2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability
FDA Comment Number : EC46
Submitter : Mr. Michael Wilt Date & Time: 11/25/2004 04:11:05
Organization : Pennsylvania Association of County Affiliated Home
Health Care Association
Category :
Issue Areas/Comments
The Pennsylvania Association of County Affiliated Homes (PACAH) represents all county and county-affiliated nursing facilities in Pennsylvania. We are an affiliate of the County Commissioners Association of Pennsylvania and wish to provide comments on this draft guidance. PACAH is concerned that the dimensional limitations will be applied retroactively for existing beds, which were not designed to meet these new dimensional requirements. This will create a huge unplanned and unbudgeted cost for our facilities, who rely heavily on inadequate Medicaid funding to operate. Furthermore, to do a safety test of all existing beds to reach the conclusion that they don't meet the dimensional requirements appears to be a large waste of scarce dollars. While even one death by entrapment is one too many, it is not practical to retroactively impose these requirements on nursing facilities. A more important use of the dimensional guidance is in concert with the clinical assessment of the resident's condition to see if they are at potential for bed entrapment. Once that is acomplished the main priority should be the assessment of the bed in use and what modifications might have to be done for the safety of the resident. The draft must be revised to indicate clearly that the dimensional guidelines must be on new beds manufactured after the implementation date of this document. We are also very concerned about the variability of the regulations related to compressed mattresses. This would appear to be unrealistic considering compressibility depends on the size of the resident and what body part is on the mattress at the time. Please reconsider setting dimensional limits at the various zones and apply dimensional limitations only to the beds in the flat deck position. Many of our facilities question the vaguenss of requirements for existing beds, and will not have the financial resources to make wholesale purchases of new beds for their facilities. Many of the county and county affiliated nursing facilities in Pennsylvania are very large with hundreds of licensed beds within their buildings. If these guidelines are to go into effect, then a clear implementation date with 'grandfathering' provisions needs to be established. Thank you for the opportunity to comment.