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