2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC53
Submitter : Mr. Jeffery Melton Date & Time: 12/15/2004 11:12:53
Organization : Memorial Health Care
Health Professional
Category :
Issue Areas/Comments

Subject: Hospital Bed System Dimensional Guidance to Reduce Entrapment.

Reference: Docket:2004D-0343

Thank You for the opportunity to comment on the FDA draft: Docket #2004D-0343.

I have reviewed your draft to assess and improve the safety of Bed Rail-Entrapment. I understand that there have been approximately 575 entrapments within the last 19 years resulting in 271 deaths. The deaths were usually relating to elderly or confused patients with memory, incontinence, pain, and uncontrolled body movements. You have provided guidelines of testing exhisting beds for possible patient entrapment. I see that you are working closely with Hospital Bed Safety Workgroup (HBSW) Organizations to improve new production of, providing safety and preventing future entrapment of patients.

I agree that newly manufactured bed design should be reviewed and companies work toward meeting safer guidelines to prevent entrapment. The guidelines and testing criteria to test exhisting beds seem pointless and a waste of time and money. The majority of exhisting Hospital Beds currently in use, will not pass your proposed testing criteria. While proactive bed testing may seem useful, the data will not eliminate entrapment. The focus should be on root causes and risk reduction strategy put in place. Currently there is no assessment standard. The number of death related events from entrapment lack evidence or detailed information that can suggest that the bed is totally the problem and the amount of additional safety gained from doing exhisting bed testing has not been determined. Staffing, restraint ussage, and lack of proper intervention should be clinically assessed. Patients come in all shapes and sizes and the modification of the bed position can change the patients environment. FDA must revise this draft document to clearly identify existing beds are not unsafe even though they do not meet the new dimensional limits established.

Health Care Facilities today are limited with funding, FTE's, and time to conduct this type of testing. JCAHO has already addressed the potential for entrapment in an Alert that each hospital is addressing. ASHE estimates that it will cost the Healthcare community in excess of $17 million to test every existing hospital bed. The guidelines were initially developed to apply to new beds and should continue to focus on new bed guidelines. We spend an estimeted $50,000 annually in FTE's and close to $30,000 annually in parts. to assure proper function on our existing beds and would probably exceed this cost by "triple" annually to comply with your proposed testing requirements.

Please reconsider evaluating your proposed plan and focus on the production of new beds and patient risk reduction through clinical assessments.

Thank You,
Jeffery Melton