2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC58
Submitter : Mr. Wayne Klingelsmith Date & Time: 12/15/2004 11:12:52
Organization : Athens Regional Medical Center
Health Professional
Category :
Issue Areas/Comments
Most hospitals today are in a current state of financial distress. Placing a rule that would require all beds to be tested, and the majority modified, is not in the best interest of healthcare today.
Please consider this rule only for the manufacture of NEW hospital beds and allow hospitals to develop programs for identifying patients who might be prone to entrapment for special attention and/or equipment.

The November 1-2, 2001 minutes of the Hospital Bed Rail Safety Workgroup meeting states "The over-arching observation from the study was that the majority of bed systems do not meet the proposed dimensional criteria." If this is true, there should be no elaborate testing of existing hospital beds. Guidance information could be made available for modifying existing beds to minimize the possibility of entrapment. However, new hospital beds must definitely be made to correct this fault. In addition, the same Hospital Bed Rail Safety Workgroup meeting minutes go on to say "...patient falls are far more prevalent than entrapment; e.g. out of 692 recorded events, 4 were entrapments and the balance were falls...". Hospitals definitely want to reduce or eliminate patient falls and entrapments and a program for identifying patients prone to falls or entrapments could be implemented much quicker and allow significant improvement in the number of falls and entrapments in a much shorter time than as currently provided in the draft guidance document.

Our recommendation is to make this action mandatory ONLY for the manufacture of new hospital beds, and allow existing beds to remain is service for a minimum of 10 years, subject to each facility instituting a program to identify high risk patients and minimize falls and entrapments.