DOTmed recently reported that CDC and FDA reaffirmed the position that fingerstick devices like blood glucose monitors should not be used on more than one patient even when sterile lancets are employed. Fingerstick monitors are in widespread use in health care settings but due to difficulty with cleaning and disinfection, proper protocols are not always observed, experts say. DOTmed conducted an email interview with
Dr. Ana K. Stankovic, Medical and Scientific Affairs and Clinical Operations, BD Diagnostics - Preanalytical Systems.

DM: What are your views about the FDA and CDC recommendations?
AKS: The CDC has become increasingly concerned about the risks for transmitting hepatitis B virus and other bloodborne pathogens to persons undergoing fingerstick procedures for blood sampling. There have been incidents in long-term care facilities and at a health fair in New Mexico where patients were potentially exposed to bloodborne pathogens through the reuse of fingerstick devices on multiple persons.

DM: How can safety be assured?
AKS: Blood collection devices should not be used on more than one patient. After use, these blood collection devices should also be discarded into a sharps collection container to minimize risk of a needlestick injury to other patients, clinicians, and housekeeping staff. In addition to the CDC(1) and FDA(2) guidelines, use of manual lancets or blades without a retractable feature is also a violation of OSHA regulations. Further, the Clinical Laboratory Standards Institute (CLSI) states that a skin puncture device should be sterile, disposable, and single use with a permanently retractable blade or needle to reduce the possibility of needlestick injuries and reuse(3).

DM: What are your products in these categories and where are they used?
AKS: The BD Microtainer® Contact-Activated Lancets are a line of single-use, auto-disabling devices which are designed to help reduce the risk of reuse of fingerstick devices, providing the optimum safety and comfort for both the clinician and the patient. The device activates only when it is positioned and pressed against the skin and automatically retracts the lancet back into the device after puncture. The BD Microtainer® Contact-Activated Lancet is available in three different gauges and depths. Selection of the appropriate BD Microtainer® Contact-Activated Lancet is according to the necessary blood flow to perform the required test. Typically the purple lancet, designed for low flow, is used for testing requiring a single drop or for use with point-of-care devices. It has been rated as the least painful device when compared to three other comparable lancets designed for low flow use(4). The blue lancet, design for high flow, it is used for conventional lab testing with capillary blood like hematology, CBC and some other chemistry testing. It yields more than twice the flow than other comparable lancets(5).

DM: Your other comments on safe practices?
AKS: BD is committed to optimizing the safety of clinicians and patients and reducing the risk of needlestick injuries and exposure to bloodborne pathogens by designing and providing safety-engineered and auto-disabling devices.

Healthcare facility administrators should empower the staff to take safety in their own hands and contribute to the evaluation and selection of the safest devices best suited for their professional settings, while taking into consideration all aspects of patient care.
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(1) CDC Clinical Reminder - http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.htm
(2) FDA Safety Information: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm224135.htm
(3) CLSI H4-A6. Procedures and Devices for the Collection of Diagnostic Blood Specimen by Skin Puncture; Approved Standard-Sixth Edition, Vol. 24, No. 21, 2008.
(4) Clinical Documentation VS 7499
(5) Clinical Documentation VS 7607

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