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Home > Archive > Hepatitis disease > September 2005 > FDA Reverses Course on Needle Sticks,
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FDA Reverses Course on Needle Sticks,
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| 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.
http://www.citizen.org/pressroom/release.cfm?ID=2041
Alan
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http://veloceraptor.blogspot.com/
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http://www.700women.org/
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