2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability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