Prosthetists in the US are closely watching the developments in Ohio as a new law gives anyone with a 3D printer the ability to begin providing artificial limbs.
This chain of events started when Aaron Westbrook, now a 20-year-old Ohio State University student, used recycled plastic and a 3D printer at his old high school to create a prosthetic arm when he was 15 years old. Born without a hand and wrist on his right arm, Westbrook used his first creation.
Westbrook, who is also the CEO of Form5 Prosthetics, a nonprofit that provides 3D printed prosthetics to those in need, started providing 3D printed devices for others. In 2016, he created a prosthetic arm for then first-grader Maddie Horvath. The following year, Westbrook created a 3D printed prosthesis for then fifth-grader Tate Simmons that would allow him to hold a bow to play the cello. Moreover, just last summer, he worked with five individuals to outfit them with adaptive devices.
An amendment to offer “flexibility” to innovate
Westbrook caught the attention of Lt. Governor Jon Husted, who oversees the red tape-cutting Common Sense Initiative, and Senator Robert McColley. Both of them sponsored and fast-tracked an amendment in Ohio’s Biennial Budget bill, which intended to offer “flexibility” for people like Westbrook to engage in 3D printing of open-source kits for prostheses.
The initiative intended to make it easier for individuals to “innovate in prosthetic device design.” Through the use of open-source kits, anyone with a 3D printer can create their own prosthetic designs with an intent to provide them to the amputee community.
McColley and Husted announced this amendment during a press conference in June without asking the input of the professional prosthetic practitioner community. Unfortunately, several misleading and inaccurate statements were made about the prosthetic community, leaving many with less than favorable impressions about the prosthetic profession.
Attempts were made by the Ohio Orthotic & Prosthetics Association to persuade Sen. McColley to include additional language to his amendment that would restrict the 3D devices to upper limb prosthetics. His preference was to leave the amendment as written.
What about regulation?
Clearly, 3D printing has a place in the future of health care. We cannot deny the benefits that it brings for prosthetic users: affordability, customization, flexibility, and innovation. What the amendment is not clear on is whether 3D printed assistive devices will be regulated. It is not clear if some form of oversight will be put in place.
The importance of regulation cannot be stressed enough in a field like prosthetics. People’s lives and safety are on the line when they wear 3D printed prosthetics for general use.
We beg to ask: What happens when someone wears a 3D printed prosthetic leg that breaks down because it wasn’t meant to carry a person’s weight?
Without proper regulation and oversight, the use of 3D printed medical devices could easily lead to dangerous outcomes while no one takes responsibility for the misstep. Will the digital CAD file programmer be held liable? Or perhaps the materials manufacturer? The law needs to answer these questions to ensure the safety of every prosthetic user.
What does this mean for the quality of care?
Many prosthetists are also concerned that the quality and care synonymous with the prosthetic community will be lost if laws allow people to purchase 3D printed limbs online. It raises the question of who will be responsible for maintaining the 3D printed limbs? Will the responsibility fall on the designer, the owner of the 3D printer, or will the user of the 3D printed prosthetic device need to consult with a prosthetist?
While there is nothing wrong with innovation, it shouldn’t be done at the expense of end-user safety and quality care.
The prosthetic community is willing to work with the government to help create a law that allows for innovation but prioritizes the safety of the prosthetic user.As a prosthetic user, do you feel the laws should limit open-source 3D printed limbs to upper extremities only? And what’s your take on this new Ohio bill? Do you think your future prosthetic care is in jeopardy, or do you think this bill allows for greater innovation within the field? Please share your thoughts in the comment section below.