The smallpox vaccine is made from a live virus related to smallpox called vaccinia

Hello, Jeff - If you read down the page, at the very end, it is stated that "a bifurcated needle should not be reprocessed and reused more than 50 times."

Patricia Doyle

8. 2002 CDC Recommendations for Handling, Cleaning, and Sterilizing Bifurcated

Immunization Needles in Healthcare Settings

Background

Sterile, bifurcated needles are used to administer smallpox immunization. The needles are designed to hold the designated dose of vaccine (2.5l) between the needle prongs to allow delivery to the skin surface. Once on the skin, the needle is used to make 15-16 superficial punctures at the vaccination site to permit percutaneous penetration of the vaccine. Trace amounts of blood at the vaccination site are evidence of successful vaccine delivery. Bifurcated needles may arrive from the manufacturer sterilized and individually wrapped, or in bulk, requiring subsequent sterilization prior to use. These needles are intended for single-patient use followed by disposal in a puncture-resistant sharps container. Because of limited supplies, especially during mass vaccination programs, it may be necessary to reprocess and reuse these needles.

The strategies and procedures described here are restricted to the cleaning and reprocessing of bifurcated needles ONLY.

Protocols for reprocessing bifurcated needles must address: 1) the prevention of blood exposures and patient-to-patient transmission of bloodborne viruses (i.e., hepatitis B and C viruses [HBV, HCV], and human immunodeficiency virus [HIV]); and 2) prevention of sharps injury and occupational transmission of bloodborne viruses to healthcare personnel. The following procedures are designed to protect both patients and healthcare personnel involved in smallpox vaccination programs.

1. Initial Sterilization of Unsterile Bifurcated Needles Received From the Manufacturer in Bulk Supply. Needles received in bulk from the manufacturer should be assumed to be clean and ready for packaging and sterilization. If there is any concern regarding the cleanliness of these items, they should be cleaned then sterilized as described below.

2. Identify Resources. Identify equipment and personnel to carry out reprocessing. The reprocessing area should either have an ultrasonic bath, commercial dishwasher, and an autoclave or dry heat sterilizer. The area should be of sufficient size to have clearly demarcated dirty and clean areas. The flow of traffic should always be from dirty to clean.

3. Methods for Reprocessing Bifurcated Needle. Moist heat sterilization (i.e., autoclaving) or dry heat sterilization are the preferred methods for sterilizing cleaned bifurcated needles. However, boiling or flaming, as described below, may be used if an autoclave or a forced air dry heat oven is not available. These alternative methods have some historical precedence, especially in developing nations, but have not been validated. A. Care in handling. To prevent worker injury, used needles should be handled as little as possible during reprocessing. The use of fine mesh containers with secure tops that facilitate containment and transfer during reprocessing is preferred. Tongs, forceps, hemostats, or other devices that eliminate the need for hands-on contact with needles should be used to transfer them from their container.

B-17B. Cleaning

Used needles MUST BE CLEANED prior to sterilization. Place needles in a soaking solution immediately after use and prior to any physical cleaning. Soaking will facilitate cleaning by preventing blood and organic soil from drying on the needle. Commercial products used by healthcare facilities for soaking contaminated instruments (e.g., any detergent, detergent-disinfectant, enzyme formulation/cleaner) are appropriate for this purpose. Do not use alcohol, glutaraldehyde, or formaldehyde as a soaking solution for the needles (these will fix protein to the needle surfaces). Also avoid use of strong oxidizing solutions (hypochlorites, peroxides, peracetic acid) because these may damage the needle tip,. Transport used needles in the soaking solution (cover or cap the container) and send to designated area for cleaning and reprocessing. Automated cleaning with an ultrasonic cleaning device or commercial dish/glassware washer is preferred to manual cleaning as there is less opportunity for worker injury. The manufacturer's instructions for use of the device should be followed.

The needles should then be rinsed with potable water, and allowed to air dry on a clean surface . Personnel should wear gloves during the cleaning process and use transfer devices (e.g., tongs, forceps, or hemostats) as needed to avoid direct handling of needles. C. Autoclaving. Bifurcated needles that have been cleaned and dried are ready to be packaged and autoclaved. Needles may be individually wrapped or placed in groups of 10 to 15 in plastic/paper peel-down packages or pouches, or clean screw-top glass container, and autoclaved. The bifurcated end of the needle should point toward the bottom of the tube/ pouch away from the opening to allow easy aseptic retrieval. The manufacturer's instructions for use of the autoclave should be followed. Sterilization times will vary depending on temperature and load (i.e., 121ºC for 30 minutes or 133ºC for 4 minutes).

The tubes/packs should be placed in a rack or carrier that holds the tubes in a horizontal or slightly slanted position to ensure that the steam will penetrate fully to the bottom. During autoclaving, tops of glass tubes should be loose enough to allow penetration of steam and prevent breakage of the container. After autoclaving and cooling, caps should be tightly screwed. D. Dry Heat Sterilization. Screw capped glass test tubes are the best choice for dry heat sterilization. Clean and package bifurcated needles as above for glass tubes (i.e., cap tubes but leave loose enough to allow for air). The needles can be placed in a dry heat oven and baked as follows: (i) 170°C for 60 minutes; (ii) 160°C for 120 minutes; (iii) 150°C for 150 minutes; (iv) 140°C for 180 minutes; or (v) 121°C overnight.

B-184. Other Sterilization Alternatives

Boiling and flaming are alternative methods for sterilizing bifurcated needles, but should be used only when other options are not available.

A. Boiling. After cleaning, needles that will be reused may be placed in boiling water for 20 minutes, allowed to air dry, and then stored in a sterile receptacle. To minimize handling before and after sterilization heat-resistant fine mesh containers should be used where possible. If such containers are not available, a transfer device (e.g., tongs, forceps, hemostat) should be used to insert and remove needles from the water bath. The transfer device should be boiled along with the needles to facilitate aseptic removal. Although the handle of the transfer device need not be immersed in the boiling water, it will become very hot during needle reprocessing. Care should be taken to prevent burn injury during handling. Needles must be thoroughly dried to ensure that no residual water enters the vaccine vial. This is best accomplished by placing the needles on one half of an absorbent, plastic-backed, sterile barrier and folding the other have over the needles, providing a protective cover. When dry, the needles should be transferred aseptically into a dry sterile container (e.g., glass tube) with the bifurcated ends pointed away from the opening to permit aseptic retrieval. The top of the receptacle should be secured tightly to prevent contamination.

B. Flaming. In the past, flaming has been used to reprocess bifurcated needles, but no data exists on sterilization efficacy. Flaming should be used only when the needle must be reused immediately (i.e., a mass vaccination campaign is underway, vaccine recipients are present, and a supply of new or reprocessed sterile needles is not available) and only when none of the other sterilization methods described above are available. Pass the bifurcated end of the needle through the flame of an alcohol lamp or Bunsen burner. If an alcohol burner is used, the concentration of the alcohol must be 95% for adequate burn. The optimal duration of exposure to the flame is not known. The needle must become sufficiently hot to allow sterilization. However, to maintain needle integrity, the needle should not remain in the flame for more than 3 seconds. Measures should be taken to prevent burn injury to the fingers by handling the blunt end of the needle with a non-conductive device (i.e., forceps or tweezers with rubber or hard plastic handles). Allow the needle to cool completely before inserting into the vaccine. Flaming is not considered a terminal reprocessing procedure as it does not provide an environment for maintaining sterile conditions. If needles that have been flamed for immediate reuse will be used again in the future, they should be cleaned and sterilized (autoclaving, baking, or boiling), as described above.

Frequency Of Reuse

A bifurcated needle should not be reprocessed and reused more than 50 times. Reports have shown that vaccination effectiveness was reduced to 80.8% with needles used 86 to 172 times.

Procedures should be established to monitor the frequency of needle reuse. Prevention of cross-contamination.Patient-to-patient transmission of bloodborne viruses has been associated with contamination of multi-dose vials. To prevent opportunity for such transmission, a contaminated needle should never be allowed to reenter a vaccine vial. Furthermore, surfaces where vaccine is being handled should be free of visible blood, body fluids or other organic soil. Preparation of vaccine and needle reprocessing should be physically separate. If a contaminated needle is inadvertently redipped into a vaccine vial, that vial should be removed and not used for further vaccination.

Patricia A. Doyle, PhD

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