As needlestick prevention legislation storms through Congress, it seems like deja vu all over again.
Early this month the Needlestick Safety and Prevention Act easily passed the House of Representatives by a voice vote. The bill aims to reduce the estimated 1 million needlestick injuries that occur in the healthcare workplace annually, thus preventing the transmission of bloodborne infections such as tuberculosis, hepatitis and HIV.
A corresponding bill was fully expected to pass through the Senate sometime this session.
"It's a love fest," says Kevin Seifert, vice president of advanced protection technologies at BD, Franklin Lakes, N.J., the needle manufacturing giant. Becton Dickinson has initiated an education campaign and spent several hundred thousand dollars putting together a safety compliance kit for hospitals.
Besides broad bipartisan support in Congress, the legislation has received resounding applause from such diverse interests as the Service Employees International Union, the American Hospital Association, Premier hospital alliance and the American Nurses Association--to name a few.
But the cooperative spirit begs a question: What makes this legislation any different from the widely publicized update of the 1991 Bloodborne Pathogens Standard that was issued by the federal Occupational Safety and Health Administration in November 1999? Or from the widely publicized California legislation that passed in September 1998? Or from legislation that has since passed in some 16 states?
In substance, nothing is different.
The federal legislation will merely seal the deal, requiring full compliance six months after it is signed into law. More important, it draws attention to what many people describe as "a stealth regulation," Seifert says.
In Seifert's estimation, confusion about complying with safe needle regulations and legislation abounds because of the order in which changes have occurred.
Legislation was first implemented in California. The law mandated regulatory action which in turn specified a drop-dead compliance date--July 1999. "That seems to be a regulation that people understood," Seifert says.
The exact opposite occurred at the national level. OSHA implemented its regulations before needlestick safety was even a gleam in Congress' eye.
Indeed, as far as OSHA is concerned, the broadly written regulations have been in place since 1991, says Melody Sands, director of health compliance assistance at OSHA. Like the U.S. Constitution, the standard was written so that it could easily change with the times, "so that 20 years from now when we are not even using needles, that standard will still be good," she says.
The 1991 standard prescribes that healthcare organizations take precautions against accidents involving bloodborne pathogens; at that time that largely meant wearing gloves, masks and gowns. With only a few choices on the market, the technology for engineered needles with built-in safety devices had not yet arrived, Sands says.
That's all changed now. In the years since, a plethora of engineered products is on the market, including self-sheathing syringes, retractable scalpels and needleless intravenous systems.
Sands characterizes the 1999 OSHA directive as an "amplification" of "what is available in engineering control to reduce or eliminate exposure" to bloodborne pathogens. Like Seifert, she says the legislation serves to raise awareness.
"If there is any doubt in anybody's mind," Sands says, "the legislation will certainly clarify it."
But that hasn't changed the hard fact that hospitals nationwide are already under federal orders to offer their workers state-of-the-art technology in safe medical devices. Sands says OSHA inspectors are routinely asking hospitals how they are meeting their exposure-control requirements. And although she cannot give an exact number, she says hospitals have been cited and fined--up to $7,000 for each violation.
Seifert says BD has noted that whenever legislation has passed at a state level, there has been "aggressive" movement to comply. Prior to enactment of the legislation in California, about 20% of the market was converted to safe needles, he says. Now it's more than 75%.
Phillip Zweig, a spokesman for Retractable Technologies, Little Elm, Texas, says, "The demand for these products exceeds the ability of all manufacturers to supply it." Incorporated in 1994, Retractable traces its beginnings to the safe needle movement. Net sales from year-end 1998 to year-end 1999 grew by 300% to $3.4 million from $846,000, principally because of sales in California, Zweig says.
With the California law in place for well over a year now, Enid Eck, a senior consultant for HIV and infectious disease at Oakland-based Kaiser Permanente, reports some challenges in complying with the law, primarily because the technology is still developing for a wide range of sharp devices used in hospitals.
Kaiser has seen no noticeable reduction in needlestick injuries from the most highly visible sharps in a hospital: syringes for intramuscular injections. Those types of needles don't come with the highest injury risk anyway, she adds. But although she can't quantify it, Eck says there has been a noticeable reduction of injuries in the most risky needlestick situations--drawing blood and starting IVs.
Eck has this advice for material managers: "I think it's very important to have the frontline workers participate in product selection," she says. "I don't think administrators who are removed from the bedside have all the information on all the ways the devices are used. When frontline workers use them and give feedback, it saves an awful lot of time and angst."