• 문화기술의 융합
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• 제8권5호
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• pp.1-7
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• 2022

한국의 의료기기 산업은 1995년부터 시작된 G7 의료공학기술개발사업으로 본격적인 성장과 발전의 기틀을 마련하였으며 2020년 한국 의료기기 생산실적은 2001년에 비하여 8.52배, 수출 실적은 13.94배 성장하였다. 의료기기 국산화 개발 초기에 초음파 의료기기 등 전자 의료기기의 개발이 활발하였던 것과 비교하여 2020년에는 체외진단시약과 치과용 임플랜트의 생산 및 수출 실적이 상위권을 차지하고 있다. 그러나 한국 의료기기 시장에서 수입 의료기기가 차지하는 비중은 60-70%에서 큰 변화가 없는데 이는 한국의 의료기기 산업이 중저가 의료기기를 생산 수출하고, 기술집약적이고 자본집약적인 고가 의료기기는 주로 수입에 의존하고 있기 때문이다. 본 논문에서는 한국과 세계시장의 주요 의료기기 회사들의 생산 품목을 비교하여 한국 의료기기 산업의 세계 시장 진출에 대한 전략을 제시하고자 한다.

• 보건행정학회지
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• 제33권2호
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• pp.173-184
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• 2023

Background: The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the point of care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classify self-testing IVDs using the analytic hierarchy process technique. Methods: Two dimensions of the characteristics embedded in the IVDs and the diseases to be diagnosed with self-testing IVDs were parallelly considered and independently investigated. In addition, three expert panels consisting of laboratory medical doctors (n=11), clinicians (n=10), and citizens (n=11) who have an interest in the selection of self-testing IVDs were asked to answer to questionnaires. Priorities were derived and compared among each expert panel. Results: First of all, ease of specimen collection (0.241), urgency of the situation (0.224), and simplicity of device operation (0.214) were found to be the most important criteria in light of the functional characteristics of self-testing IVDs. Medical doctors valued the ease of specimen collection, but the citizen's panel valued self-management of the disease more. Second, considering the characteristics of the diseases, the priority criteria were shown in the order of prevalence of diseases (0.421), fatality of disease (0.378), and disease with stigma (0.201). Third, medical doctors responded that self-testing IVDs were more than twice as suitable for non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen's group responded that self-testing IVDs were slightly more suitable for infectious diseases (0.511 vs. 0.489). Conclusion: Our findings suggested that self-testing IVDs could be primarily classified as the items for diagnosis of non-communicable diseases for the purpose of self-management with easy specimen collection and simple operation of devices, taking into account the urgency of the situation as well as prevalence and fatality of the disease.

• 대한수의학회지
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• 제55권2호
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• pp.97-103
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• 2015

In this study, the Korean veterinary medical devices management system was evaluated relative to systems in the USA, EU, and Japan. Veterinary medical devices are regulated in Korea based on the Medical Appliance Act of 1997. This was initially supervised by the Ministry of Agriculture, Food and Rural Affairs and Korea Animal Health Products Association, and subsequently by the Animal and Plant Quarantine Agency (QIA) in 2000. These devices were classified approximately 1,400 categories as instruments, supplies, artificial insemination apparatus, and other categories. Each of these devices was assigned to four regulatory grades by the QIA in 2007. The ranking system for veterinary medical devices was implemented in 2014 with 820 products from 162 companies registered by that year. However, in vitro diagnostic devices (IVDDs) for animals were managed as medical devices and biological medicine. In vitro diagnostic reagents for treating infection diseases are not subjected to either a classification or grading system. Veterinary medical devices are currently exempt from good manufacturing practices (GMP) and device tracking requirements. Due to gradual growth of the domestic veterinary medical devices market since 2008, regulation of these devices should be improved with re-examination of IVDDs and GMP certification for the effective operating system.

• 한국표면공학회지
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• 제55권6호
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• pp.390-397
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• 2022

Parylene-C which was mainly used for industries such as electronics, machinery and semiconductors has recently been in the spotlight in the medical field due to its properties such as corrosion resistance and biocompatibility. In this study we intend to derive a plan to improve the bonding strength of Parylene-C coating with the SUS304 base material for medical use which can be applied to various medical fields such as needles, micro needles and in vitro diagnostic device sensors. Through plasma pretreatment the bonding strength between Parylene-C and metal materials was improved. It was confirmed that the coated surface was hydrophobic by measuring the contact angle and the improvement of the surface roughness of the sample manufactured through CNC machining was confirmed by measuring the surface roughness with SEM. Through the above results, it is thought that it will be effective in increasing usability and reducing pain in patients by minimizing friction when inserting medical devices and in contact with skin. In addition it can be applied to various application fields such as human implantable stents and catheters, and is expected to improve the performance and lifespan of medical parts.

• 정보처리학회논문지:컴퓨터 및 통신 시스템
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• 제12권2호
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• pp.77-84
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• 2023

뎅기열 발병은 전 세계 인구의 약 1/3이 거주하고 있는 열대, 아열대 기후에 집중되며, 우리나라도 아열대 기후로 바꾸고 있어 뎅기열 발병에 취약해지고 있다. 뎅기열은 감염병 관리 차원에서 진단 이력 관리가 중요하다. 감염병 이력에 따라서 지역별, 연령별, 남녀비율 등에 따라서 개개인의 치료 방법과 전략을 수립할 수 있는 체계가 필요하다. 본 논문에서는 뎅기열 관제시스템을 제안하며, 이러한 시스템은 뎅기열의 발병에 대한 체외진단기기를 이용한 실시간 집계방식으로 발병률과 사망률을 감소시킬 수 있는 전략을 수립하는 데 유용하게 활용될 수 있다. 뎅기열 관리를 위한 관제시스템 구성으로 형광면역진단 키트를 이용한 뎅기열 체외진단기기와 실시간 뎅기열 관제시스템으로 구성되어 있다. 본 논문으로 개발된 뎅기열 관제시스템은 향후 정부의 감염병 통합정보와 결합되어 다양한 감염병 관리 및 정책 활용을 위해서 활용될 수 있을 것이다.

• 대한의용생체공학회:의공학회지
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• 제43권4호
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• pp.199-213
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• 2022

EN ISO 14971:2012 a risk management standard approved and applied as a European standard in 2012, will be adopted and applied as ISO 14971:2019 published in December 2019, ISO/TR 24971(Guidance) published in June 2020 from May 2022. After that, it is applied to IVDD surveillance and IVDR new and conversion, and the manufacturer is already preparing for application or is starting preparation for application. In addition, 98/78/EEC IVDD applied from 1998 will also be applied as REGULATION (EU) 2017/746 IVDR from May 2022. In particular, in IVDR, the requirements for post-marketing investigations such as Post Market Surveillance (PMS), Summary of safety and performance(SSP), Periodic Safety Update Report(PSUR) and Post Market Performance Follow Up(PMPF), which were not required in the existing IVDD, increased, and the contents were also specified. This study focused on ISO14971:2019 among these strengthened and newly applied regulations, and tried to present a detailed analysis and application plan of Post Market Surveillance (PMS) required by 2017/746 IVDR.

• 대한수의학회지
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• 제57권2호
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• pp.71-78
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• 2017

Well-established standards and specifications for medical devices not only provide clarity and consistency in licensing processes but also secure device safety and effectiveness. This study reviewed regulatory standards and specifications for veterinary medical devices in Korea based on data obtained through analyses of those medical devices. General standards for electromechanical, electromagnetic, and biological safety and individual standards for 76 electric and 70 general medical device products have been established by the Korean Ministry of Food and Drug Safety. However, the first standards and specifications for veterinary medical devices were established in March 2000 for two products (disposable needle and syringe). Similar to the large number of standards for medical devices, there have been general standards for safety and individual standards for 72 veterinary medical devices (27 electric medical devices, 12 non-electric medical devices, 10 medical supplies, and 23 other types) established since 2014. These new standards considered, among other aspects, the devices' applications, usage characteristics, and industrial environment. To date, the establishment of standards and specifications for veterinary medical devices remains limited. This study suggests that improvements should be made to the regulation of general and individual standards associated with various veterinary medical instruments, supplies, and in vitro diagnostic medical reagents.

• 한국의학물리학회지:의학물리
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• 제9권2호
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• pp.115-121
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• 1998

본 연구는 암을 조기진단을 위한 장치개발의 기초 연구로서, 질병(암)을 검출할수 있는 광 특성의 존재를 결정하기 위하여 12개 생체조직의 계층별 시료와 인체의 혈액에서 광 특성을 측정하였다. 실험은 동물의 지방 및 근육 조직과 인체 혈액 HCT의 27.3%, 35.4%, 45.6%과 59.1%을 대상으로, 광파장이 630nm, 660nm, 780nm, 880nm, 940nm 에서 흡수 계수, $\mu$$_{\alpha}$를 측정하였다. 측정된 흡수계수는 일정하고 특이한 변화를 보여 주었다. 본 연구의 결과에 의하면 생체조직의 계층별과 광파장의 특정 파장대에서 분명한 차이를 구분할 수 있었다. 차이를 구분할 수 있었다.

• 여성건강간호학회지
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• 제26권4호
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• pp.300-317
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• 2020

Purpose: Hysteroscopy can be used both to diagnose and to treat intrauterine pathologies. It is well known that hysteroscopy helps to improve reproductive outcomes by treating intrauterine pathologies. However, it is uncertain whether hysteroscopy is helpful in the absence of intrauterine pathologies. This study aimed to confirm whether hysteroscopy improves the reproductive outcomes of infertile women without intrauterine pathologies. Methods: We conducted a systematic review of 11 studies retrieved from Ovid-MEDLINE, Ovid-Embase, and the Cochrane Library. Two independent investigators extracted the data and used risk-of-bias tools (RoB 2.0 and ROBINS-I) to assess their quality. Results: Diagnostic hysteroscopy prior to in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) was associated with a higher clinical pregnancy rate (CPR) and live birth rate (LBR) than non-hysteroscopy in patients with recurrent implantation failure (RIF) (odds ratio, 1.79 and 1.46; 95% confidence interval, 1.40-2.30 and 1.08-1.97 for CPR and LBR, respectively) while hysteroscopy prior to first IVF was ineffective. The overall meta-analysis of LBR showed statistically significant findings for RIF, but a subgroup analysis showed effects only in prospective cohorts (odds ratio, 1.40 and 1.47; 95% confidence interval, 0.62-3.16 and 1.04-2.07 for randomized controlled trials and prospective cohorts, respectively). Therefore, the LBR should be interpreted carefully and further research is needed. Conclusion: Although further research is warranted, hysteroscopy may be considered as a diagnostic and treatment option for infertile women who have experienced RIF regardless of intrauterine pathologies. This finding enables nurses to educate and support infertile women with RIF prior to IVF/ICSI.

• Imaging Science in Dentistry
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• 제43권3호
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• pp.171-177
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• 2013

Purpose: The purpose of this study was to compare the efficacy of two imaging modes in a cone beam computed tomography (CBCT) system in detecting root fracture in endodontically-treated teeth with fiber posts or screw posts by selecting two fields of view. Materials and Methods: In this study, 78 endodontically-treated single canal premolars were included. A post space was created in all of them. Then the teeth were randomly set in one of 6 artificial dental arches. In 39 of the 78 teeth set in the 6 dental arches, a root fracture was intentionally created. Next, a fiber post and a screw post were cemented into 26 teeth having equal the root fractures. High resolution (HiRes) and standard zoom images were provided by a CBCT device. Upon considering the reconstructed images, two observers in agreement with each other confirmed the presence or absence of root fracture. A McNemar test was used for comparing the results of the two modes. Results: The frequency of making a correct diagnosis using the HiRes zoom imaging mode was 71.8% and in standard zoom was 59%. The overall sensitivity and specificity in diagnosing root fracture in the HiRes mode were 71.79% and 46.15% and in the standard zoom modes were 58.97% and 33.33%, respectively. Conclusion: There were no significant differences between the diagnostic values of the two imaging modes used in the diagnosis of root fracture or in the presence of root canal restorations. In both modes, the most true-positive results were reported in the post space group.