(California Code of Regulations, 2011). At the completion of surgery, all contaminated solid waste shall be disposed of according to applicable local, state, and federal Sterilizer monitoring Proper functioning of the sterilization cycle of all sterilization devices is essential. Although section 1005 only requires the use of weekly biological indicators, sterilizers should be monitored by additional methods, including observations of mechanical indicators and chemical indicators (CDC, 2003; AAMI, 2017). Chemical indicators measure parameters of sterilization such as heat and length of time, and mechanical indicators are the gauges and digital indicators on the sterilizer that will alert a user to an equipment malfunction. DHCP should regularly evaluate the mechanical aspects of their sterilizers by observing the gauges or displays to assess the time cycle, temperature, and pressure. Chemical indicators Chemicals are used to assess physical conditions (e.g., time and temperature) during the sterilization process. Although chemical indicators do not prove that sterilization has been achieved, they confirm that certain essential parameters for sterilization have been met. External indicators applied to the outside of a package (e.g., chemical indicator tape or special markings) change color rapidly when a specific parameter (temperature) is reached, and they verify that the package has been through the sterilization process. Internal chemical indicators verify that the sterilizing agent has penetrated the packaging material and reached the instruments inside. A single-parameter internal chemical indicator provides information regarding only one sterilization parameter (e.g., time or temperature). Multi- parameter internal chemical indicators are designed to react to two or more parameters (e.g., time and temperature, or time, temperature, and the presence of steam) and can provide a more reliable indication that sterilization conditions have been met. The CDC recommends a chemical indicator be placed inside each pack of instruments to be sterilized. If the indicator cannot be seen Low-, intermediate-, and high-level disinfection Disinfection is a process that is required for specific clinical surfaces, equipment, prosthetic devices, and other items used in patient care that cannot be heat sterilized. Unlike sterilization, disinfection does not destroy all forms of microbial life, but instead kills various microbes dependent on the concentration and combination of active chemicals. Disinfectants must be mixed, stored, and used exactly as directed or their effectiveness may be altered. Disinfectants are categorized as high-, intermediate-, and low-level products, according to the germicidal resistance of the organisms the product is able to inactivate. High-level disinfectants are those that kill viruses, bacteria, fungi, Mycobacterium tuberculosis var. bovis (a difficult pathogen to inactivate), and some, but not all, bacterial spores. High- level disinfectants are intended for use with heat-sensitive semi-critical items and may only be used as an immersion disinfectant. High-level disinfectants should never be used on clinical surfaces. An intermediate-level product kills Mycobacterium tuberculosis var. bovis and many other pathogens; however, it does not necessarily kill spores. Low-level disinfectants are the least effective. They kill some bacteria, some viruses, and some fungi, but do not kill bacterial spores or Mycobacterium tuberculosis var. bovis (California Code of Regulations, 2011). Facilities Environmental surfaces fall into two categories: clinical contact surfaces and housekeeping surfaces. Section 1005 states, “If non-critical items or surfaces likely to be
environmental standards (California Health and Safety Code, 2017).
from the outside, an additional indicator should be placed on the outside of the package (CDC, 2003). The chemical indicator test results that are received when the sterilization cycle is complete can provide an early indication of a problem and when in the process the problem might exist. If the indicators demonstrate that the sterilization cycle was inadequate, the instruments in that load should not be used for patient care. Biological indicators Biological indicators (spore tests) are the most accurate method for evaluating whether sterilization was achieved. They work by determining if the highly resistant microorganisms (e.g., Geobacillus or Bacillus species) have been destroyed, rather than merely testing the physical and chemical conditions necessary for sterilization. Because these spores are more resistant and present in greater numbers than the other contaminants found on instruments and equipment, an inactivated biological indicator suggests that other potential pathogens in the load have been inactivated. The California Minimum Standards for Infection Control, Section 1005, state, “Proper functioning of the sterilization cycle of all sterilization devices shall be verified at least weekly through the use of a biological indicator (such as a spore test). Test results shall be documented and maintained for 12 months” (California Code of Regulations, 2011). The test must be conducted for each sterilizer in the office, either by sending the test to a commercial lab or testing with an in-office system. The California Code of Regulations requires that these results be available upon inspection if requested. A combination of biological indicators, chemical indicators, and review of the mechanical indicators on the sterilizer should be used by DHCP to closely monitor the effectiveness of their sterilizing systems (CDC, 2003). contaminated are manufactured in a manner preventing cleaning and disinfection, they shall be protected with disposable impervious barriers. Disposable barriers shall be changed when visibly soiled or damaged and between patients. Clean and disinfect all clinical contact surfaces that are not protected by impervious barriers using a California Environmental Protection Agency (Cal/EPA) registered, hospital grade low- to intermediate-level germicide after each patient. The low-level disinfectants used shall be labeled effective against HBV and HIV” (California Code of Regulations, 2011). To ensure that disinfection is effective, all surfaces must be cleaned as the first step, and disinfectants must be used in accordance with the manufacturer’s instructions. Surfaces must be thoroughly cleaned to remove the bioburden (blood, saliva, OPIM). When these substances exist on the surface, they act as a barrier, preventing penetration of the disinfectant. For patient care, use of impervious barriers or surface disinfectants, or a combination of both, is acceptable. Barrier protection of surfaces and equipment can prevent contamination of clinical contact surfaces but is particularly effective for those that are difficult to clean. Barrier protection also prevents discoloration, drying and cracking of materials, rusting, and corrosion. Because such coverings can become contaminated, they should be removed and discarded between patients, while DHCP are still gloved. A clean barrier should be placed prior to the next patient,
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