FDA Issues New Finger-Stick Device Guidance

Citing a rise in blood-borne infections in long-term care, the FDA has issued new guidance calling for restricted use and better labeling procedures for fingerstick devices.

The new guidance recommends that all fingerstick devices be labeled for use on just a single resident. Previously, some devices were cleared to for use on multiple residents. The FDA also wants manufacturers to include the following on their product labeling:

• Notification that reusable portions of a device are for single resident use only
• Instructions that such devices should not be used for assisted blood draws in LTC settings or reused by anyone else, including family members
• Instructions for cleaning and disinfecting reusable portions of devices after each use

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