手术用棉制品和绷带辐射灭菌的生物负荷及理论无菌剂量计算

Bioburden and theoretical sterility dose calculation for radiation sterilization of surgical cotton and bandages.

作者信息

Khurshid S J

机构信息

Nuclear Chemistry Division, Pakistan Institute of Nuclear Science and Technology, P.O. Nilore, Islamabad.

出版信息

J Pak Med Assoc. 1993 Jan;43(1):8-10.

PMID:8474221

Abstract

The initial bioburden, count of colony forming unit (CFU) was determined on the locally manufactured non-sterilized surgical cotton and bandages. In all 489 tests were conducted on 163 cotton samples and 246 tests on 82 bandage samples. The surgical cotton showed an average of 198 microbes with a maxima of 287 and minima 94 whereas bandages showed an average of 179 microbes with a maxima of 268 and minima of 89. In the 20% samples subjected to identification no anaerobic microorganism was isolated while the aerobic microorganisms isolated were all bacilli. The sterilization dose (SD) for sterility assurance level (SAL) of 10(-6) was 2.23 Mrads and 2.21 Mrads, whereas the device verification dose (DVD) was 0.6 and 0.59 Mrads for cotton and bandages respectively as calculated by the method proposed by the Sterilization Standard Committee, Association of Advancement of Medical Instrumentation (AAMI).

摘要

对本地生产的未灭菌手术棉和绷带进行了初始生物负荷（菌落形成单位计数，CFU）测定。对163个棉花样本共进行了489次测试，对82个绷带样本进行了246次测试。手术棉平均有198个微生物，最多287个，最少94个；而绷带平均有179个微生物，最多268个，最少89个。在20%进行鉴定的样本中，未分离出厌氧微生物，分离出的需氧微生物均为杆菌。按照医疗器械促进协会（AAMI）灭菌标准委员会提出的方法计算，达到无菌保证水平（SAL）为10^(-6)时，棉花和绷带的灭菌剂量（SD）分别为2.23兆拉德和2.21兆拉德，而器械验证剂量（DVD）分别为0.6兆拉德和0.59兆拉德。