醫療器材風險評估與管理之初步研究

The Preliminary Study of medical Device Risk Evaluation and Management

蘇明綢(Ming-Chour Su)

指導教授 ： 蘇振隆

中原大學/工學院/醫學工程研究所/碩士(2006年)

https://doi.org/10.6840/CYCU.2006.00489

摘要

為確保醫療器材產品品質符合世界趨勢、提升醫療臨床服務品質及保障人類健康，全球各國對醫療器材產品都進行全面的控管與審核，並將「風險評估與管理」導入醫療器材之管理，以研擬各類醫療器材查驗品項審查基準，作為上市前審查及上市後抽驗之依據。醫療器材管理之國際化是無法避免的，故本研究主要是研究如何將上述之觀念，針對國內之需求而導入現有規範進行初步之評估與探討。
本研究透過問卷調查國內醫療器材管理制度執行現況，其中醫療院所從業人員對現行醫療器材管理制度熟悉情形：「很熟悉」及「熟悉」合計28.4%、「普通」為41.8%、「不熟悉」及「未了解」合計29.8%；製造或代理廠商對現行醫療器材管理制度熟悉情形：「很熟悉」及「熟悉」合計15.6%、「普通」為33.3%、「不熟悉」及「未了解」合計51.1%，45份問卷中已建立不良醫療器材通報系統者19位（42.2%）。本研究並以風險矩陣分數值，評估國內醫療院所常用之43項醫療器材風險值，此外並針對美國ECRI網站近三年不良醫療器材通報及產品回收相關資訊，依據危害影響等級差異分別加權及彙整統計風險排序，並以臨床應用角度分別檢討國內外風險排序差異。
研究結果顯示醫療院所從業人員或廠商對醫療器材管理制度普遍不熟悉或未了解，而對不良醫療器材通報作業只有5位(11.1％)曾通報衛生署ADR中心顯示仍未落實ADR通報作業。就國內醫療院所常用之43項醫療器材，統計結果屬於高風險者計有呼吸器、麻醉機二項，屬於中度風險者有34項，屬於低風險者有7項；本研究並就屬於高風險醫療器材且排序第一之呼吸器，參酌國際ISO、美國、歐盟所制定之標準及美國FDA指引內容，完成其審查基準草案之研擬。
本研究已確認國內醫療院所常用醫療器材之風險等級，並完成呼吸器查驗品項審查基準，其結果可供醫療院所作為醫療器材維護管理與採購之參考、可供製造廠商作為生產製造風險管理之參考及作為政府未來上市前審查及上市後監督之重點品項參考。此外為落實國內醫療器材管理制度，本研究認為政府應推動醫工專業證照制度，衛生行政主管機關應加重醫療器材維護管理與品質安全監控之醫院評鑑分數比重並邀請醫工學者專家參與，廠商應建立定期器材追蹤制度及定期提報不良醫材通報作業，醫療院所應設置醫工人員負責醫療器材之維護管理與品質安全監控，才能有效確保醫療器材品質及安全，避免危害以保障國人健康。

關鍵字

查驗登記審查 ； 醫療器材標準 ； 醫療器材指令 ； 優良製造規範 ； 風險評估與管理

並列摘要

In order to guarantee the quality of medical device and protect the human health, the global various countries all inducts "risk evaluation and management" into the management of the medical device, and draw up the inspection and investigation standard of each kind of medical device for pre-marketing investigation and post-marketing verification. Global harmonization of the medical device management is unavoidable, therefore this study according to the above idea, domestic requirement and the existing standard, to carry on the preliminary study of medical device risk evaluation and management.
This study investigates the performance current situations of the domestic medical device management system through the questionnaire. The familiar situation to the medical device management system for medical institute staffs are "very familiar" and " familiar" as 28.4%, "ordinary" as 41.8%, "unfamiliar" and "unknown" as 29.8%, for the manufacturer are "very familiar" and " familiar" as 15.6%, "ordinary" as 33.3%, "unfamiliar" and "unknown“ as 51.1%, and in 45 questionnaires there are 19(42.2%) have already built up the ADR system. A risk matrix method is used to evaluate the risk level for the 43 items medical device of the domestic medical institute commonly used. We also collected the American ECRI Health Devices Alerts issue for latest three years, and statistics the risk sequence based on “critical” and “high” risk influence rank with difference weighting, and discussed the difference risk sequence between domestic and foreign by the clinical application view.
The preliminary results show that most of the medical institute staffs and manufacturer were not familiar to the medical device management system, among them only 5 (11.1%) had ever notify to the Department of Health ADR center also show that the ADR system has not carry out well. The risk level of the domestic used medical device in which the ventilator and anesthesia machine two items belong to the high risk level, 34 items belong to the medium risk level and 7 items belong to the low risk level. We also deliberated the ISO, EU standards and FDA guideline to accomplish the standard for instrument with high risk level.
This study has already confirmed the risk level of the domestic used medical device, and accomplished inspection standard. The result may refer to the medical institute as the medical device maintenance management and the purchase reference, to the manufacturer as pre-marketing risk management reference, and to the government as pre-marketing investigation and post-marketing verification reference. In order to effectively guarantee the medical device quality and safety, avoids harming and ensure the people health, four suggestions were made in this study. There are 1.The government should impel the professional license system of biomedical engineering; 2.The Department of Health should increase the score proportion of the medical device maintenance management and the quality safety monitoring in hospital review system, and then invite the biomedical engineering professional to review the system; 3.The manufacturer should establish the medical device tracing system and reporting system regularly; 4.Tthe medical institute should set up the biomedical engineering personnel to be responsible for the maintenance management and quality monitoring of the medical device.

並列關鍵字

Inspection Registration and Investigation ； Medical Device Standard ； Medical Device Directive(MDD) ； Risk Evaluation and Management ； Good Manufacturing Practice(GMP)

參考文獻

(1) 中華民國藥事法，行政院衛生署，2005。

(2) 醫療器材優良製造規範，行政院衛生署，1999。

(13) 醫療器材分類分級及其管理模式，行政院衛生署，2004。

(16) 醫療器材管理辦法，行政院衛生署，2005。

(8) US. Congress, “FEDERAL FOOD, DRUG, AND COSMETIC ACT”，Portions Revised or new 1997.