• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.15 no.2
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• pp.164-177
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• 2022

Medical device usability evaluation refers to the evaluation of medical devices through actual users before the final prototype production is completed. IEC 62366, one of the international safety standards for electronic medical devices, is a standard that must be applied to obtain medical device licenses in major advanced countries such as Europe and the United States. In Korea, through the Ministry of Food and Drug Safety's notice, from January 2021, sequential application by grade has been implemented. In this study, 15 participant specialists were recruited through the Incheon G University Hospital Medical Device Convergence Center for formative evaluation during user suitability evaluation of the focused ultrasound stimulation system being developed by Icleo Co., Ltd., and the test was conducted through joint scenario development. . In the result of task performance, the performance rate was 90.67%, and after the completion of the performance, 86.67% of 'Easy user interface' and 94% of 'Identification/Readability/Understanding of information' questions in the participant survey results analysis by question. The response rate was above average.

• Journal of Korean Society of Occupational and Environmental Hygiene
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• v.34 no.1
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• pp.48-56
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• 2024

Objectives: The coronavirus pandemic that began in 2019(COVID-19) has been one of the worst pandemics of the 21st century. Masks have been used to prevent COVID-19, but there are currently no standards for the long-term use of masks in the Republic of Korea. This study was conducted to assess the microbiological safety of KF94(Korea Filter 94) disposable face masks according to wearing duration by evaluating the bacterial filtration efficiencies of masks worn by research participants. Methods: A commercially available KF94 mask certified by the Ministry of Food and Drug Safety(MFDS) in the Republic of Korea was selected as the test mask. The research participants(n = 15) wore masks for the durations of one, three, and seven days. Participants also reported several parameters, including wearing time, makeup frequency, and storage. Bacterial filtration efficiencies of the worn masks were measured by a mask bioaerosol filtration tester. Staphylococcus aureus(S. aureus) was used as the test bacteria and quantitatively measured through the cultivation method. Then, bacterial filtration efficiency was calculated using the formula suggested by the MFDS. Results: All worn masks showed over 99.98% of mean bacterial filtration efficiency for S. aureus. There were no significant differences among bacterial filtration efficiencies of face masks according to wearing duration. There was also no significant difference among bacterial filtration efficiencies among participants. There was no correlation between the results of bacterial filtration efficiencies and reported parameters from participants. Conclusions: In the absence of significant external damage to the mask, the bacterial filtration efficiency of the mask can be maintained even after seven days of wearing. This result suggests that KF94 masks certified by the MFDS can be used repeatedly for about a week without loss of bacterial filtration efficiency.

• The Journal of the Acoustical Society of Korea
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• v.42 no.5
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• pp.469-490
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• 2023

Survey was carried out on the acoustic outputs from 12 shock wave fields produced by the 10 extracorporeal shock wave lithotriptors whose technical documents are available, among the 33 devices approved by the Ministry of Food & Drug Safety (MFDS).The results show that the acoustic outputs (P+, P-, efd, and E), critical to the therapeutic efficacy and the patient safety, are largely different between the devices. The maximum values of P+, P-, efd, and E vary up to 2.08, 3.72, 3.89, and 15.98 times, respectively. The acoustic output parameters are not thoroughly provided in the technical documents, and some of data (eg. efd) are suspected to be abnormal outside usual ranges. The large device to device differences in the shock wave outputs are likely to undermine equivalence between the ESWL devices approved for the same indication. To verify the reliability of the data in the technical documents of the approved devices and to confirm if the acoustic outputs from the devices in clinical use are the same as those in their technical documents, an authorized test laboratory should be available. A postapproval monitoring led by the regulatory agency is suggested to maintain the acoustic outputs from the ESWL devices that suffer from degrading in performance due to aging.

• Parasites, Hosts and Diseases
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• v.53 no.3
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• pp.299-305
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• 2015

Tapeworms of the genus Spirometra are pseudophyllidean cestodes endemic in Korea. At present, it is unclear which Spirometra species are responsible for causing human infections, and little information is available on the epidemiological profiles of Spirometra species infecting humans in Korea. Between 1979 and 2009, a total of 50 spargana from human patients and 2 adult specimens obtained from experimentally infected carnivorous animals were analyzed according to genetic and taxonomic criteria and classified as Spirometra erinaceieuropaei or Spirometra decipiens depending on the morphology. Morphologically, S. erinaceieuropaei and S. decipiens are different in that the spirally coiled uterus in S. erinaceieuropaei has 5-7 complete coils, while in S. decipiens it has only 4.5 coils. In addition, there is a 9.3% (146/1,566) sequence different between S. erinaceieuropaei and S. decipiens in the cox1 gene. Partial cox1 sequences (390 bp) from 35 Korean isolates showed 99.4% (388/390) similarity with the reference sequence of S. erinaceieuropaei from Korea (G1724; GenBank KJ599680) and an additional 15 Korean isolates revealed 99.2% (387/390) similarity with the reference sequences of S. decipiens from Korea (G1657; GenBank KJ599679). Based on morphologic and molecular databases, the estimated population ratio of S. erinaceieuropaei to S. decipiens was 35: 15. Our results indicate that both S. erinaceieuropaei and S. decipiens found in Korea infect humans, with S. erinaceieuropaei being 2 times more prevalent than S. decipiens. This study is the first to report human sparganosis caused by S. decipiens in humans in Korea.

• Korean Journal of Environmental Agriculture
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• v.41 no.2
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• pp.108-114
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• 2022

BACKGROUND: This study was performed to determine residual characteristics of soil-treated metalaxyl-M and dinotefuran in crown daisy and to evaluate the risks from intake of the residual pesticides in the crop. METHODS AND RESULTS: The pesticide granules were treated in soil on two levels, and the plants samples were collected 51 days after seeding. The analytes were extracted and partitioned using the QuEChERS extraction packet (MgSO₄ 4 g, NaCl 1 g). The quantitative methods for metalaxyl-M and dinotefuran were validated in linearity, accuracy, and precision. Risk assessments of the pesticides were performed using Korea national nutrition statistics 2019. CONCLUSION(S): The residual concentrations of metalaxyl-M in crown daisy were 0.09-0.10 mg/kg (for the treatment at 6 kg/10 a) and 0.17-0.19 mg/kg (12 kg/10 a), respectively. The residual concentrations of dinotefuran in the crop were 0.53-0.75 mg/kg (3 kg/10 a) and 1.17-1.26 mg/kg (6 kg/10 a). The amounts of pesticides were less than MRL (Maximum Residue Limits) according to the Korean MFDS (Ministry of Food and Drug Safety). The HI (Hazard Index) of metalaxyl-M and dinotefuran for consumers was 0.0075% and 0.2250%, respectively. For females in the age between 50-64, the major consumer group, the HIs of the pesticides were <3%. Considering the consumption of crown daisy, they are not considered to be of toxicological concern.

• Parasites, Hosts and Diseases
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• v.54 no.2
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• pp.181-185
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• 2016

Human sparganosis is a zoonotic disease caused by infection with larval forms (procercoid/plerocercoid) of Spirometra spp. The purpose of this study was to identify Spirometra spp. of infected snakes using a multiplex PCR assay and phylogenetic analysis of mitochondrial DNA sequence data from the spargana of terrestrial snakes obtained from Korea and China. A total of 283 snakes were obtained that included 4 species of Colubridae comprising Rhabdophis tigrinus tigrinus (n=150), Dinodon rufozonatum rufozonatum (n=64), Elaphe davidi (n=2), and Elaphe schrenkii (n=7), and 1 species of Viperidae, Agkistrodon saxatilis (n=60). The snakes were collected from the provinces of Chungbuk, Chungnam, and Gyeongbuk in Korea (n=161), and from China (n=122). The overall infection rate with spargana was 83% (235/283). The highest was recorded for D. rufozonatum rufozonatum (100%), followed by A. saxatilis (85%) and R. tigrinus tigrinus (80%), with a negative result for E. davidi (0%) and E. schrenkii (0%). The sequence identities between the spargana from snakes (n=50) and Spirometra erinaceieuropaei (KJ599680) or S. decipiens (KJ599679) control specimens were 90.8% and 99.2%, respectively. Pairwise genetic distances between spargana (n=50) and S. decipiens ranged from 0.0080 to 0.0107, while those between spargana and S. erinaceieuropaei ranged from 0.1070 to 0.1096. In this study, all of the 904 spargana analyzed were identified as S. decipiens either by a multiplex PCR assay (n=854) or mitochondrial cox1 sequence analysis (n=50).

• The Journal of the Acoustical Society of Korea
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• v.39 no.4
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• pp.303-317
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• 2020

Extracorporeal Shock Wave Therapy (ESWT) is an innovative treatment in chronic musculoskeletal pain management and cardiovascular diseases. In this study, we surveyed the acoustic shock wave outputs from the domestically used focal type ESWT devices. The survey data were collected through 30 technical documents registered to the Ministry of Food and Drug Safety (MFDS), Rep. Korea. The results show that the focusing geometry varies largely, 5 mm to 65 mm in the focal length, 3 mm to 30 mm in focal width, and 4 mm to 108 mm in focal depth. The maximum positive pressure (P+) ranges from 7 MPa to 280 MPa, the focal Energy Flux Density (EFD) from 0.0035 mJ/㎟ to 35 mJ/㎟, and the energy per pulse (E) from 0.737 mJ to 80.86 mJ. All domestic PE-type (five) and one EM-type domestic devices included in the analysis of the correlation between P+ and EFD are shown to be far beyond the usual ranges and do not comply with expected correlation so that the reliability of their data was suspected. For the suspected, post-performance tests are required by a recognized testing agency. MFDS guidelines need to be revised so that the pass criteria for the shock wave acoustic outputs can be based on the clinical tests for indications.

• Korean Journal of Acupuncture
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• v.40 no.4
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• pp.156-168
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• 2023

Objectives : This study aimed to determine the status of thermal stimulation devices approved in Korea for medical applications over the past 10 years, and based on this, to obtain insight for future thermal treatment in Korean medical institutions. Methods : We searched the item classification list entitled "Regulations on Medical Device Items and Rating by Item" from the Ministry of Food and Drug Safety Notice No. 2021-24, 2021 (Enforced March 19, 2021; www.mfds.go.kr) for individually licensed heaters using the terms "heat" and "heating". Results : We identified 17 items of thermal stimulation product group, of which 1,308 devices were licensed by February 4, 2022, and 53.2% of them (n=696) were devices with valid permits for distribution in Korea. Among the licensed devices, heating pad systems under/overlay (electric, home use) were approved the most, but combinational stimulator (for medical use, home use; Grade 2) accounted for the highest percentage among the current valid permission. Moxibustion apparatuses were licensed separately for electrical use and non-electrical use, and occupied a low percentage of the total devices. We analyzed 307 devices that were accompanied by technical documents and found that the heat sources were wires in 145 (47.2%), infrared rays in 44 (14.3%) and ultrasonic waves in 42 (13.7%) devices. Most (83.1%) devices were used for pain relief, while other applications included beauty, cancer treatment, maintenance of infant body temperature, and healing fractures. Conclusions : Thermal stimulation devices accounted for about 0.9% of all medical devices, and among them, combinational stimulators and heating pad systems under/overlay had the most valid permits. Thermal stimulation devices using heating wires and infrared rays were the most prevalent, and most were used to relieve pain. In order to develop a range of thermal stimulation devices that can be utilized in Korean medical institutions, it is imperative that they have potential applications beyond pain management, addressing various medical purposes. To achieve this, foundational research is necessary to effectively apply diverse heat sources based on medical objectives.

• Journal of Life Science
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• v.31 no.1
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• pp.47-51
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• 2021

In today's society, functional whitening cosmetics are important to beauty. Fungi are known to produce a variety of whitening-related metabolites. In this study, we searched for tyrosinase inhibitors with metabolic products derived from Trichoderma atroviride supernatant in order to apply a material for whitening functional cosmetics. In addition, the inhibitory effect was compared to arbutin, which has already been approved as a whitening raw material by the Korea Ministry of Food and Drug Safety (KMFDS). The metabolites from the T. atroviride supernatant showed higher tyrosinase inhibitory activity than that of arbutin. Some of the tyrosinase inhibitors were stable to heat, whereas some were unstable. The heat unstable material was exhibited in the case of samples treated with little amounts, such as 0.02~0.2%. They were very unstable in acidic and alkali pHs, especially under acidic conditions. However, it was found that a weakly-acidic to neutral pH range was the optimal working pH, especially neutral pH. Since the activity of the inhibitory substances in the T. atroviride supernatant was maintained regardless of proteinase K treatment, it was assumed that the metabolites, but not the bioactive peptides, were involved in the activity. In summary, we propose that the metabolites derived from T. atroviride supernatant have strong potential as whitening raw material.

• Plant Breeding and Biotechnology
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• v.5 no.4
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• pp.334-343
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• 2017

Eclipta prostrata and E. alba are annual herbal medicinal plants and have been used as Chinese medicinal tonics. Both species are widely distributed in tropical and subtropical regions as well as in Korea. Both species have similar morphological features but E. alba has smoother leaf blade margins compared with E. prostrata. Although both species are utilized as oriental medicines, E. prostrata is more widely used than E. alba. Morphological semblances have confounded identification of either species. Here, we report the complete chloroplast genomes of both species to provide an authentication system between the two species and understand their diversity. Both chloroplast genomes were 151,733-151,757 bp long and composed of a large single copy (83,285-83,300 bp), a small single copy (18,283-18,346 bp), and a pair of inverted repeats (25,075-25,063 bp). Gene annotation revealed 80 protein coding genes, 30 tRNA genes and four rRNA genes. A phylogenetic analysis revealed that the genus Eclipta is grouped with Heliantheae tribe species in the Asteraceae family. A comparative analysis verified 29 InDels and 58 SNPs between chloroplast genomes of E. prostrata and E. alba. The low chloroplast genome sequence diversity indicates that both species are really close to each other and are not completely diverged yet. We developed six DNA markers that distinguish E. prostrata and E. alba based on the polymorphisms of chloroplast genomes between E. prostrata and E. alba. The chloroplast genome sequences and the molecular markers generated in this study will be useful for further research of Eclipta species and accurate classification of medicinal herbs.