Robert J. Moss is co-director, Section of Geriatric Medicine, and Clinical Ethics Scholar-in-Residence, Lutheran General Hospital. John La Pluma is director, Center for Clinical Ethics, Lutheran General Hospital, Park Ridge, Ill. As mechanical restraints have never been proven effective in clinical practice, they should not be used routinely. They should be considered a nonvalidated therapy requiring consent. Mechanical restraints are leather or cloth devices, bedrails, or geri-chairs, used to modify the behavior of an individual through the limitation of physical movement. They may be applied as many as 500,000 times a day in the United States in acute and long-term care settings, particularly in providing care for persons over the age of sixty.[1] When restraints are used to protect a patient from harm, their use is for therapeutic purposes. There is considerable uncertainty, however, about whether restraints are safe or effective and whether their benefits outweigh their risks in clinical care. Thus, as Rubenstein and colleagues have noted, the use of mechanical restraints appears to have emerged as a of care by consensus rather than by scientific data.[2] Given that available empirical data suggest that restraints can be inefficacious and dangerous, we contend that mechanical restraints should be considered an investigational or nonvalidated therapy. At the very least, this requires that patients or their reliable proxies give formal informed consent to use of restraints, following full disclosure of their likely risks and benefits. In this context, we Will briefly review current empirical data on restraint utilization and efficacy, and identify the ethical considerations posed for health care professionals when they consider using mechanical restraints in the care of elderly patients. Epidemiology: The incidence of mechanical restraints in the United States varies by setting: 7.4 percent to 22 percent of acute care patients, 3.6 to 5 percent of psychiatric patients, 33 percent of patients in rehabilitation settings, and from 25 percent to 41 percent of patients in long-term care settings may be restrained.[3] In the acute hospital setting, wrist and jacket or chest restraints are most commonly used, particularly on medical and surgical floors. In the hospital, moreover, often more than one restraint is applied simultaneously; up to 20 percent of patients may concurrently be taking major tranquilizers.[4] In extended care settings, lap belts are common, and 40 percent of physically restrained residents also receive psychotropic medications.[5] Depending on the setting, restraints may be used for different reasons. In the acute setting, the most commonly noted indication is perceived danger to self or others.[6] In one prospective study, nurses restrained patients to allow treatments to be implemented (34%), to prevent patients from wandering (23%), and from falling of bed (11%), to violent behavior (11%), to promote sitting balance (11%), and to protect themselves (11%).[7] On the rehabilitation unit, restraints are used to keep the patient in a bed or chair (presumably to prevent them from falling). On the psychiatric ward, the management of violent or out of control behavior is the most frequent reason for restraints; it may also be one of the more common reasons for their application in the nursing home. According to the National Nursing Home Survey, restraints are used in managing 33.4 percent of agitated residents, 36 percent of aggressive residents, and 34 percent of residents who wander or pace.[8] However, the motivation for restraining patients in both the acute and long-term care settings may not always be patient safety. Restraints are frequently applied to protect an institution from liability subsequent to a patient's fall.[9] Such institutions may breach the standard of care if physicians have failed to order restraint use and bedrail elevation, or have allowed a patient to ambulate prematurely. …