Clinical Guidance

For the Assessment and Implementation of

Bed Rails

**In Hospitals, Long Term Care Facilities, and**

**Home Care Settings**

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######### Developed by the 

######### Hospital Bed Safety Workgroup 

Table of Contents

Preface........................................................................................
ii

Introduction...................................................................................
1

Guiding
Principles.........................................................\..................
3

Policy
Considerations......................................................................
4

Process/Procedure
Considerations..................................................... 5

Risk
Intervention.............................................................................
9

Individualized Environmental
Changes................................................ 10

Patient
Choice................................................................................
10

Bed Rails as
Restraints....................................................................
10

Education
/Training.........................................................................
10

Bed Rail Safety
Guidelines...............................................................
11

Appendix 1:
Glossary......................................................................
12

Appendix 2: Bed Rails - Intended Purpose and Potential
Risks................ 14

Appendix 3: Bed Side Rail
Types....................................................... 15

Appendix 4: Hospital Bed Safety Workgroup Member Organizations

that Signed on to the Clinical
Guidance............................................... 17

Appendix 5:
Authors........................................................................
18

Clinical Guidance

For The Assessment and Implementation of Bed Rails

**In Hospitals, Long Term Care Facilities, and Home Care Settings**

# [Introduction]{.underline}

Every patient, regardless of care setting, deserves a safe and
comfortable sleeping and bed environment. The goal of this clinical
guidance is the provision of such an environment to patients in
hospitals, long term care facilities, and home care settings. (Note: The
term *patient* as used in this document refers to patients in hospitals,
residents in long term care facilities, and clients in home care
settings.) The purpose of this guidance is to provide a uniform set of
recommendations for caregivers in hospitals, long term care facilities,
and home care settings to use when assessing their patients' need for
and possible use of bed rails. The guidance is deliberately basic in
design and content to allow each setting to adapt it to meet the unique
needs of their respective patients and environments.

The guidance that follows is intended to assist caregivers in making
decisions about the care for their patients. Its components are not
intended to serve as clinical standards or requirements for care. They
are not intended to serve as applicable federal, state or local
regulations or guidelines governing care in respective settings.
Likewise the recommendations should not be interpreted as the best or
only options, professional standards of care, or legal protection for
the users.

The term *bed rails* is used in this document. Commonly used synonymous
terms are *side rails, bed side rails, and safety rails*. Bed rails are
adjustable metal or rigid plastic bars that attach to the bed and are
available in a variety of shapes and sizes from full to half,
one-quarter, and one-eighth in lengths.[^1] In the spectrum of care
including hospital, long term care and home care settings, bed rails
serve a variety of purposes, some of which are in the best interest of
the patient's health and safety. Bed rails:

-   are used on stretchers or beds while transporting patients following
    surgery or when relocating a patient to a new room or unit;

-   can facilitate turning and repositioning within the bed or
    transferring in or out of a bed;

-   may provide a feeling of comfort and security, or facilitate access
    to bed controls; and

-   may be used as a physical barrier to remind the patient of the bed
    perimeters, to ask for nursing assistance, or to restrict voluntary
    movement out of bed.[^2],[^3]

Achieving the goal of a safe and comfortable bed and sleeping
environment may necessitate the reduction or elimination of bed rail use
in cases in which the bed rail is not in the best interests of the
patient's health and safety.

Although various types may be used depending on a patient's medical and
functional needs, bed rails may pose increased risk to patient safety.
Clinical research suggests that bed rails may not be benign safety
devices. For example, evidence indicates that half-rails pose a risk of
entrapment and full rails pose a risk of entrapment as well as falls
that occur when patients climb over the rails or footboards when the
rails are in use.[^4],[^5] Recognizing this risk, the U.S. Food and Drug
Administration (FDA) and Centers for Medicare & Medicaid Services (CMS),
formerly known as the Health Care Financing Administration (HCFA), have
taken action aimed at reducing the likelihood of injuries related to bed
rails. The FDA MedWatch Reporting Program receives reports of entrapment
hazards.[^6] In 1995 the FDA issued a Safety Alert entitled,
"*Entrapment Hazards with Hospital Bed Side Rails*."[^7] In 1997, the
FDA authored an article, based on the reported hospital bed adverse
events, that identified potential risk factors and entrapment locations
about the hospital bed. The FDA continues to receive reports of patient
deaths and injury that provide documentation of patient entrapment.[^8]

CMS has imposed performance expectations on hospitals and nursing
facilities. For example, in implementing federal regulations that apply
to the use of physical restraints, CMS issued guidance in June 2000 for
surveyors to determine hospitals' compliance with these regulations. One
section of the guidance states, "*It is important to note that side
rails present an inherent safety risk, particularly when the patient is
elderly or disoriented. Even when a side rail is not intentionally used
as a restraint, patients may become trapped between the mattress or bed
frame and the side rail. Disoriented patients may view a raised side
rail as a barrier to climb over, may slide between raised, segmented
side rails, or may scoot to the end of the bed to get around a raised
side rail. When attempting to exit the bed by any of these routes, the
patient is at risk for entrapment, entanglement, or falling from a
greater height posed by the raised side rail, with a possibility for
sustaining greater injury or death than if he/she had fallen from the
height of a lowered bed without raised siderails."*[^9]

In September 2000 CMS (then HCFA) issued revisions to surveyor guidance
for determining nursing facilities' compliance with federal Medicare and
Medicaid regulations governing the use of restraints, which similarly
describes the potential risks of using bed rails.[^10] For example, the
guidance states, "*The same device may have the effect of restraining
one individual, but not another, depending on the individual resident's
condition and circumstances. For example, partial rails may assist one
resident to enter and exit the bed independently while acting as a
restraint for another."*

**[Guiding Principles]{.underline}**

National surveys of patient deaths occurring in the bed environment
demonstrate the risk of entrapment when a patient slips between the
mattress and bed rail or when the patient becomes entrapped in the bed
rail itself. The population at risk for entrapment are patients who are
frail or elderly or those who have conditions such as agitation,
delirium, confusion, pain, uncontrolled body movement, hypoxia, fecal
impaction, and acute urinary retention that cause them to move about the
bed or try to exit from the bed. The absence of timely toileting,
position change, and nursing care are factors that may also contribute
to the risk of entrapment. The risk may also increase due to technical
issues such as the mis-sizing of mattresses, bed rails with winged
edges, loose bed rails, or design elements such as wide spaces between
vertical bars in the rails themselves.

The principles that follow are intended to guide the development of
patients' care plans.

1.  The automatic use of bed rails may pose unwarranted hazards to
    patient safety.

When planning patient care the following should be considered:

-   The potential for serious injury is more likely to be related to a
    fall from a bed with raised bed rails when the patient attempts to
    climb over, around, between, or through the rails, or over the foot
    board, than from a bed without rails in use.

-   Evaluation is needed to assess the relative risk of using the bed
    rail compared with not using it for an individual patient.

-   Bed rails sometimes restrain patients. When used as restraints, bed
    rails can pose the same risk to patient safety as other types of
    physical restraints.

-   Patient safety is paramount. In an emergent situation the caregiver
    needs to do whatever is necessary in his or her professional
    judgment to secure the patient's safety. Consider that using a bed
    rail or other device to restrain the patient could place the
    patient's safety at risk.

-   Physical restraints such as vest/chest, waist, or leg/arm restraints
    used simultaneously with raised bed rails may be medically indicated
    in certain limited circumstances in the acute care environment.
    Consider that when physical restraints and bed rails are used
    simultaneously:

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-   the risk to patient safety, e.g., suffocation or accidental
    suspension, may increase;

-   patients should be monitored closely;

-   appropriate care such as toileting should be provided; and

-   reassessment for medical necessity and removal is needed on a
    regular basis.

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-   Strangling, suffocating, bodily injury, or death can occur when
    patients or parts of their bodies are caught between rails or
    between the bed rails and mattresses.

2.  Decisions to use or to discontinue the use of a bed rail should be
    made in the context of an individualized patient assessment using an
    interdisciplinary team with input from the patient and family or the
    patient's legal guardian.

3.  The patient's right to participate in care planning and make choices
    should be balanced with caregivers' responsibility to provide care
    according to an individual assessment, professional standards of
    care, and any applicable state and federal laws and regulations.

**[Policy Considerations]{.underline}**

1.  Regardless of the purpose for which bed rails are being used or
    considered, a decision to utilize or remove those in current use
    should occur within the framework of an individual patient
    assessment**.**

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1.  Because individuals may differ in their sleeping and nighttime
    habits, creation of a safe bed environment that takes into account
    patients' medical needs, comfort, and freedom of movement should be
    based on individualized patient assessment by an interdisciplinary
    team.

-   The composition of the interdisciplinary team may vary depending
    upon the nature of the care and service setting and the patient's
    individual needs. Team members for consideration should include, but
    are not limited to: nursing, social services, and dietary personnel;
    physicians (or their designees); medical director; rehabilitation
    and occupational therapists; patient; family (or authorized
    representative); and medical equipment suppliers.

-   The patient and family (or authorized representative) play a key
    role in the creation of a safe and comfortable bed and sleeping
    environment. These individuals can provide information about the
    patient's previous sleeping habits and bed environment that
    caregivers need to design the bed environment. Their participation
    in discussions facilitates creation of a bed and sleeping
    environment that meets patients' needs.

3.  Use of bed rails should be based on patients' assessed medical needs
    and should be documented clearly and approved by the
    interdisciplinary team.

-   Bed rail effectiveness should be reviewed on a regular basis.

-   The patient's chart should include a risk-benefit assessment that
    identifies why other care interventions are not appropriate or not
    effective if they were previously attempted and determined not to be
    the treatment of choice for the patient. (See Appendix 1: Glossary
    for patient/caregiver assist items.)

4.  Bed rail use for treatment of a medical symptom or condition should
    be accompanied by a care plan (treatment program) designed for that
    symptom or condition.

-   The plan should present clear directions for further investigation
    of less restrictive care interventions.

-   The documentation should describe the attempts to use less
    restrictive care interventions and, if indicated, their failure to
    meet patients' assessed needs.

5.  Bed rail use for patient's mobility and/or transferring, for example
    turning and positioning within the bed and providing a hand-hold for
    getting into or out of bed, should be accompanied by a care plan.

-   The patient should be encouraged to participate in care planning to
    help design a safe and comfortable bed environment.

-   The care plan should:

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-   include educating the patient about possible bed rail danger to
    enable the patient to make an informed decision; and

-   address options for reducing the risks of the rail use.

6.  The process of reducing and/or eliminating existing use of bed rails
    should be undertaken incrementally using an individualized,
    systematic, and documented approach.

7.  Creating a safe bed environment does not necessarily preclude the
    use of bed rails. However, a decision to use them should be based on
    a comprehensive assessment and identification of the patient's
    needs, which include comparing the potential for injury or death
    associated with use or non-use of bed rails to the benefits for an
    individual patient. In creating a safe bed environment, the
    following general principles should be applied:

-   Avoid the automatic use of bed rails of any size or shape.

-   Restrict the use of physical restraints, including chest, abdominal,
    wrist, or ankle restraints of any kind on individuals in bed.

-   Inspect, evaluate, maintain, and upgrade equipment
    (beds/mattresses/bed rails) to identify and remove potential fall
    and entrapment hazards and appropriately match the equipment to
    patient needs, considering all relevant risk factors.

-   Re-assess the patient's needs and re-evaluate the equipment if an
    episode of entrapment or near-entrapment occurs, with or without
    serious injury. This should be done immediately because fatal
    "repeat" events can occur within minutes of the first episode.

**[Process/Procedure Considerations]{.underline}**

The items listed below are not meant to be all-inclusive. Caregivers may
identify other concerns that need to be addressed.

1.  Individualized Patient Assessment

> Any decision regarding bed rail use or removal from use should be made
> within the framework of an individual patient assessment. If a bed
> rail has been determined to be necessary, steps should be taken to
> reduce the known risks associated with its use. The individual patient
> assessment includes[^11],[^12],[^13],[^14],[^15],[^16],[^17],[^18]

# Medical diagnosis, conditions, symptoms, and/or behavioral symptoms

# Sleep habits

-   Medication

-   Acute medical or surgical interventions

-   Underlying medical conditions

-   Existence of delirium

-   Ability to toilet self safely

-   Cognition

-   Communication

-   Mobility (in and out of bed)

-   Risk of falling

2.  Sleeping environment assessment

> This assessment includes elements or conditions that may affect the
> patient's ability to sleep and may be considered in evaluating areas
> to address in a patient's care plan.

# Comfort

-   pain

-   hypoxia

-   grieving

-   loneliness

-   hunger, thirst

-   hydration

-   calorie intake and protein calories

-   boredom

-   amount of time spent in bed

-   light levels

-   temperature

# Understanding of self and family

-   hobbies, interests, religion

-   pictures of family

# Proximity to toilet

-   toilet within view

-   toilet accessible

-   strategy (patient with or without help from caregiver) for toileting

# Appropriate bed

-   comfortable

-   safe

-   height

-   mattress/overlay

-   mattress edge definition (if necessary)

-   support for turning (if necessary)

-   strategy for safe egress

-   elevation for head of bed

# Support by Caregivers

-   individualized toileting schedule

-   routine comfort assessment

-   skin care and hygiene

-   emotional and physical support

# Medical Stabilization

-   treatment of underlying acute medical problems

-   dosages and types of medication

-   effects of long-term use of hypnotics

-   pain treatment strategy

-   caution with orthostatic medications (diuretics, short-acting
    antihypertensives)

-   diuretics (if indicated) not given at night

-   diabetic snack given at night

-   treatment for nocturnal esophageal reflux

-   bowel elimination plan for regularity

3.  Treatment Programs/Care Plans

# Address diagnoses, symptoms, conditions, and/or behavioral symptoms for which the use of a bed rail is being considered. 

# Identify nursing/medical and environmental interventions (e.g., for a patient with a life-long habit of staying up at night, provide nighttime activity). 

# If clinical and environmental interventions have proven to be unsuccessful in meeting the patient's assessed needs or a determination has been made that the risk of bed rail use is lower than that of other interventions or of not using them, bed rails may be used. Documentation of the risk-benefit assessment should be in the patient's medical chart. 

# The team should review the treatment program and determine its effects on the patient through an ongoing cycle of evaluation that includes assessment of outcomes and adverse effects.

# When planning care for the patient for whom a low bed is selected, consideration should be given to potential effects on the patient such as restraining desired voluntary movement or creating an unwanted psychological effect by being placed close to the floor. The individualized care plan and risk benefit considerations should address these issues and the plan modified accordingly.

# General guidance:

a.  A patient is assessed to be at low risk for injury, as defined by
    these factors:

-   transfers safely to and from the bed to a wheelchair without
    assistance;

-   ambulates without assistance to and from the toilet without falling;

-   has not fallen, or is unlikely to fall, out of bed; and

-   notifies staff appropriately using call system.

> *Consider using a bed for this patient without a bed rail.*

b.  A patient is assessed to be unsafe in bed, or at high risk for
    injury, as defined by these factors:

-   inability to transfer safely to and from the bed to a wheelchair;

-   previous entrapment or near-entrapment episode;

-   inability to ambulate to and from the toilet without falling;

-   history of bed-related serious injury;

-   episodes of falling out of bed, or likelihood that such episodes
    will occur; or

-   inconsistent in notifying staff of needs or unable to access the
    call system.

> *Consider placing this patient in an adjustable height bed that can go
> very low to the floor for sleeping and raised for transfers and
> activities of daily living care, or an alternative such as a concave
> mattress as determined by the interdisciplinary care team. Use a
> high-impact mat next to the bed.*

c.  A patient is assessed to require a bed in a low position but has
    difficulty getting into the low bed from the standing position:

> *Consider an adjustable-height bed. If this is not available, consider
> adding a quarter rail or transfer device (See Appendix 1: Glossary) to
> a low bed for the patient to hold for support while entering the low
> bed.* When selecting a support hold, consider:

-   Such rails should contain cross bars close enough to prevent the
    passage of the patient's head or body part through the rail and fit
    closely enough to the mattress to prevent entrapment.

-   Other interventions exist, such as secured vertical poles used for
    transferring in and out of bed. These poles, which are secured into
    the ceiling and floor, have weight limits. Tape applied to the pole
    may increase traction. They are generally used with more cognitively
    functional individuals.

d.  A patient is assessed to need a low bed, but an assessment
    determines that the patient is in danger of hurting him/herself
    while exiting from the low bed or is in danger of an unstable
    transfer after standing up by grabbing onto a bed side table or
    sink:

> *Consider using a bed alarm to alert nursing staff when patient is
> leaving the bed*.

-   Base the decision on the individual patient's clinical condition and
    assessment.

-   Carefully consider the use of bed alarms for the patient who is
    agitated or confused.

e.  Steps should be taken to reduce risk of injury to patients and
    caregivers. Keep the bed in the lowest position with the wheels
    locked when occupied, adjusting the level for activities such as
    administering care or for patient transfers in/out of bed:

-   Place a high impact mat next to the low bed to cushion falls from
    the low bed as long as this does not create a greater risk of
    accident to the patient or caregivers.

-   Raise the bed to give care and lower it when finished. If the bed is
    not adjustable, utilize body mechanics techniques such as kneeling
    on one or both knees on the high impact mat rather than bending
    over.

-   Store the high impact mat when it is not in use.

-   Assess area for objects that may cause injury.

-   Move furniture far enough away from the bed to avoid risk of injury.

-   Train caregivers on the proper use of low beds and proper body
    mechanics.

**[Risk Intervention]{.underline}**

Assessment of risk should be part of the individual patient's
assessment, and steps to address the risk should be incorporated into
the patient's care plan. The following are examples of risk intervention
approaches.

1.  [Nursing]{.underline}

-   Provide individually scheduled toileting.

-   Develop a schedule for turning and positioning.

-   Clean urine and/or feces promptly.

-   Elevate head of bed for patients with congestive heart failure
    (CHF), chronic obstructive pulmonary disease (COPD), reflux, and
    actively infusing enteral fluids.

-   Position patients to maximize comfort and change positions in a
    timely manner, maintaining comfort and reducing risk for skin
    breakdown.

-   Accommodate patients' preferred bedtime habits whenever possible.

-   Restrict use of physical restraints on patients in bed.

-   When medically indicated, use padded bed rails for individuals with
    an active seizure disorder or active movement disorder.

-   Provide distractions such as music, television, or food and fluids
    for patients who do not sleep through the night.

-   Provide calming interventions and pain relief.

-   Plan time during the day to provide periods of physical activity
    that help promote a restful sleep.

-   Re-evaluate and revise patient's treatment program as needed if an
    episode of entrapment or near-entrapment occurs with or without
    serious injury.

2.  [Medical]{.underline}

-   Minimize use of medications that alter mental status.

-   Use alternatives to sleeping medications.

-   Dispense diuretics before the late afternoon/evening.

-   Treat pain.

-   Screen and treat for hypoxia.

-   Assess the clinical status of delirious patients to rule out
    reversible etiologies.

-   Promote mobility and fitness, e.g., restorative care to enhance
    abilities to stand safely and to walk.

3.  [Patient and Family]{.underline}

-   Seek and utilize input about the patient from the patient and family
    (or authorized representative) to assist in identifying nursing and
    medical risk interventions.

-   If patients or family members ask about using bed rails, encourage
    them to talk to the health care team about whether bed rails are
    indicated.

-   Since the patient and family are integral members of the team, they
    should be encouraged to learn about bed safety and appropriate care
    options.

# [Individualized Environmental Changes]{.underline}

The environmental changes listed below are suggestions for
consideration. Whether they will be used for an individual patient
depends on the patient's assessment.

1.  Use of low beds with adjacent mat on the floor (with consideration
    given to using mechanical lifts and proper lift technique training
    for caregiver staff).

2.  Use of low beds that can be elevated electronically for transfer and
    activities of daily living (ADL) care.

3.  Placement of the patient's call bell within easy reach and provision
    of visual and verbal reminders to use the call bell when necessary.

4.  Use of bed alarms to warn of patients' attempts to exit from bed.

5.  Use of "perimeter reminders" or "border definers" such as body
    pillow/cushions or mattresses with lipped/raised edges.

#### Use of a trapeze affixed to bed to increase patient's bed mobility. (For patients with shoulder conditions, trapeze use should be carefully scrutinized.)

6.  Placement of inconspicuous signs, without patients' names, to inform
    caregivers of interdisciplinary care team recommendations.

###### Patient Choice

As with any other device that may be used as a restraint, if a patient,
family member, or authorized representative requests the inappropriate
use of side rails, then the interdisciplinary care team has a
responsibility to discuss the risks involved, as well as the benefits of
any clinical and/or environmental interventions that may be safer in
meeting the patient's assessed needs, individual circumstances, and
environment. The patient's right to participate in care planning and
make choices should be balanced with caregivers' responsibility to
provide care according to an individual assessment, professional
standards of care, and any applicable state and federal laws and
regulations.

# [Bed Rails as Restraints]{.underline}

When bed rails have the effect of keeping a patient from voluntarily
getting out of bed, they fall under the definition of a physical
restraint. If they are not necessary to treat medical symptoms, and less
restrictive interventions have not been attempted and determined to be
ineffective, bed rails used as restraints should be avoided.[^19],[^20]
Bed rails used on the bed of a patient who is completely immobile do not
serve as restraints, but may not be medically necessary. It is
recommended that they be avoided.

## Education /Training

Hospitals, long term care facilities, and home health care providers
should provide education and training about bed rail use to assist in
creating and implementing a safe and comfortable sleeping environment
for their patients. It is recommended that the education and training be
directed toward the following groups:

-   Staff

-   Patient/family

-   Physicians, including medical directors and physician extenders such
    as physician assistants and nurse practitioners

-   Long term care ombudsman

-   Regulatory agencies or representatives

**[Bed Rail Safety Guidelines]{.underline}**

If it is determined that bed rails are required and that other
environmental or treatment considerations may not meet the individual
patient's assessed needs, or have been tried and were unsuccessful in
meeting the patient's assessed needs, then close attention must be given
to the design of the rails and the relationship between rails and other
parts of the bed.

1.  The bars within the bed rails should be closely spaced to prevent a
    patient's head from passing through the openings and becoming
    entrapped.

2.  The mattress to bed rail interface should prevent an individual from
    falling between the mattress and bed rails and possibly smothering.

3.  Care should be taken that the mattress does not shrink over time or
    after cleaning. Such shrinkage increases the potential space between
    the rails and the mattress.

4.  Check for compression of the mattress' outside perimeter. Easily
    compressed perimeters can increase the gaps between the mattress and
    the bed rail.

5.  Ensure that the mattress is appropriately sized for the selected bed
    frame, as not all beds and mattresses are interchangeable.

6.  The space between the bed rails and the mattress and the headboard
    and the mattress should be filled either by an added firm inlay or a
    mattress that creates an interface with the bed rail that prevents
    an individual from falling between the mattress and bed rails.

7.  Latches securing bed rails should be stable so that the bed rails
    will not fall when shaken.

8.  Older bed rail designs that have tapered or winged ends are not
    appropriate for use with patients assessed to be at risk for
    entrapment.

9.  Maintenance and monitoring of the bed, mattress, and accessories
    such as patient/caregiver assist items (See Appendix 1: Glossary)
    should be ongoing.

**Appendix 1: Glossary**

**Adjustable height bed** -- A bed with "hi-low" function such that the
height of the sleep surface can be adjusted.

**Automatic contour** - A feature of a bed where the thigh section of
the sleep surface articulates upward as the head section travels upward
thereby reducing the likelihood of patient/resident mattress from
migrating toward the foot end of the bed.

**Bed alarms** -- Alarms intended to notify caregivers of either an
unwanted patient/resident egress or that the patient/resident is near
the edge of the mattress.

**Bed rail extender** -- A detachable device intended to bridge the
space between the head and foot bed rail.

**Bed rails** --Adjustable metal or rigid plastic bars that attach to
the bed. They are available in a variety of types, shapes, and sizes
ranging from full to one-half, one-quarter, or one-eighth lengths.
Synonymous terms are *side rails, bed side rails, and safety rails.*
(See attached *Bed Side Rail Types* for illustrated definitions.)

**Control bed rail** -- A bed rail that incorporates bed function
controls for patient/staff activation.

**Fireman's pole** -- A pole secured (floor and ceiling mooring) next to
the bed that acts as a support for the patient to get into and out of
the bed.

**Handgrips** -- Devices attached to either side of the bed to provide
the patient/resident the ability to reposition themselves while in bed
as well as an aid to enter and leave the bed.

**High-impact mat (bed-side mat)** -- A mat placed next to the bed that
absorbs the shock if the patient falls from the bed.

**Entrapment** -- An event in which a patient is caught, trapped, or
entangled in the spaces in or about the bed rail, mattress, or hospital
bed frame. Entrapment can result in serious injury or death.

**Interdisciplinary team** \-- The interdisciplinary team may vary in
constituency depending upon the nature of the care and service setting
and the individual patients' needs. Members may include, but are not
limited to: patient; family member (or patient's legal representative);
nursing, social services, and dietary personnel; attending physician (or
designee); medical director; rehabilitation and occupational therapists;
and medical equipment suppliers.

**Lifting pole** -- A device suspended above the bed intended to allow
the patient to change position by gripping it.

**Low bed** -- This bed is defined according to the patient: The bed is
considered "low" if, when the patient is sitting on the side of the bed
with feet on the floor, the angle of the patient's bent knees is 90
degrees or less.

**Mattress with raised edges** -- A mattress that has a perimeter
configured in a manner to allow the patient/resident to be "cradled" in
the center of the mattress and reduces the likelihood of unwanted
patient egress. It has a central area on either side of the mattress
that is not raised and is used for egress.

**Patient assessment** -- The assessment provides ongoing information
necessary to develop a care plan, to provide the appropriate care and
services for each patient, and to modify the care plan and care/services
based on the patient's status. Details about the components of the
assessment are found on pages 5 and 6 of this document.

**Pediatric rail** -- A rail in which the bar spacing is no larger than
two and three-eighths inches.

**Pendant control** -- A means used by either the patient or the
operator to control the drives that activate various bed functions and
is attached to the bed by a cord.

**Physical restraint** -- Any manual method or physical or mechanical
device, material, or equipment attached or adjacent to the resident's
\[patient's\] body that the individual cannot remove easily that
restricts freedom of movement or normal access to one's body. (Source:
Health Care Financing Administration State Operations Manual, Rev. 274,
Guidance to Surveyors at 42 CFR Subpart B, Requirements for Long Term
Care Facilities, 483.13(a).)

**Sleeping environment** -- Includes physical components such as the bed
size and height and mattress, the accessibility of personal items and
accessories such as a call bell, and the room temperature and noise or
light levels. The environment also includes nonphysical aspects such as
comfort and security. These aspects may be related to the physical
features of the bed such as the degree of mattress firmness, or features
that facilitate freedom from physical pain, or a feeling of safety and
privacy.

**Transfer device** - Support for transfers such as half - or
quarter-length upper bed rails, bed grab bars, bed handles attached to
the bed frame, or fireman's transfer pole.

**Treatment program (care plan)** -- The treatment program includes
measurable objectives and timetables to meet the patient's medical,
nursing, and mental and psychosocial needs that are identified through
the assessment process. The effectiveness of the treatment program is
evaluated and modified as necessary. The interdisciplinary team reviews,
revises, and initiates changes to the program as needed in accordance
with professional standards of practice after each assessment.

**Seizure pads** - Padded covers for bed rails that may be used to
prevent unwanted patient/resident cuts and bruising from repeated
contact with the bed rails. Also used to cover openings within the
perimeter of the side rails and space between the head and foot rails.

**Side rails** -- See *Bed rails*.

**Stuff pads** -- Plastic covered pads used to obliterate open spaces
between bed rails and mattresses, mattresses and head/foot boards.

**Transfer bar** -- A one-piece device, attached to the bed frame on one
or both sides of the bed, that is grasped to aid in bed entry and exit.

Appendix 2: Bed Rails - Intended Purpose and Potential Risks

Intended Purpose of Bed Rails

1.  One of several methods utilized to prevent patient from falling out
    of bed.

-   Reminds patient not to get out of bed when medically contraindicated
    and/or medical equipment is attached to the patient.

-   Defines the bed edge.

-   Helps to protect patient from falling out of bed during transport.

2.  May assist patient with movement.

-   Moving within the bed.

-   Getting in and out of bed.

3.  One of several methods to provide the patient with easy access to
    bed controls.

4.  One of several methods to provide a feeling of comfort and security.

Potential Risks of Bed Rails

1.  Create a source of known morbidity and mortality such as:

-   Strangling, suffocation, serious bodily injury,\*\* or death when
    patients or parts of their bodies are caught between rails, the
    openings of the rails, or between the bed rails and mattress.

2.  Impede patients from safely getting out of bed:

-   Patients crawl over rails and fall from greater heights increasing
    the risk for serious injury.

-   Patients attempt to get out of bed over the foot board.

3.  Restrain patients in many circumstances:

-   Hinder patients from independently getting out of bed thereby
    confining them to their beds.

-   Create a barrier to performing routine activities such as going to
    the bathroom.

4.  Can create negative psychological effects:

-   Create undignified personal image.

-   Alter patient self-esteem.

-   Contribute to patient isolation.

-   Confinement can cause patients to be incontinent.

The potential risks can be exacerbated by:

-   Improper match of the bed rail to bed frame.

-   Improper installation.

-   Objects such as holders or supports that remain when the bed rail is
    removed.

\*\* May include head trauma; bruising, contusions, and/or skin
lacerations; and fractures and/or dislocations.

The drawings below are intended only to illustrate the design of bed
rails. They are not intended to represent actual or recommended
dimensions.

> ![](media/image2.png)
>
> ![](media/image3.png){width="2.873611111111111in"
> height="1.0104166666666667in"}
>
> ![](media/image4.png){width="2.873611111111111in"
> height="1.0097222222222222in"}

![](media/image5.png){width="2.873611111111111in"
height="1.0104166666666667in"}

![](media/image6.png){width="2.873611111111111in"
height="1.0104166666666667in"}

> ![](media/image7.png){width="2.879861111111111in"
> height="1.0097222222222222in"}
>
> ![](media/image8.png){width="2.873611111111111in" height="1.0in"}
>
> ![](media/image9.png){width="3.145138888888889in"
> height="0.9993055555555556in"}

# Appendix 4: Hospital Bed Safety Workgroup Member 

# Organizations that Signed on to the Clinical Guidance 

+-----------------------------------------------------------------------+
| ## AARP                                                               |
+-----------------------------------------------------------------------+
| ## American Association of Homes and Services for the Aging           |
+-----------------------------------------------------------------------+
| American Health Care Association                                      |
+-----------------------------------------------------------------------+
| American Medical Directors Association                                |
+-----------------------------------------------------------------------+
| American Nurses Association                                           |
+-----------------------------------------------------------------------+
| American Society of Healthcare Risk Management                        |
+-----------------------------------------------------------------------+
| Basic American Metal Products                                         |
+-----------------------------------------------------------------------+
| Care Providers of Minnesota                                           |
+-----------------------------------------------------------------------+
| Carroll Health Care                                                   |
+-----------------------------------------------------------------------+
| ECRI                                                                  |
+-----------------------------------------------------------------------+
| Evangelical Lutheran Good Samaritan Society                           |
+-----------------------------------------------------------------------+
| Hard Manufacturing                                                    |
+-----------------------------------------------------------------------+
| Health Safe, Incorporated                                             |
+-----------------------------------------------------------------------+
| Iona Senior Services                                                  |
+-----------------------------------------------------------------------+
| Kinetic Concepts Incorporated                                         |
+-----------------------------------------------------------------------+
| Law Offices of Julie A. Braun                                         |
+-----------------------------------------------------------------------+
| MC Healthcare                                                         |
+-----------------------------------------------------------------------+
| Medical Devices Bureau, Health Canada                                 |
+-----------------------------------------------------------------------+
| National Association of Home Care                                     |
+-----------------------------------------------------------------------+
| National Patient Safety Foundation                                    |
+-----------------------------------------------------------------------+
| National Citizens Coalition for Nursing Home Reform                   |
+-----------------------------------------------------------------------+
| Orange Grove Habilitation Center                                      |
+-----------------------------------------------------------------------+
| RN Systems +                                                          |
+-----------------------------------------------------------------------+
| Span American                                                         |
+-----------------------------------------------------------------------+
| Sunrise Medical                                                       |
+-----------------------------------------------------------------------+
| Tactilics, Inc.                                                       |
+-----------------------------------------------------------------------+
| Untie the Elderly, The Kendal Corporation                             |
+-----------------------------------------------------------------------+
| U.S. Food and Drug Administration                                     |
+-----------------------------------------------------------------------+
| Vail Products, Incorporated                                           |
+-----------------------------------------------------------------------+
| Veterans Administration National Center for Patient Safety            |
+-----------------------------------------------------------------------+

HBSW member, the Joint Commission on Accreditation of Healthcare
Organizations (JCAHO) has determined that the Clinical Guidance does not
conflict with current standards in the JCAHO *Comprehensive
Accreditation Manual for Hospitals* *2002,* *2002 Standards Manuals for
Home Care*, or the *2002-2003* *Comprehensive Accreditation Manual for
Long Term Care*.

**Appendix 5: Authors**

Doug Beardsley

Administrator/CEO

Valley Hospital at Hidden Lakes

Golden Valley, Minnesota

 

Mary Bias

Vice President

Hard Manufacturing Company

Buffalo, New York

Sarah Greene Burger, RNC, MPH

National Citizens' Coalition for Nursing Home Reform

Washington, DC

Elizabeth Capezuti, PhD, RN, CS, FAAN

Associate Professor

Independence Foundation Wesley Woods Chair in Gerontologic Nursing

Nell Hodgson Woodruff School of Nursing

Emory University

Atlanta, Georgia

Fred M. Feinsod, MD, MPH, CMD

American Medical Directors' Association

Colorado Springs, Colorado

Rita Munley Gallagher, PhD, RN, C

Senior Policy Fellow

Department of Nursing Practice and Policy

American Nurses Association

Washington, DC

Beryl Goldman, RN, MS, NHA

Director for Health Services

The Kendal Corporation

Kennett Square, Pennsylvania

Doni Haas, RN, LHRM

National Patient Safety Foundation

Stuart, Florida

Stephanie B. Hoffman, PhD

Director, Interprofessional Team Training and Development

Department of Veterans Affairs

James A. Haley Veterans Hospital

Tampa, Florida

Bill Kubat, MA

Vice President for Care Management, Clinical and Quality Affairs

Evangelical Lutheran Good Samaritan Society

Sioux Falls, South Dakota

Evvie Munley

Senior Health Policy Analyst

American Association of Homes & Services for the Aging

Washington, DC

Janet Myder, MPA

Director of Regulatory Systems

American Health Care Association

Washington, DC

Mary Lou Pijar

#### Public Health Advisor

Office of Health and Industry Programs

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Rockville, Maryland

Georgene Saliba (through 2001)

American Society of Healthcare Risk Management

Lehigh Valley Hospital

Allentown, Pennsylvania

Paul English Smith, JD, CPHRM, ASHRM

American Society of Healthcare Risk Management

Vice President and General Counsel

Cabell Huntington Hospital, Inc.

# Huntington, West Virginia 

Joan Ferlo Todd

Senior Nurse Analyst

#### Office of Surveillance and Biometrics

Center for Devices and Radiological Health

U.S. Food and Drug Administration

Rockville, Maryland

[^1]: Capezuti, E. & Lawson, WT III (1999). Falls and restraint
    liability issues. In P. Iyer (Ed.) [Nursing Home Litigation:
    Investigation and Case Preparation]{.underline}. Tucson, AZ: Lawyers
    and Judges Publishing Company.

[^2]: Braun, J.A. & Capezuti, E. (2000). The legal and medical aspects
    of physical restraints and bed side rails and their relationships to
    falls and fall-related injuries in nursing homes. [DePaul Journal of
    Healthcare Law, 3 (1) 1-72.]{.underline}

[^3]: Capezuti, E., Talerico, K.A., Cochran, I., Becker, H., Strumpf,
    N., & Evans, L. (1999). Individualized interventions to prevent
    bed-related falls and reduce side rail use. [Journal of
    Gerontological Nursing, 25, 26-34.]{.underline}

[^4]: Parker, K., Miles, SH. (1997). Deaths caused by bed rails.
    [Journal of the American Geriatrics Society]{.underline} 45:797-802.

[^5]: Feinsod, F.M., Moore, M., Levenson, S. (1997). Eliminating
    full-length bed rails from long term care facilities. [Nursing Home
    Medicine]{.underline} 5:257-263.

[^6]: [MedWatch]{.underline}, the U.S. Food and Drug Administration's
    medical products reporting program.

[^7]: Food and Drug Administration. FDA Safety Alert: Entrapment Hazards
    with Hospital Bed Side Rails (Aug 23, 1995). U.S. Department of
    Health and Human Services.

[^8]: Todd, J., Ruhl, C., & Gross, T. (1997). Injury and Death
    Associated with Hospital Bed Side-Rails: Reports to the U.S. Food
    and Drug Administration from 1985 to 1995. [American Journal of
    Public Health]{.underline} 87 (10): 1675-1677.

[^9]: Health Care Financing Administration guidance to surveyors in the
    implementation of 42 CFR Part 482 Medicare and Medicaid Programs.
    State Operations Manual Provider Certification Transmittal 17. June
    2000. A-182-183.

[^10]: Health Care Financing Administration guidance to surveyors in the
    implementation of 42 CFR Part 483.13(a). Medicare and Medicaid
    Programs. State Operations Manual Provider Certification Transmittal
    20. September 7, 2000. PP-45.

[^11]: Capezuti, E., Talerico, K.A., Strumpf, N., & Evans, L. (1998).
    Individualized assessment and intervention in bilateral side rail
    use. [Geriatric Nursing]{.underline}, 25, 26-34.

[^12]: *See* Capezuti et al., *supra* note 1.

[^13]: Donius, M. & Rader, J. (1994) Use of Side rails: Rethinking a
    Standard of Practice, [Journal of Gerontological
    Nursing]{.underline} 23, 23-27.

[^14]: Rader, J. (1995). Creating a supportive environment for
    eliminating restraints. In Rader, J. & Tornquist, E.M. (Eds.)
    [Individualized Dementia Care]{.underline}, New York: Springer
    Publishing Company.

[^15]: Donius, M., & Rader, J. (1996). Side rails: Rethinking a Standard
    Practice. In Burggraf, V. & Barry, R. (Eds.), [Gerontological
    Nursing Current Practice and Research]{.underline}. Thorofare, NJ:
    Slack, Inc.

[^16]: O'Keeffe, S., Jack, C.I.A., & Lye, M. (1996). Use of restraints
    and bed rails in a British hospital. [Journal of the American
    Geriatrics Society, 44, 1086-1088.]{.underline}

[^17]: Frengley, J.D. (1999), Bedrails: Do They Have A Benefit?,
    [Journal of the American Geriatrics Society]{.underline}, 47(5):
    627-628.

[^18]: Hammond, M., Levine, J.M. Bedrails: Choosing the Best
    Alternative. [Geriatric Nursing]{.underline}. 20(6):297-300. 1999
    Nov. -- Dec.

[^19]: *See* Health Care Financing Administration *supra* note 10.

[^20]: *See* Health Care Financing Administration *supra* note 7 at
    A-182.