Patient Restraints, Improving Safety, Reducing Use by Victor Lambert A REPRINT FROM FDA CONSUMER MAGAZINE Printed May 1993 This article originally appeared in the October 1992 FDA Consumer PUBLICATION No.(FDA) 93-4255 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. [Graphic Omitted] Unlike the restraint involved in Florence Carlson's death, this device is correctly tied to the top and bottom of the wheelchair. [Graphic Omitted] [Graphic Omitted] Above, a patient whose restraint is tied incorrectly can slide out of the device and be injured or even die by asphyxiation. Left, because restrained patients sometimes try to free themselves, it's important that the restraint is properly secured to prevent injuries. 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 them 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 requiting 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 fights 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. There is disagreement within the medical community about the extent to which restraints should be used, Cloud said, but most health professionals maintain that limited use of the devices can be beneficial. Restraints assist immobile patients to maintain good posture, help prevent falls that lead to injury, keep dangerous patients from harming others, and provide some patients with a sense of safety. New FDA Recommendations FDA sent a safety alert letter last July 15 to more than 75,000 members of the health-care community warning them about the potential hazards associated with restraint devices, particularly when they are used incorrectly. Sent to administrators, nursing directors, and emergency room service directors at all U.S. hospitals, nursing homes, and acute-care facilities, the alert outlines appropriate standards for care when using restraints, and describes new requirements for restraint manufacturers. When restraints are used, whether institutionally or in the home, FDA recommends that these guidelines be followed: * Assess the cause for which the restraint is being considered, develop alternatives to restraint use, and implement these alternatives before applying restraints. * Allow the use of restraints only under the supervision of a licensed health-care provider and for a strictly defined period. * Use with patient and family consent. * Continue assessment even after a restraint is used, and discontinue use as soon as feasible. * Check on restrained patients frequently. * Remove restraints every two hours, and more often if necessary, to allow for normal body functioning and daily activities. * Apply and adjust the restraint so that it is comfortable for the patient. * Follow the manufacturer's directions to: * select the type of restraint recommended for the patient's condition * use the correct size for the patient's weight * note the "front" and "back" of the restraint and apply correctly * tie knots that can be released quickly * secure bed restraints to the bed springs or frame, never to the mattress or bed rails. With an adjustable bed, secure the restraints to the parts of the bed that move with the patient. The following guidelines apply particularly to institutions such as nursing homes: * Define a clear, written institutional policy on the use of restraints, and make it available to patients or residents. * Display this policy and other instructions in a highly visible location and in foreign languages as well as English, if necessary. * Provide regular staff training, including demonstrations, in the proper use of restraints. * Obtain informed consent from patients or guardians before using restraints to prevent misunderstanding and to ensure cooperation. * Keep well-documented patient records of problems, including why, how, where, and for how long the restraint is used. * Follow local and state laws regarding the use of these devices. --V.L. Restraints can also help the elderly perform daily living activities, such as dressing and eating, and make it easier for health-care providers to perform certain medical procedures, such as changing intravenous lines or inserting nasal gastric robes. Danger Abounds But despite their benefits, restraints can be dangerous if applied incorrectly or left on a patient too long. Most problems associated with patient restraint devices can be attributed to poorly trained or inattentive staff, according to Mark Bruley, director of the Accident and Forensic Investigations Group at the Philadelphia-based Emergency Care Research Institute. In many cases of injury, patients had been placed in restraints unnecessarily, allowed to wander unattended in some types of restraints for long periods, or placed in restraints inappropriate for their condition. Other problems include health workers choosing the wrong size or style restraint, tying it too loosely or too tightly, or putting it on backward, all of which can result in injury and death. "The main three problem areas we've noticed have to do with health workers applying them [restraints] incorrectly, using the wrong size, and not securing them to the bed," Bruley said. [Graphic Omitted] If straps of devices are tied too loosely, confused patients can become entangled in them. "In some cases it's a systems problem. Patients have been choked to death by the restraint or bed rail because no one was paying attention. In other cases, patients have tried to get out of their restraints and injured themselves. It's a matter of providing better staff training." Some health-care facilities teach workers how to correctly apply restraint devices, but others do not. "I see the greatest problem with nurses and their aides," Bruley said. "Often times a restraint is applied for convenience. It enables staff to do other things without having to look at the patient as often as they should." Marian A. Parrott, M.D., associate professor of geriatrics in George Washington University' s Department of Health Care Sciences, Washington, D.C., said that restraint use is more reflective of staff attitude. "It's a matter of how much risk they' re willing to take," said Parrott, who is also an internist. "They're afraid of being found at fault if a patient falls." Federal law requires that restrained patients be repositioned every two hours, but there are occasions when they are not moved for longer periods, Parrott said. As a result, some develop health problems such as nerve damage and incontinence. They can also develop bed sores, loss of muscle tone, and depression. "If a patient sits in the same place long enough, he can get into all kinds of contorted positions," Bruley added. "Once that happens it's very easy for the patient to get hurt." One of the fastest-selling and most often used restraints is the V-neck vest. It costs between $8 and $14 and is more comfortable than many others. The vest, which is produced by several of the largest manufacturers of restraint devices, is made of cloth or mesh, crisscrosses the patient's chest, and is tied to a bed or chair with straps. [Graphic Omitted] When patients must be restrained, properly applied devices increase comfort and greatly reduce the risk of injuries. But while it is designed to keep a patient from tilting forward or falling out of a chair, the vest's cotton canvass material "has a lot of play," often collapsing and squeezing against the neck or stomach. Similarly, the straps used to secure the vest can entangle, strangling a patient. "We didn't know that they were as dangerous as they are," said Joanne Rader, R.N., a clinical specialist at Benedictine Institute for Long Term Care, Mount Angel, Ore., and an assistant professor at Oregon Health Sciences University. "People weren't well-educated." Benedictine, said Rader, uses restraints on fewer than 4 percent of its residents, and its ultimate goal is to become restraint-free. Reducing Restraint Use Fueling the anti-restraint movement is the notion that while restraints serve some useful purposes, they fail as a long-term method for protecting patient safety. No reliable data exists to prove that patients who are restrained are safer than those who are not, and many health practitioners feel that alternatives to restraints should be the first option. "You have to begin by assessing the patient's situation," Parrott said. "Rehabilitative approaches, like physical therapy, or an environmental approach, like safer chairs, lower beds, and safer floor material should be looked at first. "For wandering patients you could set up a special area. This would make it easy to monitor them without restricting their movement." Patients who have a history of falling out of their wheelchairs, said Rader, could have wedged pads placed on the seat to keep them from sliding out. "If a patient falls out of bed at night, you could fashion a mattress bed fight on the floor," Rader said. "Sometimes doing something as simple as putting a table in front of them to keep them from falling works. It's hard to justify using restraints with what we know now." But getting families and the medical community to embrace this philosophy has been, and will continue to be, a hard sell, she said. Barriers to Change At the heart of staff resistance, according to Rader, lies the fact that most healthcare workers were educated to believe restraints make patients safer. While they might dislike putting restraints on patients, they also feel that the pressures of heavy workloads and the difficulty in always knowing where every resident is place the confused patient at risk of injury from falling or wandering from the unit. "Even when I became convinced about not using them for wanderers, I wasn't able to see not using them for falling patients," Rader says. "Now I know that this was ridiculous. We were taught a myth." Parrott said that when she was the director of a nursing home, her staff told her that restraints had to be used and she went along with it. "But that was before I read the literature about them," she said. "For humanitarian and ethical reasons it's best to avoid them whenever possible." Another barrier to moving away from using restraints is nursing home accident reporting requirements. If a patient, for instance, has fallen and the accident report shows the patient was not restrained at the time, the attending nurse could be charged with neglect. "We have a paternalistic system," said Rader, "a model set up to make you believe that your job is to protect patients from their own poor judgment." Family resistance most often comes from this belief, Rader said. If an elderly person has a history of falling in the home, family members usually believe that a restraint is the only way to protect the person. "What they don't understand is that their father or mother would be more at risk with a restraint," Rader said. "Often times restraining patients makes it easier for them to fall because their hands or limbs are tied while they're trying to adjust to a new environment. "Restraints can be good for some acute procedures, like removing or inserting robes, but they shouldn't be used after that. They should be the last option." FDA's Benson also emphasizes the importance of using restraints properly. "Our new regulations won't solve the problem completely," he said, "but we think they will improve the safety of these devices. "We're also working with the healthcare community to increase the correct use of protective restraints when they are really needed. Together, these efforts should make a significant impact on reducing injuries and deaths." Victor Lambert is a staffwriter for FDA Consumer. We hope you found this reprint from FDA Consumer magazine useful and informative. FDA Consumer, the magazine of the U.S. Food and Drug Administration, provides a wealth of information on FDA-related health issues: food safety, nutrition, drugs, medical devices, cosmetics, radiation protection, vaccines, blood products, and veterinary medicine. For a sample copy of FDA Consumer and a subscription order form, write to: Food and Drug Administration, HFI-40, Rockville, MD 20857.