Antibody is a protein found in the blood that is produced in response to foreign substances (e.g., bacteria or viruses) invading the body. Antibodies protect the body from disease by binding to these organisms and destroying them.

Is your facility compliant with industry standards as recommended by the CDC, AAMI, AORN, ADA, OSAP, and the Joint Commission? Are you following best practice recommendations? (Some are quoted below with their cross references). Other guidelines can be viewed at: DENTAL REGULATIONS MEDICAL REGULATIONS TATTOO & BODY PIERCING REGULATIONS The CDC (Center for Disease Control and Prevention) www.cdc.gov Recommended Infection-Control Practices for Dentistry, 1993. “Proper functioning of sterilization cycles should be verified by the periodic use (at least weekly) of biological indicators (i.e. spore tests). Heat sensitive chemical indicators (e.g. those that change color after exposure to heat) alone do not ensure adequacy of a sterilization cycle but may be used on the outside of each pack to identify packs that have been processed through the heating cycle. A simple and inexpensive method to confirm heat penetration to all instruments during each cycle is the use of a chemical indic

Autoclave Log Record Keeping is essential to proper infection control management. Documentation of each sterilizer cycle proves that the cycle was monitored as it was taking place; all parameters to achieving sterility were met; and it also provides accountability. Documentation also helps the staff determine whether a recall of a particular lot or batch is needed should a biological indicator turn positive (a failed test) – suggesting there is a sterility issue. Sterilization records (mechanical, chemical, and biological) should be retained for a time period in compliance with standards (e.g., Joint Commission for the Accreditation of Healthcare Facilities requests 3 years) and state and federal regulations. The following data should be recorded for every sterilizer cycle. 1. Date, time and operators name or initials 2. The sterilizer’s content and its’ quantity 3. The contents exposure time and temperature (some sterilizers digitally record this) 4. The resul

Biological indicators are the only process indicators that directly monitor the lethality of a given sterilization process. Spores used to monitor a sterilization process have demonstrated resistance to the sterilizing agent and are more resistant than the bioburden found on medical devices. Bacillus atrophaeus spores are used to monitor EO Gas and dry heat, and Geobacillus stearothermophilus spores are used to monitor steam sterilization, hydrogen peroxide gas plasma, and liquid peracetic acid sterilizers. Geobacillus stearothermophilus spores are incubated at 55-60°C, and Bacillus atrophaeus spores are incubated at 35-37°C. Weekly Testing is minimum: Steam and low temperature sterilizers (e.g., hydrogen peroxide gas plasma, peracetic acid) should be monitored at least weekly with the appropriate commercial preparation of spores. If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of equipment malfunctions or procedural err

The number and types of viable microorganisms with which an item is contaminated; this is also called bioload or microbial load. Bioburden is microorganisms existing on a product, instrument, device and/or package. The most important step to decontaminating all reusable medical devices is thorough cleaning and rinsing. This doesn’t kill microorganisms, but removes the bioburden masses, which is then followed by a disinfection or sterilization process. Prior to cleaning, instruments should be presoaked in enzymatic solution and thoroughly rinsed afterwards. This loosens the bioburden to allow for thorough cleaning of the device. As there are many different types of medical devices which include trays, containers, instruments, etc., it is therefore critical that users follow manufacturer’s recommendations for proper cleaning, prior to disinfection or sterilization.

Microorganisms may be protected from disinfectants by production of thick masses of cells and extracellular materials, or biofilms. Biofilms are microbial communities that are tightly attached to surfaces and cannot be easily removed. Once these masses form, microbes within them can be resistant to disinfectants by multiple mechanisms, including physical characteristics of older biofilms, genotypic variation of the bacteria, microbial production of neutralizing enzymes, and physiologic gradients within the biofilm (e.g., pH). Bacteria within biofilms are up to 1,000 times more resistant to antimicrobials than are the same bacteria in suspension. Although new decontamination methods are being investigated for removing biofilms, chlorine and monochloramines can effectively inactivate biofilm bacteria. Biofilms have been found in whirlpools, dental unit waterlines, and numerous medical devices (e.g., contact lenses, pacemakers, hemodialysis systems, urinary catheters, central venous catheters, endoscopes).

Biological indicators are a device to monitor the sterilization process that consists of a standardized population of bacterial spores known to be resistant to the mode of sterilization being monitored. Biological indicators indicate that all the parameters necessary for sterilization were present. As per the FDA, “a biological sterilization process indicator is a device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor adequacy of sterilization. The device consists of a known number of microorganisms, of known resistance to the mode of sterilization, in or on a carrier and enclosed in a protective package. Subsequent growth or failure of the microorganisms to grow under suitable conditions indicates the adequacy of sterilization.” [21 CFR 880.2800(a)(1)] Biological indicators are recognized by most authorities as being closest to the ideal monitors of the sterilization process because they measure the sterilization

Blood borne pathogens are pathogenic microorganisms that are present in human blood and can cause disease in humans. These pathogens include, but are not limited to, hepatitis B virus (HBV) and human immunodeficiency virus (HIV). They are disease-producing microorganisms spread by contact with blood or other body fluids contaminated with blood from an infected person.

A Bowie-Dick test is used in pre-vacuum type (or dynamic air removal) sterilizers. They are used to detect air leaks and inadequate air removal and consist of folded 100% cotton surgical towels that are clean and preconditioned. A commercially available Bowie-Dick-type test sheet should be placed in the center of the pack. The test pack should be placed horizontally in the front, bottom section of the sterilizer rack, near the door and over the drain, in an otherwise empty chamber and run at 134°C for 3.5 minutes. The test is used each day the vacuum-type steam sterilizer is used, before the first processed load. Air that is not removed from the chamber will interfere with steam contact. Smaller, commercially available disposable test packs (or process challenge devices) have been devised to replace the stack of folded surgical towels for testing the efficacy of the vacuum system in a pre vacuum sterilizer. They should be representative of the load and simulate the greatest challenge to the l

Contact: Toll-Free #(800)CDC-INFO or check CDC’s website at: www.cdc.gov "Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number)." Guidelines for infection control in dental health-care settings - 2003. Morbidity and Mortality Weekly Report (MMWR), 52(RR-17), 19 December 2003. “Use a biological indicator for every sterilizer load that contains an implantable device…” Guidelines for infection control in dental health-care settings - 2003. Morbidity and Mortality Weekly Report (MMWR), 52(RR-17)(243-248) 19 December 2003. "All sterilizers should be monitored at least once a week with commercial preparations of spores intended specifically for the type of sterilizer." Gamer JS, Favero MS. CDC guideline for hand washing and Hospital environment control 1985. Infection Control 7(231-43), 1986. "The adequacy of sterilization cycles should be

In dental health care settings, all instrument cleaning, disinfecting, and sterilizing should occur in a designated central processing area in order to more easily control quality and ensure safety. The instrument processing area should be physically divided into sections for 1) receiving, cleaning, and decontamination; 2) preparation and packaging; 3) sterilization; and 4) storage. This division is designed to contain contaminated items in an area designed specifically for cleaning, thus preventing contamination of the clean areas where packaging, sterilization, and storage of sterile items occurs. Reusable contaminated instruments and devices are received, sorted, and cleaned in the cleaning area. The packaging area is for inspecting, assembling, and packaging clean instruments in preparation for final processing. The sterilization and storage areas contain the sterilizers and related supplies, as well as incubators for analyzing spore tests, and can contain enclosed storage for sterile items and dispo

Chemical indicators are one of the three critical devices for monitoring a sterilization process. They are designed to respond with a characteristic chemical or physical change to one or more of the physical conditions within the sterilizing chamber. Chemical indicators are intended to detect potential sterilization failures immediately that could result from incorrect packaging, incorrect loading of the sterilizer, or malfunctions of the sterilizer. The Association for the Advancement of Medical Instrumentation has defined five classes of chemical indicators: Class 1 (process indicator); Class 2 (Bowie-Dick test indicator); Class 3 (single-parameter indicator); Class 4 (multi-parameter indicator); and Class 5 (integrating indicator). FDA defines a physical*/chemical sterilization process indicator (21 CFR 880.2800(b)) as: A device intended for use by a health care provider to accompany products being sterilized through a sterilization procedure and to monitor one or more parameters of the sterilization

Chemical Vapor Sterilization process uses a solution of alcohol, water, and trace formaldehyde which is heated to produce an unsaturated vapor that must reach a specified temperature, pressure and exposure time in order to achieve sterility. Users should follow the sterilizer manufacturers’ strict guidelines for proper packaging, loading and operation of this type of sterilizer.

Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Also, if soiled materials dry or bake onto the instruments, the removal process becomes more difficult and the disinfection or sterilization process less effective or ineffective. Surgical instruments should be presoaked or rinsed to prevent drying of blood and to soften or remove blood from the instruments. Manual cleaning is done in use areas without mechanical units (e.g., ultrasonic cleaners or washer-disinfectors) or for fragile or difficult-to-clean instruments. With manual cleaning, the two essential components are friction and fluidics. Friction (e.g., rubbing/scrubbing the soiled area with a brush) is an old and

Cleaning is the removal of foreign material (e.g., soil, and organic material) from objects and is normally accomplished using water with detergents or enzymatic products. Thorough cleaning is required before high-level disinfection and sterilization because inorganic and organic materials that remain on the surfaces of instruments interfere with the effectiveness of these processes. Mechanical Cleaning is the preferred method to cleaning instruments or devices – known to be 16 times more effective then cleaning manually. The most common types of mechanical or automatic cleaners are ultrasonic cleaners, washer-decontaminators, washer-disinfectors, and washer-sterilizers. Ultrasonic cleaning removes soil by cavitation and implosion in which waves of acoustic energy are propagated in aqueous solutions to disrupt the bonds that hold particulate matter to surfaces. Bacterial contamination can be present in used ultrasonic cleaning solutions (and other used detergent solutions) because these solutions ge

Automated cleaning (or mechanical cleaning) is the preferred method to cleaning instruments or devices – known to be 16 times more effective then manual cleaning. Because instruments cleaned with automated cleaning equipment do not need to be presoaked or scrubbed, the use of automated equipment can increase productivity, improve cleaning effectiveness, and decrease worker exposure to blood and body fluids. Thus, using automated equipment can be more efficient and safer than manually cleaning contaminated instruments. Automated cleaning and rinsing process utilize equipment such as: Utensil or cart washers, washer-sterilizer, pasteurization equipment, washer-disinfectors, or washer-sanitizers. Considerations in selecting cleaning methods and equipment include their effectiveness, their compatibility with the items to be cleaned, and the occupational health and exposure risks they pose. Some are made to clean specific devices, such as endoscopes. It is recommended that the manufacturer’s instructi

The state of having actual or potential contact with microorganisms. As used in health care, the term generally refers to the presence of microorganisms that could produce disease or infection.

A Control BI is a biological indicator from the same lot as a test indicator that is left unexposed to the sterilization cycle and then incubated to verify the viability of the test indicator. The control indicator should yield positive results for bacterial growth.

Decontamination is a process or treatment that renders a medical device, instrument, or environmental surface safe to handle. Decontamination is, according to OSHA, “the use of physical or chemical means to remove, inactivate, or destroy bloodborne pathogens on a surface or item to the point where they are no longer capable of transmitting infectious particles and the surface or item is rendered safe for handling, use, or disposal” [29 CFR 1910.1030]. Proper cleaning of instruments or devices involves a multi-step process, which includes: Presoaking, disassembling, cleaning, rinsing, packaging, sterilization, storage and shelf-life. See other recommendations on decontamination at www.cdc.gov. See also “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”.

Disassembling of instruments that have more than one part is required to expose all surfaces to the cleaning process (e.g. procedure needles, dental hand pieces, laparoscopic instrumentation, rigid containers…etc). Medical instruments with multiple pieces must be disassembled and equipment such as endoscopes that have crevices, joints, and channels are more difficult to disinfect than are flat- surface equipment because penetration of the disinfectant of all parts of the equipment is more difficult.

A chemical agent used on non-living objects (e.g., floors, walls, sinks) to destroy virtually all recognized pathogenic microorganisms, but not necessarily all microbial forms (e.g., bacterial endospores). The EPA groups disinfectants on whether the product label claims "limited," "general" or "hospital" disinfectant. Disinfection is generally a less lethal process than sterilization. It eliminates nearly all recognized pathogenic microorganisms but not necessarily all microbial forms (e.g., bacterial spores) on inanimate objects. Disinfection does not ensure an “overkill'' and therefore lacks the margin of safety achieved by sterilization procedures. The effectiveness of a disinfection procedure is controlled significantly by a number of factors, each one of which may have a pronounced effect on the end result. Among these are: • the nature and number of contaminating microorganisms (especially the presence of bacterial spores); • the amount of organic matte

Distilled water is water heated to boiling point, vaporized, cooled, condensed, and collected so that no impurities are reintroduced. Most sterilizer manufacturers require that distilled water is used for steam sterilizers. Using tap water will adversely affect the quality of the steam and cause sterilization failures and possibly damage the sterilizer itself. ATS, Inc. offers quality water distillers allowing you to distill your own tap water. Advantages in buying a water distiller: 1. No longer need to transport heavy gallons of distilled water! 2. Store-bought distilled water costs average of $1.20 versus tap water costs 10-15¢ per gallon. 3. IT’S HEALTHY FOR YOU TOO – not just for your sterilizer! Distilled water is great drinking water as it is PURE water - all impurities are boiled off. Usually found to be 0-5 TDS

Dry Heat sterilization should be used only for materials that might be damaged by moist heat or that are impenetrable to moist heat (e.g., powders, petroleum products, sharp instruments). The primary lethal process is considered to be oxidation of cell constituents. The most common time-temperature relationships for sterilization with hot air sterilizers are 170°C (340°F) for 60 minutes, 160°C (320°F) for 120 minutes, and 150°C (300°F) for 150 minutes. Advantages and Disadvantages of Dry Heat Sterilization: The advantages for dry heat include the following: it is nontoxic and does not harm the environment; a dry heat cabinet is easy to install and has relatively low operating costs; it penetrates materials; and it is noncorrosive for metal and sharp instruments. The disadvantages for dry heat are the slow rate of heat penetration and microbicidal killing makes this a time-consuming method. In addition, the high temperatures are not suitable for most materials. Two Types of Dry Heat Sterilize

Ethylene Oxide sterilization is a low temperature sterilization process designed to sterilize instruments or devices that are sensitive to heat and/or moisture. ETO is a colorless gas that is flammable and explosive. The four essential parameters (operational ranges) are: gas concentration (450 to 1200 mg/l); temperature (37 to 63°C); relative humidity (40 to 80%) (water molecules carry ETO to reactive sites); and exposure time (1 to 6 hours). These influence the effectiveness of ETO sterilization. Within certain limitations, an increase in gas concentration and temperature may shorten the time necessary for achieving sterilization. The basic ETO sterilization cycle consists of five stages (i.e., preconditioning and humidification, gas introduction, exposure, evacuation, and air washes) and takes approximately 2-1/2 hrs excluding aeration time. Mechanical aeration for 8 to 12 hours at 50 to 60°C allows desorption of the toxic ETO residual contained in exposed absorbent materials. Most modern ETO st

A storage practice that recognizes that a package and its contents should remain sterile until some event causes the item(s) to become contaminated. Although some hospitals continue to date every sterilized product and use the time-related shelf-life practice, many hospitals have switched to an event-related shelf-life practice. This latter practice recognizes that the product should remain sterile until some event causes the item to become contaminated (e.g., tear in packaging, packaging becomes wet, seal is broken). Event-related factors that contribute to the contamination of a product include bioburden (i.e., the amount of contamination in the environment), air movement, traffic, location, humidity, insects, vermin, flooding, storage area space, open/closed shelving, temperature, and the properties of the wrap material. There is data that support the event-related shelf-life practice; one study examined the effect of time on the sterile integrity of paper envelopes, peel pouches, and nylon sleeve

Flash sterilization is a sterilization process that allows for immediate use of patient care items, performed at the time of a surgical procedure. Flash-sterilized items or devices are to be used immediately following sterilization. When using flash sterilization, make sure the following parameters are met: 1. Clean the item before placing it in the sterilizing container (that are FDA cleared for use with flash sterilization) or tray; 2. Prevent exogenous contamination of the item during transport from the sterilizer to the patient; 3. Monitor sterilizer function with mechanical, chemical, and biologic monitors. EXCEPTION: Do not flash sterilize implanted surgical devices unless doing so is unavoidable. Do not use flash sterilization for convenience, as an alternative to purchasing additional instrument sets, or to save time. Do not use packaging materials and containers in flash sterilization cycles unless the sterilizer and the packaging material/container are designed for this

Biological indicators are the only process indicators that directly monitor the lethality of a given sterilization process. Spores used to monitor a sterilization process have demonstrated resistance to the sterilizing agent and are more resistant than the bioburden found on medical devices. While Bacillus atrophaeus spores are used to monitor ETO and dry heat sterilizers, Geobacillus stearothermophilus spores are used to monitor steam sterilization, hydrogen peroxide gas plasma, and liquid peracetic acid sterilizers. Geobacillus stearothermophilus spores are incubated at 55-60°C and Bacillus atrophaeus spores are incubated at 35-37°C. Weekly testing is minimum: Steam and low temperature sterilizers (e.g., hydrogen peroxide gas plasma, peracetic acid) should be monitored at least weekly with the appropriate commercial preparation of Geobacillus stearothermophilus spores. If a sterilizer is used frequently (e.g., several loads per day), daily use of biological indicators allows earlier discovery of

Germicide is an agent that destroys microorganisms, especially pathogenic organisms. Other terms with the suffix "–cide" (e.g., virucide, fungicide, bactericide, tuberculocide, sporicide) are agents that destroy the microorganism noted in the prefix. Germicides may be used to inactivate microorganisms in or on living tissue (antiseptic) or on environmental surfaces (disinfectants).

Huck towel is an all-cotton surgical towel with a honey-comb weave; both warp and fill yarns are tightly twisted. Huck towels can be used to prepare biological indicator challenge test packs (or PCD’s).

According to the Food and Drug Administration (FDA), "device that is placed into a surgically or naturally formed cavity of the human body if it is intended to remain there for a period of 30 days or more" [21 CFR 812.3(d)]. Sterilizing implantable devices: Because of the potential for serious infections, flash sterilization is not recommended for implantable devices (i.e., devices placed into a surgically or naturally formed cavity of the human body); however, flash sterilization may be unavoidable for some devices (e.g., orthopedic screw, plates). If flash sterilization of an implantable device is unavoidable, recordkeeping (i.e., load identification, patient’s name/hospital identifier, and biological indicator result) is essential for epidemiological tracking (e.g., of surgical site infection, tracing results of biological indicators to patients who received the item to document sterility), and for an assessment of the reliability of the sterilization process (e.g., evaluation of biologi

Steam sterilization is commonly used by on-site medical centers and hospitals for their medical waste treatment. Many such facilities are periodically monitoring the efficacy of their sterilization process with Biological Indicators (BIs). In most states, the Dept. of Health has set up regulations requiring the periodic monitoring of such sterilization cycles. The BIs commonly used to monitor the steam sterilization cycles are spore strips or small crushable types of plastic self-contained indicators. THE PROBLEM: A common but inappropriate method used to monitor the sterilization cycles for medical or micro lab waste is where the spore strips are placed directly into the bag of medical waste prior to sterilization. The load is processed and upon cycle completion, the spore strips are removed. The strips must then be transferred aseptically to a tube of culture media and incubated for growth / no growth testing. The spore strip transfers could be done on-site or by a contract laboratory where test

Mechanical indicators are devices such as gauges, meter, display, or printout from a sterilizer display an element of the sterilization process (e.g., time, temperature, pressure). This is one of the three parameters required to monitor sterilizer cycles. Internal and external chemical indicators and biological indicators are to be used along with mechanical monitoring of sterilizer, to ensure sterilization is being reached in every cycle.

Microbicidal methods (lethal kill of microorganisms) include disinfection or sterilization by thermal or chemical means. This is the final step in the decontamination process. Knowledge is critical in selecting the correct microbicidal process as it depends on the device manufacturers’ recommendations, the manufacturer of the disinfectant solution and what the device has been exposed to. See the complete recommendations on sterilizer and disinfection at www.cdc.gov “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”.

Thorough cleaning required before disinfection and sterilization: All other conditions remaining constant, the larger the number of microbes, the more time a germicide needs to destroy all of them. Spaulding illustrated this relation when he employed identical test conditions and demonstrated that it took 30 minutes to kill 10 Bacillus atrophaeus (formerly Bacillus subtilis) spores but 3 hours to kill 100,000 Bacillus atrophaeus spores. This reinforces the need for scrupulous cleaning of medical instruments before disinfection and sterilization. Reducing the number of microorganisms that must be inactivated through meticulous cleaning, increases the margin of safety when the germicide is used according to the labeling and shortens the exposure time required to kill the entire microbial load. Accessibility of sterilant to microorganisms: The location of microorganisms also must be considered when factors affecting the efficacy of germicides are assessed. Medical instruments with multiple pieces mus

Once items are cleaned, dried, and inspected, those requiring sterilization must be wrapped or placed in rigid containers and should be arranged in instrument trays/baskets. Best practice states that hinged instruments should be opened; items with removable parts should be disassembled unless the device manufacturer or researchers provide specific instructions or test data to the contrary; complex instruments should be prepared and sterilized according to device manufacturer’s instructions and test data; devices with concave surfaces should be positioned to facilitate drainage of water; heavy items should be positioned not to damage delicate items; and the weight of the instrument set should be based on the design and density of the instruments and the distribution of metal mass. While there is no longer a specified sterilization weight limit for surgical sets, heavy metal mass is a cause of wet packs (i.e., moisture inside the case and tray after completion of the sterilization cycle). Other parameters

Pasteurization is a process developed by Louis Pasteur of heating milk, wine, or other liquids to 65–77°C (or the equivalent) for approximately 30 minutes to kill or markedly reduce the number of pathogenic and spoilage organisms other than bacterial spores. Pasteurization is not a sterilization process; its purpose is to destroy all pathogenic microorganisms. However, pasteurization does not destroy bacterial spores. The time-temperature relation for hot-water pasteurization is generally ~70°C (158°F) for 30 minutes. The water temperature and time should be monitored as part of a quality-assurance program. Pasteurization of respiratory therapy and anesthesia equipment is a recognized alternative to chemical disinfection. Pasteurization of respiratory therapy and anesthesia equipment is a recognized alternative to chemical disinfection. The efficacy of this process has been tested using an inoculum that the authors believed might simulate contamination by an infected patient. Use of a large inocu

Peracetic acid is a highly biocidal oxidizer that maintains its efficacy in the presence of organic soil. Peracetic acid removes surface contaminants (primarily protein) on endoscopic tubing. An automated machine using peracetic acid to sterilize medical, surgical, and dental instruments chemically (e.g., endoscopes, arthroscopes) was introduced in 1988. This microprocessor-controlled, low-temperature sterilization method is commonly used in the United States. The sterilant, 35% peracetic acid, and an anticorrosive agent are supplied in a single-dose container. The container is punctured at the time of use, immediately prior to closing the lid and initiating the cycle. The concentrated peracetic acid is diluted to 0.2% with filtered water (0.2 μm) at a temperature of approximately 50°C. The diluted peracetic acid is circulated within the chamber of the machine and pumped through the channels of the endoscope for 12 minutes, decontaminating exterior surfaces, lumens, and accessories. Interchangeab

Presoaking instruments with an enzymatic solution is recommended to assist in loosening soil and therefore making the cleaning process easier. Presoaking instruments or devices is recommended immediately following a procedure which will prevent staining or pitting of the instrument(s). A complete rinsing should be done once presoaking is complete, removing any loosened and harmful residue. See the complete recommendations on sterilizer and disinfection at www.cdc.gov “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”.

Process challenge device (or PCD) is an item designed to simulate product to be sterilized and to constitute a defined challenge to the sterilization process and used to assess the effective performance of the process. A PCD is a challenge test pack or test tray that contains a biologic indicator, a Class 5 integrating indicator, or an enzyme-only indicator. The size and composition of the biological indicator test pack should be standardized to create a significant challenge to air removal and sterilant penetration and to obtain interpretable results. There is a standard 16-towel pack recommended by AAMI for steam sterilization consisting of 16 clean, preconditioned, reusable huck or absorbent surgical towels each of which is approximately 16 inches by 26 inches. Each towel is folded lengthwise into thirds and then folded widthwise in the middle. One or more biological indicators are placed between the eighth and ninth towels in the approximate geometric center of the pack. When the towels are folded

Instruments should be handled as though contaminated until processed through the sterilization cycle (unless the instrument has been processed with a thermal washer/disinfector that has a high-level disinfection cycle). To avoid injury from sharp instruments, personnel should wear puncture-resistant, heavy-duty utility gloves when handling or manually cleaning contaminated instruments and devices. Because splashing is likely to occur, they should also wear a facemask, eye protection or face shield, and gown or jacket. Employees should not reach into trays or containers holding sharp instruments that cannot be seen. To reduce their risk of injury, they should instead remove instruments using forceps or empty them onto a towel. See the complete recommendations on sterilizer and disinfection at www.cdc.gov “Guideline for Disinfection and Sterilization in Healthcare Facilities, 2008”.

The Smart-Read EZTest Biological Indicator Monitoring System allows an organization to release sterile product with true biological confirmation faster and easier than ever before. This unique system uses a real biological indicator (BI) -- with no added enzyme or chemical integrator -- which is incubated, evaluated, and documented in one simple, automated operation. Quick! Detect failed-tests within 3 to 5 hours! Relying only upon bacterial spore growth, the Smart-Read system can detect sterilization failure in as few as three to five hours, and confirm sterilization in only ten hours. Though a highly sophisticated tool, the Smart-Well incubator is easy to configure with its simple touch-screen interface. The incubator can evaluate up to ten Smart-Read BIs independently, and contains one additional incubation cell for a positive control unit. Each BI test result is automatically documented in a user-customizable printed report, and an alarm is sounded the moment that sterilization failure is det

Regulated Waste is liquid or semi-liquid blood or other potentially infectious materials; contaminated items that would release blood or other potentially infectious materials in a liquid or semi-liquid state if compressed; items that are caked with dried blood or other potentially infectious materials and are capable of releasing these materials during handling; contaminated sharps; and pathological and microbiological wastes containing blood or other potentially infectious materials.

Rinsing is a must, following the initial presoaking process and then after mechanical or manual cleaning of the instrument or device. This ensures that loosened debris and residue of detergents from the cleaning process are completely removed. Tap water is acceptable for rinsing; however, for the final rinse, treated water is recommended to avoid staining, corrosion or pitting of the instrument or device. Rinsing endoscopes: Rinsing endoscopes and flushing channels with sterile water, filtered water, or tap water will prevent adverse effects associated with disinfectant retained in the endoscope (e.g., disinfectant-induced colitis). Items can be rinsed and flushed using sterile water after high-level disinfection to prevent contamination with organisms in tap water, such as nontuberculous mycobacteria, Legionella, or gram-negative bacilli such as Pseudomonas. Alternatively, a tap water or filtered water (0.2μ filter) rinse should be followed by an alcohol rinse and forced air drying. Forced-air dr

Sanitizer is an agent that reduces the number of bacterial contaminants to safe levels as judged by public health requirements. Commonly used with substances applied to inanimate objects. According to the protocol for the official sanitizer test, a sanitizer is a chemical that kills 99.999% of the specific test bacteria in 30 seconds under the conditions of the test.

Shelf life of sterile items is event-related, depending on the quality of the packaging material, storage conditions, conditions during transport, and the amount it was handled. Generally, sterile items should be rotated using the “first-in, first-out” principle. See also event-related packaging.

Of all the methods available for sterilization, moist heat in the form of saturated steam under pressure is the most widely used and the most dependable. Steam sterilization is nontoxic, inexpensive, rapidly microbicidal, sporicidal, and rapidly heats and penetrates fabrics. Like all sterilization processes, steam sterilization has some deleterious effects on some materials, including corrosion and combustion of lubricants associated with dental headpieces; reduction in ability to transmit light associated with laryngoscopes; and increased hardening time with plaster-cast. The basic principle of steam sterilization, as accomplished in an autoclave, is to expose each item to direct steam contact at the required temperature and pressure for the specified time. Thus, there are four parameters of steam sterilization: steam, pressure, temperature, and time. The ideal steam for sterilization is dry saturated steam and entrained water (dryness fraction >97%). Pressure serves as a means to obtain the high te

Sterilant is a liquid chemical germicide that destroys all forms of microbiological life, including high numbers of resistant bacterial spores. When chemicals are used to destroy all forms of microbiologic life, they can be called chemical sterilants. These same germicides used for shorter exposure periods also can be part of the disinfection process (i.e., high-level disinfection). Liquid chemical sterilants reliably produce sterility only if cleaning precedes treatment and if proper guidelines are followed regarding concentration, contact time, temperature, and pH.

Sterilization is extremely important in the healthcare field. Proof of sterilization reduces practice liability, and ensures the health and safety of your patients and staff. Biological Spore Testing on a routine basis will provide proof of sterilization. The CDC, AAMI, USP, health departments, and many other healthcare agencies recommend biological spore testing on a routine basis. The death of Bacillus spores which document through their death that sterilization was actually achieved is the only valid proof of sterility assurance.

The Sterilization Area is a designated area of a health-care facility designed to house sterilization equipment, such as steam ethylene oxide, hydrogen peroxide gas plasma, or ozone sterilizers. It is one of the three areas discussed below, critical to proper infection control. Sterilization Area Guidelines: The central processing area(s) ideally should be divided into at least three areas: decontamination, packaging, and sterilization and storage. Physical barriers should separate the decontamination area from the other sections to contain contamination on used items. In the decontamination area, reusable contaminated supplies (and possibly disposable items that are reused) are received, sorted, and decontaminated. The recommended airflow pattern should contain contaminates within the decontamination area and minimize the flow of contaminates to the clean areas. The American Institute of Architects recommends negative pressure and no fewer than six air exchanges per hour in the decontamination are

Gravity displacement steam sterilizers facilitate incoming steam which displaces residual air through a port or drain in or near the bottom (usually) of the sterilizer chamber. Typical operating temperatures are 121–123°C (250–254°F) and 132–135°C (270–275°F). After Installation: Three consecutive BI tests must be completed using PCD’s with biological indicators, one right after the other, all showing negative results (no growth). Place the BI PCD in the area of the sterilizer least exposed to the sterilant - usually in the center near the front or near the drain of the sterilizer. Run the three consecutive BI tests in an empty chamber.

An infrared radiation prototype sterilizer was investigated and found to destroy Bacillus atrophaeus spores. Some of the possible advantages of infrared technology include short cycle time, low energy consumption, no cycle residuals, and no toxicological or environmental effects. This may provide an alternative technology for sterilization of selected heat-resistant instruments but there are no FDA-cleared systems for use in healthcare facilities.

Pre-vacuum steam sterilizers depend on one or more pressure and vacuum excursions at the beginning of the cycle to remove air. This method of operation results in shorter cycle times for wrapped items because of the rapid removal of air from the chamber and the load by the vacuum system and because of the usually higher operating temperature (132–135°C [270–275°F]; 141–144°C [285–291°F]). Eliminating air-pockets is critical to steam penetration in all areas of the sterilizer chamber. This type of sterilizer generally provides for shorter exposure time and accelerated drying of fabric loads by pulling a further vacuum at the end of the sterilizing cycle. A Bowie-Dick diagnostic test is to be used before the first processed load of each day. It is a sensitive and rapid means of detecting air leaks, or inadequate air removal or inadequate steam penetration. Insufficient air removal in a pre-vacuum cycle will leave air-pockets, affecting the lethality of the sterilizer cycle, causing non-steri

Steam-Flush Pressure-Pulse sterilizers use a repeated sequence consisting of a steam flush and a pressure pulse system that removes air from the sterilizing chamber and processed materials using steam at above atmospheric pressure (no vacuum is required). Like a pre-vacuum sterilizer, a steam-flush pressure-pulse sterilizer rapidly removes air from the sterilizing chamber and wrapped items; however, the system is not susceptible to air leaks because air is removed with the sterilizing chamber pressure at above atmospheric pressure. Typical operating temperatures are 121–123°C (250–254°F), 132–135°C (270–275°F), and 141–144°C (285–291°F).

A compact gravity-displacement steam sterilizer that has a chamber volume of not more than 2 cubic feet and that generates its own steam when distilled or deionized water is added. Portable (table-top) steam sterilizers are used in outpatient, dental, and rural clinics. These sterilizers are designed for small instruments, such as hypodermic syringes and needles and dental instruments. The ability of the sterilizer to reach physical parameters necessary to achieve sterilization should be monitored by mechanical, chemical, and biological indicators.

Since sterilization failure can occur (about 1% for steam sterilizers), a procedure to follow in the event of positive spore tests with steam sterilization has been provided by CDC and the Association of periOperative Registered Nurses (AORN). The 1981 CDC recommendation is that "objects, other than implantable objects, do not need to be recalled because of a single positive spore test unless the steam sterilizer or the sterilization procedure is defective." The rationale for this recommendation is that single positive spore tests in sterilizers occur sporadically. Most “Positive Test Results” occur within 24 hours, with the sterilizer user notified immediately of the test failure. Most failed tests are caused by operator error – overloading being a common reason for failed tests. Chemical vapor and Dry Heat sterilizers are especially sensitive to overloading. Running or testing a sterilizer from a COLD start can also cause sterilizer failure. Sterilizer manufacturers recommend initia

When it comes to the steam sterilization of liquid media, there are a number of user concerns that are handled in various ways. Monitoring these cycles with biological indicators (BIs) and the various restrictions and cycle modifications that are done can lead to a false positive or a failed cycle. Here are only a few of the cycle modifications done or restrictions applied by users for the steam sterilization of liquid media: § User needs to keep the media flask in a container while being sterilized so the boil-over does not get all over the autoclave. § According to the manufacturer’s instructions, the user needs to sterilize the media at 121°C for 15 minutes. The user can’t find a BI that will die in this short cycle. § User can’t run a longer cycle time since the media is heat sensitive and may not promote growth if a longer cycle time is used. § User’s protocol states to run only in a 15 minute, 121°C cycle. § User has determined a cycle exposure time for

Studies in the early 1970s suggested that wrapped surgical trays remained sterile for varying periods depending on the type of material used to wrap the trays. Safe storage times for sterile packs vary with the porosity of the wrapper and storage conditions (e.g., open versus closed cabinets). Heat-sealed, plastic peel-down pouches and wrapped packs sealed in 3-mil (3/1000 inch) polyethylene overwrap have been reported to be sterile for as long as 9 months after sterilization. The 3-mil polyethylene is applied after sterilization to extend the shelf life for infrequently used items. Supplies wrapped in double-thickness muslin comprising four layers, or equivalent, remain sterile for at least 30 days. Any item that has been sterilized should not be used after the expiration date has been exceeded or if the sterilized package is wet, torn, or punctured. Event-Related Storage: Although some hospitals continue to date every sterilized product and use the time-related shelf-life practice, many hospitals h

Is surface disinfection necessary? The effective use of disinfectants is part of a multi-barrier strategy to prevent health-care-associated infections. Surfaces are considered noncritical items because they contact intact skin. Use of noncritical items or contact with noncritical surfaces carries little risk of causing an infection in patients or staff. Thus, the routine use of germicidal chemicals to disinfect hospital floors and other noncritical items is controversial. A 1991 study expanded the Spaulding scheme by dividing the noncritical environmental surfaces into housekeeping surfaces and medical equipment surfaces. The classes of disinfectants used on housekeeping and medical equipment surfaces can be similar. However, the frequency of decontaminating can vary. Medical equipment surfaces (e.g., blood pressure cuffs, stethoscopes, hemodialysis machines, and X-ray machines) can become contaminated with infectious agents and contribute to the spread of health-care-associated infections. For thi

Ultrasonic cleaners is a device that uses waves of acoustic energy (a process known as "cavitation") to loosen and break up debris on instruments. They are a mechanical or automatic cleaner, listed in the same family as washer-decontaminators, washer-disinfectors, and washer-sterilizers. Ultrasonic cleaning removes soil by cavitation and implosion in which waves of acoustic energy are propagated in aqueous solutions to disrupt the bonds that hold particulate matter to surfaces. Bacterial contamination can be present in used ultrasonic cleaning solutions (and other used detergent solutions) because these solutions generally do not make antibacterial label claims. Even though ultrasound alone does not significantly inactivate bacteria, sonication can act synergistically to increase the cidal efficacy of a disinfectant. Users of ultrasonic cleaners should be aware that the cleaning fluid could result in endotoxin contamination of surgical instruments, which could cause severe inflammatory reaction

An unwrapped cycle (sometimes called flash sterilization) is a method for sterilizing unwrapped patient-care items for immediate use. The time required for unwrapped sterilization cycles depends on the type of sterilizer and the type of item (i.e., porous or nonporous) to be sterilized. The unwrapped cycle in tabletop sterilizers is preprogrammed by the manufacturer to a specific time and temperature setting and can include a drying phase at the end to produce a dry instrument with much of the heat dissipated. If the drying phase requirements are unclear, the operation manual or manufacturer of the sterilizer should be consulted. If the unwrapped sterilization cycle in a steam sterilizer does not include a drying phase, or has only a minimal drying phase, items retrieved from the sterilizer will be hot and wet, making aseptic transport to the point of use more difficult. For dry-heat and chemical-vapor sterilizers, a drying phase is not required. Unwrapped sterilization should be used only under certa

A washer-disinfector is an automatic unit designed to clean and thermally disinfect instruments. The unit uses a high-temperature cycle rather than a chemical bath. This type of equipment increases productivity, improves cleaning effectiveness, and decreases worker exposure to blood and body fluids. See also Cleaning – Mechanically explaining the advantages of this type of cleaning equipment.

Wicking is the absorption of a liquid by capillary action along a thread or through the material (e.g., the enhanced penetration of liquids through undetected holes in a glove). The dry time following sterilization is important as handling processed items that are still wet increases the chance of wicking contaminants into the processed items’ packaging. Hot packs that have just been sterilized can act like wicks, absorbing moisture and possibly bacteria from hands; therefore, cooling time is a critical part of proper sterilization.