The American Academy of Orthotists and Prosthetists (The Academy) is the premier organization representing professionals in the field of orthotics and prosthetics. The Academy is dedicated to promoting professionalism and advancing the standards of care through education, literature, research, advocacy, and collaboration.

In keeping with our mission, the Academy supports the use of additive manufacturing (3D printing) and other innovative manufacturing processes to advance orthotic and prosthetic patient care. Such emerging techniques have the potential to improve strength-to-weight ratio, enhance fabrication consistency, and improve access to care. Additive manufacturing technologies are continually advancing. As new materials and techniques emerge, the opportunities for utilization will also continue to increase.

As the profession adopts new technological advances, we must ensure the orthoses and prostheses we provide continue to be appropriate, safe, and meet or exceed the current standard of care. Stringent safeguards are required to accomplish this, so individuals with disabilities can benefit over the long term. These safeguards will serve to ensure quality and efficacy as new options are being explored.

Certified/Licensed Orthotist and Prosthetists are healthcare providers who undergo rigorous education in anatomy, physiology, kinesiology, pathology, biomechanics, materials science and clinical assessment directly related to the provision of orthoses and prostheses. Proficiency standards are set and regulated by the National Commission on Orthotic and Prosthetic Education (NCOPE) and the Commission on Accreditation of Allied Health Education Programs (CAAHEP). Orthotic and Prosthetic professionals must pass certification examinations and maintain certification via continuing education, and they are ethically bound to their credentialing body’s Code of Professional Responsibility. See the Academy’s Position Statement on Minimum Education Standards and Credentialing for more details.

It is incumbent upon credentialed providers of orthoses and prostheses to adhere to American Board of Certification in Orthotics, Prosthetics and Pedorthics (ABC) or Board of Certification/Accreditation (BOC) guidelines and any applicable state licensure requirements. Additionally, all 3D printed devices whether custom or off-the-shelf should meet the established criteria of the American Academy of Orthotists and Prosthetists (the Academy) listed below:

1. The safety of all patients receiving 3D printed orthoses, prostheses, or associated components, must be of paramount importance. ‘Safety’ is identified as structural integrity, appropriate material selection and integration, durability, and intimacy of fit to mitigate skin irritation or breakdown. Orthoses and prostheses must be designed for long-term use during normal activities of daily living. Or, as necessary, designed to accommodate high level activities such as recreation and sport.
2. Functional outcomes with 3D printed devices should be held to the same standards of rigor of devices manufactured in any other manner. They must be minimally consistent with current standards of practice and meet applicable or relevant regulations and guidelines provided by ISO, FDA and other organizations.
3. The provision of custom orthoses and prostheses must be justified as medically necessary and authorized via medical prescription and with appropriate physician oversight.
4. Assessment, design criteria, componentry selection, fabrication oversight, fitting(s) and device delivery, must be done only by certified and/or licensed orthotists or prosthetists to ensure optimal outcomes, functional efficacy, patient safety and liability protections.
5. The Academy encourages efforts to develop standards associated with the provision of 3D printed orthoses and prostheses and are committed to developing standards for the provision of orthotic and prosthetic technology, guided by clinical practice guidelines (CPGs) and evidence-based practices, to ensure consistent, high-quality, patient-centered care.