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Harmonization of Standards for Assistive Technology (AT)

Harmonization of Standards for Assistive Technology (AT). Rory A. Cooper, Ph.D. Departments of Rehabilitation Science & Technology, and Bioengineering University of Pittsburgh Division of Physical Medicine and Rehabilitation UPMC Health System Human Engineering Research Laboratories

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Harmonization of Standards for Assistive Technology (AT)

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  1. Harmonization of Standards for Assistive Technology (AT) Rory A. Cooper, Ph.D. Departments of Rehabilitation Science & Technology, and Bioengineering University of Pittsburgh Division of Physical Medicine and Rehabilitation UPMC Health System Human Engineering Research Laboratories VA Pittsburgh Health Care System

  2. The Need for AT Standards • To provide means of comparing products. • To investigate the safety and efficacy of AT Devices. • To promote international sales and market access. • To quantify and elevate the quality of AT Devices.

  3. Assistive Technology and ISO • Most active participation comes from Europe, North America, and Asia • Only medical devices are addressed (e.g., wheelchairs, hearing aids, walkers) • Some AT are consumer devices (e.g., non-slip mats, reading glasses)

  4. Organization Structure of AT Standards • International Organization for Standardization (ISO) • Technical Committee 173 • SC-1 Wheelchairs • SC-2 Classification and Terminology • SC-3 Aids for ostomy and incontinence • SC-4 Aids and adaptations for communications • SC-6 Hoists for transfer of persons

  5. National and Regional Structures • Most countries or regions have a similar structure to ISO for AT Standards. • For example, Europe uses CEN with AT under Technical Committee TC273 • WG-1 Walking Aids • WG-2 Wheelchairs • WG-3 Transfer Hoists • WG-4 Adjustable Beds • WG-5 Prostheses and Orthoses

  6. Government Regulation of AT • Many governments regulate AT. • US FDA regulates AT for “Safety and Efficacy”. A Class system is used. • Class I: Minimal risk with least amount of testing (manual wheelchairs). • Class II: Moderate risk with substantial testing (electric powered wheelchairs). • Class III: New device categories and “high risk” devices. Requires “Pre-Market Approval” (PMA), e.g., Stair-Climbing • Wheelchairs.

  7. European Regulations • Regulatory authority provided by Medical Device Directive (MDD) • Testing determined by MDD classification, similar to FDA. • Manufacturers and distributors may “self-certify”. No third-party testing required. • CEN and ISO standards provide guidance.

  8. Influence of Third-Party Payers • Set “eligibility” requirements for purchase. May refer to standards (e.g., VA) • Prospect of payment based upon compliance with standards provides manufacturers with incentives. • Product comparison data provides means of defining quality.

  9. Discussion • Standards benefit manufacturers, payers, clinicians, and consumers. • Government regulatory bodies gain broader perspective through application of standards. • Stimulates global thinking about AT. • Standards for many products have yet to be addressed.

  10. Acknowledgement This work was partially supported by the Paralyzed Veterans of America, and the NIDRR-RERC on Wheelchair Technology. Review this Lecture

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