<!-- PERSPECTIVE --> Additive manufacturing (AM), or 3D printing, allows for production of complex shapes that would be cost prohibitive or impossible to produce with traditional manufacturing methods. AM allows for quick, iterative prototyping to speed up the design process, characteristics that lend themselves well to applications in O&P that could reduce overall costs. Medical professions, including O&P, are just starting to scratch the surface of the clinical possibilities that this technology can hold for treating patients. The ease with which AM allows for the creation of complex objects has led online communities to explore the use of 3D printing to create prosthetic hands for children with upper-limb differences, a population that has been historically underserved by O&P. The energy and enthusiasm within these online groups is contagious and their popularity has increased exponentially. The media loves to cover the stories, but has also perpetuated the falsehood that all prosthetists are trying to take advantage of an innocent population by selling $80,000 prostheses when a $50 3D-printed hand would have sufficed. Of course, nothing could be further from the truth. In reality, any comparison between an admittedly expensive but U.S. Food and Drug Administration (FDA)-approved medical device fit by a certified prosthetist and an inexpensive 3D-printed hand fit by an untrained individual is wholly inappropriate. The only thing that these two devices share is that they are both attempting to replicate the function of the human hand. Medical devices to be sold and used on a patient must meet FDA regulations to help ensure patient safety. By not charging patients for the 3D-printed devices, these groups are attempting to-and currently succeeding at-avoiding regulatory scrutiny. Whether or not the patient is billed for a prosthesis does not discharge the supplier from his or her obligation to meet FDA requirements for medical devices. There are three areas related to patient safety of AM prostheses that the FDA and O&P professional organizations need to address: <ol> <li>Provision of clinical O&P services to patients by untrained, uncertified, and unlicensed individuals</li> <li>Manufacturing and distribution of unregulated 3D-printed medical devices</li> <li>Lack of institutional review board (IRB) oversight for human subjects testing of 3D-printed investigational medical devices</li> </ol> I am inspired to see so much energy and enthusiasm in these online groups as they attempt to develop functional, cost-effective prostheses for people with upper-limb amputations. Due to the collaborative nature of these groups, the rate at which device designs can be refined is impressive. Some designs are now quite advanced. As a profession, we need to invite that same enthusiasm into our ranks by forming a synergistic relationship with the 3D-printing community in which patients benefit from innovative, functional, safe, and cost-effective medical devices fit by certified clinicians. However, this union cannot be forged haphazardly by abandoning FDA patient safety rules and regulations. AM needs to be used and embraced for what it is: another method that can be integrated appropriately into our fabrication processes. <em>Chris Baschuk, MPO, CPO, LP, is an upper extremity prosthetics specialist for Handspring, headquartered in Middletown, New York. He serves as the treasurer for the Upper Limb Prosthetics Society of the American Academy of Orthotists and Prosthetists.</em>
<!-- PERSPECTIVE --> Additive manufacturing (AM), or 3D printing, allows for production of complex shapes that would be cost prohibitive or impossible to produce with traditional manufacturing methods. AM allows for quick, iterative prototyping to speed up the design process, characteristics that lend themselves well to applications in O&P that could reduce overall costs. Medical professions, including O&P, are just starting to scratch the surface of the clinical possibilities that this technology can hold for treating patients. The ease with which AM allows for the creation of complex objects has led online communities to explore the use of 3D printing to create prosthetic hands for children with upper-limb differences, a population that has been historically underserved by O&P. The energy and enthusiasm within these online groups is contagious and their popularity has increased exponentially. The media loves to cover the stories, but has also perpetuated the falsehood that all prosthetists are trying to take advantage of an innocent population by selling $80,000 prostheses when a $50 3D-printed hand would have sufficed. Of course, nothing could be further from the truth. In reality, any comparison between an admittedly expensive but U.S. Food and Drug Administration (FDA)-approved medical device fit by a certified prosthetist and an inexpensive 3D-printed hand fit by an untrained individual is wholly inappropriate. The only thing that these two devices share is that they are both attempting to replicate the function of the human hand. Medical devices to be sold and used on a patient must meet FDA regulations to help ensure patient safety. By not charging patients for the 3D-printed devices, these groups are attempting to-and currently succeeding at-avoiding regulatory scrutiny. Whether or not the patient is billed for a prosthesis does not discharge the supplier from his or her obligation to meet FDA requirements for medical devices. There are three areas related to patient safety of AM prostheses that the FDA and O&P professional organizations need to address: <ol> <li>Provision of clinical O&P services to patients by untrained, uncertified, and unlicensed individuals</li> <li>Manufacturing and distribution of unregulated 3D-printed medical devices</li> <li>Lack of institutional review board (IRB) oversight for human subjects testing of 3D-printed investigational medical devices</li> </ol> I am inspired to see so much energy and enthusiasm in these online groups as they attempt to develop functional, cost-effective prostheses for people with upper-limb amputations. Due to the collaborative nature of these groups, the rate at which device designs can be refined is impressive. Some designs are now quite advanced. As a profession, we need to invite that same enthusiasm into our ranks by forming a synergistic relationship with the 3D-printing community in which patients benefit from innovative, functional, safe, and cost-effective medical devices fit by certified clinicians. However, this union cannot be forged haphazardly by abandoning FDA patient safety rules and regulations. AM needs to be used and embraced for what it is: another method that can be integrated appropriately into our fabrication processes. <em>Chris Baschuk, MPO, CPO, LP, is an upper extremity prosthetics specialist for Handspring, headquartered in Middletown, New York. He serves as the treasurer for the Upper Limb Prosthetics Society of the American Academy of Orthotists and Prosthetists.</em>
