AGING AND DISABILITY SERVICES ADMINISTRATION

2005 BH "Dear Provider" Letters

December 15, 2005

ADSA:  BH #2005-020
Medical Device Safety

Dear Boarding Home Provider:

In 2001, the department issued a letter (#2001-026) discussing safety concerns related to the use of side rails.  There had been deaths and significant injury associated with the use of side rails.  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.

Since that time there have been several additional deaths and significant injuries from the use of medical devices, including side rails, in nursing homes, boarding homes and adult family homes.  This includes a recent death related to the use of a transfer pole. 

I am taking this opportunity to remind you of the continued potential dangers that the use of medical devices poses to certain residents.  While medical devices should not be automatically considered restraints, neither should they be used as restraints.

In August 1995, the federal Food and Drug Administration (FDA) issued a safety alert on the entrapment hazards of side rails on hospital beds.  A brochure entitled ”A Guide to Bed Safety” was developed by a workgroup, which included representation from patient advocacy groups and bed manufacturers, as well as the FDA.  Although the brochure is not new, the contents continue to be relevant. 

The brochure can assist you with staff training and resident and family education.  You may access the brochure electronically at http://www.fda.gov/cdrh/beds/bedrail.pdf to enable you to print copies to assist with staff training, and resident and family education

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 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;
• Preventing residents from being able to go to the bathroom or to get clothing from the closet or dresser drawers.

Before using the device, the resident must be assessed by a person qualified to do assessments.  The assessment should identify what the need for the device use is.  Questions to be asked include, but are not limited to:  Why is the device or intervention being used with, on, or for the resident?  What is the purpose of the special mattress, side rails, seat belt, gerichair, or transfer pole?  Does it enhance or restrict the resident’s mobility?

If you identified a need for the use; the risks, or inherent dangers, and possible benefits to the specific resident must then be considered and addressed.  Possible questions to ask are:  Does the benefit of the device outweigh the risk to this particular resident given their physical, cognitive and functional ability?  Do the resident and family understand the level/significance of the risk?

Through an explanation of the risks and benefits, the resident is given the opportunity to make an informed decision about the use of the device.  The resident always has the right to refuse to use the device.  

This letter is intended to alert you to the ongoing dangers of medical device use.  The provider must continue to follow all boarding home regulations regarding assessment and the use of restraints.  If you have any questions about this issue, please contact your local Residential Care Services (RCS) Field Manager.

Sincerely,

Joyce Pashley Stockwell, Director
Residential Care Services