June 4, 2001

Judy Hintzman, Manager Infection Control
Columbia - St. Mary's, Inc.
2025 East Newport Avenue
Milwaukee, WI 53211

Dear Ms. Hintzman:

Thank you for your March 28, 2001 letter to the Occupational Safety and Health Administration (OSHA). Your letter was forwarded from OSHA's Milwaukee Area Office to the Directorate of Compliance Programs in Washington, DC for a response to your specific questions regarding the applicability of the Bloodborne Pathogens Standard (29 CFR 1910.1030) to the withdrawal of medications from a vial in a clinical setting. Your question is outlined below followed by OSHA's response. 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.

The pharmacy and nursing staff (of our facility) use large bore needles to withdraw medication from a vial and then remove that needle, placing a smaller gauge safety needle on the syringe to administer the medication to the patient.

Do we have to use a safety needle to withdraw the medication from the vial even though it will not have contact with the patient?

In the situation that you describe, the practices your facility uses are compliant with the Bloodborne Pathogens standard and no further controls would be required. The standard applies to all occupational exposure to blood or other potentially infectious materials (OPIM). Therefore, during a procedure where there is no exposure to blood or OPIM, such as withdrawing medication or pharmaceuticals from a vial, it would not be necessary to implement the use of engineering controls.

If, during this procedure, the same needle used to withdraw the medication is also used to administer it to a patient through injection, OSHA would require the use of an appropriate engineering control (e.g., safer medical device, sharp with engineered sharps injury protection). As you have stated, you use a straight needle to withdraw the medication from the vial and then switch to a "safety" needle for administration; this is acceptable.

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 at (202) 693-2190.

Sincerely,



Richard E. Fairfax, Director
Directorate of Compliance Programs

CC: Area Director, Milwaukee Area Office