June 21, 2007

Ms. Marcia Fusilli
Sr. Product Manager — Safety Hypodermic
BD Medical Surgical Systems
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Ms. Fusilli:

Thank you for your letter to the Occupational Safety and Health Administration's (OSHA's) Directorate of Enforcement Programs (DEP) regarding the applicability of your product, the BD SmartSlip™, [and whether it] would enable employers to comply with the engineering control provision of the Bloodborne Pathogens Standard, 29 CFR 1910.1030(d)(2)(i). The scenario you provided and your question are 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.

Scenario: Becton Dickinson (BD) has developed the BD SmartSlip™ technology as an engineering control for use with smooth-tipped Luer Slip syringes which do not possess the locking threads of a Luer Lock syringe. Previously manufactured safety devices do not fit securely onto Luer Slip syringes which, in the United States, are used most frequently on 1 ml syringes in neonatal intensive care and pediatric units. BD created the SmartSlip™ technology to provide a secure attachment of BD safety needles to Luer Slip syringes.

Question: Would OSHA consider BD SmartSlip™ technology an engineering control that prevents unintentional needle disengagement which can potentially cause inadvertent sharps injuries?

Reply: OSHA may not and does not endorse or approve products. Compliance with the bloodborne pathogens standard is established on a case-by-case, facility-by-facility basis. As you may know, it is not merely the device itself that determines compliance, but the appropriate selection of engineering controls, accompanied by safe use of the device, safe work practices, and annual employee training. The final determination of whether a safety-engineered device prevents inadvertent sharps injuries must take into account all factors pertaining to the use of the safety device at a particular worksite. This must include an evaluation, including direct observation of employee work practices and all conditions of use in the workplace as well as an assessment of the equipment or device itself.

Although OSHA cannot, of course, approve or endorse particular products, the BD SmartSlip™ technology appears to be an acceptable safety-engineered device for employer consideration and use. The employer is ultimately responsible for ensuring compliance with the Bloodborne Pathogens Standard, including soliciting input from non-managerial employees responsible for direct patient care in the selection of appropriate safety devices and ensuring that employees are trained on the proper use of new devices and work practices necessary to prevent needlestick injuries [29 CFR 1910.1030(g)(2)(vii)(F)].

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.

Sincerely,



Richard E. Fairfax
Directorate of Enforcement Programs