(We encourage you to copy and distribute this Alert)
August 23, 1995
TO: Biomedical/Clinical Engineers Hospital Administrators
Directors of Nursing Nursing Associations
Home Healthcare Agencies Nursing Homes
Hospices Risk Managers
This Safety Alert concerns entrapment hazards associated with the
use of hospital bed side rails in a small, identifiable patient
population, and recommends certain actions to prevent
such hazards. The Alert is not specific to any manufacturer or
product; it is part of a cooperative effort between FDA, the
healthcare industry, and manufacturers to resolve the
problem. Currently, no universal standards exist for design of
hospital bed side rails.
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. The U.S.
Consumer Product Safety Commission, the United Kingdom Department
of Health, and the Canadian Health Protection Branch have also
received similar reports of entrapment.(1,2,3) Although the number
of reported incidents is small relative to the large number of
patients who use hospital beds, we believe appropriate precautions
can reduce further incidents.
All reported entrapments occurred in one of the following ways
(numbered 1-4 in the diagram below):
1. through the bars of an individual side rail;
2. through the space between split side rails;
3. between the side rail and mattress; or
4. between the headboard or footboard, side rail, and
mattress.
![[CDRH Bed Side Rails]](r_r_bedr.gif)
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.
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.
If an adverse event or device problem or malfunction is not
reportable under SMDA, or if you do not work in a user facility
that is required to report under SMDA, we encourage you
to report directly to MedWatch, the FDA's voluntary reporting
program.
Write to: Medical Product Reporting Program
MedWatch, HF-2
Food and Drug Administration
5600 Fishers Lane
Rockville, MD 20857
Phone: Medical Product Reporting Program
at 1-800-FDA-1088
(also call for MedWatch information)
Modem: 1-800-FDA-7737 (9600 baud rate)
Getting more information:
If you have questions regarding this publication, please contact
the Issues Management Staff, Office of Surveillance and Biometrics
(HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, by fax
at 301-594-2968, or by e-mail at phann@cdrh.fda.gov . Additionally,
a voice mail message may be left at
240-276-3357 and your call will
be returned as soon as possible.
Sincerely yours,
D. Bruce Burlington, M.D.
Director
Center for Devices and
Radiological Health
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.
Updated May 2, 1996
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