FDA to consider banning conventional needles

Labeling, restrictions are other options

The Food and Drug Administration (FDA) will consider restrictions on conventional needle devices, including the possibility of removing some devices from the market. While an outright ban is unlikely — it has happened only once before in FDA history — the agency will consider design criteria, new labeling, and other actions that could impact the marketing of sharps devices.

The Service Employees International Union (SEIU) and Public Citizen, a consumer advocacy group, petitioned the FDA last year to ban blood collection devices without safety features, glass capillary tubes, and IV infusion equipment that doesn’t use needleless technology. While the agency rejected the petition, Linda S. Kahan, deputy director, said the FDA would publish an advance notice of proposed rulemaking to gather information on possible actions, including a ban.

The FDA announcement is a tentative but favorable step for the SEIU and Public Citizen, which contend that FDA action should follow naturally from a federal law that mandates the use of needle safety devices. The Needlestick Safety and Prevention Act, which became law in 2000, mandated that the Occupational Safety and Health Administration (OSHA) rewrite its rules and require employers to use safety-engineered devices. "Basically, the FDA is giving employers tacit approval to violate the OSHA standard" by allowing conventional devices to remain on the market, says Bill Borwegen, MPH, SEIU’s occupational health and safety director. "It’s a great example of government noncooperation."

The FDA asserts that it has worked closely with OSHA. In fact, the OSHA standard still allows the use of conventional devices if medical professionals determine that, for a particular procedure and patient care needs, a safety engineered device would not be acceptable. "There’s flexibility in the interpretation of the law," says Timothy Ulatowski, ME, director of the division of dental, infection control, and general hospital devices in the office of device evaluation at FDA’s Center for Devices and Radiologic Health. "The law speaks of using available devices," he says. "The uses are evaluated at the specific site and under the specific conditions of use."

Previous petitions rejected outright

"If Congress, in its wisdom, wanted FDA to take action also with regard to [needle devices], they had the opportunity to do so. But they did not," he adds.

Still, the FDA now is at least willing to listen to arguments about restrictions on conventional devices. In the past, similar petitions have been rejected outright by the agency. In her letter, Kahan noted, "the FDA may undertake some of the actions you requested in your petition or [take] other appropriate actions."

The agency will host a public meeting to gather input from employers, employees, and other concerned parties. The FDA will review and possibly revise its needlestick safety alert and guidance document. However, it’s unclear whether the FDA actually could ban conventional needle devices, Ulatowski says. The Federal Food, Drug, and Cosmetic Act states that a device can be banned if it presents "an unreasonable and substantial risk of illness and injury." But the law also allows manufacturers to market devices that are "substantially equivalent" to those already available. "If you’re substantially equivalent to a product that’s legally on the market then you can market your product," he says. "We’re talking about products that have been out there for many, many years."

The FDA seems inclined to leave the enforcement of safer needles in the workplace to OSHA. "FDA believes that the OSHA rule, when fully implemented, could reduce needlestick injuries significantly," Kahan said in her letter. "It may be premature to take additional federal regulatory measures to control the use of these kinds of devices without first evaluating the effect of the amended OSHA rule on injury rates."