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Needle safety issue takes another dizzying turn
Public Citizen — a Washington, DC-based watchdog group founded by consumer activist Ralph Nader — has joined forces with a leading health care union to formally petition the Food and Drug Administration (FDA) to withdraw conventional needle devices from the market place. The demand could force the health care industry — already reeling from an unprecedented run of state and federal activity on the issue — to convert almost exclusively to needle safety devices designed to prevent occupational bloodborne infections.
In making the case for recall, the petition asks the FDA to act now to limit the continuing spread of bloodborne infections to health care workers, who each year sustain some 590,000 needlestick injuries nationwide. Noreen Prill, RN, a nurse who was occupationally infected with hepatitis C in 1978, appeared at the Nov. 29, 2000, filing of the petition, noting that it was "sad and ironic that the same kind of needle that infected me more than 20 years ago is still on the market." Prill’s hand was stuck with a contaminated phlebotomy needle when a dialysis patient grabbed her arm during a blood draw. (See workers’ cases, p. 4.)
Emphasizing the human toll of needlesticks, the petition cites 55 documented and 136 possible cases of occupationally acquired HIV among health care workers in the United States. While hepatitis B (HBV) still takes a toll among the unvaccinated, the greater emerging fear is HCV — for which there is neither vaccine nor post-exposure prophylaxis. Citing a risk of occupational HCV transmission from a needlestick of 1.8%, the petition charges that hundreds of health care workers are acquiring HCV occupationally each year in the United States.
"It is time for the FDA to live up to its responsibility to regulate unsafe medical devices and take them off the market," says Sidney Wolfe, MD, director of the health research group at Public Citizen. "The FDA needs to act now. Otherwise, hundreds of workers will continue to be infected each year."
A game of momentum
While such a demand would have seemed far-fetched only a few years ago, the needle safety issue has gathered so much momentum that the outcome of the petition is less predictable than a similar failed effort by the Service Employees International Union (SEIU) in 1991. The health care landscape has changed considerably since then, with passage of 17 state laws on needle safety and more recently, passage of the federal Needlestick Safety and Prevention Act. (See related story, p. 5.) Now the SEIU has joined in the petition with Public Citizen, the advocacy group founded by Nader in 1971, to demand FDA action on the issue.
"There is no reason for people to remain at risk just because the FDA doesn’t do its job properly," says Peter Lurie, MD, deputy director of the health research group at Public Citizen. "This is an issue that has languished for many years. Clearly the momentum is on our side. The area that has been relatively unexplored has been the FDA and its jurisdiction specifically over medical devices. We think this petition stands a better chance than the one in 1991 because the climate is different, the devices are better, and it is more narrowly tailored to identify specific devices."
The FDA is in receipt of the petition, confirmed Sharon Snyder, spokeswoman for the agency. "The law gives us 180 days to respond, and we will move as quickly as we can," she tells Hospital Infection Control.
Asked if there is any precedent for the FDA to remove a device from the market based on such a petition, Snyder says, "I don’t know the answer to that. These are approved products that are on the market. We are not talking about products that have not been approved."
Public Citizen and the SEIU specifically asked the FDA to ban high-risk needle devices such as IV catheters and phlebotomy equipment for which there is currently available FDA-cleared technology to minimize exposure.
In addition, the organizations seek the replacement of IV tubing with needleless designs and a recall of glass capillary tubes in favor of plastic products that won’t shatter in the hand. However, the groups concede there are not sufficient alternatives to replace ubiquitous syringes in health care, so they are asking for a warning label requirement for those devices. (See demands, at right.)
"There has to be an alternative for [them]," Lurie says. "For syringes we are not sure that the unsafe versions could be completely phased out. We just asked for a labeling requirement on that. But for the rest of them, there are clear, safer alternatives."
Rick Wade, spokesman for the American Hospital Association (AHA), which supported passage of the federal needle safety law, says granting the petition’s demands could create "chaos" in the health care system.
"It’s a very powerful, symbolic move, but one that they can’t accomplish," Wade says. "Giving the public impression that you can ban these devices overnight, and you can have something else safer’ in their place with people trained to use them isn’t realistic. We just passed a [federal] law to try to move that process forward. We [should] move in some measured way to those devices that are deemed to be safer — after we have given people a change to evaluate them. If the FDA said that they were seriously considering a ban on these needles, we would enter the fray."
At the very least, the AHA would fight to ensure that there was some kind of process in place to be certain everyone who was using a new device would be properly trained, the supply of the devices was adequate to cover all patient care areas, and there was a thorough analysis of the cost impact, he says.
"We would petition the federal government to be sure that the Medicare payment rates and other payment rates were adequate to make that transition if indeed, [the FDA] said by a certain date that something had to be different," he says.
"Otherwise, we have a very effective law in place that is going to involve nurses and other caregivers in evaluating these technologies and moving toward them as quickly as we can. Hospitals have already said, in effect, by supporting the [federal] law that they understand that there are going to be additional costs," Wade points out. "As we move forward, that is going to be the cost of providing a safe workplace for caregivers and a safe environment for patients."
But Wade argues that the process should be done in "an orderly way," not by trying to force the FDA’s hand just when the health care system is gearing up for compliance with the new federal law.
"Nobody disagrees with the notion that we ought to be moving toward safer technologies for both the patient and the worker," he says. "The question is how do you do it? [We] want to do it in a way that minimizes any more needlestick injuries for any worker. We have OSHA [the Occupational Safety and Health Administration} and the law in place now. Let’s vigorously enforce that law and get moving."
The petition was surprising to some because a federal law formerly amending the OSHA bloodborne pathogen standard will become effective in the coming months. ICPs still were trying to determine the compliance issues related to that law when the FDA petition followed. One thing is clear, OSHA sees the new federal law as empowering its inspection and enforcement capabilities.
"It will be easier for us to enforce the requirement [for needle safety devices] because very specific language has been added to our standard." says Melody Sands, MS, director of health compliance at OSHA. "It has been congressionally mandated for us to change the standard. It’s the law of the land, and we are hoping it will save a lot of lives."
The petition agreed that the agency has been strengthened by the federal act, but emphasized that the agency still relies on a "process approach" that mainly requires employers to evaluate alternatives to unsafe devices rather than remove them from use. The federal law and subsequent petition are complementary, not competing initiatives, Lurie argues.
"[The law] is supposed to push in the direction of safer medical devices, and it calls for the hospital to evaluate those devices," he says. "But fundamentally that doesn’t do the job because the people with the expertise to evaluate a device exist not at OSHA but at FDA. When it comes to actual regulating devices, the authority resides exclusively within the device division of the FDA. [Only] FDA can say this device is unsafe, and we are going to take it off the market."
Data cited in the petition include a study where the number of catheter stylet injuries was reduced 84% by switching to a safety design. The injury rate was 7.5 per 100,000 devices for conventional catheters, but fell to 1.2 per 100,000 devices for safety catheters, a reduction of 84%.1
Similarly, blood-drawing devices that incorporate a protective mechanism in their design have been shown to be effective in reducing needlesticks. In one study, statistically significant reductions of 66% and 76% were demonstrated for two blood collection devices.2 If such clear efficacy could be used to offset the expense and emotional trauma of needlesticks and subsequent infections, the petitioners make the case that a switch to needle safety will be cost-effective.
Regardless, the time has come, says Lurie, and "the only way to make everybody switch over is to by taking the unsafe stuff off the market."
1. Jagger J. Reducing occupational exposure to bloodborne pathogens: where do we stand a decade later? Infect Control Hosp Epidemiol 1996; 17:573-575.
2. 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. n