- 學位論文
醫療器材管理與風險評估之研究
The Study of medical Device Management and Risk Evaluation
摘要
研究目的 本研究之目的為探討國內醫療院所常用醫療器材之風險度，建立其風險評估模式，依風險評估結果，確認具有高風險之醫療器材。提供衛生主管機關、醫療器材製造或代理廠商、醫療院所等相關單位參考，以確保醫療器材之品質及安全，避免危害以保障國人健康。 研究方法 本研究資料收集後，以 SPSS for Windows12.0進行資料建檔、資料轉換與統計分析，依據變項的類別及研究目的進行下列分析 本研究為瞭解目前國內高風險醫療器材，以問卷調查方式進行，篩選 43 項醫療器材品項列入問卷調查。採用風險矩陣分數值估計風險等級，定義醫療器材所存在之風險危害影響幅度為最嚴重、嚴重、中等、不嚴重、可忽略等五個等級，定義其危害發生頻率為有時發生、偶而發生、很少發生、極少發生、不會發生等五個等級 統計風險值時頻率與損害幅度合併，並根據風險矩陣的分數值，區分 2~4 分為低風險，5~7 分為中度風險，8~10 分為高風險。 研究結果 1.醫院與廠商對藥事法、醫療器材藥物不良反應通報辦法法令認知、呼吸器影響幅度、呼吸器影響幅度風險認知有顯著性差異。 2.醫院與廠商對醫療器材管理辦法、醫療器材優良製造規範、醫療器材查驗登記審查辦法、呼吸器發生頻率、麻醉機影響幅度、麻醉機發生頻率、醫療器材不良通報系統認知、醫療器材風險發生頻率、醫療器材風險影響幅度通報系統認知無顯著性差異。 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30.6%、「普 通」為39.9%、「不熟悉」及「未了解」合計29.9%；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 13.3%、「普通」為 33.3%、「不熟悉」及「未了解」合計 53.3%。 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。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 。 結論與建議 本研究針對國內醫療院所常用之醫療器材，建立其危害分析模式，完成其風險分數值評估，並確認具有高風險之醫療器材，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。
關鍵字
醫療器材管理風險評估並列摘要
Objectives This study aims to explore the risk of those popular medical devices used by the hospitals in Taiwan, to establish a risk evaluation system, and to define the medical devices with high risk. The health governors, medical device manufacturers or agents, and the hospitals could be provided with the result to ensure the quality of medical devices and to avoid jeopardizing the people’s health. Methods The collected research data were filed, transferred, and analyzed by SPSS for Windows 12.0. The following analyses were made based on the categories of variables and study purposes: In order to know more about the medical devices with high-risk in Taiwan, this study chooses 43 medical devices to design the questionnaire.Using the Risk- Metrics, this study defines the risk levels as most dangerous, more dangerous, dangerous, little dangerous, not dangerous and defines the danger happening frequency as usually, . frequently, occasionally, rarely, never. The risk levels and danger frequencies are combined to evaluate the Value at Risk. Based on the Value at Risk of Risk-Metrics, 2~4 are defined as low risk, 5~7 as medium risk, and 8~10 as high risk. Results 1. There are significant differences in cognition of medicine pharmacist manages, National reporting rules of adverse medical device and drug reactions, effecting ranges of respirators, and risk of respirators existing between hospitals and medical device agents. 2. There is no significant difference in cognition of managerial regulations of medical devices, good manufacturing practice of medical devices, rules of inspection, registration and investigation for medical devices, happening frequency Ventilator, effecting ranges of Anesthesta, happening frequency Anesthesta, reporting system of medical device reactions, the danger happening frequency of medical devices, and reporting system of the risk of medical devices existing between hospitals and medical device agents This study investigates the management of medical devices in Taiwan through questionnaire. By analyzing the questionnaire, there are 30.6% of medical personnel familiar with the managerial rules of medical devices, 39.9% of medical personnel knowing the rules with common sense, and 29.9% of medical personnel not familiar with the rules. While there are 13.3% of medical device agents familiar with the managerial rules, 33.3% of medical device agents knowing the rules with common sense, and 53.3% of medical device agents not familiar with the rules. This study evaluates the risk levels of 43 medical devices according to their Values at Risk of Risk-Metrics. The result expresses that respiratorVentilator and Anesthesta are with high-risk; other 34 devices are with medium risk; only 7 devices are with low risk. Conclusion and Suggestion The study establishes a danger analyzing model of medical devices and evaluates the Value at Risk of the devices to define those medical devices with high risk. The hospitals could be provided with the results as reference for maintaining, managing or purchasing the medical devices.