Safer needles work, but not penetrating market
Workers urged to support nurse’s campaign
The first two large, independent trials of several safer needle devices shows that the new technology decreases the number of needlesticks. But without more employee activism and government intervention, hospitals will continue to move slowly in converting to safer devices, say needlestick experts.
The two studies were reported recently in the Morbidity and Mortality Weekly Report.1,2 The first study, conducted from 1993 to 1995 in six hospitals, showed that safer devices for phlebotomy are generally accepted by users and resulted in significantly fewer percutaneous injuries (PIs) compared to traditional phlebotomy devices. The second study compared PIs (e.g., needlestick injuries and cuts with sharp objects) for blunt suture needles vs. traditional curved suture needles. The study found that while skin penetration is more difficult with blunt needles, their use reduced PIs during surgery without causing adverse effects on patient care.
The Centers for Disease Control and Prevention evaluated phlebotomy and suture needles because they account for a disproportional percentage of PIs that have resulted in transmission of bloodborne pathogens, particularly HIV. Phlebotomy drawing blood from veins and arteries accounts for 13% to 62% of injuries reported to hospital occupational health services, but accounts for 39% (20 of 51) of cases of occupational HIV transmission, the CDC notes. Two years ago, a National Phlebotomist Association survey found that in 1994, 24% of health care workers who draw blood had been stuck by a needle.
"In terms of a risk-benefit analysis, this type of needle seems to be a good place to focus prevention efforts. So many of these needles tend to be involved, not necessarily in all the injuries, but they make up a large fraction of injuries contributing to infection," says Scott Campbell, RN, MSPH, a CDC epidemiologist and an author of the phlebotomy study.
Products studied included a resheathing winged steel needle, a bluntable vacuum-tube blood-collection needle activated once it entered the patient’s vein, and a vacuum-tube blood-collection needle with a hinged recapping sheath. The products are designed so workers must activate the safety features during or after phlebotomy. For approximately one year, the hospitals used conventional devices and monitored PIs. During the second phase of the study, hospitals replaced conventional phlebotomy devices with safety devices and monitored for PIs. Nearly 1,700 health care workers responded in the first phase, while 1,421 responded in the second phase.
A total of 41 PIs were associated with safety devices 25 before activation of the safety feature, and six during activation; for an additional eight PIs, the safety feature was not activated, and two PIs were of unknown mechanical origin. This compares with 86 PIs associated with conventional devices. Additionally, a preference survey found that 44% of the health care workers said they preferred safety devices to conventional ones, while 33% preferred conventional devices and 23% were unsure.
Blunt needles safer than curved ones
In the study comparing blunt and traditional curved suture devices, investigators found that the use of blunt suture needles reduced suture-related PIs during gynecological surgical procedures. The authors concluded that blunt suture needles should be used more widely during surgery. They note that 1% to 15% of surgical procedures result in PIs, most often from suturing. While blunt needles often require more pressure to penetrate tissue, they were not associated with adverse effects on the patients, they added.
Although CDC officials say further studies are needed to assess whether these results might vary by hospital, city, occupation, and devices used, they conclude that the safety devices studied were safer than conventional devices and generally well-accepted.
Needlestick experts welcomed the study, the first of its kind conducted by the government, and said it would help spur the changeover to safer devices.
"The study provides some real ammunition in terms of hard data that health care workers can use to make changes in their facilities," says Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Research and Resource Center and associate professor of neurosurgery at the University of Virginia Medical Center in Charlottesville. "We have had a lot of anecdotal evidence that safety devices prevent injuries in significant ways, but getting the scientific documentation has been hard."
The studies come amid a national campaign by Lynda Arnold, RN, a Lancaster, PA, nurse who was infected with HIV from a needlestick, to push hospitals to adopt safer needle devices. (See related story in AIDS Alert, October 1996, p. 112.) Arnold has drawn up a pledge and sent it to most U.S. hospitals, requesting they agree to implement safety devices within a year for blood drawing and IV catheter systems. Those hospitals that don’t pledge are being listed on her Internet site, says Jagger.
"Linda has carefully targeted her campaign to those high-risk devices, and all these things are adding up a to a new level of attention and activity," she says.
The study is particularly important for making blunt suture needles more acceptable to surgeons, who are known for not making PI prevention a high priority, she says. "We know that they aren’t in widespread use at all, so the study is very powerful because you are not asking surgeons to make big sacrifices, yet the injury prevention potential is significant and irrefutable."
Conventional devices still prevail
Nonetheless, the pace of changeover for all safety devices has been slow. While a variety of safer needle devices has received approval from the Food and Drug Administration during the past decade, their market share has been relatively small. Safety devices make up as much as 50% of IV lines, but Jagger estimates they account for less than 15% each for phlebotomy, syringes, and catheters.
Such slow progress is unacceptable and unethical, considering the estimated 1 million PIs that endanger health care workers each year in the United States, says Bill Boegan, director of health and safety for the Washington, DC-based Service Employees International Union (SEIU), which represents 500,000 health care workers.
"It’s a tragedy, and I don’t know how these CEOs of medical device companies can sleep at night knowing they are killing health care workers with products that could be immediately prevented today," he tells AIDS Alert. "There is no other industry in the country where government agencies would allow workers to sustain 1 million puncture injuries a year with a potential lethally contaminated instrument. And yet industry experts have stated that 85% to 90% of all needlestick injuries can be prevented through the use of safer needle devices."
The FDA has urged health care facilities to switch to safety devices, but has chosen not to make the changes mandatory. At the same time, the FDA raised the standards for approving safety devices, making it difficult for manufacturers to justify developing new devices, Boegan says.
Concerned that manufacturers were making claims about the devices that had not been confirmed by large studies, the FDA first proposed tougher standards three years ago. The outcry from unions and manufacturers was so strong that the agency compromised. Its current guidelines, however, are still more stringent than those for existing needles, many of which were grandfathered in before the FDA began requiring clinical efficacy with its 1989 devices act.
"They have done just the opposite of what we wanted them to when we filed our petition," Boegan adds.
The SEIU petitioned the FDA to require facilities to adopt commercially available safer needle devices about four years ago. But forcing providers to use a particular device didn’t make sense then and still doesn’t today, primarily for two reasons, says Timothy Ulatowski, director of the FDA’s division of general hospital, infection control, and dental devices. First, some devices may be safer than others, but they may not be as suitable for certain clinical situations, such as emergency procedures. Second, mandating technologies dampens innovation.
"To say you have to have such and such a device, you begin to screw down the sorts of flexibility you want to have inherent in the development of technology," he says, adding that manufacturers are constantly trying to improve their products.
Although the Health Industry Manufacturers Association in Washington, DC, is opposed to mandating safety devices, it also considers the FDA testing requirements overstringent. "There are still significant regulatory hurdles to getting these products out," says Ann Baldwin, director of technology and regulatory affairs. "They are held to a higher standard, so manufacturers have to put more time and resources into conducting these types of studies."
The FDA hasn’t drawn up a list of approved safer needle devices, "and I suppose we need to be doing that if there is an interest in that area," Ulatowski says. After an initial burst of development in the mid-1980s, applications appear to have slowed down in recent years, but generally products have moved forward "pretty quickly," he adds.
One area where the FDA and other agencies have had less success is selling the importance of safety devices to hospital administrators, Ulatowski says. "The idea of anti-needlestick usage and bottom-line savings really hasn’t gotten across to administrative people who purchase products," he says.
Better technological transfer between providers and manufacturers also is needed so good ideas don’t wither on the vine for financial considerations, he adds.
Another barrier to acceptance is cost. Although she didn’t have any figures, Baldwin says safer needle devices cost more than conventional needles, and hospital administrators can’t always justify their expense. "Hospital have to be willing to pay higher prices for devices that historically were never available," she explains.
"The bottom line," Boegan says, "is that hospitals aren’t going to pay 20 cents or whatever more these devices cost until they are forced to, either by manufacturers withdrawing them or the FDA requiring their removal."
Without FDA action, manufacturers are unlikely to voluntarily do that because they will lose their share of the market, Boegan says. Indeed, they would rather settle cases out of court than take that risk, he adds.
"There have been many lawsuits against these needle manufacturers, and yet these companies simply can’t be moved to throw out their inherently dangerous devices and only sell safety devices," Boegan says.
Workers need to complain
While agreeing that cost is an issue, Jagger, like Ulatowski, sees a bigger hurdle to adopting safety devices in hospital bureaucracy and lack of outcry from health care workers.
"I don’t think cost is the main issue," she says. "Every device in every hospital has to go through a bureaucratic process, so there is tremendous inertia to overcome."
What can health care workers do to speed up the process?
First, they can join Arnold’s campaign and follow up to see whether hospitals have received her pledge and responded. Two pledges were sent to each hospital, one to the hospital director and another to the infection control department, Jagger adds.
"They should make it a top priority now and find out where Lynda’s appeal is in their hospital," she says. "They should find out their response and express their concern about whether the hospital agrees to it."
Pushing for improved engineering controls including safer needle devices, sharps disposal containers, and education is cost-effective in the long run, considering that the cost of treating each exposed health care worker with combination therapy will cost between $700 and $900 per exposure, say health officials.
"Prevention is always better than trying to fix it afterwards, particularly with something like HIV," says Linda Martin, PhD, the Atlanta-based director of HIV activity for the National Institute for Occupational Safety and Health. "In this case, hospitals may want to look a little more at engineering controls because it is going to be expensive to treat workers."
[Editor’s note: Janine Jagger, along with colleagues from Italy, is completing a 90-page booklet that updates the prevention and management of occupational exposures to HIV. The publication will include an appendix listing all safety device products on the market relating to blood drawing and IV catheters, as well as post-exposure follow-up forms updated for the new CDC guidelines on preventive therapy. The data collection forms will allow hospitals to participate in national surveillance surveys. Published by Advances in Exposure Prevention, the booklet is titled Preven tion Management and Chemoprophylaxis of Occupational Exposures to HIV. It will be mailed free to members of APIC, SHEA, and AHEP. For more information, call Jane Perry at (804) 982-3763.
Also, for more information about Lynda Arnold’s Campaign for Health Care Worker Safety, call Gina Johnson at (713) 297-5898 or Jerry Alwais at (713) 297-5897.]