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FDA NEWS RELEASE
FOR IMMEDIATE RELEASE
FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment
The Food and Drug Administration (FDA) today published final guidance designed to reduce the occurrence of hospital bed entrapments. Entrapment can occur when part of a patient's body becomes caught between parts of the bed, such as in the space between the mattress and the side rail. This can cause strangulation and death. This guidance was prepared using input from both government and private sector groups.
The guidance, entitled "Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment" identifies special issues associated with hospital bed systems and provides design recommendations for manufacturers of new hospital beds and suggestions for health care facilities on ways to assess existing beds. The guidance characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas, recommends dimensional criteria for new hospital bed systems, provides information about reporting entrapment adverse events, and includes a description of recommended test methods for assessing gaps in hospital bed systems.
Key body parts at risk of entrapment are:
Potential zones of entrapment in a hospital bed system are:
- Zone 1 : Within the rail
- Zone 2 : Under the rail, between the rail supports or next to a single rail support
- Zone 3 : Between the rail and the mattress
- Zone 4 : Between the rail, at the ends of the rail
- Zone 5 : Between split bed rails
- Zone 6 : Between the end of the rail and the side edge of the head or foot board
- Zone 7 : Between the head or foot board and the mattress end
"This guidance will assist individuals, families and health care facilities in making better informed decisions to ensure a safe sleeping environment for people who need these beds," said Larry Kessler, Sc.D., Director, Office of Science and Engineering Laboratories, FDA's Center for Devices and Radiological Health. "While not all patients are at risk for an entrapment, and not all hospital beds pose a risk of entrapment, this new guidance will help ensure that new hospital beds are designed to reduce the potential for entrapment and that entrapment risks that may exist with current hospital bed systems are identified. The dimensional assessment described in this guidance may be used as part of a manufacturer's or facility's comprehensive bed safety program."
This guidance document is the result of a years-long partnership between the FDA and the Veterans Administration, Health Canada's Medical Devices Bureau, representatives from national health care organizations and provider groups, patient advocacy groups, and medical bed and equipment manufacturers, who formed a working group in 1999 known as the Hospital Bed Safety Workgroup (HBSW). The HBSW also worked in cooperation with the Joint Commission on Accreditation of Healthcare Organizations, the Center for Medicare & Medicaid Services, and the Consumer Product Safety Commission to improve patient safety associated with the use of hospital beds.
FDA has received approximately 691 entrapment reports over a period of 21 years from January 1, 1985 to January 1, 2006 . In these reports, 413 people died, 120 were injured, and 158 were near-miss events with no serious injury as a result of intervention. These entrapment events have occurred in openings within the bed rails, between the bed rails and mattresses, under bed rails, between split rails, and between the bed rails and the head or foot boards. Elderly patients in hospitals and nursing homes, especially those who are frail, confused, restless, or who have uncontrollable body movement, are most vulnerable to entrapment. Entrapments have occurred in a variety of patient care settings, including hospitals, nursing homes, and private homes. Long-term care facilities reported the majority of the entrapments.
"While these numbers appear small, we believe they are signals about significant adverse events. Often, adverse events such as these go unreported to the FDA making it likely our counts of these tragic adverse incidents is lower than the number that actually occurs," said Dr. Kessler.
The final guidance, "Guidance for Industry and FDA Staff; Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment," is available on FDA's website at: http://www.fda.gov/cdrh/beds/.