March 2, 2007

Mr. Drew Callison
Medical Surgical Systems
BD Medical
1 Becton Drive
Franklin Lakes, NJ 07417

Dear Mr. Callison:

Thank you for your July 20, 2006 letter 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 question(s) not delineated within your original correspondence. You had specific questions regarding use of engineering controls for immunization in the event of an influenza pandemic. We apologize for the delay in our response.

Question 1: Many state and local public health officials, as well as hospital administrators and purchasers, are beginning to mobilize to procure supplies and relevant resources, such as medical devices, that will be needed to immunize the public in the event of an influenza pandemic. When stockpiling syringes for pandemic influenza vaccination and treatment, are healthcare facilities and public health practitioners required to procure safety-engineered sharps in adherence with the OSHA Bloodborne Pathogens Standard (29 CFR 1910.1030)?

Reply 1: As you may know, state and municipal public health officials do not fall under the jurisdiction of federal OSHA. States and municipal employers in states with OSHA state plans must comply with state bloodborne pathogens standards (generally the same as the federal standard.) Hospitals and others over whom federal OSHA does maintain regulatory authority must comply with 29 CFR 1910.1030, the federal bloodborne pathogens standard. Also, outside of OSHA state plan states, state and local public hospitals receiving Medicare payments must comply with the federal bloodborne pathogens standard as a condition of their agreements with Medicare [42 USC §1395 cc(a)(1)(V)]. The standard at 29 CFR 1910.1030 applies whenever there are employees with occupational exposure to blood or other potentially infectious materials (OPIM). Using needles and syringes for vaccination is one way that employees may become exposed to blood, specifically through a needlestick from a used needle.

As you may know, the Department of Health and Human Services (DHHS) has been assigned the responsibility for developing a national stockpile of vaccine for influenza strains with pandemic potential and to expedite the rapid development, licensure, and production of new influenza vaccines.¹ DHHS recommends that each state develop a plan for receiving and managing the storage and distribution of supplies from the Strategic National Stockpile (SNS). Additionally, DHHS recommends that during the pre-pandemic phase, healthcare facilities work with state and local health departments on plans for distributing pandemic influenza vaccine.² It is recommended that health care administrators with the responsibility of preparing for pandemic influenza keep abreast of updates to the recommendations from the DHHS. Healthcare facilities may need to stockpile a wide range of medical supplies, including syringes, when preparing for possible disruptions in delivery service. It is a requirement of OSHA's bloodborne pathogens standard that employers, who have employees exposed to blood and/or OPIM, evaluate, select, and use engineering controls (e.g., sharps with engineered sharp injury protections, SESIPs) to eliminate or minimize exposure [29 CFR 1910.1030(c)(1)(v) and 1910.1030(d)(2)(i)]. It is advisable for healthcare facilities to anticipate their needs for specific consumable and durable medical supplies, including safety syringes and to develop a plan for stockpiling.

Question 2: A possibility exists that some portion of the pandemic influenza vaccine will be packaged in pre-filled syringes. Historically, vaccines and other curatives and therapeutics packaged in pre-filled syringes have not been accompanied (or prepackaged) with safety-engineered needles. If pandemic influenza vaccine is packaged in a pre-filled syringe, will those employers administering the vaccine be required to purchase safety needles to attach to those pre-filled syringes per paragraph [1910.130(d)(2)(i)] of the OSHA Bloodborne Pathogen Standard?

Reply 2: As you stated, it has been the practice for a variety of vaccines to be made available in pre-filled syringes, many of which are not equipped with safety devices. 29 CFR 1910.1030(d)(2)(i) requires employers to make available safety devices for use by employees who are exposed to blood or OPIM. It is uncertain exactly how the occurrence of a pandemic influenza situation will impact the healthcare community and the market availability of safety syringes. However, where safety-engineered equipment, such as add-on safety devices, is commercially available, employers are expected to implement their use to prevent needlestick incidents. Furthermore, we are unaware of any technical reasons that would prevent the use of safety-engineered needles for pre-filled syringes at this time.

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, Director
Directorate of Enforcement Programs

¹ HHS Pandemic Influenza Plan Supplement 6 Vaccine Distribution and Use. [ back to text ]

² HHS Pandemic Influenza Plan Supplement 3 Healthcare Planning. [ back to text ]