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Drug & Device News
FDA Issues Guidance on Hospital Bed Design
Elderly patients in hospitals and nursing homes are prone to entrapment in their beds, which has resulted in a reported 413 deaths in the past 21 years. To study and combat this problem, the Food and Drug Administration (FDA), Veterans Administration, Health Canada's Medical Devices Bureau and representatives of several other groups formed an organization in 1999 known as the Hospital Bed Safety Workgroup (HBSW). Their recommendations have just recently been published in an FDA final guidance entitled 'Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.' The final guidance offers suggestions for health care facilities on ways to assess the safety of their existing beds by identifying the locations of hospital bed openings that are potential entrapment areas. It also offers recommendations for how to choose new hospital bed systems. The guidance is available on the FDA's Web site at: http://www.fda.gov/cdrh/beds/.
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The Article 8 Opt In
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