Responding to studies showing that U.S. health care workers sustain 590,000 needle sticks each year, Public Citizen and the Service Employees International Union (SEIU) petitioned the FDA in 2001 to ban a variety of unsafe devices used by health care workers, including certain intravenous (IV) catheters, blood collection devices, blood collection needle sets (butterfly syringes), glass capillary tubes and IV infusion equipment. Thousands of health care workers have contracted HIV and hepatitis B or C after being accidentally stuck by infected needles while on the job and many have died
The FDA issued an "Advance Notice of Proposed Rulemaking" to gather information about the hazard, but today announced that it was withdrawing the rulemaking because the agency
believes that the actions it has taken and continues to take along with the actions taken by the Occupational Safety and Health Administration (OSHA) are addressing the issue adequately at this time.Dr. Peter Lurie of Public Citizen stated that the FDA's action "shows a profound indifference to the safety of workers and is yet another example of the Food and Drug Administrations (FDA) failure to do its job."
The FDA has increasingly come under fire for its refusal to ensure that prescription drugs are safe before being placed on the market. In most cases where unsafe drugs have had to be removed from the market, safer, equally effective alternatives have existed. Here, again, the agency is eschewing its responsibility to ensure the safety of the products it regulates. By allowing considerably more dangerous devices to stay on the market when equally effective, safer alternatives are available, the FDA has endangered the lives of hundreds of thousands of health care workers in this country.Last week a high level FDA official resigned in protest over the agency's decision to further delay a final ruling on whether the "morning-after pill" should be made more easily accessible.
