Infection Control for Dental Professionals: The California Requirement _______________________________
Storage practices for wrapped sterilized instruments can be either date- or event-related. Packages containing sterile sup- plies should be inspected before use to verify barrier integrity and dryness. Although some facilities continue to date every sterilized package and use shelf-life practices, other facilities have switched to event-related practices [10]. This approach recognizes that the product should remain sterile indefinitely, unless an event causes it to become contaminated (e.g., torn or wet packaging). Even for event-related packaging, the date of sterilization should be placed on the package, and if multiple sterilizers are used in the facility, the sterilizer used should be indicated on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure [10]. If packaging is compromised, the instruments should be re-cleaned, sterilized again, and packaged in new wrap. Categorizing Patient-Care Items Patient-care items (e.g., dental instruments, devices, and equipment) are categorized using the Spaulding classification system as critical, semicritical, or noncritical, depending on the potential risk for infection associated with their intended use. Critical items are those items that enter sterile spaces, such as soft tissue or bone, or items that come into contact with the bloodstream. These items pose the greatest risk of transmitting infection and require sterilization. Examples of critical dental instruments include surgical instruments, periodontal scalers, scalpel blades, and surgical dental burs [9; 10]. Critical instru- ments, items, and devices should be discarded or pre-cleaned, packaged or wrapped, and sterilized after each use. Methods of sterilization include steam under pressure (autoclaving), chemical vapor, and dry heat. If a critical item is heat-sensitive, it should, at minimum, be processed with high-level disinfec- tion and packaged or wrapped after disinfection. These instru- ments, items, and devices shall remain sealed and stored in a manner so as to prevent contamination and shall be labeled with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility [9]. Semicritical items touch intact mucous membranes or non- intact skin and have a lower risk of transmission. Examples of semicritical dental instruments include mouth mirrors, amalgam condensers, reusable dental impression trays, and dental handpieces. Because the majority of semicritical items in dentistry are heat-tolerant, they should be sterilized using heat. If a semicritical item is heat-sensitive, it should, at a minimum, be processed with high-level disinfection, which kills all microbial life except spores [9; 10; 21]. Semi-critical instruments, items, and devices should be pre-cleaned, pack- aged or wrapped, and sterilized after each use. Methods of sterilization include autoclaving, chemical vapor, and dry heat. If a semi-critical item is heat sensitive, it should, at minimum, be processed with high-level disinfection and packaged or wrapped upon completion of the disinfection process. These packages or containers shall remain sealed, shall be stored in a manner so as to prevent contamination, and shall be labeled
with the date of sterilization and the specific sterilizer used if more than one sterilizer is utilized in the facility [9]. Noncritical items pose the least risk of transmission of infec- tion and include devices, equipment, and surfaces that come in contact with soil, debris, saliva, blood, OPIM, and intact skin, but not mucous membranes [9]. Noncritical items include radiograph heads/cones, blood pressure cuffs, facebows, and pulse oximeters. In the majority of cases, cleaning and disin- fection with a California Environmental Protection Agency (CalEPA)-registered hospital low-level disinfectant labeled effective against HBV and HIV is adequate. When the item is visibly contaminated with blood or OPIM, a CalEPA-registered hospital intermediate-level disinfectant with a tuberculocidal claim (i.e., intermediate-level disinfectant) should be used [9; 10]. High-speed dental hand pieces, low-speed hand pieces, rotary components and dental unit attachments (e.g., reusable air or water syringe tips and ultrasonic scaler tips) shall be pack- aged and heat-sterilized in a manner consistent with the same sterilization practices as a semi-critical instrument or item [9]. Single-use disposable items such as prophylaxis angles, cups, brushes, tips for high-speed evacuators, saliva ejectors, air and water syringe tips, and gloves must be used for one patient only and discarded. California requires proper functioning of the sterilization cycle of all sterilization devices be verified at least weekly through the use of a biologic indicator (such as a spore testing monitor). Test results should be documented and maintained for 12 months [9]. Studies have demonstrated variability among dental practices in meeting sterilization standards. In one study, 49% of respondents did not challenge autoclaves with biological indicators. Other studies using biologic indicators found a high proportion (15% to 65%) of positive spore tests after assessing the efficacy of sterilizers used in dental offices [21]. Laboratory Areas According to California regulations, splash shields and equip- ment guards should be used on dental laboratory lathes. Fresh pumice and a sterilized or new ragwheel should be used for each patient. Devices used to polish, trim, or adjust contami- nated intraoral devices must be disinfected or sterilized and stored in a manner so as to prevent contamination [9]. All intraoral items, such as impressions, bite registrations, and prosthetic or orthodontic appliances, must be cleaned and disinfected with an intermediate-level disinfectant before manipulation in the laboratory and before placement in the patient’s mouth. Such items should be thoroughly rinsed prior to placement in the patient’s mouth [9]. Reprocessing Reusable Medical Equipment Reusable instruments, medical devices, and equipment should be managed and reprocessed according to recommended and appropriate methods. Industry guidelines as well as equipment
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