• Journal of Biomedical Engineering Research
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• v.34 no.2
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• pp.69-72
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• 2013

The goal of this study is to develop test method for evaluating the drug eluting properties of drug eluting stents (DES). PBS and the detergent solutions, presented by each DES manufacturer, were used for drug release of DES coated with paclitaxel, zotarolimus and everolimus. The drugs which are coating DES were not released by PBS but released by the detergent solutions, finally paclitaxel 83.38%, zotarolimus 103.85% and everolimus 115.78%. It seems that the use of the detergents is necessary in order to release the drugs because those drugs are extremely hydrophobic. In conclusion, using of detergent solutions presented by each manufacturer were suitable for evaluating the drug eluting property of drug eluting stent.

• The Korean Society of Law and Medicine
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• v.9 no.2
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• pp.209-229
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• 2008

When we are totalizing the lawsrelated to the medical, as the Laboratory medical testing is a kind of the medical act, it is the regulation that the medical technologist can analyze the specimen using in vitro diagnostic devices and diagnosticdrugs under the guidance of doctor or dentist from a corresponding medical institution and can report through verification and interpretation. However, in real medical fields, 'the guidance of doctor' is seriously in-sufficient or even the person who is not the medical technologist is executing. Furthermore the cases that produce inspection results with devices or reagents which are not validated nor approved have been frequently occurred. The result of Laboratory medical testing derived from this procedure can become the important information for the disease control of a country, and also can be decisive to the definite diagnosis and the prognostic monitoring about the patient disease. In spite of its significant medical act to be applicable to an unique proof with the related expert appraisal result in the medical mal-practice lawsuit, our reality in which the quality control is not properly working due by the costs and the labor shortage related to the Laboratory medical testing is quietly in bad condition. Even from now, the government should recognize the significance of the Laboratory medical testing and must achieve more strict administrative management as well as the law maintenance.

• Proceedings of the KIEE Conference
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• 2007.07a
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• pp.1902-1903
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• 2007

인구의 급속한 고령화에 따른 가정에서의 의료서비스나 건강관리를 위한 홈 헬스케어 및 실버케어 의료기기가 점차적으로 보급, 확대되고 있다. 또한 관련된 가정용 전기기기나 의료기기가 개발됨에 따라 이들기기의 공통 표준화가 필요하며 본 논문에서는 사용시에 가장 중요한 인체에 대한 전기적 안전에 관한 기준연구를 수행하였다.

• Journal of Biomedical Engineering Research
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• v.33 no.2
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• pp.89-97
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• 2012

The purpose of this study is to develop the guideline of the physicochemical and mechanical properties evaluation for silicone gel filled breast implants. First of all, the use and development status for silicone gel filled breast implants were investigated, and then, standard and criteria about performance evaluation established by the international organizations such as ASTM, FDA guidance and ISO were examined. To evaluate the mechanical properties, data research and testing for breaking strength, elongation, tensile set, joint intensity, silicone gel cohesion, weight loss from heating, static rupture resistance, impact resistance test, fatigue test, and gel bleed were performed. On the other hand, to evaluate the physicochemical properties, volatile matter, extent of cross linking, heavy metals, and extractable were analyzed. In this study, results for general function, mechanical properties and physicochemical properties were examined and reviewed for the accordance with international standard, and objective and standardized guideline was provided.

• Genomics & Informatics
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• v.17 no.3
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• pp.34.1-34.3
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• 2019

Direct-to-consumer (DTC) genetic testing is a controversial issue although Korean Government is considering to expand DTC genetic testing. Preventing the exaggeration and abusing of DTC genetic testing is an important task considering the early history of DTC genetic testing in Korea. And the DTC genetic testing performance or method has been rarely reported to the scientific and/or medical community and reliability of DTC genetic testing needs to be assessed. Law enforcement needs to improve these issues. Also principle of transparency needs to be applied.

• Annals of Laboratory Medicine
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• v.38 no.6
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• pp.585-590
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• 2018

Background: Although testing to detect weak D antigens using the antihuman globulin reagent is not required for D- patients in many countries, it is routinely performed in Korea. However, weak D testing can be omitted in D- patients with a C-E- phenotype as this indicates complete deletion of the RHD gene, except in rare cases. We designed a new algorithm for weak D testing, which consisted of RhCE phenotyping followed by weak D testing in C+ or E+ samples, and compared it with the current algorithm with respect to time and cost-effectiveness. Methods: In this retrospective study, 74,889 test results from January to July 2017 in a tertiary hospital in Korea were analyzed. Agreement between the current and proposed algorithms was evaluated, and total number of tests, time required for testing, and test costs were compared. With both algorithms, RHD genotyping was conducted for samples that were C+ or E+ and negative for weak D testing. Results: The algorithms showed perfect agreement (agreement=100%; ${\kappa}=1.00$). By applying the proposed algorithm, 29.56% (115/389 tests/yr) of tests could be omitted, time required for testing could be reduced by 36% (8,672/24,084 min/yr), and the test cost could be reduced by 16.53% (536.11/3,241.08 USD/yr). Conclusions: Our algorithm omitting weak D testing in D- patients with C-E- phenotype may be a cost-effective testing strategy in Korea.

• Journal of Applied Reliability
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• v.16 no.3
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• pp.216-223
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• 2016

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.

• Rapid Communication in Photoscience
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• v.1 no.2
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• pp.56-56
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• 2012

• Journal of Genetic Medicine
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• v.4 no.1
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• pp.1-5
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• 2007

Unprecedented amount of genetic information being generated from the result of Human Genome Project (HGP) and advances in genetic research is already forcing changes in the paradigm of health and disease. The ultimate goal of genetic medicine is to use genetic information and technology to develop new ways of treatment or even prevention of the disease on an individual level for 'personalized medicine'. Genetics is play ing an increasingly important role in the diagnosis, monitoring and management of common multifactorial diseases in addition to rare single-gene disorders. While wide range of genetic testing have provided benefits to patients and family, uncertainties surrounding test interpretation, the current lack of available medical options for the diseases, and risks for discrimination and social stigmatization may remain to be resolved. However an increasing number of genetic tests are becoming commercially available, including direct to consumer genetic testing, yet public is often unaw are of their clinical and social implications. The personal nature of information generated by a genetic test, its power to affect major life decisions and family members, and its potential misuse raise important ethical considerations. Therefore appropriate genetic counseling is needed for patient to be informed with the benefits, limitations and risks of genetic tests, prior to informed consent for the tests. Physician also should be familiar with the legal and ethical issues involved in genetic testing to tell patients how w ell a particular genetic risk factor relates with likelihood of disease, and be able to provide appropriate genetic counseling. Genetic counseling become a mandatory requirement as global standard for many genetic testing such as prenatal diagnosis, presymtomatic DNA diagnostic tests and cancer susceptibility gene test for familial cancer syndrome. In oder to meet the challenge of genetic medicine of 21 century in korean health care system, professional education program and certification board for medical genetics specialist including non-MD genetic counselors should be addressed by medical society and regulatory policy of national health insurance reimbursement for genetic counseling to be in place to promote the implementation of clinical genetic service including genetic counseling for proper genetic testing.

• Clinical and Experimental Pediatrics
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• v.53 no.3
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• pp.273-285
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• 2010

Completion of the human genome project has allowed a deeper understanding of molecular pathophysiology and has provided invaluable genomic information for the diagnosis of genetic disorders. Advent of new technologies has lead to an explosion in genetic testing. However, this overwhelming stream of genetic information often misleads physicians and patients into a misguided faith in the power of genetic testing. Moreover, genetic testing raises a number of ethical, legal, and social issues. Diagnostic genetic tests can be divided into three primary but overlapping categories: cytogenetic studies (including routine karyotyping, high-resolution karyotyping, and fluorescent in situ hybridization studies), biochemical tests, and DNA-based diagnostic tests. DNA-based testing has grown rapidly over the past decade and includes preandpostnatal testing for the diagnosis of genetic diseases, testing for carriers of genetic diseases, genetic testing for susceptibility to common non-genetic diseases, and screening for common genetic diseases in a particular population. Theoretically, once a gene's structure, function, and association with a disease are well established, the clinical application of genetic testing should be feasible. However, for routine applications in a clinical setting, such tests must satisfy a number of criteria. These criteria include an acceptable degree of clinical and analytical validity, support of a quality assurance program, possibility of modifying the course of the diagnosed disease with treatment, inclusion of pre-and postnatal genetic counseling, and determination of whether the proposed test satisfies cost-benefit criteria and should replace or complement traditional tests. In the near future, the application of genetic testing to common diseases is expected to expand and will likely be extended to include individual pharmacogenetic assessments.