FDA Consumer

Prescription required for patient restraints

Prescription required for patient restraints

Patient restraint devices, used on more than half a million people in nursing homes and hospitals, are now available by prescription only, as a result of a recent FDA action. FDA took this step because, as currently labeled and used, the devices may pose serious risks to patients.

FDA proposed other regulatory changes for the devices, including requiting premarket approval, in the June 19, 1992, , Federal Register.

“When they are necessary, medical restraints provide benefit to many patients and their care-givers,” said FDA Commissioner David A. Kessler, M.D. “But if they are used improperly, patients may suffer injuries or even death.”

The restraints, which include safety vests, jackets, lap and wheelchair belts, and fabric body holders, are intended to prevent falls or other injuries. Their incorrect use, however, is responsible for an estimated 100 or more deaths each year, mostly due to strangulation. Broken bones, bums, and other injuries have also been reported.

An FDA review of reported incidents shows that inappropriate patient selection, incorrect restraint selection, errors in applying the devices, and inadequate patient monitoring are the primary causes of injuries related to their use. FDA also proposed that:

* labels for the devices provide clearer directions for use with warnings about potential hazards

* the devices be used under the supervision of a health-care professional or other trained individual

* health-care facilities train their staffs in proper use of the restraints

* alternatives to restraints be used whenever possible

* patients be observed frequently for comfort and safety.

The Health Care Financing Administration already requires distribution of educational information to advise patients that they have a right to refuse restraints and to be informed of facilities’ policies regarding their use, and that use of restraints should be monitored and documented by staff specially trained for this purpose.

COPYRIGHT 1992 U.S. Government Printing Office

COPYRIGHT 2004 Gale Group