| Summary: | 碩士 === 中原大學 === 醫學工程研究所 === 95 === The performance of hemodialysis equipments will directly influence the safety of dialysis patients. Therefore regulatory standards become the basis of manufacturing and pre-market approval of hemodialysis equipments in advanced countries. It, is worthful to refer and regulate the related standards in Taiwan.
This study has been divided into two parts, including the warning systems of AAMI’s regulatory standards for equipment (part 1) and the requirements of compliance testing for AAMI (part 2). In part 1, four types of requirements have been organized including monitors and alarms for dialysate and blood circuits, back-siphon protection from the drain, water system back-flow protection and deaeration systems. In addition, FDA’s pre-market notifications for equipment have been also organized into part A and B. In part A, four types of requirements have been sorted including physical and/or electronic components, features and functions, materials and biocompatibility as well as software. In part B, four types of requirements have also been sorted including functional testing, system-level hazardous analysis, electrical safety testing and electromagnetic compatibility testing.
According to the reorganization results of AMMI’s regulatory standards for equipment, those requirements have explicitly concluded that the related functions such as monitor, control, detection and display should be reached in relatively accuracy, sensitivity and safety when the equipments are operating or the safety alarms are warning. In addition, as the reorganization results of FDA’s pre-market notifications for equipment, those requirements have explicitly pointed out that the documents associated with functions of equipment’s components and testing of equipment should be fully offered. Furthermore, as the results of compliance testing for marketed equipments, the alarm values for transmenbrane and venous pressure are different from AAMI’s regulatory standards because the alarm values could be adequately tunable. On the other hand, other functions such as monitor, control, display and safety are satisfied with AAMI’s regulatory standards for equipments.
This study systematically concludes AAMI’s regulatory standards for equipments and the requirements of FDA’s pre-market notifications. In addition, some marketed hemodialysis equipments have been analyzed by compliance testing associated with the regulatory standards of AAMI and the requirements of FDA. This could be an important reference that could assist to establish domestic regulatory standards and pre-market notification for hemodialysis equipments.
|
|---|
