2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC38
Submitter : Mr. Kirk Bantz Date & Time: 11/23/2004 04:11:09
Organization : Saint Alphonsus Regional Medical Center
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
The recommendations intended to reduce life-threatening entrapments associated with hospital bed systems appear to discount the manufacturer's responsibility to provide safe products to consumers. Hospitals, as a major consumer of these beds should be protected from having to bear the costly burden of retrofitting faulty or inherently unsafe products.
The U.S. Consumer Product Safety Commission is charged with protecting the public from unreasonable risks of serious injury or death from consumer products. The CPSC should be consulted in this matter to achieve a balanced approach to the replacement of defective or inherently dangerous beds. CPSC is committed to protecting consumers from products that pose a fire, electrical, chemical, or mechanical hazard. The FDA should consult with (the CPSC) experts in this field, not take the stance that seems to infer that the product is safe enough that the manufacturers have no liability but that hospitals do.
Your own statistics indicate that the manufacturers and FDA knew of this problem for nineteen years but feels the hospitals should pay to fix the poor design and oversight respectively. This type of heavy handed regulation results in decreased capital for the care of our underinsured population and increased insurance rates for those with adequate insurance.
Hospitals are not cash cows, we operate on small margins, most on a non-profit basis and many hospitals are on the verge of financial collapse. Offering up a solution that shifts the burden and cost for poor design onto the consumer is outrageous. Have the manufacturers recall the defective equipment and repair it.