2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability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.