News
06/16/1992

<TITLE>Patient Restraint Devices can be Dangerous</TITLE>
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P92-17                                      Food and Drug Administration
FOR IMMEDIATE RELEASE                       Susan Cruzan - (301) 443-3285

    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 restraints 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.
                                   -MORE-

                                      Page 2, P92-17, Patient 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 educational information be distributed to      
advise patients that they should be aware of their rights to refuse           
restraints, 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 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 the 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.
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