• 제목/요약/키워드: Drug safety assessment

검색결과 245건 처리시간 0.022초

식품의약품안전처의 위생점검표에 의한 육아지원기관 급식소 평가 및 개선대책 (Assessment and Corrective Measures of Child-care Foodservices by Sanitary Inspection Checklist Suggested by Korea Food and Drug Administration)

  • 안수정;문혜경
    • 대한영양사협회학술지
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    • 제21권3호
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    • pp.227-240
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    • 2015
  • The purpose of this study was to assess the hygiene status of 145 child-care foodservices, which were newly registered in the Center for the Children's Foodservice Management (CCFSM) in Changwon, Gyeongnam. Sanitary inspection checklist (40 food safety items) of Korea Food and Drug Administration (KFDA) was used by the CCFSM in Changwon, Gyeongnam. Average score from the total safety items in 145 child-care foodservices was 21.41 points out of 40 points. Score gaps between the lower group (71 foodservices, 13.92 points) and higher group (74 foodservices, 28.61 points) showed a significant difference (P<0.001). The top five priorities of sanitary measures needing corrective actions for child-care foodservices were as follows: 'provide hand washing and sanitizing tools, and supply manuals on how to wash hands properly', 'supply record form for access/inspection', 'conduct education for cooks on standards in the selection of sanitizer for raw vegetables and proper methods to wash and sanitize raw vegetables', 'provide a refrigerator and a freezer with installed thermometers and temperature record monitoring logs', 'encourage separation of contamination operating zone and clean zone or conduct training for cooks on ways to prevent cross-contamination by performing work separately by the hour'. For the higher group, most were national/public facilities (83.3%), whereas in the lower group, private facilities (62.1%) were more common than national/public ones (37.9%). Therefore, a significant difference (P<0.001) was detected in the two groups. These private facilities should be supported.

델파이기법을 활용한 식품안전 기술수준 진단 (Application of delphi method to the technology level assessment of food safety)

  • 권소영;이예슬
    • 식품과학과 산업
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    • 제51권3호
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    • pp.209-217
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    • 2018
  • 본 연구는 식품안전 분야 기술수준을 주요 5개국과 비교하여 현재의 기술수준에 대한 평가와 기술개발의 기초자료로 활용하기 위하여 수행하였다. 식품안전 분야 기술수준 평가 결과 미국이 모든 분야에서 최상의 기술을 보유한 것으로 나타났으며, 우리나라의 경우 최고기술 보유국인 미국과 비교할 때 4위를 차지하는 것으로 나타났다. 또한, 우리나라는 논문 점유율과 영향력은 주요 5개국 기준으로 최하위를 차지하였으며, 특허 기술력으로 볼 때, 특허 인용도는 3위, 특허 영향력은 1위로 나타나 점유율은 낮으나 질적으로 우수한 특허를 보유하고 있는 것으로 나타났다. 본 연구결과로 볼 때 식품안전 분야의 현재 수준의 기술을 향상시키기 위해서 전문인력 양성을 위한 정책적 접근이 필요할 것으로 사료되며, 해당 분야의 논문 저술활동이 저조하므로 연구결과 확산활동에 노력이 필요하다고 판단된다. 전문가들의 추가 제언 내용으로는 식품분야 관련 연구자 및 종사자의 역량강화를 위한 제도 마련과 지속적인 교육을 통해 안전기술에 대한 이해도 증진이 지속적으로 필요하다는 것과 향후 연구 기획시 실수요자의 의견을 반영할 수 있는 상향식 연구지원 방식도 고려하는 것이 필요하다는 의견이 제시되었다. 또한, 식품 안전기술은 정부 주도의 투자 뿐만 아니라 산업계 및 연구계가 함께 발전시켜 나가야하는 분야로 민간 투자 활성화를 유도할 수 있는 제도마련도 필요하다는 의견이 있었다. 본 연구를 통해 도출된 결과를 바탕으로 평가대상 기술의 속성이나 특성을 고려하여실효성 있는 기술개발 및 진흥 관련 계획수립이 이뤄져야 할 것으로 생각되며, 이번 연구에서는 식품안전 분야의 식품과 영양 안전관리 15개 기술로 제한하였으나, 향후 에는 식품안전 분야 신기술 및 세부기술에 대한 기술수준 평가도 개별적으로 수행하는 것을 고려하여야 할 것이다.

피리미설판(Pyrimisulfan)의 독성평가와 일일섭취허용량 설정 (Toxicity Assessment and Establishment Acceptable Daily Intake of Pyrimisulfan)

  • 정미혜;박경훈;박재읍;곽승준;김용범;한범석;손우찬
    • 농약과학회지
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    • 제15권2호
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    • pp.208-217
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    • 2011
  • 피리미설판에 대한 독성을 평가하고 일일섭취허용량을 설정하기 위하여 다양한 인축독성 시험성적서를 검토하였다. 대사시험결과, 주로 대변을 통해 배설되었으며, 급성독성은 낮았고, 피부, 안점막자극성과 피부감작성은 없었다. 랫드 90일 반복투여 경구독성시험결과에서 피리미설판 투여에 따른 영향은 혈액학적지표 및 간장에서 확인되었고 발암성은 없었으며, 번식독성, 기형독성 등에서 번식능력 몇 기형에 대한 영향 및 유전독성은 확인되지 않았다. 최대무작용량은 개 90일 반복투여 경구독성시험 10 mg/kg/day였으며, 안전계수 100으로 나눈 0.1 mg/kg/day을 일일섭취허용량(ADI)으로 설정하였다.

한국인의 유해물질 식이 노출량 평가를 위한 대표식품 선정과 mapping (Selection of Representative Foods and 'Best-fit' Mapping of Other Foods for Estimation of a Comprehensive Exposure to Food Contaminants in a Korean Total Diet Study)

  • 고은미;신혜형;연미영;남은정;이윤나;김도희;이지연;김미혜;박성국;최훈;김초일
    • 한국식품과학회지
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    • 제43권6호
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    • pp.773-782
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    • 2011
  • 한국형 TDS에 필요한 차별화된 포괄적인 식품목록을 도출하기 위해, 가장 최근에 실시된 2009년 TDS에서 사용된 것과 동일한 식품섭취량 자료를 사용하여 대표식품 선정기준을 확대 보완하고 그 결과를 비교하였다. 식품별 섭취량 누적비율 90%까지 확대, 섭취빈도 5% 이상으로 확대 및 추가 고려요인으로 지용성 오염물질을 위한 지방섭취량 누적비율 80%까지에 포함되는 식품을 고려하여 총 161종의 식품이 선정되었다. 도출된 대표 식품 목록은 우리 국민이 2007년에 섭취한 것으로 조사된 모든 식품군을 포함하고 있어 그 포괄성이 입증되었다. 다음 단계로, 한국인의 일상적인 식이를 대표할 수 있는 식품섭취량 자료를 확보하기 위해, 총 18,022명을 대상으로 실시된 2008년도와 2009년도 국민건강영양조사의 식품섭취량 자료를 통합하고 여기에 등장한 687종 식품을 이용하여, 상기 기술된 선정기준에 따라 165종 식품을 선정하여 기본목록을 작성하였다. 이들을 식품군별로 분류한 후 유사식품의 중복선정을 피하기 위해 매우 유사한 식품 30종에 대해 각 식품군 내에서 다소비 순위와 다빈도 순위를 비교하여 상대적으로 순위가 낮은 식품 15종을 제외시키고, 각 식품군에서 대표식품으로 선정되지 않은 식품에 대한 검토를 통해 식품 구성과 성상이 현저히 달라서 mapping이 어려운 식품 10종을 추가하여 160종이 대표식품으로 최종 선정되었다. TDS 분석대상으로 최종 선정된 160종의 식품목록은 식품섭취량의 90.93%, 에너지 섭취량의 91.36%, 지방섭취량의 89.05%를 포괄하는 것으로 나타났다. 예산과 연구기간의 제약으로 모든 식품이 분석될 수는 없으므로 분석되지 않은 식품을 가장 유사한 대표 식품의 유해물질 분석결과에 매칭하는 방법인 'best-fit' mapping 과정을 적용한다면 유해물질별 총 섭취량의 산출이 가능하게 될 것이다. 본 연구에서는 우리 국민의 식생활을 반영할 수 있는 대표성 있는 식품섭취량 자료를 확보하여 체계적인 방법으로 대표 식품을 선정하고, mapping을 통해 모든 식품을 포괄할 수 있는 방법을 제시함으로써 유해물질별 총 노출량을 평가할 수 있는 기반을 마련하였다.

Gadolinium Deposition in the Brain: Current Updates

  • Jin Woo Choi;Won-Jin Moon
    • Korean Journal of Radiology
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    • 제20권1호
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    • pp.134-147
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    • 2019
  • Gadolinium-based contrast agents (GBCAs) are commonly used for enhancement in MR imaging and have long been considered safe when administered at recommended doses. However, since the report that nephrogenic systemic fibrosis is linked to the use of GBCAs in subjects with severe renal diseases, accumulating evidence has suggested that GBCAs are not cleared entirely from our bodies; some GBCAs are deposited in our tissues, including the brain. GBCA deposition in the brain is mostly linked to the specific chelate structure of the GBCA: linear GBCAs were responsible for brain deposition in almost all reported studies. This review aimed to summarize the current knowledge about GBCA brain deposition and discuss its clinical implications.

약인성 간손상의 원인물질에 관한 국내연구의 체계적 고찰 (Systematic Review of the Cause of Drug-Induced Liver Injuries in Korean Literature)

  • 윤영주;신병철;이명수;조성일;박재현;이혜정
    • 대한한의학회지
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    • 제30권2호
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    • pp.30-45
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    • 2009
  • Background: The safety of herbal products is an important issue in Korea. It is more complicated because of the concomitant use of conventional western drugs and herbal medicine, including prescribed medicine, folk herbs and food supplements. Although both western and traditional Korean medical doctors have studied on the safety of HMP, their results did not show relevant or consistent conclusions because of the poor quality of studies, including bias. Objectives: The aim of this study was to review the studies in Korea related to drug induced liver injury (DILI) systematically. We tried to estimate the proportion of causative materials of DILI and evaluate the clinical difference of DILIs from different materials. Methods: Systematic searches were performed on MedRIC and MEDLIS in Korea. The extraction of data as well as selective screening of the studies was carried out independently by two of the authors. There were no restrictions on the types of publication, including grey literature. Results: Twenty-one articles were included. Of them only 7 adapted prospective design and only 6 were published in peer-reviewed journals. The proportion of conventional drugs associated with hepatotoxic injuries in all DILI ranged from 15.8% to 83.3% and that of herbal medicine was from 28.9% to 44.7%. However, the criteria for herbal medicine were not clearly defined and concomitant medications were not fully investigated in most studies. There were limited objective data in the clinical differences of liver injuries from different materials and their results were conflicting. Conclusions: The causality assessments regarding DILI of herbal medicine were not performed properly and causative materials were misclassified in most of the studies published in Korea. These make the safety issue still ambiguous because of the limitations and lack of objectivity of the studies. More rigorous studies are required for clearly addressing these conflicting issues with cooperative investigation between traditional Korean and western medicine.

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Microbial Risk Assessment of Non-Enterohemorrhagic Escherichia coli in Natural and Processed Cheeses in Korea

  • Kim, Kyungmi;Lee, Heeyoung;Lee, Soomin;Kim, Sejeong;Lee, Jeeyeon;Ha, Jimyeong;Yoon, Yohan
    • 한국축산식품학회지
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    • 제37권4호
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    • pp.579-592
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    • 2017
  • This study assessed the quantitative microbial risk of non-enterohemorrhagic Escherichia coli (EHEC). For hazard identification, hazards of non-EHEC E. coli in natural and processed cheeses were identified by research papers. Regarding exposure assessment, non-EHEC E. coli cell counts in cheese were enumerated, and the developed predictive models were used to describe the fates of non-EHEC E. coli strains in cheese during distribution and storage. In addition, data on the amounts and frequency of cheese consumption were collected from the research report of the Ministry of Food and Drug Safety. For hazard characterization, a doseresponse model for non-EHEC E. coli was used. Using the collected data, simulation models were constructed, using software @RISK to calculate the risk of illness per person per day. Non-EHEC E. coli cells in natural- (n=90) and processed-cheese samples (n=308) from factories and markets were not detected. Thus, we estimated the initial levels of contamination by Uniform distribution ${\times}$ Beta distribution, and the levels were -2.35 and -2.73 Log CFU/g for natural and processed cheese, respectively. The proposed predictive models described properly the fates of non-EHEC E. coli during distribution and storage of cheese. For hazard characterization, we used the Beta-Poisson model (${\alpha}=2.21{\times}10^{-1}$, $N_{50}=6.85{\times}10^7$). The results of risk characterization for non-EHEC E. coli in natural and processed cheese were $1.36{\times}10^{-7}$ and $2.12{\times}10^{-10}$ (the mean probability of illness per person per day), respectively. These results indicate that the risk of non-EHEC E. coli foodborne illness can be considered low in present conditions.

Risk assessment of heavy metals in tuna from Japanese restaurants in the Republic of Korea

  • Seong-Jin Bae;Kyu-Sik Shin;Chulyong Park;Kiook Baek;So-Young Son;Joon Sakong
    • Annals of Occupational and Environmental Medicine
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    • 제35권
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    • pp.3.1-3.11
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    • 2023
  • Background: Studies on the risk of mercury (Hg) in Korean fishery products focus primarily on total Hg levels as opposed to methylmercury (MeHg) levels. None of the few studies on MeHg in tuna investigated tuna from Japanese restaurants. Few have evaluated lead (Pb), cadmium (Cd) and arsenic (As) in tuna. Thus, this study aimed to conduct a risk assessment by evaluating heavy metal concentrations in tuna from Japanese restaurants. Methods: Thirty-one tuna samples were collected from Japanese restaurants in the Republic of Korea. They were classified according to region and species. The concentration of heavy metals in the samples was analyzed using the Ministry of Food and Drug Safety Food Code method. The rate of exceedance of maximum residue levels (MRLs) and the risk compared to the provisional tolerable weekly intake (PTWI) set by the Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives (%PTWI) were evaluated for risk assessment. Results: The mean of MeHg, Pb, Cd and As concentrations were 0.56 ± 1.47 mg/kg, 33.95 ± 3.74 ㎍/kg, 14.25 ± 2.19 ㎍/kg and 1.46 ± 1.89 mg/kg, respectively. No sample exceeded the MRLs of Pb and Cd, but 9.7% of the samples exceeded the MRL of MeHg. The %PTWIs of MeHg, Pb, Cd and As were 4.2037, 0.0162, 0.0244 and 1.1627, respectively. The %PTWI of MeHg by age group and sex was highest among men aged 19-29 years (10.6494), followed by men aged 30-49 years (7.2458) and women aged 19-29 years (4.8307). Conclusions: We found that 3 out of 31 samples exceeded the MRL of MeHg. The %PTWI of MeHg showed significant differences based on age and sex, and the value was likely to exceed a safe level depending on individuals' eating behaviors. Therefore, improved risk management for MeHg is required.

우리나라의 골반 및 요추 엑스선검사에서의 환자선량 권고량 (Diagnostic Reference Levels for Patient Radiation Doses in Pelvis and Lumbar spine Radiography in Korea)

  • 이광용;이병영;이정은;이현구;정승환;김병우;김혁주;김동섭
    • 대한방사선기술학회지:방사선기술과학
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    • 제32권4호
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    • pp.401-410
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    • 2009
  • 목 적 : 골반 및 요추 엑스선검사는 진단 엑스선검사 중 생식선을 포함하고 있고 환자가 받는 방사선량이 많은 검사로서 우리나라에는 골반 및 요추 엑스선검사에서의 환자선량 권고량이 마련되어 있지 않다. 따라서 국내 의료기관에서의 골반 및 요추 엑스선검사 시 환자가 받는 방사선량을 측정 평가하고 골반 및 요추 엑스선검사에서 환자의 방사선 방어 최적화를 위한 환자선량 권고량을 확립한다. 방 법 : 전국 125개 의료기관에서 골반 전후면 촬영, 요추 전후면 및 측면 촬영시 촬영조건과 진단영상정보를 조사 분석하고 환자가 받는 입사표면선량을 유리선량계를 사용하여 측정 평가한다. 환자가 받는 방사선량 중 제3사분위값에 해당하는 선량값을 의료기관에 권고할 골반 및 요추 엑스선검사에서의 환자선량 권고량으로 확립한다. 결 과 : 전국 125개 의료기관에서 골반 및 요추 엑스선검사 시 진단영상정보를 조사하고 환자가 받는 입사 표면선량을 측정한 결과 골반 전후면 엑스선검사에서는 관전압이 60~97 kVp, 평균 75 kVp를 사용하였고, 관전류-시간곱(mAs)는 8~123 mAs, 평균 29.7 mAs를 사용하였다. 요추 전후면 및 측면 엑스선검사에서는 관전압을 각각 65~100 kVp, 평균 78 kVp와 70~109 kVp, 평균 87 kVp를 사용하였고, mAs도 각각 10~100 mAs, 평균 35.2 mAs와 8.9~300 mAs, 평균 64.1 mAs를 사용하였다. 골반 및 요추 엑스선검사에서의 환자가 받는 입사표면선량을 측정한 결과, 골반 전후면 엑스선검사에서는 최소값 0.59 mGy, 최대값 12.69 mGy, 평균값 2.88mGy이었으며, 제1사분위값은 1.91 mGy, 중앙값은 2.67 mGy, 제3사분위값은 3.42 mGy이었다. 요추 전후면 엑스선검사에서는 최소값 0.64 mGy, 최대값 23.84 mGy, 평균값 3.68 mGy이었으며, 제1사분위값은 2.41 mGy, 중앙값은 3.40 mGy, 제3사분위값은 4.08 mGy이었다. 요추 측면 엑스선검사에서는 최소값 1.90 mGy, 최대값 45.42 mGy, 평균값 10.08 mGy이었으며, 제1사분위값은 6.03 mGy, 중앙값은 9.09 mGy, 제3사분위값은 12.65 mGy이었다. 결 론 : 우리나라의 의료기관에서 골반 전후면 엑스선검사에서 의료기관에 권고할 환자선량 권고량은 3.42 mGy, 요추 전후면 엑스선검사에서는 4.08 mGy, 요추 측면촬영에서는 12.65 mGy로 세계보건기구 등 6개 국제기구가 공동으로 권고한 골반 전후면 검사 10 mGy, 요추 전후면 검사 10 mGy 및 요추 측면 검사 30 mGy 보다는 낮았다.

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인공호흡기 중앙감시시스템 소프트웨어의 사용적합성 총괄평가 (Summative Usability Assessment of Software for Ventilator Central Monitoring System)

  • 정지용;김유림;장원석
    • 대한의용생체공학회:의공학회지
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    • 제44권6호
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    • pp.363-376
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    • 2023
  • According to the COVID-19, development of various medical software based on IoT(Internet of Things) was accelerated. Especially, interest in a central software system that can remotely monitor and control ventilators is increasing to solve problems related to the continuous increase in severe COVID-19 patients. Since medical device software is closely related to human life, this study aims to develop central monitoring system that can remotely monitor and control multiple ventilators in compliance with medical device software development standards and to verify performance of system. In addition, to ensure the safety and reliability of this central monitoring system, this study also specifies risk management requirements that can identify hazardous situations and evaluate potential hazards and confirms the implementation of cybersecurity to protect against potential cyber threats, which can have serious consequences for patient safety. As a result, we obtained medical device software manufacturing certificates from MFDS(Ministry of Food and Drug Safety) through technical documents about performance verification, risk management and cybersecurity application.The purpose of this study is to conduct a usability assessment to ensure that ergonomic design has been applied so that the ventilator central monitoring system can improve user satisfaction, efficiency, and safety. The rapid spread of COVID-19, which began in 2019, caused significant damage global medical system. In this situation, the need for a system to monitor multiple patients with ventilators was highlighted as a solution for various problems. Since medical device software is closely related to human life, ensuring their safety and satisfaction is important before their actual deployment in the field. In this study, a total of 21 participants consisting of respiratory staffs conducted usability test according to the use scenarios in the simulated use environment. Nine use scenarios were conducted to derive an average task success rate and opinions on user interface were collected through five-point Likert scale satisfaction evaluation and questionnaire. Participants conducted a total of nine use scenario tasks with an average success rate of 93% and five-point Likert scale satisfaction survey showed a high satisfaction result of 4.7 points on average. Users evaluated that the device would be useful for effectively managing multiple patients with ventilators. However, improvements are required for interfaces associated with task that do not exceed the threshold for task success rate. In addition, even medical devices with sufficient safety and efficiency cannot guarantee absolute safety, so it is suggested to continuously evaluate user feedback even after introducing them to the actual site.