AGING AND DISABILITY SERVICES ADMINISTRATION

December 10, 2001

AASA:? NH #2001-029

SUBJECT:? SIDE RAIL SAFETY

Dear Nursing Home/Facility Administrator:

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 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 rails to assist in turning and repositioning, 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 Hospital Bed Safety 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 in the brochure are:

? Strangling, suffocating, bodily injury or death when residents or part of their body are caught between the side rails and the 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 get clothing from the closet or dresser drawers.

The brochure includes a number of ways to help 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 of the caregivers;

? 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); and

? Offer food and fluids, schedule ample toileting, provide calming interventions such as music or walks, and provide pain relief.

In addition some facilities have used concave mattresses and long body pillows to help the resident feel and be safer in bed.

The following Code of Federal Regulations (CFR), and Washington Administrative Code (WAC) requirements apply to side rail and medical device use:

? 42 CFR 483.10(b)(3) and WAC 388-97-0060;

? 42 CFR 483.13(a) and WAC 388-97-075;

? 42 CFR 483.20(b)(1)(xv) and WAC 388-97-085(o); and

? WAC 388-97-195.

The facility must continue to comply with these requirements by ensuring that:

? Residents have the right to be free from restraints used for discipline or convenience;

? The resident is assessed to determine if the device (side rail or other) is a restraint or an enabler.? Because both cognitive status and functional ability to move in bed influence the degree of risk associated with use of the device these areas must be included in the assessment;

? Less restrictive alternatives to the use of side rails or other medical devices are considered;

? Information regarding the safety risks and possible benefits of side rail or other medical device use is provided to the resident prior to use (informed consent);

? Policies and procedures provide staff with specific direction related to medical device use, including restraint and side rail issues;

? The use of the device is included in the plan of care, with interventions to mitigate the potential safety risks of use; and

? Staff are familiar with, understand, and follow the policies and procedures, including the need for assessment, informing the resident of potential safety risks and possible benefits, and the plan of care portion of the process.

Several long-term care facilities in Washington have programs that have enabled them to greatly reduce or eliminate the use of restraints and side rails.? You may contact the Washington Association of Housing and Services for the Aging (WAHSA) at (206) 248-7434 or the Washington Health Care Association (WHCA) at (360) 352-3304 for more information.

This letter is intended to alert the facility to the dangers of side rail use.? The facility must continue to follow all nursing home/facility regulations regarding safety and 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