財團法人環境資源研究發展基金會 Institute of Environment and Resources - 廢棄物滅菌效能測試程序研訂及醫療廢棄物管理成效提升專案管理計畫
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  本計畫主要的目的在協助環保署研訂廢棄物滅菌效能測試程序及提升醫療廢棄物管理成效,本年度之工作項目包括五大部分:(一)彙集國內外廢棄物滅菌處理技術資料,建立廢棄物高溫高壓滅菌處理最佳化操作條件及實測數據;(二)研訂廢棄物高溫高壓滅菌處理標準、操作規定與滅菌效能測試標準程序,研提環保機關查核措施;(三)編印醫療廢棄物管理作業參考手冊,辦理教育宣導增進醫療機構廢棄物管理知能;(四)擇定不同類型、規模之醫療廢棄物產出事業,檢視其醫療廢棄物產出質、量參數及管理流程,建立提升管理成效作業指引;(五)輔導小型診所提升醫療廢棄物管理成效。工作內容摘要如下:

一、彙集國內外廢棄物滅菌處理技術資料,建立廢棄物高溫高壓滅菌處理最佳化操作條件及實測數據

 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。

二、研訂廢棄物高溫高壓滅菌處理標準、操作規定與滅菌效能測試標準程序,研提環保機關查核措施

 本計畫研訂「醫療事業廢棄物高溫高壓滅菌處理操作手冊」,內容中著重真空滅菌鍋及重力置鍋之操作模式,以利操作單位遵循。經實機測試後,參考本土化數據,以及歐美相關規定,研訂「廢棄物高溫高壓滅菌處理滅菌效能測試標準程序」,作為處理單位、環保及衛生單位評估滅菌成效之參考。進ㄧ步研訂滅菌設備查驗辦法「醫療事業廢棄物高溫高壓滅菌設施稽查手冊」,作為環保及衛生主管機關查驗的依據。

三、編印醫療廢棄物管理作業參考手冊,辦理教育宣導增進醫療機構廢棄物管理知能

 本計畫編撰「醫療機構事業廢棄物管理作業參考手冊」,並於97年1月至4月完成辦理10場次教育宣導活動,宣導醫療廢棄物相關法規最新修正內容、介紹新版手冊編撰內容,以及宣導滅菌處理,並彙集各方意見,以提升管理成效;配合教育宣導活動之辦理,提供3則提升醫療廢棄物管理成效相關新聞資料;另製作環保署醫療廢棄物管理資訊網頁資料,以提供各界參考。

四、擇定不同類型、規模之醫療廢棄物產出事業,檢視其醫療廢棄物產出質、量參數及管理流程,建立提升管理成效作業指引

 本計畫針對區域醫院、地區醫院、中/西/牙醫診所、以及生物安全等級第二級以上實驗室,進行問卷調查,蒐集其一個月之醫療廢棄物產出量,並進一步分析不同科別、病床之廢棄物產出情形,同時亦調查廢棄物清理流程,並建立不同規模、類型醫療廢棄物減廢、分類、包裝、資源回收清理作業指引;本計畫建議醫院評鑑之廢棄物評鑑重點及量化指標,評鑑重點包括文件管理、運作管理與管理組織等,供衛生主管機關辦理醫院評鑑之參考。

五、輔導小型診所提升醫療廢棄物管理成效

 本計畫實地訪查100家小型診所,包括洗腎診所與設有三個診療科別以上之診所,並彙整輔導訪查現場與後續追蹤改善情形,以使診所落實醫療廢棄物管理,另提列醫療院所常見廢棄物違規樣態與稽查重點,提供環保機關督導醫療機構落實廢棄物管理之參考;本計畫亦針對非有害之玻璃醫療廢棄物之特性及處理、再利用技術及再生市場、以及再利用管道進行資料調查整理,經彙整共有4家廢玻璃再利用機構表示對醫療廢棄物有回收的意願,且只對無感染性且已妥善分類的點滴瓶、藥瓶有回收意願,分別為春池玻璃實業有限公司(新竹)、天九興業股份有限公司(台南)、俊行記實業股份有限公司(桃園)及華夏玻璃股份有限公司(新竹)。

十六、英文摘要:

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).