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*

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

PURPOSE: Treatment of diabetic foot infection due to methicillin-resistant Staphylococcus aureus (MRSA) remains challenging. Applying vancomycin-impregnated cement is one of the best methods of treatment. Vancomycin-impregnated cement has been used worldwide; however, to date, there is a limited number of studies regarding its use. We evaluated the duration of antimicrobial activity of vancomycin-impregnated cement stored at room temperature after manufacturing. MATERIALS AND METHODS: The vancomycin-impregnated cement was manufactured by mixing 1 g of vancomycin with 40 g of polymer and adding 17.90 g of liquid monomer. The cement dough was shaped into flat cylinders with diameter and height of 6 mm and 2 mm, respectively. Another cement of the same shape without mixing vancomycin was prepared as the negative control. All manufactured cements were sterilized with ethylene oxide gas and stored at room temperature. Each cement was placed on Mueller Hinton agar plate lawned with standard MRSA strain. Standard vancomycin disk and gentamicin disk were placed together. After 24 hours, the diameter of inhibition zone was measured, and if the diameter was less than 15 mm, vancomycin-impregnated cement was regarded as a loss of antimicrobial activity. The study was repeated every 2 weeks until vancomycin-impregnated cements lost their antimicrobial activity. RESULTS: Vancomycin-impregnated cement stored for a duration of 16 weeks created a 14 mm inhibition zone, while vancomycin disk created a 15 mm inhibition zone. Vancomycin-impregnated cement stored for a duration of 17 weeks created 7 mm and 9 mm inhibition zones, while vancomycin disk created 16 mm and 15 mm inhibition zones, respectively. CONCLUSION: We found a decrease of antimicrobial activity in vancomycin-impregnated cements after 16 weeks. After 17 weeks, they showed definite loss of antimicrobial activity. Therefore, we recommend not using vancomycin-impregnated cement spacers that has been stored for more than 16 weeks at room temperature.
Agar ; Diabetic Foot ; Ethylene Oxide ; Gentamicins ; In Vitro Techniques* ; Methicillin Resistance* ; Methicillin-Resistant Staphylococcus aureus* ; Polymers ; Vancomycin

OBJECTIVES: This study compared the amount of apically extruded bacteria during the glide-path preparation by using multi-file and single-file glide-path establishing nickel-titanium (NiTi) rotary systems. MATERIALS AND METHODS: Sixty mandibular first molar teeth were used to prepare the test apparatus. They were decoronated, blocked into glass vials, sterilized in ethylene oxide gas, infected with a pure culture of Enterococcus faecalis, randomly assigned to 5 experimental groups, and then prepared using manual stainless-steel files (group KF) and glide-path establishing NiTi rotary files (group PF with PathFiles, group GF with G-Files, group PG with ProGlider, and group OG with One G). At the end of canal preparation, 0.01 mL NaCl solution was taken from the experimental vials. The suspension was plated on brain heart infusion agar and colonies of bacteria were counted, and the results were given as number of colony-forming units (CFU). RESULTS: The manual instrumentation technique tested in group KF extruded the highest number of bacteria compared to the other 4 groups (p < 0.05). The 4 groups using rotary glide-path establishing instruments extruded similar amounts of bacteria. CONCLUSIONS: All glide-path establishment instrument systems tested caused a measurable apical extrusion of bacteria. The manual glide-path preparation showed the highest number of bacteria extruded compared to the other NiTi glide-path establishing instruments.
Agar ; Bacteria* ; Brain ; Enterococcus faecalis ; Ethylene Oxide ; Glass ; Heart ; In Vitro Techniques* ; Molar ; Stem Cells ; Tooth

Reversible cerebral vasoconstriction syndrome (RCVS) is characterized by thunderclap headache and multiple reversible intracranial vasoconstrictions. Here we report a case of RCVS after exposure to ethylene oxide (EO) gas, which is a widely used sterilant. A 34-year-old woman presented with aphasia, right-arm weakness, and severe headache after inhaling EO gas. Brain imaging revealed multiple infarcts and multiple intracranial stenoses. The stenotic lesions completely regressed on follow-up CT angiography. This is the first report of RCVS after exposure to EO gas.
Adult ; Angiography ; Aphasia ; Constriction, Pathologic ; Ethylene Oxide* ; Female ; Follow-Up Studies ; Headache ; Headache Disorders, Primary ; Humans ; Inhalation* ; Neuroimaging ; Vasoconstriction*

This paper selects the bag-type infusion sets for single use as samples, which are produced by different manufacturers and based on the ethylene oxide sterilization. The ethylene oxide sterilization residues in different parts of samples are detected by colorimetric analysis. Combined the comparison of the ethylene oxide residues testing results in the different parts of the same sample with the actual situation in clinical use, more reasonable sampling positions are found to detect the ethylene oxide sterilization residues. The result of this experiment will play a guiding role in the detection of the actual samples.
Disposable Equipment ; Equipment Contamination ; prevention & control ; Ethylene Oxide ; analysis

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*

Air ; analysis ; Chromatography, Gas ; methods ; Ethylene Oxide ; analysis ; Furans ; analysis ; Methylene Chloride ; analysis ; Workplace

Acute Disease ; Adult ; Ethylene Oxide ; poisoning ; Female ; Humans ; Male ; Middle Aged

PURPOSE: Laparoscopic instruments have been remarkably developed through many trials. Various studies and experiments on laparoscopic instruments are underway in other countries. Laparoscopic surgery is also very actively applied in Korea. However, research on the use and safety of the instruments is stagnant. Furthermore, reuse of some disposable laparoscopic instruments is frequently observed, but there are only rare studies on the safety of this. Thus, we tried to provide study cases on the safety of repeated use of disposable laparoscopic instruments. METHODS: To investigate the effectiveness of sterilization and a re-package procedure, we divided the laparoscopic instruments that are commonly used in our institution into 10 types. Among all the available instruments, 32 instruments were selected for the simulation experiment. Each instrument was sterilized using ethylene oxide gas or glutaraldehyde 2%, and then packaged. Then, each was observed grossly and microscopically under aseptic conditions and we looked for any remnant foreign body or contaminant. When remnant foreign body or contaminant was found, they were collected and separately cultured. RESULTS: Residual contaminants were found in 15 instruments (46.9%) out of a total of 32 and microorganisms, including coagulase-negative staphylococcus and gamma-hemolytic streptococcus, were cultured from (9.38%), and each had different types of microorganisms. CONCLUSION: It is remarkable that the bacteria were cultured from recycled laparoscopic instruments after sterilization. The reuse of laparoscopic instruments might be cost-effective, but further studies on its safety are required. Moreover, careful inspection on the method of surgical instrument sterilization in each institution will be necessary.
Bacteria ; Ethylene Oxide ; Ethylenes ; Foreign Bodies ; Glutaral ; Korea ; Laparoscopy ; Staphylococcus ; Sterilization ; Streptococcus ; Surgical Instruments