MEDLINE ZIPPER SLEEVED VEST

{0} MEDLINE Medline Industries, Inc. One Medline Place Mundelein, Illinois 60060.4486 1.847.949.3109 1.800.950.0128 Fax 1.847.949.2643 Corporate Quality Assurance/Regulatory Affairs X 96 3452 # SAFETY AND EFFECTIVENESS SUMMARY Medline Industries, Inc. One Medline Place Mundelein, IL 60060 Phone #: (847) 949-2639 Fax #: (847) 949-2643 Lara N. Simmons Corporate Regulatory Affairs Manager August 28, 1996 OCT 18 1996 | Device Name: | Protective Restraint, Vest Wheelchair Accessory, Vest Restraint | | --- | --- | | Proprietary: | Medline Zippered Sleeved Vest Restraint | | Common: | Vest Restraint | | Classification: | Protective Restraint Wheelchair Accessory | These devices have been legally marketed prior to the date of this submission. The intended use and claims, technological features, materials and physical and mechanical specifications have not been changed. ## 1.0 General Description Medline’s Zippered Sleeved Vests are intended to be utilized as a patient safety device when physical restraint of the patient is deemed necessary. They may be utilized in either a bed or wheelchair. The short sleeves and zippered back make the vest more difficult for the patient to remove. Vest may be used with detachable shoulder straps (provided) to help prevent sliding down in the wheelchair or bed. ## INTENDED USE Medline Zippered Sleeved Vest Restraints may be used either in a bed or wheelchair. They are intended for use with patients or residents that need a “gentle reminder” for the patient to stay in their bed or wheelchair. These products are designed for use with a carefully defined medical treatment program which addresses (but is not limited to) restorative nursing, patient release, and pressure sore prevention. Aggressive, agitated or restless patients require increased monitoring and a systematic review and evaluation of both their physical and psychological status. Page 15 {1} Page 16 Medline Patient Safety Products are intended to be used for those patients suffering from temporary medical related cognitive deficits, for agitated patients, or to help patients feel safer in a bed or wheelchair. Medline Zipper Sleeved Vest Restraints are not intended for use with stretchers, on toilets or shower chairs or in the shower or tub, and should always be secured to the movable portion of the bed frame, never to the side rails. Vest restraints may get tight over the chest, possibly compromising breathing, in which case the patient may require a safety product with a pelvic portion between the legs. Medline Patient Safety Products are not intended for use in a motorized vehicle., as they are not designed to withstand the force of a crash. Medline Patient Safety Products are not intended for home use. These devices are for use in hospitals and/or nursing homes to help maximize patient safety and are not intended to preclude good nursing care and common sense. {2} Page 17 A reasonable search of all information known or otherwise presently available to Medline Industries, Inc. has been conducted. Such a search is defined as examining articles in medical literature, FDA literature, and company documents concerning safety and effectiveness information for safety restraints. Following is a summary of and citation to the safety and effectiveness data found in that search. Specific safety and effectiveness data outlined in the literature include actual as well as potential complications which may occur and are summarized as follows: Emotional desolation, agitation, fractures, chafing, burns, nerve damage, circulatory impairment, decubitus ulcers, death, and strangulation attributed to incorrect supervision, handling or application of protective restraint devices by medical or paramedical personnel. These incidences seem to be the result of inappropriate patient selection (physically restraining a patient for whom physical restraint is contraindicated), incorrect restraint selection, errors in correctly applying the device, and/or inadequate monitory of patients when restrained. When used correctly and for indicated circumstances, protective restrains provide benefits to many patients, such as precluding patients with temporary medical related cognitive deficits from impairing the resolution of their physical problems by involuntarily discontinuing life-support or other needed medical interventions, temporarily reducing the mobility of agitated patients, or helping patients feel safer in a bed or wheelchair. Medline Industries, Inc. offers a variety of additional materials to help insure the safe and proper use of it's patient safety products, including posters and videos. Medline Industries, Inc. stresses the importance of patient monitoring, and that these products should only be used upon advice of a physician or other trained, licensed healthcare professional. A total of thirteen articles were reviewed for this 510(k) submission. The articles listed in the citation contained pertinent data for establishing the safety and efficacy of protective restraints. {3} Page 18 # CITATION Physical Restraints: An FDA Update, American Journal of Nursing From FDA Nurses 1992; 74: November 1992, Mary D. Weick, RN, MSN. Potential Hazards With Protective Restraint Devices; FDA Medical Alert, dated November 14, 1991; MDA91-3 The Misuse of Physical Restraints in the Confused Patient; This paper was presented by Ms. Barbara Fitgerald, Ward Sister, Geriatric Unit, St. James Hospital Dublin at the INO Nursing Association for the Elderly Day Conference in April, 1986. Federal Register/Vol. 57, No. 119/Friday, June 19, 1992/ Proposed Rules Potential Hazards with Physical Restraint Devices; FDA Safety Alert, dated July 15, 1992 Restraint and Seclusion; Journal of Psychosocial Nursing, June 1985, Vol. 23, No. 6, Janice M. Roper, RN, MS, Adam Courtts, MS Janet Sather, RN, and Rosella Taylor, RN.