• Journal of the Institute of Electronics Engineers of Korea SC
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• v.49 no.2
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• pp.55-62
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• 2012

Convergence of information technology (IT) and medical devices enables people to measure health-related information ubiquitously, such as measuring blood glucose at home and checking cardiac signals during exercise and it allows us to access to medical care anywhere and anytime. Nowadays, the market for U-healthcare medical devices is growing rapidly, but guidelines for the evaluation of safety and effectiveness of such devices remain to be formulated. We performed a study on the development of safety and performance evaluation method for portable, hand-held, U-healthcare medical devices. We reviewed current guidelines and standards for home-health devices from the Korea Food and Drug Administration (KFDA) and related international committees such as the ISO/IEEE and CE. We summarized the test methods and items for the evaluation of safety and performance related to U-healthcare medical devices from the above guidelines and standards. We defined requirements for a U-healthcare medical device to demonstrate good performance. In conclusion, we propose an evaluation method for U-healthcare medical devices, which will help improve the safety and reliability of these devices.

• Progress in Medical Physics
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• v.20 no.4
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• pp.317-323
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• 2009

The standard dosimetry systems based on an absorbed dose to water recommend to use a planeparallel chamber for the calibration of such a low-megavoltage electron beam as a nominal energy of 6 MeV. For this energy ranges of an electron beam a cylindrical chamber should not be used for the routinely regular beam calibration, but the feasibility of the temporary use of a cylindrical chamber was studied to give temporary solutions for special situations users meet. The PTW30013 chambers and the electron beam quality of $R_{50}=2.25\;g/cm^2$ were selected for this study. 10 PTW30013 chambers, a cylindrical type of chamber, were calibrated in KFDA, the secondary standards dosimetry laboratories, and given the absorbed dose-to-water calibration factors, respectively. A "temporary" $k_{Q,Q_0}$ for each chamber were calculated using the absorbed dose determined by a cross-calibrated planeparallel chamber, with the result of an average 0.9352 for 10 chambers. This value for PTW30013 chamber was used to determine an absorbed dose to water at the reference depth. The absorbed doses determined by PTW30013 chambers were in an agreement within 2% with that by ROOS chamber. In a certain situation where a cylindrical chamber be used instead of a planeparellel chamber, the value of 0.9352 might be useful to determine an absorbed dose to water in the same beam quality of electron beam as this study.

• Journal of radiological science and technology
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• v.32 no.1
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• pp.1-15
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• 2009

Newly published IEC 60601-1-3 ; 2008 2nd Edition has two important meanings. First, Radiation Quality and Dose should make sure for safety of patient and staff in manufacturing diagnostic X-ray equipment. Second, it should be minimized of Leakage Radiation, Residual Radiation, and Stray Radiation. The requirement to make enactment or revision of national standard for diagnostic X-ray Equipment is as follows : 1. It should be adjusted the new standard to the recent IEC Publication under the consideration of the Korea medical circumstances. 2. For focus to the Radiation Safety, IEC 60601-1-3 (General requirements for radiation protection in diagnostic X-ray equipment) could be applied to the new regulation. It should be compact sentence. 3. A sudden Notification change should not be desired. It needs a enough time to make easy the circumstances.

• Journal of Food Hygiene and Safety
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• v.19 no.2
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• pp.84-96
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• 2004

This study aims at developing an easily-applicable Sanitation Standard Operating Procedure(SSOP) program for Fresh raw-fish manufacturing. It compares the sanitation inspection results of SSOP-program-applied procedure and non-applied procedure. The samplings for bacteriological examination were collected from the touching surface of food and from the personal workers. The sanitation status was recorded in the check-up list. The results were statistically analyzed to ascertain the efficiency of the SSOP program. The present official KFDA check-up list for sanitation inspection is composed of 51 items. Each item is judged to be fit or unfit to the standards. When the unfit items are more than 6, the work-place is judged to be insanitary. But in this study, the results of sanitation inspection are scaled in points in the 70％ allotment, and the results of bacteriological examination are scaled in points in 30％, totaling 100％. Below 60 scores are judged to be insanitary and administratively punished; 61-75 scores are judged to be average; 76-85 good; above 86 excellent. The sanitation inspection scores by the improved check-up list went up by two grades from 71.8 (before SSOP program) to 88.6 (after SSOP program). The results of bacteriological examination also improved from 57.5 to 98.2. The total scores of both results converted in the allotment of 70％ and 30％ also showed an improvement by two grades from 66.4 (before SSOP program) to 93.4 (after SSOP program). The above results show that the manufacturers participated in this study are following the 8 essential sanitary procedures which are needed to anchor the HACCP system.

• Progress in Medical Physics
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• v.17 no.4
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• pp.246-251
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• 2006

The purpose of this study was to evaluate SUV (standard uptake value) using different reconstruction methods in whole body PET/CT Imaging. PET/CT studies were peformed with and without correction for effect of contrast media. The patients data were acquired using GE DSTe commercial PET/CT system. The liver disease (hepatocellular carcinoma, HCC) and renal disease (renal ceil carcinoma, RCC) patients were selected for this study, The PET/CT data were reconstructed using post CT scan with and without correction for effect of contrast media. We selected ROIs (region of Interest) at the same location and same area for the same patient to compare SUVs in these two methods. For HCC and RCC, the average differences of SUVs were measured as $1.5{\pm}1.2%\;and\;1.0{\pm}0.9%$, respectively. For HCC and RCC, the maximum differences of SUVs were measured as 4.3% and 1.9%, respectively. We observed that SUVs without correction for effect of contrast media were higher than SUVs with correction for effect of contrast media. However the differences of SUVs were very minimal. These results may be limited to HCC and RCC and further studies will be Heeded for other organs or diseases to see any changes in SUV with and without correction for effect of contrast media.

• Progress in Medical Physics
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• v.16 no.2
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• pp.62-69
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• 2005

The purpose of this study has been performed to investigate the possibility of external audit program using thermoluminescence dosimetry for electron beam in korea. The TLD system consists of LiF powder, type TLD-700 read with a PCL 3 reader. In order to determine a calibration coefficient of the TLD system, the reference dosimeters are irradiated to 2 Gy in a $^{60}CO$ beam at the KFDA The irradiation is performed under reference conditions is water phantom using the IAEA standard holder for TLD of electron beam. The energy correction factor is determined for LiF powder irradiated of dose to water 2 Gy in electron beams of 6, 9, 12, 16 and 20 MeV (Varian CL 2100C). The dose is determined according to the IAEA TRS-398 and by measurement with a PTW Roos type plane-parallel chamber. The TLD for each electron energy are positioned in water at reference depth. In this study, to verify of the accuracy of dose determination by the TLD system are performed through a 'blind' TLD irradiation. The results of blind test are $2.98\%,\;3.39\%\;and\;0.01\%(1\sigma)$ at 9, 16, 20 MeV, respectively. The value generally agrees within the acceptance level of $5\%$ for electron beam. The results of this study prove the possibility of the TLD quality assurance program for electron beams. It has contributed to the improvement of clinical electron dosimetry in radiotherapy centers.

• Journal of the Korean Society of Food Culture
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• v.24 no.3
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• pp.331-337
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• 2009

The principal objective of the present study was to survey the demands of an education program for evaluations of the efficacy of health functional foods. A questionnaire was developed and sent to 2,225 members of the Biofood Network Center. A total of 101 (4.6%) individuals responded, 54.5% of the respondents were male and 45.5% were female; the respondents' occupations (in order of prevalence) were as follows: company worker (48.5%)>researcher (27.7%)>student (13.9%)>professor (5.0%)>pharmacist (2%), and dietitian (2%). The businesses in which the respondents worked were (again in order of prevalence) as follows: research & development (64.4%)>marketing (11.9%)>consultation and education (5.9%)>manufacturing and others (17.9%). 41.6% of the respondents reported experience in businesses relevant to KFDA approval for functional ingredients and health functional foods. The results showed that 63.4% of the respondents had previously been educated about functional foods; the types of education program reported were (in order of prevalence): 'overview and acts of health functional food' (n=49)>'standards and specification for health functional food' (n=41)>'efficacy evaluation-human study' (n=24)>'safety evaluation' (n=21)>'efficacy evaluation-in vivo study' (n=13)>and 'others' (n=10). Respondents preferred off-line education programs (62.4%) to on-line programs (22.8%). The preferred duration of an educational program was '$2{\sim}3$ days: total $14{\sim}24$ hours' (30.7%); thus, short-term programs were favored. The primary requirements of a program, from the perspective of the learner, were as follows (scored on a 7-point scale); 'efficacy evaluation and case study-human study' (5.80 points)>'standards and specification for health functional food' (5.72 points)>safety evaluation' (5.7 points)>'overview and acts of health functional food' (5.67 points) and 'efficacy evaluation methods of health functional food by efficacy (intensive)' (5.67 points). Preference for functionality was as follows; 'body weight & body fat' (21.8%), 'immune function' (18.8%) > 'blood glucose' (10.9%). In summary, the educational demand for 'efficacy evaluation and case study' was highest among the curriculum options provided, and with regard to functionality, 'body weight & body fat', 'immune function' and 'skin care' were considered most important by respondents. These results differed among respondents with different jobs and duties, and this suggests that customized education programs for health functional food should be developed.

• The Korean Journal of Nuclear Medicine Technology
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• v.15 no.2
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• pp.26-29
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• 2011

Purpose: The general test method of the Korean Pharmacopeia specifies the test method on the clauses of quality control after manufacturing. According to KFDA Guidance for Medicines, standards of residual solvents regulates the maximum permissible dose of acetonitrile as 400 ppm, ethanol as 5,000 ppm, and acetic acid as 5,000 ppm. This study aims at identifying the type of resiual solvents in the final [F-18]FDG vial of an automatic synthesizer and measure its residual quantity. Materials and Methods: The center carried out residual solvents test of [F-18]FDG injection using Agilent Technologies 7890A with a Flame Ionization Detector. The column of Agilent Technologies 7890A used in measuring of residual solvents was CP WAX column ($30m{\times}0.53mm{\times}1.0{\mu}m$) and analysis condition was split mode 1:1 at the initial temperature $70^{\circ}C$ which was increased $20^{\circ}C/minute$ after two minutes and maintained at the final $140^{\circ}C$ for two minutes. The analysis method was as following: Firstly, ethanol-acetonitrile-acetic acid mixture was classified into four types of concentration (250-25-250 ppm, 1,000-100-1,000 ppm, 3,000-300-3,000 ppm, and 6,000-600-6,000 ppm), and $1.0{\mu}L$ of each type of concentration was injected into gas chromatography followed by an analysis of its peak domain. Then, a calibration-curve by the external standard method was drawn based on the analysis result. Results: While ethanol and acetonitrile were detected in TRACERlab MX, FASTlab had additional acetic acid. The residual quantity of the ethanol-acetonitrile-acetic acid mixture evaluated using the calibration-curve was average 72 ppm ethanol, 54 ppm acetonitrile, and 1030 ppm acetic acid for FASTlab, whereas average 439 ppm ethanol and 79 ppm acetonitrile for TRACERlab MX. This indicated that both of them were within the maximum permissible dose. Conclusion: Solvent residues in the [F-18]FDG injection were all within maximum permissible doses and proper to be used to examine a patient. The result indicated that types and quantities of solvent resides of radioactive pharmaceuticals vary depending on the automatic synthesizer.

• Korean Journal of Ecology and Environment
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• v.43 no.2
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• pp.288-297
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• 2010

This study was to evaluate the ecological stream health through the Multimetric Fish Assessment Index (MFAI) along with fish fauna analysis based on the tolerance and trophic guilds at Miho stream in 2008 and 2009. Also, we analysed total mercury concentration in fish tissues to examine heavy metal contamination. Total sampled fish were 40 species and 2,557 individuals and Zacco platypus was the most dominant with 35% relative abundance. It was sampled with 11.4% RA for Korean endemic species (10 species 291 individuals) less than average RA 39.3% for the Geum river watersheds. According to the tolarance guild analysis, tolerant species was more dominant with 58.9% RA (15 species, 1,507 individuals) than sensitive species with 6.6% RA. Trophic guild analysis also suggested that omnivores were more dominant (60.5% RA) than insectivores (31.5% RA). Riffle-benthic species was also sampled with 7.7% RA. Ecological stream health based on the MFAI were averaged 25.3 (n=3) with fair-poor condition in 2008 and also 26.3 (n=3) with fair condition in 2009, just slightly increased than 2008. Qualitative habitat evaluation index was averaged 134 (n=3) with fair condition but most of sites had sediment accumulation that reflected substrate degradations proceeding. From the result of total mercury accumulation in fish tissues, kidney and liver tissues showed the highest but the lowest for gill tissues. Overall mercury concentration were not exceed the national standards by Korean Federation of Drug and Administration (KFDA). Consequently, our result could correspond with the characteristics of Miho stream where point sources such industrial complexes and wastewater treatment plant widely distributed around the stream along the gradient of up and downstream.

• Journal of Dairy Science and Biotechnology
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• v.34 no.2
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• pp.99-116
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• 2016

We herein performed animal safety assessment in accordance with Good Laboratory Practice (GLP) regulations with the aim of developing sialic acid from glycomacropeptide (hereafter referred to as "GMP") as an index ingredient and functional component in functional foods. GMP is a type of whey protein derived from milk and a safe food, with multiple functions, such as antiviral activity. A test substance was produced containing 7% (w/w) sialic acid and mostly-hydrolyzed whey protein (hereafter referred to as "7%-GNANA") by enzymatic treatment of substrate GMP. The maximum intake test dose level was selected based on 5,000 mg/kg/day dose set for male NOEL (no-observed-effect-level) and female NOAEL (no-observed-adverse-effect-level) determined by a dose-range finding (DRF) test (GLP Center of Catholic University of Daegu, Report No. 15-NREO-001) that was previously conducted with the same test substance. To evaluate the toxicity of a repeated oral dose of the test substance in connection with the previous DRF study, 1,250, 2,500, and 5,000 mg/kg of the substance were administered by a probe into the stomachs of 6-week-old SPF Sprague-Dawley male and female rats for 90 d. Each test group consisted of 10 male and 10 female rats. To determine the toxicity index, all parameters, such as observation of common signs; measurements of body weight and food consumption; ophthalmic examination; urinalysis, electrolyte, hematological, and serum biochemical examination; measurement of organ weights during autopsy; and visual and histopathological examinations were conducted according to GLP standards. After evaluating the results based on the test toxicity assessment criteria, it was determined that NOAEL of the test substance, 7%-GNANA, was 5,000 mg/kg/day, for both male and female rats. No animal death was noted in any of the test groups, including the control group, during the study period, and there was no significant difference associated with test substance, as compared with the control group, with respect to general symptoms, body weight changes, food consumption, ophthalmic examination, urinalysis, hematological and serum biochemical examination, and electrolyte and blood coagulation tests during the administration period (P<0.05). As assessed by the effects of the test substance on organ weights, food consumption, autopsy, and histopathological safety, change in kidney weight as an indicator of male NOAEL revealed up to 20% kidney weight increase in the high-dose group (5,000 mg/kg/day) compared with the change in the control group. However, it was concluded that this effect of the test substance was minor. In the case of female rats, reduction of food consumption, increase of kidney weight, and decrease of thymus weight were observed in the high-dose group. The kidney weight increased by 10.2% (left) and 8.9% (right) in the high-dose group, with a slight dose-dependency compared with that of the control group. It was observed that the thymus weight decreased by 25.3% in the high-dose group, but it was a minor test substance-associated effect. During the autopsy, botryoid tumor was detected on the ribs of one subject in the high-dose group, but we concluded that the tumor has been caused by a naturally occurring (non-test) substance. Histopathological examination revealed lesions on the kidney, liver, spleen, and other organs in the low-dose test group. Since these lesions were considered a separate phenomenon, or naturally occurring and associated with aging, it was checked whether any target organ showed clear symptoms caused by the test substance. In conclusion, different concentrations of the test substance were fed to rats and, consequently, it was verified that only a minor effect was associated with the test substance in the high-dose (5,000 mg/kg/day) group of both male and female rats, without any other significant effects associated with the test substance. Therefore, it was concluded that NOAEL of 7%-GNANA (product name: Helicobactrol) with male and female rats as test animals was 5,000 mg/kg/day, and it thus was determined that the substance is safe for the ultimate use as an ingredient of health functional foods.