2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability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