Highlighting long-term care concerns, FDA issues new guidance for finger-stick devices

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The U.S. Food and Drug Administration has issued new guidance, calling for restricted use and better labeling procedures for fingerstick devices. The agency noted a rise in blood borne infections, particularly in long-term care facilities, in recent years, while reversing one of its earlier stances on the devices.

The FDA now recommends that all fingerstick devices be labeled for use on just a single patient. Previously, it had cleared some devices to be used on multiple patients. Monday's announcement also noted that the government wants manufacturers to include the following on their product labeling: notification identifying reusable portions of the device as “single-patient use only;” instructions that such devices should not be used for assisted blood draws in long-term care settings, or re-used by anyone else, including family members; and instructions for cleaning and disinfecting portions of such devices after each use.

Over the past 10 to 15 years, the FDA says it has seen a “progressive increase” in the number of blood-borne infection transmissions in all healthcare settings. Officials attribute the rise to reusable finger-stick devices and point of care blood testing devices, such as blood glucose meters, PT/INR anticoagulation meters and cholesterol testing devices. Among other assertions health officials say that caregivers should use auto-disabling devices and always change gloves between patients.