AGING AND DISABILITY SERVICES ADMINISTRATION

2007 BH "Dear Provider" Letters

July 17, 2007

ADSA: BH #2007-008
ENTRAPMENT IN BED RAILS AND TRANSFER AIDS

Dear Boarding Home Administrator:

It was recently brought to my attention that the Federal Food and Drug Administration (FDA) issued an article entitled: “Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment”. The FDA provides expanded guidance on patient/resident entrapment related to the use of bed rails and transfer aids, characterizes the body parts at risk for entrapment, identifies the locations of hospital bed openings that are potential entrapment areas and recommends dimensional criteria for these devices.

Here are a few highlights:

• The FDA does not make distinction between home and medical bed. The term “hospital bed” is used broadly and refers to a bed used in any long-term care setting. Guidance applies to all bed rails.
• The FDA has also received reports of entrapment occurring between a wall and the side of a mattress. When providers push beds against walls, some research literature has considered this analogous to physical restraint.
• Three key body parts at risk for life-threatening entrapment in the seven zones of a hospital bed system are the head, neck and chest.
• Relative sizes of body parts for the population at greatest risk for entrapment and guidance for the dimensional limits that would reduce their risk of entrapment are outlined in the article.
• Reducing the risk of entrapment involves a multi-faceted approach that includes bed design, clinical assessment and monitoring, as well as meeting patient, resident and family needs.

The FDA article does not establish legally enforceable responsibilities but instead offers nonbinding recommendations. It is always important to evaluate and assess for safety of each resident and recognize the risk for entrapment. Please see the attached link for the article in its entirety: http://www.fda.gov/cdrh/beds/guidance/1537.html

If you have any questions, please feel free to contact your local RCS Field Manager.

Sincerely,

Joyce Pashley Stockwell, Director
Residential Care Services