Document issued on: November 29, 2010
For questions regarding this document contact Sheila A. Murphey, MD, 301-796-6302, [email protected] or Neil Ogden, 301-796-6397, [email protected].
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Division of Surgery, Orthopedic and Restorative Devices
Preface
Public Comment
You may submit written comments and suggestions at any time for Agency consideration to the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, rm. 1061, (HFA-305), Rockville, MD, 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register. Comments may not be acted upon by the Agency until the document is next revised or updated.
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1732 to identify the guidance you are requesting.
Guidance for Industry and Food and Drug Administration Staff
Blood Lancet Labeling
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm
Read the CDC Clinical Reminder at:
http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.html
Read the CMS Survey and Certification Memorandum at:
http://www.cms.gov/surveycertificationgeninfo/downloads/SCLetter10_28.pdf
Additional information on the safe use of blood glucose meters and other “Point of Care†(POC) devices is available at:
http://www.cdc.gov/injectionsafety/blood-glucose-monitoring.html
http://www.cdc.gov/hepatitis/Settings/GlucoseMonitoring.htm
Recommended Blood Lancet Device Labeling
FDA recommends that all blood lancet devices be labeled for use only on a single patient. A statement limiting use to a single patient should appear on the labeling attached to the device, if possible.
The device labeling, including the Instructions for Use, for all blood lancet devices should clearly and prominently state that the device is intended for “single patient use only.†We recommend that all written, printed, and graphic matter that accompanies the blood lancet device also contain the same language.
Recommendations for Multiple Use-Capable Blood Lancets
For a blood lancet device designed to be used multiple times, the reusable base portion of the device should carry labeling with the limitation, “single patient use only.â€Â
In addition, the Instructions for Use of these devices should contain language that multiple use devices should not be used for assisted blood draws by healthcare providers or at healthcare provision sites*, and should never be shared with anyone else, even a family member.
Blood lancet devices designed for multiple use also should provide manufacturer-validated user instructions for the cleaning and the disinfection of the reusable lancet device base after every use by the individual patient. Manufacturers of blood lancets with a reusable device base and single use lancet blades should include in the labeling, including the Instructions for Use and the written, printed, and graphic matter that accompanies the blood lancet device, instructions for the safe disposal of the single use lancet blades.
Single use only, disposable blood lancets minimize the risk of transmitting bloodborne pathogens. The labeling of single use disposable blood lancets, which may include a self-disabling feature, should include language that only single use disposable blood lancets should be used for assisted blood draws by healthcare providers or at healthcare provision sites. These devices should be clearly labeled as “single use onlyâ€Â. Manufacturers of single use disposable blood lancets should include in the labeling, including the Instructions for Use and the written, printed, and graphic matter that accompanies the blood lancet device, instructions for the safe disposal of these blood-contaminated devices. If the device contains a sharps safety/self-disabling feature, the Instructions for Use should include a description of its use.
References
- Centers for Disease Control and Prevention. Transmission of hepatitis B virus among persons undergoing blood glucose monitoring in long-term-care facilities – Mississippi, North Carolina and Los Angeles County, California, 2003-2004. MMWR 2005; 54: 220-223
- Patel AS, White-Comstock MB, Woolard D, Perz JF. Infection Control Practices in Assisted Living facilities: A Response to Hepatitis B Virus Infection Outbreaks. ICHE 2009; 30(3): 209-214
- Thompson ND, Perz JF. Eliminating the Blood: Ongoing Outbreaks of Hepatitis B Virus Infection and the Need for Innovative Glucose Monitoring Technologies. J Diabetes Sci Technol 2009; 3 (2): 283-288
- Thompson ND, Perz JF, Moorman AC, Holmberg SD. Nonhospital Health Care-Associated Hepatitis B and C Virus transmission: United States, 1998-2008. Ann Int Med 2009; 150: 33-39
- Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer guidance (1996). http://www.fda.gov/downloads/MedicalDevices/ DeviceRegulationandGuidance/GuidanceDocuments/ucm080268.pdf
* Any setting where fingerstick procedures are performed, including assisted living or residential care facilities, skilled nursing facilities, clinics, health fairs, shelters, detention facilities, senior centers, schools, and camps.
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