• Title/Summary/Keyword: Ministry of Food and Drug Safety

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The Effect of Communication Distance and Number of Peripheral on Data Error Rate When Transmitting Medical Data Based on Bluetooth Low Energy (저 전력 블루투스 기반으로 의료데이터 전송 시 통신 거리와 연동 장치의 수가 데이터 손실률에 미치는 영향)

  • Park, Young-Sang;Son, ByeongJin;Son, Jaebum;Lee, Hoyul;Jeong, Yoosoo;Song, Chanho;Jung, Euisung
    • Journal of Biomedical Engineering Research
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    • v.42 no.6
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    • pp.259-267
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    • 2021
  • Recently, the market for personal health care and medical devices based on Bluetooth Low Energy(BLE) has grown rapidly. BLE is being used in various medical data communication devices based on low power consumption and universal compatibility. However, since data errors occurring in the transmission of medical data can lead to medical accidents, it is necessary to analyze the causes of errors and study methods to reduce data error. In this paper, the minimum communication speed to be used in medical devices was set to at least 800 byte/sec based on the wireless electrocardiography regulations of the Ministry of Food and Drug Safety. And the data loss rate was tested when data was transmitted at a speed higher than 800 byte/sec. The factors that cause communication data error were classified, and the relationship between each factor and the data error rate was analyzed through experiments. When there were two or more activated peripherals connected to the central, data error occurred due to channel hopping and bottleneck, and the data error rate increased in proportion to the communication distance and the number of activated peripherals. Through this experiment, when the BLE is used in a medical device that intermittently transmits biosignal data, the risk of a medical accident is predicted to be low if the number of peripherals is 3 or less. But, it was determined that BLE would not be suitable for the development of a biosignal measuring device that must be continuously transmitted in real time, such as an electrocardiogram.

Salinity Monitoring of Soups of The Institutions Enrolled at Center for Children's Foodservice Management (어린이급식관리지원센터 등록 시설 국물음식의 염도 모니터링)

  • Park, Hyun Nae;Kim, Soon Mi
    • Journal of the East Asian Society of Dietary Life
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    • v.26 no.6
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    • pp.507-516
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    • 2016
  • The salinity of soups of institutions enrolled at the Center for Children's Foodservice Management was monitored to reduce sodium intake of children by continuously managing salinity of soups provided by children food service. Monitoring of salinity was conducted by a salinity meter (SB-1500H, HM digital) three times in 2016 by patrolling children's institutions for the instruction of public health. The average salinity of soups provided by total children's institution showed a significant decrease in salinity - $1^{st}$ 0.45%, $2^{nd}$ 0.41% and $3^{rd}$ 0.39% - as monitoring was proceeded (p<0.01). When salinity of soups was analyzed according to the type of children's institution, the salinity of national and public institutions showed no significant decrease. In contrast, the salinity of private institutions decreased significantly (p<0.05). Depending on the enrollment of the food service, there was no significant difference in average salinity of soups between large food services, which have over 50 children, and small food services, which have less than 50 children. However, all food services showed a salinity decrease from the $1^{st}$ monitoring to the $3^{rd}$ monitoring. Salinity according to the type of soup showed that salinity of clear soup, miso soup, and stew except beef soup decreased from the $1^{st}$ monitoring to $3^{rd}$ monitoring. However, there was no significant difference in salinity according to the type of soup which can be attributed to a large difference in salinity among the same type of soup. The individual soup showing the biggest difference between maximum and minimum salinity of soup was egg soup (0.62%), potato soup (0.54%), and mushroom soup (0.64%). The present average salinity of soup provided by children's institutions was less than 0.5% which is the recommended standard of the Ministry of Food and Drug Safety. However, the salinity of soups should be managed within a certain range including the minimum salinity regarding the taste education of children.

Bacterial Contamination in Disposable Wet Wipes in General Restaurants 2nd (대중음식점 일회용 물티슈의 세균 오염도 조사(2))

  • Chong, Moo-Sang
    • Korean Journal of Clinical Laboratory Science
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    • v.54 no.1
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    • pp.23-27
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    • 2022
  • Disposable wet wipes provided by general restaurants in the Jeju Special Self-Governing Province were evaluated for compliance with the labeling requirements and the degree of bacterial contamination set by the Ministry of Food and Drug Safety. Of the 32 types of disposable wipes, five types of disposable wipes did not indicate the name and location of the business office of the manufacturer. Only 12 types of wet wipes were marked with the date of manufacture and expiration date. Bacterial contamination was seen in 9 types of wet wipes through bacterial culture but these were absent in the remaining 23 types (71.9%). The results of the antimicrobial susceptibility test for the 9 identified strains showed no methicillin-resistant coagulase-negative staphylococci (MRCNS) or multidrug-resistant bacteria. Through this study, it is recommended that the date of manufacture and expiration date must be indicated on the surface of disposable wet wipes designated as hygiene products, and clean uncontaminated wet wipes must comply with storage standards. In addition, the results are expected to contribute to the enhancement and improvement of hygiene management supervision, personal hygiene management, and an improvement in national health.

BCAR3 Activates the Estrogen Response Element through the PI3-kinase/Akt Pathway in Human Breast MCF-12A Cells (인간 유방 MCF-12A 세포에서 PI3-kinase 경로를 통한 BCAR3의 estrogen response element 활성화)

  • Myung-Ju, Oh;Joo-Yeon, Ha;Byung H., Jhun
    • Journal of Life Science
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    • v.32 no.11
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    • pp.882-889
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    • 2022
  • Breast cancer anti-estrogen resistance 3 (BCAR3) has been identified as one of the genes that induces anti-estrogen resistance in breast cancer. We have previously reported that BCAR3 activates promoters of c-Jun, activator protein-1, and the serum response element. In this study, we investigated the functional role of BCAR3 in the activation of the estrogen response element (ERE) in normal human breast MCF-12A cells. Transient expression of BCAR3 induced ERE activation, which was further increased by 17β-estradiol treatment but was not blocked by the anti-estrogen tamoxifen. Next, we studied the signaling pathway of BCAR3 leading to ERE activation. BCAR3-mediated ERE activation was inhibited by LY294002 and AZD5363, inhibitors of the phosphatidylinositol (PI) 3-kinase pathway, but not by PD98059 and U0126, inhibitors of the mitogen-activated protein kinase pathway. ERE activation was induced by the catalytic subunit p110α. of PI3-kinase or the active mutant of Akt, and this activation was not further increased by additional BCAR3 transfection. Based on these results, we propose that BCAR3 plays an important role in ERE activation through the PI3-kinase/Akt pathway in human breast MCF-12A cells.

A Study on the Analysis of Virus Barrier Materials in a Chest X-ray Laboratory to Respiratory and Droplet Infections Only Patients (호흡기 및 비말감염 환자 전용 흉부 X-선 검사실의 바이러스 차단제 분석에 관한 연구)

  • Kim, Hyeon-Ju;Lee, Jun-Ho;Choi, Kwan-Yong
    • Journal of the Korean Society of Radiology
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    • v.16 no.2
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    • pp.169-175
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    • 2022
  • In this study, envisioned a laboratory equipped with virus blocking equipment for chest X-ray examinations of respiratory or droplet-transmitted virus-infected patients, and the material with the least deterioration in X-ray output and image quality among the proven blocking materials that block viruses in the design process. and experimented to find the thickness. As a result, when 1 cm of acrylic was applied, the X-ray output was reduced by only about 3.27 % compared to the absence of the barrier material, the SNR was 40.7 and CNR was 30.9, which was the best. The SSIM index result was analyzed as 0.891, which was analyzed to be implemented as the most similar image compared to the original image. The barrier material applied in the research method was objective in that it used a product approved by the Ministry of Food and Drug Safety. the results of this study are expected to provide useful information when installing X-ray examination facilities for the diagnosis and treatment of respiratory-related virus-infected patients in the future.

Characterization of Biogenic Amine-reducing Pediococcus pentosaceus Isolated from Traditionally Fermented Soybean Products (전통 장류에서 분리한 Biogenic Amines 저감 유산균 Pediococcus pentosaceus의 분리 및 특성)

  • Oh, HyeonHwa;Ryu, MyeongSeon;Heo, Jun;Jeon, SaeBom;Kim, Young Sang;Jeong, DoYoun;Uhm, Tai-Boong
    • Korean Journal of Microbiology
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    • v.50 no.4
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    • pp.319-326
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    • 2014
  • Two bacterial strains, named as LE17 and LE22, were isolated from traditionally fermented soybean products in order to select lactic acid bacteria for the reduction of biogenic amines and harmful bacteria. Both strains were identified as Pediococcus pentosaceus by 16S rRNA sequence analysis and additional biochemical tests. The strain LE17 reduced the amines by 13.7% for histamine and by 25.9% for tyramine, when it grew in minimal synthetic media containing 0.1% (w/v) histamine and 0.1% tyramine at $30^{\circ}C$ for 48 h, while the strain LE22 reduced the amines by 23.7% for histamine and by 15.7% for tyramine. Both strains also had broad inhibition spectra against pathogens. Considering their properties, they could be used as starters for industrial soybean fermentation.

Inspection on the acoustic output of the focused extracorporeal focused shock wave therapeutic devices approved by MFDS (식약처에서 허가된 집속형 ESWT 치료기의 음향 출력 분석)

  • Choi, Min Joo;Jeon, Sung Joung;Kwon, Oh Bin;Lee, Min Young;Cho, Jin Sik;Kim, Han Soo;Maeng, Eun Ho
    • 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.

Survey of Operation and Status of the Human Research Protection Program (HRPP) in Korea (2019) (임상시험 및 대상자보호프로그램의 운영과 현황에 대한 설문조사 연구(2019))

  • Maeng, Chi Hoon;Lee, Sun Ju;Cho, Sung Ran;Kim, Jin Seok;Rha, Sun Young;Kim, Yong Jin;Chung, Jong Woo;Kim, Seung Min
    • The Journal of KAIRB
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    • v.2 no.2
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    • pp.37-48
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    • 2020
  • Purpose: The purpose of this study is to assess the operational status and level of understanding among IRB and HRPP staffs at a hospital or a research institute to the HRPP guideline set by the Ministry of Food and Drug Safety (MFDS) and to provide recommendations. Methods: Online survey was distributed among members of Korean Association of IRB (KAIRB) through each IRB office. The result was separated according to topic and descriptive statistics was used for analysis. Result: Survey notification was sent out to 176 institutions and 65 (37.1%) institutions answered the survey by online. Of 65 institutions that answered the survey; 83.1% was hospital, 12.3% was university, 3.1% was medical college, 1.5% was research institution. 23 institutions (25.4%) established independent HRPP offices and 39 institutions (60.0%) did not. 12 institutions (18.5%) had separate IRB and HRPP heads, 21 (32.3%) institutions separated business reporting procedure and person in charge, 12 institutions separated the responsibility of IRB and HRPP among staff, and 45 institutions (69.2%) had audit & non-compliance managers. When asked about the most important basic task for HRPP, 23% answered self-audit. And according to 43.52%, self-audit was also the most by both institutions that operated HRPP and institutions that did not. When basic task performance status was analyzed, on average, the institutions that operated HRPP was 14% higher than institutions that only operated IRB. 9 (13.8%) institutions were evaluated and obtained HRPP accreditation from MFDS and the most common reason for obtaining the accreditation was to be selected as Institution for the education of persons conducting clinical trial (6 institutions). The most common reason for not obtaining HRPP accreditation was because of insufficient staff and limited capacity of the institution (28%). Institutions with and without a plan to be HRPP accredited by MFDS were 20 (37.7%) each. 34 institutions (52.3%) answered HRPP evaluation method and accreditation by MFDS was appropriate while 31 institutions (47.7%) answered otherwise. 36 institutions answered that HRPP evaluation and accreditation by MFDS was credible while 29 institutions (44.5%) answered that HRPP evaluation method and accreditation by MFDS was not credible. Conclusion: 1. MFDS's HRPP accreditation program can facilitate the main objective of HRPP and MFDS's HRPP accreditation program should be encouraged to non-tertiary hospitals by taking small staff size into consideration and issuing accreditation by segregating accreditation. 2. While issuing Institution for the education of persons conducting clinical trial status as a benefit of MFDS's HRPP accreditation program, it can also hinder access to MFDS's HRPP accreditation program. It should also be considered that the non-contact culture during COVID-19 pandemic eliminated time and space limitation for education. 3. For clinical research conducted internally by an institution, internal audit is the most effective and sole method of protecting safety and right of the test subjects and integrity for research in Korea. For this reason, regardless of the size of the institution, an internal audit should be enforced. 4. It is necessary for KAIRB and MFDSto improve HRPP awareness by advocating and educating the concept and necessity of HRPP in clinical research. 5. A new HRPP accreditation system should be setup for all clinical research with human subjects, including Investigational New Drug (IND) application in near future.

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Comparison of volatile flavor compounds of yuzu, kumquat, lemon and lime (유자, 금귤, 레몬 및 라임의 휘발성 향기성분의 비교)

  • Hong, Young Shin;Lee, Ym Shik;Kim, Kyong Su
    • Food Science and Preservation
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    • v.24 no.3
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    • pp.394-405
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    • 2017
  • This study was conducted to confirm the usefulness of essential oil components in yuzu and kumquat cultivated in Korea for comparison with those in lemon and lime. The volatile flavor compounds in citrus fruits (yuzu, kumquat, lemon and lime) were extracted for 3 h with 100 mL redistilled n-pentane/diethylether (1:1, v/v) mixture, using a simultaneous steam distillation and extraction apparatus (SDE). The volatile flavor compositions of the samples were analyzed by gas chromatography-mass spectrometry (GC-MS). The aroma compounds analyzed were 104 (3,713.02 mg/kg) in yuzu, 87 (621.71 mg/kg) in kumquat 103 (3,024.69 mg/kg) in lemon and 106 (2,209.16 mg/kg) in lime. Limonene was a major volatile flavor compound in four citrus fruits. The peak area of limonene was 35.03% in yuzu, 63.82% in kumquat, 40.35% in lemon, and 25.06% in lime. In addition to limonene, the major volatile flavor compounds were ${\gamma}$-terpinene, linalool, ${\beta}$-myrcene, (E)-${\beta}$-farnesene, ${\alpha}$-pinene and ${\beta}$-pinene in yuzu, and ${\beta}$-myrcene, ${\alpha}$-pinene, (Z)-limonene oxide, (E)-limonene oxide, geranyl acetate and limonen-10-yl acetate in kumquat. Furthermore, ${\gamma}$-terpinene, ${\beta}$-pinene, ${\beta}$-myrcene, geranyl acetate, neryl acetate and (Z)-${\beta}$-bisabolene in lemon and ${\gamma}$-terpinene, ${\beta}$-pinene, (Z)-${\beta}$-bisabolene, neral, geranial and neryl acetate in lime were also detected. As a result, it was confirmed that the composition of volatile flavor compounds in four citrus fruits was different. Also, yuzu and kumquat are judged to be worthy of use alternatives for lemon and lime widely used in the fragrance industry.

Induction of c-Jun Expression by Breast Cancer Anti-estrogen Resistance-3 (BCAR3) in Human Breast MCF-12A Cells (정상적인 인간유방상피세포인 MCF-12세포에서 유방암 항에스토젠 내성인자-3 (BCAR3)에 의한 c-Jun 발현 유도 연구)

  • Oh, Myung-Ju;Kim, Ji-Hyun;Jhun, Byung Hak
    • Journal of Life Science
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    • v.26 no.12
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    • pp.1383-1391
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    • 2016
  • Anti-estrogen drugs such as tamoxifen have been used for treating patients with ER-positive, early breast cancer. However, resistance to anti-estrogen treatment is inevitable in most patients. Breast cancer anti-estrogen resistance-3 (BCAR3) has been identified as the protein responsible for the induction of tamoxifen resistance in estrogen-dependent human breast cancer. We have previously reported that BCAR3 regulates the cell cycle progression and the signaling pathway of EGF and insulin leading to DNA synthesis. In this study, we investigated the functional role of BCAR3 in regulating c-Jun transcription in non-tumorigenic human breast epithelial MCF-12A cells. A transient transfection of BCAR3 increased both the mRNA and protein of c-Jun expression, and stable expression of BCAR3 increased c-Jun protein expression. The overexpression of BCAR3 directly activated the promoter of c-jun, AP-1, and SRE but not that of $NF-{\kappa}B$. Furthermore, single-cell microinjection of BCAR3 expression plasmid in the cell cycle-arrested MCF-12A cells induced c-Jun protein expression, and co-injection of dominant negative mutants of Ras, Rac, and Rho suppressed the transcriptional activity of c-Jun in the presence of BCAR3. Furthermore, stable expression of BCAR3 increased the proliferation of MCF-12A cells. The microinjection of inhibitory materials such as anti-BCAR3 antibody and siRNA BCAR3 inhibited EGF-induced c-Jun expression but did not affect IGF-1 induced upregulation of c-Jun. Taken together, we propose that BCAR3 plays a crucial role in c-Jun protein expression and cell proliferation and that small GTPases (e.g., Ras, Rac, and Rho) are required for the BCAR3-mediated activation of c-Jun expression.