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FDA, CDC Warn of Misuse of Fingerstick, Point-of-Care Blood Testing Devices
Hepatitis B Outbreaks Linked to Shared, Improperly Cleaned Items
By News Staff
The FDA said in its Aug. 26 safety alert that both agencies have noted a steady increase in reports of bloodborne infection transmission during the past 10-15 years resulting from the shared use of fingerstick and point-of-care blood testing devices.
Although the infections have occurred in a variety of health care settings, the agencies point to a significant increase in hepatitis B virus infection outbreaks linked to misuse of the devices in long-term care and assisted living settings.
According to the FDA alert, unclear labeling and ineffective cleaning and disinfection instructions for fingerstick and point-of-care devices may have contributed to these outbreaks.
The FDA and the CDC made the following recommendations for health care professionals and patients:
- Fingerstick devices should never be used for more than one person.
- Single-use self-disabling fingerstick devices -- sometimes called safety lancets -- should be used for assisted monitoring of blood glucose.
- Whenever possible, point-of-care blood testing devices should be used on only one patient and not shared. If dedicating such a point-of-care device to a single patient is not possible, the device should be properly cleaned and disinfected after every use as described in the device's labeling.
- Health care workers should change gloves between patients, even when patient-dedicated point-of-care blood testing devices and single-use self-disabling fingerstick devices are used.
FDA Safety Information: Fingerstick Devices to Obtain Blood Specimens: Initial Communication -- Risk of Transmitting Bloodborne Pathogens
(Aug. 26, 2010)
CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens
CDC: Infection Prevention During Blood Glucose Monitoring and Insulin Administration