Patient Restraints: Suggestions From The FDA

Legal Eagle Eye Newsletter for the Nursing Profession

April 1996 

  For the time being, the FDA has a number of advisory suggestions for healthcare facilities in which patient restraints are used, based upon studies the FDA has conducted, published literature, and public comments the FDA has been receiving to proposed regulations published in 1992.   FEDERAL REGISTER, March 4, 1996 Pages 8432 - 8439.

   The U.S. Food and Drug Administration has published a number of suggestions for how patient restraints should be used in healthcare facilities. The FDA’s suggestions are only advisory at the present time.

   The FDA supports a "prescription" requirement, under which restraints may be applied only by licensed healthcare providers under physicians’ orders. Physicians’ orders should specify the appropriate restraint type, duration of application and circumstances of use.

   The FDA has no comment at this time on the appropriate frequency for patients under restraint to be monitored.

   Although restraints, when safely applied, must be tied securely, it is also vital that care providers be instructed to use knots which can be easily untied in the event of an emergency. The FDA is considering regulations to require patient restraints to have clasps which caregivers can quickly unfasten.

   Selection of the appropriate size and type of restraint, particularly with vest restraints, is critical for safe and effective use. It may be helpful for the brand and types of restraints to be standardized for all units of a particular facility. Clinicians as well as purchasing agents should consult medical practice guidelines for selection of restraints, although no source is cited for this in the literature other than the FDA’s own safety alert disseminated in 1992.

   The FDA advises that patients under restraint must not be allowed to smoke. Further, family members and visitors should be cautioned not to furnish smoking materials to patients in restraints and that they themselves should not smoke around patients who are in restraints. The problem can be particularly acute when oxygen is in use.

   Caregivers should be particularly vigilant with any patient in restraints who has a history of setting fires to the room, to furnishings, to the patient’s own person or to the restraints as a means of attempting to get free of them.

   The FDA encourages the use of posters and other visual aids in the training of staff who will care for patients who are in restraints, especially where staff would not be expected to gain full benefit from complicated verbal instructions, or from instructions presented only in English. Posters and other visual aids should be readily noticeable in patient rooms, nurses stations and physical therapy areas.

   The FDA is considering regulations to require approved staff training materials to be provided by manufacturers along with restraining devices themselves, as a part of the FDA approval process for sale of restraint devices. It encourages healthcare facilities to make full use of any training aids and in-service presentations currently being made available by manufacturers and their representatives.