This study briefly introduces the basic theory of sterilization, the characteristics of ethylene oxide sterilization for medical devices and the key factors about sterilization effectiveness, analyzes and compares three methods used in the product release of medical devices sterilized by ethylene oxide: test for sterility, traditional release and parametric release, and focuses on the theoretical basis, feasibility, validation requirements, advantages and disadvantages of parametric release.
Ethylene Oxide ; Sterilization/methods*

Recently, we performed an ezperi nlent to detect residual ethylene oxide(EO) gas and methylmethacrylate(MMA) monomer in the intraocular lenses from eleven different makers using gas-liquid chromatography. The residual EO gas over 25ppm was seen in 2 makers and also the MMA monomer over 2% was present in two makers. As a result, we recommend that the precise product quality-control of the IOLes is necessary especially for the lenses from foreign manufacturers.
Chromatography, Gas ; Ethylene Oxide* ; Lenses, Intraocular

Recently, we performed an ezperi nlent to detect residual ethylene oxide(EO) gas and methylmethacrylate(MMA) monomer in the intraocular lenses from eleven different makers using gas-liquid chromatography. The residual EO gas over 25ppm was seen in 2 makers and also the MMA monomer over 2% was present in two makers. As a result, we recommend that the precise product quality-control of the IOLes is necessary especially for the lenses from foreign manufacturers.
Chromatography, Gas ; Ethylene Oxide* ; Lenses, Intraocular

A variety files made of stainless steel (S-S) or nickel-titanium (Ni-Ti) are used during endodontic treatment. The purpose of this study was to evaluate the corrosion susceptibility of S-S and Ni-Ti endodontic files. Three brands of files were used for this study: K-flex(R) S-S files (Maillefer, USA), Profile(R) Ni-Ti files (Maillefer, USA), K-3(R) Ni-Ti files (SybronEndo, USA). 120 files of each brands (21mm, ISO size #20) were divided into 12 groups according to 1) sterilization methods using Autoclave or Ethylene Oxide (E-O) gas, 2) Irrigation solutions using 5.25 % NaOCl or Saline, 3) the number of sterilization (1, 5, 10 times). After above procedures, each of the files was inspected by three examiners with a light microscope and camera at X25. Each file was judged and ranked according to the following criteria: 0; no corrosion, 1; mild corrosion, 2; moderate corrosion, and 3; severe corrosion. The files of high score were examined under the Scanning Electron Microscope. Data were statistically analyzed with the Kruskal-Wallis test (p < 0.05). Most of the ten time-autoclaved files had showed mild to moderate corrosion. But, one or five time-autoclaved files did not show corrosive surface. NaOCl treatment and E-O gas sterilization did not influence on corrosion. There was a significant difference in corrosion susceptibility between sterilization methods and the number of autoclaving. However, there was no significant difference between brands and file materials.
Corrosion* ; Ethylene Oxide ; Stainless Steel ; Sterilization*

Using the all closed covering low-temperature method, we successfully made the packaging and sampling of ethylene oxide standard.
Ethylene Oxide ; standards ; Sterilization ; instrumentation ; methods

One of the reasons for insertion of endotracheal tube is to provide a patent airway. Unfortunately, the tube itself may become the cause of airway obstruction. Especially, armored tube is known to be most effective in maintenance of airway patency. However, airway obstruction has been reported by a varity of causes even though armored tube was used. We experienced airway obstruction with armored tracheostomy tube by swelling of inner layer near the cuff. The tube was reused one and had been disinfected with ethylene oxide. Therefore, to prevent complication such as airway obstruction by use of armored tubes, it is desirable to avoid reusal of armored tube and to examine the lumen as well as cuff before intubation when reused.
Airway Obstruction* ; Ethylene Oxide ; Intubation ; Tracheostomy*

PURPOSE: This was a study on the expiration date of Ethylene Oxide (EO) gas sterilization and effects of the environmental factors of temperature, humidity and type of cabinet in sterile goods storage area on the expiration date. METHODS: Sterile goods storage areas from 13 departments in one hospital were selected and 455 EO gas sterilization samples were prepared and kept in those areas over the 14 months of the study. Each sample was tested with a microbiological culture in the laboratory every week. If the result was positive, the sample was regarded as contaminated. The researcher visited once a month to check the temperature, humidity and type of cabinet. RESULTS: With the exception of 1 sample which was positive at 56th week. 454 samples were confirmed as negative. The environment of the samples storage area was measured monthly. The annual average temperature was 24.2+/-1.6degrees C, and the mean relative humidity 34.7+/-15.2%. The types of cabinet were 7 open and 6 closed. CONCLUSION: The results of the microbiological culture at 13 months showed that none of the samples were contaminated. Therefore the hospital's existing Expiration Date can be extended from 6 months to 13~14 months.
Equipment Contamination ; Ethylene Oxide* ; Humidity ; Sterilization*

No abstract available.
Chromosome Aberrations* ; Ethylene Oxide* ; Lymphocytes* ; Transferases*

At present, the most commonly used sterilization method for medical devices is ethylene oxide sterilization. The residue after sterilization is closely related to the health of the people who contacted with the medical devices. The study team analyzed the possible residues of medical devices after sterilization with ethyleneoxide. It is suggested that ethylene oxide, 2-chloroethanol and ethylene glycol should be evaluated comprehensively through the analysis of factors such as production links of medical devices, production process of ethylene oxide, sterilization process, sterilization environment and detection method.
Equipment and Supplies ; Ethylene Oxide ; Humans ; Sterilization

OBJECTIVES: the effect of different sterilization methods on the surface morphology of PPDO-hybrid-PLGA nanofiber scaffold and attachments of PC12 cell were investigated. METHODS: Poly (p-dioxone)-hybrid-Poly (lactide-glycolide) (PPDO-hybrid-PLGA) nanofiber scaffold, fabricated in a tube form with 1.5 mm internal diameter, 0.2 mm thickness and 5 mm length, was prepared using electrospinning method. To study the surface morphology using SEM, The study group and control group in respective were; Control:Non-sterilized scaffold, Group I:scaffold sterilized with 70% Alcohol, Group II: scaffold sterilized with Ethylene Oxide at 65 degrees C, and Group III: scaffold sterilized with Ethylene Oxide at 37 degrees C. To investigate viability of the PC12 cell on the scaffold, The study group and control group in respective were; Control: sterilized with 70% Alcohol, Group I: sterilized with Ethylene Oxide at 65 degrees C, and Group II: sterilized with Ethylene Oxide at 37 degrees C. RESULTS: 1. The surface morphology was slightly changed in Group I, II and GroupIII, compared with control. 2. The attachment of PC12 cells in Group I, II was not higher than in control DISCUSSION: The attachment of PC12 cell is not influenced by different sterilization methods.
Animals ; Ethylene Oxide ; Ethylenes ; Nanofibers ; PC12 Cells ; Sterilization