• YAKHAK HOEJI
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• v.55 no.4
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• pp.345-351
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• 2011

Gastritis is the most common disease among Korean. The demand for the development of gastritis drugs has been increasing. Currently, however, there is no guideline available for the clinical evaluation of gastritis drugs worldwide. As a consequence, domestic and international pharmaceutical companies make errors in the drug development processes, and it becomes difficult for them to establish the scientific validity and objectivity of newly developed drugs. The objective of this study was to develop the Guideline for Clinical Trials Evaluation of Gastritis which can be used in improving the quality and consistency of clinical trials. First, we collected and reviewed the clinical trials on gastritis drugs that were available from Japan Pharmaceuticals and Medical Devices Agency and Korea Food and Drug Administration (KFDA), and investigated the recent research trends on clinical trials of gastritis drugs. Reviewers from KFDA and National Institute of Food and Drug Safety Evaluation and scientific experts from the pharmaceutical industries developed the guidelines through regularly scheduled meetings. Opinions and consultation from academic fields and industry experts were also obtained. This project will provide the clinical trial practitioners, investigator and reviewers the scientific and rational guidelines for performance and evaluation of clinical trials for gastritis drugs. Furthermore, we hope this guideline contributes to establishing the national competitiveness, improving the quality of clinical trial, and encouraging researches on drug development for gastritis.

• The Korean Society of Law and Medicine
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• v.15 no.2
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.73-79
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• 2023

The purpose of this study is to derive medical devices with different management systems through comparison of domestic and overseas medical device product classification systems and to propose management conversion measures for the products. The definitions of medical devices were compared and the scope of medical devices defined by each country was confirmed through surveys of the Medical Device Act, Federal Food, Drug & Cosmetics Act (FD&C) in the U.S., and Medical Device Regulations (MDR) in Europe. Using the Ministry of Food and Drug Safety's regulations on medical device products and grades, 21 CFR part 860-892 and product code classification files in U.S., and EMDN in Europe as basic data to compare medical device products and derive medical devices with different management systems. As a result of comparing the definition and product classification systems of medical devices in Korea, the U.S. and Europe, medical device accessories, prosthetic limbs and aids among assistive devices for persons with disabilities, drugs, quasi-drugs and industrial products that are not managed by medical devices in Korea are managed as medical devices in the U.S. and Europe. This study aims to improve public health by securing systematic product safety management and essential performance under medical device regulations. Management within a single medical device system will increase the efficiency of licensing work of domestic medical device manufacturers and related organizations. It is also expected to help advance the system according to the international harmony of the item classification system and enhance smooth import and export competitiveness.

• Journal of the Korea Safety Management & Science
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• v.12 no.3
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• Korean Journal of Clinical Pharmacy
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• v.24 no.4
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• pp.282-287
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• 2014

Objective: Objective of this study was to investigate community pharmacy-based pharmaceutical care accessibility in Korea. Survey on the current pharmaceutical care service provision was performed by PM2000 XE, a real-time pharmacy manager program, operated by Korea Pharmaceutical Information Center beginning November 4, 2013 until December 6, 2013 towards all community pharmacies throughout the nation which use the program. Method: The survey questionnaire consisted of four sections: pharmacy type, time-based accessibility, item-based accessibility, and spatial accessibility for non-prescription drugs. Results: Number of pharmacy responded to the survey was 331, and size of the responding pharmacy was mostly medium-scale (66.47%) with 30-99 prescription fillings a day. Proportion of pharmacy with opening hour of 12 hours or longer was only 53.77% and it was less than 25% during saturdays and holidays. Item-based accessibility was generally acceptable for prescription and non-prescription drugs, medical devices, and health supplements. However, spatial accessibility for non-prescription drugs was problematic because only one quarter of the drugs was displayed over the counter, and most of the drugs were behind the counter so that customers could not reach out. Conclusion: Based on the survey result, current situation for accessibility of pharmaceutical care service in Korea is concluded inadequate and therefore needs multidimensional efforts to improve accessibility of the service at national level such as Korea Pharmaceutical Association and Ministry of Health and Welfare.

• Journal of Information Processing Systems
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• v.13 no.5
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• pp.1243-1258
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• 2017

A new medical materials scheduling system and its modeling method for the complex rescue are presented. Different from other similar system, first both the BeiDou Satellite Communication System (BSCS) and the Special Fiber-optic Communication Network (SFCN) are used to collect the rescue requirements and the location information of disaster areas. Then all these messages will be displayed in a special medical software terminal. After that the bipartite graph models are utilized to compute the optimal scheduling of medical materials. Finally, all these results will be transmitted back by the BSCS and the SFCN again to implement a fast guidance of medical rescue. The sole drug scheduling issue, the multiple drugs scheduling issue, and the backup-scheme selection issue are all utilized: the Kuhn-Munkres algorithm is used to realize the optimal matching of sole drug scheduling issue, the spectral clustering-based method is employed to calculate the optimal distribution of multiple drugs scheduling issue, and the similarity metric of neighboring matrix is utilized to realize the estimation of backup-scheme selection issue of medical materials. Many simulation analysis experiments and applications have proved the correctness of proposed technique and system.

• Health Policy and Management
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• v.10 no.1
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• pp.126-147
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• 2000

This paper empirically explores the nature of the medical service industry and its various propagation effects on the economy in the input-output model, as revealed by a comparative analysis between Korea and Japan. The main findings of the paper are as follows; First, the growth of medical industry induces above-average effect on employment. Second, the industry is of the characteristics of weak both backward and forward linkage effects implying a 'final demand dependency industry'. When compared with public service sectors, however, the medical services industry shows stronger backward linkage effect than those sectors. Furthermore, it has strong repercussion effects on the goods industries. Third, in order to produce per unit of services, the medical services industry of Korea uses relatively more drugs and medical devices than that of Japan. In general, it has been shown that production structure of medical service industry in Korea is 'hardware-oriented' one; on the other hand, 'software-oriented' in Japan which means that, as intermediate inputs, outsourcing and informatization has been used than those of Korea. From the findings of the paper it could be emphasized that the medical organizations in Korea should put more efforts on shifting the current hardware-oriented production structure to strengthen core competence by enhancing productivity and by outsourcing to improve efficiency of production process. However, the medical organizations in Korea would not have enough incentives for high value-added production structure because they enjoy high operating surplus. Therefore, it would be necessary that government policy should be taken into account of these environments.

• Journal of Preventive Medicine and Public Health
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• v.51 no.1
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• pp.15-22
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• 2018

Objectives: The use of administrative data is an affordable alternative to conducting a difficult large-scale medical-record review to estimate the scale of adverse events. We identified adverse events from 2002 to 2013 on the national level in Korea, using International Classification of Diseases, tenth revision (ICD-10) Y codes. Methods: We used data from the National Health Insurance Service-National Sample Cohort (NHIS-NSC). We relied on medical treatment databases to extract information on ICD-10 Y codes from each participant in the NHIS-NSC. We classified adverse events in the ICD-10 Y codes into 6 types: those related to drugs, transfusions, and fluids; those related to vaccines and immunoglobulin; those related to surgery and procedures; those related to infections; those related to devices; and others. Results: Over 12 years, a total of 20 817 adverse events were identified using ICD-10 Y codes, and the estimated total adverse event rate was 0.20%. Between 2002 and 2013, the total number of such events increased by 131.3%, from 1366 in 2002 to 3159 in 2013. The total rate increased by 103.9%, from 0.17% in 2002 to 0.35% in 2013. Events related to drugs, transfusions, and fluids were the most common (19 446, 93.4%), followed by those related to surgery and procedures (1209, 5.8%) and those related to vaccines and immunoglobulin (72, 0.3%). Conclusions: Based on a comparison with the results of other studies, the total adverse event rate in this study was significantly underestimated. Improving coding practices for ICD-10 Y codes is necessary to precisely monitor the scale of adverse events in Korea.

• The Research Journal of the Costume Culture
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• v.17 no.2
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• pp.320-329
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• 2009

This research attempts to develop a method to relieve dysmenorrhea, which is an obstacle to many women's social activities, by designing a smartwear with built-in thermotherapy and TENS device. TENS therapy has the advantages of being controlled by patients and not depending on the use of drugs. The TENS device is designed as a stomach band so as to be unnoticeable to others when outer clothes are worn; the size was minimized and attached to underwear to facilitate use everywhere at any time. A current problem is the limitation of minimizing, but as battery technology is further developed, we can anticipate much smaller devices. The development of aforementioned smartwear function will increase women's choices in occupations and general improvement in quality of life.

• Proceedings of the Korean Vacuum Society Conference
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• 2016.02a
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• pp.78-78
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• 2016

For the past three decades, extensive research has been performed in the surface design of new polymers for a variety of medical applications. Great progress in therapeutics and diagnostics can be attributed to these scientific advances in biomedical polymers. A variety of bioinert materials or bioactive materials using drugs, cells, and growth factors are widely utilized for the implants, devices and tissue regeneration. These materials provide an improved biocompatible materials to host, to significantly decrease or increase the host/tissue/blood response to the foreign materials. In the future, biomaterials will play a different role in modern therapeutics. New materials will be tailored to interact more on a protein and cellular level to achieve high degree of biocompatibility, biospecificity and bioacitivity. In this presentation, various biocompatible materials based on surface/bulk engineering will be demonstrated, which can be utilized as therapeutics implants and therapeutic vehicles for biologically active molecules such as cell, protein /peptide and gene.