Federal needle safety mandate appears likely; will OSHA finally act?
Experts advise providers to begin implementation
The same day that federal legislators introduced bills to require hospitals to replace conventional needle devices with safer technology, the U.S. Occupational Safety and Health Administration (OSHA) quickly announced plans that would accomplish essentially the same goal, drawing criticism from observers who charge the agency’s move is a smoke screen for years of foot-dragging on the issue. Regardless, the growing consensus is that hospitals should begin preparing now for federal requirements to implement the use of needleless systems and other safety mechanisms designed to prevent sharps injuries.
In fact, some critics point out that OSHA can enforce the present bloodborne pathogens standard to require hospitals to evaluate and use safer devices right now. However, they’re concerned that OSHA’s plans may never materialize into action.
Federal legislation modeled after California law
The Health Care Worker Needlestick Prevention Act of 1999 (HR 1899), a bill to reduce the risk of transmission of bloodborne diseases via needlestick injuries, is modeled after a California law set to be enacted this summer. (See Hospital Employee Health, December 1998, pp. 144-146.) The federal legislation was introduced in the House by Rep. Pete Stark (D-CA) and Rep. Marge Roukema (R-NJ). At press time, 47 other Democrats and eight more Republicans had signed on as co-sponsors.
A companion bill is sponsored in the Senate (SB 1140) by Barbara Boxer (D-CA), who last year successfully introduced a directive aimed at pushing OSHA and other federal agencies to accelerate the use of safer needle devices nationwide and to mandate more accurate needlestick injury reporting. (See HEH, March 1999, pp. 25-28.)
The current bills not only require the use of needleless systems and other safety mechanisms to prevent injuries, but also would enhance current needlestick reporting requirements and establish a clearinghouse for data collection on safer technologies within the National Institute for Occupational Safety and Health (NIOSH). In addition, the clearinghouse would serve as a resource for hospitals by designing a training curriculum for selecting and using safer devices.
OSHA’s plans include three elements:
• bolstering contaminated sharps injury reporting by requiring all those injuries to be recorded on OSHA logs;
• revising the bloodborne pathogens compliance directive later this year to reflect the newer, safer technologies now available;
• taking steps to amend the bloodborne path ogens standard by placing needlestick injuries on its regulatory agenda this fall.
In a prepared statement, Secretary of Labor Alexis M. Herman said OSHA’s plans resulted in part from comments received from nearly 400 hospitals and other interested parties in response to the agency’s request for information on minimizing needlesticks. (See related story, p. 88.)
"We can and must reduce the estimated 590,000 needlesticks that occur each year among our 5.6 million health care workers. It’s time to make sure that health care workers have up-to-date devices that limit the risk of needlesticks and the potential for contracting deadly diseases such as AIDS and hepatitis," Herman’s statement reads.
Union pursues grass-roots campaign
However, some critics assert that the time is long overdue.
"Talk is cheap," states William K. Borwegen, MPH, occupational safety and health director of the Washington, DC-based Service Employees International Union (SEIU), which led the fight for the California law. The 650,000-member union recently launched a state-by-state grass-roots campaign to implement needle safety legislation similar to that in California, while continuing to lobby for a national law and urging OSHA to act. At present, 20 states are considering bills designed to help protect health care workers from accidental injuries.
"This is an agency that can’t get out of its own way. This agency seems incapable of doing anything, but I wish they’d prove me wrong," says Borwegen. "I would love for them to get this thing done, and then I’ll be glad to be embarrassed and eat crow, but they’ve been talking about it for years and haven’t actually done anything yet."
OSHA announced its plans simply "for cover," he states. "There’s a difference between actually doing something and trying to make it look as though you’re doing something."
Borwegen charges that OSHA finished revising the compliance directive seven months ago, but has lagged on the internal review and issuance. He says the agency also has failed to obey the congressional directive handed down last fall to revise its record-keeping requirements for contaminated sharps exposures.
Why isn’t OSHA citing hospitals now?
Additionally, he notes that OSHA cited a Denver hospital recently for failing to evaluate and implement safer needle devices (see Hospital Employee Health, April 1999, pp. 37-40), a move that proves the agency can enforce present versions of the bloodborne pathogens standard and compliance directive.
"Health care workers are risking their lives using unsafe needles today while OSHA is talking about putting out a [new] compliance directive," Borwegen says. "The current wording allows hospitals to be cited, so why are they not citing hospitals all over the place right now?"
Although contacted repeatedly for a response, OSHA officials declined to comment on criticism or its own announced plans.
The legislation would in effect force OSHA to require safer needle devices, with some exceptions, such as when the devices are unavailable for certain procedures or if they would compromise patient safety. However, Stark points out that provisions of the bill exceed OSHA’s authority and scope. For example, OSHA cannot establish the NIOSH clearinghouse. In addition, OSHA does not cover public employees. He thinks legislation is needed for another reason as well.
"OSHA testified on this issue in 1992, and we still haven’t seen anything. I intend for health care workers to be protected from needlestick injury by whatever means is the quickest way to do it," Stark tells Hospital Employee Health. "If the fact that there’s a bill in Congress with a lot of support makes OSHA do something on its own, that’s fine with me. There needs to be a symbiosis of Congress and an agency wanting to accomplish the same thing."
Stark says the legislation is important because technology exists to prevent many needlesticks, and "it’s wrong that it’s not being used." Health care facilities will save money in the long run by not having to pay health care costs of workers who are injured and require treatment, he adds.
Two previous versions of the bill were defeated due to controversial provisions. Stark’s 1993 version included an excise tax penalty for the sale of unsafe devices, and a bill introduced last year threatened hospitals with expulsion from the Medicare program for not using safer devices.
"That’s a very heavy hammer," he says. "It raised strong opposition from the hospital industry. This year we chose an approach that has been tried at the state level and worked. Changing the way we’re doing it to a successful model makes it more palatable to a broader array of members of Congress."
AHA still opposes legislation
However, the hospital industry still is against any legislative action, although officials say they support its intent.
Richard Wade, a senior vice president of the Chicago-based American Hospital Association, says the organization fears that a law will be too rigid, and has "made it clear to OSHA that we think they have all the power they need" to accomplish most of what’s in Stark’s bill.
"We think they should move ahead and develop guidelines for the field very quickly. Passing a law is a long and arduous process to get to something we have a regulatory process in place to do," Wade states.
Others support the legislation, especially in light of OSHA inaction.
Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville and a world-renowned needle safety expert, says if OSHA fails to voluntarily enforce the bloodborne pathogens standard using the criteria of safety devices as engineering controls, legislation forcing the agency to do so is the answer.
"It appears [OSHA is] not going to move any farther than they’re forced to," Jagger says. "The only kind of action I would recognize as definite is something that has actually been done, as opposed to what an agency says it’s going to do. To say they’re going to do it could go on forever. Until they actually take a step, I would not regard statements as actions."
Becton Dickinson (BD), the largest worldwide manufacturer of both conventional and safety devices, also backs the bill, but officials of the Franklin Lakes, NJ-based company say they would prefer regulation to legislation.
"It makes more sense to let federal OSHA take care of it," says Kevin Seifert, director of business development and policy. "We support the legislative action in the form of the Stark bill because it’s a mechanism to make OSHA react."
BD introduced the first safety-engineered device — a safety syringe — 11 years ago, but "in the past 11 years, conversion to safety devices just didn’t happen in most product areas," Seifert notes.
Supplier says costs are overstated
He cites end-user resistance as the cause, due both to lack of training in how to use safer devices and concerns over cost. However, Seifert says company estimates show that for an average 300-bed hospital converting to safer products in the categories of syringes and needles, blood collection devices, and IV catheters, the increased cost would be about $71,000 per year.
"For the budget size of a 300-bed institution, I wouldn’t think that would be viewed as crippling or even substantial," he says. "It’s not the millions that many people sometimes automatically think it is."
While costs of different product categories vary widely, Seifert notes that conventional needles cost 6 cents to 8 cents each, while safer versions cost 22 cents to 25 cents each. He expects that as demand volume increases, as it would if all hospitals were required to purchase safer devices, prices for those devices would decrease.
In fiscal year 1998, 29% of the company’s revenues from its needle-based medical device businesses came from safety-engineered products. A variety of conventional devices still would be in use after legislation or regulation, either due to patient safety considerations or because safer technology is not available or necessary, so Seifert cannot presently predict how that percentage might change after widespread device conversion.
"We’re in favor of good legislation that allows for good patient care, end-user selection of technology they want to use, and no prevention of advancement to future technologies," he states. "If the law says the customer chooses what product they think is the most appropriate, and if it’s effective and protects the worker, why wouldn’t we want to support that? We’re assuming this is coming and we’re preparing for it."
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