Leaky needles raise device supply issue

HHS bought needles for H1N1 vaccine

The sharps safety devices provided with the 2009 H1N1 vaccine provoked a flurry of complaints as nurses found them to be difficult to activate, leaky, or too large. Many of those complaints focused on the BD Integra, a retractable needle that has been on the market since 2002. The experience highlights the difficulties inherent in the large government purchase of safety devices that the users are not familiar with, safety experts say.

When the U.S. Department of Health and Human Services promised to provide devices along with more than almost 200 million doses of vaccine, the first question was one of supply. Who could accommodate a surge in manufacturing sufficient to supply a nationwide mass vaccination?

The Biomedical Advanced Research and Development Authority (BARDA) acknowledged this concern when it put out an expedited request for proposals in August, without the usual bidding process: "Manufacturers with a demonstrated manufacturing capacity to produce between 10 to 30 million needle and syringe units per month beginning in September 2009 and lasting until February 2010 will be necessary to meet [U.S. government] needs for 600 million vaccinations."

At the time, it was not clear whether the novel H1N1 vaccine would require two doses or whether adjuvant would be used to extend the supply. As it turned out, one dose is sufficient and no adjuvant is being used.

However, the kits were packaged and shipped with oversized syringes and needles — 21 gauge retractable VanishPoint needles and 5 ml syringes — that were intended for use in mixing adjuvant. Instead, employee health professionals were perplexed when they received needles and syringes that weren't appropriate for routine vaccination. "If we had waited until a decision was made about adjuvants, there's no way we could have gotten them to states in time," says HHS spokeswoman Gretchen Michael.

Becton, Dickinson and Company of Franklin Lakes, NJ, the world's largest supplier of needles and syringes, also had the greatest immediate manufacturing capacity. It told BARDA it could supply 15 to 25 million syringes and needles per month. Covidien (formerly Tyco Healthcare), headquartered in Dublin, Ireland, offered capacity of 10 to 13 million units per month. Retractable Technologies of Little Elm, TX, had capacity to produce 10 million a month, ramping up to 30 million per month in about four months. Smiths Medical of St. Paul, MN, had capacity to produce 10 million units.

"We were dealing with enormous quantities," says Michael, who said BARDA was ultimately looking for 200 million syringes. "We did a survey of what was feasible, who were the manufacturers and what was their capacity."

In the fall, concerns began to arise, particularly about the BD Integra. The device requires a half-turn to secure the needle before administration. But some users reported that the needle hub still leaked after turning it.

"You gave the person an injection and you don't know how much they got of the vaccine," says Bruce Cunha, RN, MS, COHN-S, manager of employee health and safety at the Marshfield (WI) Clinic.

The BD Integra brochure indicates that activation can occur before or after removing the needle from the patient's arm — a different technique from the VanishPoint, the first retractable device that entered the market. The VanishPoint touts single-handed activation that occurs when the plunger is fully depressed, before it is withdrawn from the patient.

Users complained to the Centers for Disease Control and Prevention that the Integra was too difficult to activate. "We have received reports and questions about ancillary supplies, with the vast majority focusing upon one specific product that providers may not be accustomed to using and which requires a half-twist of the needle to prevent vaccine from leaking," CDC spokesman Joe Quimby said in an e-mail response to Hospital Employee Health.

As of mid-December, BD had shipped about 100 million syringes and needles, including 13 million of the Integra. "Since the product began shipping for the H1N1 flu vaccination campaign via the U.S. government's distribution channels in October, we have received a small handful of complaints about the BD Integra syringe via our customer complaint process," Alyssa Zeff, director of worldwide public relations for BD, said in an e-mail response. "While this number is less than we received during the same time frame last year, we will remain vigilant in assessing customer issues and have taken some additional steps to increase our ability to respond to customers.

"We recognize that personnel giving H1N1 vaccinations may be expected to use a safety-engineered device with which they are not familiar. For that reason, we have developed an online training tool that includes both video and step-by-step printable instructions on how to use each of the BD safety-engineered syringes that the U.S. government is distributing as part of its national flu vaccination campaign."

In fact, users had very little time to get acclimated to the devices. Emma S. Smith, RNC, COHN, employee/occupational health coordinator at Mount Nittany Medical Center in State College, PA, received the hospital's first doses of 2009 H1N1 vaccine at 12:30 p.m. on a Friday and was vaccinating employees by 2 p.m. "As I was administering some of the first ones, I recall thinking, 'I don't like these needles,'" she says. "You get used to using a certain device and then you get a different device handed to you. Sometimes there's a learning curve."

At Concord (NH) Hospital, nurses initially also had problems with leakage. One device actually fell apart, says Anne C. Mills, RN, MSN, COHN-S, director of Employee Health Services. She contacted her materials management department and they received assistance from a BD representative. She demonstrated the correct use of the device and brought educational materials.

The hospital had no further problems after the training, says Mills. "Some of it is technique, changing the way you've been doing shots for 35 years."

Some users felt the needle device should have been more intuitive. "We're not talking about people who are not normally used to using needles," says Cunha. "It should work as a normal retractable needle."

Marshfield Clinic, which administered more than 8,000 doses, began attaching its own safety needles to the syringes. "They wasted a ton of money," Cunha said of BARDA. "We're all throwing this stuff out, basically. We're just not using it at all here."

(Editor's note: Information from CDC about the vaccine devices is available at www.cdc.gov/vaccines/ed/ciinc/specialtopics/2009_flu.htm and www.cdc.gov/h1n1flu/vaccination/slv/pdf/2009_H1N1_Influenza_ Vaccine_Ancillary_final_11-12-2009.pdf. Information about BD syringes and needles is available at www.bd.com/hypodermic/.)