Abstract
Background
The utilization of neuromodulation therapy continues to grow as therapeutic indications
expand. These conditions often present with comorbid physical, visual, and auditory
impairments. Patients with disabilities in these categories may have difficulty operating
their devices. Thus, reviewing the accessibility and inclusive design of neuromodulation
devices is imperative to ensure equal access for patients of all ability levels. To
date, the literature provides little insight into this topic.
Materials and Methods
Manufacturers of Food and Drug Administration-approved neuromodulation devices in
the United States completed our electronic survey to assess neuromodulation device
features, universal/inclusive design guidelines, and methods used to make the device
accessible to patients with disabilities.
Results
We assessed 11 devices from seven manufacturers. Of those, there were six spinal cord,
two peripheral nerve, and three deep brain stimulators. Of all respondents, 91% used
universal inclusive design guidelines. Of the studied devices, 91% have an interface
that uses visual feedback, and 82% have an interface that uses auditory feedback.
All surveyed devices were reported to have an interface that requires physical handling.
Discussion
Our study found that most devices incorporate auditory signals, buttons with raised
indentations, speech commands, or other useful features to assist those with visual
disabilities. Visual interfaces may be sufficient for a patient with hearing impairment
to use all the surveyed devices. However, dual sensory impairment presents a significant
limitation in all devices surveyed. Furthermore, the biggest barrier to using neuromodulation
devices was physical impairment because all surveyed devices require physical handling.
Conclusions
Manufacturers have awareness of universal inclusive design principles. However, our
study was unable to find a device that is accessible to all users regardless of ability.
As such, it is critical to involve universal design principles to ensure that inclusive
devices are available to improve patient adherence, treatment efficacy, and outcomes.
Keywords
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References
- Neuromodulation: present and emerging methods.Front Neuroeng. 2014; 7: 27https://doi.org/10.3389/fneng.2014.00027
- Incidence and predictive factors of spinal cord stimulation treatment after lumbar spine surgery.J Pain Res. 2017; 10: 2405-2411https://doi.org/10.2147/JPR.S143633
- The evolution of neuromodulation in the treatment of chronic pain: forward-looking perspectives.Pain Med. 2019; 20: S58-S68https://doi.org/10.1093/pm/pnz074
- A narrative review and future considerations of spinal cord stimulation, dorsal root ganglion stimulation and peripheral nerve stimulation.Curr Opin Anaesthesiol. 2021; 34: 774-780https://doi.org/10.1097/aco.0000000000001072
- Disease-related disability burden: a comparison of seven chronic conditions in middle-aged and older adults.BMC Geriatr. 2021; 21: 201https://doi.org/10.1186/s12877-021-02137-6
- Neurostimulation devices for the treatment of neurologic disorders.Mayo Clin Proc. 2017; 92: 1427-1444https://doi.org/10.1016/j.mayocp.2017.05.005
- Design of Medical Devices—a home perspective.Eur J Intern Med. 2011; 22: 39-42https://doi.org/10.1016/j.ejim.2010.09.017
- Designing for all: consumer response to inclusive design.J Consum Psychol. 2021; 31: 360-381https://doi.org/10.1002/jcpy.1225
- An information model to support user-centered design of medical devices.J Biomed Inform. 2016; 62: 181-194https://doi.org/10.1016/j.jbi.2016.07.010
- Prevalence of multiple chronic conditions among US adults, 2018.Prev Chronic Dis. 2020; 17: E106https://doi.org/10.5888/pcd17.200130
- Prevalence of chronic pain among adults in the United States.Pain. 2022; 163: e328-e332https://doi.org/10.1097/j.pain.0000000000002291
- National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP). Encyclopedia of Global Health. Sage Publications, 2008
- Fast facts about vision loss. Centers for Disease Control and Prevention.(Accessed August 21, 2022)
- Worldwide prevalence of red-green color deficiency.J Opt Soc Am A Opt Image Sci Vis. 2012; 29: 313-320https://doi.org/10.1364/josaa.29.000313
- Hearing loss prevalence in the United States.Arch Intern Med. 2011; 171: 1851-1852https://doi.org/10.1001/archinternmed.2011.506
- Self-reported dual sensory impairment and related factors: a European population-based cross-sectional survey.Br J Ophthalmol. Published online February 9. 2023; https://doi.org/10.1136/bjo-2022-321439
- How common is essential tremor? update on the worldwide prevalence of essential tremor.Tremor Other Hyperkinet Mov (N Y). 2021; 11: 28https://doi.org/10.5334/tohm.632
- Prevalence of peripheral neuropathy defined by monofilament insensitivity in middle-aged and older adults in two US cohorts.Sci Rep. 2021; 1119159https://doi.org/10.1038/s41598-021-98565-w
Gelzayd E. Spinal cord stimulation trial in a visually impaired patient. Poster presented at: North American Neuromodulation Society 26th Annual Meeting; January 12–15, 2023; Las Vegas, Nevada.
Gardner-Bonneau D. The United States’ journey to achieve accessibility of medical devices. Paper presented at: Proceedings of the 20th Congress of the International Ergonomics Association; August 26–30, 2018; Florence, Italy.
- Americans with disabilities act of 1990 (United States).in: Albrecht G.L. Encyclopedia of Disability. Sage Publications, 2006https://doi.org/10.4135/9781412950510.n42
- Rehabilitation act of 1973 (United States).in: Albrecht G.L. Encyclopedia of Disability. Sage Publications, 2006
- Applying the principles of universal design to medical devices.in: Medical Instrumentation. CRC Press, 2006: 83-92
- Home healthcare: Applying inclusive design principles to medical devices.in: Designing Usability Into Medical Products. CRC Press, 2005: 227-234https://doi.org/10.1201/9781420038088.ch23
- Effect of high-frequency (10-KHz) spinal cord stimulation in patients with painful diabetic neuropathy: a randomized clinical trial.JAMA Neurol. 2021; 78: 687-698https://doi.org/10.1001/jamaneurol.2021.0538
- Development of the Medical Equipment Device Accessibility and universal design information tool.in: Medical Instrumentation. CRC Press, 2006: 283-296https://doi.org/10.1201/9781420006223-22
MED-AUDIT (Medical Equipment Device–Accessibility and Universal Design Information Tool): usability analysis. 29th Annual RESNA Conference Proceedings. Accessed August 21, 2022. https://www.resna.org/sites/default/files/legacy/conference/proceedings/2006/Research/Outcomes/Mendonca.html
Article info
Publication history
Published online: April 10, 2023
Accepted:
March 8,
2023
Received in revised form:
February 20,
2023
Received:
December 15,
2022
Publication stage
In Press Corrected ProofFootnotes
Source(s) of financial support: The authors reported no funding sources.
Conflict of Interest: Johnathan Goree has received compensation for consulting services with organizations including Abbott, Saluda, and Stratus Medical. Erika Petersen works extensively in the field of neuromodulation and has received grants and/or consulting fees from Abbott, Biotronik, Medtronic, Nalu, Nervo, Neuros Medical, Presidio Medical, ReNeuron, Saluda, SPR, and Vertos. She has also received honoraria, travel support, and/or leadership positions from AANS/CNS, ASPN, ASRA, Cleveland Clinic Pain Symposium, INS, and NANS. She has one patent in this field and stock options for Neuro.42 and SynerFuse, where she is also a board member. Vinicius Tieppo Francio receives funding from Nevro with an investigator-initiated study grant. The remaining authors reported no conflict of interest.
Identification
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© 2023 International Neuromodulation Society. Published by Elsevier Inc. All rights reserved.
