近年來「病人安全」已成為公共衛生重要之議題，受到世界各國的重視，並陸續引用工業界已使用30餘年之失效模式影響與關鍵性分析。在美國自2003年起美國醫療機構評鑑單位已將HFMEA列為正式的標準；此方法逐漸成為醫療照護單位因應病人安全與風險降低作業之執行工具。傳統FMEA最大的缺點為風險係數計算法並非其原始值，而是由各項衡量因子相乘而得：發生率 × 嚴重度× 可偵測度。該方法容易造成當衡量值計算結果為同分時，無法辨識的盲點。此外衡量因子彼此之間並非線性關係，無法真正客觀判斷其風險值，故不適用於風險性極高的醫療照顧體系。本研究嘗試結合DEA本身具客觀量化的優越性，以改進FMEA之缺點。個案數據取自瑞士日內瓦大學附設醫院所採用FMECA分析藥局製作腸胃外營養溶液的過程所做之醫療風險評估（改善前之數據），使用四種不同模式分別探討。本研究結果建議以模式四為最佳分析方式，此模式可快速獲得正確之風險迴避係數。研究結果的風險迴避指數越小，代表風險越高，必須優先處理。經過處理後的風險係數可以做客觀的線性排序，以改進傳統之FMEA使用RPN做為風險評估之缺點。本研究個案共計18個失效模式，並以醫療風險迴避係數分級為十一級，其中研究結果顯示以第13.項「劑量錯誤」和第11.項「生產交換」為最危險的失效模式，需優先改善。本研究建議降低風險的首先改善目標為第十級須RPN由512、384分改善到 336、360分改善52%左右，如此可以善用有限的醫療資源，循序漸進的改善醫療風險流程，以提升病人安全。

In recent years, the Patient Safety has become one of the most important issues to Public Healthy service area. Many countries have taken this topic seriously. FMECA, applied by manufacturing industry for decades, has been introduced to this field. In U.S., since 2003 the Joint Commission on the Accreditation of Healthcare Organizations (JCAHO) has taken HFMEA as official standard (JCAHO Standard LD.5.2) to decrease the Patient Medical risk. Hence FMEA is an official tool widely introduced to US medical care system by JCAHO.RPN manipulation was calculated by its measurement factors: occurrence x severity x detectability. Traditional FMECA principle is not applicable to medical healthcare risk analysis. Medical industry requires higher safety standard. RPN was calculated by measurement each factor’s value and multiple one another other. When the calculation result is the same, it is easily to have judgment troubles, however. Due to these shortcomings, the traditional FMEA is not recommended to high-risk healthcare systems.This study was an exploratory research. DEA was applied on FMEA to overcome its defects. The study data were referred to “A FMECA method ‘Use of a systematic risk analysis method to improve the safety in the production of pediatric parental nutrition solution’”, Geneva University Hospital, Switzerland. We choice one of the two processes and had it be manipulated by four model analyses. Model 4 researches result was the best; it had provided correct Risk Avoidance Number (RAN) quickly if its RAN is the smallest. Through quantitative linear risk rankings, we learned the priority queue and its factors.
The case was resulted with eighteen failure modes, and it was ranked with eleven levels. Item no. thirteen“Dosage error”and no. eleven“ product exchange” are the most dangerous failure modes; it should be corrected in the first priority. The research result recommended risk deduction can start from item ten, fix RPN score from 512, 384 to 336, 360. By improving item ten, it enhanced the medical efficiency and improved medical care, and patient safe.

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相關網站
1. 美國National Patient Safety Foundation
http：//www.npsf.org
2. 英國National Patient Safety Agency
http：//www.npsa.org
3. 英國National Healthcare System
http：//www.nhs.uk
4. 澳州Australia Patient Safety Foundation
http：//www.research@ npsf.net.an
5. 美國JCAHO（Joint Commission on Accreditation of Health Organizations）
http：//www.jcaho.org
6. 行政院衛生署
http://www.doh.gov.tw
7. 財團法人醫院評鑑暨醫療聘品質策進會
http://www.ticha.org.tw
8. 財團法人彰化基督教醫院網站
http://www.qi.org.tw/tqm/aims/fmea/fmea_c.asp
9、 經濟部工業局工安環保
http://she.moeaidb.gov.tw/tai/reg.htm