“确保无菌安全：医疗机构中包装袋密封完整性”（英文版）.pdf

1、Ensuring Sterile Safety:Pouch Seal Integrity in Healthcare FacilitiesA review of two studiesMary Ann Drosnock,DrHSc,CIC,CFER,RM(NRCM),AAMIF,FAPICHead of Clinical AffairsHealthmark,A Getinge company1AIM Study#1 To evaluate the effectiveness of current practices,equipment maintenance protocols&user te

2、chniques to provide insights into mitigating seal failures.Investigate&identify the underlying factors contributing to seal integrity issues observed in heat-seal and self-seal pouches within healthcare facilities.By highlighting critical deficiencies,the study aims to equip educators and healthcare

3、 leadership with the necessary knowledge&strategies to enhance sterile processing standards&safeguard patient safety.This study is a retrospective cross-section 12-month study that was conducted from January to December 2023,across 39 healthcare facilities.When the Seal Breaks:Evaluating the Factors

4、 Behind Packaging Integrity Failures2Methods Conducted using multiple test methods:o For heat sealers,the Pouch Seal Integrity Test(PSIT)was employed alongside visual observation,both with magnification and the unaided eye.o The testing process involved roll stock pouch material designed for either

5、steam or low-temperature sterilization.PSIT example of a failure on both ends3Methods The facilities heat sealer was utilized to create a test pouch which included the PSIT inside.The ink in the PSIT was then activated to detect any potential seal integrity issues.This method was complemented by mag

6、nified visual inspection of the pouch seals as necessary.For facilities utilizing bar heat-sealers,additional inspection was performed on the Teflon rolls within the equipment.4Methods Ready-to-use sterile pouches were also examined for integrity issues.At each facility,ten pouches(five self-seal an