[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