2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability

  


  

  


  

  


  

  


  

  
FDA Comment Number : 
  

  
EC12
  



  

  

  



  

  
Submitter : 
  

  
Dr. S Hignett
  

  
Date & Time: 
  

  
12/10/2004 05:12:35
  



  

  
Organization : 
  

  
Loughborough University
  



  

  
Academia
  


  

  
Category : 
  


  

  
Issue Areas/Comments 
  


  

  



  

  
GENERAL
  


  

  



  

  
GENERAL
  


  

  



  

  
 General comments

1) There need to be full references for the anthropometric dimensions not 

just a general reference list.  This should indicate the population used 

by country and age range as well as sex and percentile  (already listed). 

It is important to identify the user population for this product range e.g. USA population (including ethnic groups) rather than for other geographical populations.  The source for the head width dimension (see point 2) needs to be clearly referenced, it seems to refer to child data rather than adult data.

There should be clear rationale for using dimensions above/below those specified in the anthropometric data sources.

 

2) Definitions of the anthropometric dimensions.  Diagrams might be useful 

for this also.  For example two definitions for head breadth as follows:

- Measured horizontally across the head, above and behind the ears, where 

the head is broadest.  Hair is compressed

 

- Measured horizontally between tragia (just above the small projection of 

cartilage or trague, which is found just in front of the external opening 

of the ear).

 

3) There seem to be very limited data about some of the circumferential 

dimensions.  Any assumptions should be clearly explained (and referenced) 

otherwise it would be very easy to misinterpret the recommendations.

 

Specific request for comments

(1) page 7.  Yes framed flotation products should be included. 

 

(2).  page 15.  No, better to advise mattress checks and replacement 

programmes

 

(3) Page 16.  Yes, there should be a zero gap.

 

(4).  page 20.  As generic comments above.  The dimensions should be based 


  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  


  

  








  

  
 on referenced anthropometric data. 

 

(5).  page 21.  Yes, but it would be better to make this a larger gap 

rather than a smaller one.

 

(6).  page 22.  Zero gap as comment (3)

 

(7).  page 23.  Not aware of any entrapments when bed is articulated.

 

(8). page 23.  Guidance should apply to the use of hospital beds in all 

care settings.