本計畫彙集國內外測定方法、效能評估指標、歐盟滅菌設備品管方案、分析滅菌與焚化處理成本。使用Heterotrophic Plate Count (HPC)方法評估滅菌效能，使用快速判讀生物指示劑 (Rapid Readout Bioloigcal Indicator) 與化學指示劑 (Chemical Intergrator) 進行平行比對。選定六家為檢測對象，分別以空機試驗與填充率試進行檢測。結果顯示袋內袋外之滅菌效能有顯著性差異，滅菌袋會阻絕蒸汽穿透影響滅菌效能；袋內與針筒內滅菌效能無顯著差異；大袋與小袋滅菌效能亦無顯著差異；真空式135℃ 45分鐘與重力式121℃ 60分鐘滅菌效能有顯著差異，真空式135℃ 45分鐘較佳。另外針對針筒、軟袋、軟管的滅菌效能選一家滅菌鍋進行測試，並使用挑戰包之滅菌效能進行比對，兩組實驗結果均顯示使用挑戰包作為滅菌效能測試有其代表性。
The aim of this project is to assist Environmental Protection Administration (EPA) in establishing the performance test process of waste sterilization and promoting efficiency of medical waste management. The main works in this project will include: (1) to collect domestic and foreign literature of the medical waste sterilization technologies, and to establish optimizing operating conditions and real data of the steam sterilization system for sterilizing medical waste. ; (2) to establish the standard of the medical waste sterilization, operating regulations and the performance test process, and to advance the inspection measures for the Environmental Protection Bureau (EPB) ; (3) to compile the medical waste management handbook and hold educational meetings to enhance the knowledge and abilities for the health care facilities ; (4) to survey medical waste average amounts and management process of different types and scales facilities, and to establish guidelines of promoting management efficiency ; (5) to guide small-scale clinics to promote efficiency of medical waste management.
This study collected sterilization performance test methods and indicators, European Union’s equipment quality assurance, and incineration and sterilization treatment costs. The hetrohtophic plate count (HPC) method and rapid readout biological indicator (RRBI) method were used for comparison of sterilization performance efficiency. Six commercial autoclaves were selected, each for empty and filling tests. The results show that there was significant difference in sterilization efficiency between the in-bag and out-bag tests, suggesting steam penetration would affect sterilization efficiency. There was no significant difference in efficiency between the large bag and small bag, and between the in-bag and in-syringe. The sterilization efficiency operated at vacuum-assisted 135 oC for 45 minutes was significantly better than at the gravity 121 oC for 60 minutes. In addition, one autoclave was chosen for the evaluation of syringes, soft bags, and soft tubes. The results showed that the challenge test was capable of simulating the in-bag test.
This study proposed a Manual of high temperature and high pressure sterilization operation for medical wastes. The manual emphasizes vacuum-assisted and gravity operating procedures useful to the operators. In reference of the full-scale test data and the information applicable to USA and Europes, this study proposed a Standard operating procedure of performance efficiency for high temperature and high pressure sterilization to be followed by treatment facilities and environmental protection authorities. Furthermore, this study proposed a Manual of inspection for high temperature and high pressure sterilization for environmental protection and sanitary authorities.
With respect to compiling the medical waste management handbook and holding ten educational meetings from January to April 2008, the new amended regulations of medical waste, the new contents of the handbook, and waste sterilization were introduced, and many discussions and comunication were collected for promoting efficiency of medical waste management. There were three pieces of news about promoting efficiency of medical waste management. The website of medical waste management information was set up to provide references.
In terms of surveying medical waste average amounts and management process of regional hospitals, district hospitals, chinese medicine clinics, western medicine clinics, dental clinics and biosafety level 2-4(P2-P4) laboratories, different departments and hospital beds medical waste average amounts and management process were analyzed. Based on our survey, the quidelines of medical waste reduction, classification, packing, and recycling for different types and scales facilities was established. With the suggestions from experts, the hospital accreditation concerning medical waste was proposed for Department of Health, which including documents management, operating management, and organization management.
Regarding guiding 100 small-scale clinics, including more than three deparments clinics and dialysis clinics, the clinics were more improve their medical waste management. The common illegalized conditions and the inspection points about medical waste were proposed for EPB. Additionally, the property, treatment, recycling and reuse technology, market, and channel of the non-hazardous glass medical waste were investigated. There are four facotories of recycling and reuse waste glass willing to recycle medical waste, but they are only interested in non-infectious and properly classified glass drips and glass medicine bottles. They are Spring Pool Glass Industrial Company Limited (Hsinchu City), Team Joy Enterprise Company Limited (Tainan County), Jun-Xing-Ji Company Limited (Taoyuan County), and Hwa Hsia Glass Company Limited (Hsinchu City).