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Flu syringe debacle points to priority of sharps safety
Novartis syringes had no safety feature
When a local public health department in California opened packages of FluVirin pre-filled syringes to start the flu immunization campaign, the vaccine administrators were stunned. Contrary to federal law and regulation, the syringes had a fixed needle with no safety device.
The California Department of Health had received 50,000 of those syringes through the Centers for Disease Control and Prevention (CDC), but the packaging did not indicate that they had a fixed, conventional needle. California immediately contacted Novartis, the manufacturer, and the CDC to substitute the syringes for a safe version.
Nationwide, CDC contracted for 200,000 of the FluVirin syringes that were delivered to 17 states with fixed, conventional needles. It was up to the consumers the health departments or private customers to swap them for other syringes or multidose vials. To sharps safety experts, the incident highlights the need for greater vigilance and a renewed focus on sharps safety. In fact, after an initial significant drop in needlesticks after the Needlestick Safety and Prevention Act of 2000, sharps injuries have reached a plateau, according to available tracking data.
"The idea of needle safety hasn't penetrated through the whole medical culture," says June M. Fisher, MD, director of the TDICT (Training for Development of Innovative Control Technologies) Project in San Francisco. "I think this is the most egregious example of that. How else could you explain it?"
In fact, a spokeswoman for Novartis Vaccines in Cambridge, MA, seemed unaware of the federal law and Occupational Safety and Health Administration regulation. "The fixed 5/8-[inch] needle has been FDA-approved and CDC-supported, and it's been available in the United States since 1993," says Beth Birke, director of global vaccines communication.
However, Birke said Novartis notified all customers both public health departments and private customers that they could exchange the syringes for "alternate presentations." Novartis will not sell the fixed needle syringes in subsequent flu seasons, she says.
In its Vaccines for Children program, the CDC contracts with four manufacturers for flu vaccine. Traditionally, the pre-filled syringes have a Luer-Lock, which enables the user to insert their preferred safety-engineered needle. The contract didn't specify that the syringes needed to have a safety device or a Luer-Lock because this had never been an issue before, says Jeanne M. Santoli, MD, MPH, deputy director of the Immunization Services Division in the CDC's National Center for Immunization and Respiratory Diseases. "We knew we were getting pre-filled syringes. We did not realize they had staked needles attached," she says. "We weren't intending to contract for needles with syringes.
"We purchased 12 to 13 million doses to be available to state programs [of which about 200,000 were the fixed needle syringes]. This is a relatively small part of our total purchase, but it's an important issue," she says. "Our contracts in the future will address the fact that staked needles are not something we want to enable state programs to purchase."
The CDC states that one of its seven "health care challenges," or goals, is to "eliminate occupational needlestick injuries among health care personnel." However, that goal was set by CDC's Division of Healthcare Quality Improvement, while the vaccine was ordered by the Immunization Services Division.
Employers carry burden of compliance
Under the needle safety law and bloodborne pathogen standard of the Occupational Safety and Health Administration (OSHA), employers, not manufacturers, carry the responsibility for providing safe sharps. Hospitals and other device purchasers must influence the market by demanding safer products, sharps safety experts say.
The Food and Drug Administration approves medical devices, but it considers only patient-related issues and not worker safety. Purchasers can feel confounded when they receive pre-filled, non-safety syringes or open kits that contain conventional devices.
Gina Pugliese, RN, MS, vice president of the Premier Safety Institute, part of the Charlotte, NC-based Premier health care alliance, worked for years to convince manufacturers not to sell pre-filled syringes with fixed, conventional needles or kits with nonsafety syringes. "I'm surprised that in 2008, that there would be a pre-filled vaccine made without a safety needle, considering OSHA has specifically mandated safety devices since 2001," Pugliese says.
"We're not talking about a syringe that could be used for research," she says. "The implication is that it would be injected into a patient and therefore put the [vaccine administrator] at risk."
In fact, it was a shock for health care purchasers, as well. MaryAnn Gruden, MSN, CRNP, NP-C, COHN-S/CM, employee health coordinator at Western Pennsylvania Hospital in Pittsburgh, opened up packages two days before her flu vaccine campaign, prepared to place safety needles on syringes with Luer-Locks. She was taken aback by the fixed needle, but she felt she needed to move forward with her vaccination campaign. "It's really unnerving to me to have a needle without a safety feature on it," says Gruden. "How can they put this out without any safety [feature]?"
That question has been asked by many, and that might be a powerful impetus for change, says Pugliese. "When something like this happens, it really provides an opportunity to take a closer look at an issue," she says.