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|
| Bed Safety
and the 7 Zones of Entrapment |
| These areas are where patients are most
often entrapped. |
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 headboard or footboard |
Zone 7. |
Between the headboard or footboard
and the mattress end. |
| |
Illustration
from FDA |
Safety Measures
To increase safety, the SleepSafe® Bed design has virtually
eliminated gaps in all seven zones. |
Bed Safety! We are registered
and listed with the FDA.
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
recent article from the New York Times.
All reported entrapments occurred
in one of the following ways:
| 1. |
Through the bars of an individual side rail. |
| 2. |
Through the space between split side rails |
| 3. |
Between the side rail
and mattress |
| 4. |
Between the headboard
or footboard, 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 FDA recommends the following
actions to prevent deaths and injuries from entrapment in hospital
bed side rails:
Inspect all hospital bed frames,
bed side rails, and mattresses as part of a regular maintenance
program to identify areas of possible entrapment. Regardless of
mattress width, length, and/or depth, alignment of the bed frame,
bed side rail, and mattress should leave no gap wide enough to
entrap a patient's head or body.
Be aware that gaps can be created
by movement or compression of the mattress which may be caused
by patient weight, patient movement, or bed position.
Be alert to replacement mattresses
and bed side rails with dimensions different than the original
equipment supplied or specified by the bed frame manufacturer.(4)
Not all bed side rails, mattresses, and bed frames are interchangeable.
Variation in bed side rail design and thickness and/or density
of the mattress may affect the potential for entrapment. When
bed side rails and mattresses are purchased separately from the
bed frame, check with the manufacturer(s) to make sure the bed
side rails, mattress, and bed frame are compatible.
Check bed side rails for proper installation
using the manufacturer's instructions to ensure a proper fit (e.g.,
avoid bowing, ensure proper distance from the headboard and footboard).
Additional safety measures should
be considered for patients identified as high risk for entrapment.
Such patients include those with altered mental status (organic
or medication related) or general restlessness. Increased risk
also occurs when the patient's size and/or weight are inappropriate
for the bed's dimensions. Bed side rail protective barriers may
be used to close off open spaces in which these patients might
accidently become entrapped. Follow the healthcare facility's
procedures and/or manufacturers' recommendations/specifications
for installing and maintaining bed side rail protective barriers
for the particular bed frame and bedside rails used.
Bed side rails should not be used
as a substitute for patient protective restraints. Patients who
need a protective restraint, such as a vest or wrist/leg device,
must be monitored frequently while wearing it.(5) If a protective
restraint is used, follow your facility's protocol and the restraint
manufacturer's instructions for proper use, in addition to the
federal, state, and local regulations regarding the use of protective
restraints.
FDA is interested in receiving reports
concerning problems with hospital bed frames, bed side rails,
mattresses, and any other medical device. The Safe Medical Devices
Act of 1990 (SMDA) requires hospitals and other user facilities
to report deaths, serious illnesses, and injuries associated with
the use of medical devices. Healthcare workers should follow the
procedures established by their healthcare facility for such mandatory
reporting. Practitioners who become aware of any adverse event
(i.e., death, serious illness, or injury) that may be related
to a medical device product problem or malfunction should report
it to their facility's contact person who is responsible for reporting
these events to the FDA.
SleepSafe® Beds are registered
and listed with the FDA.
REFERENCES:
1. U.S. Consumer Product Safety Commission,
National Injury Information Clearinghouse, January 1994 - July
1995.
2. Great Britain Medical Devices Directorate.
"Use of Hospital Bed Safety Sides and Side Rails," London:
Department of Health, January 1994.
3. Health and Welfare Canada, Health
Protection Branch.
Medical Devices Alert No. 107, "Hazards with Hospital Bed
Split Side Rails."
4. Roy, D. "Beds and Side
Rails: How Safe are They?"
Dimensions in Health Service, 67(4):10,14, May 1990.
5. Department of Health and Human
Services, Food and Drug Administration Safety Alert
"Potential Hazards With Restraint Devices," July 15,
1992.
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