FDA may ban some conventional needles
Petition says only safety devices should be sold
Saying that conventional sharps devices are inherently unsafe, a health care workers union and consumer advocacy group jointly petitioned the Food and Drug Administration (FDA) to ban them. The Service Employees International Union (SEIU) and Public Citizen are targeting conventional IV catheters, blood collection devices, blood collection needle sets (butterfly syringes), IV infusion equipment, and glass capillary tubes.
"It’s complimentary to our tremendous victory in passing federal legislation," says Bill Borwegen, MPH, SEIU’s occupational health and safety director. "The FDA is going to continue to allow devices to be sold on the market that are essentially going to be illegal under the OSHA [Occupational Safety and Health Administration] standard."
In November, President Clinton signed the Needlestick Safety and Prevention Act, which had passed Congress through an expedited, unanimous consent. The law mandates the use of safety devices and maintenance of a needlestick log and amends the OSHA bloodborne pathogen standard, bypassing the lengthy process of rule-making.
In 1999, OSHA had already issued a compliance directive ordering hospitals and other health care facilities to use "engineered controls" to reduce needlesticks. But Borwegen contends those actions aren’t enough. "We’re trying to have some consistency here. It also would have more immediate impact rather than leaving it up to hospitals one on one to try to comply with the OSHA standard."
An FDA spokesperson declined to comment on the petition. The agency is required to respond within 180 days.
The groups also asked the FDA to use its own criteria for safety devices as a performance standard for new products — in effect, preventing new conventional devices from reaching the market. The petition does not request the FDA to ban conventional syringes, which can have a number of uses. But it asks for labeling, which states, "to prevent possible exposure to HIV and hepatitis, do not use for standard blood draws."
The SEIU petitioned the FDA to ban certain conventional needle devices in 1991, but the agency met with representatives from manufacturers and decided that the market was changing rapidly to the safer devices. However, a substantial demand for safer devices didn’t occur until 1998, when California passed the first needlestick safety law.
Borwegen says he is hopeful about the current petition. "We know the FDA has actually put out alerts on two of the items we’re asking them to ban," he says. "If they put out alerts, in light of the new federal law, they should ban these products."
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