2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability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
Category :
Issue Areas/Comments
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

(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.