2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC36
Submitter : Mr. William Morgan Date & Time: 12/10/2004 05:12:10
Organization : St. Alphonsus Regional Medical Center
Health Professional
Category :
Issue Areas/Comments
GENERAL
GENERAL
First, thank you for this opportunity for comment. I have several concerns about this guide.
1. If there is a problem with the function or design of the bed it should be the responsibility of the manufacturer to recall and repair the problem. By shifting the burden to the user it transfers the problem vs. fixing it.

2. The cost for hospitals to manage this process of inspections is expensive and has a very high opportunity for failure. The test procedure is at best a limited measure of safety and will be undone if a mattress is replaced or a bed rail is not in the perfect position it was on testing when used by a patient.

3. If a patient is identified through assessment to be a risk for entrapment the staff should put that patient in a bed designed for protecting them. It is my understanding the majority of patient accident and deaths have been from long term care where the patient has less supervision than at a hospital.

4. If I take my limited resources and assign them the responsibility of making sure 350 beds are inspected and checked at all times it will reduce the time we have to maintain other equipment and safety needs in our facility. I think the service we have to let go to keep this process in line will actually reduce the overall safety of healthcare.

5. Speaking strictly for myself, We need a focus on risk based regulation. What are the numbers that support this. Why are government agencies looking for new avenues to regulate and manage? Hospitals throughout the United States are struggling to keep their doors open with reduced income and increased expenses. Now we can add additional costs to that to keep on top of this one?

6. I would appreciate anything you can do to just drop this guide. It will do more harm than good.

Thank your for your time, sorry if I seem a little emotional on this issue but try to spend a day in a Facility Manager's shoes staying on top of JCAHO, CMS, EPA, OSHA, NFPA, UBC, UMC, UFC, CDC, state and local regs and now FDA?