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Compliance on Pre-filled Syringes

Q: May we use the non-safety needles that come with pre-filled vaccine syringes provided by the pharmaceutical company without violating OSHA standards?

A: No. Manufacturer-supplied pre-filled syringes without safety needles do not exempt employers from compliance with the Bloodborne Pathogens standard as a 2007 OSHA letter of interpretation, “Requirements for safety-engineered sharps for stockpiled pandemic influenza vaccines and pre-filled syringes” makes clear:

“…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.”

This became an actual concern late in 2008 when Novartis supplied pre-filled flu vaccines without safety needles.

To make things perfectly clear following this event, OSHA issued a notice stating:

“OSHA™s Bloodborne Pathogens Standard, 29 CFR 1910.1030 requires that employers who have employees with reasonably anticipated exposure to blood and/or other potentially infectious materials (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(b), 29 CFR 1910.1030(c)(1)(v), and 1910.1030(d)(2)(i)]. This applies to the pre-filled injection devices for influenza vaccine or other vaccines.”

Compliance is not limited to pre-filled syringes; surgical kits are also subject to the standard.

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