August 31, 2010
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CDC, FDA recommend that finger sticks should not be used for more than one patient

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The CDC and FDA have updated recommendations for blood lancing and point-of-care blood testing devices.

Devices in this category include reusable finger-stick (blood lancing) devices and point-of-care blood testing devices, including blood glucose meters, anticoagulation meters and cholesterol testing devices, among others.

The recommendation is targeted at personnel who perform blood testing in any health care capacity and patients who self-administer with these devices.

Shared use of finger-stick and point-of-care devices has led to an increase in bloodborne infection transmission — particularly hepatitis B virus —in a variety of health care settings in the past 10 to 15 years, according to agency officials. The outbreaks may also have been caused by unclear labeling or ineffective instructions for disinfection.

The two agencies recommend that the following immediate precautions be taken:

  • Finger-stick devices should never be used for more than one person.
  • Auto-disabling, single-use finger-stick devices should be used for assisted monitoring of blood glucose. These devices are designed to be used only once, after which the blade is retracted, capped or otherwise made unusable. These may also be called "safety" lancets.
  • Whenever possible, [point-of-care] blood testing devices, such as blood glucose meters and prothrombin time/international normalized ratio anticoagulation meters, should be used only on one patient and not shared. If dedicating [point-of-care] blood testing devices to a single patient is not possible, the devices should be properly cleaned and disinfected after every use as described in the device labeling.
  • Change gloves between patients, even when patient-dedicated [point-of-care] blood testing devices and single-use, self-disabling finger-stick devices are used by health care personnel.
  • Some legally marketed finger-stick devices have been cleared for use on more than one patient. The FDA will issue a separate communication describing the actions it will take to assure that these devices are labeled for use on only one patient to reduce the risk of bloodborne infection transmission.

Clinicians are encouraged to report problems or concerns to the FDA. For more information, please visit the CDC website.

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