During our sales process we are occasionally asked if iFIX is a form of stabilization or if it could it be considered a restraint. This is a valid question considering all of the requirements associated with placing a patient in restraints.
To answer the restraint vs stabilization question, it is helpful to review the definition of restraint as outlined by US Code of Federal Regulations and adopted by both The Joint Commission (TJC) and the Centers for Medicare & Medicaid Services (CMS).
Defining restraint in healthcare - what it is
Code 42 CFR 482.13 details the general rights of all patients as well as their rights to safety, privacy (including medical record privacy), as well as their rights when restraints are considered by medical staff. The definition of a restraint is as follows: “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”.1,2
Reading this, it is easy to understand why the questions regarding iFIX would arise. The standard goes on to explain that devices, like iFIX, are not considered restraints if used for the purpose intended.
Defining restraint in healthcare - what it isn't
Code 42 CFR 482.13 “A restraint does not include devices, such as orthopedically prescribed devices, surgical dressings or bandages, protective helmets, or other methods that involve the physical holding of a patient for the purpose of conducting routine physical examinations or tests, or to protect the patient from falling out of bed, or to permit the patient to participate in activities without the risk of physical harm.”1,2
The CMS Manual expands on this definition: A medically necessary positioning or securing device used to maintain the position, limit mobility, or temporarily immobilize the patient during medical, dental, diagnostic, or surgical procedures is not considered a restraint.3
So, as its name implies, the iFIX Patient Stabilization System is designed to comfortably and safely stabilize a patient for medical imaging or procedures.
The intent of patient stabilization in any imaging modality is to reduce or eliminate motion artifact, ensure the patient does not fall off the table, and keep the patient as comfortable as possible.
Comfortable, safe, secure, and versatile stabilization
iFIX is designed to replace the vinyl hook and loop straps that are provided by the table manufacturer. The iFIX system is composed of reusable anchors that connect to the imaging table in the same manner that your current straps attach.
The disposable element of the system consists of fleece that is cut to size, attached to one anchor, then stretched across the patient to the anchor on the opposite side of the table.
What is very difficult to communicate without seeing the product, is the strength with which the fleece attaches to the anchors. It is very strong, and this benefit often leads to the restraint question.
The developers of this technology incorporated two features to assist accessing the patient while stabilized. The first is the ability of the fleece, when pulled in the opposite direction of application, to easily disengage from the anchor. This is extremely helpful when the technologist needs to reposition a patient or roll a nauseous patient onto their side.
The second feature that helps with accessibility is the ability to cut an access port into the material without compromising the strength of the fleece or the stability of the patient. The provided cutter can be inserted into the fleece and a square window can easily be cut to access a treatment site or adjust a positional IV.
To learn more about the iFIX Patient Stabilization System call 1-800-233-5539 or email firstname.lastname@example.org.
1. Govregs.com [Internet]. Washington DC: U.S. Code of Federal Regulations, 482.13(e)(1)(i)(a) [Dec 27, 2019] – [cited 2019 Dec 27]. Available from: https://www.govregs.com/regulations/expand/title42_chapterIV_part482_subpartB_section482.13
2. Nonviolent Crisis Intervention CPI [Internet]. Joint Commission Standards on Restraint and Seclusion/ Nonviolent Crisis Intervention® Training Program. Milwaukee (WI): Page 4. [2010 Dec] - [cited 2019 Dec 26]. Available from: https://www.crisisprevention.com/CPI/media/Media/Resources/alignments/Joint-Commission-Restraint-Seclusion-Alignment-2011.pdf
. The CMS Manual [Internet]. New York (NY) Department of Health and Human Services (US), Centers for Medicare and Medicaid Services (CMS). Interpretive Guidelines for 482.13(e)(1)(i)(C) page 100.  – [cited 2019 Dec 27] Available from: https://www.cms.gov/Regulations-and-Guidance/Guidance/Transmittals/downloads/R37SOMA.pdf
Director of Training