infection control guidelines for dentists

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VI. Sterilization and Disinfection of Patient-Care Items

A. General Recommendations

1. Use only FDA-cleared medical devices for sterilization and follow the manufacturer’s instructions for correct use (IB).
2. Clean and heat-sterilize critical dental instruments before each use (IA)
3. Clean and heat-sterilize semicritical items before each use (IB).
4. Allow packages to dry in the sterilizer before they are handled to avoid contamination (IB).
5. Use of heat-stable semicritical alternatives is encouraged (IB).
6. Reprocess heat-sensitive critical and semi-critical instruments by using FDA-cleared sterilant/high-level disinfectants or an FDA-cleared low-temperature sterilization method (e.g., ethylene oxide). Follow manufacturer’s instructions for use of chemical sterilants/high-level disinfectants (IB).
7. Single-use disposable instruments are acceptable alternatives if they are used only once and disposed of correctly (IB, IC).
8. Do not use liquid chemical sterilants/high-level disinfectants for environmental surface disinfection or as holding solutions (IB, IC).
9. Ensure that noncritical patient-care items are barrier-protected or cleaned, or if visibly soiled, cleaned and disinfected after each use with an EPA-registered hospital disinfectant. If visibly contaminated with blood, use an EPA-registered hospital disinfectant with a tuberculocidal claim (i.e., intermediate level) (IB).
10. Inform DHCP of all OSHA guidelines for exposure to chemical agents used for disinfection and sterilization. Using this report, identify areas and tasks that have potential for exposure (IC).

B. Instrument Processing Area       

1. Designate a central processing area. Divide the instrument processing area, physically or, at a minimum, spatially, into distinct areas for 1) receiving, cleaning, and decontamination; 2) preparation and packaging; 3) sterilization; and 4) storage. Do not store instruments in an area where contaminated instruments are held or cleaned (II).
2. Train DHCP to employ work practices that prevent contamination of clean areas (II).

C. Receiving, Cleaning, and Decontamination Work Area

1. Minimize handling of loose contaminated instruments during transport to the instrument processing area. Use work-practice controls (e.g., carry instruments in a covered container) to minimize exposure potential (II). Clean all visible blood and other contamination from dental instruments and devices before sterilization or disinfection procedures (IA).
2. Use automated cleaning equipment (e.g., ultrasonic cleaner or washer-disinfector) to remove debris to improve cleaning effectiveness and decrease worker exposure to blood (IB).
3. Use work-practice controls that minimize contact with sharp instruments if manual cleaning is necessary (e.g., long-handled brush) (IC).
4. Wear puncture- and chemical-resistant/heavy-duty utility gloves for instrument cleaning and decontamination procedures (IB).
5. Wear appropriate PPE (e.g., mask, protective eyewear, and gown) when splashing or spraying is anticipated during cleaning (IC).

D. Preparation and Packaging

1. Use an internal chemical indicator in each package. If the internal indicator cannot be seen from outside the package, also use an external indicator (II).

2. Use a container system or wrapping compatible with the type of sterilization process used and that has received FDA clearance (IB).

3. Before sterilization of critical and semicritical instruments, inspect instruments for cleanliness, then wrap or place them in containers designed to maintain sterility during storage (e.g., cassettes and organizing trays) (IA).

E. Sterilization of Unwrapped Instruments

1. Clean and dry instruments before the unwrapped sterilization cycle (IB).
2. Use mechanical and chemical indicators for each unwrapped sterilization cycle (i.e., place an internal chemical indicator among the instruments or items to be sterilized) (IB).
3. Allow unwrapped instruments to dry and cool in the sterilizer before they are handled to avoid contamination and thermal injury (II).
4. Semicritical instruments that will be used immediately or within a short time can be sterilized unwrapped on a tray or in a container system, provided that the instruments are handled aseptically during removal from the sterilizer and transport to the point of use (II).
5. Critical instruments intended for immediate reuse can be sterilized unwrapped if the instruments are maintained sterile during removal from the sterilizer and transport to the point of use (e.g., transported in a sterile covered container) (IB).
6. Do not sterilize implantable devices unwrapped (IB).
7. Do not store critical instruments unwrapped (IB).

F. Sterilization Monitoring

1. Use mechanical, chemical, and biological monitors according to the manufacturer’s instructions to ensure the effectiveness of the sterilization process (IB).
2. Monitor each load with mechanical (e.g., time, temperature, and pressure) and chemical indicators (II).
3. Place a chemical indicator on the inside of each package. If the internal indicator is not visible from the outside, also place an exterior chemical indicator on the package (II).
4. Place items/packages correctly and loosely into the sterilizer so as not to impede penetration of the sterilant (IB).
5. Do not use instrument packs if mechanical or chemical indicators indicate inadequate processing (IB).
6. Monitor sterilizers at least weekly by using a biological indicator with a matching control (i.e., biological indicator and control from same lot number) (IB).
7. Use a biological indicator for every sterilizer load that contains an implantable device. Verify results before using the implantable device, whenever possible (IB).
8. The following are recommended in the case of a positive spore test:

a. Remove the sterilizer from service and review sterilization procedures (e.g., work practices and use of mechanical and chemical indicators) to determine whether operator error could be responsible (II).
b. Retest the sterilizer by using biological, mechanical, and chemical indicators after correcting any identified procedural problems (II).
c. If the repeat spore test is negative, and mechanical and chemical indicators are within normal limits, put the sterilizer back in service (II).

9. The following are recommended if the repeat spore test is positive:

a. Do not use the sterilizer until it has been inspected or repaired or the exact reason for the positive test has been determined (II).
b. Recall, to the extent possible, and reprocess all items processed since the last negative spore test (II).
c. Before placing the sterilizer back in service, rechallenge the sterilizer with biological indicator tests in three consecutive empty chamber sterilization cycles after the cause of the sterilizer failure has been determined and corrected (II).

10. Maintain sterilization records (i.e., mechanical, chemical, and biological) in compliance with state and local regulations (IB).

G. Storage Area for Sterilized Items and Clean Dental Supplies

1. Implement practices on the basis of date- or event-related shelf-life for storage of wrapped, sterilized instruments and devices (IB).
2. Even for event-related packaging, at a minimum, place the date of sterilization, and if multiple sterilizers are used in the facility, the sterilizer used, on the outside of the packaging material to facilitate the retrieval of processed items in the event of a sterilization failure (IB).
3. Examine wrapped packages of sterilized instruments before opening them to ensure the barrier wrap has not been compromised during storage (II).
4. Reclean, repack, and resterilize any instrument package that has been compromised (II).

5. Store sterile items and dental supplies in covered or closed cabinets, if possible (II).