| 2004D-0343 - Draft Guidance for Industry and Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability|
|FDA Comment Number :||EC10|
|Submitter :||Mr. Thomas Zahorsky||Date & Time:||11/09/2004 02:11:00|
|Organization :||Texas Association of Healthcare Facilities Managem|
|Health Care Association|
| As hospital reimbursement continues to decline due to the alarming number of uninsured, hospital maintenance departments are hard pressed to maintain the physical plant, systems and equipment essential to the provision of a safe, secure and comfortable healing environment. Regulatory agencies continue to attempt to add to their burdon, with over-reactive rules or rules that are simply the result of effective lobbying on the part of those who stand to make a profit as a result of new regulations.
The bed-rail measurement proposal is such a potential regulation. A significant issue in healthcare today is the number of nosocomial infections that occur, causing an estimated 90,000 deaths annually. In the 10 or more years in which 15 deaths by entrapment have occured, over 1,000,000 people have died from nosocomial infections, yet little resource is applied to improvement there. Hospitals and nursing homes are only beginning to investigate ways to resolve this genuinely significant issue, and do not need the distraction of an over-bearing set of guidelines that will take valuable resources away from efforts to identify, control and improve upon issues of far more significance.
As a Hospital Facilities Director with over 20 years of experience, and a member of the Board of Directors of the Texas Association of Healthcare Facilities Management (TAHFM), I strongly oppose the issuance of these guidelines except for new bed manufacturing.