- 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 http://www.osha.gov.
December 9, 2004
Ms. Kathy Toriello, RN, MHA, CIC
Corporate Director of Employee Services
601 E. Pratt Street
Baltimore, MD 21202
Dear Ms. Toriello:
Thank you for your inquiry to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP). This letter constitutes OSHA's interpretation only of the requirements discussed and may not be applicable to any scenarios not delineated within your original inquiry. You had specific questions regarding the administration of a new drug, Forteo®, and its applicability to OSHA's bloodborne pathogens standard, 29 CFR 1910.1030. Your question is restated below followed by OSHA's response.
Scenario: The FDA has recently approved a new osteoporosis drug, Forteo®, which is being prescribed for use in long term care facilities. The drug is currently only available in a pen-type syringe, which is attached to an unprotected needle prior to administration. This pre-filled pen contains multiple doses and may be administered for up to 28 days after the first injection. As there is currently no other way a patient may be injected with Forteo®, the practice in long term care facilities is to remove the used needle after administration of this drug, either by recapping and removing the needle manually, or by using a sharps container equipped with a mechanical unwinding device. The pre-filled pen is then recapped and refrigerated for future use.
Question: How does this current practice affect a facility's compliance with the requirements of OSHA's bloodborne pathogens standard?
Reply: OSHA's bloodborne pathogens standard prohibits the bending, recapping or removal of a contaminated needle or other contaminated sharp [29 CFR 1910.1030(d)(2)(vii)(A)]. The standard also provides an exception where an "employer can demonstrate that no alternative is feasible or that such action is required by a specific medical or dental procedure. Such bending, recapping or needle removal must be accomplished through the use of a mechanical device or a one-handed technique" [29 CFR 1910.1030(d)(2)(vii)(B)]. The preamble to the bloodborne pathogens standard notes that the administration of incremental doses of a medication is one medical procedure, among others, to which this exception refers [56 FR 64118 (1991)].
In the scenario you described, patients are required to be injected with medication that is not commercially available in a device with a safety engineered sharp injury protection (SESIP) system. Also, as we understand, the drug itself is not available in any other format, meaning Forteo® is not presently available from the manufacturer in a liquid format which could be drawn (like other drugs/medications) from a vial into a safety engineered (SESIP) syringe. OSHA interprets this to mean that under special circumstances where, for example, "SESIP" use is not technically feasible and the medical procedure requires the removal of a contaminated sharp, the use of a mechanical device (e.g., sharps container with an unwinder) would be allowed. Thus, under these circumstances, the needle used to administer Forteo® may be removed by a mechanical device, such as a sharps container with an unwinder, or a one-handed technique. An explanation for the medical need for needle removal must be documented in the employer's Exposure Control Plan [29 CFR 1910.1030(d)(1)(ii)(B)].
In order to limit the practice of removing contaminated needles and lessen the likelihood of employees suffering needlestick injuries, employers must train employees on the purpose of the mechanical needle removal device and ensure that it is only available for use in extreme circumstances like the use with the Forteo® Pen [29 CFR 1910.1030(g)(2)(vii)(F)]. Each employer is responsible for ensuring that employees do not utilize needle removal procedures for situations where other methods of disposal are feasible or where SESIPs are commercially available and appropriate for use.
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