[Federal Register Volume 75, Number 228 (Monday, November 29, 2010)]
[Notices]
[Pages 73107-73108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-29795]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-D-0590]


Guidance for Industry and Food and Drug Administration Staff; 
Blood Lancet Labeling; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the guidance entitled ``Guidance for Industry and Food 
and Drug Administration Staff; Blood Lancet Labeling.'' FDA is issuing 
this guidance with labeling recommendations because of concerns that 
both healthcare providers and patients may be unaware of the serious 
adverse health risks associated with using the same blood lancet device 
for assisted withdrawal of blood from more than one patient, even when 
the lancet blade is changed for each blood draw. 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 also appear on the 
label attached to the device, if possible. The guidance document is 
immediately in effect, but it remains subject to comment in

[[Page 73108]]

accordance with the Agency's good guidance practices.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Guidance for Industry and Food and Drug 
Administration Staff; Blood Lancet Labeling'' to the Division of Small 
Manufacturers, International, and Consumer Assistance, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 4613, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request, or fax your request to 301-847-8149. See the 
SUPPLEMENTARY INFORMATION section for information on electronic access 
to the guidance.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Shelia Murphey, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2510, Silver Spring, MD 20993-0002, 301-796-6302.

SUPPLEMENTARY INFORMATION:

I. Background

    On August 26, 2010, the FDA and Centers for Disease Control and 
Prevention (CDC) issued a joint Initial Communications warning that the 
use of fingerstick devices (blood lancets) to obtain blood from more 
than one patient poses a risk of transmitting bloodborne pathogens. The 
Agencies recommended that blood lancet devices should never be used to 
obtain blood samples from more than one person.
    CDC has noted a progressive increase in reports of bloodborne 
pathogen transmission (primarily hepatitis B) resulting from the use of 
a blood lancet in multiple patients in various healthcare provision 
settings. These settings include acute care hospitals, long term care 
facilities and assisted living facilities as well as non-residential 
care settings.
    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 followed in their entirety. 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 
also appear on the label attached to the device, if possible.
    FDA is making this guidance document immediately available because 
prior public participation is not appropriate. Due to the urgent public 
health need to support the joint Initial Communications issued by CDC 
and FDA concerning the risk of hepatitis transmission caused by the use 
of blood lancets on more than one patient, FDA believes that current 
lancet labeling which does not restrict the use of lancets to a single 
patient must be corrected as quickly as possible. FDA believes that 
this guidance will provide significant assistance to lancet 
manufacturers as they work to improve their labeling as recommended.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
Agency's current thinking on blood lancet labeling. It does not create 
or confer any rights for or on any person and does not operate to bind 
FDA or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. A search capability for all CDRH guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. To receive 
``Guidance for Industry and Food and Drug Administration Staff; Blood 
Lancet Labeling,'' you may either send an e-mail request to 
<a href="/cdn-cgi/l/email-protection#0d697e60646e6c4d6b696c2365657e236a627b"><span class="__cf_email__" data-cfemail="3753445a5e545677515356195f5f4419505841">[email protected]</span></a> to receive an electronic copy of the document or 
send a fax request to 301-847-8149 to receive a hard copy. Please use 
the document number 1732 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance contains information collection provisions that are 
subject to review by the Office of Management and Budget (OMB) under 
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collection of information in this guidance was approved under OMB 
control number 0910-0485.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES), either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments with the docket number found in brackets in the heading of 
this document. Received comments may be seen in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: November 22, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-29795 Filed 11-26-10; 8:45 am]
BILLING CODE 4160-01-P


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