Petitioners detail demands to FDA

Health care worker safety advocates petitioning the Food and Drug Administration (FDA) to withdraw conventional needle devices outlined their request for action as follows:

- The FDA has identified five design criteria for these medical devices, all of which should be met in order to maximize safety to the health care worker:

1. A fixed safety feature provides a barrier between the hands and the needle after use.

2. The safety feature allows or requires the worker’s hands to remain behind the needle at all times.

3. The safety feature is an integral part of the device and not an accessory.

4. The safety feature is in effect before disassembly, if any, and remains in effect after disposal.

5. The device should be simple and easy to use, requiring little training.

- This petition requests that the FDA take three types of action:

1. We request that the FDA ban the following devices:

A. unsafe IV catheters that do not meet the above criteria;

B. blood collection devices (needles and tube holders) that do not meet the above criteria;

C. blood collection needle sets ("butterfly syringes") that do not meet the above criteria;

D. glass capillary tubes;

E. IV infusion equipment that does not use needleless technology or recessed needles.

2. We request that the FDA issue the five criteria above as performance standards following the procedures set forth in 21 CFR Part 861 to prevent new unsafe devices from entering the market.

3. We request a performance standard requiring that labeling for conventional syringes indicate: "To prevent possible exposure to HIV and hepatitis, do not use for standard blood draws."