血液透析設備標準規範與性能特性研究

Regulatory standards and performance characteristics for hemodialysis equipment

呂景揮(Ching-Hui Lu)

指導教授 ： 張炎林

中原大學/工學院/醫學工程研究所/碩士(2007年)

https://doi.org/10.6840/cycu200700619

摘要

血液透析設備性能的好壞，會直接影響透析病患的生命安全。因此，全球各先進國家對於設備性能特性的管理，大都採用標準規範，做為設備製造品質系統查驗與設備上市審查的依據，以確保設備的安全性與功效性，值得在國內參考、訂定與推廣。
本研究包括兩個部份。第一部分根據AAMI設備標準規範中的警報系統條款，進行包含1.除氣系統；2.排水的虹吸逆流防護；3.供水系統的逆流防護；4.透析液系統與血液迴路的監測與警報等四類條款的要求條件整理。另根據FDA設備上市審查指引中的申請設備之描述，進行包含1.物理的且/或電子的零組件；2.作用及功能；3.材料及生物相容性；4.軟體等四類，以及申請設備之性能，進行包含1.功能測試；2.水平危害分析；3.電學安全性測試；4.電磁相容性測試等四類要求資料整理。第二部根據第一部所整理的AAMI設備標準規範之要求條件，執行相關的查核檢驗。
由AAMI設備標準規範整理結果得知，這些要求條件已明確訂定設備運行中與即將產生安全危害時，其監測、控制、偵測與顯示等相關功能，應達到相當的準確度、靈敏度與安全防護措施等要求條件；由FDA設備上市審查指引整理結果得知，這些要求資料已明確指引申請設備應提供設備各組件的作用與相關功能之全面性的資料，以及設備的測試與相關分析之全面性的資料。另由已上市設備查核檢驗結果得知，膜上壓與靜脈壓之壓力警報值與AAMI標準規範有所不同，原因為壓力警報值的設定範圍可以適時變更調整；其他監測、偵測、控制、顯示與達到警報條件應產生安全防護措施等相關功能，皆符合AAMI設備標準規範的準確度、靈敏度與安全防護措施等要求條件。
本研究有系統的整理AAMI設備標準規範與FDA上市審查指引的管理要求，並由設備查核檢驗了解已上市血液設備符合標準規範之要求條件的實際情形，未來將有助於國內制定設備標準規範或設備上市審查要求法規一個重要的參考依據。

關鍵字

查核檢驗 ； 上市審查 ； 血液透析設備 ； 標準規範

並列摘要

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.

並列關鍵字

Compliance testings ； Hemodialysis equipment ； Regulatory standards ； Premarket notifications

參考文獻

[2]顏士翔, 微控制器在適化透析之應用,中原大學醫學工程學系碩士

教育部顧問室,2000.

unit, DBB27- Hemodialysis system Operating Instructions manual,

[3]葉日兆, 血液透析用從透析液供應鐵劑之調製方式,中原大學醫學

Software version 3.2, Article No.:672 076 1, Fresenius Medical Care