Patient Restraints: Improving Safety, Reducing Use

by Food and Drug Administration (FDA)

When Florence Carlson had a stroke and could no longer walk, nurses at Augustana Home in Minneapolis said she needed a wheelchair restraint belt for her safety.

Her daughter agreed, fearing that her 85-year-old mother might fall and injure herself without such a device.

On Oct. 8, 1987, the same restraint that was supposed to protect Carlson's health took her life. The former school teacher and mother of two was found slumped on the footrests of her wheelchair with the restraint belt tightly around her chest. She had died from asphyxiation.

After an investigation, the Minnesota Department of Health ruled that Augustana was negligent because the nurse aide caring for Carlson had applied the restraint belt incorrectly. Rather than anchoring the device to the bottom of Carlson's wheelchair, the aide secured it behind her in a manner that was too restricting.

The aide, according to the investigator's report, had also looped the device's ties around the arms of Carlson's wheelchair before securing them, although the belt was not designed to be secured that way.

Carlson's case is a tragic example of what can happen when a restraint device is applied and used incorrectly.

Restraints are physical or mechanical devices — usually safety vests and lap and wheelchair belts — used to limit a person's body movement. They are regulated by the Food and Drug Administration as medical devices.

While most restraints are used without mishap, FDA estimates that hundreds of restraint-related injuries occur each year, with at least 100 deaths taking place in nursing homes, hospitals, and private homes annually.

The majority have involved elderly nursing home patients who became entangled while trying to free themselves of the restraints, but there has also been at least one reported case of a child dying while restrained.

"FDA had received increasing numbers of reports on patient restraints that raised serious questions about the safety of these devices," said James S. Benson, director of FDA's Center for Devices and Radiological Health. "We found additional reports in the literature, and the reports covered all types of devices. This pointed to a significant problem that required our immediate attention."

FDA found that in many cases the labeling for restraints was not adequate, or directions for use were not attached to the devices. Care-givers often were not taught how to apply the devices correctly, or how to choose the appropriate device for the patient's need.

In March 1992, FDA began requiring manufacturers of restraints to label them "prescription only."

FDA has also proposed revising its current restraint device regulations to require manufacturers to demonstrate the safety of their products and include adequate labeling.

In addition, the new regulations would have manufacturers provide clearer instructions for applying restraints and encourage health-care facilities to establish staff training programs that focus on their proper use.

Evolving Restraint Use

Restraining patients with devices, as well as drugs, became popular during the late 19th century, when American and British psychiatric hospitals relied on them to help subdue individuals with psychiatric disorders.

More recently, restraints have primarily been used by hospitals and nursing homes to keep patients suffering from dementia, Alzheimer's disease, and other debilitating ailments from hurting themselves.

This widespread use started to wane in the mid-1980s, when nursing homes, placing more of an emphasis on patient rights and quality of life, began to look for alternatives, said Deborah Cloud, associate director of communications for the American Association of Homes for the Aging (AAHA).

This reduction, Cloud said, was reinforced by the Omnibus Budget Reconciliation Act of 1987, which included the Nursing Home Reform Law.

"The law basically required nursing homes to severely reduce the use of restraints," Cloud said. "We've concentrated on developing alternatives and minimizing the use of restraints from a standpoint of resident dignity, but you can't just stop something overnight."

A recent AAHA survey showed that nursing homes across the country reduced their use of restraints by 47 percent between 1989 and 1991.

Still, safety belts, vests and jackets, lap and wheelchair belts, and fabric body holders are placed on more than a quarter of a million nursing home residents a year.

In some cases the decision to restrain a patient is made by the primary attendant, usually a nurse. Other times the decision is reached after consultation among the patient's nurse, physician and family. In all cases, the patient's physician must sign the order to use the restraint, a requirement initially mandated by 1974 federal regulations governing skilled nursing homes.

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.