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FDA & CDC WARNING: Limit Fingerstick Devices to Just One Patient

Posted: Tuesday, September 14, 2010

Fingerstick devices along with insulin pens should never be used with more than one person.

In the war against the transmission of blood borne pathogens such as the hepatitis B virus, the US Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA) recommended last week that fingerstick devices should never be used with more than one person. They issued similar guidance for point-of-care (POC) blood-testing devices such as glucometers and instruments for insulin administration.

The two federal agencies said the shared used of blood lancing and POC testing devices has led to a steady rise in reports of blood borne-pathogen infections -- mostly involving hepatitis B virus -- during the past 10 to 15 years. Such communal bloodletting occurs in settings that range from public health fairs to physician offices, but the problem is most serious in long-term care and assisted-living facilities.

In addition to stipulating a rule of one fingerstick device for one person, the FDA and CDC recommended that when clinicians obtain blood samples to monitor blood glucose levels, they should rely on fingerstick devices that automatically disable themselves after a single use -- those in which the blade retracts, for example. These single-use, auto-disabling instruments are also known as safety lancets.

The new recommendation applies to fingerstick devices that are approved for obtaining blood from multiple individuals. The FDA stated that it would soon take action to have these items labeled for use for only a single person.

Insulin Pens Also Should Not Be Shared: The FDA and CDC did not take as tough of a precautionary stand on POC testing devices such as blood glucose and anticoagulation meters. They recommended that these devices should be used with only one person "whenever possible." However, if it is not possible to dedicate a POC testing device to a single patient, clinicians should properly clean and disinfect the device between every use, as described in the product label.

The same concerns about preventing the spread of blood borne pathogens extend to insulin administration. Insulin pens, which contain several doses of insulin that patients can administer to themselves, should never be shared, according to the FDA and CDC. When clinicians assign them to patients, the devices should be labeled for single-patient use.

Whenever possible, multidose vials of insulin should be limited to a single person. If not, the vials should be stored and prepared in a dedicated area away from the patient care environment and potentially contaminated equipment. Insulin should always be administered with a new needle and syringe, which likewise should never be used to administer insulin to more than one person, and then "disposed of immediately after use in an approved sharps container."

Physicians should wear gloves for any task that potentially exposes them to blood or body fluids, and they should change gloves between patient contacts, even when they work with patient-dedicated POC devices or single-use, self-disabling fingerstick devices.

More information about the warning is available on the websites of the FDA and the CDC.

Source: http://www.diabetesincontrol.com/index.php?option=com_content&view=article&id=9787&catid=53&Itemid=8

 
 
 
 
 
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