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U.S. Department of Health and Human Services

  

This is an archived document. The links are no longer being updated.

TB Notes 3, 2004

Information on Safer Medical Devices for Placing the Tuberculin Skin Test

The Mantoux tuberculin skin test (TST), which detects Mycobacterium tuberculosis infection, is administered by needle and thus can result in health care workers receiving needlestick injuries. In 2001, when the Needlestick Safety and Prevention Act was passed, the Occupational Safety and Health Administration (OSHA) revised the Bloodborne Pathogens standard to require that employers select and use effective and safer medical devices to protect health care workers from contaminated-sharps injuries and to reduce occupational exposure to bloodborne diseases. The Needlestick Safety and Prevention Act requires health care employers to document in their exposure control plans that they have evaluated and implemented safety-engineered sharp devices and needleless systems. In 2003, CDC produced the Mantoux TST Training Materials Kit for use in training health care workers to administer the Mantoux TST and interpret the reaction. 

Syringe and needle technologies that help prevent needlestick injuries have been evolving and continue to do so. Any medical device designed to administer the TST should meet specific criteria for placing the TST accurately or should address these criteria through the design of the device. DTBE undertook a project that involved gathering information on the current and future availability of safe medical devices for placing TSTs. The objective of this effort was to assist in developing a resource document, to be shared with TB programs, that lists the safer medical devices that meet the design criteria.

CDC located 26 needle manufacturers by Internet search and sent information to the  manufacturers in a letter highlighting the procedures for placing an accurate Mantoux TST. The needle manufacturers were invited to share information on their existing or planned safer medical devices for administering the TST and to describe how the criteria on the procedures list are or will be addressed by each medical device. All of the 26 needle manufacturers responded, with 16 indicating that they had no safety injection equipment and 10 replying that they had injection devices that met the criteria on the procedures list. In addition, third-generation needleless jet injection devices, which currently are not FDA approved for tuberculin skin testing, have reportedly produced intradermal injections successfully.

We determined that medical devices that can be used in administering the standard TST and that incorporate needles with engineered sharps injury protection equipment are reportedly available from several manufacturers. DTBE has now developed a resource document that lists the available medical devices, which can be obtained by contacting Judy Gibson by e-mail at jsgibson@cdc.gov. The use of safety injection device trade names and manufacturing companies is for identification and information only and does not imply endorsement by DTBE, CDC, or the National TB Nurse Consultant Coalition (NTNCC).

The above was presented as an abstract at the NTCA meeting in June 2004.

—Submitted by Judy Gibson
Div of TB Elimination

 


Released October 2008
Centers for Disease Control and Prevention
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