AGING AND DISABILITY SERVICES ADMINISTRATION

 

 

Dear Adult Family Home Provider:

In August 1995 the federal Food and Drug Administration (FDA) issued a safety alert on the entrapment hazards of side rails on hospital beds.? I know that adult family homes (AFHs) frequently ask questions about side rail use, and am taking this opportunity to remind you of the potential dangers that the use of side rails pose, and that side rails are considered medical devices.

NOTE:? Side rail use always poses a potential safety risk, whether full, half, or quarter rails.? There is a potential safety risk whether the resident uses the side rail to assist in turning and repositioning in bed, or to treat medical symptoms.? The best way to prevent exposing residents to the risk of being trapped is not to use side rails.

In the past year the department was made aware of four incidents where residents in Washington long-term care facilities had become entrapped in side rails.? Three of these residents were found dead; one survived but sustained physical injury.? In some of these cases, the use of an over-lay type pressure mattress or other pressure mattress was being used in conjunction with the side rails.

Enclosed is a brochure entitled, ? A Guide to Bed Safety?, which was developed by the workgroup which included representation from patient advocacy groups, bed manufacturers, as well as the FDA.? The brochure can be accessed electronically at http://www.fda.gov/cdrh/beds/bedrail.pdf to enable you to send for more copies to assist with staff training, and resident and family education.? Some information from this brochure follows.

Between 1985 and 1999, 371 incidents of residents being caught, entrapped, entangled, or strangled in beds with rails were reported to the FDA.? These reports indicated that 228 of these residents died and 87 had non-fatal injuries.? Most of the residents were frail, elderly or confused.? Some dangers associated with side rail use listed on the brochure are:

• Strangling, suffocating, bodily injury or death when residents or part of their body is caught between the bed rails and mattress;
• Serious injuries from falls when residents climb over the side rails to get out of bed;
• Skin bruising, cuts and scrapes;
• Increased resident agitation due to the inability of the resident to move freely;
• Residents feeling isolated, or unnecessarily restricted; and
• Preventing residents from being able to go to the bathroom or to get clothing from the closet or dresser drawers.

The brochure also includes a number of ways of helping a resident feel and be safer in bed.? Some examples listed were to:

• Use beds that can be raised, and lowered close to the floor to meet both the needs of the resident and the caregiver;
• Keep the bed in the lowest position with the wheels locked
;
• When the resident is at risk of, or afraid of, falling out of bed, place mats next to the bed, as long as this does not increase the risk of accident;
• Provide transfer and mobility devices to help the resident in transferring in and out of bed such as canes, walkers, transfer poles (floor to ceiling poles bolted in place and positioned by the bed according to the resident?s identified needs);
• Monitor residents frequently; and
• Offer food and fluids, schedule ample toileting, provide calming interventions such as music or walks, and provide pain relief to lessen situations that might cause the resident to get out of bed.

In addition, some long-term care settings have used concave mattresses and long body pillows to help residents feel and be safer in bed.? By using some of these techniques, several long-term care facilities in Washington have greatly reduced or eliminated the use of side rails and restraints.

This letter is intended to alert the provider to the dangers of side rail use.? The provider must continue to follow all adult family home regulations regarding the use of restraints.? If you have any questions about this issue, please contact your local Residential Care Services (RCS) Field Manager.

Sincerely,

Patricia K. Lashway, Director
Residential Care Services

Enclosure

cc:????? RCS Regional Administrators