- Standard Number:
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 https://www.osha.gov.
May 27, 2004
Zeil Rosenberg, M.D., M.P.H.
Worldwide Business Leader and Medical Director
BD Medical Systems
1 Becton Drive
Franklin Lakes, New Jersey 07417
Dear Dr. Rosenberg:
Thank you for your January 28, 2003 letter to the Occupational Safety and Health Administration (OSHA). Your letter was referred to OSHA's Directorate of Enforcement Programs (DEP) for a response to your questions regarding OSHA's bloodborne pathogens standard and its applicability to the administering of smallpox vaccine using BD's Eclipse Bifurcated Needle. This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to issues not delineated within your original correspondence. Your questions are restated below followed by OSHA's response.
Question 1: Are employers (facilities administering the smallpox vaccine) required to evaluate commercially available safety bifurcated needles? If so, would they then be required to select and use the safety device deemed to be appropriate and effective?
Response 1: Yes, OSHA's bloodborne pathogens standard requires employers who have employees exposed to blood and/or other potentially infectious materials (OPIM) to annually document consideration and implementation of appropriate commercially available and effective safer medical devices to eliminate or minimize exposure [29 CFR 1910.1030(c)(1)(iv)(B)]. Non-managerial employees who are affected by product selections must participate in the product evaluation process [29 CFR 1910.1030(c)(1)(v)]. After soliciting input from affected non-managerial employees regarding the appropriateness of a particular engineering control, employers must select and use engineering controls (e.g., SESIPs) to eliminate or minimize employee exposure [29 CFR 1910.1030(d)(2)(i)].
Question 2: If employers are required to select and use safety bifurcated needles, is it reasonable and responsible for the federal government to provide a bifurcated needle without safety features in the National Pharmaceutical Stockpile?
Response 2: In an effort to address the appropriateness of available bifurcated needles, the CDC is organizing a research group to evaluate the acceptability and usability of safety bifurcated needles. The study was set to begin in March 2004 and will involve experienced vaccinators from state health departments who will evaluate the available safety devices.
Question 3: How will OSHA communicate to the CDC, and to those responsible for administering the smallpox vaccine, the requirements of the Needlestick Safety and Prevention Act, especially as CDC considers the procurement of additional bifurcated needles in the future?
Response 3: In January 2003, OSHA's Assistant Secretary, Mr. John Henshaw, wrote to the HHS Deputy General Counsel, Stewart Simonson, concerning OSHA's requirement for the use of engineering controls as it applies to the administration of smallpox vaccinations. In this letter, OSHA acknowledged CDC's assessment that the safety bifurcated needle available at that time was "neither appropriate nor effective" and that, "Under these circumstances, your [CDC's] determination that the [safety] device is neither appropriate nor effective for smallpox vaccination is reasonable, and the standard does not require employers to consider using it for that purpose. If, in the future, an improved safety device becomes commercially available, employers will be responsible for evaluating whether that device is appropriate for the work practices of their employees."
The FDA has since given pre-market 510(k) approval of other bifurcated needles with safety engineered features. As noted in response #2, the CDC is organizing a research group to evaluate the acceptability and usability of the safety bifurcated needles that are currently approved and available.
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 Enforcement at (202) 693-2190.
Richard E. Fairfax, Director
Directorate of Enforcement Programs