The Food and Drug Administration (FDA) cited the following response to a petition demanding the agency take action to protect health care workers from bloodborne infections due to needlesticks.1 The response is summarized as follows:
Banning conventional needle devices: The legal standard to be applied by the FDA in deciding whether it is appropriate to ban a device is set out in section 516 of the act (21 U.S.C. 360f). In short, this section states that the FDA may ban a device if it finds that the device presents a "substantial deception or an unreasonable and substantial risk of illness or injury." The regulations implementing section 516 state that, in determining whether the risk of illness or injury is substantial, the FDA will need to consider whether the risk posed by continuing marketing of the device is important, material, or significant in relation to the benefit to the public health from continued marketing [21 CFR 895.21(a)(1)]. In its petition response, the FDA stated that it did not have sufficient information to conclude that there is a legal basis for banning the devices identified in the petition.
Although the petition addressed the number of injuries related to generic types of devices, it did not show: which specific devices were used; how many devices of that type were used during the relevant time period; and what the design characteristics of those devices were or whether the devices met any or all of the design criteria listed.
In the absence of such information about specific devices, the 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 invites interested people to submit data and information that would provide insight on the basis for banning one or more of these devices.
Performance standards: The petition requested that the FDA issue performance standards based on five design criteria previously identified by the FDA:
- A fixed safety feature provides a barrier between the hands and the needle after use.
- The safety feature allows or requires the worker’s hands to remain behind the needle at all times.
- The safety feature is an integral part of the device and not an accessory.
- The safety feature is in effect before disassembly, if any, and remains in effect after disposal.
- The device should be simple and easy to use, requiring little training.
The petition listed the criteria but did not discuss how the FDA could apply these criteria to specific devices in the context of a mandatory performance standard, or how such a standard would provide reasonable assurance of the safety and effectiveness of these devices.
In its response, the FDA stated that it did not have sufficient information to develop a standard to address the risk of needlestick injury. The FDA believes that these criteria are a good starting point to develop a standard, but it needs additional information to determine how best to apply these criteria to specific devices in the context of a standard. The FDA invites interested people to submit any information or data addressing the appropriateness of developing a performance standard, based on these criteria or others. The FDA is also prepared to enter into discussions with any organization that wishes to develop a voluntary consensus standard for one or more of these devices that the FDA may adopt or recognize in some form.
Labeling: The petition requested that the FDA require that the labeling for "conventional syringes" state: "to prevent possible exposure to HIV and hepatitis, do not use for standard blood draws." The petitioners stated that current labeling for syringes does not contain adequate warning of the hazards that the device presents. In its response, the FDA stated that the information in this statement is well known to health care professionals who use these types of devices and, therefore, under 21 CFR 801.109(c), it would not ordinarily require such a statement in the labeling. The FDA invites interested people to comment on whether the proposed labeling statement or any other labeling requirement is necessary to provide reasonable assurance of the safety and effectiveness of these devices.
Reference
1. 67 Fed Reg 41,890-41,892 (June 20, 2002).
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