Contains Nonbinding Recommendations 
Guidance for Industry and  
Food and Drug Administration 
Staff 
 
Blood Lancet Labeling  
 
Document Issued on: November 29, 2010 
 
 
 
 
 
For questions regarding this document contact Sheila A. Murphey, MD, 301-796-6302, 
sheila.murphey@fda.hhs.gov or Neil Ogden, 301-796-6397, neil.ogden@fda.hhs.gov.  
 
 
 
 
 
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 
 
 
 
 
 
 
 
 
 
  1 Contains Nonbinding Recommendations 
 
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 at: 
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/uc
m234577.htm   You may also send an e-mail request to dsmica@fda.hhs.gov 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.  
 
  2 Contains Nonbinding Recommendations 
 
 
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.  
 
Introduction  
 
This guidance recommends changes in the labeling of blood lancet (e.g., fingerstick) devices 
(21 CFR 878.4800) (included under manual surgical instruments for general use). FDA is 
concerned about the risk of transmission of hepatitis and other bloodborne pathogens when 
blood lancets are used to obtain blood from more than one patient. FDA is recommending 
that all blood lancets designed to be used more than once (for example, when a blade 
attached to a reusable base device is changed) be labeled for use only on a single patient 
obtaining personal blood samples. Manufacturers of blood lancets should clearly state in 
their labeling that blood lancets are intended only for single use or, in the case of lancet 
devices designed to be used more than once, for multiple uses in only a single patient. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required.  
 
 
 
  3 Contains Nonbinding Recommendations 
 
Scope 
 
This guidance document applies to all blood lancet devices (21 CFR 878.4800). 
 
FDA is issuing this guidance with labeling recommendations for single patient use only of 
blood lancets.  FDA has concerns that both healthcare providers and patients may not be 
aware of the serious adverse health risks associated with the use of a blood lancet device for 
the assisted withdrawal of blood from more than one patient and when sharing the same 
device, including among family members, even when the lancet blade is changed for each 
blood draw.  FDA is also recommending labeling changes for single use only blood lancets. 
 
Background 
 
On August 26, 2010, the FDA and the Centers for Disease Control and Prevention (CDC) 
issued communications warning that the use of blood lancets to obtain blood from more than 
one patient poses a risk of transmitting bloodborne pathogens. The FDA and CDC 
recommend that blood lancet devices should never be used to obtain blood samples from 
more than one person.  Additionally, on August 27, 2010, the Centers for Medicare and 
Medicaid Services (CMS) issued a Survey and Certification Memorandum for Point of Care 
Devices and Infection Control in Nursing Homes identifying the use of lancet devices for 
more than one patient as an infection control standards deficiency.  
 
FDA and CDC are concerned about the risk of transmitting hepatitis and other bloodborne 
pathogens resulting from the use of blood lancet devices in multiple patients in various 
healthcare provision settings. These include acute care hospitals, long term care facilities,  
assisted living facilities, and non-residential care settings. CDC has noted increasing reports 
of outbreaks of hepatitis B transmission due to the use of blood lancet devices on multiple 
patients.   
 
Blood lancet devices may be unsafe when used to draw blood from more than one patient for 
several reasons. Improper device design, device malfunction or user error may leave the 
blood from one patient on the reusable lancet device base and in a position to contaminate a 
new lancet blade. Healthcare users of blood lancets may have difficulty ensuring that all 
blood contamination has been successfully removed from a reusable lancet base device. The 
cleaning and disinfection instructions provided with reusable lancet devices may not be 
adequately validated for efficacy or may not be followed in their entirety by healthcare users.   
 
In addition, single use only lancets, which minimize the risk of transmitting bloodborne 
pathogens arising from multiple patient use, should contain language in the labeling 
identifying the device as single use only and instructing for their safe disposal.   
 
 
Read the FDA Initial Communication at: 
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025.htm 
 
  4 Contains Nonbinding Recommendations 
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.    
 
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 instructions5 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. 
 
 
 
Recommendations for Single Use Only Blood Lancets 
                                                           
* 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. 
  5 Contains Nonbinding Recommendations 
 
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 only. 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 
 
1. 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 
 
2. 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 
 
3. 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 
 
4. 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 
 
5. Labeling reusable medical devices for reprocessing in health care facilities: FDA reviewer 
guidance (1996). 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDo
cuments/ucm080268.pdf  
 
 
 
 
  6