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Note of Clarification, March 20, 2003
This research was conducted in 2001 when the Hospital Bed Safety Workgroup (HBSW) dimensional guidelines were under development. The dimensional guidelines and measurement methodology used here do not necessarily reflect current recommendations neither of the HBSW nor of the guidance document that will eventually be released by the FDA.
For current information on the HBSW work, refer to: /cdrh/beds /cdrh/beds
For information about the availability of the toolkit, refer to: /bedsafety /bedsafety
Hospital Bed Safety Evaluation in Hospitals and Nursing Homes
Investigators: G. Powell-Cope, A. Nelson1, S. Hoffman1, M. Tate, L. Rathvon1, D. Bradham, S. Luther1
Introduction: The Veterans Health Administration is committed to improving patient safety. The VHA-funded center based in Tampa FL, The VISN 8 Patient Safety Center of Inquiry, focuses on safe patient mobility for frail elderly and the disabled. In 2000, our center partnered with the Food and Drug Administration (FDA) and representatives from the medical bed industry, national health care organizations, patient advocacy groups, and other federal agencies (Health Care Finance Administration; Consumer Product Safety Commission) to improve the safety of hospital beds for patients who are most vulnerable to the risk of side rail entrapment.
Problem Statement: Hospital bed systems can contribute to significant injury or death. Today there are about 2.5 million hospital and nursing home beds in use in the United States. Between 1985 and 1999, 371 incidents of patients caught, trapped, entangled, or strangled in beds with rails were reported to the U.S. Food and Drug Administration. Of these reports, 228 people died, 87 had a nonfatal injury, and 56 were not injured because staff intervened. Most of these patients were frail, elderly, or confused. Generally, it is assumed that most of these “close calls” are not reported. The FDA Hospital Bed Safety Workgroup dev
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