2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC54
Submitter : Mr. Clayton Denny Date & Time: 12/15/2004 11:12:02
Organization : Ephraim McDowell Regional Medical Center
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
I can understand the point of view of the FDA in recognizing hospital bed rail devices as entrapment potentials. However it would be a serious financial burden upon healthcare institutions to retrofit every bed with new bed rail devices that meet new standards. The risk is not applicable to every patient that is in the bed but the type of patient in the bed. Risk management techniques and investigative medical history of each patient would be able to single out those in need of increased protection from entrapment hazards. Legacy equipment should not be considered as needing to meet the new standards but should be phased in with bed replacement planning. An immediate financial drain to replace all bed rails would not be feasible for some institutions. The trend needs to be more toward recognizing issues with the patients instead of additional mechanical devices.The current bed testing methods have already proven existing designs produce entrapment risks. The time taken to test the beds in a facility and then go back and retrofit each bed to new would create an expense that some organizations would not be able to afford. At this point the best proven method of bed safety is to do a clinical assessment of the patient, their physical condition and the type of protection needed to prevent entrapment injuries/death. The support staff for the patient is responsible for insuring adequate protection for the patient's safety and should be relied upon more than a mechanical device. The term 'legacy beds' should be included in the language as to not having to be retrofitted with the new safety rails until such time as replacement beds are financially feasible for the organization.
Thank you for allowing me to comment.
Clayton Denny
Director of Engineering
Ephraim McDowell Regional Medical Center