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Journal List > Prog Med Phys > v.28(4) > 1098574

Bae, Hwang, Kim, and Lee: A Study on the Usefulness of Development of a Steam Sterilizer Equipped with an Electronic Bowie-Dick Test System

Abstract

To verify the usefulness of a steam sterilizer equipped with an electronic Bowie-Dick test system, this study was carried out using two methods, utilizing both a steam sterilizer and an electronic Bowie-Dick tester. The first method is to confirm the error detection of the chemical Bowie-Dick test pack and the electronic Bowie-Dick tester in a malfunctioning sterilizer environment. For this purpose, the Bowie-Dick test program for the steam sterilizer was used to test three types of test packs commonly used in hospitals and the electronic Bowie-Dick tester by changing the set values of temperature, time, and vacuum frequency. The second is an experiment to check the sterilizer's normal operation with the electronic Bowie-Dick tester and the usefulness of grasping the cause of the malfunction. The results showed that the sterilization temperature was the same as that of the test pack at a temperature 1~6°C lower than the reference temperature of 134°C. In the test with the sterilization exposure time as a variable, there was a normal discoloration at a time difference of 30~90 s. In the experiment using the number of vacuum cycles, the test was correct by performing the normal discoloration only at the normal condition of 3 times. The test results of 30 hospitals were 100 failure tests by a total of 291 Bowie-Dick tests. Of these, the failure factors related to an internal temperature that the chemical test packs could not detect were the greatest, and the four factors related to temperature, including the internal temperature, were found to be 71.18% of total malfunctions. In addition, the Bowie-Dick tester was provided within 30 min after the start of the Bowie-Dick test to confirm the performance of the sterilizer and the detailed cause. A steam sterilizer equipped with an electronic Bowie-Dick test system is used to manage individual sterilizers. In the current steam sterilizer with many temperature-related errors, it is possible to check the malfunction of the temperature difference that the test pack cannot detect, and the cause of error for the sterilizer is immediately detected after the test. The steam sterilizer equipped with the electronic Bowie-Dick test system assists with infection control with accurate sterilizer performance assurance.

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REFERENCES

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7.Yushi Uetera, Hiroshi Shigematsu. A Simple Method to Control Bowie–Dick Test Cycle Correctly in the Pre-vacuum Autoclave without the Automatic Bowie–Dick Test Mode. PDA journal of GMP and Validation in Japan. 2005. 7:55–58.
8.Research on the utility of developing a steam sterilizer equipped with an electronic Bowie–Dick test system.
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pmp-28-156f1.tif
Fig. 1
Steam sterilizer equipped with electronic Bowie–Dick test system.
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pmp-28-156f2.tif
Fig. 2
(a) Unevaluated result value and (b) measurement data of the Winlog.med program.
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pmp-28-156f3.tif
Fig. 3
Analysis of malfunctions based on (e) evaluation results provided by the program and characteristic graph waveforms of (a) air pocket, (b) wet steam, (c) leakage, and (d) overheated steam.
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Table 1
Sterilization temperature and exposure time satisfying normal discoloration.
pmp-28-156t1.tif
Table 2
Discoloration and Winlog.med program data according to the number of vacuum cycles.
pmp-28-156t2.tif
Table 3.
Cause of failure according to the experiments using the electronic Bowie–Dick tester EBI 15.
Hospital Experiment day Number of tests Failure Count Fail factor
Internal temp. No temp. reached Sensor temp. difference Temp. range Exposure time Residual air Equilibration time
1 2013-10-31 to 11-08, 2013-12-13,16 Numbers 1 to 4, each once 2015-08-06 Numbers 1 to 4, each 3 times 56 14 5 6 1 4 7    
1-1 2013-10-02 to 12-04 Numbers 1 to 4, each 3 times each 1 to 2 times 104 2 2   2        
2 2015-08-12 8 5 2 2   2 1    
3 2014-08-12 5 5 5   4 2 3 1 2
4 2014-03-04, 21 8 5 3   1   4    
5 2014-01-27 4 1     1        
6 2015-09-17, 2016-02-18 7 6 3   2 2 2 1  
7 2014-04-09 2 2   2          
8 2013-12-26 3 3   2       1  
9 2013-12-26 1 1   1          
10 2015-01-07 3 2       2     1
11 2014-07-22 2 2 1     1   1  
12 2014-01-10, 28 7 3     1     3  
13 2014-07-15 2 0   2          
14 2013-11-05 4 2 1   2        
15 2015-02-04 1 1       1   1 1
16 2014-07-06, 08 6 1             1
17 2015-01-19 3 1 1   1 1      
18 2014-02-03 2 2   2          
19 2014-07-04 to 08-20 21 13 3 9   2 1 1  
20 2014-08-07 2 1 1   1   1 1 1
21 2015-07-24 2 0              
22 2015-08-06 4 3 1 1   1   2  
23 2014-07-10 1 0              
24 2014-09-16 5 3 1   1 2   1 1
25 2014-03-25, 2013-11-04 4 2 1   1     1  
26 2014-07-28 3 3 3       3    
27 2014-06-11, 08-01, 2015-09-04 7 6 4 2 2 1 1 3  
28 2015-01-08 7 4 2 2 2     2  
29 2016-01-14, 2017-03-14 5 5 2 1 1 1      
30 2017-11-28 2 2 2   1        
Total 2013-10-01 to 2017-11-28 291 100 43 32 24 22 23 19 7
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