to Marge’s continued health. The evaluator recommended a manual wheelchair with an adjustable seat-to-back angle, pressure-relieving cushion, off-the-shelf back with right lateral trunk support, and right arm trough. Once the facility supervisor and Marge’s family understood why this equipment was required, the order was approved. Restraints Government policies and regulations present slightly varying definitions of what constitutes a restraint. However, generally speaking, a restraint is something that limits movement. Definitions also vary with specific setting. Seating and mobility technologies are often used to support a very specific position or posture of a body part as well as minimize migration in a specific direction. The term restraint is sometimes used to describe a device employed to limit harmful motion in a vehicular transportation system. In wheelchair seating, a restraint is an apparatus whose use is carefully controlled in many settings and governed by federal or state regulations or local policies (Babinec et al., 2015). Title 42 of the Code of Federal Regulations makes clear that uses of restraints have their legal limitations. CFR 42 Part 482.13 (e) (Patient Rights) states the following: All patients have the right to be free from physical or mental abuse, and corporal punishment. All patients have the right to be free from restraint or seclusion, of any form, imposed as a means of coercion, discipline, convenience, or retaliation by staff. Restraint or seclusion may only be imposed to ensure the immediate physical safety of the patient, a staff member, or others and must be discontinued at the earliest possible time. (U.S. Government Publishing Office, 2016) This regulatory language does not apply to wheelchairs, seating systems, or secondary supports when used to provide postural support, stability, pressure distribution, and pressure relief, as opposed to being used as a means of “coercion, discipline, convenience, or retaliation by staff.” According to CFR 482.13(e)(1), “A restraint is … any manual method, physical or mechanical device, material, or equipment that immobilizes or reduces the ability of a patient to move his or her arms, legs, body, or head freely.” However, 482.13(e)(1)(i) (C) clarifies that “a restraint does not include … orthopedically prescribed devices …” (U.S. Government Publishing Office, 2016). In other words, this definition does not apply to wheelchairs, seating systems, or secondary supports when used to provide postural support, stability, pressure distribution, and pressure relief, as opposed to intentionally immobilizing or reducing movement. Movement may be limited by this seating technology; however, the intent is postural support, stability, pressure distribution, and pressure relief for improved function, not limitation of movement. The Interpretive Guidelines for this standard further clarify that a mechanical support used to achieve proper body position, balance, or alignment so as to allow greater freedom of mobility than would be possible without the use of such a mechanical support is not considered a restraint (Centers for Medicare and Medicaid Services [CMS], n.d.). Wheelchairs, seating systems, and secondary supports are used to achieve proper body position, balance, and alignment. Depending on the complexity of the client’s needs, mobility may not be improved; however, the intent is not to limit movement (Jones, 2018). The issue of physical restraint regulation and interpretation becomes further complicated when some agencies continue to use definitions that are not current. Until 2007, a physical restraint was considered to be “any manual method or physical or mechanical device, material, or equipment attached or adjacent to the resident’s body that the individual cannot remove easily which restricts freedom of movement or normal
shoulders and that the client is trained in propulsion techniques that also reduce risk of injury. Seating evaluation is rarely a one-time appointment but rather an ongoing relationship. The client’s positioning needs will change over time, and seating systems will require modification or replacement. Follow-up is critical to ensure successful outcomes now and in the future. Case study Marge is 78 years old and recently had a left CVA, resulting in right hemiparesis. She is leaning to her right side and has a significant kyphosis secondary to osteoporosis. She resides in a long-term care facility and is seated in a standard manual wheelchair with a sling seat and back. The chair has fixed armrests, and someone has placed a pillow between Marge and the right armrest to minimize her lateral lean. She is quite flexed forward and must hyperextend her neck to eat at mealtimes, which places her at risk of aspiration. In the geriatric population, aspiration often leads to pneumonia, a very serious health risk in an elderly person. The evaluator convened a meeting to discuss her recommendations and why they were so important Regulations and policies Although clinicians can justify the use of wheelchair seating components, it is imperative that they be familiar with applicable regulations so that, by following these guidelines, they can provide appropriate seating interventions despite a particular The Omnibus Budget Reconciliation Act of 1987 (OBRA) mandates that the individual’s preference regarding use of a restraint must be met, if possible (P.L. 100-203, 1987). An individual may prefer specific seating interventions (that may be misconstrued as a restraint) for functional purposes or to minimize the risk of injury. If the individual requests such intervention, it can be used despite other policies that may be in place. For example, an adult with cerebral palsy who has significantly increased muscle tone may be able to drive his power wheelchair with his chin- mounted joystick if his arms are strapped to the arm support. The client does not consider these straps to be restraints and has requested their use. Removing the arm straps, in this case, would be restraining, as the individual would no longer be independently mobile in the powered mobility device. setting’s policies concerning restraints. Omnibus Budget Reconciliation Act OBRA regulations state the following: “Restraints may only be imposed, 1) to ensure the physical safety of the resident or other residents, and 2) only upon written order of a physician that specifies the duration and circumstances under which restraints are to be used” (P.L. 100-203, 1987). OBRA regulations apply to facilities receiving federal funding, though other settings may adopt these regulations, interpret them, and add to them. Federal law concerning the use of restraints Title 21 of the Code of Federal Regulations defines “restraint” for the U.S. Food and Drug Administration (FDA; 21 CFR Section 880.6760), referring to a restraint as follows: 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. (FDA, 2015) This definition applies specifically to devices that attach directly to a person with the specific intent of controlling the movement of the person or a part of the person. The FDA regulates products for which restraint is a specific intent, but it does not define as restraints any other products or devices that may be adjacent to a person and that are also used to control movement of a person. This means that the FDA regulations do not apply to wheelchairs, seating systems, or secondary supports when the intent is to provide postural support, stability, pressure distribution, and pressure relief.
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