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Public Citizen, SEIU Petition FDA to Immediately Ban

Nov. 29, 2000

Public Citizen, SEIU Petition FDA to Immediately Ban
Unsafe Medical Needles

Health Care Workers Infected by Unsafe Devices Call for Safer Alternatives

WASHINGTON, D.C. — The Food and Drug Administration (FDA) should immediately ban a variety of unsafe devices used by health care workers so they can be protected from contracting deadly diseases from accidental needle sticks, Public Citizen and the Service Employees International Union (SEIU) said in a petition filed today with the FDA.

U.S. health care workers sustain 590,000 needle sticks annually. Thousands have contracted HIV or hepatitis C after being accidentally stuck by infected needles while on the job, and many have died. Their deaths and suffering are unnecessary because safer alternatives exist.

“The FDA is the only entity that can completely remove these unsafe devices from all health care facilities,” said Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “For the sake of medical workers throughout the country, the FDA s immediate action on this petition is imperative. Cutting off an epidemic of needle-borne infections at the source is the only effective public health strategy.”

Said SEIU President Andrew L. Stern, “Without FDA action, thousands of nurses, doctors and other health care workers will lose their lives. Not one more health care worker should needlessly suffer from unsafe needles when proven, safer alternatives exist.”

The petition calls for the FDA to remove from the market all unsafe intravenous catheters, blood collection devices, blood collection needle sets (also known as butterfly syringes), glass capillary tubes and intravenous infusion equipment. The petition also asks the FDA to issue performance standards to ensure that similar unsafe devices do not enter the market.

There have been 49 documented cases of U.S. health care workers contracting HIV from patients after being stuck by infected needles or similar sharp medical devices, although the actual number is likely much higher because there have been no needle stick reporting requirements. One hundred to 200 other workers die annually from hepatitis B, and the Centers for Disease Control and Prevention (CDC) believes most of these cases are occupationally acquired. Hundreds of health care workers also contract hepatitis C every year.

Noreen Prill, a nurse who became infected with hepatitis C in 1978 and who appeared at today’s press conference, said the ban is long overdue. Her hand was pierced by a contaminated needle when a dialysis patient grabbed her arm while she was taking blood from him.

“It is sad and ironic that the same kind of needle that infected me more than 20 years ago is still on the market today,” Prill said.

Ellen Dayton, a California nurse, became infected on the job in 1996. She was reaching to grab several blood-collection tubes that were rolling off a counter top when her finger was pricked by a contaminated butterfly syringe. She subsequently tested positive for HIV and hepatitis C. Although she was too sick to travel to today=s press conference, she provided a videotaped statement.

“It is time for the FDA to act to take needles like the one that I was stuck with off the market, so that no other nurses will have to suffer like I have,” Dayton said.

Safer devices exist, including retractable needles, self-blunting needles and protective shields. Plastic capillary tubes used for measuring red blood cell counts can replace glass tubes. Intravenous catheters can be equipped with plastic shields that lock and cover the needle after it has been removed from a patient. Intravenous tubing that uses no needles has been developed and has been shown to reduce needle sticks.

Such devices can be more expensive, but their cost can be offset by the number of needle sticks prevented, the petition states. Such injuries typically cost between $500 and $1,000 for each worker who sustains a needle stick, including blood tests, counseling and appropriate medications. Treatment costs increase dramatically if workers become sick.

In 1991, the SEIU petitioned the FDA to issue performance standards for a variety of unsafe needles devices, but the FDA refused to do so. Since the petition was filed, millions of workers have been stuck by needles and thousands have contracted deadly diseases. Many hospitals and health care facilities have begun to use safer devices, but their use is not widespread.

Congress recently approved a law that strengthened the Occupational Safety and Health Administration’s (OSHA) Bloodborne Pathogens Standard to require most?– but not all — health facilities to evaluate the needles they are using and use safer needles. During the evaluation process, unsafe needles will continue to be used. The evaluation process will be inconsistent and unnecessarily time-consuming unless the FDA leads the way by banning devices that have been proven unsafe and for which there are proven, safer alternatives.

“It is time for the FDA to live up to its responsibility to regulate unsafe medical devices and take them off the market,” said Dr. Sidney M. Wolfe, director of Public Citizen’s Health Research Group. “The FDA needs to act now. Otherwise, hundreds of workers will continue to become infected each year.”