Ohio Administrative Code › Title 4755 - Ohio Occupational Therapy, Physical Therapy Board, and Athletic Trainers Board › Chapter 4755-62 - Definitions; Scope of Practice › Section 4755-62-02 - Device-related and scope of practice definitions

Current through all regulations passed and filed through July 1, 2024
The following definitions must apply to
				the language of Chapter 4779. of the Revised Code:
(A)
								"Accommodative"
			 as defined at division (A) of section
			 4779.01 of the Revised Code
			 means in addition that the item is designed to conform to the anatomy of the
			 particular person who purchases and wears the item., . "Accommodative" may
			 describe an item sold on a strictly retail basis, but may also describe an item
			 requiring custom fitting or custom fabricating as required by patient
			 presentation and medical order.
(B)
								"Arch support" as
			 used in division (G) of section
			 4779.01 of the Revised Code
			 means an item sold off-the-shelf on a retail basis to be accommodative to the
			 anatomy of the foot for the person who uses it; and which is not custom fitted
			 or custom fabricated, and is not provided to fill a doctor's order or
			 healthcare prescription.
(C)
								"Nontherapeutic" as used in divisions (D) and (G) of
			 section 4779.01 of the Revised Code
			 means an item sold off-the-shelf on a retail basis, which is not custom fitted
			 or custom fabricated, and is not delivered to fill a doctor's order or
			 healthcare prescription.
(D)
								"Therapeutic" as used in division (A) of section
			 4779.01 of the Revised Code
			 refers to an item delivered to fill a patient-specific doctor's order or
			 healthcare prescription.
(E)
								"Custom fabricated or fitted medical device" as
			 referenced in divisions (E), (G), or (I) of section
			 4779.01 of the Revised Code
			 means an orthotic, prosthetic or pedorthic device that is individually made
			 (custom fabricated) or fitted (custom fitted) for a specific patient. Further,
			 it is a device the provision of which requires access to a facility with the
			 equipment necessary to fulfill the ongoing consumer-care responsibility to
			 provide follow-up treatment, including modification, adjustment, maintenance
			 and repair of the item(s).
(1)
									A custom fabricated item is defined as a device which
			 is individually made for a specific patient. No other patient would be able to
			 use this item. A custom fabricated item is a device which is fabricated based
			 on clinically derived and rectified castings, tracings, measurements, and/or
			 other images (such as x-rays or digital scans) of the body part. The
			 fabrication may involve using calculations, templates and components. This
			 process requires the use of basic materials including, but not limited to
			 plastic, metal, leather or cloth in the form of uncut or unshaped sheets, bars,
			 or other basic forms and involves substantial work such as vacuum forming,
			 cutting, bending, molding, sewing, drilling and finishing prior to fitting on
			 the patient.
A molded-to-patient-model item is a
				particular type of custom fabricated device in which either:
(a)
										An impression
			 (usually by means of a plaster or fiberglass cast) of the specific body part is
			 made directly on the patient, and this impression is then used to make a
			 positive model of the body part from which the final product is crafted;
			 or
(b)
										A digital image of the patient's body part is made
			 using computer-aided design-computer aided manufacture (CAD-CAM) systems
			 software. This technology includes specialized probe/digitizers and scanners
			 that create a computerized positive model and then direct milling equipment to
			 carve a positive model. The device is then individually fabricated and molded
			 over the positive model of the patient. The use of CAD/CAM software or digital
			 software packages and hardware to generate a negative model (3D printing) can
			 be used for direct fabrication of intermediate stages of the device up to and
			 including the final or definitive device itself.