[Federal Register Volume 80, Number 28 (Wednesday, February 11, 2015)]
[Notices]
[Pages 7612-7614]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-02802]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0630]


Safety Considerations To Mitigate the Risks of Misconnections 
With Small-Bore Connectors Intended for Enteral Applications; Guidance 
for Industry and Food and Drug Administration Staff; 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 ``Safety Considerations to 
Mitigate the Risks of Misconnections with Small-Bore Connectors 
Intended for Enteral Applications.'' The use of common connector 
designs, such as Luer connectors, has led to unintended connections 
between devices that have different intended uses and has resulted in 
serious and sometimes fatal consequences to patients. This guidance 
provides recommendations to manufacturers regarding the expectations 
for design and testing of small-bore connectors intended for enteral 
applications (``enteral devices''). FDA is making these recommendations 
to reduce the risk of unintended connections between enteral and non-
enteral devices.

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: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Safety Considerations to Mitigate the Risks of Misconnections with 
Small-Bore Connectors Intended for Enteral Applications'' to the Office 
of the Center Director, Guidance and Policy Development, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. 
Send one self-addressed adhesive label to assist that office in 
processing your request.
    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: Priya Venkataraman-Rao, Center for 
Devices and Radiological Health, Food and Drug Administration, 10903 
New Hampshire Ave., Bldg. 66, Rm. G222, Silver Spring, MD 20993-0002, 
301-796-6243.

SUPPLEMENTARY INFORMATION:

I. Background

    Numerous publications regarding patient injury and death from 
tubing and catheter misconnections indicate that reports of 
misconnections have increased in frequency over the past several years. 
On July 9, 2010, FDA issued a letter to healthcare professionals, 
hospital purchasing departments, and manufacturers of enteral feeding 
tubes regarding Luer lock misconnections (Ref. 1). FDA advised 
manufacturers to assess the risks of misconnections for their devices 
and provide proposed solutions with validation for premarket review. At 
that time, some manufacturers were using color-coding and labeling to 
reduce the risk of misconnections; others were creating proprietary 
connectors designed to be incompatible with devices for non-enteral 
applications (``non-enteral devices''). However, recent reports of 
adverse events have demonstrated that reliance on color-coding and 
tagging of enteral devices alone cannot adequately mitigate the risk of 
misconnections, especially with similarly color-coded intravenous PICC 
(percutaneously inserted central catheter) lines with Luer connectors.
    This guidance provides updated recommendations to manufacturers of 
small-bore connectors intended for enteral applications. The guidance 
recommends that manufacturers: (1) Design and test enteral connectors 
based upon Association for the Advancement of Medical Instrumentation 
(AAMI)/CN3:2014 (PS), ``Small-bore connectors for liquids and gases in 
healthcare applications--Part 3: Connectors for enteral applications'' 
and AAMI/CN20:2014 (PS), ``Small-bore connectors for liquids and gases 
in healthcare applications--Part 20: Common test methods''; (2) for 
connectors that do not meet AAMI/CN3:2014 (PS), design and test 
connectors based upon the AAMI/American National Standards Institute 
(ANSI)/International Organization for Standardization (ISO) 80369-1 
standard ``Small-bore connectors for liquids and gases in healthcare 
applications--Part 1:

[[Page 7613]]

General requirements''; (3) no longer rely solely on color-coding, 
labeling, and tagging to prevent misconnections; and (4) perform and 
document risk assessments to demonstrate that the proposed design and 
testing have effectively mitigated the risk of the enteral connector 
misconnecting to non-enteral devices.
    Elsewhere in this issue of the Federal Register, we are announcing 
a publication containing modifications to the list of standards that 
FDA recognizes for use in premarket reviews (``FDA Recognized Consensus 
Standards''). Specifically, this publication announces the addition of 
a list of recognized standards that are relevant to safety 
considerations to mitigate the risks of misconnections with small-bore 
connectors intended for enteral applications. This publication, 
entitled ``Modifications to the List of Recognized Standards, 
Recognition List Number: 039'' (``Recognition List Number: 039''), will 
assist manufacturers who elect to declare conformity with consensus 
standards to meet certain requirements for medical devices, 
specifically small-bore connectors for enteral applications.
    In the Federal Register of July 27, 2012 (77 FR 44256), FDA 
announced the availability of the draft guidance document. We invited 
interested persons to comment by October 25, 2012. Seven sets of 
comments were received and offered strong support for the finalization 
of this guidance as part of a continued effort to reduce the likelihood 
of incidents involving unintended connections between connectors with 
different intended uses. Multiple comments also applauded FDA for 
collaborating with the standards organizations to address this issue.
    The comments also noted the potential drawbacks of aligning the 
recommended testing with the current version of the AAMI/ANSI/ISO 
80369-1 standard. Its methodologies, particularly those in Annex B, 
seek to demonstrate that each proposed enteral connector is physically 
incompatible with non-enteral devices. However, ISO is proposing 
substantial changes for future versions that could affect the 
recommended testing. FDA acknowledges this potential drawback; however, 
the current version of 80369-1 was the available reference at the time. 
As noted above, additional consensus standards relating to the design 
and testing of small-bore connectors intended for enteral applications 
have been published and recognized. Therefore, the guidance has been 
modified accordingly to reference and align with these recognized 
standards.
    Multiple comments also suggested that the description of included 
and excluded devices be modified and clarified, and gave examples for 
consideration. The guidance has been modified accordingly. Several 
comments requested language and definition changes to provide more 
clarity and consistency with the published standard, which FDA has 
considered and incorporated as appropriate. Lastly, due primarily to 
space considerations on the label affixed to a device, multiple 
comments expressed concern regarding FDA's recommendation to eliminate 
the use of shortened terms such as ``enteral-only'' or ``non-IV'' in 
favor of more descriptive labeling. FDA has considered these comments 
and recommends that the device's instructions for use, as opposed to 
its affixed label, fully describe the subject connector's 
interconnectability. The instructions for use will afford adequate 
space for the recommended longer phrases describing the devices to 
which the subject connector can and cannot connect. However, for 
connectors for which non-interconnectability has been demonstrated, the 
product design could also incorporate color-coding, labeling, and 
tagging or imprinting on the connector.

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 mitigating the risks of misconnections 
with small-bore connectors intended for enteral applications. 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 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Safety Considerations to 
Mitigate the Risks of Misconnections with Small-Bore Connectors 
Intended for Enteral Applications'' may send an email request to [email protected] to receive an electronic copy of the document. 
Please use the document number 1784 to identify the guidance you are 
requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (the PRA) (44 U.S.C. 3501-
3520). The collections of information in 21 CFR part 820 have been 
approved under OMB control number 0910-0073; the collections of 
information in 21 CFR part 812 have been approved under OMB control 
number 0910-0078; the collections of information in 21 CFR part 807, 
subpart E have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR 56.115 have been approved under 
OMB control number 0910-0130; the collections of information found in 
21 CFR part 814 have been approved under OMB control number 0910-0231; 
the collections of information in 21 CFR part 803 have been approved 
under OMB control number 0910-0437; and the collections of information 
in 21 CFR part 801 have been approved under OMB control number 0910-
0485.
    The labeling provisions of this guidance are not subject to review 
by OMB because they do not constitute a ``collection of information'' 
under the PRA. Rather, the recommended enteral connector labeling is a 
public disclosure of information originally supplied by the Federal 
Government to the recipient for the purpose of disclosure to the public 
(see 5 CFR 1320.3(c)(2)).

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of 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, and will be posted to the docket at http://www.regulations.gov.

VI. References

    The following reference has been placed on display in the Division 
of Dockets Management (see ADDRESSES) and may be seen by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday, and is 
available

[[Page 7614]]

electronically at http://www.regulations.gov. (FDA has verified the Web 
site addresses in this reference section, but FDA is not responsible 
for any subsequent changes to the Web sites after this document 
publishes in the Federal Register.)

    1. FDA Center for Devices and Radiological Health, Letters to 
Industry Page, ``Letter to Manufacturers of Enteral Feeding Tubes,'' 
(http://www.fda.gov/downloads/MedicalDevices/ResourcesforYou/Industry/UCM218631.pdf).

    Dated: February 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-02802 Filed 2-10-15; 8:45 am]
BILLING CODE 4164-01-P