Ohio officials seek to promote 3D-printing of prosthetics via law change

Jon Husted prosthetics press conference

Lt. Gov. Jon Husted, at podium, speaks during a Statehouse news conference on June 13. Also pictured (from left) is Aaron Westbrook, a 20-year-old Ohio State student who runs a prosthetics-manufacturing charity, state Sen. Rob McColley and Carrie Kuruc, director of the state Common Sense Initiative.

COLUMBUS, Ohio — Lt. Gov. Jon Husted wants to change Ohio law to encourage organizations like a Columbus-area charity that manufactures artificial limbs and gives them away for free.

Aaron Westbrook, a 20-year-old Ohio State University student, runs a charity that uses 3D printers and recycled plastic to make “task-specific” prosthetic limbs — which traditionally can run tens of thousands of dollars — and gives them to children. Westbrook says even without recycled materials, the limbs cost just $250.

But under a 2001 state law, prosthetics manufacturers need a state prosthetics manufacturing license, requirements for which include a bachelor’s degree, eight months of supervised work under a licensed prosthetist and other steps. That process can take six years.

Husted, who runs a new state agency dedicated to fostering innovation, said his office learned of a push to prevent the unlicensed use of 3D printers to make artificial limbs. He said often, pushes for regulation can come from efforts to ward off competition.

“Aaron is providing an innovative and creative solution to a problem that he and many other people face, and I don’t want outdated laws to stand in his or anyone else’s way,” Husted said during a Statehouse news conference on Thursday.

Husted said he’s working with state Sen. Rob McColley, a Henry County Republican, to try to change the licensure law. McColley said he will submit an amendment to the state budget allowing unlicensed people to use 3D printing of open-source prosthetic kits. State senators are expected to vote on the state budget next week.

Diane Farabi, executive director of the Ohio Orthotics and Prosthetics Association, said in an email that her profession recognizes there is “exciting” innovation in the field that has the “potential to offer life-changing care” for patients.

“Those in the field of physical rehabilitation recognize that in most instances, it is important for those who receive prosthetic care be treated by an appropriately trained individual,” she said. “It is important to understand that prosthetic care is much more than simply manufacturing and delivering a device.

In written testimony to the U.S. Food and Drug Administration in 2016, the national AOPA referred to making sure regulations allow for safety and maintain “consistency and a level regulatory playing field for the devices without regard to the specific method of fabrication employed by the manufacturer.”

Missy Anthony, executive director of the state board that licenses prosthetics manufacturers, said her board, which also oversees athletic trainers and physical therapists, is studying the issue.

“3-D printing of prosthetics is a cutting edge technology that was not contemplated when Ohio’s prosthetics statute was written,” she said in an email. “The Ohio Occupational Therapy, Physical Therapy, and Athletic Trainers Board looks forward to working with Lt. Gov. Husted on this issue in an effort to balance public protection and innovative practice.”

Westbrook, who was born with an underdeveloped right arm that stops below his forearm, has been making prosthetic limbs since he created a prosthetic arm for himself using a 3D printer when he was a sophomore in high school. He is from New Albany, a Columbus suburb.

Aaron Westbrook, Form 5 Prosthetics

Aaron Westbrook (Andrew J. Tobias)

Westbrook today runs Form 5 Prosthetics, which uses recycled Number 5 plastic — things like margarine tubs and baby bottles — to make task-specific limbs for children. Westbrook said the costs of prosthetics and insurance restrictions on how frequently they can be replaced can limit how often a family can get a new one without paying the full sticker price.

This can mean a family can only afford to buy their child one general-purpose prosthetic a year, he said.

Westbrook said his prosthetics that are more specialized than those made by large manufacturers, allowing kids to use one in their daily life and another to play sports or musical instruments, or perform specialized activities like fishing. His work has drawn media attention in the Columbus area.

“The laws that we need should foster innovation and make prosthetics more accessible. The law in its current form could prevent more work to provide better prosthetics,” he said.

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