CDC and FDA Issue Alerts for Point-of-Care Testing

November 18, 2010

Over the last few years, the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) have become increasingly concerned about the number of serious infections related to the use of fingerstick devices and point-of-care (POC) testing instruments. Improper use of these can lead to the spread of blood-borne infections such as hepatitis. While infections from misuse have been occurring in a wide variety of settings, such as clinics, health fairs and hospitals, an inordinate number have been seen in long-term care facilities, notes the CDC. Moreover, most have involved hepatitis B, an infection that can lead to serious complications, especially in the elderly and those with weakened immune systems.

Point-of-care testing instruments are convenient and quick because they are portable and can be used, for example, at a patient's bedside. They perform tests used to monitor blood glucose,hemoglobin, PT/INR and other substances in the body. Typically, a single drop of blood is the only sample required for testing. The sample is obtained by pricking a fingertip with a sharp lancet or needle-like device, often included as part of the testing kit. The drop of blood is then analyzed by a POC instrument or meter.

In recent alerts on their web sites, the FDA and CDC reminded those who perform point-of-care tests and people who undergo fingersticks to be aware of some important precautions:

• Lancets or other devices that are used to prick fingertips in order to produce a drop of blood shouldNEVER be used for more than one person. Some fingerstick devices are referred to as single-use and are designed to be discarded after one test. Other fingerstick devices have handles that resemble pens and the tips or lancets are removed and discarded after each use. The handles may be used more than once but must be properly cleaned and disinfected after each use and, as stated above, should never be shared between people.

If you assist a patient in performing tests that monitor blood glucose, be sure that you use only fingerstick devices that are designed to be used once and then disabled automatically so that they cannot be reused. Note that such devices may be called "safety lancets," according to the FDA.

• The FDA alert states, "Whenever possible, POC blood testing [instruments], such as blood glucose meters and PT/INR anticoagulation meters, should be used only on one patient and not shared. If dedicating POC blood testing [instruments] to a single patient is not possible, the [instruments] should be properly cleaned and disinfected after every use as described in the [instrument] labeling." This should be done to protect both the patient and the person performing the test.

If you are a patient or a loved one caring for a patient and you are unsure about the POC testing instrument, you can ask the health care professional who administers the test whether the instrument is dedicated to a single patient, and if not, when it last was cleaned and disinfected.

• Again, the FDA states that health care professionals should "change gloves between patients, even when patient-dedicated POC blood testing devices [instruments] and single-use, self-disabling fingerstick devices are used." If you have any reason to suspect that the health care professional might have forgotten to change his or her gloves, you should ask just to be sure.

[Source: FDA, Use of Fingerstick Devices on More Than One Person Poses Risk for Transmitting Bloodborne Pathogens]

Point-of-care tests are valuable tools for testing and monitoring various conditions, if used properly. If you or someone you know is to undergo fingerstick procedures, whether at a clinic, nursing facility or health fair, be conscious of the proper precautions to ensure that they are followed and in order to be protected from potential harms.

The FDA points out that some fingerstick devices were previously approved and marketed for use for more than one person. Now, the agency plans to take steps to ensure that these devices are labeled with instructions that they are to be used on one patient only. It will be releasing a statement to this effect soon.