Safety needles for patients who self-infuse at home

October 4, 2007

Mr. Paul Dufresne, R.Ph., MS

Pharmacy Manager

American Homecare Federation

[Recipient address omitted]

Dear Mr. Dufresne:

Thank you for your inquiry to the Occupational Safety and Health Administration. Your letter was forwarded to OSHA's Directorate of Enforcement Programs (DEP) for a response. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenarios or questions not delineated within your original inquiry. You had specific questions regarding the applicability of OSHA's bloodborne pathogens standard, 29 CFR 1910.1030 to the use of needles with self-infuse bleeding products. Your questions are restated below followed by OSHA's responses.

Scenario: A hemophilia home healthcare company supplies bleeding products to patients nationwide. Many patients with bleeding disorders self-infuse their products while other patients have professional nursing services provide in-home assistance with venipuncture and infusion.

Question 1: Does OSHA's bloodborne pathogens standard, 29 CFR 1910.1030, require that safety needles be sent to patients who self-infuse?

Reply 1: No. Your company is not required to send safety needles to persons who self-infuse bleeding products or who self-inject any other medication. The Occupational Safety and health Act of 1970 (OSH Act) only protects employees. 29 USC §653(a) states that the OSH Act applies to employment.

Question 2: Does OSHA's Bloodborne Pathogens Standard, 29 CFR 1910.1030, require us to provide safety needles when an outside party (e.g., home healthcare professional) uses our products to infuse a patient in his/her home?

Reply 2: The standard applies to employers having employees with occupational exposure to blood or other potentially infectious materials (OPIM). During a phone conversation with a member of our staff, you mentioned that your company, a pharmacy which supplies medical products and equipment, does not employ nor contract with in-home healthcare professionals to assist patients in infusing bleeding products. Since your company does not have employees with occupational exposure to blood or OPIM, you do not have a responsibility under OSHA's Bloodborne Pathogens Standard to supply your customers with safety-engineered sharps.

However, it is advisable that patients who rely on the services of healthcare professionals to be supplied with sharps with engineered sharps injury protections (SESIPs) and/or needleless devices for the protection of healthcare workers.

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 may consult OSHA's website at http://www.osha.gov. If you have any further questions, please feel free to contact the OSHA Office of Health Enforcement at (202) 693-2190.

Sincerely,

Richard E. Fairfax, Director

Directorate of Enforcement Programs