| Abstract: | 醫療器材在醫療過程中，扮演十分重要的角色。藉由它的協助，可快速準確的診斷與治療病患，達到維護及促進健康之目的。但醫療器材的應用充斥著各式各樣的潛在風險、人為因素、環境因素及相關之法規規定。在這樣高風險的環境下，可否藉由一套有效、完善的內控稽核機制來規避可能發生之損失。本研究主要在進行醫療器材風險管理稽核機制之相關研究，並依據研究的結果，建立一套稽核機制，將其應用於醫療器材管理上，使相關人員於作業上有其準則且持續落實的執行，以降低危害的風險，進而提升醫療品質。藉由文獻探討及德爾菲專家問卷的辨識，彙整出醫療機構內醫療器材之風險與問題，整列出風險因子，再依據學者吳思華「策略九說」中之「風險說」作為分類架構，在各風險類別下發展出COSO各控制構面的醫療器材內部控制稽核要項。後續透過與風險類別之對應，歸納出該項稽核要項可用來檢驗內部控制是有機會解決該類醫療器材之風險。最後，以個案研究方式，來驗證本研究產出之風險管理稽核機制之可行性，根據受訪者之建議獲得最後之成果。而本研究之檢核表，配合CMMI能力成熟模型的運用，可做為評估對於醫療器材之風險是否有相關之內部控制制度有效的管理。研究之結果，可促進醫療機構對風險管理的引用，預先做好防範的控管，以達到維護病人安全之原則。對於法規的遵循、管理政策的調整及監督機制的落實，也有一定程度之協助。另外在學術上，也提供後續研究者其嚴謹及完整的研究方式，可從中探究更深一層之認知。
Medical device in the treatment process, play a very important role. By its assistance, can rapidly and accurately diagnose diseases and treat patients, to maintain and improve health. However, the use of medical device is filled with a wide range of potential risks, human factors, environmental factors and related regulations. In the high-risk environment, an effective and comprehensive internal control audit mechanism to avoid possible losses. This study conducting research related to audit risk management mechanism of medical device, and according to the results of the study, establish a mechanism for auditing, will apply on medical device management, personnel on the job has continued to implement its guidelines and implementation . In order to reduce the risk of harm, thereby enhancing the quality of medical care.This research collects and organizes all the risks and issues of medical device in health care organizations by identifying literature reviews and the Delphi questionnaire. Based on THE NATURE OF THE STRTEGY by Sehwa Wu, in chapter 8, RISK, risk factors in each category transform into items of COSO (Committee of Sponsoring Organizations of the Treadway Commission) internal control and audit. The next step is to collate the factors and the category, then to generalize the audit items, which can be inspected internally. Therefore, it’s likely that the risks related to medical device could be reduced. Lastly, research is valid for the feasibility of risk management audit mechanism by using a case study method. The result is based on interviewees’ suggestions. The checklist of this research has been applied to CMMI (Capability Maturity Model Integration). It has been evaluated to verify medical device risks and is an effective management as well as internal control system.The results of this research, can promote the medical institutions to risk management reference. In advance to prevent the prevention of control, in order to achieve the principle of maintaining patient safety. For the compliance of the regulations, the adjustment of management policies and the implementation of the supervision mechanism, there is a certain degree of assistance. In addition, in the academic, but also provide follow-up researchers rigorous and complete research methods, from which to explore a deeper understanding. |
