Unprotected needles on prefilled influenza vaccine syringes

November 24, 2008

Clement Lewin, PhD, MBA

Head, Strategic Immunization Planning

Novartis Vaccines and Diagnostics

[Recipient address omitted]

Dear Dr. Lewin:

The Occupational Safety and Health Administration (OSHA) has been made aware of a recent issue regarding nationwide dissemination of Novartis' Fluvirin® Suspension for Intramuscular Injection 2008-2009 Formula (NDC #66521-111-01) in pre-filled injection syringes with permanently affixed, unprotected needles. We understand that Novartis has been made aware of the occupational health hazard that these devices present and that the company has been working with Cal/OSHA and public health officials in the state of California to address the issue. We would like to inform Novartis that this issue is also of great concern to Federal OSHA and request your cooperation in addressing the matter in other affected states.

OSHA estimates that 5.6 million workers in the health care industry and related occupations are at risk of occupational exposure to bloodborne pathogens, including human immunodeficiency virus (HIV), Hepatitis B virus (HBV), Hepatitis C virus (HCV), and others. Needlestick injuries pose one of the greatest risks of bloodborne pathogens exposure in healthcare. 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.

Federal OSHA has been notified that Cal/OSHA has made a notification to the public health community in California by placing a notice of this issue on their website. Federal OSHA is preparing to place a similar notification on the OSHA website. The use of the Fluvirin® device with an affixed, unprotected needle violates the requirement of 29 CFR 1910.1030(d)(2)(i) to use engineering controls. OSHA is aware that Novartis markets the vaccine in pre-filler syringes with a "luer" lock connection which allows employers to make the selection of a SESIP to use for injections and that the company has agreed to replace the unprotected devices disseminated in the state of California. As in California, we are requesting that Novartis does the same in other states where the pre-filled devices with affixed needles have been shipped.

We appreciate your cooperation in addressing this issue and look forward to your actions which will assist employers in effectively providing protection to employees who use the Novartis' Fluvirin® vaccine.

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