2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC60
Submitter : Mrs. Michelle Holland Date & Time: 12/15/2004 11:12:09
Organization : Saint Agnes Medical Center
Health Care Association
Category :
Issue Areas/Comments
Our 327 Bed acute care facility evaluated the status of our beds at the beginning of 2003 when the first work groups were assembling. At that time we estimated that it would cost us approximately $28,500 to replace the side rails with safety rails (the Z rails now supplied by Hill Rom). Without knowing what the eventual acceptable gap measurements would be, we were unable to quantify the cost. However, Hill Rom was more than willing to offer us a PM program to the tune of almost $100,000 a year to PM and retrofit our beds to the new standards. Our Medical Center feels that the bed rail replacements are a must. When we evaluate mattresses we ensure that they are a tight fit on our beds. Please hold the bed manufacturer responsible for making existing beds and new beds safe or insist that they offer the replacement parts at a deep discounted price. What about a RECALL - just like cars? The beds are unsafe - make them safe - isn't it the same thing as a defective automobile?