2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC29
Submitter : Mr. Dan Evans Date & Time: 12/10/2004 05:12:37
Organization : Southern Illinois Ch. for Healthcare Engineering
Health Care Association
Category :
Issue Areas/Comments
We understand and appreciate the intention of this document to minimize the risk of patient entrapment in hospital beds. However, the document indicates proactive testing will be required on existing beds, which will be prohibitively expensive yet do little to reduce the risk. The existing resources in hospitals throughout southern Illinois are already stretched to their limits. Adding a financial burden of this magnitude will only divert scarce dollars away from those issues which we have determined pose a higher risk than bed entrapment.

Pilot tests have already proven that existing beds, which were never designed to meet the requirements of the draft document, cannot pass. Additionally, the pilot testing itself resulted in more injuries to testing staff than the number of entrapments the proposal was developed to prevent. Many hospitals already perform ongoing clinical assessments to identify patients at risk for entrapment and address those patients at high risk. This should be the focus for existing beds. The additional burden of testing with no risk reduction is a total waste.

The FDA must revise the draft document to delete the testing requirements for existing beds, focus instead on the design of new beds, and insure that clinical/support staff practices include assessments of patients and follow-up for those determined to be at high risk.

Respectfully submitted,

Dan Evans, Chairman
Codes & Standards Advocacy Committee
Southern Illinois Chapter for Healthcare Engineering
Dan Evans
Facilities Engineering Manager
Memorial Hospital of Carbondale
Carbondale, Illinois