From: Carlson, Keith A [kcarlson@MHHC.SISUNet.org] Sent: Wednesday, December 22, 2004 9:00 AM To: Dockets, FDA Subject: 2004D-0343 Thank you for the opportunity to comment on the FDA draft guidance: Hospital Bed System Dimensional Guidance to Reduce Entrapment. I understand and appreciate the intention of this document, to minimize the potential of patient entrapment in a hospital bed. But I feel that the introduction statement and Appendix F will focus attention on proactive testing of existing beds with little or no actual risk reduction. In fact, this focus will stretch currently scarce resources that would be better spent on patient assessment and modification of the bed environment if warranted based on patient size and/or condition. As written, this guidance will create an expectation of our hospital and long term care facility inspecting all of our existing beds for compliance with these dimensional limitations. My understanding is that pilot testing of existing beds has revealed that most if not all existing beds will not meet these dimensional limitations. So the extensive time and effort that will be required to determine that our 124 existing hospital and long term care beds will not pass is wasted with no risk reduction. The dimensional guidance has value to existing beds if it is clearly stated that the primary focus must first be clinical assessment of the patient physical condition to establish that they are vulnerable to the risk of bed entrapment. At that point, the focus of the clinical and support staff should be the assessment of the hospital bed system with a clear plan for addition or modification of that system to meet that specific patient's needs. FDA must revise this draft document to clearly identify existing beds are not inherently "unsafe" even though they do not meet the new dimensional limits established in this document. The focus on dimensional limits must be on new beds manufactured after the implementation of this document. The focus on legacy equipment is patient assessment first, with risk mitigation efforts based on meeting that patient's/resident's need. Thank you. Keith Carlson Director, Facilities Management Mercy Hospital and Health Care Center 710 Kenwood Avenue Moose Lake, MN 55767 218.485.5520 Fax 218.485.4833 DISCLAIMER: The information in this message is confidential and may be legally privileged. Access to this message by anyone other than the intended recipient is unauthorized. If you are not the intended recipient, any disclosure, copying, or distribution of the message, or any action taken or omission of action by you in reliance upon it, is prohibited and may be unlawful. Please immediately notify the sender by reply e-mail and permanently delete all copies of the message if you have received this message in error. Please Note: E-mail transmitted over the internet is not secure and may be accessed by unauthorized individuals. Thank you.