2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC40
  



  

  

  



  

  
Submitter : 
  

  
Mr. Glenn Patrick
  

  
Date & Time: 
  

  
12/10/2004 05:12:33
  



  

  
Organization : 
  

  
Portage Health System
  



  

  
Health Care Association
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 We feel the Hospital Bed Entrapment Guidelines should not be retroactive to existing beds.  The Guidelines may be applicable to newly manufactured beds which can be manufactured to meet the guideline.  



The existing beds can be monitored on a case-by-case basis only when a patient is determined to be at risk or vulnerable to bed entrapment.  The excessive cost associated with measuring and monitoring all existing beds is prohibitive in relation to the small gain in safety.  The same safety measures can be attained on the case-by-case assessment of patient and then the bed.



Sincerely,



Glenn Patrick

Director of Facilities 

Portage Health System