“Custom-made foot orthotics are medical insoles worn inside footwear. They are designed and manufactured based on a specific individual’s feet and footwear to address a need determined during a clinical assessment by a qualified footcare professional.”
Theories and approaches continue to evolve as pedorthists are moving beyond traditional Root Theory onto understanding the Tissue Stress-based model, sensorimotor, vibratory, and texture-based designs. The updated PAC definition of custommade foot orthotics is intended to keep its policies and communications in alignment with evolutions in technology.
Historically, defining a foot orthotic as custom-made has been strongly focused on the manufacturing process. However, one cannot ignore the relevance of clinician assessment and design skills. It is important to acknowledge that it would be inaccurate to define foot orthotics as custom-made based on the manufacturing process alone. And it would be equally erroneous to limit the definition to only one aspect of the manufacturing process, such as casting technique, or brand name of scanner used.
Whether the pedorthist builds their own orthotics in an in-house lab or uses an external central fabrication facility, each pedorthist is responsible to authenticate and use clinical discretion in the processes and technologies used when manufacturing and dispensing their patients’ orthotics. Below you will find a critical pathway of thinking and rationale, designed to help members scrutinize the processes and technologies they use in their everyday practice to ensure members accountability to the CPC Code of Ethics and Standards of Practice, which can be found here.
Please note, by answering “no” to any one of the questions below will disqualify the orthotics as “custom- made” unless reasonable medical justification can be provided.
Is the patient assessment provided in alignment with the CPC Code of Ethics and Standards of Practice?
Information gathered during the assessment provides the knowledge that the clinician uses to design the orthoses “custom” to patient need. Understanding the appropriate footwear that will optimize the intended outcome.
Does the design provided in the work order medically meet the needs of the patient to appropriately manage, and achieve the intended outcome for each patient?
The orthotic description contained in the work order is formal communication from the clinician to the manufacturer. The design of the orthotic must offload and/or address the corrections outlined in the work order, as required.
Does the negative casting process capture an accurate replica of the patient’s foot in weight bearing, semi-weight bearing and non-weight bearing positions?
The skillset of the person taking the negative cast of the patient’s foot is much more influential on patient success than the actual type of cast taken. However, the clinician needs to use a casting process that captures the unique anatomy of the patient’s foot, and that cast must be utilized throughout the full manufacturing process. Systems and processes that rely on extensive algorithms eliminate the clinician’s ability to implement unique observations found during the assessment.
Does the positive casting process allow all needed correction to be added to the negative cast?
This manufacturing stage is paramount to being able to provide a device that is custom to the patient’s need, unique to their anatomy, and is a crucial step to ensure compliance with the clinician’s work order. Systems and processes that rely on extensive algorithms inhibit the technician’s ability to implement unique observations found during the assessment.
Does the shell fabrication process utilize raw materials shaped to the positive cast of the patient’s foot?
This manufacturing stage is critical to provide a device that is custom to the patient’s need, unique to their anatomy, and is a vital step to ensure compliance with the clinician’s work order. Technology that can only mill one type, thickness or durometer of material would limit the diversity to provide the most medically justified design for their patients.
Does the assembly process allow all needed correction to be added to the final orthotics?
This manufacturing stage is fundamental to being able to provide a device that is custom to the patient’s need, unique to their anatomy and is a crucial step to ensure compliance with the clinician’s work order.
Was a fitting and follow-up provided?
A vital stage to increase patient care and compliance, as it serves to improve patient education, reinforce expectations, verifies orthotic/footwear interfacing, and formally addresses the possibilities of adjustments and fine tuning of the orthotics.