• Title/Summary/Keyword: Medical Device Safety

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A Study on the Safety of a Screening X-ray Laboratory Using Containers in accordance with the COVID 19 Outbreak (COVID 19 유행에 따른 컨테이너를 이용한 선별 X-선 검사실의 안전성에 대한 고찰)

  • Kim, Jae-Seok
    • Journal of the Korean Society of Radiology
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    • v.14 no.4
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    • pp.425-431
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    • 2020
  • When a radiation generating device is installed in an export container due to COVID-19, the purpose of this study was to measure the space dose in the radiation room and to study the effectiveness of the shielding wall in the laboratory. Air dose measurement method was set behind the X-ray tube, 50 cm, 100 cm, 200 cm, and measured 12 locations. The dose values before and after the use of the movable radiation shielding wall were compared by measuring 3 locations behind the X-ray tube using the movable radiation shielding wall. The measured values were 50 cm on the left behind the X-ray tube: 1.446 μSv, behind the X-ray tube: 0.545 μSv, and 50 cm on the right behind the X-ray tube: 1.466 μSv. Measurements behind the radiation barrier were 0.190 μSv, 0.204 μSv, and 0.191 μSv. As a result of performing the corresponding sample t test of the average value according to the use of movable barrier walls, p <0.001 was found. As a result of the actual measurement, the medical exposure of the examiner due to the shielding wall in the laboratory decreased to 82.3%. In order to reduce occupational exposure in screening radiological laboratories, it is recommended that sufficient separation from radiation sources and the use of shielding walls are recommended.

A Study on Development of ECS for Severly Handicaped (중증 장애인을 위한 생활환경 제어장치개발에 관한 연구)

  • 임동철;이행세;홍석교;이일영
    • Journal of Biomedical Engineering Research
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    • v.24 no.5
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    • pp.427-434
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    • 2003
  • In this paper, we present a speech-based Environmental Control System(ECS) and its application. In the concrete, an ECS using the speech recognition and an portable wheelchair lift control system with the speech synthesis are developed through the simulation and the embodiment. The developed system apply to quadriplegic man and we evaluate the result of physical effect and of mental effect. Speech recognition system is constructed by real time modules using HMM model. For the clinical application of the device, we investigate the result applied to 54-years old quadriplegic man during a week through the questionnaires of Beck Depression Inventory and of Activity Pattern Indicator. Also the motor drive control system of potable wheelchair lift is implemented and the mechanical durability is tested by structural analysis. Speech recognition rate results in over 95% through the experiment. The result of the questionnaires shows higher satisfaction and lower nursing loads. In addition, the depression tendency of the subject were decreased. The potable wheelchair lift shows good fatigue life-cycle as the material supporting the upper wheelchair and shows the centroid mobility of safety. In this paper we present an example of ECS which consists of real-time speech recognition system and potable wheelchair lift. Also the experiments shows needs of the ECS for korean environments. This study will be the base of a commercial use.

A Study of Structural Analysis Simulation for Squat Exercise Foot Plate (스쿼트운동장치의 풋플레이트 구조해석에 관한 연구)

  • Jung, Byung-Geun;Kim, Ji-won;Jeong, Byeong-Ho
    • Journal of the Korea Convergence Society
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    • v.8 no.9
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    • pp.365-372
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    • 2017
  • Squat exercise is one of the important free weight exercises that can safely and effectively expect the athletic performance by establishing the rationale. Therefore, it is necessary to study the side effects caused by incorrect exercise, scientific countermeasures and to develop a exercise estimation model. It is effective and accurate to use a variety of assistive devices to calibrate athletic posture. The issues of the structural analysis for designing a foot plate for squat exercise is to model the behavior by the dynamic behavior. It should be consider that the center of gravity of each segmented body is different when the maximum load is applied. It is applied to complete system design through simulation method with kinematic dynamic, ground reaction force and load analysis for the free weight exercise equipment, VR device, and safety foot plate. In this paper, the authors propose the design method for the vertical load distribution applied in the design of the foot plate used for the squat exercise mechanism, and based on these results, design make the more safe and reliable free weight exercise equipment system.

The Realization on GAS Sensor Module for Inteligent Wireless Communication (지능형 무선통신용 가스 센서 모듈 구현)

  • Kim, Hyo-Chan;Weon, Young-Su;Cho, Hyung-Rae
    • The Journal of The Korea Institute of Intelligent Transport Systems
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    • v.11 no.6
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    • pp.123-132
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    • 2012
  • Gas sensors has been used very differently that depending on following purposes; Automotive (exhaust gas, fuel mixture gas, oxygen, particulates), agriculture / food industry (fresh, stored, CO2, humidity, NH3, nitrogen oxide gas, organic gas, toxic gas emitted from pesticides and insecticides), industrial / medical (chemical gas, hydrogen, oxygen and toxic gases), military (chemical weapon), environmental measurements (CO and other air pollution consisting of sulfur and nitrogen gas), residential (LNG, LPG, butane, indoor air, humidity). The types of industrial toxic substances are known about 700 species and many of these exist in gaseous form under normal conditions. he multi-gas detection sensors will be developed for casualties that detect the most important and find easy three kinds of gases in marine plant; carbon dioxide(CO2), carbon(CO), ammonia(NH3). Package block consists of gas sensing device minor ingredient, rf front end, zigbee chip. Develope interworking technology between the sensor and zigbee chip inside a package. Conduct a performance test through test jig about prototype zigbee sensor module with rf output power and unwanted emission test. This research task available early address when poisonous gas leaked from large industrial site and contribution for workers' safety at the enclosed space.

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.

Radiation Exposure Dose on Persons Engaged in Radiation-related Industries in Korea (한국에서 방사선 관련 종사자들의 개인피폭선량 실태에 관한 연구)

  • Lim, Bong-Sik
    • Journal of radiological science and technology
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    • v.29 no.3
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    • pp.185-195
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    • 2006
  • Purpose: This study investigated the status of radiation exposure doses since the establishment of the "Regulations on Safety Management of Diagnostic Radiation Generation Device" in January 6, 1995. Method: The level of radiation exposure in people engaged or having been engaged in radiation-related industries of inspection organizations, educational organizations, military units, hospitals, public health centers, businesses, research organizations or clinics over a 5 year period from Jan. 1, 2000 to Dec. 31, 2004 was measured. The 149,205 measurement data of 57,136 workers registered in a measurement organization were analysed in this study. Frequency analysis, a Chi-square test, Chi-square trend test, and ANOVA was used for data analysis. Results: Among 57,136, men were 40,870(71.5%). 50.3% of them were radiologic technologists, otherwise medical doctors(22.7%), nurse(2.9%) and others(24.1%). The average of depth radiation and surface radiation during the 5-year period were found to decrease each year. Both the depth radiation and surface radiation exposure were significantly higher in males, in older age groups, in radiological technologists of occupation. The departments of nuclear medicine had the highest exposure of both depth and surface radiation of the divisions of labor. There were 1.98 and 2.57 per 1,000 person-year were exposed more than 20 mSv(limit recommended by International Commission on Radiological Protection) in depth and surface radiation consequently. Conclusion: The total exposure per worker was siginifcantly decreased by year. But Careful awareness is needed for the workers who exposed over 20 mSv per year. In order to minimize exposure to radiation, each person engaged in a radiation-related industry must adhere to the individual safety management guidelines more thoroughly. In addition, systematic education and continuous guidance aimed at increasing the awareness of safety must be provided.

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A Study on the Countermeasures Taken By the Korean Healthcare and Life Sciences Industry Regarding U.S. Import Refusals: Focus on the Analysis of FDA Violation Codes (한국 바이오헬스 산업의 미국 수입거부 대응 방안 연구 : FDA 위반코드 분석을 중심으로)

  • Yu-Han Lee;Hag-Min Kim
    • Korea Trade Review
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    • v.48 no.3
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    • pp.131-150
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    • 2023
  • The purpose of this study was to find a countermeasure to the U.S. import refusals for the Korean healthcare and life sciences industry. To this end, an analysis of trends during the pandemic was conducted using the KITA Border Rejection Database, which includes information on items and types of import refusals. The reason for rejection was also analyzed according to the FDA violation codes. The degree of countermeasure for import refusals was identified by measuring the unit rejection rate (URR). The results of the analysis showed that the major U.S. import refusals for the Korean healthcare and life sciences industry had expanded from contact lenses to COVID-19 diagnostic kits and drugs after the pandemic broke out. The major reasons for import refusals were non-compliance with the Predicate Device and Drugs Act and non-approval by the FDA for products and facilities. On the other hand, the unit rejection rate (URR) of major items in the Korean healthcare and life sciences industry was measured higher than the industry average. The results therefore showed a low level of response to U.S. import refusals. The results of the analysis of reasons for import refusals by item according to FDA violation codes were as follows. First of all, the main violation for contact lenses and COVID-19 diagnostic kits corresponded to misbranding. This was often due to the fact that Korean companies did not provide the relevant notices and information required by the FDA. Many cases also failed to demonstrate a substantial equivalency compared to predicate devices already on the market. On the other hand, applications for new unapproved drugs were not accepted as they had yet to pass relevant regulations that would prove their safety and efficacy. In conclusion, import refusals for the Korean healthcare and life sciences industry were found to be closely related to technical barriers to trade (TBT).

The Association of Blood Concentrations of Healvy Metals and Blood Pressure in Residents Living Near Janghang Copper Smelter in Korea (제련소 주변 지역 주민들의 혈중 중금속 농도와 혈압과의 관련성)

  • Eom, Sang-Yong;Yim, Dong-Hyuk;Moon, Sun-In;Ochirpurev, Bolormaa;Choi, Young-Sook;Park, Choong-Hee;Kim, Guen-Bae;Yu, Seung-Do;Choi, Byung-Sun;Park, Jung-Duck;Kim, Yong-Dae;Kim, Heon
    • Journal of agricultural medicine and community health
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    • v.42 no.1
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    • pp.13-23
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    • 2017
  • Objectives: This study was conducted to evaluate a relationship between the blood concentrations of toxic metals and the blood pressure in people living near the copper smelter. Methods: The study included 570 adults living within 4km of the smelter. We compared systolic and diastolic blood pressure between tertiary groups for blood cadmium, mercury and lead levels, respectively. Multiple regression analysis was performed to identify risk factors affecting systolic and diastolic blood pressures. Results: In male subjects, there is a significant difference in the mean of systolic and diastolic blood pressure between tertiary groups of blood cadmium and mercury levels, but in women, there was no significant difference in the mean systolic and diastolic blood pressures in all tertiary groups of heavy metals. The results of multiple regression analysis showed that age, BMI, and cadmium concentration in men were risk factors for blood pressure. In women, age and BMI, drinking and smoking, and blood mercury were significantly influenced to blood pressure. Conclusions: Residents living near the Janghang smelter showed high concentrations of blood lead and cadmium, suggesting that they were exposed to high concentrations of heavy metals released from the smelter in the past. Such exposure may have caused some blood pressure increase. Especially, the concentration of cadmium in the case of men and the concentration of mercury in blood in the case of women were found to be significantly related to the increase of blood pressure. The local population should be advised to make efforts to reduce exposure to environmental contaminants, in order to minimize cardiovascular disease, and to pay close attention to any health problems possibly related to toxic metal exposure.

Study of External Radiation Expose Dose on Hands of Nuclear Medicine Workers (핵의학 종사자에서 손 부위의 외부 피폭선량 연구)

  • Park, Jun-Chul;Pyo, Sung-Jae
    • Journal of radiological science and technology
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    • v.35 no.2
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    • pp.141-149
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    • 2012
  • The aims of this study are to assess external radiation exposed doses of body and hands of nuclear medicine workers who handle radiation sources, and to measure radiation exposed doses of the hands induced by a whole body bone scan with high frequency and handling a radioactive sources like $^{99m}Tc$-HDP and $^{18}F$-FDG in the PET/CT examination. Skillful workers, who directly dispense and inject from radiation sources, were asked to wear a TLD on the chest and ring finger. Then, radiation exposed dose and duration exposed from daily radiation sources for each section were measured by using a pocket dosimeter for the accumulated external doses and the absorbed dose to the hands. In the survey of four medical institutions in Incheon Metropolitan City, only one of four institutions has a radiation dosimeter for local area like hands. Most of institutions uses radiation shielding devices for the purpose of protecting the body trunk, not local area. Even some institutions were revealed not to use such a shielding device. The exposed doses on the hands of nuclear medicine workers who directly handles radioactive sources were approximately twice as much as those on the body. The radiation exposure level for each section of the whole body bone scan with high frequency and that of the PET/CT examination showed that radiation doses were revealed in decreasing order of synthesis of radioactive medicine and installation to a dispensing container, dispensing, administering and transferring. Furthermore, there were statistically significant differences of radiation exposure doses of the hands before and after wearing a syringe shielder in administration of a radioactive sources. In this study, although it did not reach the permissible effective dose for nuclear medicine, the occupational workers were exposed by relatively higher dose level than the non-occupational workers. Therefore, the workers, who closely exposed to radioactive sources should be in compliance with safety management regulations, and take actions to maximally reduce locally exposed dose to hands monitoring with ring TLD.