2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC17
Submitter : Mr. Steven Taylor Date & Time: 12/10/2004 05:12:29
Organization : Stillwater Medical Center
Health Professional
Category :
Issue Areas/Comments
Thank you for the opportunity to commment on the FDA draft guidance: Hospital Bed System Dimensional Guidance to Reduce Entrapment.

We understand and appreciate the purpose of this guidance document to minimize the potential for patient entrapments in hospital beds. However, we feel that the assessment and modification of existing (legacy) hospital bed systems will focus attention on testing of existing beds with little or no actual risk reduction. Initial testing of existing beds would require extensive man hours, not to mention the man hours that would be required for continued testing of beds to ensure they meet dimensional limitations with changes due to different mattress set ups and/or patient differences. This focus will stretch currently scarce resources that would be better spent on patient assessment and modification of the bed environment if necessary based on patient condition.
Our understanding is that pilot testing of existing beds has revealed that most if not all existing beds will not meet these dimensional limitations. Again, the extensive man hours that will be required to determine that existing beds will not pass is wasted with no risk reduction. The dimensional limitations has value to existing beds as long as the primary focus is clinical assessment of the patient to establish whether or not the patient is vulnerable to the risk of bed entrapment.

FDA must revise this draft document to clearly identify existing beds are not inherently unsafe even though they do not meet the new dimensional limitations established. The primary focus on dimensional limitations must be on new beds manufactured after implementation of this document.

Steven Taylor
Director of Facilities Management
Stillwater Medical Center