Flu syringe debacle underscores that sharps safety may be slipping as priority
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, 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 U.S. 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 either 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 U.S. Occupational Safety and Health Administration, 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.
FDA weighs pt safety only
The Food and Drug Administration approves medical devices but 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," she says. "We're not talking about a syringe that could be used for research. 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 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 is a question many have asked - and that may 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.
Need for clear message
The International Health care Worker Safety Center at the University of Virginia in Charlottesville contacted the CDC five years ago to ask whether safety-engineered needle protection was required for pre-filled vaccine syringes, as with other sharp devices. "We didn't get a clear answer at that time, and it continues to be a controversial issue. I think there is a need for a consistent national policy, however," says associate director Jane Perry.
Flu vaccine isn't the only area of concern. Medications such as insulin sometimes come in pre-filled syringes to make dosing easier. And while insulin may be self-injected by patients, the same syringes may be used in long-term care or other settings, notes Dionne Williams, MPH, senior industrial hygienist with OSHA.
Don't use nonsafety syringes
While the role of manufacturers in sharps safety may be debated, there's no question about an employer's responsibility. "It's not permitted to use a conventional needle where there are acceptable alternatives and there certainly are acceptable alternatives [to conventional pre-filled vaccine syringes], some of them manufacturer by the same manufacturer [who produced the nonsafety devices]," says Deborah Gold, MPH, CIH, senior safety engineer in the research and standards health unit at Cal-OSHA in Oakland.
When Cal-OSHA learned of the syringe problem, it immediately began working with Novartis and CDC to arrange for a substitution of safe devices. Due to supply limitations, Novartis swapped one-quarter of the syringes with pre-filled syringes with a Luer-Lock and three-fourths of the supply with multidose vials, Santoli says.
Still, Cal-OSHA worried that some flu clinics would proceed and vaccine administrators wouldn't be aware of the device problem until they opened the packages. Cal-OSHA placed an alert on its web site in late October. "The problem is getting the word out to people before they start to use them," says Gold.
Federal OSHA placed a link on its web site to a Letter of Interpretation related to pre-filled vaccine syringes that might be used during a pandemic. "Any kind of injection or vaccination is going to raise the same issues if you're using an unprotected needle," says Williams.
Meanwhile, health care providers need to make their preferences known to manufacturers, she says. "I know that manufacturers are interested in being a part of the process. They're in business to sell devices," she says. "If they make a device and it's not selling, it's not going to be beneficial to them."
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OSHA: Plan for safety syringes in flu pandemic In response to questions about safety-engineered syringes for use during a pandemic, the U.S. Occupational Safety and Health Administration issued the following interpretation of the bloodborne pathogen standard: 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 health care 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. 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, health care facilities work with state and local health departments on plans for distributing pandemic influenza vaccine. 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. Health care 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 health care 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 health care 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. |
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