FDA, CDC Warn of Misuse of Fingerstick, Point-of-Care Blood Testing Devices

Hepatitis B Outbreaks Linked to Shared, Improperly Cleaned Items

September 07, 2010 04:50 pm News Staff

The FDA has issued a safety alert(www.fda.gov) about the potential for bloodborne infection transmission associated with misuse of fingerstick devices and point-of-care blood testing devices, including blood glucose meters and cholesterol testing devices.

At the same time, the CDC has updated its safety information for clinicians(www.cdc.gov) related to this topic.

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.

The FDA said it previously had approved some fingerstick devices for use in multiple patients. However, the agency said it now plans to change the labeling for those products to indicate they are intended for use on only one patient.