| 2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability|
|FDA Comment Number :||EC19|
|Submitter :||Mr. Gary Jackson||Date & Time:||12/10/2004 05:12:48|
|Organization :||Longmont United Hospital|
| We understand and appreciate the intention of this document, to minimize the potential of patient entrapment in a hospital bed. But we feel that the introduction statement and Appendix F will focus attention on proactive testing of existing beds with little or no actual risk reduction. The cost to upgrade our existing beds will be at least $15,000.
As written, this guidance will create an expectation of hospitals and long term care facilities inspecting all of their existing hospital beds for compliance with these dimensional limitations. Our understanding is that the 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 rquired to determine that our 185 existing beds will not pass is wasted with no risk reduction. The dimensional guidance has value to existing beds 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 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 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 existing equipment is patient assessment first, with risk mitigation efforts based on meeting that patient's need.