Sept. 8, 2005
FDA Reverses Course on Needle Sticks,
Shows Profound Indifference to Worker Health
Statement of Dr. Peter Lurie,
Deputy Director of Public Citizen’s Health Research Group
Today’s withdrawal of a rulemaking initiated to protect health care workers from accidental needle sticks shows a profound indifference to the safety of workers and is yet another example of the Food and Drug Administration’s (FDA) failure to do its job.
In 2000, Public Citizen and the Service Employees International Union (SEIU) petitioned the FDA 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. The problem is significant: Each year, U.S. health care workers sustain 590,000 needle sticks, according to the University of Virginia, and thousands have contracted HIV and hepatitis B or C after being accidentally stuck by infected needles while on the job. Many have died. These deaths and injuries were unnecessary because devices that are equally effective, yet have safety features such as retractable needles, self-blunting needles and protective shields, exist.
In response to the petition, the FDA issued an advance notice of proposed rulemaking, in which the agency acknowledged the dangers associated with needles and began the process of addressing them. Now, the agency has retreated in the face of industry pressure. The agency claims that not enough detailed data exist to warrant action. However, an extensive body of research documents the ability of the safer devices to reduce needle sticks. As the American Medical Association concluded in 2001, “Scientific data now indicate that the appropriate use of needlestick prevention devices, especially in comprehensive prevention programs, significantly reduces the incidence of needlestick injuries.”
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.
To read the 2000 petition, click here.