The FDA guidance was developed to improve the safety of hospital beds by identifying guidelines to reduce the risk of the most serious hazards—patient death or injury from entrapment in the openings and gaps in hospital bed systems. The guidance will help ensure that all new hospital beds are designed to reduce the potential for entrapment and that risks with existing (legacy) bed systems are identified.
In 1995, FDA noticed a pattern of deaths and injuries in hospital beds that investigation indicated may have been largely preventable. Our August 23, 1995, Safety Alert (Available at: Hospital Beds.) generated considerable interest from the healthcare community. In fact, reports of this type of incident increased following the alert, which suggested we had tapped into an important health issue.
FDA held a meeting with many stakeholders including representatives of the hospital bed system industry, patient care advocacy groups, healthcare providers, and organizations that investigate this type of incident. As a result of the discussions, FDA realized that the problem was multidimensional and that a single regulatory solution would not be effective in addressing the many facets of entrapment. A voluntary consortium of national bed system experts, known as the Hospital Bed Safety Workgroup, was formed to address the complex problem.