64B11-4.001. Use of Prescription Devices

(1) Electrical Stimulation Device.

(a) Use of an electrical stimulation device for which a prescription is required by Federal law, 21 C.F.R. §801.109, is expressly prohibited by Section 468.203(4), F.S., except by an occupational therapist or an occupational therapy assistant who has received training as prescribed in this rule.

(b) For purposes of this rule, an “electrical stimulation device” is any device for which a prescription is required which employs transcutaneous electric current (direct, alternating, or pulsatile) for therapeutic purposes.

(c) The training required for students, postgraduates, and licensees to qualify for the use of an electrical stimulation device shall include didactic training of at least four (4) hours and performance of at least five (5) treatments under supervision in a clinical setting. The required training may be obtained through educational programs, workshops, or seminars offered at a college or university approved for training of occupational therapists by the American Occupational Therapy Association or of physical therapists by the American Physical Therapy Association or at clinical facilities affiliated with such accredited colleges or universities or through educational programs offered by the American Society of Hand Therapists or Florida Occupational Therapy Association. Didactic training may be in person or from interactive, real-time courses. An interactive, real-time course may be a web-based, satellite transmitted, or video conference, or online instruction program that allows or requires the licensee to interact in real time, including live chat, with the instructor during the presentation of the program.

(d) Supervised treatment sessions shall be conducted under the personal supervision of licensed occupational therapists and occupational therapy assistants who have completed four hours of coursework in the use of electrical stimulation devices and five (5) supervised treatments or licensed physical therapists and physical therapist assistants trained in the use of electrical stimulation devices. Treatment supervisors must have a minimum of 24 months prior experience in the use of electrical stimulation devices. Personal supervision means that the supervisor is in the room with the trainees and actively provides guidance and supervision of the performance treatments.

(e) The training provided which teaches the therapeutic uses of electrical stimulation devices shall provide for the following minimum competency level:

1. Standards.

a. The expected outcome of treatments with Therapeutic Electrical Current (hereinafter T.E.C.) must be consistent with the goals of treatment.

b. Treatment with T.E.C. must be safe, administered to the correct area, and be of proper dosage.

c. Treatment with T.E.C. must be adequately documented.

2. Current Duration and Mode.

a. Ability to determine the duration and mode of current appropriate to the patient’s neurophysiological status while understanding Ohm’s Law of electricity, physical laws related to the passage of current through various media, as well as impedance.

b. Ability to describe normal electrophysiology of nerve and muscle; understanding generation of bioelectrical signals in nerve and muscle; recruitment of motor units in normal muscle and in response to a variety of external stimuli.

c. Ability to describe normal and abnormal tissue responses to external electrical stimuli while understanding the differing responses to varieties of current duration, frequency and intensity of stimulation.

3. Selection of Method and Equipment.

a. Ability to identify equipment with the capability of producing the preselected duration and mode.

b. Ability to describe characteristics of electrotherapeutic equipment and understanding the therapeutic value of different electrotherapeutic equipment.

c. Ability to describe safety regulations governing the use of electrotherapeutic equipment.

d. Ability to describe principles of electrical currents.

e. Ability to describe requirements/idiosyncrasies of body areas and pathological conditions with respect to electrotherapeutic treatment.

4. Preparation of Treatment.

Ability to prepare the patient for treatment through positioning and adequate instructions.

5. Treatment Administration.

a. Ability to correctly operate equipment and appropriately adjust the intensity and current while understanding rate of stimulation, identification of motor points, and physiological effects desired.

b. Ability to adjust the intensity and rate to achieve the optimal response, based on the pertinent evaluative data.

6. Documentation of Treatments.

Ability to document treatment including immediate and long-term effects of therapeutic electrical current.

(f) Any occupational therapist or occupational therapy assistant who uses such electrical stimulation device shall, upon request of the Board, or the Department, present proof that he or she has obtained the training required by this rule.

(2) Ultrasound Device.

(a) Use of an ultrasound device for which a prescription is required by Federal law, 21 C.F.R. §801.109, is expressly prohibited by Section 468.203(4), F.S., except by an occupational therapist or occupational therapy assistant who has received training as prescribed in this rule.

(b) For purposes of this rule, an “ultrasound device” is any device intended to generate and emit ultrasonic radiation for therapeutic purposes at ultrasonic frequencies above 100 kilohertz (kHz).

(c) The training required for students, postgraduates, and licensees to qualify for the use of an ultrasonic stimulation device shall include didactic training of at least four (4) hours and performance of at least five (5) treatments under supervision in a clinical setting. The required training may be obtained through educational programs, workshops, or seminars offered at a college or university approved for training of occupational therapists by the American Occupational Therapy Association or of physical therapists by the American Physical Therapy Association or at clinical facilities affiliated with such accredited colleges or universities or educational programs offered through the American Society of Hand Therapists or Florida Occupational Therapy Association. Didactic training may be in person or from interactive, real-time courses. An interactive, real-time course may be a web-based, satellite transmitted, or video conference, or online instruction program that allows or requires the licensee to interact in real time, including live chat, with the instructor during the presentation of the program.

(d) Supervised treatment sessions shall be conducted under the personal supervision of licensed occupational therapists and occupational therapy assistants who have completed four hours of coursework in the use of ultrasound devices and five (5) supervised treatments or licensed physical therapists and physical therapist assistants trained in the use of ultrasound devices. Treatment supervisors must have a minimum of 24 months prior experience in the use of ultrasound devices. Personal supervision means that the supervisor is in the room with the trainees and actively provides guidance and supervision of the performance treatments.

(e) The training provided which teaches the therapeutic uses of ultrasound devices shall provide for the following minimum competency level:

1. Standards.

a. The expected outcome of treatment with ultrasound must be consistent with the goals of treatment.

b. Treatment with ultrasound must be safely administered to the correct area, and be of proper dosage.

c. Treatment with ultrasound must be adequately documented.

2. Instrumentation.

a. Ability to describe the physiological effects of pulsed versus continuous modes as well as differentiate tissue responses to the modes of application.

b. Ability to describe ultrasound absorption characteristics of various body tissues and identify sources and causes of excessive absorption in normal versus abnormal tissue.

c. Ability to determine the medium to be used and the temperature of that medium.

d. Ability to select the appropriate sound head size and contour considering the area and condition being treated.

e. Ability to describe equipment characteristics, indications and contraindications for treatment, including identifying source and mechanisms of generation of ultrasound energy and its transmission through air and physical matter.

3. Preparation for Treatment. Ability to prepare the patient for treatment through positioning and adequate instruction.

4. Determination of Dosage. Ability to determine dosage through determination of target depth, chronicity versus acuteness of the condition, and application of power/dosage calculation rules.

5. Treatment Administration. Ability to administer treatment through identification of controls, sequence of operation, correct sound head application techniques and application of all safety rules and precautions.

6. Documentation of Treatment. Ability to document treatment, including immediate and long-term effects of clinical ultrasound.

(f) Any occupational therapist or occupational therapy assistant who uses such ultrasound device shall, upon request of the Board, or the Department, present proof that he or she has obtained the training required by this rule.

(3) Neurofeedback Device.

(a) Use of a neurofeedback device for which a prescription is required by Federal law, 21 C.F.R. §801.109, is expressly prohibited by Section 468.203(4), F.S., except by an occupational therapist or occupational therapy assistant who has received training as prescribed in this rule.

(b) For purposes of this rule, a “neurofeedback device” is any device that provides immediate feedback from a computer-based program that measures brainwave activity with the use of sound, visual and/or tactile input to cue the brain to reorganize and retrain itself.

(c) The training required for students, postgraduates, and licensees to qualify for the use of a neurofeedback device shall include didactic training of at least sixteen (16) hours and performance of at least five (5) treatments under supervision in a clinical setting. The required training may be obtained through educational programs, workshops, or seminars offered at a college or university approved for training of occupational therapists by the American Occupational Therapy Association or of physical therapists by the American Physical Therapy Association or at clinical facilities affiliated with such accredited colleges or universities or educational programs offered through the American Society of Hand Therapists or Florida Occupational Therapy Association. Didactic training may be in person or from interactive, real-time courses. An interactive, real-time course may be a web-based, satellite transmitted, or video conference, or online instruction program that allows or requires the licensee to interact in real time, including live chat, with the instructor during the presentation of the program.

(d) Supervised treatment sessions shall be conducted under the personal supervision of licensed occupational therapists and occupational therapy assistants who have completed sixteen (16) hours of coursework in the use of neurofeedback devices and five (5) supervised treatments, licensed physical therapists and physical therapist assistants who have completed sixteen(16) hours of coursework in the use of neurofeedback devices and five (5) supervised treatments, medical doctors trained in the use of neurofeedback devices, psychologists trained in the use of neurofeedback devices, or other licensed healthcare professionals trained in the use of neurofeedback devices. Treatment supervisors must have a minimum of 24 months prior experience in the use of neurofeedback devices. Personal supervision means that the supervisor is in the room with the trainees and actively provides guidance and supervision of the performance treatments.

(e) The training provided which teaches the therapeutic uses of neurofeedback devices shall provide for the following minimum competency level:

1. Standards.

a. The expected outcome of training with neurofeedback devices must be consistent with the goals of treatment.

b. Training with neurofeedback devices must be safely administered to the scalp.

c. Training with neurofeedback devices must be adequately documented.

2. Instrumentation.

a. Ability to describe core concepts, methods, and instrumentation of neurofeedback.

b. Ability to interpret the EEG (electroencephalogram) with respect to signal integrity and the presence of artifacts.

c. Ability to understand and describe concepts of frequency and amplitude.

d. Ability to create, adjust and adapt training protocols based on the EEG, clinical observation, and response to training.

e. Ability to describe equipment characteristics, indications and contraindications for training.

3. Preparation for Training. Ability to prepare the patient for training through positioning and adequate instruction.

4. Determination of training duration and intensity.

a. Ability to discern when a trainee exhibits limited tolerance for an extended training session.

b. Ability to judge the pacing of training sessions based on tolerance and response to the training session.

5. Training Administration. Ability to administer neurofeedback training through identification of controls, sequence of operation, and application of all safety rules and precautions.

6. Documentation of Neurofeedback Training. Ability to document training, including immediate and long-term effects of clinical neurofeedback training.

(f) Any occupational therapist or occupational therapy assistant who uses such neurofeedback device shall, upon request of the Board, or the Department, present proof that he or she has obtained the training required by this rule.

(g) This rule shall be reviewed, and if necessary, repealed, modified, or renewed through the rulemaking process five years from the effective date.

Rulemaking Authority 468.203(4), 468.204 FS. Law Implemented 468.203(4) FS. History–New 1-1-88, Formerly 21M-15.001, 61F6-15.001, Amended 12-4-95, Formerly 59R-63.001, Amended 8-9-99, 7-2-00, 4-1-13, 9-2-20, 1-16-23, 10-1-23.