Assistive device manufacturers

Measurements, and concepts with which they are associated, can contribute to a shift from experience-based knowledge acquisition to rule-based, engineering-like methods. This requires (1) a widely accepted conceptual framework (i.e., known to assistive device manufacturers, rehabilitation engineers, and other professionals within the rehabilitation community), (2) a more complete set of measurement tools that are at least standardized with regard to the definition of the quantity measured, (3) special analysis and assessment software (that removes the resistance to the application of more rigorous methods by enhancing the quality of decisions as well as the speed with which they can be reached), and (4) properly trained practitioners. Each is a necessary but not sufficient component. Thus balanced progress is required in each of these areas. 

Rehabilitation technology (or assistive technology) narrowly defined is the selection, design, or manufacture of augmentative or assistive devices that are appropriate for the individual with a disability. Such devices are selected based on the specific disability, the function to be augmented or restored, the user s wishes, the clinician s preferences, cost, and the environment in which the device will be used. 

What has changed since the ANSi/iSA-84.01-1996 standard is that SiF devices have become much more compiex, using embedded software, more compiex appiication circuits, and extended use of iimited variabiiity programming for PE iogic soivers. Manufacturers aiso now revise devices more often to add features and address component obsoiescence. Therefore owners/operators need the assistance of manufacturers to deveiop devices that meet safety requirements and have management-of-change processes in piace. These attributes are the center piece of iEC 61508 compiiance. 

Yang M, Zang Z, Hahn C, Laroche G, King MW, Guidoin R. Totally implantable artificial hearts and left ventricular assist devices selected impermeable polycarbonate urethane to manufacture ventricles. J Biomed Mater Res 1999 48(1) 13-23. 

U.S. Food and Drug Administration. Office of Health and Industry Programs. Division of Small Manufacturers Assistance. Project Officers James Park, Marsha Melvin, Althea Barcome. Investigational Device Exemptions Manual. HHS Publication FDA 96-4159. Rockville, MD U.S. Department of Health and Human Services, 1996. 

---