Proposed federal law could mandate safer needles
Proposed federal law could mandate safer needles
Medicare funding threatened for noncompliance
A proposed law has been introduced into the U.S. House of Representatives that would withhold federal funding to hospitals that fail to evaluate and purchase needle safety devices designed to prevent bloodborne infections in health care workers.
The Health Care Worker Protection Act of 1997 (HR 2754) calls for the U.S. Food and Drug Administration (FDA) in consultation with an advisory council composed of representatives from consumer groups, front-line health care providers, industry, and technical experts to establish safety standards for hypodermic devices that minimize the risk of occupational needlestick injuries. Such designs typically include mechanisms to retract, shield, or blunt needles after medication has been administered or blood drawn.
$5 million requested for education, training
U.S. Rep. Pete Stark (D-CA) introduced the bill on Oct. 29, 1997, and hearings are expected to begin this month. The bill is designed to reduce the risk of needlestick injuries to health care workers by requiring hospitals to use only those hollow-bore needles that meet the safety standards. Hospitals that fail to comply would not be permitted to participate in the Medicare program if the bill passes. In the proposed legislation, Stark requests an appropriation of $5 million for health care worker education and training in the use of approved devices.
"Health care workers shouldn’t have to risk their lives while saving the lives of their patients," he says. "This bill would ensure that the necessary tools better information and better medical devices are made available to our front-line health care workers to reduce the injury and death that may result from needlesticks each year."
Stark also notes in a news release that "while you can’t put a dollar figure on the psychological toll of a needlestick," the direct cost to treat one needlestick injury can average $2,809. If an HIV infection occurs, direct and indirect costs can total more than $500,000, he says.
The issue has been the subject of debate and controversy for years, with the most recent example being a decision by the Centers for Disease Control and Prevention not to recommend specific devices in its new employee health guidelines due to insufficient data and the need for a broader consensus at the agency. (See related story, p. 1.) By the same token, federal regulators have been reluctant to force a phase-out of conventional needle devices while data gradually accumulate on the efficacy of the various safety designs.
Yet there is growing evidence that broad implementation of at least some of the devices could reduce infections in health care workers. For example, a multi-hospital study of three eedle safety devices reduced percutaneous injuries by a range of 23% to 76% during phlebotomies, which have been strongly linked to transmission of bloodborne pathogens to health care workers.1 (See Hospital Infection Control, April 1997, pp. 56-59.)
The legislation is supported by a number of professional organizations, including the American Nurses Association (ANA) in Washington, DC. The ANA met with Stark and his staff during the drafting and will continue to lobby for passage of the bill, says Susan Wilburn, RN, MPH, senior specialist for occupational safety and health at the ANA.
"I don’t know how specific the [device] recommendations would be, but it would go to an advisory committee that would include front-line health care workers as well as hospital administrators, working with the FDA medical device division to create a format for review," she says. "What I am envisioning is that the advisory committee would both develop criteria to assist hospitals in evaluating the most appropriate devices, as well as determining whether a device fits in the category of needlestick prevention."
While there has been some implementation of needle safety devices, the ANA and other health care worker advocates feel the process is stalled and warrants either legislation, or as an alternative, enforcement of requirements for ongoing evaluation of engineering controls in the Occupational Safety and Health Administration’s bloodborne pathogen standard.
"We think that the language in the bloodborne pathogen standard means that institutions should be [implementing devices], and they are not," Wilburn says. "There is a wide variety of both availability and use. I have been talking to [ANA] members in many different states where in some places they are not available at all."
On the other hand, some facilities have implemented needle-less intravenous systems, but not hypodermic safety designs. Still others have chosen to make the devices available only on certain units such as the emergency room, or they make them available but do not encourage their use, she adds.
While expecting "a struggle" to get the legislation passed, Wilburn says public support should be widespread once the issue is in discussion.
"At least 800,000 and probably upwards of a million health care workers are getting stuck on an annual basis," she tells Hospital Infection Control. "I don’t think the American public wants nurses to be made sick when it can be prevented with a device. If this was in any industry other than health care the auto industry, steel work this kind of engineering control would have been already implemented."
Reference
1. Centers for Disease Control and Prevention. Evaluation of safety devices for preventing percutaneous injuries among health-care workers during phlebotomy procedures Minneapolis-St. Paul, New York City, and San Francisco, 1993-1995. MMWR 1997; 46:21-25.
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