Bedrail entrapment: is your facility safe? A comprehensive look at strategies to reduce these often fatal mistakes.

More than 2.5 million hospital beds are in use in the United States. (1) The U.S. Food and Drug Administration (FDA) received approximately 575 entrapment reports from January 1, 1985, to January 1, 2004. (2,3) During this 19-year period, 358 people died, 111 were injured, and 106 were near-miss events with no injury. One limitation of the report data is that many adverse events may not be reported to the FDA; thus, the true number of bedrail entrapments may be unknown. Entrapments happen in all care settings--nursing homes, hospitals, and home healthcare. (4) Entrapment occurs when a resident/patient is caught, trapped, or entangled in the space in or about the bedrail, mattress, or hospital bed frame. (5) Sadly, entrapments can result in serious injury or death. Clearly, risk management strategies aimed at reducing or eliminating entrapment occurrence best serve resident/patient interests and an institution's legal interests.

The Hospital Bed Safety Workgroup

In response to continued reports of entrapment, the Hospital Bed Safety Workgroup (HBSW) was born in 1999 with membership consisting of, but not limited to:

* the FDA;

* other U.S. governmentagencies such as the Centers for Medicare & Medicaid Services, Consumer Product Safety Commission, and Department of Veterans Affairs;

* the Medical Devices Bureau of Health Canada;

* national healthcare organizations and provider groups;

* resident/patient advocacy groups (e.g., Untie the Elderly and National Citizens' Coalition for Nursing Home Reform);

* ECRI, a nonprofit health services research organization;

* attorneys;

* nurses;

* doctors; and

* hospital bed and equipment manufacturers.

The HBSW creates educational materials seeking to raise awareness of entrapment hazards and educate caregivers along with family members about the risks and benefits associated with bedrail use. The HBSW developed clinical guidance to reduce the occurrence of resident/patient entrapment, and it is creating procedures for measuring and assessing hospital bed systems with plans to make this information available shortly.

Draft Dimensional Guidelines for Hospital Beds

A recent effort to reduce life-threatening entrapment events involves evidence-based dimensional guidelines for hospital beds, now available for public review. The FDA released Draft Guidance for Industry and FDA Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment on August 30, 2004, with a 90-day comment period ending November 29. (6) The draft:

* reviews historical entrapment data;

* presents a retrospective study of entrapment reports to the FDA to verify proposed dimensional limits;

* characterizes body parts at risk for entrapment (such as the head, neck, and chest);

* shares line drawings of potential entrapment events (figure 1);

* identifies locations of hospital bed openings that can serve as potential entrapment areas;

* recommends maximum and minimum dimensional limits for gaps or openings in hospital bed systems;

* provides a scientific basis for the dimensional limits derived from a review of international anthropometric data;

* relates dimensional limits for the identified entrapment zones (figure 2);

* offers additional resources concerning hospital bed entrapment; and

* conveys information for healthcare providers and healthcare facilities, including suggestions about what information to relay when reporting entrapment events.

Products excluded from dimensional criteria. The dimensional criteria described do not apply to a number of products. Draft dimensional guidance lists the products totally or partially excluded. For example, air-fluidized therapy beds are totally excluded from the guidance's scope because the nature of the therapy does not allow the resident/patient to exit the bed easily. When these products are used, the therapeutic benefit is expected to outweigh the risk of entrapment.

Seven entrapment zones. Healthcare facilities can use the FDA draft guidance as part of a bed safety program to help identify entrapment risks that may exist with current hospital bed systems. The guidance considers seven potential entrapment zones (figure 2). Descriptions of these zones appear in the guidance accompanied by illustrations. International anthropometric data references were used to determine the relative sizes of key body parts--head, neck, and chest--for the vulnerable, at-risk population and provide a guide for the dimensional limits that would reduce their entrapment. For example, to reduce the risk of head entrapment, openings in the bed system should be small enough to prevent passage of the widest part of the head (i.e., head breadth measured across the face from ear to ear). The FDA is recommending fewer than 4 3/4" (120 mm) for the head breadth dimension.

Reporting Entrapment Events to the FDA

The Safe Medical Devices Act of 1990 requires hospitals, long-term care facilities, and others to report to the FDA any deaths, serious illnesses, and injuries associated with the use of medical devices, including bedrails. The FDA MedWatch reporting program receives reports of entrapment hazards. Manufacturers and users, however, often fail to report the events to regulatory agencies such as the FDA or fail to note event details. To improve the quality of entrapment event reports, the FDA recommends reporting the following important and helpful details:

* Exact location or zone of entrapment

* Body part entrapped and, if possible, the part's size (e.g., head breadth, neck diameter, chest depth)

* Rail position (e.g., fully raised, intermediate, or lowered)

* Type of rails in use (e.g., full length, 3/4-length, 1/2-length, split rails, or 1/4-length)

* Number of rails raised at the time of the adverse event

* Mattress height and height of the rail from the top of the mattress

* Information on the size of the gap that contributed to the entrapment

The FDA also recommends reporting the articulation of the bed deck (i.e., which sections of the deck were raised) and the approximate degree of elevation for each deck section. Resident/patient care and rest occur in different deck positions and, in accommodating these, bedrails may be an integral part of the bed frame or be removable. They may consist of one full-length rail per side or one or more shorter rails per side. Bedrails may be a fixed height or adjustable in height and may move as the head or foot sections of the bed are raised or lowered. This bed movement is known as articulation. Some entrapment areas change in size upon articulation and may pose additional entrapment risks. The articulation of the bed introduces complex geometries that make applying the dimensional criteria to reduce entrapment difficult. The dimensional recommendations in the draft guidance apply to hospital beds in the flat deck position and rails in the fully raised position, except where noted.

Assessment of Risks

Individual (re)assessments. Individuals differ in their sleeping and nighttime habits. Therefore, creating a safe bed environment should take into account resident/patient medical needs, comfort, and freedom of movement. Consider additional safety measures for residents identified as highrisk for entrapment (e.g., individuals with preexisting conditions such as altered mental status [organic or medicationrelated] or confusion, restlessness, lack of muscle control, or a combination of these factors). The individual assessment should be conducted by an interdisciplinary team (e.g., nursing, social services, and dietary personnel; physicians; medical director; rehabilitation and occupational therapists; and medical equipment suppliers, with input from the resident/patient, family, or authorized representative).

Reassess resident/patient need for bedrails on a regular basis or face a potential fine or lawsuit if an adverse event occurs. For example, a 202-bed nursing home in southern Illinois was fined $10,000 following the death of an 88-year-old resident who had gotten her neck, chin, and head area wedged between the half siderails and mattress of her bed. This was the second (and this time fatal) such incident for the resident, who was totally dependent on staff for bed mobility and transfers. Bedrail usage was not reassessed after the first incident, nor were any interventions initiated to prevent recurrence. (7)

Environmental assessment. Environmental accommodations might include, among other options: (1) low beds with adjacent floor mat (with consideration for the use of mechanical lifts and proper lift technique training for caregiver staff); (2) low beds that can be elevated electronically for transfer and activities of daily living (ADL) care; (3) placement of a call bell within easy reach and providing visual and verbal reminders to use it when necessary; (4) bed alarms to warn of residents'/patients' attempts to exit the bed (selection is based on the individual's clinical condition, although be judicious in considering the use of bed alarms for the resident/patient who is agitated or confused); (5) perimeter reminders or border definers such as body pillows or mattresses with lipped/raised edges; and (6) a trapeze affixed to the bed.

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Official Guidance on Assessment

The HBSW clinical guidance supplies a uniform set of recommendations for caregivers in hospitals, long-term care facilities, and home care settings to use when assessing their residents'/patients' need for and possible use of bedrails. (8,9) The guidance is basic in design and content so that each care setting can adapt it to meet its unique needs. Since residents/patients and family members are critical to the decision-making process, an educational brochure that describes risks and benefits associated with bedrail use, as well as alternative interventions, is available at www.fda.gov/cdrh/beds.

Risk Intervention

Steps to address any identified risk should be incorporated into the care plan. (10) Examples of risk intervention approaches involving nursing care include: providing individually scheduled toileting; developing a schedule for turning and positioning; accommodating a resident's/patient's preferred bedtime habits whenever possible; providing distractions such as music, television, or food and fluids for individuals who do not sleep through the night; offering calming interventions and pain relief; and planning time during the day to provide periods of physical activity that help promote a restful sleep.

Medical care interventions include: minimizing use of medications that alter mental status; using alternatives to sleeping medications; dispensing diuretics before the late afternoon/evening; treating pain; screening for and treating hypoxia; assessing the clinical status of delirious residents/patients to rule out reversible etiologies; and promoting mobility and fitness (e.g., restorative care to enhance abilities to stand safely and to walk).

Education and Training

Another component of good risk management involves extensive education about entrapment dangers for staff at all levels within the nursing home, including physicians such as medical directors and physician extenders (physician assistants and nurse practitioners). Introduction to this topic should be an essential part of a new employee's orientation. Furthermore, a facility should establish regular staff training programs that:

* share research findings concerning bedrail use and their application to clinical practice (10);

* explain the ineffectiveness of bedrails as a fall-prevention strategy;

* reinforce facility philosophy regarding bedrail use;

* review institutional policy and procedure regarding bedrails and stress the importance of institutional compliance with its own protocols;

* invite staff from nursing homes with successful bedrail reduction programs to share their experiences;

* incorporate educational videos on bedrail issues;

* relate categories of at-risk residents/patients (e.g., those with a fall history);

* describe individualized interventions to address the at-risk individual's unique needs;

* illustrate behavioral approaches in the management of behavioral symptoms such as wandering and agitation; and

* highlight legal liability associated with bedrails.

Educate residents/patients and families (or authorized representatives) about the purpose and potential dangers of bedrails. (11) If residents/patients or family members ask about the possibility of using bedrails, encourage them to talk to the healthcare team about whether rails are indicated. Since residents/patients and families are integral team members, they should be encouraged to learn about bed safety and appropriate care options.

Conclusion

Every effort should be made to reduce the risk of resident/patient entrapment in hospital bed systems. Specific risk reduction steps are listed in "Suggestions to Reduce Entrapment Risk," p. 59. In general, risk reduction can be accomplished through the development of new hospital bed or rail design configurations and the assessment and modification of existing (legacy) hospital bed systems. An effective risk management strategy to prevent entrapment deaths and injuries will be multifaceted.

References

1. A Guide to Bed Safety for Patients and Families--Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts. Tampa, Fla.: Veterans Health Administration Center for Patient Safety, VISN 8 Patient Safety Center of Inquiry, 2000. Available at: www.patientsafetycenter.com/bedsafe.htm.

2. Draft Guidance for Industry and FDA Staff: Hospital Bed System Dimensional Guidance to Reduce Entrapment. Rockville, Md.: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Services and Radiological Health, Aug. 30, 2004. Available at: www.fda.gov/cdrh/ocer/guidance/1537.pdf; or e-mail [e-mail] document number 1537 to identify the guidance.

3. Todd JF, Ruhl CE, Gross TP. Injury and death associated with hospital bed side-rails: Reports to the US Food and Drug Administration from 1985 to 1995. American Journal of Public Health 1997;87:1675-7.

4. Braun JA, Capezuti E. The legal and medical aspects of physical restraints and bed siderails and their relationship to falls and fall-related injuries in nursing homes. DePaul Journal of Health Care Law 2000;3:1-72. For an electronic copy, e-mail [e-mail]; "DePaul Article" in subject line.

5. Parker K, Miles SH. Deaths caused by bedrails. Journal of the American Geriatrics Society 1997;45:797-802.

6. U.S. Department of Health and Human Services, Food and Drug Administration. Draft Guidance for Industry on Food and Drug Administration Staff; Hospital Bed System Dimensional Guidance to Reduce Entrapment; Availability. Federal Register 2004;69:52907.

7. Three northern illinois facilities disciplined. Springfield, III.: Illinois Department of Public Health, Aug. 26, 2003. Available at: www.idph.state.il.us/public/press03/08.26.03.htm.

8. Guideline for the prevention of falls in older persons. American Geriatrics Society, British Geriatrics Society, and American Academy of Orthopaedic Surgeons Panel on Falls Prevention. Journal of the American Geriatrics Society 2001;49:664-72.

9. Capezuti E, Maislin G, Strumpf N, Evans LK. Siderail use and bed-related fall outcomes among nursing home residents. Journal of the American Geriatrics Society 2002;50(1):90-6.

10. Capezuti EA, Talerico KA, Cochran I, et al. Individualized interventions to prevent bed-related falls and reduce siderail use. Journal of Gerontological Nursing 1999;25:26-34.

11. A Guide to Bed Safety; Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts. Rockville, Md: U.S. Department of Health and Human Services, Food and Drug Administration, Center for Devices and Radiological Health. Available at: www.fda.gov/cdrh/beds/bedrail.pdf.

RELATED ARTICLE: Suggestions to Reduce Entrapment Risk

An effective risk management strategy to prevent entrapment deaths and injuries is multifaceted and includes, among other possibilities, the following:

* Check with bed system manufacturers to ensure compatibility of beds, mattresses, rails, and accessories.

* Install bedrails according to manufacturer instructions. This should make for a proper fit and avoid bowing, among other possible problems.

* Confirm that the mattress matches and fits relative to the associated rail's width and height. Replacement mattresses and rails might have dimensions that differ from the original equipment supplied or specified by the bed frame manufacturer. Not all rails, mattresses, and bed frames are interchangeable. When rails and mattresses are purchased separately from the bed frame, check with the manufacturer(s) to ensure compatibility of the rails, mattresses, and bed frame.

* Follow manufacturer instructions regarding use and recommended care setting.

* Follow facility protocols concerning bedrail use. These protocols should meet government regulations and accreditation standards.

* Assess current bed system combinations. For example, undertake reassessment: (1) if the facility suspects that some components are worn (e.g., rails wobble or are damaged, mattresses are softer), leading to increased spaces opening up; (2) when adding or removing accessories such as mattress overlays or positioning poles; or (3) when changing or replacing bed system components such as bedrails or mattresses.

* Evaluate legacy (existing) equipment. Conduct a risk-benefit analysis to ensure that appropriate steps are taken to mitigate the risk of entrapment without creating different, unintended risks or reducing clinical benefits available to residents/patients using the legacy equipment.

* Inspect all bed frames, bedrails, and mattresses during a regular, preventive maintenance program to identify possible entrapment areas.

* Contact equipment suppliers for available entrapment-mitigating solutions. A resource list of accessories and the companies that offer them is available at www.patientsafetycenter.com/bedsafe.htm. The list is not all-inclusive; other companies may provide similar accessories.

* Assess bed selection and fit. Mattress width, length, and/or depth; alignment of the bed frame; type of siderail; and condition of mattress should leave no gap wide enough to entrap a resident's head or body. This is particularly important with confused or restless residents. Consider that movement or compression of the mattress caused by a resident's weight, movement, or bed position may cause gaps.

* Eliminate entrapment between split rails by leaving the foot-end siderail in the down position or removing the foot-end rail.

* Make sure the top of the compressed mattress is above the bottom edge of the lowest rail and above the bottom of the headboard or footboard in all articulated bed positions and rail height settings.

* Add stuffers in gaps between the rail and mattress or between the headboard and footboard and mattress.

* Use bedrail protective barriers to close off open spaces in which a person might accidentally become entrapped. Follow facility procedures and/or manufacturer recommendations for installing and maintaining the protective barriers for a particular bed frame and siderail.

* Reevaluate equipment immediately if an episode of entrapment or near-entrapment occurs, with or without serious injury. Fatal "repeat" events can occur within minutes of the first episode. A 143-bed facility in northern Illinois was fined $10,000 after one resident died of asphyxiation and two more sustained injuries when their heads became caught in siderails. (1) All three residents had identical bed types with the same rail configuration and similar sized gaps between the rail and mattress. Even after the two residents were injured, staff did not evaluate the use of the rails nor take corrective action.

* Avoid automatic use of bedrails of any size or shape. Routine, automatic bedrail use may pose unwarranted hazards to resident/patient safety and needlessly expose a facility to increased risk of liability.

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

* Undertake a retrospective audit of incident reports related to entrapment events.

* Require completion of a risk management occurrence report for every rail-related incident to be forwarded to the risk management department or officer within 24 hours.

* Follow federal, state, and local regulations regarding bedrail and physical restraint use. Bedrails can be considered a restraint under specific circumstances.

* Give careful (and creative) thought to developing interventions to replace traditional bedrail use. Remember, all devices must be assessed individually for their impact on the individual's safety, burden, comfort, and well-being.

by Julie A. Braun, JD, LLM, and Elizabeth A. Capezuti, PhD, RN, APRN-BC, FAAN.

Julie A. Braun, JD, LLM, is a Chicago-based attorney and writer. Braun chairs the legal subcommittee of the FDA's Hospital Bed Safety Workgroup considering bed siderail safety in nursing homes, hospitals, and home healthcare environments. She is also a coinvestigator with Elizabeth A. Capezuti, PhD, RN, APRN-BC, FAAN, in an FDA-funded study exploring the legal liability issues of siderail use in these same settings. Braun is also a corecipient (along with Capezuti and Andrew D. Weinberg) of a Borchard Foundation Center on Law & Aging grant for a medicolegal analysis of bed-related falls among hospitalized older adults. Capezuti is Associate Professor, Division of Nursing, The Steinhardt School of Education, New York University. To comment on this article, please send e-mail to [e-mail]. To order reprints in quantities of 100 or more, call [phone].