2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC20
Submitter : Mr. Timothy Johnson Date & Time: 12/10/2004 05:12:09
Organization : District One Hospital
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
Thank you for the opportunity to comment on the FDA draft guidance: Hospital
Bed System Dimensional Guidance to Reduce Entrapment.

I understand and appreciate the intention of this document, to minimize the
potential of patient entrapment in a hospital bed. But I feel that the
focus on proactive testing of existing beds will have 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 on patient size and/or condition.

As written, this guidance will create an expectation of hospitals and long
term care facilities inspecting all of their existing (legacy) hospital beds
for compliance with these dimensional limitations. I understand
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 (60)
existing hospital beds will not pass is wasted with no risk reduction. The
dimensional guidance has value to existing beds if it is clearly stated that
the primary focus must first be clinical assessment of the patient physical
condition to establish that they are vulnerable to the risk of bed
entrapment. At that point, the focus of the clinical and support staff
should be the assessment of the hospital bed system with a clear plan for
addition or modification of that system to meet that specific patient's
needs.

FDA must revise this draft document to clearly identify existing (legacy)
beds are not inherently "unsafe" even though 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. The focus on legacy equipment is patient assessment first, with
risk mitigation efforts based on meeting that patient's need.

Timothy O Johnson
Facility Manager
District One Hospital