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FDA ISSUES NEW GUIDELINES ON PATIENT RESTRAINTS

 FDA ISSUES NEW GUIDELINES ON PATIENT RESTRAINTS
 WASHINGTON, June 16 /PRNewswire/ -- Saying that patient restraint


devices can be dangerous when used improperly, the Food and Drug Administration is seeking improved labeling and more supervision by trained health professionals when these devices are used. Restraints include safety vests, jackets, lap and wheel chair belts and fabric body holders.
 To help decrease the risks, FDA is requiring manufacturers to label restraints "prescription only" and proposing that they be required to provide clearer directions for use.
 "FDA's proposal provides for training, education and guidelines for the safe use of protective restraints. This action will help ensure that these devices are used properly," said FDA Commissioner David A. Kessler, M.D. "When they are necessary, medical restrains provide benefit to many patients and their caregivers, but if they are used improperly, patients may suffer injuries or even death."
 In a letter sent to manufacturers of patient restraints, FDA cited inadequate warning labels and described potential hazards associated with misuse of the devices as factors contributing to injuries and deaths.
 Every day, restraints are used on more than half a million people in health care facilities, primarily to prevent falls or other injuries. However, FDA has estimated that at least 100 deaths occur annually from their improper use in nursing homes, hospitals and private homes. Most of the deaths are due to strangulation. The agency has also received reports of broken bones, burns and other injuries related to improper use of restraints.
 The agency's review of the reported incidents has shown that they may have resulted principally from incorrect use, including inappropriate patient selection, incorrect restraint selection, errors in applying the devices and inadequate monitoring of patients when restrained.
 In response to the reports of serious injury and death, the agency is proposing to change the products' regulatory status to allow review of these devices and their labeling before they are marketed, and identification of any potential problems.
 "We are proposing, based on our evaluation of these products, that patient restraints be used under the supervision of a health care professional or other trained individual, and that the labeling provide adequate information to ensure safe and effective use," said James S. Benson, director of FDA's Center for Devices and Radiological Health. The agency is also encouraging health care facilities to train their staffs in proper use of restraints.
 The guidelines include using alternatives to restraints whenever possible, observing patients in restraints frequently, adjusting for patients' comfort and following manufacturers' directions for use. FDA's actions are in agreement with the Health Care Financing Administration guidelines that emphasize the safe use of these devices in long-term care facilities.
 The agency's proposed rule would permit FDA to require that all restraints incorporate simple and easy to follow directions for use. Manufacturers would have to provide clear label instructions with warnings about potential hazards. FDA believes that new labeling is needed to ensure that personnel select the correct size and correctly determine the front and back. Manufacturers would also be required to include statements that restraints should be secured to bed springs or frames rather than to movable rails, and that knots used to secure the restraints should be tied so that they can be quickly released.
 HCFA already requires that the educational information be distributed to advise patients that they should be aware of their rights to refuse restraint, the facilities' policies for use of restraints and the need for documentation and monitoring of the use of restraints by health care professionals or other professionals or other professional staff trained in the use of restraining devices.
 Available evidence does not indicate that problems are related to the design of any particular restraint type, model or manufacturer.
 Written comments on the proposal, which will be published in the June 19 Federal Register, may be sent, by Aug. 18, to Dockets Management Branch (HFA-305), Food and Drug Administration, Rm. 1-23, 12420 Parklawn Drive, Rockville, Md., 20857.
 FDA is one of the eight Public Health Service agencies within HHS.
 -0- 6/16/92
 /NOTE: TV Broadcasters please use open caption for the hearing impaired./
 /CONTACT: Susan Cruzan of the Food and Drug Administration, 301-443-3285 or, after hours, 301-926-7081/ CO: Food and Drug Administration ST: District of Columbia IN: MTC SU:


TW -- DC012 -- 0737 06/16/92 14:17 EDT
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Date:Jun 16, 1992
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