Patient Restraints : Part 3

by Food and Drug Administration (FDA)

(Page 3 of 3)

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 right 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 health-care 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 tubes, 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 health-care 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."

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.

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.

About the Author

www.fda.gov
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.