FDA suggests safer needle device criteria
May 1, 1999
FDA suggests safer needle device criteria
In response to the U.S. Occupational Safety and Health Administration’s (OSHA) recent request for information on needlestick injuries among the nation’s health care workers, the Food and Drug Administration (FDA) has submitted a list of design features and related performance characteristics for sharps injury prevention devices.
The FDA recommends its suggestions be considered in evaluations of equipment such as syringes, intravenous catheters, and blood collection sets having anti-needlestick protective mechanisms.
"Incorporating these design features and performance characteristics in the design of sharps injury prevention devices is likely to assist in reducing percutaneous injury rates," says Lireka P. Joseph, DrPH, director of the Office of Health and Industry Programs of the FDA’s Center for Devices and Radiological Health in a recent letter to OSHA.
Protective device features are designed to protect both HCWs and patients from needlesticks, the FDA notes, and usually can be identified by visual inspection of the device or by simple manipulation of the mechanism. These include:
• a protective covering into which the needle can be easily retracted and that provides a barrier between the hand and needle;
• an integral shield that moves forward or swings on a hinge over the needle, providing a protective barrier;
• an integral blunt needle/stylet that effectively blunts the sharps;
• a needleless device.
In evaluating performance characteristics, the FDA suggests that evaluators at health care facilities try out devices and ask targeted questions of practitioners who have used the devices. The following performance characteristics are considered important:
• HCWs are shielded from the needle during and after use and after disposal.
• The protective mechanism can be engaged by either hand.
• Few, if any, additional steps to the usual procedure are needed to activate the protective mechanism.
• If additional steps are required, they do not interfere with the usual procedure.
• The device user does not need to place either hand near the needle during a procedure.
• The protective shield or retracted needle locks securely into place with little effort.
• The protective mechanism provides visual or tactile feedback so the user is aware whether it is or is not in place.
• The design allows appropriate visualization during device preparation and use (e.g., cc/ml marks and fluid levels are clear).
• Disassembly does not expose the user to the needle.
• The mechanism is compatible with the facility’s sharps disposal system (e.g., device size does not impose inordinate requirements for waste disposal units).
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