2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC21
Submitter : Ms. Ted Cohen Date & Time: 12/10/2004 05:12:15
Organization : UC Davis Health System
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
Take a common sense approach as recommended by ASHE including:
- first consider the patient population that is served and their risk for bed rail entrapment
- then, only if appropriate, focus on the bed rail dimensions.
- testing all beds is neither an effective solution nor proper use of resources.
- Conducting a periodic sample of your hospital beds to verify that they are in good repair
- properly select beds, and mattresses that properly fit those beds, for your patient population
- identify patients ?at risk? for bed rail entrapment, and select the appropriate bed for them.