06/12/2002 - 
Re-use of blood tube holders.
U.S. Department of Labor
Occupational Safety & Health Administration
www.osha.gov
       
Standard Number:1910.1030(d)(2)(vii)(A)

      June 12, 2002
      Mr. Douglas E. Kline
      Infection Control Practitioner
      
      Dear Mr. Kline:
      Thank you for your March 20, 2001 letter to the Occupational Safety and 
      Health Administration (OSHA) regarding the applicability of OSHA's 
      Bloodborne Pathogens Standard (29 CFR 1910.1030) to the safe practice of 
      phlebotomy and blood tube holder use. This letter constitutes OSHA?s 
      interpretation only of the requirements discussed and may not be 
      applicable to any question not delineated within your original 
      correspondence.

      We apologize for the extreme delay in our response to you. As you know, 
      based on your phone conversations with our staff, we were awaiting the 
      release of the revised compliance directive (CPL 2-2.69, November 2001) to 
      address similar issues with sweeping national implications. Removing 
      contaminated needles in order to re-use blood tube holders has gained more 
      national attention, and we felt it best to address such an important issue 
      first in our compliance directive. You can access that document on the 
      World Wide Web [http://www.osha.gov/OshDoc/Directive_pdf/CPL_2-2_69.pdf].

      Thank you for your understanding in this matter. Your question is 
      summarized below followed by OSHA?s interpretation.

      Question: What is OSHA's position regarding the use of blood tube holders, 
      specifically removing a needle in order to re-use a tube holder? Must each 
      blood tube collection device be disposed of with the needle attached each 
      time they are used?

      OSHA's Bloodborne Pathogens Standard (29 CFR1910.1030, paragraph 
      (d)(2)(vii)(A)) provides: “Contaminated needles and other contaminated 
      sharps shall not be bent, recapped, or removed, unless the employer can 
      demonstrate that no alternative is feasible or that such action is 
      required by a specific medical or dental procedure.” More specifically, 
      our new compliance directive, CPL 2-2.69 at XIII.D.5 states, “removing the 
      needle from a used blood-drawing/phlebotomy device is rarely, if ever, 
      required by a medical procedure. Because such devices involve the use of a 
      double-ended needle, such removal clearly exposes employees to additional 
      risk, as does the increased manipulation of a contaminated device.” In 
      order to prevent potential worker exposure to the contaminated hollow bore 
      needle at both the front and back ends, blood tube holders, with needles 
      attached, must be immediately discarded into an accessible sharps 
      container after the safety feature has been activated.

      Using a syringe to collect blood would be an example of a situation where 
      clinical or medical necessity would dictate the need for transferring the 
      collected blood to a test tube before disposing of the contaminated blood 
      collection device. If drawing blood with a syringe is necessary, 
      engineering controls (engineered sharps injury protection) and safe work 
      practices (including mechanical means of removal if available) must be 
      used and needleless blood transfer devices must be implemented.

      Removing contaminated needles and subsequently reusing blood tube holders 
      poses multiple potential hazards. The increased manipulation required to 
      remove a contaminated needle from a blood tube holder is unnecessary and 
      may result in a needlestick from either the front or back end of the 
      needle. According to information available from the International Health 
      Care Worker Safety Center at the University of Virginia, injuries 
      occurring in phlebotomy are among the highest-risk for transmitting 
      bloodborne pathogens such as HIV, HCV and HBV, because they involve 
      hollow-bore, blood-filled needles.

      Further, improper disposal of used, unprotected needle devices potentially 
      affects more than just the user. According to data presented by the 
      California Department of Health Services (January 2002), close to half of 
      all injuries from contaminated sharps occur to those who are not in 
      immediate control of the device, but to those who come in contact with the 
      unprotected needle downstream (e.g., nursing assistants, housekeepers, 
      maintenance personnel). Therefore, disposing of single-use 
      safety-activated blood collection devices decreases potential injuries 
      downstream.

      While patient safety is not within the scope of OSHA's mission, we 
      recognize that tube holder reuse poses a potential health hazard to 
      patients. Some clinical studies show that 50-80% of blood tube holders may 
      be contaminated after just one use (Advance/Laboratory, p. 70, January 
      2000). While it may be difficult to document a patient-to-patient 
      cross-contamination exposure, the risk does exist and should be weighed 
      when making decisions regarding overall safety.

      Thank you for your interest in occupational safety and health. We hope you 
      find this information helpful. OSHA requirements are set by statute, 
      standards and regulations. Our interpretation letters explain these 
      requirements and how they apply to particular circumstances, but they 
      cannot create additional employer obligations. This letter constitutes 
      OSHA's interpretation of the requirements discussed. Note that our 
      enforcement guidance may be affected by changes to OSHA rules. Also, from 
      time to time we update our guidance in response to new information. To 
      keep apprised of such developments, you can consult OSHA's website at 
      http://www.osha.gov. If you have any further questions, please feel free 
      to contact the Office of Health Compliance Assistance at (202) 693-2190.

      Sincerely, 
      Richard E. Fairfax, Director
      Directorate of Compliance Programs