2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC1
Submitter : Mr. Thomas Stacy Date & Time: 09/23/2004 11:09:06
Organization : BedRail Solutions, LLC
Device Industry
Category :
Issue Areas/Comments
GENERAL
GENERAL
We at BedRail Solutions, LLC consider the problem of bedrail entrapment a very serious one. Patient/clients should not be at risk of injury or death in an environment where they entrust their safety and well being to others. Nor should they be at the mercy of inadequately engineered bed systems that also put them at risk. To that end, we have developed, produced and successfully field tested a product called the SABER(TM) System to address the issues of entrapment. The SABER(TM)System is a patent pending retrofit product that can be utilized with any existing mattress. The System is applied to the existing mattress, then encased in a form fitting cover. The device provides an elevated mattress edge of four inches without compromising any sleep surface. Even at points of ingress and egress, the SABER(TM) prevents compression of the mattress edge. Side panels and mattress are also encased in a fire block material. The cover products are standard hospital grade materials that meet NFPA 701 Small Scale standards. The use of these materials has resulted in superior performance using both the Cal TB 129 and Boston IX-XI flammability test methods.

We have had both Resdiential and Gatch(articulating)models in service for approximately one year, and are very pleased with the feedback we have received regarding the performance and durability of the SABER(TM) System. The units have been in place at facilities for the Developmentally Disabled, and the complete removal of the consumer's bedrails has been accomplished utilizing our product. In view of those results, we reassert our belief that our product can effectively eliminate the risk of entrapment completely in most cases.

In response to the requests for comments: As a general statement, we believe that the dimensional limits set forth in this guidance may be adequate, but still leave room for that what-if or exception to the rule case.

1.)We believe that the implementation and use of our product will significantly, if not entirely eliminate most of the listed entrapment zones, or far exceed the limits set forth in this guidance. The type of mattress or application is irrevlevant with the use of the SABER(TM) System and thus any exclusions would not be necessary.

2.)As the SABER(TM) provides a rigid elevated edge, The gap at Zone 2 is eliminated. Also note that the elevated edge also reduces accesability and minmizes the gap at Zone 1.

3.) Again, the elevated edge and enclosed mattress features of the SABER(TM) System eliminates the gap at Zone 3.

4.) The gap at Zone 4 is again reduced significantly or eliminated by the rigid edge preventing compression.

5.) We find the limits set forth for Zone 5 to be adequate, however the issue of articulation can change that gap dimension. The split rail configuration and engineering improvements to that system must be addressed by the bed manufacturers.

5.) We find the limits set forth for Zone 6 adequate. With the SABER(TM) in place however, as it extends the full length of the mattress, that gap dimension is greatly reduced or eliminated.

6.) While we have no comment as specifically referenced, the SABER(TM) can be modified to provide and end panel to also be enclosed in the cover to eliminate Zone 7.

7.) In review of the Zones of entrapment, it appears that the bedrail configuration bears most of the burden in the flucuation of the gap dimensions. For a more complete evaluation of the Adverse Event Reports, perhaps a standardized form, asking for all relevant details of the event would be helpful.

8.) We can find no reason to exclude anyone's safety at any time in any place.


We greatly appreciate the opportunity to take part in this program, and would like to be added to the list of Participating Organizations.

For more information on our our products and the field tests we have performed, please visit our website at www.bedrailsolutions.com, or contact us at info@bedrailsolutions.com.