Since January 1990, FDA has received 102 reports of head and body entrapment incidents involving hospital bed side rails. The 68 deaths, 22 injuries, and 12 entrapments without injury occurred in hospitals, long-term care facilities, and private homes. Read this article from the New York Times.
All reported entrapment occurred in one of the following ways:
– Through the bars of an individual side rail.
– Through the space between split side rails.
– Between the side rail and mattress.
– Between the headboard or foot board, side rail, and mattress.
All deaths involved entrapment of the head, neck, or thorax, while most injuries involved fractures, cuts, and abrasions to the extremities. Although an entrapment did occur in a patient two years of age, the majority of the deaths and injuries involved elderly patients. Patients at high risk for entrapment include those with pre-existing conditions such as confusion, restlessness, lack of muscle control, or a combination of these factors.
The U.S. Food and Drug Administration (FDA) identified Seven Zones of Entrapment to alert caregivers to the hazards related to these areas of a healthcare bed.
Potential Zones of Entrapment
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: Under 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\
The design of SleepSafe® Beds addresses each potential zone of entrapment.
SleepSafe® Beds, is registered as a manufacturer with the FDA. The beds are listed with the FDA.
SleepSafe® Beds, LLC is registered as a manufacturer, and its products, classified as medical devices, are listed with the Food and Drug Administration (FDA). The FDA does not provide “approval” for this type of medical device as it is exempt under FDA’s Title 21, Chapter I, Subchapter H, Part 880, Subpart F, Section 880.5100 (b).
According the the FDA, “Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by FDA.”
For questions regarding FDA regulations, please contact Bob Baldacci, Director of Quality and Regulatory Affairs at SleepSafe® Beds at firstname.lastname@example.org.
Other manufacturers of safety beds may claim approval, but they have misinterpreted the statute.