2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC5
Submitter : Dr. Ilka Behmann Date & Time: 10/12/2004 04:10:06
Organization : BfArM (German federal institute for drugs and medi
International
Category :
Issue Areas/Comments
GENERAL
GENERAL
Page 7 Request for Comment: 1 (Technical)
The mentioned products should not be excluded from the recommendations.
FDA should reconsider these exclusions.

Page 15 Request for Comment: 2 (Technical)
According to our data, 16 of in total 33 registered entrapments occurred in zone 2, 13 of them with fatal outcome. Three of those incidents happened in spaces between the bed platform and the rail with dimensions of 120 mm or smaller (105 mm in one case).
The recommendation should be modified to an additional degree of protection.

Page 16 Request for Comment: 3 (Technical)
We have no data concerning mattress-related entrapments in zone 3.

Page 20 Request for Comment: 4 (Technical)
According to our data, ten of in total 33 registered entrapments occurred in zone 5, seven of them with fatal outcome. Two of those incidents happened in spaces with dimensions of 235 mm (dimension in accordance with the IEC 60601-2-38). Concerning the angle of the openings, no data are available.
Recommendations should include zone 5.

Page 21 Request for Comment: 5 (Technical)
No data concerning entrapments in zone 6 are available.
Regarding the geometry, recommendations on the lines of zone 5 seem to be reasonable.

Page 22 Request for Comment: 6 (Technical)
We have no data concerning mattress-related entrapments in zone 7.

Page 23 Request for Comment: 7 (Technical)
Two fatal incidents, both concerning zone 5, occurred in beds with articulated position. This could be verified by photos of the setting. In both incidents, the head end of the bed platform was raised, the angle was presumed to be about 15-20?, regarding the photographs. Most further reports did not show, if the bed was articulated or not.
Entrapments can not only occur in flat deck position.

Page 23 Request for Comment: 8 (Technical)
Entrapment is a design-related problem, which concerns beds with the described purpose and which is independent from the location, where the device is used.
There are no reasons, why these recommendations should not concern all care settings.