2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC33
  



  

  

  



  

  
Submitter : 
  

  
Ms. Marie Conti
  

  
Date & Time: 
  

  
12/10/2004 05:12:33
  



  

  
Organization : 
  

  
North Philadelphia Health System
  



  

  
Health Professional
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 The bed measurement requirement proposed would be an onerous burden to most hospitals. We propose a comprehensive approach using inspections, monitoring, criteria for high risk patients, assessments and checklists for these patients, education of staff and families and FMEA and RCA techniques on bed entrapment.