| 摘要: | 為持續提升醫療院所的醫療品質並減少無菌醫療器材的微生物汙染所產生的危害，可靠的醫療包材品質是保障病患安全的重點。醫療包材的完整性與滅菌品質息息相關，臨床上若因醫療包材破損而造成滅菌不完全，極可能導致病患發生感染。因此為確保包材品質的有效性，醫療包材需遵守國際法規ISO11607 Packaging for terminally sterilized medical devices(2019)確保醫療器材在使用時不因微生物汙染而影響其安全。
法規中廣泛了針對包裝材料的各種要求，包含加速老化、微生物屏障、運輸模擬、環境模擬等，其中最具代表性的是包材封邊的兩種物理性實驗，其一是ASTM F88(2015)也稱為封口強度實驗，另一個則是針對內部壓力實驗則是ASTM F1140(2020)。
ASTM F88(2015)主要針對封邊的封接強度進行驗證，而ASTM F1140(2020)則包含爆破及緩破兩種實驗，爆破是加壓到包材破損，並紀錄其壓力值(kPa)。而緩破則是輸入爆破數值的80%，並維持一定時間。但緩破實驗的內部壓力時間在業界上尚有爭議，依據規範ASTM F1140(2020)中要求緩破時間進行15秒至30秒，但需要定義更嚴謹且明確的秒數以便提升醫療品質。
有鑒於此，本研究對於緩破實驗設定15到60秒等十種秒數作為變數，接著對緩破實驗後的樣品對其封邊進行撕裂並記錄強度，善用統計方法先以ANOVA對不同時間點群組的封邊強度進行分析，找出秒數與強度的關聯性依據，並進一步以邏輯回歸的公式通過logit(log odds)給出的線性模型進行訓練，並通過logit轉換找出破壞機率P。此實驗訓練集設定為90%，測試集10%，在最不利的樣品下結果準確率為80%，並以Youden's index分析最大機率出現破損的秒數為40秒。此結果若能導入醫療機關的審核機制，促使主管機關以最嚴謹的方式進行控管，確保醫療包材品質來保證器械滅菌狀態減少微生物汙染的風險，對保障病患的安全並對提升醫療品質有絕對的正向助益。
To improve the medical quality and reduce the microbial harm contamination of sterile medical devices, the quality of medical packaging materials ensures patient safety. The integrity of the medical packaging material is closely related to the quality of sterilization. In the clinic, if the medical packaging material is damaged and the sterilization is incomplete, it is very likely to cause infection in the patient. Therefore, to ensure the effectiveness of the quality of packaging materials, medical packaging materials must comply with the international regulations ISO11607 Packaging for terminally sterilized medical devices(2019)to ensure that the safety of medical devices will not be affected by microbial contamination during use.
The regulations include a wide range of requirements for packaging materials, including accelerated aging, microbial barriers, transportation simulations, environmental simulations, etc. The most representative of which are the two physical experiments of packaging material, one of which is ASTM F88(2015)is also called the sealing strength test, and the other is called ASTM F1140(2020) for the internal pressure test.
ASTM F88 (2015)mainly verifies the sealing strength, and ASTM F1140(2020) includes two types of tests: burst and creep. The burst is to pressurize the packaging material to damage and record the pressure value (kPa). The creep is to enter 80% of the burst value and maintain few seconds. However, the internal pressure time of the creep experiment is still controversial in the industry. According to the standard ASTM F1140(2020), the time is required to be 15’s to 30’s, but more rigorous and clear seconds are required to improve the quality of medical treatment.
Given this, the study set 10 kinds of seconds, ranging from 15’s to 60’s, as variables for the creep experiment. then tear the sealing of the sample after the creep and record the strength, Firstly, the statistical method was used to the ANOVA, analyze the sealing intensity of groups at different time points to find out the basis for the correlation between the each other, and further train the linear model is given by logit (log odds) with the logit regression formula, and find out through logit conversion Probability of destruction. In this experiment, the training is set to 90%, the test is 10%, and the accuracy rate is 80% under the most unfavorable sample. The maximum probability of breakage in Youden's index analysis is 40 seconds. If this result can be introduced into the review mechanism of medical institutions, it will prompt the competent authority to control and control most rigorously to ensure the quality of medical packaging materials to ensure the sterilization state of devices and reduce the risk of microbial contamination, which will help ensure the safety of patients and improve the quality of medical care. |
