(53 days)
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.
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 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.
Medline's Safety Vests are intended to be utilized as a patient safety device when physical restraint of the patient is deemed necessary.
The four types of vests are described as follows:
A. Security Vest - Criss-Cross vest with waist belt that ties out of reach. Shoulder loops may be used with extra straps (provided) to help prevent patient from sliding down or sitting up in bed. All straps are intended to the bed frame or to the wheelchair kick spurs utilizing an overhand knot and magnus hitch. Vest criss-crosses in front through a sewn in web loop. See tab C (labeling page 5A ) for illustration of appropriate tie methods and directions. Reference Attachment A for a pictorial of this device. This vest is manufactured of "Koolnit" material which is a polyester mesh.
B. Economy Vest - Criss-Cross vest with waist belt that ties out of reach. All straps are intended to be tied to the bed frame or to the wheelchair kick spurs utilizing an overhand knot and magnus hitch. Vest criss-crosses in front through a sewn in web loop. See tab C (labeling page 5A) for illustration of appropriate tie methods and directions. Reference Attachment A for a pictorial of this device.
C. Safety Vest - Criss-Cross vest with waist belt that ties out of reach. This vest differs from the Security Vest and Economy in that there are no shoulder loops and there is a sewn slot in the front of the vest which the material passes through, as opposed to a sewn web loop. All straps are intended to the bed frame or to the wheelchair kick spurs utilizing an overhand knot and magnus hitch. See tab C (labeling page 5A) for illustration of appropriate tie methods and directions. Reference Attachment A for a pictorial of this device.
D. Tie-Back Vest - Vest crosses and ties in back, making it more difficult for the patient to remove. Shoulder loopsmay be used with extra straps (provided) to help prevent patient from sliding down or sitting up in bed. Corset buckles are used to secure straps to bed frame or wheel-chair kick spurs. See tab C (labeling page 5A) for illustration of appropriate tie methods and directions. Reference Attachment A for a pictorial of this device.
This document does not contain an acceptance criteria table or a study description of a device meeting that criteria. Instead, it describes information regarding Medline's Protective Restraint, Vest Wheelchair Accessory, Vest Restraint devices, and references existing literature on the safety and effectiveness of protective restraints generally.
Therefore, I cannot provide the requested information.
§ 880.6760 Protective restraint.
(a)
Identification. A protective restraint is a device, including but not limited to a wristlet, anklet, vest, mitt, straight jacket, body/limb holder, or other type of strap, that is intended for medical purposes and that limits the patient's movements to the extent necessary for treatment, examination, or protection of the patient or others.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.