| Objectives:The efficiency of several vacuum steam sterilization PCDs under different sterilization procedures was observed through laboratory tests in order to research their conditions and parameters.The purpose of the survey in the hospital was to know the general situation of surgical instruments and hollow devices monitor.The laboratory results of hollow PCD were verified in a hospital supply room to provide technical data for the steam sterilization PCD evaluation criteria in China.Methods:1.In the laboratory,two spiral hollow PCDs were tested in a vacuum steam sterilizer (XHJC-A B-D resistance comprehensive detector) to observe the efficiency and research the main influencing factors of hollow PCD in steam sterilization process. The test cycle was sub-atmospheric air removal,temperature was 134.0℃,and time was 3.4 min.Vacuum depth was 5kpa,20kpa and 21～30kpa.Vacuum rate was 50～100kpa/min,100～200kpa/min,200～400kpa/min and＞400kpa/min.Display styles included vertical putting and horizontal putting.2.Porous PCD was tested under the processes of sub-atmospheric air removal, super-atmospheric air removal,impaired sub-atmospheric air removal,impaired super-atmospheric removal and air injection test to observe the efficiency in different cycles and research the main influencing factors of hollow PCD in steam sterilization process.The temperature was 134.0℃,and time was 3.4 min.3.The spiral hollow PCDs were tested under the processes of sub-atmospheric air removal,super-atmospheric air removal at the qualified conditions of porous PCD to compare the test results.The temperature was 134.0℃and time was 3.4 min.Vacuum rate was no more than 50 kpa/min.4.Identical B-D tests were carried out on disposable B-D simulation test pack and standards B-D test pack under the processes of sub-atmospheric air removal, trans-atmospheric air removal,super-atmospheric air removal,modified air removal stage(sub-atmospheric removal,4 times to 2 times;trans-atmospheric air removal, 4-2 times to 2-1 times),induced leak and air injection test to observe and compare the test results and research the main failure reasons of B-D test. 5.Both the disposable chemical test pack and the standard test pack were both experimentized under the same conditions,setting different temperature and time respectively.Test cycle includes sub-atmospheric air removal,trans-atmospheric air removal and super-atmospheric removal.The results were observed to compare the consistency of the hindrance and penetrativity of two packs to the dry saturated steam.6.The purpose of the survey in the hospital was to know the general situation of surgical instruments and hollow devices monitor and to verify the laboratory results in the hospital supply room.Results:1.In the cycle of hollow PCD,when the temperature was 134.0℃,and time was 3.4 min,and vacuum depth was 5 kpa and 20 kpa,1-PCD could be qualified for four times and 15 times,2-PCD could be qualified for three times and 12 times.When the vacuum depth was adjusted to 21 kpa and 30 kpa,1-PCD and 2-PCD could not be qualified after 15 times pulsing.When the vacuum rate was more than 100kpa/min, the efficiency of 1-PCD was influenced.When it was more than 200kpa/min,the efficiency of 2-PCD was influenced.Putting style affected 1-PCD test results.Vertical putting passed and horizontal putting failed,but 2-PCD was not affected.2.In the cycle of porous PCD,the temperature was 132.0℃,and time was 3.0 min, the test pack could be qualified after 7 times pulsing under sub-atmospheric air removal and 3 times pulsing under super-atmospheric air removal.After modified air removal stage,the test pack could not be qualified after 5 times pulsing under sub-atmospheric air removal and 2 times pulsing under super-atmospheric air removal. When we injected air for 100 mL under the process of sub-atmospheric air removal, the porous PCD was qualified and we injected air for 200mL,the cycle failed.When we injected air for 500mL under the process of super-atmospheric air removal,the porous PCD was qualified and we injected air for 530 mL,the result was failed.When the vacuum rate was≤50kpa/min,100～200kpa/min,200～400kpa/min and＞400kpa/min,the result of sub-atmospheric air removal could not be influenced.When it was＞400kpa/min under the process of super-atmospheric air removal,the result was failed.3.When the hollow PCDs were tested at the qualified conditions of porous PCD,the temperature was 132.0℃and time was 3.0min,sub-atmospheric air removal, vacuum depth was 20kpa,7 times pulsing,1-PCD and 2-PCD was both failed.When the hollow PCDs were tested under super-atmospheric air removal,3 times pulsing, 1-PCD and 2-PCD was both failed.4.When experimentized under the processes of sub-atmospheric air removal, trans-atmospheric air removal and super-atmospheric air removal,the B-D sheets in the standard B-D test pack and the disposable B-D simulation test pack could change color uniformly except for the disposable B-D simulation test pack under the process of sub-atmospheric air removal.If modified air removal stage,induced leak and air injection,the B-D sheets in standard B-D test packs showed uneven color change.The B-D sheets in the disposable B-D simulation test pack could not change color uniformly except for sub-atmospheric air removal under three failed test conditions. Two B-D test sheets used in the B-D test packs showed no discernible color change after exposure to dry heat condition.5.Both the disposable chemical test pack and the standard test pack were both experimentized under the sub-atmospheric air removal,trans-atmospheric air removal and super-atmospheric air removal,and the chemical indicators in two packs of the pass cycle and fail cycle almost achieved identical results.However,the clean standard test pack could be different with the disposable test pack after 15 times use, and false positive results probably appeared.6.The operators in the hospital supply room could use different sterilization cycle according to different items when used sterilizers.The spiral PCDs used in the laboratory and the compact PCD used daily in the hospital passed the experiments. The vacuum rate of the sterilizers of the hospital was far away from 50kpa/min.Conclusions:1.The main influencing factors to the hollow PCDs sterilization included vacuum depth,vacuum rate and putting style.The deeper vacuum depth was,the less times of the air removal stage required.The vacuum rate should be controlled within 50kpa/min and the longer PCD was more sensitive.Vertical putting influenced the sterilization results of the longer PCD.2.The main influencing factors to the porous PCD sterilization included pulsing times, air rejection and vacuum rate(The vacuum rate only influenced the results of super-atmospheric air removal sterilization).3.The hollow PCD passed more difficult than porous PCD under the identical test condition.4.Both standards B-D test pack and disposable B-D simulation test pack could detect the failure results because of inefficient air removal,air leak and non-condensable gases.But the disposable B-D simulation test pack failed under the process of sub-atmospheric air removal.5.The disposable chemical test pack and the standard test pack can monitor the effects of sterilization,but with the increasing times of the standard test pack being used,the steam penetration of the test pack could be even worse.To avoid the wrong results,the standard test pack should be paid special attention to the issue of cleaning.6.Daily sterilization monitoring records of the hospital supply room were complete perfectly.They used compact PCD for B-D test and monitoring,but the service life of the hollow PCDs should be noted in order to ensure the quality of monitoring. |
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