Ohio officials want to start a process that would change a state law to encourage organizations such as a Columbus-area charity that manufactures artificial limbs and gives them away for free.
Lt. Gov. Jon Husted, who runs a new state agency that fosters innovation, said his office learned of a push to prevent the unlicensed use of 3D printers to make artificial limbs, according to the website Cleveland.com. The effort stems from an Ohio State University student, Aaron Westbrook who has a limb deficiency on his right arm, and runs a charity that uses 3D printers and recycled plastic to make task-specific prosthetic limbs to give away to children. “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is providing an innovative and creative solution to a problem that he and many other people face, and I don’t want outdated laws to stand in his or anyone else’s way,” Husted told Cleveland.com during a news conference.
A state law passed in 2001 requires licensure for anyone fabricating prostheses, which include a bachelor’s degree, and residency with a licensed O&P facility. Husted said he’s working with state Sen. Rob McColley to try to change the licensure law, Cleveland.com reported. McColley said he will submit an amendment to the state budget allowing people without a license to use 3D printing of open-source prosthetic kits, the website said.
Though state senators are expected to vote on the state budget later in June, the legislation faces opposition from the O&P industry.
Diane Farabi, executive director of the Ohio Orthotics and Prosthetics Association, said in an email to Cleveland.com, 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 told the website. “It is important to understand that prosthetic care is much more than simply manufacturing and delivering a device.
The American Orthotic and Prosthetic Association (AOPA) provided written testimony to the U.S. Food and Drug Administration (FDA) in 2016, that would make certain 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. “3D printing of prosthetics … was not contemplated when Ohio’s prosthetics statute was written,” she said in an email to Cleveland.com.
