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Alert:   Danger of Deaths Associated with Side Rail Use

PDF Version of BQA 99-053 (PDF, 23 KB) - includes attachment

You are encouraged to copy and distribute this information.

Date: September 14, 1999 -- DSL-BQA-99-053

To:   Adult Family Homes AFH - 09, Facilities for the Developmentally Disabled FDD-22, Hospitals HOSP - 21, Hospices HSPC - 17, Nurse Aide Training Programs NATP - 13, Nursing Homes NH - 29, Community Based Residential Facilities CBRF - 18

From: Susan Schroeder, Director, Bureau of Quality Assurance

There has recently been an increase in unexpected deaths of persons who have side rails on their beds. During each of the last three months, June, July and August, bed side rails have been a factor in the unexpected death of a resident in a Wisconsin nursing home. This is equal to the number of nursing home residents who generally die in this manner over the course of a full year. In 1997, a resident in a Community-Based Residential Facility (CBRF) died in this manner. Side rails may be present on beds in a number of types of providers. All providers are reminded that any device used by or near a resident or patient can present a hazard, regardless of its purpose, or whether or not it meets the definition of a restraint.

Each provider is strongly encouraged to examine its setting for potential dangerous situations and take prompt preventative actions. There is no automatic solution. Immediate removal of devices without appropriate assessment, intervention and monitoring may also place individuals at great risk. Each provider must assess each person individually and use appropriate, individualized, protective and preventative measures for each person.

Any person, especially one who is cognitively impaired or has uncontrolled, poorly coordinated or restless movements is at high risk of getting entangled in a life threatening position with a side rail. Entrapment by a side rail can easily result in an obstructed airway or circulatory impairment and quickly lead to death. These recent accidents have resulted in asphyxiation, strangulation, chest compression or other contorted positioning with the outcome of airway obstruction, a stoppage of breathing or markedly impaired circulation.

A person may be too weak, frail or cognitively impaired to correct his or her own position as a life-saving measure. Entrapment can occur with all types of side rails, including one-quarter side rails, half side rails, three-quarter side rails, full side rails, or other similar devices. These devices may not meet the definition of a restraint for the individual, especially when he or she is awake and somewhat alert; however, they may still be a hazard. Those that are not properly fitted or not properly designed for the bed or the mattress pose an even greater hazard.

In 1995 the federal Food and Drug Administration (FDA) published a safety alert regarding the dangers of side rail entrapment. A copy of that alert is attached and it can be obtained from the Internet at http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/
PublicHealthNotifications/ucm062884.htm
(exit DHFS).

The Code of Federal Regulations (exit DHFS) for Nursing Homes at 42 CFR 483.25(h) requires that "The facility must ensure that—(1)The resident environment remains as free of accident hazards as is possible; and (2) Each resident receives adequate supervision and assistance devices to prevent accidents." (F323/F324)

The Code of Federal Regulations (exit DHFS) for Intermediate Care Facilities for the Mentally Retarded (ICF-MRs) at 42 CFR 483.450(b)(2) requires that "Interventions to manage inappropriate client behavior must be employed with sufficient safeguards and supervision to ensure that the safety, welfare and civil and human rights of clients are adequately protected." (W285)

The Federal Conditions of Participation for Hospices at 42 CFR 418.56(c) [Code of Federal Regulations (exit DHFS)] require that "The hospice retains professional management responsibility for those services and ensures that they are furnished in a safe and effective manner by persons meeting the qualifications of this part, and in accordance with the patient’s plan of care and the other requirements of this part." (L124)

The Federal Conditions of Participation for Hospitals at 42 CFR 482.13(e)(4) [Code of Federal Regulations (exit DHFS)] require that "The condition of the restrained patient must be continually assessed, monitored, and reevaluated."

The Wisconsin Administrative Code for Community-Based Residential Facilities (CBRFs) at HFS 83.21(4)(w) (exit DHFS) requires that "…The CBRF shall safeguard residents who cannot fully guard themselves from an environmental hazard to which it is likely that they will be exposed, including both conditions which would be hazardous to anyone, and conditions which are hazardous to the resident because of the resident’s condition or handicap."

The Wisconsin Administrative Code for Adult Family Homes at HFS 88.10(3)(L) (exit DHFS) requires that "A resident shall have all the following rights…To a safe environment in which to live. The adult family home shall safeguard residents who cannot fully guard themselves from environmental hazards to which they are likely to be exposed, including conditions which would be hazardous to anyone and conditions which would be or are hazardous to a particular resident because of the resident’s condition."

Manufacturers and sales representatives do not make the final determination of whether or not a device is a restraint. The provider is responsible for the assessment of the resident/patient/client and for making the determination on an individual basis of what is or is not a restraint. The provider is responsible for assessing the safety of a person and the potential hazards for any device used on or near a resident/patient/client regardless of whether or not it meets the definition of a restraint. If side rails or other similar devices are used, protective measures, such as proactively checking the person, need to be put into place to protect the person from the negative outcomes associated with that hazard.

Many residents/patients/clients may be safer without a side rail than with a side rail. Using lower beds, floor cushioning such as exercise mats, frequent supervision or other appropriate measures can often ensure better safety than the use of a side rail because the side rail can be a life-threatening hazard.

Previous Bureau of Quality Assurance (BQA) training and memos, as well as professional health care literature, have presented multiple techniques and suggestions for how to facilitate safety without increasing the risk of accidental death. Attached to this memo is a recommended reading list that can be used for training staff on alternatives to restraints. These and other timely resources can be obtained from the sources listed or from your local hospital or medical library.

The federal Health Care Financing Administration (HCFA) has a web site that provides a newsletter with up-to-date information on restraint reduction at: http://www.hcfa.gov/pubforms/rrnews.htm [no longer operating].

Resources from the Wisconsin Association of Medical Directors (WAMD) are available through the American Medical Directors Association (AMDA) on the national web site, including a recent newsletter article entitled "Today’s Problems are a Result of Yesterday’s Solutions": http://www.amda.com (exit DHFS). Select State Chapters from the menu, then click on Wisconsin.

Questions about the information in this memo may be directed to the following contact persons:

Questions regarding hospitals and hospices should be directed to Beth Stellberg, Chief, Health Services Section [replaced by Cremear Mims].

Questions for nursing homes, facilities for the developmentally disabled, community-based residential facilities and adult family homes should be directed to the appropriate Regional Office.

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