Ohio Set to Implement Rules for 3D-printed Prostheses

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By Dianne Farabi

Changes to Ohio's orthotics, prosthetics, and pedorthics (OPP) licensure law will allow the Occupational Therapy, Physical Therapy, and Athletic Trainers (OTPTAT) Board to grant authority to an individual who is not licensed to practice prosthetics to engage in the 3D printing of upper-limb prostheses using open-source prosthetic kits.

The draft rules for 3D printing of prostheses came out of work group meetings that began last summer. The board solicited input from licensed O&P practitioners who use 3D printing and others, local and national, including those who live with limb loss. The draft rules were approved by the OPP Advisory Council and the OTPTAT Board and submitted to the Common Sense Initiative (CSI)*, a requirement to determine whether the rule would have an adverse impact on businesses. The board also completed a business impact analysis and submitted the rule for CSI review.

CSI Asks, "Why Regulation?"

The OTPTAT Board submitted the following information to the CSI: "As technology of 3D printing evolves, there is a national movement to provide an alternative product in the prosthetics space that is 3D printed. This technology is typically developed by individuals with knowledge, interest, or experience in engineering, but not necessarily with a medical background, such as training in prosthetics. As more individuals get involved in filling a demand for 3D printed prosthetics, it is important to have some oversight of this niche as it evolves with the ultimate goal of protecting the patient/limb recipient. The legislature gave the Board oversight in this area and the Board hopes to learn more about the training and activities of 3D printing with the goal of evolving regulation as the technology changes."

According to the draft rules, the applicant will demonstrate proficiency through review of 3D-printing coursework, relevant training or credentials (knowledge of appropriate material use, etc.), an understanding of how a person with limb difference uses the printed device, and examples of experience printing 3D products for individuals in the limb-different community.

The agency stated that the rule attempts to balance basic public protection with the flexibility to allow technology to develop.

The OTPTAT Board says it hopes to begin accepting applications this spring. Applications will be considered by board members and recommendations made for approval. Over time, the board will be able to gather more information on what to expect in an application and standard guidelines to issue authority for 3D printing of open source prosthetic kits.

See the following links for the draft rule language, CSI Business Impact Analysis, and the revision to the relevant code:

The official deadline for initial comments has passed. However, thoughts and questions can be sent to the OTPTAT board at rules@otptat.ohio.gov.

* The Common Sense Initiative was established "to eliminate excessive and duplicative rules and regulations that stand in the way of job creation." Agencies "must balance the critical objectives of regulations that have an adverse impact on business with the costs of compliance by the regulated parties."

Dianne Farabi is the executive director of the Ohio Orthotics and Prosthetics Association. She can be contacted at 614-659-0197 or dffarabi@gmail.com.