April 1, 2010 | by I Advance Senior Care

Reducing the risk of accidental hangings, entrapment

At a glance…

Accidental deaths by hanging and entrapment should refocus nurse leaders’ efforts on the important job of providing a safe environment for residents. Many residents use assistive devices that are not considered restraints, however, all of the precautions required for restraint use should be enacted.

In December 2009, two resident deaths occurred in nursing homes in Colorado from side rails used as assistive devices,

1 even though they were designed to cover a quarter or less of the length of the resident’s bed. Many similar deaths have resulted elsewhere in our nation from entrapment.

As nurse leaders, these tragic events should refocus our efforts on the important job of providing a safe environment for our residents. Many residents use assistive devices and because they are not considered a restraint, all of the precautions required for restraint use may not be put into place.

What went wrong?

In these specific examples, the rails were used as mobility assistive devices and were not intended to serve as restraints. In reviewing what went wrong, Colorado Department of Health surveyors determined that there were several common factors in these deaths:

  • Because the rails were considered assistive devices, the facilities had not conducted a restraint or safety assessment for their use.

  • Because the rails were not considered restraints, informed consent was not obtained for their use. There had been no documented discussion of potential threats versus expected benefits.

  • The devices, when attached to the bed, left a 3″ to 4″ gap between the inside edge of the device and the mattress.

  • In each death, the resident’s upper head, neck, or torso became entangled between the device and the mattress.1

Frail elders are especially vulnerable to entrapment, which often results when a resident is caught or entangled in spaces such as a bed rail, between the mattress and bed frame, between the mattress and side rail, or in a wheelchair between the seat and an attached restraint. Entrapment can result in serious consequences including significant injury or death.

There were 691 entrapment reports received by the Food and Drug Administration (FDA) over a period of 21 years, from January 1, 1985 to January 1, 2006. These reports told of patients becoming entrapped in beds while in healthcare facilities. Of the 691 patients, 413 died, 120 were injured, and 158 avoided injury thanks to prompt intervention.2 It is evident from the 2009 deaths that this issue has not been resolved.

Three primary body parts are at risk for life-threatening entrapment in seven zones of a bed system. They are the individual’s head, neck, and chest. The seven potential zones of entrapment are (1) within a bed rail; (2) under a rail, between the rail supports, or next to a single rail support; (3) between the rail and mattress; (4) under the rail, at the ends of the rail; (5) between split bed rails; (6) between the end of the rail and the side edge of the head- or footboard; and (7) between the head- or footboard and the mattress end.2

Bed safety program

Evaluating dimensional limits of gaps in beds is one component of a bed safety program, which should also include a comprehensive plan for a resident/bed assessment to determine the right size and type of bed for the specific resident using it. The FDA has determined the size of gaps that place residents at risk for entrapment based on the most likely body parts to be impacted. Gap limits for use in monitoring efforts are: head-4¾; neck-2⅜, and an angle >60 degrees; and chest-12½.2

Ben Franklin’s quote, “An ounce of prevention is worth a pound of cure,” is so true when applied to our efforts to ensure resident safety. As nurse leaders, we should schedule periodic reassessment of assistive and restraint devices, looking for worn bed components (e.g., wobbly bed rails, damaged rails, too soft mattresses) that could cause increased spaces within the bed system.

If your facility does not have a bed safety program in place, it is critical that it be initiated immediately.

Reassessment should be conducted when mattress overlays or positioning items are added or removed, when bed rails or mattresses are changed, or when a resident is placed into a different bed. Most residents can be in bed safely without rails when appropriate safety actions are taken. These include using beds that can be raised and lowered close to the floor to accommodate both resident and caregiver needs, and that are kept in the lowest position with wheels locked when care is not being given. Mats by the bedside, concave mattresses, or positional padding may help reduce the risk of falls with injury and may help to protect residents from entrapment, strangulation, or other serious injuries. An overhead trapeze may meet the needs of some residents for mobility assistance. If a bed rail is used as a bed mobility aid, it must be monitored for safety just as closely as if it were considered a restraint.

About AANAC

The American Association of Nurse Assessment Coordinators (AANAC) is a nonprofit professional association representing nurse executives working in the long-term care industry. AANAC is operated by nurses for nurses and is dedicated to providing members with the resources, tools, and support they need in their specialized role of leaders and managers in long-term care.

AANAC offers the nurse executive:

  • The opportunity to discuss common challenges and problem-solve with peers and experts from across the country via a widely attended online discussion group

  • Quick and easy access to current long-term care news, regulatory updates, manuals, and publications

  • Weekly e-mail reminders about important dates, deadlines, and current events

  • Educational programs and CEs encompassing the essential job functions of the long-term care nurse executive

  • A weekly newsletter addressing tough issues and topics of current interest on the impact of regulation on facilities

AANAC is the organization chosen by successful leaders in long-term care. To join or get more information about AANAC, visit https://www.aanac.org or call (800) 768-1880.

F-tag 221 Restraints in the State Operations Manual (SOM) defines a restraint as “any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal access to one’s body.” CMS expects facilities to work toward reducing unnecessary physical restraint use to ensure that residents are free of devices unless they fully meet the definitions provided in F-tag 221. Current data on Medicare’s Nursing Home Compare Web site (https://www.medicare.gov/NHCompare) shows that nationally 3% of residents in nursing homes are restrained. This is a significant improvement from a study conducted in 1991 that revealed 59% restraint use,3 but further efforts may result in successfully removing restraints from even more individuals.

The renewed Advancing Excellence in America’s Nursing Homes campaign has designed Goal #3 to improve quality of life for residents and staff by targeting restraints for reduction to <2% by December 31, 2011. This translates to 19,200 fewer residents using daily physical restraints.4 (To view the detailed restraint reduction guide, visit https://www.nhqualitycampaign.org by selecting Resources, then Goal #3.) Advancing Excellence has developed an approach to achieving this target that includes the following steps:

  • Identify areas for improvement in processes and practices.

  • Identify causes of barriers to restraint reduction and/or appropriate use and determine root cause.

  • Reinforce optimal practice and performance to include doing the right thing the right way.

  • Implement necessary changes.

  • Monitor and reevaluate performance, practices, and results.

For those residents determined by the facility’s interdisciplinary team (IDT) to need restraints based on their medical symptoms, CMS expects that the following probes will be included in the decision process:

  1. What medical symptoms led to consideration of the use of restraints?

  2. Are the medical symptoms caused by failure to meet individual needs; use rehabilitative or restorative care; provide meaningful activities; or adjust the environment, including seating?

  3. Did the IDT address the risk of decline when the restraint was initiated, and does the care plan reflect consistently applied steps to prevent decline?

  4. Can the cause of the medical symptoms be eliminated or reduced? If not, have attempts been made to use alternatives to avoid physical function decline associated with restraint use?

  5. If alternatives have been unsuccessful, is the least restrictive restraint used for the least amount of time? Is use monitored and is care adjusted to reduce potential negative outcomes while further attempts are made to use less restrictive alternatives?

  6. Was the resident or legal surrogate provided with information to support making an informed choice about restraint use, and were risks, benefits, and alternatives explained?

  7. Has the IDT periodically re-evaluated for restraint need and made efforts to eliminate use and to maintain resident strength and mobility?

  8. Is the care plan consistently followed?5

Periodic assessments

A final essential action in our efforts to provide resident safety is periodically performing entrapment assessments as part of a bed safety program and when restraints or assistive devices are used while a resident is out of bed. If your facility does not have a bed safety program in place, it is critical to initiate one immediately. Periodic re-education for staff on the dangers of entrapment is essential. We must guide our nursing team to action in a campaign designed to prevent additional entrapment injuries or deaths. The FDA has provided guidelines to assist our efforts in assessing and preventing entrapment risks. This information is available at: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072662.htm. Efforts toward restraint and risk reduction should be included as part of a total facility Quality Improvement Program.

Betty MacLaughlin Frandsen has more than 30 years of experience in long-term care, as a Director of Nursing, Administrator, and Regional Consultant. She is currently Vice President of Education and Regulatory Affairs for AANAC.

To send your comments to the editor, please e-mail mhrehocik@iadvanceseniorcare.com.

References

  1. Muramoto D. Assistive Devices and Potential Threats to Residents: a Surveyor’s Perspective. Received 1/8/10 from the Colorado Department of Public Health & Environment.
  2. U.S. hospital bed system dimensional and assessment guidance to reduce entrapment (CDRH Doc. No. 1537).Food and Drug Administration. Rockville, Md.: March 2006 ;4, 14. Available at:https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072662.htm
  3. Tinett M, Liu W, Marottoli R, Ginter, S. Mechanical restraint use among residents of skilled nursing facilities: Prevalence, patterns, and predictors. Journal of the American Medical Association 1991; 265 (4): 502-3.
  4. Advancing Excellence in America’s Nursing Homes, Implementation Guide: Goal 3: Reducing the Use of Daily Physical Restraints.Available at: www.nhqualitycampaign.org
  5. The Long Term Care Survey. AHCA:Washington D.C. ,September 2009.

Long-Term Living 2010 April;59(4):38-41

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