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THE ORTHOTIC & PROSTHETIC COMMUNITY NEWS SOURCE
How Do FDA Rules Apply to O&P? PG. 13 Liner With Embedded Electrodes for Myoelectric-Controlled Prosthesis PG. 17
O&P PG. 4
Choosing the Optimal PD-AFO for Your Patient PG. 22
Tom Watson, CP, LP PG. 26
P & O
Emerging Technologies PG. 32
YOUR CONNECTION TO
Vol. 27 â€˘ No. 3 | March 2018
Departments & Columns 29 State by State A monthly column dedicated to
the most important state and local O&P news.
30 In the News 30 Classified Ads 30 Ad Index 31 Meetings & Courses
32 Tech Tips How emerging technologies
Drawn to O&P
will revolutionize O&P
Individuals who treat and advocate for O&P patients come from a wide array of educational and professional backgrounds. Meet a physical therapist, a nurse, a researcher, and a student who have adopted O&P as an integral part of their profession. Contributions from Chris Doerger, PT, CP; Nancy Payne, RN, MSN, CWCN; Stephanie Huang, PhD; and Josef Borrayo
FDA and O&P Which rules set forth by the U.S. Food & Drug Administration apply to O&P businesses? By Thomas F. Fise, JD
Research & Presentations 17
Liner With Embedded Electrodes for Myoelectric-Controlled Prosthesis
Choosing the Optimal PD-AFO for Your Patient
26 O&P Visionary Tom Watson, CP, LP, advocates for increased collaboration with allied health professionals, payors, and government agencies.
By David Knapp, CPO
By Matthew Wernke, PhD; Cody Doddroe; Alexander Albury, CPO; Michael Haynes, MS; and Luke Beery
O&P News | March 2018
A strong voice today… and for the next 100 years Editorial Board Glenn Hutnick, CPO, CTP, FAAOP
Together we are AOPA.
Randall Alley, CP, BSc, FAAOP Biodesigns Inc.
Hutnick Rehab Support Services Inc.
Kevin Carroll, MS, CP, FAAOP
Greg Mattson, CTPO
Fabtech Systems LLC
Glenn Garrison, CPO
Hospital for Special Surgery
Fabtech Systems LLC
JoAnne Kanas, PT, CPO, DPT
O&P Industry 100 years ago Pediatric Orthotic and our Pros- O&P predecessors thetic Services, LLC, Shriners thought we needed a unified Michael voice Angelicoto secure International Headquarters Advanced O&Pwere Solutions the future of our profession. They right.
Thomas P. Karolewski, CP, FAAOP Hines VA Hospital
Robert S. Lin, MEd, CPO, FAAOP Hanger Clinic
Jonathan Naft, CPO
Geauga Rehabilitation Engineering
Matthew Parente, MS, PT, CPO
University of Hartford
Nabtesco & Proteor in USA
Justina S. Shipley CO, MEd, BOCP, FAAOP
Eric Shoemaker, MS, CPO
Orthotic Holdings Inc.
Jeffry G. Kingsley
Ability Prosthetics & Orthotics Inc.
Rhonda F. Turner, PhD, JD, (BOCPO, CFm)
Brad Mattear, LO, CPA, CFo
American Association of Breast Care Professionals
O&P Researchers and Educators
Steven A. Gard, PhD
Northwestern University Prosthetics-Orthotics Center
Amputee Coalition Nabtesco & Proteor in USA
Coyote Design and Rehab Systems
Don Pierson, CO, CPed Arizona AFO
Össur Americas Inc.
100 years ago our O&P predecessors thought we needed a unified voice to secure the future of our profession. They were right.
Mark D. Geil, PhD
Our profession needs a strong voice today and for the next 100 years. Your membership matters!
Ability Prosthetics & Orthotics Inc.
Shriners Hospital For Children
Together we are AOPA.
for CertificaOur profession needs aAmerican strongBoard voice tion in Orthotics, Prosthetics, Joel J. Kempfer, CP, FAAOP today and for the next 100 years. and Pedorthics Inc. Kempfer P&O Your membership matters! Jeffrey M. Brandt, CPO
O&P News | March 2018
Georgia State University
Mark Pitkin, PhD, DSc
Tufts University School of Medicine
Jon Shreter, CPO
Prosthetic and Orthotic Management Associates Corporation
Grace Prosthetic Fabrication Inc.
Steve Hill, CO, BOCO
MBA, CAE, Board of Certification/Accreditation
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Drawn to O&P
How four professionals from various backgrounds found their way to the O&P profession
P & O 4
O&P News | March 2018
alk into any O&P business, and you will likely find a diverse group of employees from varying backgrounds. While some arrived at an O&P career having grown up in a family business, others pursued the profession after spending time as O&P patients. Still others gravitated toward the profession because they enjoyed classes in high school or college that provide a solid basis for continuing O&P education. Today, young O&P professionals are coming from an even broader spectrum of backgrounds. Engineering students and researchers, allied health-care professionals, and even computer scientists are finding a place in the ever-growing O&P landscape. In this series of first-person profiles, a panel of individuals from vastly different backgrounds describe their introductions to the O&P profession and discuss the roles they now fill.
The Physical Therapy Route Chris Doerger, PT, CP EDITOR’S NOTE: We caught up with OPIE Software Clinical Advisor Chris Doerger, PT, CP, at the Annual Meeting of the American Academy of Orthotists and Prosthetists, where we asked her how she became part of the O&P profession, what roles she has taken on since becoming a certified prosthetist, and her vision of a diverse future in O&P.
On Finding O&P My first exposure to orthotics and prosthetics was as a physical therapy student at the UniverChris Doerger, sity of Miami, but it PT, CP wasn’t a focal point in my education. When I was first introduced to the practice of O&P, I was working for a large hospital system as a PT in a neuro outpatient clinic. It was a multidisciplinary clinic; we had orthopedics across the hall and a physiatrist upstairs, and we even had neuro-psych on the second floor. For one hour on Thursdays we had an “orthotics clinic.” For that one hour, our local CPO would come to the clinic and would see our patients that could potentially benefit from orthotic intervention. So, in our little mini-clinic, we would have the physiatrist, the CPO, and the therapists, and we would look at the patients together, in real time; talk about their cases; and get them what they needed. I participated in that orthotics clinic for quite a while, and it was shortly after I started that Scott Saunders, CPO, first asked me if I would see any of his amputees. Of course, I said, “No,” because I didn’t work with amputees; I worked with neurological, traumatic brain injury, and
Chris Doerger, PT, CP, with a patient during an OPAF First Clinic.
stroke patients. But he kept coming back to me and asking if he could send his amputee patients to me; I said, “Surely, there is someone in Orlando that can do a better job than I could, which is the only reason I’m telling you no.” He said, “Well, you’d be surprised.” I said, “OK, fine. Well, if that’s the case, send them over, and let’s see what we can do.” That relationship developed my interest in performing rehab and doing physical therapy with the limb loss population. It got to the point, being the curious person that I am, that I wanted to learn more about prosthetics. Scott was a phenomenal resource. He was there for me when I called him, he would tell me what the different knees did, and he taught me about socket fit. Ultimately, he encouraged me to go back to school. He suggested a number of great programs, and I ended up at Northwestern. After graduating from Northwestern, I got started in the profession at Evolu-
tion Industries. Craig MacKenzie, CP, was nice enough to hire me and teach me about what he was doing with his business at the time, which was custom liner design, central fabrication work, socket design, and even management of his central fabrication. I became the clinical and technical director at Evolution. Eventually Össur acquired Evolution, and I moved into a clinical position that was more of a teaching position. I was teaching clinicians, students, and even PTs about the different Össur products and about how they could more effectively teach their patients to use the devices. Toward the end of my Össur career, I was probably spending more time talking to PTs on subjects that were less about Össur products and more about documentation, like documenting K levels, and how they could help O&P clinicians by providing corroborating information that the payors were seeking.
O&P News | March 2018
Now, I am in a new position at OPIE Software where I am a clinical advisor, doing something very similar. I am doing a bit of teaching and training on OPIE Software, but also working in the background on updating clinical notes, making them more clinically accurate, and communicating that information to our customers. Obviously, legislation just dropped, so documentation is more important than ever before.
Different Hats Outside of my work at OPIE, I volunteer with a Wounded Warrior Group called Taskforce Dagger, and I work with the Orthotic and Prosthetic Activities Foundation (OPAF) in its First Clinics. We are attaching PT credits to the First Clinics so that we can continue to bring PTs over into the O&P world. I’m also an adjunct faculty member at the University of Central Florida in the DPT program. As a caveat, the one hat you will not hear me describe is that of a clinical practitioner. I didn’t work in O&P clinical practice much—not like I did in PT. The week after I finished my residency, my nephew was diagnosed with cancer. I had a decision to make; I was done with residency and it was time to take my Board exam, but my family needed my help. I was fortunate to have a PT job that knew me and would allow me to take the time off I needed to help support my family. The irony of the story is, where most people would go through a clinical track, and work in patient care for a while, and then go work for a manufacturer, I went about it completely backwards. By the time I could focus, pass my Boards, and apply for a clinical practice position, there weren’t any positions open in the Orlando area, but there was the position at Evolution. Because I had gone back to a PT position after school, there was a chance that I wouldn’t make it back to working in O&P. It had been a year and a half,
O&P News | March 2018
or more, when I started thinking about O&P again, and I probably spent a good six more months working in PT, but it just kept gnawing at me. I knew I completed school and completed the residency, and I just felt like I needed to get back there. I had to come back to O&P. It’s almost like I found the profession twice: once when I met Scott and started my CP education, and then again when my inner self told me not to let it go.
Vision of the Future Given what we know about healthcare statistics and what we know about the potential growth of the profession, there are going to be more opportunities in the profession in the future than there are today. There is more visibility outside of our profession into what we do now because of the military complex and the way technology is booming, I don’t think the growth is going to be limited to clinicians. When I see the free papers at the Academy meeting on socket comfort, followed by one on 3-D printing, that’s your indication that there are going to be opportunities in materials, technology, and CAD/CAM, and all the diversity of backgrounds that those areas bring with them. Whether it’s health care, electronics, engineering, or material science, I think all aspects of the profession are going to grow. With the increased visibility to the profession, people from engineering fields will come in. And we will just get deeper and richer in the knowledge that we have about the materials that we use with our patients and how they can impact their function. The one thing that I maintain, right now, is that where the folks in 3-D printing and other technologies think that they will be disruptors, that might not actually come to fruition. Ultimately, the technique used to create the device doesn’t matter; determining when to use a certain material and what
device is most appropriate to put on a patient will always be the role of the clinician. How to apply that clinical knowledge, education, and skill set will always be unique to O&P. The most important tool clinicians have is their critical thinking. There might be a number of industry disruptors that transform O&P, but what is not going to change is role of the clinician in taking these disruptive technologies and knowing when to use them judiciously, in order to create the best outcome for the patient.
The Unique Role of the Nurse Specialist Nancy Payne, RN, MSN, CWCN EDITOR’S NOTE: Nancy Payne, RN, MSN, CWCN, is the limb loss nurse specialist at Duke University Hospital and is the only nurse specialist in the country with that designation. Nancy shared the story of her introduction to O&P, and her view of the importance of the multidisciplinary team in caring for limb loss and mobility challenged patients. The role of limb loss nurse specialist was not a position at Duke or anywhere else before I took on the job. I was an orthopedic nurse and Nancy Payne, RN, MSN, followed my surgeon CWCN into the room of a patient one day. I listened to him speak so gently and kindly to this patient who needed a hip disarticulation surgery due to cancer. I thought, “What a way with words he has,” and hoped to be like him one day.
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He had an amputee clinic where diabetic foot infections were treated. I realized that there was this pattern in patients—I was seeing it over and over again, with infections, disease, and cancer. I wanted to be part of the solution. When the surgeon retired, I realized that someone would need to fill the void. I thought, “Why can’t a nurse coordinate the care of this patient population and work with all the teams that care for these patients?” Watching children and parents, adults, and cancer patients smile after their amputations, knowing they were past the hardest part, filled my heart with pleasure. I thought, “I can make a difference.” The limb loss population has medical and surgical needs, both of which I felt empowered to push Duke to do a better job providing care for. The surgical management of a patient does not typically include an assessment of the specific needs at home or take into account the difference between acute rehab and skilled nursing facilities. To make it more complicated, medical teams do not typically operate on these ischemic or infected patients with traumatic wounds. Wounds fascinated me, and I desired to help this population stay out of the hospital, be relieved of pain, and become mobile again. I thought, “Yes, I can do this!” The job of prosthetists and orthotists is to work with what others have left them. Excess tissue is not always easy to work with; adherent tissue due to failure of primary healing process means that closer attention must be paid to the patient, which results in more visits to the prosthetist. Orthotists rely on custom-fit or off-the-shelf orthoses to support a body part to promote a better and safer functionality. These were all areas of the patient-care process that I understood. I also understood that the type of education provided to the patient must parallel the education level of the patient. This was not always happening in the hospital. I now work with nursing residents
O&P News | March 2018
Nancy Payne, RN, MSN, CWCN; Congressman Brian Mast; Stella Sieber; and Erica NeSmith pose for a photo after meeting in the U.S. Capitol Building tunnel during the 2017 AOPA Policy Forum.
of the vascular, orthopedic, and plastic surgical teams to provide the patient and, subsequently, the prosthetist/orthotist, with the best outcomes possible. I truly believe that it is not just one person treating a patient, but that it should be an entire team. I wish there were more nurses in the same role I fill at Duke. I help educate patients and their families, help direct peer visitors, and help organize the physicians, prosthetists, orthotists, and wound care staff—all on behalf of the limb loss patients at the hospital. I feel connected to the team I work with: physiatrists, physical therapists, occupational therapists, prosthetists, and nurses. Without one of these team members, the patient does not receive the multidisciplinary team approach to help them recover and reintegrate into their world. Seeing individuals walk
again, or young children run and play again, has been my greatest pleasure in my career. Yes, I also know that the 90-year-old should be given a chance. The older patients are often pretty excited to show everyone that they can beat the odds. Some may give little-to-no hope to the geriatric population to ever walk again after amputation. No matter the patient’s age, I get to work with the prosthetist to meet their goals and those of their family. When they aren’t sure what to ask for, education is key; as a nurse, I always love to educate. I hope to one day convince the Wound, Ostomy, and Continence Nursing Society to view amputation teaching and care similar to that provided to the ostomate. Both patient populations have had a chronic problem, experienced surgery to remove some-
thing, and now have an external device to provide the functionality they previously had, yet one benefits from a fully supported plan of care, while the other does not. I personally see individuals who need Stephanie Huang, PhD higher-functioning prostheses, and I know that better technology will help EDITOR’S NOTE: Stephanie Huang, them get out of their wheelchair or PhD, is a research assistant professor at bed sooner, preventing further medical North Carolina State University. She issues. Likewise, I believe that lighter- works in the Closed-Loop Engineering weight prostheses should be available for for Advanced Rehabilitation (CLEAR) neuropathic patients. Lab, housed in the Joint Department The orthoses and prostheses these of Biomedical Engineering at North patients need should be considered a Carolina State University and the Unimedical necessity, like blood pressure versity of North Carolina–Chapel Hill. medications or an anterior cruciate ligament repair for an athlete to be able My research career beto play another season. The insurance gan very early, during companies have too much control over the first year of my unwhat the patient has access to, with no dergraduate studies at real understanding of what the patient the University of Michineeds in order to progress to his or her Stephanie gan, where I eventufull potential. ally earned my bachelor’s Huang, PhD
The Call to O&P Research
degree in mechanical engineering and master’s and PhD degrees in biomedical engineering. I was drawn to research because I’ve always been allured by the challenge of problem solving—trying to figure out something new even when I didn’t quite have all the knowledge I needed to answer a question. Research also gave me something that I could be good at and excel at outside of the classroom, where I could depend on my tenacity and perseverance to achieve success. I was drawn to the broad field of human biomechanics and rehabilitation because living in a human body, it was something that was tangible and that I could easily relate to. What’s allowed me to develop a multifaceted and comprehensive approach to my research is that I had a wide variety of research experiences within studying human movement. I’ve worked in various research labs with different perspectives and approaches under different academic departments,
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Stephanie Huang, PhD, and amputee volunteer James Frazier
where I acquired and gradually accumulated unique skill sets that I could use to solve new research questions. In particular, understanding how to design for humans and how to accommodate humans in the design process is something that I feel is a strong asset for me in pursuing the research I do now in the field of lower-limb prosthesis control. The importance of understanding the needs of your target population or end user (for designing prostheses, that’s the amputee) is something that is often underestimated or overlooked. I was first introduced to prosthetics research as a doctoral student at the University of Michigan, where my advisor gave me the opportunity to work on part of a grant from the Department of Defense involving myoelectric control of lower-limb prostheses using residual muscles of below-knee amputees. There are many ways that residual muscles can be used for myoelectric control of powered lower-limb prostheses, but my PhD advisor pushed me to pursue direct continuous proportional myoelectric control, free of automation—pure voluntary control. If I’m being completely honest, I didn’t
10 O&P News | March 2018
become fully invested in this research direction and realize its importance until I saw the emotional effect that direct voluntary control had on amputees. When the amputees I worked with realized they could use their residual muscles of their amputated leg to directly control the behavior of a powered prosthesis, they were amazed and it was empowering. One amputee would later tell me that the experience of this direct voluntary control felt to her like a sense of rebirth; another amputee said he felt like Avatar with a new body; yet another amputee said he felt younger and freer. This sense of freedom that comes from being reconnected to their complete body (by way of controlling a powered ankle prosthesis directly using their residual muscles) was what made it very clear to me that there was a still a lot to gain in prosthesis technology to get amputees to the height of living that they once had with two intact legs, prior to limb loss. After realizing the potential impact of this line of research, along with noticing that very few researchers were exploring this space, I became fully invested. Before I started with lower-limb research, I hadn’t known much at all
about amputees or prosthetics. The amputees and clinicians that I worked with became my greatest teachers. During the height of my dissertation research, I spent long hours over the course of many days with a handful of amputees during my experimental testing sessions that allowed me to build close relationships. Through these relationships, I really started to understand, the best I could as someone with fully intact limbs, what being a lower-limb amputee was like in their daily life, in their thought and decision-making processes, in their general outlook and perspective on various aspects of living with limb loss. What I’ve come to realize in my research approach is that I truly consider the amputees I work with as an integral part of the team. It’s an important mindset and a mindset from which I never waver. Together, we are a team, and we are in it together, and there is trust. On this foundation of trust, I have learned so much from the amputees through their willingness to share experiences, opinions, and thoughts—both directly related to and indirectly related to my research—which continuously shapes my research trajectory. The amputees that I have worked with throughout my research career also have proven to be some of my strongest and truest advocates; they continue to be the support system I need to continue pushing through my research challenges and struggles, and it is also a sort of validation that the research we are working toward together is achievable and worthwhile. Just as important as the amputees are the clinicians, including prosthetists and physical therapists, who are able to see things during my testing sessions that I lack the experience and clinical background to see. The clinicians have been invaluable to fostering both creative and critical thinking in working with the amputees to achieve my research goals. Having the opportunity to work with a certain prosthetist at the Orthotics and
The experimental powered ankle prosthesis is a test bed for direct continuous myoelectric control via residual muscles. The actuators are called pneumatic artificial muscles (PAMs) because their dynamics are similar to skeletal muscle. PAMs can generate high torque output and their compliance provides ample back drivability, which makes them ideal for the powered prosthesis test bed. The inflation pressure of the dorsiflexor/plantar flexor PAMs is directly proportional to the control signal from the residual dorsiflexors/plantar flexors. This allows the amputee to freely control the behavior of the experimental powered ankle.
Frazier is learning to use direct continuous myoelectric control to alter the mechanics of the experimental powered ankle prosthesis according to various environmental conditions. Above, he is freely exploring how he can use his residual ankle muscles to interact with a highly compliant surface (the blue mat). The computer screen shows real-time feedback of his residual muscle control signals.
Prosthetics Center at the University of Michigan really set a high bar, a necessary standard, for the clinicians with whom I seek collaborations today. Currently, I am at North Carolina State University. I am continuing and expanding my research working with below-knee amputees and proportional myoelectric control. I am directing my energy toward a case study with one representative below-knee amputee with hopes that researchers and clinicians in the field who read this case study will be able to gain a comprehensive understanding of what is necessary for amputees to learn to use their residual muscles (plantarflexors and dorsiflexors, independently) for direct neural control of a powered ankle prosthesis and to demonstrate the functional gains that can be
Frazier is balancing on a 2x4 without holding onto hand rails, and he was able to use the direct continuous myoelectric control to generate small corrective movements using his residual dorsiflexor and residual plantarflexor muscles to generate similar behavior to his intact ankle.
achieved in standing balance and stability with adequate training. Although in my research I am seeking prosthesis technology that is decades out from reaching the amputee user population, along the way I can see opportunities for delving into more clinically direct questions that will inevitably need to be addressed for future feasibility of implementing direct neural control using residual muscles. Specifically, I’ve learned the importance of residual muscles—not only for future direct neural control of powered prostheses, but also for improving rehabilitation for amputees following limb loss and for improving the residual limb/ prosthesis socket interface to allow amputees to actively use their residual muscles when using passive devices to enhance the
connection between their body (including their prosthesis) and their environment. I am actively working with a prosthetist now to bring this clinical aspect of the research regarding socket fit and residual muscle health to the attention of clinicians nationwide. Bridging the gap between clinicians and researchers/engineers/scientists is a longstanding issue and challenge. In fact, it was something that was told to me during my very early years as an undergraduate researcher—that bridging that gap is very difficult. And it is true: Clinicians and researchers coming together, working together, and sharing together on a consistent basis has proven to be a challenge. To address this challenge, it’s going to require a cumulative effort on the small scale of individuals.
O&P News | March 2018
If each of us involved in research does our duty to reach out to make new connections, foster connections to build up the clinician/researcher community, and break down barriers of judgement to gain mutual respect for one another, then gradually we’ll see a shift and a formation of a true conglomerate of clinicians and researchers that is necessary to make a realizable impact in the advancement of prosthesis technology that can improve patient outcomes.
The Computer Science & Engineering Connection Josef Borrayo EDITOR’S NOTE: Josef Borrayo is one member of a group of undergraduate electrical engineering students at the University of Washington who found their way to O&P through a capstone project with an outside advisor, David Boone, MPH, PhD, chief executive officer of Orthocare Innovations. Other members of the group include William Aguilar, Sammy Souaiaia, and Naveed Safavi. Here, Borrayo shares his first experience with O&P. At the beginning of our capstone assignment, we were presented with a number of projects that all seemed enticing. This project, however, was unique in such a way that what we produce would not sit on some shelf; it would be beneficial to society. Our capstone advisor, Joe Decuir, told us to pursue challenges that we would be proud of. Instinctively, the Outcome Assessment Reporting System (OARS) project came to mind. Prior to the OARS project, we knew very little about orthotics and pros-
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Josef Borrayo is one member of a group of undergraduate electrical engineering students. From left: Borrayo, William Aguilar, Sammy Souaiaia, and Naveed Safavi.
thetics. Some members of our group were familiar with a project on campus that involved a 3-D-printed hand/wrist prosthesis. Other than this, all four of us [Borrayo, Aguilar, Souaiaia, and Safavi] are undergraduates on the electrical engineering path and entering unfamiliar territory, as this project is mainly computer science. From our very first meeting with Dr. Boone at his office in Edmonds, Washington, he was generous enough to give us a full tour and a general overview of how prostheses are meticulously
engineered and manufactured, then tested. He also presented his team’s goals and discussed how prostheses can be useful for amputees in improving their mobility and, most importantly, their overall quality of life. We believe that the utilization of computer science and engineering can be very useful in the future of orthotics and prosthetics to provide pathways that lead to cheaper and smarter prostheses, that are both more efficient and adaptable to provide the best outcome from the user’s experience.
The team of students meets with its advisor, David Boone, MPH, PhD, (left), at his office in Edmonds, Washington.
FDA and O&P
Which rules set forth by the U.S. Food & Drug Administration apply to O&P businesses? By Thomas F. Fise, JD
efore we begin, let’s conduct a quick test of your current knowledge about the U.S. Food & Drug Administration (FDA), and how it does and can impact the activities of O&P facilities that fall within the law. Take the following True/False quiz: 1. All O&P devices are Class I, and, therefore, good manufacturing practices (GMPs) do not apply to any manufacturer, distributor, or patient-care facility that might be inspected by FDA.
2. FDA is required to notify you in advance to clear a date for inspection.
3. Devices that have qualified for exemption from the GMP/quality system regulations (QSRs) of 21 CFR, Part 820, are the only O&P devices that are completely exempted from the unique device identifier (UDI) rules.
4. An O&P patient-care facility that does not operate central fabrication facilities for others is not required to register with FDA.
5. Any entity that serves as the initial U.S. distributor of imported medical devices can expect that FDA will hold it to the same responsibilities that would apply if it were the manufacturer of the device.
Now that you have completed the quiz, let’s discuss some important topics regarding how FDA regulations may affect O&P companies.
Good Manufacturing Practices O&P professionals may wonder, “Does my business have any responsibility to meet FDA requirements on manufacturers, such as GMPs?” This is an important question and determines how deeply your company should be focused on FDA matters. The answer should be—and used to be—an easy one. The current answer is somewhat more complicated due to some changes relevant to O&P businesses as well as changes regarding how aggressively FDA is seeking to assert its authority. Here are some guidelines. Generally, O&P suppliers, being those who actually make the components and raw materials that are used in devices furnished to patients in O&P care, are manufacturers, which must register with FDA, list their devices, meet GMPs for any devices they make to which those GMPs apply, and be subject to FDA reporting and recordkeeping guidelines. Distributors, which sell devices— from off-the-shelf (OTS) orthotics to components of custom-fabricated orthotics and prosthetics—are generally not considered manufacturers unless one or both of the following are true: 1. They are the initial U.S. distributors of medical devices that originate outside the United States (or perhaps private labelers); and/or
O&P News | March 2018
relatively close to, your patient-care office, you are unlikely to be deemed a manufacturer by FDA. 2. If you are a patient-care facility and you run a central fab, for your patients and for patients from other practices, there is a decent chance FDA will see that as a manufacturing operation. 3. The further removed your central fab for your patients is from your patient-care facility, the more likely that FDA will see that as a separate manufacturing facility, distinct from your patient-care facility. 4. If you are a manufacturer that runs a central fab facility, you can be virtually certain that the central fab will be considered by FDA as a full-fledged manufacturing facility. 2. They engage in some activity in fabrication that FDA considers to be manufacturing. Retail orthotic and prosthetic facilities do not need to register with FDA or provide annual listings of devices, provided that what they do is limited to providing patient care. Even though the regulations in 21 CFR 870.65(i) state that “retail orthotic and prosthetic facilities” are not required to register with FDA, this does not absolutely mean that a patient-care facility will not be considered by FDA as being a manufacturer. It really depends on what happens in that facility. FDA has recently conducted inspections claiming that facilities that engage in central fabrication activities are manufacturers, even though those facilities also may offer patient care. If the FDA makes that claim stick legally— a question that is not yet resolved—then it would expect such fabrication facilities to meet GMPs as to products to which GMPs apply, and be subject to all FDA reporting and record-keeping obligations imposed on traditional manufacturers. So, if your company only provides patient care, then you can feel relatively safe in not being required to either
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register with FDA or comply with GMPs, and/or meet full record-keeping requirements. You may be required to maintain complaint records, report device deficiencies/patient injuries, etc., to provide to FDA upon request, and to assist with any FDA recalls. You will nonetheless want to consider some items below, such as what to do when the inspector calls and how to establish a sample company policy on inspections. If you have a central fabrication operation in addition to patient care (and the more sophisticated your lab facilities are, the more likely it is that FDA might assert that those facilities make you subject to manufacturer controls), you are now in a gray area. We cannot ignore that FDA has inspected some of these facilities and treated them as manufacturers, and expected them to meet the full range of manufacturer obligations above, including meeting GMPs and full FDA reporting and record-keeping guidelines. The responsibilities surrounding central fabrication are still not absolutely clear, but the following will serve as some general markers: 1. If you are a patient-care facility and you run a central fab, just for your patients, either on the site of, or
FDA and 3-D Printing On May 10, 2016, FDA released Technical Considerations for Additive-Manufactured Devices: Draft Guidance for Industry and Food and Drug Administration Staff. The publication of this document marked the first foray of the FDA into potential regulation of devices that use additive manufacturing as a means of fabrication of medical devices. Additive manufacturing is a broad term that encompasses 3-D printing as a means of creating functional medical devices. The guidance document has been published in order to solicit public comment regarding the FDA’s current thinking on the topic of 3-D printing and “is not intended to be a binding document on either the FDA or the public.” It is clear from this FDA notice that whatever rules apply to traditional O&P devices will also apply to similar devices fabricated using 3-D techniques and introduced for sale/commerce. So, while FDA does grant exemptions on both premarket notification (510k) and from GMPs/QSRs, it is important to note that FDA continues to require manufacturers of all Class I devices to register with the FDA through its device establishment registration process.
While some Class I O&P devices have been designated as not being subject to more rigid regulation, such as the 510(k) premarket notification process and complete compliance with all aspects of GMPs, virtually no one is exempted from complaint record rules under the GMPs, and failure to comply with the record-keeping and complaint file requirements could lead to trouble for both traditional O&P manufacturers and those that incorporate 3-D printing into their manufacturing process. The complete document may be viewed at bit.ly/additivedevices.
UDI Final Regulations On September 20, FDA issued a final rule for a new UDI system, which FDA believes will provide a consistent way to identify, and potentially recall, medical devices after they are in commercial distribution. FDA received a specific statutory charge from Congress to implement this system, which has been in the works for several years and evolves from a proposed rule published in July 2012. FDA has prioritized both the applicability of the UDI regulations, as well as the compliance dates, based on the levels of risk associated with devices. Higherrisk devices have less time before they need to be in compliance. The regulations include exceptions from the UDI rule: 1. FDA is granting an exception [Section 801.30(a)(2] from the specific rules applicable to the UDI as to medical devices classified in Class I, and as to which FDA also has granted exemptions from GMP/QSR regulations. Many O&P devices will have the benefit of this exception—you will find a specific listing of devices within the FDA Physical Medicine Devices grouping under 21 CFR Section 890 that FDA has exempted from GMP/QSR regulations, and which therefore also are granted the exception from the UDI. 2. Because there are some O&P devices that are assigned to FDA’s Class I,
On September 20, FDA issued a final rule for a new UDI system, which FDA believes will provide a consistent way to identify, and potentially recall, medical devices after they are in commercial distribution.
but which have not received an FDA exemption from GMP/QSR regulations, device manufacturers also will be very interested in Section 801.40(d), which has been amended to provide “that a Class I device that bears a UPC (universal product code) on its label and device packages and is deemed to meet all UDI labeling requirements and that the UPC will serve as the UDI required by Section 801.20. This grants exceptions for a Class I device with a UPC on its label and packages from UDI labeling requirements, regardless of to whom or through what channels it is sold. … The labeler of such a device is still required to submit data concerning the device to the Global Unique Device Identification Database (GUDID), unless the UPC device also qualifies for the exemption under Section 801.30(a)(2) as a Class I GMP exempt device.”
Regarding compliance dates, it is possible, in theory, that there are O&P devices that: (a) are not exempted from GMP/QSR regulations, and (b) where labeling does not bear a UPC, and which therefore would be subject to UDI, which also would apply to devices falling into FDA Class II or Class III. Here are the most relevant dates when compliance is required: • Class II device — Sept. 24, 2018. • Class I device — Sept. 24, 2020.
Initial U.S. Distributor and Private Labeling Liability FDA has prescribed that, to the extent that a distributor is the “initial U.S. distributor of an imported device,” that distributor is essentially treated as if it were the manufacturer in terms of FDA rules for registration, listing, GMPs, etc., being applied to these products. Similarly, if a U.S. company enters a private labeling agreement so devices manufactured by someone else are sold with your name on the package, you also are likely to be treated by FDA as the manufacturer. The idea is that if something goes wrong and the only label on the device carries your name, then you must be treated as if you were the manufacturer. Purchasing Used Custom O&P Components Prosthetic and orthotic components are intended for use by certified and/ or licensed prosthetists and orthotists to build custom medical devices. AOPA is concerned about a growing number of instances in which prostheses (artificial limbs) and orthoses (orthopedic braces) are being resold—for example, sold as auction items on eBay. AOPA believes this practice is unfortunate, dangerous, and, in most cases, likely illegal. Both manufacturers/suppliers and patient-care facilities have substantial concerns about how a medically unsupervised user of a used device impacts device warranties, malpractice coverage, FDA GMPs, and records and reports
O&P News | March 2018
requirements. These devices may or may not be regulated by FDA and the 510(k) premarket notification process, and they should be limited to single-patient use. In addition, this new methodology negatively affects device tracking for purposes of potential FDA or manufacturer recalls, compliance with physician prescription requirements by bodies that accredit O&P facilities, and the patientcare facility’s ability to assure that the component has never been used or delivered previously and has not been damaged in any way in the time between its departure from the manufacturer facility and its arrival at the patient-care facility.
Takeaways After reviewing the various rules and regulations above, O&P businesses should take away the following important information: • O&P is not exempt from FDA. • Manufacturers have responsibilities to register, file product listing and complaint reports, and quite possibly comply with GMP rules. • Visit bit.ly/opfedregs to find out how an O&P device is classified (Class I, II, or III) and what the exemptions are. • Get and use the AOPA FDA Compliance Manual. • When you are thinking about new products … don’t forget about the FDA! • When CMS; the pricing, data analysis, and coding contractor; or anyone else talks about what should be in your labeling … don’t forget about the FDA! • When you think about whether CMS should consider your product as an OTS orthotic device … don’t forget about the FDA! Finally, how did you do on the FDA quiz? Here are the answers to those five questions we started with:
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ANSWERS/COMMENTARY TRUE 1.
All O&P devices are Class I, and, therefore, GMPs do not apply to any manufacturer, distributor, or patient-care facility that might be inspected by FDA.
Most, but not all, O&P devices are Class I—a small number are Class II and Class III. Class I devices are subject to both premarket notification rules under Section 510(k) and GMPs. Many O&P devices have received exemptions from one or both of these rules. Consult 21 CFR, Section 890, to check for exemptions—but even if exempted from GMPs, the record-keeping and complaint files sections of GMPs virtually always are applicable and maintained in force. 2. FDA is required to notify you in advance to clear a date for inspection.
Class I devices must either display a UPC as a substitute or fully meet the compliance requirements of these FDA regulations.
In the United States, FDA is entitled to conduct an inspection, unannounced, at any time of its choosing. You may ask the inspector to wait a brief period to allow your designated FDA contact person to return to the office to meet the inspector. Devices that have qualified for exemption from the GMP/QSR regulations of 21 CFR, Part 820, are the only O&P devices that are completely exempted from the UDI rules.
Essentially, these GMP-/QSRexempt devices are, as a practical matter, the only devices to enjoy complete exemptions from UDI. The best treatment does apply to these devices that have qualified for exemption from the GMP/QSR regulations of 21 CFR, Part 820. Nonexempted
An O&P patient-care facility that does not operate central fabrication facilities for others is not required to register with FDA.
This activity falls clearly within the exemption from registration under 21 CFR, Section 807.65(i), which exempts “personnel from a hospital, clinic, dental laboratory, orthotic, or prosthetic retail facility, whose primary responsibility to the ultimate consumer is to dispense or provide a service through the use of a previously manufactured device.” Therefore, this type of O&P facility is not required to register with FDA. 5. Any entity that serves as the initial U.S. distributor of imported medical devices can expect that FDA will hold it to the same responsibilities that would apply if it were the manufacturer of the device. While not every FDA requirement for manufacturers would apply, many would indeed apply. Since there is no other entity under the jurisdiction of the United States, FDA largely looks to the initial U.S. distributor of an imported device to “stand in the shoes” of the manufacturer for many obligations, e.g., registration and listing of the device. Thomas F. Fise, JD, is executive director of AOPA and publisher of O&P News.
This material is not intended, and should not be relied on, as legal advice. Readers should consult with their own counsel about the legal matters discussed here.
Research & Presentations
Liner With Embedded Electrodes for MyoelectricControlled Prostheses By Matthew Wernke, PhD; Cody Doddroe; Alexander Albury, CPO; Michael Haynes, MS; and Luke Beery
Background Achieving robust control of a myoelectric prosthesis utilizing skin surface electrodes is highly dependent on acquiring noise-free surface electromyography (sEMG) signals. Acquiring noise-free signals is complicated by the variety of positions and loading conditions experienced by the prosthesis in use, which can further degrade signal quality.1-6 The traditional approach to myoelectric socket interfaces is to embed the electrodes into the wall of the socket. In this design, the metal dome electrodes can separate from the skin due to translation of the socket, presenting significant challenges to the goal of collecting high-quality sEMG signals.7-10 These movements typically lead to inconsistent or varying signals that greatly diminish control.7 To address the challenges associated with incorporating electrodes directly into the socket, several attempts have been made to incorporate a gel liner into myoelectric socket interfaces.11-15 These attempts involved retroactive changes to the liner and therefore reduced the mechanical durability of the assembly and complicated the donning process. More recently, the Shirley Ryan AbilityLab (formerly the Rehabilitation Institute of Chicago) developed a gel liner with integrated electrodes for use with a pattern recognition system
such as Coapt Complete Control. Preliminary testing showed that the system maintained electrical signal quality after eight weeks of at-home use (although electrical resistance did increase) and was preferred by the test participants over their existing systems. Further development of the system was performed by the authors. Mechanical testing to evaluate the performance of the new myoliner over the expected lifetime is warranted. Further, the ability to don the liner in a consistent orientation and place the electrodes within the liner system accurately should be investigated to explore possibilities of the liner system to work with two-site control systems. The purpose here is to investigate these areas.
Methods Two sets of experiments were conducted to evaluate the myoliner. The first set focused on the mechanical durability of the myoliner using both ultimate strength and fatigue testing. The second set focused on the accuracy of electrode placement. Mechanical Durability
Both an ultimate strength test and a fatigue strength test were conducted on a tension-compression machine (Figure 1). The ultimate strength test was used to
Tension-compression machine used to mechanically test the myoliner.
verify the myoliner could withstand a predetermined axial tension force. The predetermined axial tension force was chosen to be 200 pounds. This force was selected with the consideration that the weight limit of most myoelectric upper-limb components being around 50 pounds and increasing that by a safety
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Research & Presentations
factor of four. The fatigue strength test was used to evaluate the change in linear resistance of the electrode leads after repeated stress. The linear resistances of the conductive leads were measured before and after the fatigue strength. A cyclic load was applied, keeping the myoliner in constant tension, where the tension varied with time. To execute the various procedures, a myoliner prototype was donned over a rigid core and connected to the tension-compression machine. The assembly was oriented so the force was applied along the long axis of the liner directly through the center of the distal end. Donning Repeatability and Electrode Accuracy
A grid mapping concept was used to translate electrode positions from a 3-D liner form to a 2-D panel form where the electrodes are actually integrated. The concept under evaluation consists of the patient donning a grid-marked liner without electrodes and selecting the desired grid location for the electrodes to be placed. This information
Residual limb models used for the study. Screws represented desired electrode positions.
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would then be used by manufacturers to fabricate a myoliner with the electrodes in the desired locations. The team conducted two subtests. The first subtest determined the ability of an individual to don a gel liner in a repeated orientation (donning repeatability). The second subtest determined the accuracy of the grid-mapping system to translate the electrode position from the prosthetist to the manufacturing team (electrode accuracy). Two residual limb models were fabricated (Figure 2). The residual limb models represented limb geometries that would utilize a small and medium size liner, respectively (size information according to WillowWood sizing chart). An upper and lower band was marked on the core to distinguish a practical myosite range. The practical myo-site range excluded: 1) the distal end, as electrodes in this location will have poor contact with the skin, and 2) the area greater than 20 cm from the distal end, as the proximal joint of the user would impede electrode placement in this region. A total of 14 tapping screws were drilled into specific locations on the residual limb as shown in Figure 2. These locations were chosen to provide a variety of distances from the distal end and from the seam of the liner. To evaluate donning repeatability, gel liners were donned by three able-bodied participants using a one-handed donning technique (Figure 3A) to simulate a donning technique that would be used by a person with unilateral upper-limb loss. The participants then marked the location of the center of the screw heads with a marker (Figure 3B). The participants then doffed the liner, placed the liner in their non-donning hand, and transferred the liner back into the donning hand before starting the next don attempt. This process was repeated for a total five times per participant. A different colored marker was used for each participant. Clusters of the 15 marker dots for each electrode position were visually
A) Single-handed donning process. B) Marking of the center of the screw head onto the liner surface.
inspected to determine the greatest distance between two dots within a cluster. This distance was recorded as the TOTAL spread. The greatest distance between two dots of the same color was also measured and then recorded as the P01, P02, or P03 spread. Average and standard deviation was recorded for: 1) TOTAL, 2) P01, P02, and P03 individually, 3) P01, P02, and P03 combined, 4) Width 1, Width 2, and Width 3, and 5) Height 1, Height 2, and Height 3. To evaluate electrode accuracy, the liners used in the donning repeatability study were used. Three clusters from each side of those liners were chosen as electrode positions that the prosthetist desired. The position of a cluster position on the liner was determined by counting the number of squares in the horizontal and vertical directions from the origin of the grid. The origin was preselected as the middle grid position on the proximal liner of the grid formation. The desired grid position was then transferred to a new liner panel, and a 10-mm x 10-mm box was drawn to indicate the location of the electrode and conductive lead termination. For this experiment, the electrode and conductive thread were not added so the box served to represent this location. After the liner panels were marked with the appropriate electrode locations (marked by the red box), the panels were
Research & Presentations
used to complete the liner fabrication. Next, the donning process was repeated and screw head positions were indicated using a marker. The results were quantified as the distance from the center of the target area to the center of the cluster for the group as well as each individual participant.
Table 1 Results for the Donning Repeatability Test
Cyclic inflation test. A) Deflated or relaxed state. B) Inflated or stressed state.
Following this analysis, a cyclic inflation procedure was performed to simulate a “break-in” period for the liners. The liners were inflated to the upper circumference limit based on the WillowWood sizing chart and then deflated by reducing the internal air pressure to 0 psi (Figure 4). Each cycle lasted 60 seconds (30 seconds inflated and 30 seconds deflated) and was repeated 500 times.
Results Mechanical Durability
The myoliner exceeded the ultimate strength test criteria of 200 pounds of axial tension. Following the 2 million cycles of fatigue strength testing, the average increase in linear resistance of all of the conductive leads was 2.7Ω. This marks a dramatic reduction in the change of resistance reported with previous versions of the myoliner developed by the Shirley Ryan AbilityLab. The low
starting resistance and minimal increase in resistance show the myoliner configuration will be effective transferring muscle signals over the entire life of the liner. Donning Repeatability
The results for the donning repeatability are shown in Table 1. The greatest spread was found when calculating the TOTAL. The TOTAL was larger for the medium liner compared to the small liner. A smaller spread was found when looking at the individual participant spreads. On average, P01 had the smallest spread and P02 had the largest. The average of all of the individual spreads was 8 mm.
positions of the electrode placement on the liner (Figure 5) did not change from the results shown in Table 2.
Discussion The mechanical properties of the liner were improved compared to previous at-home testing performed by the Shirley Ryan AbilityLab. Material changes to the liner fabric and conductive material allowed for greater resistance to mechanical Figure 5
The results again showed the liner is donned repeatedly by each individual participant. The total cluster was comparable to that found in the previous study. In terms of proximity to the red box, the markers were close and even within the box on many occasions (Table 2). Following the cyclic inflation test, the
Cluster markings relative to the target area following the simulated “break-in” using cyclic air inflation procedure.
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Research & Presentations
strain and significantly reduced the change in resistance after long-term use. Keeping the resistances constant over time is important for the performance of the myoelectric system. For example, a prosthetist sets the gains for each signal channel during the fitting process in a direct control system. Changes in the resistance of the conductive pathway could alter the performance of the system and would require adjustment to the gain values. If the resistance change is too great, it may result in a signal channel that no longer provides valuable information to the control system. The donning repeatability results provide evidence that the liner can be donned in a similar orientation multiple times. The fact that the total spread (all colors) was greater than the spread for an individual test participant is not surprising and could be a result of varying donning cues and hand strength/ dexterity. However, the results showed within subject donning was highly repeatable. The spread values calculated here are point-to-point measurements, but electrodes are not point contacts and generally cover the surrounding skin surface (i.e., commercial electrodes are approximately 10-mm diameter). Therefore the electrode body will cover some of the distance measured in this study, reducing that value in clinical practice. Although some of the markers were not in the square, all of the clusters were close and repeatable. The vertical height of the clusters was relatively in line with the box locations, even after breaking in the liner by repeatedly filling it with pressurized air. Most of the error was in the horizontal direction. This suggests that the prosthetist and patient can work together upon delivery of the liner to establish a modified donning cue to get the electrodes closer to the desired location. For instance, the results here could have been better if we simply rotated the liner a few degrees. Since all of the errors were off in the same direction, this simple rotation would have corrected those posi-
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Table 2 Distance From the Center of the Target Area to the Center of the Marker Dot Clusters Since the target area was 10 mm x 10 mm, any distances under 5 mm were within the target area.
tions. We did not adjust our donning cue for this study, but perhaps this should be evaluated in future studies. The process used here was far from optimized and refinement will likely lead to better results. The grid was drawn on by hand. Although an L-frame and measurements were used, there is still room for variability. Future work should investigate the use of a more standardized and repeatable approach for applying the grid.
Conclusions The work here provides evidence that the myoliner design is mechanically sound, the system can be donned repeatedly in a similar orientation, and electrode locations can be transferred accurately. The evidence here supports the use of the myoliner for both direct and pattern recognition control strategies; however, the authors feel pairing the myoliner with pattern recognition control will offer the highest level of performance for the system. Ongoing work investigates the performance of a myoelectric prosthesis utilizing a production-like myoliner to other interface systems.
Matthew Wernke, PhD; Cody Doddroe; Alexander Albury, CPO; Michael Haynes, MS; and Luke Beery work at the Ohio Willow Wood Company in Mt. Sterling, Ohio. Doddroe also is affiliated with Wright State University in Dayton, Ohio.
References 1. Scheme E, Englehart K. Electromyogram Pattern Recognition for Control of Powered Upper-Limb Prostheses: State of the Art and Challenges for Clinical Use. J. Rehabil. Res. Dev. 2011; 48(6): 643â€“659. 2. Fougner A, Scheme E, Chan A, Englehart K, Stavdahl O. Resolving the Limb Position Effect in Myoelectric Pattern recognition. IEEE Trans. Neural Syst. Rehabil. Eng. Publ. IEEE Eng. Med. Biol. Soc. 2011; 19(6): 644â€“651. 3. Geng Y, Zhou P, Li G. Toward Attenuating the Impact of Arm Positions on Electromyography Pattern-Recognition Based Motion Classification in Transradial Amputees. J. Neuroengineering Rehabil. 2012; 9: 74.
Research & Presentations
4. Boschmann A, Platzner M. Reducing Classification Accuracy Degradation of Pattern Recognition Based Myoelectric Control Caused by Electrode Shift Using a HighDensity Electrode Array. Annual International Conference of the IEEE Engineering in Medicine and Biology Society (EMBC). 2012; 4324–4327. 5. Khushaba R, Takruri M, Miro J, Kodagoda S. Towards Limb Position Invariant Myoelectric Pattern Recognition Using Time-Dependent Spectral Features. Neural Netw. Off. J. Int. Neural Netw. Soc. 2014; 55: 42–58. 6. Masters M, Smith R, Soares A, Thakor N. Towards Better Understanding and Reducing the Effect of Limb Position on Myoelectric Upper-Limb Prostheses. Conf. Proc. Annu. Int. Conf. IEEE Eng. Med. Biol. Soc. IEEE Eng. Med. Biol. Soc. Annu. Conf. 2014; 2577–2580.
7. Hargrove L, Englehart K, Hudgins B. The Effect of Electrode Displacements on Pattern Recognition Based Myoelectric Control. Conf. Proc. Annu. Int. Conf. IEEE Eng. Med. Biol. Soc. 2006; 2203–2206. 8. Young A, Hargrove L, Kuiken T. The Effects of Electrode Size and Orientation on the Sensitivity of Myoelectric Pattern Recognition Systems to Electrode Shift. IEEE Trans. Biomed. Eng. 2011; 58(9): 2537–2544. 9. Tkach D, Huang H, Kuiken T. Study of Stability of Time-Domain Features for Electromyographic Pattern Recognition. J. Neuroengineering Rehabil. 2010; 7: 21. 10. Hargrove L, Englehart K, Hudgins B. A Training Strategy To Reduce Classification Degradation Due to Electrode Displacements in Pattern Recognition Based Myoelectric Control. Biomed. Signal Process. Control. 2008; 3(2): 175–180.
11. Salam Y., The Use of Silicone Suspension Sleeves With Myoelectric Fittings. JPO: Journal of Prosthetics and Orthotics. 1994; 6(4): 119-120. 12. Daly W. Clinical Application of Roll-On Sleeves for Myoelectrically Controlled Transradial and Transhumeral Prostheses. JPO: Journal of Prosthetics and Orthotics. 2000; 12(3): 88-91. 13. Daly WK. Electrodes Installed in Roll-On Suspension Sleeves. 2002 Myoelectric Symposium. 14. Lipschutz RD, Lock BA. A Novel Research and Clinical Approach To Using Gel Liners for Collection of Surface Myoelectric Signals for Prosthetic Control. 2011 Myoelectric Symposium. 15. Lipschutz R, et al. Systems and Methods of Myoelectric Prosthesis Control. 2012; Google Patents. 16. WillowWood Liners and Sizing Chart. https://www.willowwoodco. com/products-services/liners/.
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Research & Presentations
Choosing the Optimal PD-AFO for Your Patient By David Knapp, CPO
Introduction Passive dynamic ankle-foot orthoses (PD-AFOs) are nonarticulated AFOs that are designed to flex during the stance phase of gait and return to their neutral angle during swing phase. They are most commonly fabricated using carbon-fiber composite laminates, and consist of a cuff and a footplate that attach together with a strut. The strut flexes to accommodate ankle motion, and the footplate flexes to accommodate metatarsophalangeal joint motion. PD-AFOs are designed to replicate the functions of the ankle muscles during gait. The gait cycle can be divided into seven segments based on function (see Figure 1). Throughout almost all of stance phase, PD-AFOs accurately mimic the direction of the torques that the muscles would normally produce. During pre-swing, however, the normal ankle will produce a plantarflexion moment as it plantarflexes to about 20 degrees, while the PD-AFO stops plantarflexing at its neutral angle and stops producing a moment. The interval where this occurs is briefâ€”approximately 3 percent of the gait cycleâ€”and it results in an early toe-off from the ground. Singer1 demonstrates that this has a negligible effect on gait efficiency. Perry2 refers to this period in normal gait as roll-off, rather than push-off; the distinction is important because it reflects the fact that the plantarflexor muscles do not show any electromyography (EMG) activity at this point in the gait cycle.
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Normal ankle kinematics for normal gait. Line segments in green indicate good congruity between normal kinetics and those of the PD-AFO; red and yellow lines represent large and small disparities respectively. (Adapted from Perry)
Three factors need to be considered when designing a PD-AFO for a patient: 1. Strut and footplate stiffness: This determines the magnitude of the moments the AFO can produce. 2. Neutral angle (the angle at which the AFO produces no moment in either direction): This can be used to tune the timing of the moments. 3. The amount of energy return: This is important in the transition from stance to swing phase. The stiffness and neutral angle together will determine the functional range of motion for the AFO.
Stiffness The term quasi-stiffness is used by Shamaei3 to describe the behavior of the ankle during normal gait. Active muscles generate moments about the ankle in a repeated pattern during each step. Figure 2 shows the normal ankle during gait. The counterclockwise pattern indicates that the muscles are actively feeding energy into the system. PD-AFOs, because they are passive devices, produce a clockwise path on this type of plot, indicating that energy is lost in the deformation of the orthosis. Although it changes throughout the
Research & Presentations
gait cycle, a single average value for the quasi-stiffness of 5.2 N-m/deg can be estimated by the slope of the line through the shaded region. Bregman4 used a computer simulation to determine the optimal AFO stiffness to be about 7.15 N-m/deg based on energy cost. Customfitted AFOs on the market at the time of this publication are available in stiffnesses that range from about 0–6 N-m/deg.
Bench test results for the torque produced by the AFO when deflected into 20 degrees of plantarflexion.
The normal ankle for one gait cycle. Initial contact occurs at point “a” and toe-off occurs at point “e.” The slope of the line in the center of the shaded region represents the average stiffness during stance phase. (Adapted from Shamaei)
The ideal stiffness for your patient depends on many factors and will ultimately be a compromise between the competing demands of multiple priorities. Choosing an orthosis with suboptimal stiffness can produce new gait abnormalities and should be carefully monitored (Table 1).
The patient’s weight is one of the most influential factors in determining the stiffness requirements for the ankle. The moments required can be found by multiplying the patient’s weight by the standardized values from the literature (Perry2): The normal ankle produces a peak dorsiflexion moment of about 0.2 N-m/kg, and a peak plantarflexion moment of approximately 1.2 N-m/ kg. For example, a 50-kg (110-lb) patient produces a 10 N-m dorsiflexion moment at 5 degrees of plantarflexion, and 60 N-m plantarflexion moment at 10 degrees of dorsiflexion. In order to do this, the AFO would need to be built in slight plantarflexion so that it can be further plantarflexed to reach 5 degrees since it is the deformation from its
Table 1 Adverse Effects of Improper AFO Stiffness During Gait Too Stiff
Increased DF in stance
Increased quad demand
Decreased ankle moment
Anterior trunk lean
Decreased ankle power
External rotation of the limb
Excessive varus stress
Excessive drop of body’s center of mass
neutral angle to the new position that produces the moment. An AFO with a stiffness of 5 N-m/deg, for example, would need to be built in 3 degrees of plantarflexion in order to produce a 10 N-m dorsiflexion moment at 5 degrees of plantarflexion. That same AFO will need to deflect to 12 degrees, where it would reach 9 degrees of dorsiflexion, to produce the 60 N-m plantarflexion moment that is needed. Another factor to consider is the residual muscle strength in the patient’s ankle musculature. If the muscles are still active, they can assist the AFO in providing some of the moment needed. Manual muscle testing is recommended to make this determination, keeping in mind that although the orthosis will not fatigue, the patient’s muscles will. Every N-m of torque that the patient can produce on his own is added to the moment generated by the orthosis. If the goal is to produce a 60 N-m moment, and the patient is able to produce a 20 N-m moment with his or her plantarflexors, the AFO will only need to provide 40 N-m. To determine how much torque the patient can generate at the ankle, you can use a dynamometer.
O&P News | March 2018
Research & Presentations
it should be 1.00 m is 20 percent less than normal, so the moment will be 20 percent less as well. The clinician must decide if the patient has the potential to increase his or her stride length and provide the most appropriate AFO based on that assessment. If the desired value exceeds the options available, several manufacturers offer custom designs.
Bench test results for the torque produced by the AFO when deflected into 10 degrees of dorsiflexion.
Stride length also will affect the moment needed to achieve normal gait kinetics. As stride length decreases, so does the moment generated at the ankle. If the clinician is certain that the patient will be consistent with a shorter stride
length, he or she can safely subtract that from the moments needed. A good rule of thumb is to estimate the percentage of the normal stride length and simply subtract that fraction of the total. For example, a patient whose step length is 0.80 m when
Neutral Angle Neutral angle is the angle that is built into the orthosis. It is the angle between the footplate and the strut that the AFO will return to when there are no forces trying to deform it. It is important since it will help to determine the angles at which the AFO will produce its peak moments. The more clinically relevant parameter, however, is shank vertical angle (SVA), which combines the neutral angle of the AFO with the heel height of the shoe and the slope of the terrain. Figure 5 shows three different SVAs that occur with AFOs with the same neutral angle.
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Research & Presentations
Angular velocity of different AFOs during pre-swing on an instrumented gait simulator. Faster angular velocity indicates higher energy return.
An anterior SVA can be caused by a shoe with too high of a heel, and a posterior SVA can be caused by a heel that is too low.
Although you cannot control the terrain, tuning the AFO and shoe to have a neutral SVA on level ground is an important process and should be part of the footwear discussion with the patient when the AFO is provided.
Energy Return Many patients who suffer from foot drop have concomitant hip and knee flexor weaknesses, which further impairs swing phase clearance. A great advantage of PD-AFOs is that they store energy in terminal stance and release a portion of that energy during pre-swing. The released energy assists in hip and knee flexion, which further assists swing phase clearance. In order to take advantage of this feature, the patient needs to have a regular cadence; ataxic or staccato gait patterns do not benefit from this type of energy return. Energy return from the orthosis can be estimated by the angular velocity in plantarflexion that occurs during pre-swing (Figure 6). AFOs with the highest angular velocity return the largest amount of energy during gait. Conclusion The cliniciansâ€™ skill in assessing their patients and applying these guidelines will benefit their patients by providing them with orthoses that deliver the appropriate levels of support and the least adverse effects. It is the authorâ€™s hope
that clinicians will someday be able to ask suppliers for individualized stiffness specifications so that we can deliver products that we know will contribute to optimal performance. David Knapp, CPO, is the president of Connecticut Brace and Limb and an adjunct professor at the University of Hartford Prosthetics and Orthotics Program.
References 1. Singer ML, Kobayashi T, Lincoln LS, Orendurff M, Foreman KB. The Effect of Ankle-Foot Orthosis Plantarflexion Stiffness on Ankle and Knee Joint Kinematics and Kinetics During First and Second Rockers of Gait in Individuals With Stroke.
2014; Bristol, Avon: Clinical Biomechanics. 2. Perry J, Burnfield JM, Cabico LM. Gait Analysis: Normal and Pathological Function. 2010; Thorofare, New Jersey: SLACK. 3. Shamaei K, Sawicki GS, Dollar AM. Estimation of Quasi-Stiffness and Propulsive Work of the Human Ankle in the Stance Phase of Walking. PLoS ONE. 2013; 8(3): e59935. 4. Bregman DJJ, van der Krogt MM, de Groot V, Harlaar J, Wisse M, Collins SH. The Effect of Ankle-Foot Orthosis Stiffness on the Energy Cost of Walking: A Simulation Study. Clinical Biomechanics, 2011; 26(9), 955-961.
O&P News | March 2018
Tom Watson, CP, LP Building positive relationships with allied health professionals, payors, and government agencies would ensure optimal patient care and secure the future of the profession
hy in the world would anyone choose to make artificial limbs and braces? Well, I know why I did it. I couldn’t afford my second leg. September 1970, after a successful year on the football field at the University of Kentucky and an average year in the classroom, I was working two jobs: Mornings, I was driving a tractor trailer hauling heavy equipment, and evenings, I was running a filling station. You remember the old gas stations where someone pumps your gas, cleans your windshield, checks your oil and tire pressure? Well … maybe not. One morning, while on a bulldozer, I flipped it off the trailer and it landed on top of me, which resulted in an amputation of my right leg above the knee, multiple broken bones, and an 80-day stay in the hospital. In the ’70s, workers’ comp paid your hospital bill, gave you $2,500, bought you one prosthesis, and said, “Now you’re on your own.” When I needed a replacement prosthesis, I was working as a bank teller making $64 a week with no insurance. So, I packed everything I owned in the back of my Ford and drove to Nashville to work at the office where I had
26 O&P News | March 2018
received my first prosthesis, sweeping floors and cutting out leather straps for $2 an hour. Forty-six years later and I’m still at it. Not exactly how I would encourage anyone to start a career, especially after the first week when the owner told me I should go home—I’d never make it. I sure have seen a lot of changes in the field, and if I were king for a day, I would see what I could do to keep the flame alive—not just in making things, but in always helping people with limb loss.
O&P Wish List One of the first things I would have practitioners do as part of their continuing education is get involved in professional associations—whether that be at the state level or nationally, both socially and politically. It’s important for O&P clinicians to tell our story to the decision makers. No one can tell our story better than we can. Next, I would change how we are reimbursed. I would redo or revise the famous L-code system as we know it. I realize that would throw sheer panic and consternation into the hearts and minds of almost everyone, but for O&P
Tom Watson, CP, LP, and Senator Bob Kerrey at the 2016 AOPA Policy Forum
to become a true profession, it must be talked about. You can begin the dialogue discussing the possibility of a privately owned company that would create a true outcome-based provider system, not one designed by manufacturers that are self-serving. Former AOPA Executive Director Charles Unger talked about this in the 1980s, but it fell on deaf ears as all of us were very satisfied with the reimbursement from the goose that laid the golden egg, so why mess with it? How’s your golden egg working for you now?
Revamping the L-code system is, in my opinion, the only way we can repair our relationships with the payors—if that is even possible now. It is certainly very difficult to have a relationship with someone that is going to write you a check for your product after you have sued them and then try and make them believe that you can be friends. Quite honestly, I believe that ship may have already sailed. Another “wish” I have is a return to regional meetings to cultivate new leaders and to have a talent pool to draw from for national leaders. It also would be nice to have a combined AOPA and Academy meeting every three-to-five years, to bring everyone together as a total field. Such a meeting could be centrally located so we wouldn’t have to fly from one coast to the other. Large national meetings can be inconvenient and expensive, and there are many important issues that differ geographi-
cally. I know that’s “old school” thinking, but the smaller, rural guys kind of get left out, and it just becomes a reward for an employee to take the trip to the big national meeting. It’s just a vacation for many of those attending the meeting. I know you’re supposed to get continuing education requirements at these meetings, but you generally see the same story told by a different manufacturer with an item painted a different color and, to me, that’s not continuing education. And you add in the ridiculous “sign in and leave” issue, makes no sense to me. I know the national meetings generate the revenue that keeps us in Washington, and I’ve spent a lot of blood, sweat, and tears there with very little to show for it. Don’t get me wrong—association staff and volunteers work hard, only to come back each year with another version of the same issue. You know the saying about expecting a different result but doing the same thing over and over again?
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Another change that we should consider is that it may be time to partner with physical therapists, occupational therapists, physician assistants, nurse practitioners, and whoever else is available to give us the clout we need to properly care for our patients while discussing our problems with the state and national decision makers. The decision makers are the ones that indicate and dictate how you will be reimbursed for your product. Instead of all of us being just competitors, it would be nice if we could also become colleagues in our commitment to delivering top-notch patient care. Most of those other folks I named previously seem to be doing all right. We did have a win with Section 427 of the Benefits Improvement and Protection Act, which was very inclusive with other health-care providers and was a big deal, but 17 years later we’re still waiting to reap the reward. I wonder why that is?
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O&P News | March 2018
Another change might pertain to the U.S. Department of Veterans Affairs (VA)—as it begins to change its model, why don’t we see if we can change ours, too? I’ve been on a VA subcommittee for many years, and we’ve made little progress. They basically meet with us and tell us what they have in mind (to a certain degree), and then we all go back and see what we can do to change their minds. I wish we could see if we could actually subcontract with the VA and have private companies in the VA hospitals to provide care for the veterans because, as manufacturers discount their products to them, why should they pay us our fee when they can figure out how to save their system some money? Again, this is another adversarial relationship with a powerful government agency. It doesn’t affect a lot of the rural shops, but it is another chink in our armor as the best provider of care for the men and women who have served our country. Those folks deserve and should demand the best our profession can provide, and I believe it comes from the private sector. I fear before long, we will be a provider of things and not truly take care of the patients.
28 O&P News | March 2018
A Common Goal Having said all of this, why in the world am I still working? This answer is simple: I love helping people. When a patient rolls into my office in a wheelchair with a look of despair, and he or she has been drained physically, emotionally, and financially, I love seeing that patient stand up and take those first few steps at the parallel bars. When that happens, we all have a tear in our eye—and it’s fulfilling to hear a simple, “Thank you.” It never gets old, even though I have gotten old. Those of us who have been in the field a long time are certainly willing to do what we can to mentor younger clinicians and to share our successes and failures with those coming up behind us. Those that are just embarking on their journeys will have the opportunity to enjoy and reap the rewards of being a clinician who builds artificial limbs and braces. Tom Watson, CP, LP, is owner of Tom Watson's Prosthetic & Orthotic Lab Inc., with offices in Owensboro, Kentucky, and Evansville, Indiana. He is also the recipient of AOPA's Lifetime Achievement Award.
PHOTO: Tom Watson’s Prosthetics and Orthotics Lab
The Power of Partnerships So, let’s turn the page and begin a new era—a new era of building relationships with local, state, regional, and federal governments and agencies with a new generation of leaders dedicated to the principle of finding a way to partner with the payors, educating them on what is best for the end user with the 21st century technology we have available and the overarching thought process that an amputation is not an end, but it is truly a beginning to a journey that we can all share in and have a successful outcome. We can partner with such agencies like vocational rehabilitation, to retrain and educate end users to become successful, tax-paying citizens
and give them hope to return to a lifestyle they so desperately need. I can’t say enough about the past O&P leaders—the Snells, Fillauers, Arbogasts, Beckers, Hamontrees, Thranhardts, and others—for taking the field from a trade to a profession over the past 45 years. But we need to be more proactive instead of reactive. We’re constantly playing defense instead of offense, and it’s mainly a preventative defense, preventing the worst that could happen. I’m hoping and praying that the younger, more progressive-thinking practitioners and business owners will take it upon themselves to be more proactive than reactive. The private sector, which includes the big boys on the block, as well as the small independents, are the gold standard for delivering prostheses and orthoses to folks with limb loss and those in need of 21st century orthotic care. To create a platform to “show our stuff,” we need partners. We need partners in therapy, in government, in payors, in rehab nurses, and in doctors to achieve this goal. We must be willing to compromise for the good of all. Our services shouldn’t stop with delivery. We must make a concerted effort to ensure end users leave with a product or device where they can succeed. All too many times, the patient
leaves with a prosthesis without enough follow-up to ensure that the supposedly K3 amputee is actually living in an environment where he or she can be a K3. There again, it comes down to partnerships. By now, you can probably tell I believe we can no longer go it alone—doing so has been a fundamental flaw for O&P, of which I was a big part of for many, many years. We have a tremendous profession, trade, and business that has continued to do magnificent things for people with limb loss. I challenge the new, better educated, young practitioners and business owners to lead the charge into rebuilding and creating new relationships to keep the flame alive for generations to come. We are certainly stronger together.
State by State The latest news from Connecticut, Michigan, Minnesota, New York, Pennsylvania, and Virginia
Each month, we talk to O&P professionals about the most important state and local issues affecting their businesses and the patients they serve. This column features information about medical policy updates, fee schedule adjustments, state association announcements, and more.
Connecticut The Connecticut Amputee Network and the Amputee Coalition are lobbying Connecticut legislators to pass a bill this coming session to require insurance parity for prosthetic devices. Brenda Novak and Herb Kolodny are leading the effort on the ground in Connecticut to ensure that others who lose arms and legs have the same access to appropriate prosthetic devices and services to restart their lives as they did when they lost their limbs. "We are preparing hard for the upcoming hearings before the Insurance and Real Estate Committee,” said Kolodny, co-founder of Connecticut Amputee Network. “We hope to present testimony not only from amputees, but also their loved ones, prosthetists, physical therapists, and other medical professionals that help amputees rehabilitate."
Michigan Rep. Beau LaFave (R-District 108), who underwent an amputation of his left leg shortly after birth, has expressed interest in advancing legislation to improve the lives of people living with limb loss in Michigan, including potential introduction of insurance fairness legislation. Minnesota Sens. John Marty (D-District 66) and Tony Lourey (DDistrict 11) agreed to introduce insurance fairness for amputees legislation during the 2018 legislative session. An effort also is underway to gain sponsorship and introduction in the Minnesota House of Representatives. The Amputee Coalition is working with the Minnesota Society of Orthotists, Prosthetists, and Pedorthists to coordinate efforts on this initiative. New York New York’s insurance fairness legislation currently has 31 co-sponsors in the State Assembly (as bill A.2212) and eight co-sponsors in the state Senate (as bill S.2080). The Amputee Coalition and local advocates are actively working to secure a hearing and vote to advance insurance fairness for amputees legislation before the end of this year’s legislative session. Pennsylvania Working with the Pennsylvania Orthotic and Prosthetic
Society, the Amputee Coalition has had preliminary discussions with Rep. Bernie O’Neill (R-District 29), the former lead sponsor of the state’s insurance fairness legislation. The groups are hopeful for introduction in 2018 and are expanding outreach to other legislators and potential sponsors in the state.
Virginia On Jan. 17, 2018, Virginia State Delegate Danica A. Roem (D-District 13) introduced HB.1478, “to amend and reenact § 38.2-3418.15 of the Code of Virginia, relating to health insurance; coverage for prosthetic devices and components.” The bill was referred to the Committee on Commerce and Labor, and a hearing was held February 1. The Amputee Coalition testified at the committee hearing, but the bill was ultimately voted down by the committee, 5 to 3. “Even though the effort was ultimately voted down in committee, we are confident that this is only the beginning of our efforts in Virginia,” said Dan Ignaszewski, director of government relations at the Amputee Coalition. EDITOR'S NOTE: To submit an update for publication, please email firstname.lastname@example.org. For up-to-date information about what’s happening in O&P in your state, visit the AOPA Co-OP and join the conversation in the AOPA Google+ Community.
O&P News | March 2018
O&P IN THE NEWS
Ottobock Launches Cyberspine TLSOx4
Ottobock HealthCare has launched the universal size of the CyberspineTM TLSOx4 spinal brace. The new universal size is reportedly designed with inventory management and cost savings in mind. The Cyberspine TLSOx4 spinal brace has been designed to offer superior compression and stabilization of the spine from T2 to S1, and is an adjunct to pre- and post-operative procedures, according to Ottobock. It also may be used for compression fractures of the thoracic spine, osteoporosis, kyphosis, and thoracic mechanical back pain. The spinal brace features padded shoulder straps with quick-release buckles, tool-free adjustment, a low-profile design, and a patented mechanical advantage pulley system that maximizes stabilization and abdominal compression.
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Publisher Thomas F. Fise, JD Advertising Sales RH Media LLC Editorial Services Content Communicators LLC Design & Production Marinoff Design LLC Printing Sheridan SUBSCRIBE O&P News (ISSN: 1060-3220) is published monthly by the American Orthotic & Prosthetic Association, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314. To subscribe, contact 571/431-0876, fax 571/4310899, or email landerson@AOPAnet.org. Periodical postage paid at Alexandria, VA, and additional mailing offices. ADDRESS CHANGES Postmaster: Send address changes to: O&P News, 330 John Carlyle St., Ste. 200, Alexandria, VA 22314.
Copyright © 2018 American Orthotic and Prosthetic Association. All rights reserved. This publication may not be copied in part or in whole without written permission from the publisher. The opinions expressed by authors do not necessarily reflect the official views of the publisher, nor does the publisher necessarily endorse products shown in O&P News. The O&P News is not responsible for returning any unsolicited materials. All letters, press releases, announcements, and articles submitted to the O&P News may be edited for space and content. The magazine is meant to provide accurate, authoritative information about the subject matter covered. It is provided and disseminated with the understanding that the publisher is not engaged in rendering legal or other professional services. If legal advice and/or expert assistance is required, a competent professional should be consulted. ADVERTISE Reach out to the O&P profession and more than 13,500 subscribers. Engage the profession today. Contact Bob Heiman at 856/673-4000 or email email@example.com.
Meetings & Courses
2018 MARCH 14 AOPA Webinar: Medicare Coding Guidelines: MUEs, PTPs, PDAC, and More. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
APRIL 11 AOPA Webinar: Enhancing Cash Flow & Increasing Your Accounts Receivable. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
APRIL 26-28 New York State Chapter Annual Meeting (NYSAAOP). Rivers Casino & Resort, Schenectady, NY. For more information, visit www.NYSAAOP.org.
APRIL 30-MAY 1 Mastering Medicare: Essential Coding & Billing Techniques, San Antonio, TX. Register online at bit.ly/2018billing. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
MAY 9 AOPA Webinar: Coding: Understanding the Basics. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
JUNE 13 AOPA Webinar: Audits: Know the Types, Know the Players, and Know the Rules. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
SEPTEMBER 26-29 AOPA National Assembly. Vancouver Convention Center. For general inquiries, contact Ryan Gleeson at 571/431-0876 or rgleeson@AOPAnet.org, or visit www.AOPAnet.org.
JULY 11 AOPA Webinar: Administrative Documentation: The Must Haves and the Sometimes Needed. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
JULY 23-24 Mastering Medicare: Essential Coding & Billing Techniques, St. Louis, MO. Register online at bit.
AUGUST 8 AOPA Webinar: Outcomes & Patient Satisfaction Surveys. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
SEPTEMBER 12 AOPA Webinar: Medicare As a Secondary Payor: Knowing the Rules. Register online at bit.ly/2018webinars. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
Mastering Medicare: Essential Coding & Billing Techniques, Las Vegas, NV. Register online at bit.ly/2018billing. For more information, email Ryan Gleeson at rgleeson@AOPAnet.org.
NOVEMBER 14 Evaluating Your Compliance Plan & Procedures: How To Audit Your Practice. Register online OCTOBER 10
at bit.ly/2018webinars. For more information, email Ryan Gleeson at
AOPA Webinar: Year-End Review: What Should You Do To Wrap Up the Year & Get Ready for the New Year? Register online
information, email Ryan Gleeson at
New Codes, Medicare Changes, & Updates. Register online at
bit.ly/2018webinars. For more
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ly/2018billing. For more information, email Ryan Gleeson at rgleeson@
International Africanâ€” American Prosthetic Orthotic Coalition Annual Meeting.
AOPA Celebrates Healthcare Compliance & Ethics Week
Embassy Suites Downtown Medical
November 4-10, 2018
Center, Oklahoma City, OK. For more information, contact Tony Thaxton Jr. at 404/875-0066, email thaxton.jr@ comcast.net, or visit www.iaapoc.org.
NOVEMBER 4-10 Health-Care Compliance & Ethics Week. AOPA is celebrating Health-Care Compliance & Ethics Week and is providing resources to help members celebrate. Learn more at bit.ly/aopaethics.
O&P News | March 2018
Future Tech A glimpse into emerging technologies and 3-D-printing applications By Steve Hill, BOCO
e live in the age of technology. As it progresses, so, too, does the way we run our businesses. Billing and accounting software makes the financial side easier and more accurate. Patient management software makes organizing our patients’ information much easier, even to the point of ordering parts and suggesting L codes. We use infrared light to heat the plastic we use in thermoforming, another manufacturing technique we hijacked. Materials like carbon fiber, aluminum, titanium, composite materials, and many others have given us a seemingly limitless variety of ways to create and customize our devices to adapt to any patient’s needs. But this technology always comes to us from the outside. As a relatively small and underfunded part of the medical field, the O&P community has, by necessity, become a clever bunch, adapting technologies from other, much larger industries. Although the O&P profession has one foot in the past, with our one-size-fits-one custom work, we also keep another foot firmly planted in the promise of newand-better, always looking for the next great technology that will make our jobs and our patients’ lives easier. This creative and adaptive attitude is the point of this article. Yes, we will talk about one of the latest, greatest advances in technology and processes, but we do so with the understanding that we are always on the lookout for any type of tech that we can use in our own practice. If we keep our eyes peeled, observant and creative people can find some new invention or innovation that can make our professional lives—or our patients’ personal lives—better.
32 O&P News | March 2018
Take, for example, the ubiquitous smartphone. One of the first apps I ever downloaded was a clinometer. It gives, with a great deal of accuracy, the degree of angle in any given plane. This comes in handy for setting up socket alignments and adjusting double-action ankle joints. And if you’ve never used the AOPA 365 app during the National Assembly, you’re seeing the show and going to educational sessions the hard way. One bit of tech that’s new to O&P is 3-D printing. Although it has actually been around for more than 30 years in the form known as stereolithography, new advances in electronics and software have allowed just about anyone to make use of it in a form known as “additive manufacturing” or “fused deposition modeling”—what most laymen call “3-D printing.” Now a person can buy a small 3-D printer for as little as $200 that can print some pretty useful things. For about $1,000, you can find a unit
that will print prosthetic sockets, arch supports, ankle-foot orthoses, and even many knee-ankle-foot orthoses. Add a scanner, take a few classes in CAD (computer-aided design), and you can make just about anything that you want to make. Many people believe that you can only print with brittle, rigid plastic, but this is no longer the case. Not only are more flexible materials available in almost any durometer you want, but with multiple nozzle printers, you can mix various materials to create devices with a variety of densities and material properties. Along with the polymers we have become used to, we can now even print with materials like carbon fiber, wood, color-changing or glowin-the-dark plastic, and cement (for houses). If you really want to spend some money, you can print with steel (known as “sintering”). And that is just the beginning. 3-D printing is starting to become a viable format for making organs for transplant patients. An organ has been made by using a 3-D-printed scaffold coated in the patient’s own cells and grown in the lab. This was done back in 1999, when a patient was implanted with a bladder made in this way. The real beauty of growing organs using this method is that, since the patient’s own cells are used, there are none of the usual rejection problems that typically face such transplant patients. Similarly, cancerous cells are being harvested from patients and used to create multiple tumors used for testing different chemotherapy treatments. Clearly, 3-D printing is starting to make its way into the O&P lab. It’s possible that before we know it, this technology will be used to make entirely new limbs for our patients using their own cells. But I don’t think we will have to worry about that for some time yet. Steve Hill, BOCO, is a technical consultant at Delphi Ortho in Asheville, North Carolina.
THE PREMIER MEETING FOR ORTHOTIC, PROSTHETIC, AND PEDORTHIC PROFESSIONALS.
Vancouver is easy to explore during your time at the downtown Vancouver Convention Centre as there are many nearby top attractions. • • • • • •
Capilano Suspension Bridge Vancouver Aquarium Forbidden Vancouver Stanley Park Horse-Drawn Tours Harbour Cruises & Events Flyover Canada
• Vancouver Lookout • Dr. Sun Yat-Sen Classical Chinese Garden • Vancouver Art Gallery • Science World • Grouse Mountain
Experience Beyond Vancouver’s unbeatable location makes it the perfect gateway to the rest of British Columbia and beyond, providing you with outstanding opportunities for pre- and post-conference travel. • Whistler • Okanagan Valley • Jasper • Victoria • Banff • Cruise to Alaska
Experience all the AOPA National Assembly has to offer while visiting Vancouver.
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