[Federal Register Volume 71, Number 47 (Friday, March 10, 2006)]
[Notices]
[Pages 12365-12366]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-3369]


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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://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 [email protected] 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://www.fda.gov/cdrh. A search capability for all CDRH guidance 
documents is available at http://www.fda.gov/cdrh/guidance.html. 
Guidance documents are also available on the Division of Dockets 
Management Internet site at 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