FDA seeks comment on banning of some sharps
September 1, 2002 5 minutes read
Agency asks for device data, other options
If a federal law mandates the use of safety sharps devices, should conventional versions be banned? The Food and Drug Administration (FDA) is soliciting comment on that question and others posed by the Service Employees Inter-national Union (SEIU) in Washington, DC, and the consumer group, Public Citizen, in a petition to the agency.
While banning products is extremely rare (the FDA has done it only once before), the agency expressed an interest in considering other steps it might take to reduce needlesticks. Its Federal Regi-ster notice "invites interested persons to submit additional data and information to support these actions or any other action that the commenter may consider appropriate."1
The SEIU suggested a regulatory standard with mandatory performance criteria for safety devices and labeling of conventional syringes, warning that they should not be used for standard blood draws. The FDA has previously issued safety alerts and conducted educational efforts. (See Hospital Employee Health, January 2002, p. 6.)
"It’s a point in time when we want to get different opinions and different ideas," explains Timothy Ulatowski, MS, director of the division of anesthesiology, infection control, general hospital, and dental devices in the FDA’s office of device evaluation in Rockville, MD. "There’s more than one way to respond to the broader public need and desire out there."
One option, he says, would involve a volun- tary standard developed through the American National Standards Institute, the American Society of Testing and Materials, or the Association for the Advancement of Medical Instrumentation. Such voluntary standards are created through a consensus process that includes industry representatives and can have a strong, swift impact on device design, Ulatowski says.
FDA recognition of the voluntary standard provides benefits to manufacturers, encouraging them to comply, while the development of regulatory standards can become mired in legal obstacles, he notes.
"If we have accepted a standard, it greatly reduces the time for review and approval [of products]," Ulatowski says. "It makes it easier for them to market the product as well as [for] the international marketing of the product."
While the SEIU would welcome any moves towards ensuring the manufacture of safer devices, the union will continue to push for stronger action to eliminate conventional devices, says Bill Borwegen, MPH, SEIU’s occupational health and safety director.
"We feel we have a strong case here," he says. "It behooves the FDA to demonstrate to us why people should be able to continue to use these products when safer products are on the market that serve the same purpose, provide as good or better patient care, and protect health care workers.
"We have a nationwide epidemic of needlestick injuries," he says. "It’s not going to go away until we get these products off the market."
Just how many conventional devices, such as IV catheters and butterfly blood collection devices, are still in use? What is the impact of the Needlestick Prevention and Safety Act and the revised bloodborne pathogen standard?
The answers await completion of studies by researchers. The latest published data are from 1999, and needle safety experts say considerable progress has been made since then.
"Looking at the market data that I’ve seen from the year 2001, it’s clear that there was a massive acceleration that even predated the full implementation of the [federal] law [which was passed by Congress in 2000]," says Janine Jagger, PhD, MPH, director of the International Health Care Worker Safety Center at the University of Virginia in Charlottesville.
"We see an intent to comply with the law, but we also see that it’s not a completed fact yet," says Jagger, noting that compliance is lower in nonhospital settings. "The continued pressure on the issue is totally justified and important."
In its Federal Register notice, the FDA cited a lack of detailed data. Information from sources such as EPINet, a database of 21 health care facilities on the East Coast and Pacific Northwest regions, provide statistics on overall needlesticks and device types. But the FDA noted that the SEIU/Public Citizen petition didn’t include data on which specific devices were involved in needlesticks, how many had been in use during the data collection period, and the design criteria of those devices.
"In the absence of such information about specific devices, FDA was unable to conclude that any particular device presented a "substantial deception or an unreasonable and substantial risk of illness or injury," the agency stated. "FDA invites interested persons to submit data and information that would provide insight on the basis for banning one or more of these devices."
In fact, the link between specific devices and needlesticks is particularly hard to determine. A study by the Sharps Injury Control Program of the California Department of Health Services in Oakland found that only 24% of those reporting needlesticks knew the brand of the device they were using. (See HEH, April 2002, p. 41.)
The FDA actions also may be complicated by the wide variety of sharps devices and uses of those devices.
"Each of the product categories has to be looked at in great detail to be sure that a broad-brush approach does not overlook some very limited applications of that device category for which there is no safety alternative," Jagger says. "There are still pockets of specialized procedures for which there are no applicable alternatives."
Jagger notes that FDA scrutiny could actually promote safety measures in some of the smaller "niche" categories. "I think this is an excellent occasion for us to do that in-depth analysis which also will provide further incentive to get complete coverage even for those limited applications."
Ultimately, the greatest impact on needle safety will continue to come through enforcement by the U.S. Occupational Safety and Health Admini-stration (OSHA), Ulatowski says. "The OSHA rule has a dramatic impact.
"When Congress came out with the needlestick safety act, they could have pointed to FDA to take some action, but they didn’t. They pointed to OSHA as the primary health care worker protection agency to take action under their statutory obligations."
(Editor’s note: A copy of the Federal Register notice is available at http://www.fda.gov/cdrh/fedregin.html.)
Reference
1. 67 Fed Reg 41890 (2002).
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