2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC24
Submitter : Mr. Dan Callahan Date & Time: 12/10/2004 05:12:50
Organization : DeKalb Medical Center
Health Care Association
Category :
Issue Areas/Comments
Dear FDA:

I want to thank you for the opportunity to comment on the FDA draft guidance: Hospital Bed System Dimensional Guidance to Reduce Entrapment.

I think all of us in the healtcare industry understand and appreciate the intention of this document. Patient safety is certainly one of our highest priorities and we support any recommendations that will reduce risk and improve patient safety. However, we feel that the introduction statement[3] and Appendix F will focus attention on proactive testing of existing beds with little or no actual risk reduction.

Our Biomedical Maintenance department has already tested most of our current model beds based on FDA Safety Alert issued on August 23, 1995 and found most did not meet the recommended clearance at the four areas covered in this alert. Further testing would seem irrelevent and offers no new information. Most of us have limited resources and cannot afford to commit our technicians to a testing program that appears to provide no additional information.

Bed assessments can be included as part of the preventive maintenance programs currently in place at most healthcare facilities. Modifications of current beds may create additional hazards and will require a great deal of time and resources. This document should be clear that modifications should not be attempted by anyone other than the Original Equipment Manfacturer.

The draft guidelines makes no comment on the clinical assessment of the patient to determine the risk of entrapment. We feel this would be a critical element to reducing the risk of entrapment. Nursing protocols for at risk patients that include the additional recommendations in Appendix F would have a much greater impact on patient safety.

This draft guideline for dimensional limits must be on new beds manufactured after the implementation of this document. The focus on legacy equipment should be patient assessment first with clear recommendations for preventative measures that nursing can provide to reduce the risk.

Requezuest for comment 1: Framed flotation therapy products and powered air mattesses should be excluded. These products provide clinical benifits to the patient and it would be difficult to maintain dimensional limits on these products. Incidents for these items should be tracked to determine if certain products or models pose a risk.

I don't believe that more stringent dimensional limits on any of the zones provides any additional value since most of the beds will not meet even the less stringent standards. More stringent limits should only be implemented if data supports a risk in that particular zone may be reduced by
tighter limits.

Comment 8: I feel thie guideline should target the highest risk healthcare settings where the majority of incidents ocurred. I did not evaluate all the data but I beileve nursing homes, pediatric, and LTAC facilities would have a greater risk than acute care facilities serving an adult population.

Daniel B. Callahan
Director of Building Services
DeKalb Medical Center
Decatur, Georgia