[Federal Register: March 10, 2006 (Volume 71, Number 47)]
[Notices]
[Page 12365-12366]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10mr06-79]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2004D-0343]
Guidance for Industry and Food and Drug Administration; Hospital
Bed System Dimensional and Assessment Guidance to Reduce Entrapment;
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 ``Hospital Bed System Dimensional
and Assessment Guidance to Reduce Entrapment.'' This guidance provides
recommendations intended to reduce life-threatening entrapments
associated with hospital bed systems. It characterizes the body parts
at risk for entrapment, identifies the locations of hospital bed
openings that are potential entrapment areas, recommends dimensional
criteria for bed systems, provides information about legacy beds
including information to include when reporting entrapment adverse
events, and provides the Hospital Bed Safety Workgroup (HBSW) test
methods for assessing gaps.
DATES: Submit written or electronic 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 on a 3.5''
diskette of the guidance document entitled ``Hospital Bed System
Dimensional and Assessment Guidance to Reduce Entrapment'' to the
Division of Small Manufacturers, International, and Consumer Assistance
(HFZ-220), Center for Devices and Radiological Health, Food and Drug
Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-
addressed adhesive label to assist that office in processing your
request, or fax your request to 301-443-8818. See the SUPPLEMENTARY
INFORMATION section for information on electronic access to the
guidance.
Submit written comments concerning this guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Identify comments with the
docket number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Jay A. Rachlin, Center for Devices and
Radiological Health (HFZ-230), Food and Drug Administration, 1350
Piccard Dr., Rockville, MD 20850, 301-594-3173.
SUPPLEMENTARY INFORMATION:
I. Background
This guidance identifies special issues associated with hospital
bed systems and provides recommendations intended to reduce life-
threatening entrapments associated with these devices. Manufacturers
may use this guidance to assess current hospital bed systems and to
assist in the design of new beds. This guidance may be used as part of
a bed safety program to help identify entrapment risks that may exist
with current hospital bed systems.
Previously, FDA announced the availability of a draft guidance
document entitled ``Hospital Bed System Dimensional Guidance to Reduce
Entrapment'' in the Federal Register of August 30, 2004 (69 FR 52907).
FDA invited interested persons to comment on the guidance document by
November 29, 2004. FDA received over 110 comments. FDA changed the
draft guidance based on the comments received. The changes include the
following: (1) Addition of the HBSW test methods for assessing gaps and
(2) addition of the use of a test tool for assessing the potential for
head and neck entrapment.
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 appropriate dimensional limits for, and
assessment of, gaps in hospital bed systems to prevent entrapment. It
does not create or confer any rights for or on any person
[[Page 12366]]
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
To receive the ``Hospital Bed System Dimensional and Assessment
Guidance to Reduce Entrapment,'' you may either send a fax request to
301-443-8818 to receive a hard copy of the document, or send an e-mail
request to GWA@CDRH.FDA.GOV to receive a hard copy or an electronic
copy. Please use the document number (1537) to identify the guidance
you are requesting.
Persons interested in obtaining a copy of the guidance may also do
so by using the Internet. CDRH maintains an entry on the Internet for
easy access to information including text, graphics, and files that may
be downloaded to a personal computer with Internet access. Updated on a
regular basis, the CDRH home page includes device safety alerts,
Federal Register reprints, information on premarket submissions
(including lists of approved applications and manufacturers'
addresses), small manufacturer's assistance, information on video
conferencing and electronic submissions, Mammography Matters, and other
device-oriented information. The CDRH web site may be accessed at
http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh A search capability for all CDRH guidance documents is available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
Guidance documents are also available on the Division of Dockets
Management Internet site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/ohrms/dockets.
IV. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Comments received may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Dated: March 2, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E6-3369 Filed 3-9-06; 8:45 am]
BILLING CODE 4160-01-S