lower temperature. The total time involved, including heat-up and vent, sterilization and cooling/drying time, ranges from 25 minutes to 75 minutes, depending on the autoclave type and model. Autoclaves with lower height requirements (M3 UltraFast, Midmark) that accept standard instrument cassettes (e.g., Signa-Stat, Hu-Friedy) offer convenience without onerous space requirements. Other autoclaves offer greater capacity and will accept cassettes on racks that can be vertical or horizontal or either, depending on the auto-clave and available accessories. The instruments, cassettes, trays and containers that will be used must be considered before purchasing any sterilizer to ensure that the chamber capacity and configuration will meet requirements.
Figure 4. Vertical and horizontal loading of packaged cassettes Chemiclaves
Chemiclaves utilize unsaturated chemical vapor for ster-ilization, typically for 20 minutes at 132°C (270°F). The chemical vapor is produced using a proprietary formalde-hyde-and-alcohol formulation that is water-free. Chemi-claves use temperatures similar to autoclaves, with no risk
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of instrument corrosion. There is nonetheless still the risk of damage to heat-sensitive plastics, rubbers and o-rings due to exposure to high temperatures. There is also the possibility of exposure to chemicals with use of a chemiclave.
Dry Heat Sterilizers
Dry heat sterilizers operate at higher temperatures than auto-claves do, and the sterilant (in this case, dry heat) takes longer to penetrate materials, although no drying time is required. Two types are available – forced air and static air. Forced air dry heat sterilizers more effectively transfer heat throughout the chamber to the instruments and therefore have a quicker cycle than static air models do. The most common time-temperature cycles are 170°C (340°F) for 60 minutes, 160°C (320°F) for 120 minutes, and 150°C (300°F) for 150 min-utes. Recently, more rapid dry heat sterilizers (COX steriliz-ers) have become available; these can be operated at 370°F for 6-, 8- or 12-minute cycles, depending upon the instruments and load. W hile dry heat sterilization is useful for instruments that can be damaged by steam or for materials that are im-penetrable and unaffected by steam, the higher temperatures attained are generally considered to be unsuitable for plastic components and mechanical handpieces due to the increased risk of damage to internal components such as o-rings and turbine bearings. In addition, packaging specifically designed for dry heat sterilizers must be used to avoid scorching or melting of the packaging.
Figure 5. Autoclaves
Figure 6. Dry heat sterilizers and chemiclaves
Work Flow and Space Considerations
The available space within the instrument processing area(s) must be considered when selecting the appropriate equipment. Will the external dimensions and clearance area required for the equipment match the available space? Is plumbing required and can the device be plumbed in? Are there any special electrical requirements? Is the work surface heat- and/or moisture-resistant or resistant to the chemicals
used in a chemiclave? Can the work surface support the area and weight of the sterilizer?
Sterilization areas can be segregated, custom-designed or purchased as prefabricated units for a one-directional instru-ment processing flow. Sterilization casework offers a workflow solution for instrument processing that is prefabricated, effi-cient and convenient. Depending on the model, the unit may hold one or two tabletop autoclaves of the same size or one standard-size and one tabletop autoclave designed for one cas-sette load. The surfaces of these units are heat-, chemical- and water-resistant. In addition, some models contain large stor-age areas for sterilized instruments and separate illuminated areas for contaminated storage (Artizan? Streamline). Space and configuration of the sterilizer are particularly important if sterilization casework units are used; while within their given space they are optimally designed, there is less flexibility for moving a sterilizer if it is too large for the sterilization area. If selecting a prefabricated instrument processing center, it should also be ascertained that the design is based on current CDC, ADA and OSHA recommendations.
Figure 7. Sterilization casework
Sterility Assurance
Sterility assurance provides operators with the knowledge that sterilization procedures are effective or that corrective action is required. It should be noted that most failures in sterilization are due to operator error and not to any inher-ent defect in the sterilization device.10 In addition to errors associated with cleaning and packaging of items to be steril-ized, improper loading of the sterilizer and overloading can result in an increase in heat-up time and can delay complete penetration of the sterilant into the load. The use of instru-ment cassettes reduces the risk of inadvertently overloading sterilizers. Similarly, lack of separation between packages/cassettes can preclude or delay the sterilant from reaching all areas of all items in the sterilizer. Other operator errors related to the sterilization process include use of incorrect time and temperature for the sterilization cycle, resulting in the continued presence of organisms, incorrect maintenance of the sterilizer, and handling packaging and items that are not yet dry (if using an autoclave or chemiclave).5 To ensure sterility, mechanical, chemical and biological indicators are required to evaluate the effectiveness of sterilization.5
Mechanical/Digital Monitoring
Mechanical (analog) monitoring involves the use of time, tem-
perature and pressure gauges that can be viewed to verify these
parameters. Gauges/displays on sterilizers must be monitored
for cycle times, temperature and pressure during sterilization.
If any readings are incorrect, this is an indication that the steril-
ization device may be malfunctioning or that an operator error
has occurred. Conversely, correct readings are not conclusive
for effective sterilization and are only indicative of occur-
rences in the sterilizer where the mechanical probe is located.
Many current sterilizers have digital readings, which are more
reliable than mechanical controls. Many autoclaves now also
provide printouts of temperature, the time at the temperature,
and pressure measurements during the sterilization cycle; the
printout can then be placed in the documentation for steriliza-
tion as part of the permanent records.
Figure 8. Digital displays
Chemical Indicators
Both external and internal chemical indicators are available,
in accordance with the Association for the Advancement of
Medical Instrumentation (AAMI) guidelines. Chemical
indicators consist of heat- or chemical-sensitive ink impreg-
nated on to an indicator strip or tape. In the case of some ster-
ilization pouches, the ink may be embedded on the surface of
the pouch itself. External indicators must be used along with
internal indicators unless the internal indicator is visible from
outside the package. The internal indicator should be placed
inside the packaging among the instruments and the exter-
nal indicator should be placed on the external surface of the
packaging. External indicators (Class I and II) and internal
indicators (Class III, IV, V) are available.
Classes of Chemical Indicators
Class I:(external chemical indicators). These are process indicators. They are intended for use with individual units
(such as packs or containers) and indicate that the unit has
been exposed to the sterilization process. These indicators
distinguish between processed and unprocessed units. Class II These are indicators used for specific tests. The Bowie-Dick or air-removal test is a Class II indicator test
used only for testing of dynamic air removal steam sterilizers.
This test must be performed daily, within a test pack, in an
empty autoclave prior to that day’s use of the autoclave, in ac-cordance with AAMI standards.11 This test is also performed for sterilizer qualification.
Class III: Single-variable indicators. These are designed to re-act to one of the critical variables; intended to indicate exposure to a sterilization process at a stated value of the chosen variable. Class IV: Multi-variable indicators. These are designed to react to two or more of the critical variables in the steriliza-tion process; intended to indicate exposure to a sterilization process at stated values of the chosen variables.
Class V (integrating indicator): Internal use indicator that measures all variables for sterilization cycles. Class V indi-cators are considered adequate for all instruments except implantable devices (including dental implants).
Source: ANSI/AAMI.2006;ST79,A1,A2.
A sixth type of indicator, the Class VI emulating indi-cator, is an internal cycle verification indicator. This type of indicator is designed to react to all critical variables of the sterilization cycle for the specific sterilization process. External indicators do not indicate if the temperature was achieved for the appropriate length of time nor if the sterilant penetrated the packages. Readings from chemical indicators cannot determine that all microorganisms were killed, only that the sterilant reached that area and that there was no obvious malfunction in the operation of the sterilizer. Failed chemical indicator tests mean that the items that had been processed during that cycle should not be used and must be reprocessed.11,12
Biological Monitoring
Biological monitoring must be conducted at least weekly as well as every time an implant is sterilized, per the CDC guidelines. Many states mandate weekly testing, and the reader should check with the regulations for the state in which he or she practices to obtain up-to-date information on mandated testing and regulations. Biological indicators (BI) test the ability of the sterilization cycle to kill resistant microorganisms in a given sterilizer at a given time, and these offer greater sterility assurance than chemical indicators do. The resistance of microorganisms to sterilization ranges from low (lipids and medium-sized viruses such as hepatitis B and HIV) to high. Other than prions, the most resistant microorganisms are bacterial spores and these are used to test the ability of the sterilization process to kill microorgan-isms.13 Since spores are used as BIs, this is also known as the “spore test.” The specific spore used depends on the class of sterilizer. For steam autoclaves and chemiclaves, Geobacillus stearothermophilus(formerly Bacillus stearothermophilus) is used; for dry heat sterilizers, Bacillus subtilis is used.
Both a test and a control BI must be used. The control BI is not exposed to the sterilization procedure, with the objective of verifying that the spores were viable and that growth of spores occurred in the absence of exposure to the sterilant (if not, a negative test BI result following sterilization is meaningless). It
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is important to follow the manufacturer’s instructions on use and temperature settings for the specific spore test being used. BIs are available as self-contained vials, sealed ampoules and strips impregnated with the resistant spores. Mail-in tests using professional labs provide third-party verification for sterility assurance. In addition, because they microscopically view any positive spore tests these tests can confirm that the problem was a sterilization failure and not contamination of the test during handling. Other ways to provide a higher level of quality assurance, such as the use of a Class V indicator chal-lenge pack with each load, provide immediate verification (as a BI equivalent), which removes the drawback of waiting for up to a week for results (associated with the mailing, laboratory test and report on results with mail-in spore tests). In-house BI tests using self-contained vials remove mailing and turnaround time, and offer results within 24 hours. In-house tests therefore offer the ability to take corrective action quickly, should this be required but do not provide third-party verification. Several in-house rapid result spore tests are available (3M? Attest?; Ethox; Pro-Test; SporeCheck?, Hu-Friedy). Figure 9. Biological indicator kit
A spore test kit provides self-contained ampoules, a crusher that removes the vial’s inner barrier between the spores and the cul ture medium, and a compact tabletop incubator offers convenience (SporeCheck?, Hu-Friedy). Prior to plac-ing the test vial in the chamber, the sterilizer number, load number and processing date must be written on the vial label. After the test vial is placed in an instrument tray, peel pouch or AAMI challenge pack, it should be placed in the steril-izer together with the instruments to be sterilized, in the spot where sterilization would be hardest to achieve (typically near the door on the bottom shelf or over the drain area). The outside of the vial also has an external chemical indicator strip that turns brown if mechanical parameters were met.
Figure 10. Placing the BI in the sterilizer
Assuming this strip is brown, after 10 minutes’ cooling time has elapsed, both the test and the control vials are crushed and placed in the incubator for 24 hours. The operator can then view the color of the liquid in the test and the control vials – if the culture medium is still purple while the control test’s culture medium is yellow, the test is negative, indicat-ing sterilization occurred. If the color is yellow, the test is a fail (growth of spores has occurred during incubation).
Table 2. Test results
The steps using these tests are simple, and the results must be noted in the record book for documentation. A negative biologic indicator test gives a high level of assur-ance that the instruments were properly sterilized.
Any failed test BIs and all control test BIs must be au-toclaved at 250O F/121O C for at least 30 minutes prior to disposal. If a BI (spore) test is positive while the mechanical and chemical indicators suggested that the sterilizer was working properly, the test should be repeated using the same cycle before the sterilizer is used again, and any im-plantable devices must be pulled and (re)sterilized as well as other instruments, which should be repackaged for steril-ization. If the repeat test produces a negative test result, the sterilizer can be used again. If it is still positive, the sterilizer must be seen by a sterilizer maintenance specialist. Chemi-cal and biological indicator tests must then be run in three consecutive empty autoclave cycles and produce negative results before the sterilizer is used again. In addition, if us-ing a dynamic air removal steam sterilizer, the Bowie-Dick test (Class II chemical indicator) must also be run in the three consecutive cycles.14
Documentation
Documentation must be maintained for all sterilizers and sterilization procedures and should be initialed by the opera-tor. Maintenance records for the sterilizer should include the sterilizer’s serial and model numbers, dates and details for
maintenance/servicing, and sterilization cycles immediately following maintenance/servicing. All sterilization cycles must be fully recorded, and the time, date and sterilizer used must be noted on external packaging prior to sterilization and stor-age of the package. Against each sterilization cycle in the re-cord, the operator should record charts, note gauges and attach printouts demonstrating mechanical monitoring of appropri-ate time, temperature and pressure. All spore test results must be thoroughly documented for the specific sterilizer, with date, time and results noted.
Inventory Management
Many factors should be taken into account when determin-ing the right inventory mix to serve the needs of an individual practice. Considerations include the nature and number of procedures, the number and type of practitioners, the hours and days of operation, and the time required to process used items. Inadequate inventory may inhibit the ability to pro-vide care in a timely manner and may add pressure on staff responsible for the processing of instruments.
Management of inventory can be streamlined by main-taining sets of instruments in pouches or cassettes assembled by procedure. This makes it easier for personnel to quickly assess the availability of instruments needed, based on ap-pointment types scheduled. It is also recommended to store enough sterilized instrument sets for an entire day, so that procedures can still be performed and patient flow is unaf-fected if equipment associated with instrument processing is unavailable due to malfunction or repair.
Summary
Instrument processing requires adherence to established prin-ciples and guidelines in order to achieve a consistent outcome. Office protocols, appropriate equipment, adequate inventory and training of personnel involved in the process are impor-tant to ensure proper instrument asepsis. Instrument steriliza-tion is mandatory for all critical instruments, handpieces, and heat-resistant semicritical instruments. In order to provide assurance that sterilizers are achieving their objectives and killing microorganisms, a sterility assurance program must be conducted and documented at specified intervals, and instru-ments must be reprocessed if indicated by the test results. References
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Administration. 29 CFR Part 1910.1030 (d)(3). Bloodborne pathogens. Personal protective equipment.
2 U.S. Food and Drug Administration. Guidance on premarket
notification [510(k)] submissions for sterilizers intended for use in health care facilities. March 1993.
3 U.S. Food and Drug Administration. Labeling recommendations for
single-use devices reprocessed by third parties and hospitals; final guidance for industry and FDA. Rockville, MD: U.S. Department of Health and Human Services, Food and Drug Administration, 2001.
4 CDC. Guidelines for infection control in dental health-care
settings—2003. MMWR 2003;52(RR-17):1-66.
5 Rutala WA, Weber DJ, Healthcare Infection Control Practices
Advisory Committee. Guideline for disinfection and sterilization in healthcare facilities. CDC, 2008.
6 Harte JA, Molinari JA. Instrument cassettes for office safety and
infection control. Compendium November 2007;28(11):596-601.
7 Dunkelberg H, Fleitmann-Glende F. Measurement of the microbial
barrier effectiveness of sterilization containers in terms of the log reduction value for prevention of nosocomial infections. Am. J.
Infect. Control 2006;34:285-9.
8 Schwartz R, Davis R. Safe storage times for sterile dental packs.
Oral Surg Oral Med Oral Pathol. 1990;70(3):297-300.
9 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):184-8.
10 Andrés MT, T ejerina JM, Fierro JF. Reliability of biologic indicators
in a mail-return sterilization-monitoring service: a review of 3 years.
Quintessence Int. 1995;26(12):865-70.
11 Assocation for the Advancement of Medical Instrumentation.
ANSI/AAMI.2006;ST79, A1,A2.
12 Association of Operating Room Nurses. Recommended practices
for sterilization in perioperative practice settings. 2000 Standards, recommended practices, and guidelines. Denver, CO: AORN, 2000:347-58.
13 Schneider PM, Reich RR, Kirckof SS, Foltz WG. Performance of
various steam sterilization indicators under optimum and sub-optimum exposure conditions. In: Rutala WA, ed. Disinfection, sterilization and antisepsis: principles, practices, challenges, and new research. Washington, DC: Association for Professionals in Infection Control and Epidemiology, 2004:200-23.
14 Association for the Advancement of Medical Instrumentation.
Comprehensive guide to steam sterilization and sterility assurance in health care facilities, ANSI/AAMI ST79. 2006.
Author Profile
Eve Cuny, MS
Eve Cuny is the Director of Environmental Health and Safety and As-sistant Professor in the Department of Pathology and Medicine at the University of the Pacific School of Dentistry. She has consulted with the Centers for Disease Control and Prevention, American Dental Association, California OSHA, California Dental Board and other agencies on issues related to safety and infection control in dentistry. She has presented over 100 continuing education programs throughout the world and published numerous articles and textbooks. Ms. Cuny is also founder and managing partner of Eve Cuny Consultants, LLC, a consulting group specializing in product evaluation, professional writ-ing and other services to the dental profession and industry.
Fiona M. Collins, BDS, MBA, MA
Dr. Fiona M. Collins has authored and presented CE courses to dental professionals and students in the US and internationally, and has worked in the United States, Middle East, The Netherlands and United Kingdom. She is a past member of the Academy of General Dentistry Foundation Strategy Board, and has been a member of the British Dental Association, Dutch Dental Association, and the Inter-national Association for Dental Research. Dr. Collins has been an ac-tive consultant in the dental industry for several years, and is a member of the American Dental Association and the Organization for Asepsis and Safety Procedures.
Disclaimer
The author(s) of this course has/have no commercial ties with the spon-sors or the providers of the unrestricted educational grant for this course. Reader Feedback
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Questions
Online Completion
Use this page to review the questions and answers. Return to https://www.doczj.com/doc/4c5551832.html, and sign in. If you have not previously purchased the program select it from the “Online Courses” listing and complete the online purchase. Once purchased the exam will be added to your Archives page where a Take Exam link will be provided. Click on the “Take Exam” link, complete all the program questions and submit your answers. An immediate grade report will be provided and upon receiving a passing grade your “Verification Form” will be provided immediately for viewing and/or printing. Verification Forms can be viewed and/or printed anytime in the future by returning to the site, sign in and return to your Archives Page.
1. A systematic approach is useful in work processes where standardization is impor-tant to achieve a consistent outcome.
a. True
b. False
2. The charge of the Occupational Safety and Health Administration (OSHA) is to protect the health and safety of ________.
a. patients
b. working men and women in the United States
c. working men and women globally
d. all of the above
3. The Bloodborne Pathogens Rule is designed to reduce the risk of ________.
a. occupational exposure to bloodborne pathogens
b. occupational exposure to airborne pathogens
c. a and b
d.
none of the above
4. The FDA Medical Device and Radiologi-cal Health branch regulates the claims that manufacturers may make regarding the performance of medical devices and certain products used in health care.
a. True
b. False
5. Many state dental licensing boards
require licensees to adhere to the infection control recommendations of the CDC.
a. True
b. False
6. A protocol is necessary for instrument processing to ensure that instruments are consistently processed in an appropriate manner for safe and effective infection control.
a. True
b. False
7. Critical instruments _________.
a. only contact intact skin
b. only contact mucous membranes or skin
c. penetrate soft tissue, contact bone, enter into or contact the bloodstream or other normally sterile tissues
d. none of the above
8. Handpieces are _________ devices, and must be _________.
a. critical; cold sterilized
b. semicritical; cold sterilized
c. semicritical; heat sterilized
d.
critical; heat sterilized
9. Instrument cassettes allow procedural sets of instruments to remain intact through all parts of the use, transportation, clean-ing, sterilization, and storage processes.
a. True
b. False
10. The use of locked instrument cassettes ________.
a. aids transportation of instruments
b. reduces the risk of accidental injury to personnel transporting used instruments
c. reduces the risk of damaging or losing instruments during processing and saves time
d. all of the above
11. The use of an instrument cassette replaces the need for packaging.
a. True
b. False
12. The instrument processing work flow must follow the CDC guidelines and it is useful to designate separate areas for each step.
a. True
b. False
13. OSHA requires the transport of used sharp instruments in rigid puncture-proof containers with rigid sides and bottom.
a. True
b. False
14. Personnel should wear _________ when handling used sharp items.
a. sterile surgical gloves
b. nonsterile latex gloves
c. heavy-duty utility gloves
d.
none of the above
15. For all instruments and devices other than handpieces, cleaning can be carried out using _________.
a. ultrasonic baths
b. instrument washer/disinfectors
c. dishwashers
d.
a or b
16. Items for sterilization should be packaged in a pouch or wrap made of material intended for the particular type of sterilization process.
a. True
b. False
17. Biological monitoring must be
conducted at least weekly as well as every time an implant is sterilized.
a. True
b. False
18. Sterile pouches or wrap will maintain asepsis of instruments for prolonged peri-ods, provided they are not compromised by becoming wet or torn, and they should be stored in a dry, protected area.
a. True
b. False
19. Sterilization areas can be segregated, custom-designed or purchased as pre-fabricated sterilization casework for a one-directional instrument processing flow.
a. True
b. False
20. Gravity displacement steam sterilizers _________.
a. rely on the force of gravity to displace the trapped air
b. result in less steam penetration in lumened devices than other types of steam sterilizers
c. operate at cycles ranging from 3 to 30 minutes at 121°C (250°F) to 132°C (270°C)
d. all of the above
21. Dynamic air removal steam sterilizers use _________ to eliminate trapped air.
a. a vacuum pump
b. a mechanically controlled air valve
c. an electronically controlled air valve
d.
a or c
22. Steam Flush Pressure Pulse sterilizers remove the trapped air from sterilizer chambers and loads by __________.
a. opening an electronically controlled valve as required
b. creating pressure pulses which purge the chamber and load of air
c. opening a mechanically controlled valve as required
d. a and b
23. Documentation must be maintained for all sterilizers and sterilization procedures and should be initialed by the operator.
a. True
b. False
24. Chemiclaves utilize unsaturated chemi-cal vapor for sterilization, typically for 20 minutes at 132°C (270°F) and dry heat sterilizers utilize dry, heated air.
a. True
b. False
25. Chemical indicators consist of heat- or chemical-sensitive ink impregnated on to an indicator strip or tape.
a. True
b. False
26. Operator errors during instrument processing include __________.
a. improper loading and overloading of the sterilizer
b. lack of separation between packages/cassettes
c. use of incorrect time and temperature for the sterilization cycle
d. all of the above
27. External indicators must be used along with internal indicators unless the
internal indicator is visible from outside the package.
a. True
b. False
28. Class II indicator tests (Bowie-Dick or air-removal tests) __________.
a. are only used for dynamic air removal steam sterilizers
b. must be performed at the beginning of each day in an empty sterilizer
c. are used for sterilization qualification
d. all of the above
29. Class V integrating indicators measure all parameters for sterilization cycles and are considered adequate for all instru-ments except implantable devices.
a. True
b. False
30. Biological indicator tests _________.
a. are also known as spore tests
b. give a high level of assurance that the instruments were properly sterilized if the test is negative.
c. are required with all sterilizers
d. all of the above
For ImmeDIaTe results,
go to https://www.doczj.com/doc/4c5551832.html, to take tests online. answer sheets can be faxed with credit card payment to (440) 845-3447, (216) 398-7922, or (216) 255-6619. P ayment of $59.00 is enclosed. (Checks and credit cards are accepted.)
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following: MC Visa AmEx Discover Acct. Number: _______________________________ Exp. Date: _____________________
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If not taking online, mail completed answer sheet to
Academy of Dental Therapeutics and Stomatology,
A Division of PennWell Corp.
P .O. Box 116, Chesterland, OH 44026
or fax to: (440) 845-3447
AGD Code 148
PLEASE PHOTOCOPY ANSWER SHEET FOR ADDITIONAL PARTICIPANTS.
ANSWER SHEET
Instrument Processing, Work Flow and Sterility Assurance
Name: Title:
Specialty:
Address: E-mail:City:
State:
ZIP: Country:Telephone: Home ( )
Office ( )
Lic. Renewal Date:
Requirements for successful completion of the course and to obtain dental continuing education credits: 1) Read the entire course. 2) Complete all information above. 3) Complete answer sheets in either pen or pencil. 4) Mark only one answer for each question. 5) A score of 70% on this test will earn you 4 CE credits. 6) Complete the Course Evaluation below. 7) Make check payable to PennWell Corp. For Questions Call 216.398.7822
Educational Objectives
1. List and describe the CDC guidelines for instrument processing in the dental office setting
2. List and describe the flow of instrument processing, as well as the considerations involved
3. List and describe the types of sterilizers available for use in the dental office, the use of cassettes during instrument processing, and the considerations involved in selecting these.
4. List and describe the purpose of sterility assurance and the tests required to monitor and document sterility assurance.
Course Evaluation
Please evaluate this course by responding to the following statements, using a scale of Excellent = 5 to Poor = 0.1. W ere the individual course objectives met?
O bjective #1: Yes No Objective #3: Yes No Objective #2: Yes No
Objective #4: Yes No 2. T o what extent were the course objectives accomplished overall? 5 4 3 2 1 03. Please rate your personal mastery of the course objectives. 5 4 3 2 1 04. How would you rate the objectives and educational methods? 5 4 3 2 1 05. How do you rate the author’s grasp of the topic? 5 4 3 2 1 06. Please rate the instructor’s effectiveness.
5 4 3 2 1 07. W as the overall administration of the course effective? 5 4 3 2 1
8. Do you feel that the references were adequate?
Yes No 9. W ould you participate in a similar program on a different topic?
Yes
No
10. I f any of the continuing education questions were unclear or ambiguous, please list them.
___________________________________________________________________11. W as there any subject matter you found confusing? Please describe.
___________________________________________________________________ ___________________________________________________________________12. W hat additional continuing dental education topics would you like to see?
___________________________________________________________________ ___________________________________________________________________
AUTHOR DISCLAIMER
The author(s) of this course has/have no commercial ties with the sponsors or the providers of the unrestricted educational grant for this course.
SPONSOR/PROVIDER
This course was made possible through an unrestricted educational grant from Hu-Friedy, Inc. and Midmark Corporation. No manufacturer or third party has had any input into the development of course content. All content has been derived from references listed, and or the opinions of clinicians. Please direct all questions pertaining to PennWell or the administration of this course to Machele Galloway, 1421 S. Sheridan Rd., Tulsa, OK 74112 or macheleg@https://www.doczj.com/doc/4c5551832.html,.
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INSTRUCTIONS
All questions should have only one answer. Grading of this examination is done manually. Participants will receive confirmation of passing by receipt of a verification form. Verification forms will be mailed within two weeks after taking an examination. EDUCATIONAL DISCLAIMER
The opinions of efficacy or perceived value of any products or companies mentioned in this course and expressed herein are those of the author(s) of the course and do not necessarily reflect those of PennWell.
Completing a single continuing education course does not provide enough information to give the participant the feeling that s/he is an expert in the field related to the course topic. It is a combination of many educational courses and clinical experience that allows the participant to develop skills and expertise.
COURSE CREDITS/COST
All participants scoring at least 70% (answering 21 or more questions correctly) on the examination will receive a verification form verifying 4 CE credits. The formal continuing education program of this sponsor is accepted by the AGD for Fellowship/Mastership credit. Please contact PennWell for current term of acceptance. Participants are urged to contact their state dental boards for continuing education requirements. PennWell is a California Provider. The California Provider number is 4527. The cost for courses ranges from $49.00 to $110.00.
Many PennWell self-study courses have been approved by the Dental Assisting National Board, Inc. (DANB) and can be used by dental assistants who are DANB Certified to meet DANB’s annual continuing education requirements. To find out if this course or any other PennWell course has been approved by DANB, please contact DANB’s Recertification Department at 1-800-FOR-DANB, ext. 445.
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CANCELLATION/REFUND POLICY
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INST0510DE
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?2010 Hu-Friedy Mfg. Co., Inc. All rights reserved. Hu-Friedy, the Hu-Friedy oval logo and IMS are trademarks of Hu-Friedy Mfg. Co., Inc. Chairside efficiency means having all
the instruments you need right at your fingertips. Many dental practitioners have found this easy to accomplish once they’ve integrated Hu-Friedy’s Instrument Management System (IMS) into their practice. The IMS cassette system is designed to keep your instruments organized and intact from cleaning to chairside. It eliminates instrument scrubbing and sorting, protects against breakage, and reduces the risk of injury. Dental practitioners believe the most convincing selling point for IMS Cassettes is saving 5 to 10 minutes per procedure. Call 1-800-Hu-Friedy or contact your authorized Hu-Friedy representative for more information, or
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=洗消间、包装灭菌间管理标准操作规程（SOP） 制订者：童文芬审核者：腾红艳版次：第1版 制订日期：2015-05-26 审核日期：2015-06-15 执行日期：2015-06-15 一、洗消间管理 1. 室内布局合理，环境清洁，通风良好，待洗物品与医疗废物分别放置。 2.清洗、消毒用品齐全：超声清洗机（建议选择高频）、多酶洗液、除锈剂、高压预真空消毒锅消毒剂（75%乙醇、含氯消毒剂等）、各种刷子、20ml注射器、注油机或专用手机油、纱布等。有条件可配备压力气枪、压力水枪。 3.清洗人员职业防护用品齐全。一次性防护用品用后更换；可重复使用的防护用品，每日用后清洁、消毒。 4.多酶洗液根据使用频次进行更换。可疑传染病人器械浸泡后，及时更换。 5.超声清洗机每日使用后，清洁内壁用500mg/L含氯消毒液擦拭消毒，作用30分钟后，清水擦净。清洗用具、清洗池每日清洁与消毒。 6.预真空高压灭菌机要使用蒸馏水消毒 7、医疗废物分类放置，锐利器械装入锐器盒内或置于可防刺容器内，外套黄色塑料袋。 8、常水过滤器根据水质定期取下清洗。 二、包装灭菌间管理 1. 室内布局合理，清洁整齐，通风不畅时进行空气消毒 2. 包装、灭菌及无菌物品存放应分区，各区物品放置有序。 ⑴检查包装区：带光源放大镜、纸塑包装袋、封口机、灭菌指示卡、指示胶带等。 ⑵灭菌区：压力蒸汽灭菌器、蒸馏水或灭菌水、布手套 ⑶无菌物品存放区：无菌柜。无条件时无菌柜也可放在诊室内。 3.检查包装人员戴帽子、穿清洁工作服，包装前洗手。 4. 监测：⑴压力蒸汽灭菌 ①每日使用前做工艺监测：压力表处于“0”位，打印记录装置备用状态，锅门密封圈平整无损，锅内清洁，排水口通畅，水箱添加蒸馏水或灭菌用水。②每锅化学监测。 ③小型压力蒸汽灭菌器每周生物监测一次，自制生物测试包，放在最难灭菌的部位，灭菌器处于满载状态。灭菌器新安装或大修后，连续监测三次，合格后方可使用。 ④每锅灭菌登记：包括锅次、灭菌参数（温度、压力、时间）记录、操作人。 参考文献： 1.卫生部《医疗机构口腔诊疗器械消毒技术操作规范》. 2.卫生部《消毒技术规范》（2002年版）. 3.WS310.3-2009《医院消毒供应中心清洗消毒及灭菌效果监测标准》.
牙科器械，消毒方法及管理 清洗消毒间管理制度 一、牙科诊疗器械应统一清洗、消毒、灭菌。 二、清洗消毒间应布局合理。 1、环境宽敞、通风良好，建筑材料防水。 2、清洗去污区与检查包装区相对独立。 3、压力蒸汽灭菌器应有独立区域。 三、清洗消毒间应配备相应清洗消毒设备。 1、去污区：专用流动水清洗槽，应满足洁污清洗清洗分开的需要，超声清 洗机、计时器、高压水枪、高压气枪或干燥设备、净水机或常水过滤器，相应清洗用品有各种刷子、纱布、棉棒等。 2、检查包装区：器械检查包装台、器械柜、带光源放大镜、注油机。如使 用纸塑包装袋，还需配备包装材料切割机医用热封机。 3、灭菌区：压力蒸汽灭菌器的灭菌蒸汽用水应为软水或纯化水。 4、其它耗材： （1）清洗剂：多酶洗液。 （2）消毒剂：适用于口腔诊疗器械的消毒剂、95%酒精、75%酒精等。 （3）润滑剂：专用水溶性润滑剂。 （4）除锈剂：专门用于医疗器械锈迹去除。 四、清洗用具、清洗池等应每日清洁与消毒。 五、清洗、消毒或者灭菌人员操作时应根据《消毒供应中心不同区域人员 防护着装标准操作规程》选用口罩帽子、手套、防水服、专用鞋、防护眼罩等个人防护装备。 六、压力蒸汽灭菌器的工艺、化学、生物监测应符合《医院消毒供应中心 第3部分》；《清洗消毒及灭菌效果监测标准》要求。 注：违反本制度规定者，相应责任人每次绩效考核得分扣3分，情节严重 造成较大后果者，由总经理酌情严肃处理。 口腔器械清洗消毒灭菌操作规程 第一步：收集、分检、毁形与传送 1、收集 （1）核对：由椅旁护士收集污染的手机/器械。在收集过程中，要仔细认真检查各类器械零件是否完备，核对数量及类别后交清洗消毒室。 （2）标记：消毒护士在收取过程中对于特殊器械（除手机外）如碧兰麻注 射器、外科手术钳、正畸去戴环钳等需在登记表上做特殊标记，以免造成收发错误。 （3）登记：为了做到收发正确无误，对于手机等特殊器械，必须建立特殊 器械收取、发入登记表。在工作中加强责任心，根据登记表做到收发无误。2、分检、毁形
口腔科器械清洗灭菌流程 This model paper was revised by the Standardization Office on December 10, 2020
口腔科手机清洗灭菌流程 预处理：医生每次治疗结束后及时踩脚闸冲洗手机管腔30秒，及时卸下，用湿棉球及时擦除手机表面肉眼可见的污物，放入诊室污染器械回收容器中暂存。保湿并密闭运送至消毒供应中心或清洗消毒室 冲洗：（手工刷洗）用专用刷刷洗并用高压水枪在流动水下彻底清洗 （机械清洗） 酶洗：将擦干后的器械泡在含酶液池内，用专用刷刷洗，（刷子每次用后浸泡消毒30分钟）浸泡酶液中8-9分钟或按使用说明，并用超声振荡5-10分钟 漂洗：用蒸馏水或纯净水水下冲洗 干燥：使用高压气枪吹干管道、风轮轴承表面水分。 养护：向手机内部注入专用的手机清洁润滑油并检查手机性能 包装：用独立纸塑包装 灭菌：首选预真空压力蒸汽灭菌。若使用快速压力蒸汽灭菌，可不封装裸露灭菌。 储存 口腔科器械清洗灭菌流程 预处理：口腔科医生将使用过的器械及车针、扩大针、拔髓针、根管铿、砂石磨头等小器械上的根管糊剂、血迹等物清洗去除后放入综合治疗台上的不锈钢小杯内，做好污染物品标识。清洗人员将小器械盒连同不锈钢小杯一起回收，集中进行处理。 冲洗：用专用刷刷洗并用高压水枪在流动水下彻底清洗
酶洗：将擦干后的器械泡在含酶液池内，用专用刷刷洗，（刷子每次用后浸泡消毒30分钟）浸泡酶液中8-9分钟或按使用说明，并用超声振荡5-10分钟 漂洗：用蒸馏水或纯净水水下冲洗 干燥：烘干或使用高压气枪吹干器械 包装：将小器械分类、对号排入器械盒内，其他诊疗器械用独立纸塑包装 灭菌：压力蒸汽灭菌。 储存
医疗器械的清洗、消毒、灭菌流程 1.盆、盘、碗、药杯 回收—→常水冲洗—→复合酶浸泡10分钟—→刷洗—→常水冲洗—→消毒液浸泡30分钟—→常水漂洗二遍—→纯水漂洗二遍—→控水—→干燥（90℃20分钟） 2.手术器械（除管腔器械外） 回收—→常水冲洗—→加酶超声清洗5分钟—→刷洗—→常水漂洗二遍—→纯水漂洗二遍—→水—→干燥（90℃20分钟）—→高压蒸汽灭菌 3.管腔器械 回收—→常水冲洗—→管腔注酶—→加酶超声清洗5分钟—→常水冲洗—→毛刷刷洗管腔—→加压水枪冲洗管腔—→常水冲洗—→消毒液浸泡30分钟—→常水漂洗二遍—→纯水漂洗二遍（纯水冲洗管腔）—→压力气枪吹干管腔—→干燥（90℃20分钟） 4.穿刺针 回收—→常水冲洗—→棉签清洁针座腔内—→针腔注酶—→加酶超声清洗5分钟—→常水冲洗—→加压水枪冲洗针腔内部—→消毒液浸泡30分钟—→常水冲洗二遍—→纯水冲洗二遍，并用纯水冲洗针腔内部—→压力气枪吹干管腔—→干燥（擦干）—→高压蒸汽灭菌 5.橡胶管 回收—→常水冲洗—→松节油擦洗外面污垢（胶布印）—→常水冲洗—→管腔注酶—→复合酶浸泡10分钟—→常水冲洗—→压力水枪冲洗管道内面—→消毒液浸泡30分钟—→常水冲洗二遍—→纯水冲洗二遍，并用纯水冲洗管腔—→压力气枪吹干管腔—→干燥（擦干） 6.筒、缸、瓶 回收—→常水冲洗—→刷洗—→消毒液浸泡30分钟—→常水冲洗二遍—→纯水冲洗二遍—→干燥（90℃20分钟）7.呼吸机管道
回收—→常水冲洗—→复合酶浸泡10分钟—→常水冲洗、刷洗—→消毒液浸泡30分钟—→常水冲洗二遍—→纯水冲洗二遍—→干燥（70℃20分钟） 8.湿化罐、集水杯、Y形管、接头 回收—→常水冲洗—→复合酶浸泡10分钟—→常水冲洗、刷洗—→消毒液浸泡30分钟—→常水冲洗二遍—→纯水冲洗二遍—→干燥（70℃20分钟） 9.氧气管、氧气湿化瓶 回收—→常水冲洗—→加压水枪冲洗管腔—→消毒液浸泡30分钟—→常水冲洗二遍—→纯水冲洗二遍—→擦干 附：特殊药液污染器具处理流程 1.碘污染器具：回收—→常水冲洗—→75﹪酒精浸泡20分钟 —→常水冲洗—→按常规器具处理 2.石蜡油污染器具：回收—→常水冲洗—→洗洁精刷洗—→ 常水冲洗—→按常规器具处理 3.生锈器械：回收—→除锈剂（1：7配比浓度）水温50℃浸 泡10分钟—→纯水冲洗二遍—→润滑剂浸泡10分钟—→晾干 4.有水垢的器具：回收—→水垢去除剂（15ml原液+1000ml水） 水温50℃浸泡10分钟—→常水冲洗二遍—→纯水冲洗二遍—→干燥（根据材质选择干燥方法及温度时间） 5.不耐湿热器具（电动工具等）：回收—→75﹪酒精擦拭消毒 —→擦干 6.新器械：常水冲洗—→毛刷沾洗洁精刷洗表面、关节、齿牙、 夹缝—→常水冲洗二遍—→纯水冲洗二遍—→干燥（擦干） 7.胶污染器械：松节油擦去胶印—→常水冲洗二遍—→如果 是新器械，按新器械处理方法；如果是正在使用的器械，按常规器械处理 8.手刷清洗流程：回收—→常水冲洗—→消毒液浸泡30分钟 —→常水冲洗，棉签沿毛缝擦洗—→常水冲洗—→纯水冲洗两遍—→干燥（70℃20分钟）
手术器械的清洗流程 （一）一般手术器械的处理一般手术器械是指非感染的手术器械，如甲状腺、疝气、椎间盘等手术器械。 处理方法：将术后器械的流动水下去除血污T酶浸泡2min以上（或+超声波震荡）宀流动 水彻底冲洗T分类烘干（精细、尖锐的器械要分开）T检查T上油T包装或分类存放于器械柜内。（二）一般感染手术器械的处理 一般感染手术器械是指切开腔道（如胃、肠、胰、阑尾等）、肿瘤根治、胧肿切开、结核病 灶清除以及为感染梅毒、艾滋病、病毒性肝炎患者实施手术的器械。 处理方法：将术后器械浸泡于含氯消毒液中30min T流动水刷洗干净T分类烘干T检查T上 油T分类保存于器械柜中。 （三）特殊感染手术器械的处理 特殊感染手术器械是指气性坏疽、炭疽、破伤风手术器械。 处理方法：将术后器械浸泡于含氯消毒液中30min T初步冲洗T包装T高压灭菌T于流动水 用毛刷彻底刷洗T分类烘干T检查T上油T包装T再次高压消毒后保存无菌器械柜中备用。 （四）内镜手术器械的处理 处理方法：卸下可移动的内镜部件、光学导线的连接配件、通道阀等T张开钳夹部位，以流动水冲洗衣面血迹、小刷轻轻刷洗T高压水枪冲洗关节部位、内腔通道，去除隐藏血迹或有 机物T浸泡于酶剂（腔镜专用清洗剂）的稀释液中2min，充分去除有机物T流动水再次冲 洗T擦干T高压氧气或压缩空气吹干各部件水分T专用润滑剂直接喷于器械表面、轴节、内腔、弹簧部位，再用镜头纸擦去表面油迹T保存于专用仪器柜中。若为HBsAg阳性者，术后器械应先浸泡于0.33%戊二醛稀释液（2%戊二醛1份，加水5份）15min，然后再按上法清洗。手术器械、内镜、一般诊疗用品的消毒灭菌要求 （一）凡进入人体组织或无菌器官的手术器具及物品全部采用高压灭菌或经外科切口进入无菌室的内镜及其附件，如腹腔镜，关节镜，脑室镜，膀胱镜，宫腔镜等用前应达到灭菌水平。 （二）接触未破损皮肤的一般诊疗用品如血压计，听诊器可在清洁的基础上用乙醇擦拭消毒， 血压计袖带若被血液，体液污染应在清洁的基础上用含500mg/L 有效氯消毒浸泡30分钟后再清洗干净。 （三）接触未破损粘膜的器具如扩阴器、开口器、舌钳、压舌板、体温表等，用后先清洁去污、消毒、擦干，耐高温的器具如扩阴器，开口器，压舌板采用高温灭菌，体温表在清洁的基础上用含氯消毒剂浸泡消毒30 分钟后，清水冲净擦干备用。 （四）通过管道间接与浅表体腔粘膜接触的器具如氧气湿化瓶、呼吸机、麻醉用器具，雾化器、胃肠减压器、吸引器、引流瓶等可在清洁的基础上耐高温的可用高压灭菌，不耐高温的可清洁后用500mg/L 含氯制剂浸泡30 分钟，用清水冲净晾干备用，严格要求一用一消毒，湿化液应用无菌水，如连续使用可每天更换湿化液，并每周更换消毒所用器具。 （五）凡进入人体自然通道与管腔粘膜接触的内镜及其附件，如喉镜、气管镜、支气管镜、胃镜、乙状结肠镜、直肠镜等，可用过氧乙酸，戊二醛、万福金安等高效消毒剂。 （六）进入破损粘膜的内镜附件也应达到灭菌水平，如活检钳、高频电刀。 （七）口腔器材按照其危害程度进行不同的处理，外科器械及其它穿破口腔软组织或骨组织 的器械，不穿破口腔软组织但与软组织有接触的器械必须灭菌，口腔检查器械如镊子、压舌板、
n竹子□腔 ■RHVIEM3 DKFltHL 云南竹子口腔医院有限公司 编号：ZZKQ-YY-001 版号：2018
口腔器械消毒灭菌技术操作规范目录、范围 _ 、 三、 适用范围术语和定义 四、五、六、七、八、管理要求 口腔器械处理基本原则检测要求 消毒与火菌物品放行器械储存
口腔器械消毒灭菌技术操作规范 一、范围 规定了口腔器械消毒灭菌的管理要求、基本原则、操作流程、灭菌监测、灭 菌物品放行和器械存储要求。 二、适用范围 本标准适用于各级各类开展口腔疾病预防、诊断、治疗服务的医疗机构。已实现消毒供应中心集中供应的，其口腔器械的处置方法可参照本标准执行。 三、术语和定义 （一）口腔器械 用于预防、诊断、治疗口腔疾患和口腔保健的可重复使用器械、器具和物品。（三）牙科小器械 规格较小的牙科器械，如各种型号车针、根管器具等。 （四）牙科手机 用来向牙科工具或器具传递（带转换或不带转换）工作所需能量的手持工具夹。 （五）根管具器 用来对根管进行探查、穿透、预备或充填的器具，如根管搓、根管扩大器、 根管光滑髓针等 （六）牙洁治器 专门设计和（或）用于清除牙齿表面牙垢的手动或电动牙科器械。 （七）高度危险口腔器械
穿透软组织、接触骨、进入或接触血液或其他无菌组织的口腔器械。 （八）中度危险口腔器械 与完整黏膜相接触，而不进入人体无菌组织、器官和血流，也不接触破损皮肤、破损黏膜的口腔器械。 （九）低度危险口腔器械 不接触患者口腔或间接接触患者口腔，参与口腔诊疗服务，虽有微生物污染，但在一般情况下无害，只有收到一定量的病原微生物污染时才造成危害的口腔器械。 （十）小型压力蒸汽灭菌器自动控制型 由电加热产生蒸汽或外接蒸汽的自动控制，其灭菌室容积不超过60L的小 型自动控制蒸汽灭菌器，以下简称小型灭菌器。 （十一）A类空腔负载 单端开孔负载，其长度（L）与孔直径（D ）的比率大于等于1，小于或等 于750 （1 WL/D <750 ）并且长度不大于1500mm （L <1500mm ），或者两端开孔负载其长度与孔直径的比率大于等于2，小于或等于1500之间（2 <_/D < 1500 ）并且长度不小于3000mm （L<3000mm ），而且不属于B类空腔负载。示例：牙科手机属于A类空腔负载器械 （十二）B类空腔负载 单端开孔负载，其长度（L）与孔直径（D ）的比率大于等于1，小于或等 于5 （1
口腔器械消毒灭菌技术操作规范WＳ/50６-2016发布 中华人民共和国卫生行业标准 WS5０6-２0１6 口腔器械消毒灭菌技术操作规范 Ｒｅｇulatiｏnforｄisinfｅcｔｉoｎａnｄｓterilizationtecｈniqｕeofｄｅ ntalｉnstrumｅnｔｓ 2０16-12-２7发布201７－０６-0１实施 中华人民共和国国家卫生和计划生育委员会发布 目次 前言III 1.范围Ｉ ２.规范性引用文件1 ３.术语和定义1 ４．管理要求２ 5.口腔器械处理基本原则3 6.口腔器械处理操作流程3 7．监测要求5 8.消毒与灭菌物品放行５ ９．器械储存5 附录Ａ(规范性附录)培训内容与管理要求6 附录B(规范性附录）口腔器械危险程度分类与消毒、灭菌、储存要求7 附录C（规范性附录)器械、器具和物品的清洗操作方法8 附录D(规范性附录)牙科手机清洗、保养方法10 附录Ｅ（规范性附录)小型灭菌器灭菌与监测要求１3 附录F(资料性附录）灭菌器灭菌周期运行记录表1５? 前言 本标准的4.2.2d）、4.3.3、4.4.3、6.１．2a)和c、6．2．２、6．2．３、６.2．4、６.3、６.６．2、6.６．3、６．7．２、7.1.３为推荐性条款，其余为强制性条款。 根据《中华人民共和国传染病防治法》和《医院感染管理办法》制定本标准。 本标准按照GB／T1.１—200９给出的规则起草。 本标准起草单位:北京大学口腔医院、首都医科大学附属北京口腔医院、天津南开大学附属口腔医院、吉林大学口腔医院、中山大学附属口腔医院、中国疾病预防控制中心、北京大学第一医院。 本标准主要起草人:沈曙铭、刘翠梅、俞光岩、苏静、丁效芳、刘东玲、章小缓、班海群、李六亿、王春丽、李秀娥。 口腔器械消毒灭菌技术操作规范 1范围 本标准规定了口腔器械消毒灭菌的管理要求、基本原则、操作流程、灭菌监测、灭菌物品放行和器械储存要求。
口腔器械清洗消毒流程 规范 The document was finally revised on 2021
=洗消间、包装灭菌间管理标准操作规程（SOP） 制订者：童文芬审核者：腾红艳版次：第1版 制订日期：2015-05-26 审核日期：2015-06-15 执行日期：2015-06-15 一、洗消间管理 1. 室内布局合理，环境清洁，通风良好，待洗物品与医疗废物分别放置。 2.清洗、消毒用品齐全：超声清洗机（建议选择高频）、多酶洗液、除锈剂、高压预真空消毒锅消毒剂（75%乙醇、含氯消毒剂等）、各种刷子、20ml注射器、注油机或专用手机油、纱布等。有条件可配备压力气枪、压力水枪。 3.清洗人员职业防护用品齐全。一次性防护用品用后更换；可重复使用的防护用品，每日用后清洁、消毒。 4.多酶洗液根据使用频次进行更换。可疑传染病人器械浸泡后，及时更换。 5.超声清洗机每日使用后，清洁内壁用500mg/L含氯消毒液擦拭消毒，作用30分钟后，清水擦净。清洗用具、清洗池每日清洁与消毒。 6.预真空高压灭菌机要使用蒸馏水消毒 7、医疗废物分类放置，锐利器械装入锐器盒内或置于可防刺容器内，外套黄色塑料袋。 8、常水过滤器根据水质定期取下清洗。 二、包装灭菌间管理 1. 室内布局合理，清洁整齐，通风不畅时进行空气消毒 2. 包装、灭菌及无菌物品存放应分区，各区物品放置有序。 ⑴检查包装区：带光源放大镜、纸塑包装袋、封口机、灭菌指示卡、指示胶带等。 ⑵灭菌区：压力蒸汽灭菌器、蒸馏水或灭菌水、布手套 ⑶无菌物品存放区：无菌柜。无条件时无菌柜也可放在诊室内。 3.检查包装人员戴帽子、穿清洁工作服，包装前洗手。 4. 监测：⑴压力蒸汽灭菌 ①每日使用前做工艺监测：压力表处于“0”位，打印记录装置备用状态，锅门密封圈平整无损，锅内清洁，排水口通畅，水箱添加蒸馏水或灭菌用水。②每锅化学监测。 ③小型压力蒸汽灭菌器每周生物监测一次，自制生物测试包，放在最难灭菌的部位，灭菌器处于满载状态。灭菌器新安装或大修后，连续监测三次，合格后方可使用。 ④每锅灭菌登记：包括锅次、灭菌参数（温度、压力、时间）记录、操作人。
手术器械的清洗流程 (—）一般手术器械的处理 一般手术器械是指非感染的手术器械，如甲状腺、疝气、椎间盘等手术器械。 处理方法﹔将术后器械的流动水下去除血污→酶浸泡2min以上（或+超声波震荡）→流动水彻底冲洗→分类烘干（精细、尖锐的器械要分开)→检查→上油→包装或分类存放于器械柜内。 (二）一般感染手术器械的处理 —般感染手术器械是指切开腔道（如胃、肠、胰、阑尾等)、肿瘤根治、胧肿切开、结核病灶清除以及为感染梅毒、艾滋病、病毒性肝炎患者实施手术的器械。 处理方法:将术后器械浸泡于含氯消毒液中30min→流动水刷洗干净→分类烘干→检查→上油→→分类保存于器械柜中。 (三）特殊感染手术器械的处理 特殊感染手术器械是指气性坏疽、炭疽、破伤风手术器械。 处理方法，将术后器械浸泡于含氯消毒液中30min→初步冲洗→包装→高压灭菌→于流动水用毛刷彻底刷洗分类烘干检查→上油→包装→再次高压消毒后保存无菌器 械柜中备用。 (四）内镜手术器械的处理 处理方法:卸下可移动的内镜部件、光学导线的连接配件、通道阀等→张开钳夹部位，以流动水冲洗衣面血迹、小刷轻轻刷洗→高压水枪冲洗关节部位、内腔通道，去除隐藏血迹或有机物→浸泡于酶剂（腔镜专用清洗剂）的稀释液中2min，充分去除有机物→流动水再次冲洗→擦干→高压氧气或压缩空气吹干各部件水分→专用润滑剂直接喷于器械表面、轴节、内腔、弹簧部位，再用镜头纸擦去表面油迹→保存于专用仪器柜中。若为HBsAg 阳性者，术后器械应先浸泡于0.33%戈二醛稀释液（2%戊二醛1份，加水5份）15min，然后再按上法清洗。 手术器械、内镜、一般诊疗用品的消毒灭菌要求 (一)凡进入人体组织或无菌器官的手术器具及物品全部采用高压灭菌或经外科切口进入无 菌室的内镜及其附件，如腹腔镜，关节镜，脑室镜，膀胱镜，宫腔镜等用前应达到火菌水平。 (二)接触未破损皮肤的一般诊疗用品如血压计,听诊器可在清洁的基础上用乙醇擦拭消毒， 血压计袖带若被血液，体液污染应在清洁的基础上用含500mg/L有效氯消毒浸泡30分钟后再清洗干净。 (三）接触未破损粘膜的器具如扩阴器、开口器、舌钳、压舌板、体温表等，用后先清洁去污、消毒、擦干，耐高温的器具如扩阴器，开口器，压舌板采用高温灭菌，体温表在清洁的基础上用含氯消毒剂浸泡消毒30分钟后，清水冲净擦干备用。 (四）通过管道间接与浅表体腔粘膜接触的器具如氧气湿化瓶、呼吸机、麻醉用器具，雾化器、胃肠减压器、吸引器、引流瓶等可在清洁的基础上耐高温的可用高压灭菌，不耐高温的可清洁后用500mg/L含氯制剂浸泡30分钟，用清水冲净晾干备用，严格要求一用一消毒，湿化液应用无菌水，如连续使用可每天更换湿化液，并每周更换消毒所用器具。 (五）凡进入人体自然通道与管腔粘膜接触的内镜及其附件，如喉镜、气管镜、支气管镜、
牙科器械消毒灭菌操作流程 第一步：手机/器械收集、分检、毁形与传送 1、收集 （1）核对：由供应室人员统一到各科诊疗室内收集污染的手机/器械。在收取过程中，要仔细认真，检查手机、碧兰麻注射器等器械零件是否完备，数量及和别。 （2）标记：在收取过程中对于特殊器械（除手机外）如碧兰麻注射器、外科手术钳、正畸去戴环钳等需在登记表上做特殊标记，以免造成发送错误。（3）登记：为了做到收发正确无误，对于手机等特殊器械，必须建立手机器械收取、发入登记表。在工作中加强责任心，根据登记表做到收发数目一至无误。 2、分检、毁形 （1）初步分检：将回收的污染物品首先进行初步分人，将各科的特殊专业器械分开浸泡，做到分科明确，器械物品不混淆。 （2）一次性医疗器械毁形：对于门诊使用的一次性医疗器械，先采用1：200的84消毒液初步浸泡，再用毁形后由厂家统一焚烧处理。如遇传染病（肝炎、结核）等患者使用过的器械需特殊处理，用1：50的84消毒液隔离浸泡30分钟后再毁形，医疗器械隔离浸泡后再清洗灭菌。 （3）传送 ①明确划区：在工作中严格划分三个区域，即：污染区、清洁区、无菌区（污染区指污物回收分类的区域；清洁区也称消毒区，批消毒、清洗、干燥、检验、维修包装的区域；无菌区也换洁净区，指灭菌储存发放的区域）。由清洁区进入无菌区需摘取、更换手套并换鞋，以确保预防交叉感染。
②传送要求：器械物品的传送要由污到净，单向循环，不得逆流与交叉穿梭。第二步：清洗消毒（表1） 凡接触过病原微生物的物品，不易洗涤的器械（如玻璃板、带残留水门汀的器具和调和刀、托盘等）在进入加热、清洗/应先以化学消毒剂处理，再用手小心翼翼的去除剩污材料，同时进行预清洗一遍，再统一进入加热清洗/消毒机，选择操作程序彻底清洗。 1、去污 污物除不净不仅影响去除热原效果，对于仪器也有损坏作用，因此须高度重视。（1）玻璃板、调刀洗涤：玻璃板上的粘固剂很难去除，清洗要求高，清洗时用竖力将玻璃板及调刀上残留的水门汀粘固剂去除，并用竖刷蘸适量的洗涤剂（去污粉、消毒液等）初步处理。 （2）拔牙钳洗涤：首先将带血器械上的血污用1：200的84消毒液浸泡10分钟，再用竖刷掉。 （3）牙科车针的洗涤：牙科车针（特别是外科手术车针）由于操作中软组织卷覆表面，刷洗时用小牙刷或钢丝刷清车针工作端，必要时用镊子去除覆盖软组织，使工作端没有任何异物。 2、摆放 按要求将污染手机/器械分别码入清洗/消毒机内的手机插座、插入架、网盒及下层蓝筐内。 （！）摆放要求：根据不同需要选用不同装载框码放器械。例如：玻璃板摆放需要成排、直立、有空档。并充分固定；针针放在密闭小盒内，牙钳、挻子、口腔器械直立码放，戴关节的器械要打开。
口腔器械清洗灭菌处 理操作流程 1、牙科手机使用后在带车针情况下送 水、送气30s ，卸下取出车针，去除 表面污 染物。带 电 源 类 存放于干燥回 收容器。 2、使用后与废弃物品分开。 3、结构复杂不易清洗的牙科小器械、刮匙使用生活饮 用水保湿放置。1、使用吹风机吹干； 2、低纤维絮擦布擦干。 1、进行灭菌器运行前的安全检查。 2、待灭菌物品干燥，不能超过灭菌器最大装载量。用托盘单层摆放纸塑包装器 械和无包装器械。包装类 物品间 应留有间 隙。牙科手机与车针 、 电 动 牙 洁 治器 手柄与工作尖等分开灭 菌 3、选择灭菌周期，灭菌参数：温度132℃、4 分钟、185.4kpa ，每锅监测物理 参数、化学监 测，并记 录监 测结 果，每月使用自含式生物指示物进行生物监 测 。 灭菌周期的各种监 测或参数不合格时 不得放行使用，重新调整至合格后灭 菌器 方可再次使用。灭 菌起运行周期文件记 录保存 3 年。 回收分类 灭菌清洗干燥检查保养包装储存 消毒 1、牙科手机单独清洗、带螺纹表面 用软毛刷清洗，不能浸泡液体内； 官腔类器械拆开。 2、水温15-30℃，先冲洗，使用酶清洗剂或其他清洗剂 浸泡；然后在 水面下刷洗，擦洗、流动水漂洗。3、牙科小器械及结构复杂的器械进 行超声波清洗。冲洗去除污染物后 放入清洗机；洗涤水温≤45℃，添加清洗剂，完全浸没篮 筐、官腔内 注满水，盖上盖子，40Hz、清洗时间 <10 分钟 ；流动 水终 末漂洗。1、干燥后的器械目测器械 表面、螺旋结构处 、关节 处 无 污 渍、水渍 等残留物 质 和 锈 斑。 2、清洗质量不合格的器械 重新处理。 3、损坏或变形的器械应及 时 更 换 。 4、牙科手机的保养遵循使 用说 明书 。夹 持部分每日 手工注油、避免油雾播散。 1、根据器械特点和使用频率选择包装 材料，每日使用热封机前应 检查 参数 的准确性； 2、重度危险性物品包内、外均应有化 学指示物；低度、中度危险 的口腔器 械可不包装，消毒或灭 菌后直接放入 备用清洁 容器内保存。牙科小器械用 牙科器械盒盛装。 3、包外有灭菌化学指示物，并标有物 品名称、包装者、灭菌器编 号、灭 菌 批次、灭菌日期及失效期，纸 塑袋包 装时 应密封完整，密封宽 度≥6mm，包 内器械距包装袋封口处 ≥ 2.5cm。 1、适用于不耐热、耐 湿的中、低度危险 性物 品可用含氯 制剂 2000mg/L浸泡30min, 流动 水冲净 。 2、选择正确的化学消 毒剂 ，每次使用前检查 其有效浓 度，并达到规 定的消毒时 间要求。每 季度进 行消毒效果集 染菌量的监 测 。 1、每周清洁物品存放 柜（车），灭 菌物品与 消毒物品分开。 2、裸露灭菌及一般容 器包装的高度危险口 腔器械灭菌后使用不 超过4h；纺 织材料、牙 科器械盒包装及中、低 度危险口腔器械消毒 或灭菌后置于清洁 干 燥的容器内保存<7 天； 纸塑袋<180天。
北京大学口腔医院李秀娥 写在课前的话 本课件详细介绍了口腔诊疗器械的处理流程，包括回收与分拣、运送、清洗、干燥、维护与保养、包装、灭菌、监测、储存与发放等环节，逻辑清楚，内容丰富，并配有大量图片，学员通过本课件的学习，可以详细地了解口腔诊疗器械的处理流程。 试述诊疗器械使用、处理遵循的原则。 一、口腔诊疗器械使用、处理遵循的原则 （一）进入病人口腔内的所有诊疗器械，必须达到“一人、一用、一消毒或一灭菌”。 （二）接触病人伤口、血液、破损黏膜或者进入人体组织的各类口腔诊疗器械，如钻针、拔牙器械、种植器械等，使用前必须达到灭菌。 （三）接触病人皮肤、完整黏膜的口腔诊疗器械，如口镜、漱口杯、开口器等，使用前必须达到消毒。 （四）接触病人体液、血液的正畸、修复印模、模型等，送技工室前必须消毒。 （五）牙科综合治疗台及其配套设施应每日清洁、消毒，如有污染随时清洁、消毒。 （六）在诊疗或对口腔诊疗器械进行清洗、消毒以及灭菌的过程中，工作人员应做好个人防护。 牙科手机应如何清洗？ 二、口腔器械的处理流程 口腔诊疗器械的处理流程。应该按照以下几个方面的程序来进行：①回收与分拣；②运送；③清洗；④干燥；⑤维护与保养；⑥包装；⑦灭菌；⑧监测；⑨储存与发放。 （一）回收与分拣 一次性使用物品“一人一用一弃”，使用后应该按《医疗废物管理条例》进行分类收集。如手套、吸唾管、医用防污膜等要放入黄色的医用垃圾袋内进行焚烧。
一次性口镜、镊子、 探针等锐利器械用后置于 锐器盒内。 分拣流程：当治疗结 束后，首先拣出探针、镊子等一次性器械放入锐器合内，再拣出可重复使用的器械如牙科手机、充填 器等，然后拣出牙科钻针、各种根管挫等小器械，最后将纸杯、胸巾等用物丢弃。见左图。 首先将探针、镊子等锐器拣出，减少护士的职业暴露伤，并且按照规范的流程来进行，养成习惯后，可以减少器械的丢失及提高工作效率。 重复使用的医疗器械如牙科手机、钻针、充填器、刮匙等分类放置，这样便于清洗，可减少器械的相互碰撞与损伤。牙科手机应轻拿、轻放。 （二）运送 运送污染器械时应在密闭容器内运送，以减少诊室、走廊等所经过区域污染。 （三）清洗 《消毒技术规范》明确规定：所有被污染的物品及物体表面在消毒、灭菌前必须清洗。 清洗是灭菌的前提和基础。清洗过程中尽量使用自动化清洗设备，如自动清洗机，超声清洗器，尽量减少人工清洗。 1.清洗试剂：日常生活中常用肥皂或合成清洁剂，去除油渍、污渍，洗得更干净；医疗通常推荐酶、碱性、中性、酸性等化学物品作为清洗剂，溶解器械表面的蛋白，使清洗更彻底。 2.常用清洗方法：（1）自动清洗机；（2）超声清洗器；（3）手工清洗。国际上推荐尽量使用自动化清洗设备，可提高清洗的效果及效率，同时减少护士发生职业暴露。 （1）自动清洗机清洗 适用范围：大部分口腔诊疗器械。 工作原理：和洗碗机类似，利用高温水再循环和去污剂联合作用，以消除器械上有机物质。见右图。 （2）超声清洗机清洗 适用范围：大部分口腔诊疗器械。 工作原理：利用超声波的冲击、震荡，渗透到人工不能触及的盲管部和微细部件，可提高清洗的效果及效率。见左图。 超声清洗可减少器械间的碰撞，避免工作端损伤。超声清洗时间一般为 3-5 分钟即可，可根据器械污染情况延长清洗时间，不超过 10 分钟。
口腔消毒流程规范-标准化文件发布号：（9456-EUATWK-MWUB-WUNN-INNUL-DDQTY-KII
口腔消毒流程规范 1、收集 （1）核对：由消毒人员统一收集污染的手机/器械。在收取过程中，要仔细认真，检查手机、注射器等器械零件是否完备，数量及和别 （2）登记：为了做到收发正确无误，对于手机等特殊器械，必须建立手机器械等消毒记录 2、分检、毁形 （1）初步分检：将回收的污染物品首先进行特殊器械分开浸泡，做到分类明确，器械物品不混淆。 （2）一次性医疗器械毁形：对于门诊使用的一次性医疗器械一律毁形后由专门医疗垃圾回收站统一焚烧处理。如遇传染病（肝炎、结核）等患者使用过的器械需特殊处理，用1：50的84消毒液隔离浸泡30分钟后再毁形，医疗器械隔离浸泡后再清洗灭菌。 3、清洗消毒 凡接触过病原微生物的物品，不易洗涤的器械（如玻璃板、带残留水门汀的器具和调和刀、托盘等）在进入加热、清洗/应先以化学消毒剂处理，再用手小心翼翼的去除剩污材料，同时进行预清洗一遍，再统一进入加热清洗/消毒机，选择操作程序彻底清洗。 （1）、去污 污物除不净不仅影响去除热原效果，对于仪器也有损坏作用，因此须高度重视。 （2）、玻璃板、调刀洗涤：玻璃板上的粘固剂很难去除，清洗要求高，清洗时用竖力将玻璃板及调刀上残留的水门汀粘固剂去除，并用竖刷蘸适量的洗涤剂（去污粉、消毒液等）初步处理。 （3）拔牙钳洗涤：首先将带血器械上的血污用1：200的84消毒液浸泡10分钟，再用竖刷掉。
（4）牙科车针的洗涤：牙科车针（特别是外科手术车针）由于操作中软组织卷覆表面，刷洗时用小牙刷或钢丝刷清车针工作端，必要时用镊子去除覆盖软组织，使工作端没有任何异物。 4、选择程序 目前，我中心采用的是三次预真空高压蒸汽电脑全控制工作中需根据实际需要选择不同程序。 5、包装 包装是保持灭菌物品的无菌状态的重要手段。 （1）包装材料有良好的蒸气穿透性，能阻挡微生物侵入； （2）分类包装 塑封消毒能保证被包装物品在无菌状态下使用，半年内有效，因此除手机外，对于口腔器械，如：牙挻、牙钳、剪都可分类包装，便于使用。 （3）包装要求 包装好的物品应在袋外标记，包装日期 （4）塑封 手机清洁注油后装入纸塑复合包装袋，塑料薄膜封口塑封 6、灭菌 由于手机是空心，回吸残留各种细菌，再加上纸袋封包，封包时纸袋内存有冷空气，如不排净手机空腔及纸袋内的空气，高温蒸汽是无法进到纸袋内的，达不到灭菌目的。故应选用带3次预真空的高温高压灭菌器。 （1）包装灭菌时注意确保包装袋之间有良好的间隙，且灭菌袋纸面向上，有利于蒸气流通及空气排出。 （2）混合灭菌时织物包装和器械由下到上的放置顺序是器械包装和织物，且物品之间尽量不要接触
《口腔诊疗器械消毒灭菌技术规范》练习题 一、单项选择题 1.口腔科器械处理必须的配备的设备,下列哪项是错误的( A. 污物回收器具 B. 手工清洗池 C. 工作台 D. 牙科手机专用自动注油养护机 E. 超声清洗机及灭菌设备 2.口腔器械清洗方法包括( A. 手工清洗 B. 超声波清洗 C. 机械清洗 D. 以上都对 3.电动牙洁治器手柄宜选用什么方法清洗( A. 手工清洗 B. 超声波清洗 C. 机械清洗 D. 以上都对 4.牙科小器械及其他结构复杂的器械首选( A. 手工清洗 B. 超声波清洗 C. 机械清洗 D. 以上都对 5. 口腔诊疗器械应根据器械、器具的材料选择适宜的干燥温度, 金属类和塑料类的干燥温度分别是多少( A. 金属类干燥温度 70℃~90℃,塑料类干燥温度 50℃~60℃ B. 金属类干燥温度 70℃~90℃,塑料类干燥温度 65℃~75℃ C. 金属类干燥温度 100℃~120℃,塑料类干燥温度 50℃~60℃ D. 金属类干燥温度 100℃~120℃,塑料类干燥温度 65℃~75℃ 6. 口腔诊疗器械使用纸塑袋、纸袋包装是应密封完整, 密封宽度及包装器械距包装封口处应达到( A. 密封宽度≥ 4mm ,包装器械距包装封口处≥ 1.5mm
B. 密封宽度≥ 5mm ,包装器械距包装封口处≥ 2mm C. 密封宽度≥ 6mm ,包装器械距包装封口处≥ 2.5mm D. 密封宽度≥ 7mm ,包装器械距包装封口处≥ 3mm 7.碳钢材质的口腔诊疗器械灭菌方法宜选用( A. 压力蒸汽灭菌 B. 化学灭菌剂浸泡灭菌 C. 干热灭菌 D. 以上都不对 8.下列哪组口腔诊疗器械属于中度危险器械( A. 拔牙钳、牙挺、牙龈分离器、牙齿分离器 B. 刮治器、刮匙、挖匙、根管扩大器 C. 口镜、正畸钳、去冠器、牙科手机 D. 模型雕刻刀、牙锤、聚醚枪、技工钳 二、多项选择题 1.关于口腔科器械处理区,以下描述正确的是( A. 区域内按工作要求分为回收清洗区、保养包装及灭菌区、物品存放区 B. 回收清洗区承担器械回收、分类、清洗、除锈、干燥工作 C. 保养包装及灭菌区承担器械的保养、检查、包装、灭菌工作 D. 物品存放区存放消毒、灭菌后的物品, 以及去除外包装的一次性医疗用品回收清洗区与保养包装区之间可无物理屏障 2.以下描述正确的是( A. 灭菌器新安装或更换主要部件应进行灭菌性能确认 B. 灭菌器每使用 12个月应进行物理监测、化学监测和生物监测 C. 灭菌器维修后应进行物理监测、化学监测和生物监测
口腔器械清洗消毒灭菌操作规程 第一步：收集、分检、毁形与传送 1、收集 （1）核对：由椅旁护士收集污染的手机/器械。在收集过程中，要仔细认真检查各类器械零件是否完备，核对数量及类别后交清洗消毒室。 （2）标记：消毒护士在收取过程中对于特殊器械（除手机外）如碧兰麻注射器、外科手术钳、正畸去戴环钳等需在登记表上做特殊标记，以免造成收发错误。 （3）登记：为了做到收发正确无误，对于手机等特殊器械，必须建立特殊器械收取、发入登记表。在工作中加强责任心，根据登记表做到收发无误。 2、分检、毁形 （1）初步分检：将回收的污染物品首先进行初步分人，将各诊室的特殊专业器械分开浸泡，做到分类明确，器械物品不混淆。 （2）一次性医疗器械毁形：对于已经使用的一次性医疗器械，先采用1：200的84消毒液初步浸泡，再毁形后由装入利器盒待收。如遇传染病（肝炎、结核）等患者使用过的器械需特殊处理，用1：50的84消毒液隔离浸泡30分钟后再毁形，医疗器械隔离浸泡后再清洗灭菌。 （3）传送 ①明确划区：在工作中严格划分三个区域，即：污染区、清洁区、无菌区（污染区指污物回收分类的区域；清洁区也称消毒区，批消毒、清洗、干燥、检验、维修包装的区域；无菌区也换洁净区，指灭菌储存发放的区域）。由清洁区进入无菌区需摘取、更换手套并换鞋，以确保预防交叉感染。 ②传送要求：器械物品的传送要由污到净，单向循环，不得逆流与交叉穿梭。 第二步：清洗消毒 凡接触过病原微生物的物品，不易洗涤的器械（如玻璃板、带残留水门汀的器具和调和刀、托盘等）在进入加热、清洗前应先以化学消毒剂处理，去除剩污材料，同时进行预清洗一遍，再统一进入加热清洗/消毒机，选择操作程序彻底清洗。 1、去污：污物除不净不仅影响去除热原效果，对于仪器也有损坏作用，因此须高度重视。 （1）玻璃板、调刀洗涤：玻璃板上的粘固剂很难去除，清洗要求高，清洗时
口腔器械处理操作流程 Document number：PBGCG-0857-BTDO-0089-PTT1998
1、牙科手机使用后在带车针情况下 送水、送气30s ，卸下取出车针， 去除表面污染物。带电源类存放于干 燥回收容器。 2、使用后与废弃物品分开。 3、结构复杂不易清洗的牙科小器 械、刮匙使用生活饮用水保湿放置。 1、使用吹风机吹干； 2、低纤维絮擦布擦 干。 1、牙科手机单独清洗、带螺纹表 面用软毛刷清洗，不能浸泡液体 内；官腔类器械拆开。 2、水温15-30℃，先冲洗，使用酶 清洗剂或其他清洗剂浸泡；然后在 水面下刷洗，擦洗、流动水漂洗。 3、牙科小器械及结构复杂的器械 进行超声波清洗。冲洗去除污染物 后放入清洗机；洗涤水温≤45℃， 添加清洗剂，完全浸没篮筐、官腔 内注满水，盖上盖子，40Hz、清洗 1、干燥后的器械目测器 械表面、螺旋结构处、关 节处无污渍、水渍等残留 物质和锈斑。 2、清洗质量不合格的器 械重新处理。 3、损坏或变形的器械应 及时更换。 4、牙科手机的保养遵循 使用说明书。夹持部分每 1、根据器械特点和使用频率选择包 装材料，每日使用热封机前应检查参 数的准确性； 2、重度危险性物品包内、外均应有 化学指示物；低度、中度危险的口腔 器械可不包装，消毒或灭菌后直接放 入备用清洁容器内保存。牙科小器械 用牙科器械盒盛装。 3、包外有灭菌化学指示物，并标有 物品名称、包装者、灭菌器编号、灭 菌批次、灭菌日期及失效期，纸塑袋 包装时应密封完整，密封宽度≥ 1、进行灭菌器运行前的安全检查。 2、待灭菌物品干燥，不能超过灭菌器最大装载量。用托盘单层摆放纸塑包装 器械和无包装器械。包装类物品间应留有间隙。牙科手机与车针、电动牙洁治 器手柄与工作尖等分开灭菌 3、选择灭菌周期，灭菌参数：温度132℃、4分钟、，每锅监测物理参数、 化学监测，并记录监测结果，每月使用自含式生物指示物进行生物监测。灭菌 周期的各种监测或参数不合格时不得放行使用，重新调整至合格后灭菌器方可 再次使用。灭菌起运行周期文件记录保存3年。 1、每周清洁物品存放 柜（车），灭菌物品 与消毒物品分开。 2、裸露灭菌及一般容 器包装的高度危险口 腔器械灭菌后使用不 超过4h；纺织材料、 牙科器械盒包装及 中、低度危险口腔器 械消毒或灭菌后置于 清洁干燥的容器内保 1、适用于不耐热、耐 湿的中、低度危险性 物品可用含氯制剂 2000mg/L浸泡30min, 流动水冲净。 2、选择正确的化学消 毒剂，每次使用前检 查其有效浓度，并达 到规定的消毒时间要 求。每季度进行消毒
口腔器械处理操作流程 Prepared on 22 November 2020
1、牙科手机使用后在带车针情况下 送水、送气30s ，卸下取出车针， 去除表面污染物。带电源类存放于干 燥回收容器。 2、使用后与废弃物品分开。 3、结构复杂不易清洗的牙科小器 械、刮匙使用生活饮用水保湿放置。 1、使用吹风机吹干； 2、低纤维絮擦布擦 干。 1、牙科手机单独清洗、带螺纹表 面用软毛刷清洗，不能浸泡液体 内；官腔类器械拆开。 2、水温15-30℃，先冲洗，使用酶 清洗剂或其他清洗剂浸泡；然后在 水面下刷洗，擦洗、流动水漂洗。 3、牙科小器械及结构复杂的器械 进行超声波清洗。冲洗去除污染物 后放入清洗机；洗涤水温≤45℃， 添加清洗剂，完全浸没篮筐、官腔 内注满水，盖上盖子，40Hz、清洗 1、干燥后的器械目测器 械表面、螺旋结构处、关 节处无污渍、水渍等残留 物质和锈斑。 2、清洗质量不合格的器 械重新处理。 3、损坏或变形的器械应 及时更换。 4、牙科手机的保养遵循 使用说明书。夹持部分每 1、根据器械特点和使用频率选择包 装材料，每日使用热封机前应检查参 数的准确性； 2、重度危险性物品包内、外均应有 化学指示物；低度、中度危险的口腔 器械可不包装，消毒或灭菌后直接放 入备用清洁容器内保存。牙科小器械 用牙科器械盒盛装。 3、包外有灭菌化学指示物，并标有 物品名称、包装者、灭菌器编号、灭 菌批次、灭菌日期及失效期，纸塑袋 包装时应密封完整，密封宽度≥ 1、进行灭菌器运行前的安全检查。 2、待灭菌物品干燥，不能超过灭菌器最大装载量。用托盘单层摆放纸塑包装 器械和无包装器械。包装类物品间应留有间隙。牙科手机与车针、电动牙洁治 器手柄与工作尖等分开灭菌 3、选择灭菌周期，灭菌参数：温度132℃、4分钟、，每锅监测物理参数、 化学监测，并记录监测结果，每月使用自含式生物指示物进行生物监测。灭菌 周期的各种监测或参数不合格时不得放行使用，重新调整至合格后灭菌器方可 再次使用。灭菌起运行周期文件记录保存3年。 1、每周清洁物品存放 柜（车），灭菌物品 与消毒物品分开。 2、裸露灭菌及一般容 器包装的高度危险口 腔器械灭菌后使用不 超过4h；纺织材料、 牙科器械盒包装及 中、低度危险口腔器 械消毒或灭菌后置于 清洁干燥的容器内保 1、适用于不耐热、耐 湿的中、低度危险性 物品可用含氯制剂 2000mg/L浸泡30min, 流动水冲净。 2、选择正确的化学消 毒剂，每次使用前检 查其有效浓度，并达 到规定的消毒时间要 求。每季度进行消毒