Uploaded by USFoodandDrugAdmin on Nov 18, 2010
FDA and CDC are alerting healthcare professionals and patients about the risk of transmitting hepatitis B virus (HBV) and other infectious diseases when fingerstick lancing devices are used on more than one person. These devices puncture the skin to obtain small amounts of blood for testing someone's blood glucose, hemoglobin or other blood components. Some of them are designed for single use, others for multiple use. They can come packaged with point-of-care blood testing devices or sold separately.
In recent years, the FDA and CDC have noted an increase in reported HBV outbreaks associated with using multiple-use fingerstick devices on more than one person. Much of the increase has occurred in long-term care settings such as nursing homes and assisted living facilities, where residents often need someone to help monitor their blood glucose levels.
But this risk exists in any setting where fingerstick procedures are performed, including acute care facilities, as well as clinics, health fairs, shelters, detention facilities, senior centers, schools, and camps. For example, at a health fair in New Mexico earlier this year, dozens of people were potentially exposed to bloodborne pathogens when they were screened for diabetes with fingerstick devices that were being reused.
Using fingerstick devices on more than one person may not be safe for several reasons. For example, improper use or device malfunction can mean that a contaminated lancet blade might be used on more than one patient. It is also difficult to ensure that all blood has been removed from the reusable portions of the fingerstick device.
FDA and CDC recommend a number of precautions to help prevent transmission of bloodborne pathogens. Here are some of them:
• Never use fingerstick devices on more than one person.
• In situations where patients are assisted with blood glucose monitoring, use single-use disposable fingerstick devices that prevent reuse through an auto-disabling feature.
• Even when following these precautions, be sure to wash hands and change gloves between patients.
FDA Patient Safety News: November 2010
For more information, please see our website:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/psn/transcript.cfm?show=104#2
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