FDA ENTRAPMENT ZONES

WHAT IS ENTRAPMENT?

Entrapment is a situation where an individual can become caught by their head, neck, chest or other body parts in the tight spaces around the bed rail. The first picture below shows two bed rail products being used on a bed for illustration purposes.

ENTRAPMENT PREVENTION GUIDELINES

ZONE 1

WITHIN THE RAIL

Any open space between the perimeters of the rail can present a risk of head entrapment. The FDA recommended space is less than four and three quarters of an inch (4-3/4”). Some Stander bed rails have included sewn fabric pouch organizers that cover the openings to reduce risk of entrapment. These sewn fabric pouch organizers should not be removed from the bed rails or the user will be at risk of entrapment.

ZONE 2

UNDER THE RAIL

Between the Rail Supports or next to a Single Rail Support The gap under the rail between the mattress and rail, may allow for dangerous head entrapment. The FDA recommended space is less than four and three quarters of an inch (4-3/4”). Stander recommends Zone 2 to be well below the top of the mattress to reduce risk of entrapment.

ZONE 3

BETWEEN THE RAIL AND THE MATTRESS

If the space between the inside surface of the bed rail and the mattress is too big, it can cause a risk of head entrapment. The FDA recommended space is less than four and three quarters of an inch (4-3/4”). Stander bed rails include a safety strap that holds the bed rail against the side of the mattress. The safety strap must always be used. Do not remove safety strap from the bed rails or user will be at risk of entrapment.

ZONE 4

UNDER THE RAIL AT THE ENDS OF THE RAIL

A gap between the mattress and the lowermost portion of the rail poses a risk of neck entrapment. The FDA recommended space is less than two and three eighths of an inch (2-3/8”). Also, install the bed rail such that the angle at the end of the bed rail relative to the top of a mattress is greater than 60 degrees. Stander recommends that Zone 4 be well below the top of the mattress to reduce risk of entrapment.

RAIL PLACEMENT

Entrapment zones 5-7 are effected by correct placement of mattress and bedrail and must be resolved by the installer regardless of the bedrail design.

What considerations need to be made before installing or using bed rails/bed handles?

At least two assessments should be made by those who are using bed rails and those who are installing bed rails.

1. Installation assessment: Improper installation of bed rails has resulted in serious injury and even death. Complying with the suggested recommendations relating to the 7 zones of entrapment by the U.S. Food and Drug Administration (FDA) and the Hospital Bed Safety Workgroup (HBSW) are essential.

The type of bed and mattress should be assessed before installation. Adjustable frame beds, air mattresses, water beds, light weight foam mattresses, are some examples that may affect the 7 zones of entrapment in a negative manner. Head and foot boards also contribute to entrapment as shown in zone 6 and 7. The frame that connects the head and foot boards may also contribute to entrapment by creating a space between the inside surface of the bed rail and the mattress as shown in zone 3.

Stander Incorporated includes safety devices on certain bed rails to help prevent entrapment. Typical safety devices are sewn bed rail covers and safety straps. These safety devices must always be installed properly and must not be taken off at any time; failure to use these safety devices will increase the risk of injury or death. Stander will not be liable for injury or death.

2. User assessment: It is important for those who are installing the bed rail, and those who will be using the bed rail, to assess if those using the bed rails are susceptible to entrapment. Individuals who have problems with memory, sleeping, incontinence, pain, uncontrolled body movement, who get out of bed and walk unsafely without assistance, frail, weak, confused, restless, under the influence of drugs or any substance that could affect their judgment, are susceptible to entrapment. Even those individuals who are capable of using bed rails responsibly are at risk, so it is important for those who are installing the bed rail and those using the bed rail to be aware of these risks and make the decision to accept liability for these risks.