2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC18
Submitter : Mr. James Crandall Date & Time: 12/10/2004 05:12:39
Organization : Albemarle Hospital
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
I understand and appreciate the intent of this document, to minimize the potential of patient entrapment in a hospital bed. However, I feel that the introduction statement and Appendix "F" will focus on the testing of existing beds with little or no actual risk reduction. In fact, this focus will stretch currently scarce resources that would be better spent on patient assessment and modification of the bed environment if warranted based upon the patients size or condition.
As written, this guidance will create the expectation of hospitals and long term care facilities inspecting all of their existing (legacy) hospital beds for compliance with these dimensional limitations. Our understanding is that pilot testing of existing beds has revealed that most if not all existing beds will not meet these dimensional limitations. So, the extensive time and effort that will be required to determine that our 182 existing beds will not pass is wasted with no risk reduction. The dimensional guidance has value for existing beds if it is clearly stated that the primary focus must first be clinical assessment of the patients physical condition to establish that they are vulnerable to the risk of bed entrapment.
The FDA must revise this draft document to clearly identify existing (legacy) beds are NOT inherently "unsafe" even if they do not meet the new dimensional limits established in this document. The focus on dimensional limits must be on NEW beds manufactured after the implementation of this document.
With increased costs and declining revenue, hospitals do not have the resources to make existing beds conform to the dimensional requirements or buy new beds.
James S. Crandall, CHSP
Director of Clinical Engineering
Albemarle Hospital