CDC studies prove safety devices help stop needlesticks
Officials considering national guidelines for safer needle selection
The results of two studies recently published by the federal Centers for Disease Control and Prevention prove that the use of needle devices with safety features helps prevent percutaneous injuries among health care workers. The studies may pave the way for development of national guidelines for selecting and using safer needles in hospitals, but some observers question what effect the CDC’s findings will have on HCWs’ access to safety devices.
In one study at six university-affiliated hospitals (three in Minneapolis-St. Paul, one in New York City, and two in San Francisco) during 1993-1995, the CDC assessed safety devices intended to reduce the risk of needlestick injuries to HCWs during phlebotomy procedures. The two-phase evaluation compared the use of safety devices with conventional devices. Results showed that the use of safety needles reduced worker injuries by up to 76% without significant patient complications, and that HCWs generally accepted the safer devices.1
The second study, conducted at three New York City teaching hospitals in 1993-1994, evaluated the effectiveness of surgical suture needles with blunt tips in preventing needlestick injuries during gynecologic surgery procedures. Findings indicated that the use of blunt needles was associated with significant reductions in needlestick injury rates, minimal clinical adverse effects on patient care, and general acceptance by gynecologic surgeons.2 (For more details on both studies, see related story on p. 40.)
In editorial notes accompanying both studies, the CDC supports the use of safer needle devices to protect HCWs from blood exposures. However, in recent years, the federal agency has been barraged with criticism from HCW labor unions, safety experts, and others for failing to evaluate the efficacy of safety devices and to publish statements supporting their use. While the CDC has co-sponsored two national conferences on preventing sharps injuries and bloodborne exposures, the most recent one raised concerns among participants that the transition to safer needle devices was frustratingly slow, due in part to a lack of action by federal agencies. (See related story in Hospital Employee Health, October 1995, pp. 121-125.)
"We did get a lot of pressure from occupational groups to do things like this, and I think that’s good," says Elise Jochimsen, MD, medical epidemiologist in the CDC’s hospital infections program. "Clearly, these are difficult studies to do, but they are important to do. We are all very concerned about preventing injuries, so we should all do what we can to look at ways of accomplishing that."
Clinical evaluations of safety devices are difficult for several reasons, according to the CDC. First, ascertainment of percutaneous injuries is complicated by the underreporting of needlesticks, and in the case of phlebotomy, observation is impractical because those procedures are performed throughout hospitals by different groups of HCWs at all hours.
Second, data to calculate percutaneous injury rates are not routinely available. Other problems include the large number of phlebotomies that would have to be evaluated, and the difficulty of assessing activation rates of device safety features.
Jochimsen says phlebotomy devices and suture needles were targeted in the two studies because of high exposure rates associated with their use. No other safety device studies are planned or under way, but she says the CDC will continue to analyze data already gathered with an eye to developing guidelines for hospitals nationwide. That action presently is only in the discussion stage.
CDC may use EPINet data
"We will look at the data we have and decide if we need to make guidelines or more definite statements about what should or shouldn’t be done in hospitals," Jochimsen says. "In making guidelines, we would include outside data, too, [focus on] how to select, implement, and evaluate devices, and perhaps include specific information on efficacy."
She adds that some of that outside data probably would come from the Exposure Pre vention Information Network (EPINet), a computerized surveillance system used by more than 1,200 U.S. hospitals and in several foreign countries. Launched in 1992, the system was developed to provide standardized methods for recording percutaneous injuries and blood and body fluid exposures. It allows hospitals to share and compare information and to identify specific needle devices causing injuries, how the injuries occurred, and successful prevention measures.
EPINet founder and director Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Research and Resource Center at the University of Virginia in Charlottesville, says the CDC data are significant and relevant to the highest-risk types of exposures.
"We need these kinds of hard data," Jagger says. "[The CDC has] done the kind of studies that take time and resources to do; it’s not just passive collection of data. What we’ve predicted all along [through EPINet] is what they’ve proven safety devices can do."
More data-generating studies are needed for all safety devices on the market, she adds.
"This is just the beginning. I hope the CDC will put more resources toward this area. It’s providing hospitals with ammunition," Jagger states. "We’ve been getting calls from hospitals asking if this should affect their product selection, which is hopefully what it will do."
Cost-cutting presents obstacle
Whether results of needle safety studies conducted by the CDC whose recommendations do not carry the force of law, but generally are highly regarded in medical and legal circles will affect product choices remains to be seen. Devices with safety features are more expensive than their conventional counterparts, and cost cutting currently is a harsh reality at most hospitals.
Charlene M. Gliniecki, RN, MS, COHN-S, director of employee health and safety at 2,500-employee Camino Healthcare in Mountainview, CA, is a member of her hospital’s value analysis committee. Exposure-related costs are considered in evaluating products, she says, but decisions generally are related in large part to product costs.
"Health care is in the midst of a big challenge to deal with costs," says Gliniecki, adding that a CDC recommendation would be "a big plus," but it probably wouldn’t influence officials to purchase devices that were significantly more expensive.
Nevertheless, "if there is evidence that a safety device performs as well [as conventional devices] and that it does not require a large amount of time to learn or a major behavior change to implement, and that it does not cost dramatically more, a recommendation from the CDC probably would be useful in helping us bring in safer devices," she says. "Any evidence we have that new devices do make a difference [in percutaneous injury rates] is very positive. I welcome having information to show whether new devices that claim to be safer actually are."
Union calls for total ban
Some worker safety activists say that not only are hospitals responsible for putting so-called "unsafe" devices in the hands of HCWs, but they also blame device manufacturers for giving hospitals a choice. Officials of the Washington, DC-based Service Employees International Union (SEIU), which represents some 500,000 HCWs, maintain that manufacturers should not produce and market devices that lack safety features, an issue that evokes strong emotions from both sides.
"[Manufacturers] make safer products and think that covers their butts, but it’s ethically abhorrent that the vast majority of products they continue to manufacture are inherently dangerous. It borders on criminality," says William K. Borwegen, MPH, SEIU’s occupational safety and health director. "They’re Neanderthals in this area. When are they going to do the right thing and withdraw these products from the market? Or are they going to continue to kill health care workers?"
Borwegen adds that the union applauds CDC leadership in "finally recognizing prevention is more important than treating people after they’ve been stuck [by a contaminated needle]," and says the federal agency should join with the U.S. Food and Drug Administration in banning conventional devices from the marketplace if manufacturers won’t withdraw them voluntarily.
But manufacturers are not likely to stop producing conventional devices, says Anne Baldwin, director of technology and regulatory affairs for the Healthcare Industry Manufacturers Association (HIMA) in Washington, DC, which represents more than 700 companies.
"Health care workers and their employers have to make those kinds of decisions for themselves," Baldwin states. "I thought we still had choice in this country; I thought we could still make those kinds of purchasing decisions for ourselves. Whatever the customer wants, the manufacturer will provide."
Devices with safety features are "a little or a lot more expensive," she adds, and purchasing decisions must include that factor, as well as considerations related to time and effort required for learning to use new equipment.
Baldwin also questions whether the numbers of HCWs incurring device-related percutaneous injuries warrants exclusive use of safety devices. "Do you have data to support the incidence of needlestick injuries?" she asks. "I used to be a laboratory specialist and did many, many blood draws, many phlebotomies, and in all my years of practice I only stuck myself once. Just because somebody could have a needlestick doesn’t mean they will."
HCWs can use standard blood-collection and other sharp devices "as they have in the past carefully and following instructions doing everything they can to minimize their risk for sticking themselves," she adds.
"It’s kind of a vicious circle," says Mitchell Shore, JD, of Kolsby, Gordon, Robin, Shore, and Rothweiler in Philadelphia. "Manufacturers are trying to sell safer needles because from a cost factor, if they can sell those needles they’re going to be making more money, but hospitals right now are not willing to spend the money. In terms of what is best for the health care worker, clearly safety needles are best."
Shore represented Lynda Marie Arnold, a nurse whose career ended four months after graduating from nursing school following seroconversion from an HIV-positive needlestick her first and only percutaneous injury. (See related story in Hospital Employee Health, April 1996, pp. 37-42.) Arnold’s product liability lawsuit against the device manufacturer was settled out of court for an undisclosed sum. Shore predicts that the CDC’s studies "will edge hospitals even closer to utilizing safer needles."
Study provides additional support’
Proof of safety devices’ efficacy in preventing needlesticks already exists, Shore says. Manu facturers have evidence from their own studies, and Jagger’s work also has demonstrated efficacy, but "this is additional support; it’s another thing our experts could point to as a reason why manufacturers should provide safer needles," he adds, noting that published CDC data tend to carry more weight in court.
While HCWs who have contracted HIV or AIDS from occupational blood exposures have won large monetary awards pursuant to litigation, their hospital employers are immune to suits due to workers’ compensation statutes that limit their liability. Therefore, damages are sought from the manufacturers that produced the devices implicated in the injury. (For an example of such a case, see story in Hospital Employee Health, November 1995, pp. 137-140.) The CDC data and recommendations "could put additional pressure on manufacturers to subject them to liability in certain jurisdictions because of this increasing support," Shore notes.
And, even though hospitals are protected by workers’ comp laws, the CDC reports "may be additional motivation on a moral basis to convert to safer devices," he adds. "Some of the reasons that have been used before are that health care workers can’t adjust to them, that they’re not efficacious, that they’re expensive, and this really shows that if you give the proper instruction, you’re going to get proper utilization of the safety devices."
Shore also points out that in some jurisdictions, device manufacturers who are sued by HCWs can countersue the worker’s employer on the basis that the hospital was responsible for the decision-making process, and that although safety needles were available, the hospital did not choose to purchase them.
"Our position in these cases against the manufacturers is that they have an obligation to provide a needle that is safe and effective, and that’s what safety needles are," he states. "[Conven tional needles] lack the necessary safety elements. This is further support in the medical community that safety devices are important and should be utilized."
References
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.
2. Centers for Disease Control and Prevention. Evaluation of blunt suture needles in preventing percutaneous injuries among health-care workers during gynecologic surgical procedures New York City, March 1993-June 1994. MMWR 1997; 46:25-29.
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