Food and Drug Administration, HHS.
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.
Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time.
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.Start Further Info
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.End Further Info End Preamble Start Supplemental Information
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 Start Printed Page 12366and 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://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.
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.Start Signature
Dated: March 2, 2006.
Assistant Commissioner for Policy.
[FR Doc. E6-3369 Filed 3-9-06; 8:45 am]
BILLING CODE 4160-01-S