Regulations require that nursing home residents must be free from restraints that are used for discipline or convenience and not required to address medical symptoms.  

 Except in an emergency, use of restraints is only appropriate with the requisite documentation and orders from a treating physician. This applies to both chemical and physical restraints. According to federal law, restraint use requires a physician's written order.

Siderails may or may not constitute a restraint, depending on the particular circumstances.    When a resident becomes caught in a siderail or other physical restraint, asphyxiation is usually the cause of death in these cases. The process of death is typically slow and painful. 

The U.S. Federal Drug Administration (FDA) has studied the hazards of using restraints for several years, with the goal of reducing the risk of side rail entrapment in hospital-style beds. Between January 1, 1985 and January 1, 2008, the FDA received 772 incidents of patients caught, trapped, entangled, or strangled in hospital-style beds. The reports included 460 deaths, 136 nonfatal injuries, and 176 cases where staff needed to intervene to prevent injuries. Most patients were frail, elderly or confused.

Resources about Siderails

As part of its effort to increase resident safety, the FDA has several publications available that offer details, concerns and guidance on restraint and siderail hazards, including:

• HBSW/FDA Frequently Asked Questions (FAQ) on Entrapment Issues (updated October 9, 2007).
• A Guide for Modifying Bed Systems and Using Accessories to Reduce the Risk of Entrapment (issued June 21, 2006).
• Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment - Guidance for Industry and FDA Staff (issued March 10, 2006).  
• Press Release: FDA Issues Guidance on Hospital Bed Design to Reduce Patient Entrapment (issued March 9, 2006).    
• HBSW Bed Safety Entrapment Kit Ordering Instructions (issued March 9, 2006).
• Clinical Guidance for the Assessment and Implementation of Bed Rails in Hospitals, Long Term Care Facilities and Home Care Settings.
• Brochure: A Guide to Bed Safety; Bed Rails in Hospitals, Nursing Homes and Home Health Care: The Facts. 
• Bed Rail - Related Entrapment Deaths, Sentinel Event Alert, Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) Sentinel Event Alert, September 6, 2002.   
• Entrapment Hazards with Hospital Bed Side Rails, Food and Drug Administration Safety Alert, 1995.
• CMS/FDA Letter regarding Physical Restraint Definition.

Federal law requires nursing homes to report serious injuries or deaths associated with restraints. The FDA maintains reports about specific restraints, including siderails.

The nursing home must justify its use of a restraint as the least restrictive alternative available to meet the therapeutic needs of the particular resident. If restraints are used, the facility must document a comprehensive interdisciplinary clinical evaluation and Care Plan showing how the restraint helps the resident in reaching his or her highest level of well-being. 

The law further requires informed consent of the resident, supported by a physician's written order identifying the circumstances and duration of restraint use, which must appear in the resident's medical record. The consent of the resident or the resident’s representative should be obtained for use of a siderail. CMS guidelines emphasize the nursing home's obligation to explain to the resident the potential negative outcomes of restraint use.

For the consent to be legally binding, the resident must be fully informed of the risks and benefits associated with siderails and their alternatives, thereby permitting the resident to choose among appropriate therapies. If the resident is not capable of making an informed choice, CMS guidelines permit the "legal surrogate or representative" to exercise the right, based on the same information that would have been provided to the resident. The informed consent must be recorded in writing in the facility’s record or consent form.