FDA Issues Guidance Designed to Reduce Hospital Bed Entrapments

Using input from government and private sector groups, the Food and Drug administration (FDA) has published a new guidance designed to reduce the occurrence of potentially fatal 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. Such mishaps often lead to serious injuries as well as strangulation and death.

The guidance, “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment” identifies key issues related to hospital bed systems and provides design recommendations for hospital bed manufacturers, as well as
suggestions for health care facilities on ways to assess the safety of existing beds.

According to an FDA release, 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:

·                                 Head

·                                 Neck

·                                 Chest

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.

Kessler added: “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.”

The “guidance” 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 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 related to the use of hospital beds.

Between January 1, 1985, and January 1, 2006, the FDA has received approximately 691 entrapment reports. In these reports, 413 people died, 120 were injured, and 158 were “near-miss events” with no serious injury as a result of intervention.

According to the FDA release, these entrapment events 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 food 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 take place in many different patient care settings, including hospitals, nursing homes, and private homes. The majority of the entrapments that were reported happened in long-term care facilities.

“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/.

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