Critics say petition response paltry’
Claiming it needs device-specific data to take action on needle safety issues, the Food and Drug Administration (FDA) is requesting information as a possible prelude to regulatory action. "In the absence of such information about specific devices, the FDA was unable to conclude that any particular device presented . . . an unreasonable and substantial risk of illness or injury," the FDA stated in its request for more data.1 The deadline to submit data and comments is Sept. 19, 2002. (See editor’s note at the end of this article.)
The FDA action comes in response to a petition filed jointly last year by Public Citizen’s Health Research Group, a consumer advocacy group; and the Service Employees International Union (SEIU), a major health care union. They asked the FDA to withdraw conventional needle devices from the market place. In making the case for a recall, the petition cited the continuing spread of bloodborne infections such as HIV and hepatitis C virus to health care workers via hundreds of thousands of needlesticks annually. The petition listed 55 documented and 136 possible cases of occupationally acquired HIV among health care workers in the United States.
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 sought 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. The petition also asked for a warning label on conventional syringes. The FDA did not grant any of the requests, but agreed to pursue further data if specific hazardous devices can be identified.
"Our position is there is enough accumulated knowledge over the last 20 years of the HIV epidemic . . . to take action and not issue an extremely general request for information," says Peter Lurie, MD, deputy director of the health research group at Public Citizen. "It’s not clear to me why any device manufacturer would respond to this. I would think they would leave well enough alone from their point of view. I think that very little will come of this. As much as anything, [FDA] is wishing to demonstrate that [it is] responding to us in some way. The response is paltry."
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%.2 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.3
"In our petition, we steered away from discussions of particular devices," Lurie says. "We cited two major data-collection efforts, so I don’t see what [else] is going to come out of the woodwork on this. It is likely to not be as expansive as what we cited, otherwise it would have already been published."
However, the data that could meet the FDA criteria are in the process of being collected by the Occupational Safety and Health Administration (OSHA), says Katherine West, BSN, MSEd, CIC, infection control consultant with Infection Control/Emerging Concepts in Manassas, VA. "According to what [FDA is] held to by law, they have to have additional information and it has to be device-specific," she says. "The data are already being collected under the new OSHA 300 log and the safety sharps injury log, because you have to list the specific device and the brand.
In its response to the petition, the FDA says it has been working together with OSHA to reduce the risk of sharps injuries to health care workers and others. FDA regulates medical devices, including those containing sharps, under the Federal Food, Drug, and Cosmetic Act. OSHA has authority to regulate workplace controls for the protection of workers. That authority was extended, including the two record-keeping changes, with revisions of OSHA’s bloodborne pathogen standard mandated by the 2000 Needlestick Safety and Prevention Act.
"The mechanism is in place to collect this information," West says. "[It] probably won’t happen as quickly as these petitioning groups would like. I think it’s needed. Hospitals want to contain costs. They are looking at this as being costly, instead of looking at the fact that if you reduce exposures, you don’t have the cost of post-exposure follow-up. They’re looking at it short term, not long term, and some have been slow to respond."
Many of the devices mentioned in the petition, including nonsafety IV catheters, blood collection device, and glass capillary tubing, could be replaced by safety designs, adds Cindy Fine, RN, MSN, CIC, infection control practitioner at John Muir Medical Center in Walnut Creek, CA. "Speaking theoretically and just asking, Would it be possible?’ Yes, I think it would be," she says. "IV catheters might present the most problems because we have physicians using them for things such as external jugular lines. They need a longer IV catheter, and the safety catheters don’t come in the long length."
Despite such exceptions, in general, there are safety designs now to replace much of the conventional sharps products, she adds. "I don’t see why you couldn’t get rid of the glass capillary tubes," Fine says. "I think we could also do away with the nonsafety IV tubing without having any problems. I can’t come up with any reason why we couldn’t do away with the nonsafety devices for blood collection."
Of course, issues of worker training and compliance — some will hoard the old devices or fail to use the new ones correctly — have long been part of the needle safety issue. In addition, quality of protection varies among the various needle safety devices. "Are all of these safety devices better and safer than standard devices?" Fine asks. " I don’t think that is necessarily true." Rather than pursuing a FDA ban on devices, she favors adding to the existing momentum OSHA has achieved under its revised regulatory mandate.
"I think it would be more effective to increase OSHA enforcement, and educate OSHA inspectors a little more on what the standard requires and what a good safety device is," Fine says. "Get OSHA out there inspecting and helping people get the devices into their facilities. That would be a more effective way of increasing employee safety."
OSHA has stepped up enforcement of the needle safety provisions. The new provisions in the revised bloodborne pathogen standard became effective April 18, 2001, but OSHA delayed enforcement action until July 2001. As of May 2002, the agency had issued 1,876 citations to hospitals with penalties totaling about $1.3 million. Only 369, or 20%, were generated from inspections related to a complaint. OSHA issued 142 citations for failure to use engineering and work practice controls — including safer devices. By contrast, in a 16-month period after the 1999 compliance directive on bloodborne pathogens was released, OSHA issued a total of 144 citations to hospitals related to the standard; just 18 of those involved lack of engineering controls or safer devices.
In the past year, OSHA issued 165 citations for failure to have a written exposure control plan and 170 citations for failure to update the exposure control plan annually. The agency issued another 25 citations for failing to reflect changes in technology in the exposure control plan and failure to document annual consideration and implementation of safer devices.
[Editor’s note: Submit written comments or information to the Food and Drug Administration regarding Docket No. 01P-0120 by Sept. 19, 2002, to Dockets Management Branch (HFA-305), FDA, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. Submit electronic comments to www.fda.gov/dockets/ecomments. For further information, contact: Timothy A. Ulatowski, Center for Devices and Radiological Health (HFZ-480), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850. Phone: (301) 443-8879.]
References
1. 67 Fed Reg 41,890-41,892 (June 20, 2002).
2. Jagger J. Reducing occupational exposure to bloodborne pathogens: Where do we stand a decade later? Infect Control Hosp Epidemiol 1996; 17:573-575.
3. 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.
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