Ask the expert: OSHA safety sharps compliance on pre-filled syringes

By: January 4th, 2012 Email This Post Print This Post

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. You can read about it at “Lack of flu-shot safety device poses problem for worker.”

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 the standard, See”OSHA, GPOs, and safety devices.”


By Maureen Galvin on January 10th, 2012 at 7:31 am

Because the non safety needles can not be used why are they delivered with the pre-filled syringes? Why are the manufactures allowed to get away with this? Healthcare costs are sky-high yet we purchase a device with a needle that needs to be replaced……Cost is not considered…or maybe it is and someone is making money off this ridiculous scenario. This certainly is not in the best interest in containing the cost of healthcare today for the citizens of the United States.

By Bruce Cunha on January 10th, 2012 at 12:44 pm

I would agree. We will not change a lot of the issues we have unless we get manufacturers to assist. I would rather see prefilled without any needle than with a non-safety needle or a safety needle that our staff are not trained on.

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