국내 동물용의료기기 시장 동향 및 향후 전망

강경묵,서태영,강환구,문진산 한국임상수의학회 2019 한국임상수의학회지 Vol.36 No.1

This study reviewed the trends and prospect of the market for veterinary medical devices in Korea. The registration of veterinary medical devices has sharply increased since 2013, and a total of 2,133 products from 348 companies were registered by 2018. Of these products, the proportion of the instrument, in vitro diagnostic (IVD) reagents, medical only used for animal and supplies were 51.6%, 35.7%, 7.6% and 5.1%, respectively. The sales amount of veterinary medical devices is approximately 95.8 billion won in 2017. The sales of domestic consumption and imports were 53.9 and 41.9 billion won, respectively. They are increasing 14.9% (CAGR) in the domestic consumption, and 44.0% (CAGR) in the export from 2011 to 2017, respectively. The proportion of IVD reagents, instrument, medical only used for animal and supplies were 54.2%, 41.0%, 3.8%, and 1.0%, respectively. The top 10 items with high sales were IVD reagents for clinical immunochemistry, visceral function testing instrument, hematological testing apparatus, syringes, IVD reagents for molecular genetics, etc. They are widely used from 3,926 animal hospitals in 2017. This study suggested that registration and sales of veterinary medical devices have gradually increased since 2013 as the demand of health care services for various animals. Therefore, the veterinary medical devices industry is expected to grow in the future.

국내 동물용의료기기 부작용 관리시스템에 대한 고찰

강경묵,박희명,이창민,강민희,서태영,강환구,문진산 한국임상수의학회 2018 한국임상수의학회지 Vol.35 No.1

This study reviewed the regulatory safety management system for prevention of side effects of veterinarymedical devices in Korea based on data obtained through analyses of those medical devices. In order to ensure thesafety of medical devices, Ministry of Food and Drug Safety has established the management system include licensing,test inspection (134 designated clinical trial agencies) and post management. In addition, it was introduce the goodmanufacture practice (GMP) certification system and device tracking requirements. In contrast, it is necessary to establishregulations for side effects report and awareness on veterinary medical devices in Korea. The center for veterinarymedicine of FDA in the United States has been operated side effects reporting system of veterinary medical devicesfrom user, manufactures and distributor. Due to increase the use of various kinds of veterinary medical devices foranimals, it should be required to improve regulation related to the licensing procedures, GMP system, and the sideeffects reporting system in our country.

국내 동물병원의 진단용 방사선 발생장치 및 방사선 관계종사자 안전관리에 관한 융복합적 분석

강경묵,서태영,김용상,윤선종 한국융합학회 2020 한국융합학회논문지 Vol.11 No.4

다양한 종류의 방사선 발생장치가 동물병원에서 사용되면서 방사선 관계종사자들의 안전이 중요해지고 있으나 방사선 발생장치 및 방사선 관계종사자들에 대한 안전관리 정보가 없는 실정이다. 이에 본 연구에서는 방사선 검사기관 및 측정기관, 시·군·구에서 조사되어진 방사선 발생장치 및 관계종사자, 피폭선량 등을 조사, 분석하였다. 최근 6년간 동물병원에서의 방사선 발생장치와 관계종사자 수는 각각 2,138대에서 2,972대, 2,644명에서 5,733명으로 증가하였 다. 2019년 방사선 발생장치의 수는 일반 X-ray, CT, C-arm, 이동형 X-ray, 치과용 X-ray는 각각 2,204대, 58대, 67대, 770대, 14대인 것으로 조사되었다. 2019년 방사선 관계종사자 수는 수의사 4,236명, 수의간호사 1,080명, 업무 보조원 404명, 기타 13명인 것으로 조사되었다. 2018년 방사선 관계종사자 연간평균피폭선량은 표층선량 0.21mSv, 심부선량 0.18mSv인 것으로 나타났다. 본 연구는 동물병원에서 사용하고 있는 방사선 발생장치 및 방사선 관계종사자 의 안전관리에 대한 기초 자료가 될 것으로 기대한다. The various types of radiation-generator devices have been used in animal hospitals, and the safety for radiation workers is becoming important in Korea. This study investigated and analyzed the radiation safety management for diagnostic radiation-generator devices and radiation workers of animal hospital. The number of radiation-generator devices and radiation workers of animal hospital increased from 2,138 to 2,972 and from 2,644 and 5,733 for six years. The number of general X-ray, CT, C-arm, portable and dental X-ray in 2019 were 2,204, 58, 67, 770, and 14. The number of veterinarian, veterinary nurse, veterinary assistant, and others in 2019 were 4,236, 1,080, 404, and 13. The average exposure dose of radiation workers in 2018 were 0.21mSv in surface dose, 0.18mSv in depth doses. This study is expected to be the basic data for the safety management of radiation-generating devices and radiation workers in animal hospital.

동물용 의료기기 기준규격에 대한 고찰

강경묵,김태원,권오륜,박혜정,조수민,김충현,이명헌,문진산,Kang, Kyoung-Mook,Kim, Tae-Won,Kwon, Oh-Ryun,Park, Hea-Jung,Cho, Soo-Min,Kim, Chung-Hyun,Lee, Myoung-Heon,Moon, Jin-San 대한수의학회 2017 大韓獸醫學會誌 Vol.57 No.2

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.

Trends of Market and Approval Management System for in vitro Diagnostic Veterinary Medical Reagents in Korea Vastus Medialis without Trochleoplasty in Small Breed Dogs: A Retrospective Review of 22 Cases

강경묵,강민희,서태영,강환구,문진산 한국임상수의학회 2018 한국임상수의학회지 Vol.35 No.4

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicineby the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into classI-IV according to risks of individual and public health. However, good manufacturing practices requirements onIVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant QuarantineAgency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infectiondisease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug ofabuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association wasestimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales wereapproximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumptionand 40.4% (CAGR) in export from 2011 to 2017. muscle, patellar anti-rotational suture, fascia lata overlap, and tibial tuberosity transposition (TTT) were undertakento stabilize the patella without trochleoplasty. Data including signalment, clinical symptoms, details of the affectedhindlimb, preoperative and postoperative patellar luxation grades, postoperative recovery time, and postoperativecomplications were obtained from medical records. The grade of lameness was evaluated preoperatively andpostoperatively. Mean (± SEM) grade of medial patellar luxation was 2.64 ± 0.11 preoperatively and 0.2 ± 0.27postoperatively. Mean (± SEM) grade of lameness was 1.73 ± 0.27 preoperatively and 0.18 ± 0.15 postoperatively. Patellar reluxation occurred in 1 of 22 (4.5%) cases requiring additional surgery. At final follow-up, 2 of the 22 (9.0%)dogs, including one with reluxation, had occasional lameness. Client-based questionnaire results demonstrated significantimprovements in all parameters. Surgical treatment of MPL that included resection of the vastus medialis oblique withoutfemoral trochlear groove deepening improved surgical outcomes in dogs with up to grade 3 MPL.

랫드 피하이식에서의 천연 Gum필름의 생체적합성 연구

이수영,강경묵 서울産業大學校 1999 논문집 Vol.50 No.2

Subcutaneous implantation Films were prepared by solution blend method of natural gums for the purpose of useful bioimplants. The possibility of bioimplants which prepared from natural gums as a skin substitute was evaluated by measuring biocompatibility. These films were inserted in the back of rat and their of biocompatibility were investigated by hematological change evaluation as a function of time to the biotransformation. These values of films, which prepared from natural gums measured in this study were some satisfiable results at short period with those of ideal skin bioimplants

알긴 첨가형 고분자 블랜드의 특성과 Pot Test

홍장후,신현진,김운겸,강경묵 서울産業大學校 1999 논문집 Vol.49 No.2

PVA/Algin blend films were prepared by solution blending method for the purpose of useful biodegradable polymer. Characteristics properties of blend films such as DSC, Elongation, Tensile strength and Morphological changes by SEM were determined. Tensile strength and Elongation were rapidly reduced as increasing the blend ratio of Algin. Blend films were found that phase separation was occured as more than 25wt% increasing the blend ratio of Algin. Blend films were observed to be less partially compatibility than 10wt% increasing the blend ratio of Algin by DSC, mechanical properties and SEM Also, Blend films at the laboratory soil test(Pot Test) were completely degraded in months with four kinds of soils by microganisms.

purple membrane에 대한 Ca(OH)₂의 결합 상수 결정

이수영,유승교,강경묵 서울産業大學校 1998 논문집 Vol.47 No.1

선택적 이온 전극에 의한 Bacteriorhodopsin(bR)의 칼슘 양이온에 대한 강한 두 결합 상수들(K₁과 K₂)은 Scatchard 그림 해석법을 이용하여 결정되었으며, 더욱이 분광학적 방법으로부터 얻어진 결합 상수 Ks는 bR의 색깔 변화 즉 푸른색에서 보라색으로의 전이에 관련되는 상수 값으로 얻어졌다. 이때, Ks와 K₂를 상호 비교 해보면 이들 두 값은 서로 동등한 것으로 나타나며, 이러한 사실은 이전의 다른 실험들에 의한 양이온 결합에 의 한 bR의 변색 결과들과 잘 일치함이 보여졌다. The binding constants, K₁ and K₂, and the number of Ca²+ ions in each of the two high affinity sites of Ca²+ -regenerated bacteriorhodopsin(bR) are determined potentiometrically at different pH values by using the Scatchard polt method. Furthermore, We have measured by a direct spectroscopic method the association constant, Ks, for the binding of Ca²+ to deionized bR. which is responsible for producing the blue to purple color change. Comparing the value of K8 and its pH dependence with those of K₁ and K₂ showed that the site corresponding to Ks is to be identified with K₁of Ca(OH)²to deionized blue bR, this is in agreement with the conclusion reached previously, using a different approach, which showed that it is the metal binding that causes the blue to purple color change.

순환전압 전류법의 한계전류 계산

이수영,강경묵 서울産業大學校 1996 논문집 Vol.43 No.1

ErCi의 화학반응에 따른 전하 이전 관계를 디지털 시뮬레이션으로 연구하였다. 비평면 전극의 종류에 따른 순환 전압전류법에 전위를 계산 하였으며 주사 속도 범위는 kτ=10-³~10³에서 균일 화학반응 효과와 전극 지름 영역은 Ro=0.1~10 6까지 광범위 하게 조사 하였다. 이들 봉우리 값은 이론적으로 일치하는 대시간 전류의 특성을 나타내었다. 또한 기하학적으로 다른 두 전극의 식을 만들어 전류 봉우리에 대한 작업 곡선을 비교하였다. 시뮬레이션 한 모든 산화환원 전류값은 순환 전류의 이론 값에 일치하는 정밀도를 보여 주었다. A reversible electron transfer followed by an irreversible first-order homogeneous chemical reaction was studied by digital simulation technique. The cyclic voltamograms of nondancer electrodes computed at the radious Ro(range 0.1~10 6) and the effect of homogeneous reaction kinetics or scan rate (kτrange 10-³~10³) on the CV response. where have the characteristics of those at a theoretical chronoamperometry. The working curves of the two different geometrycal electrodes are also compared. All the simulated curves, that show the resonable precision of theory in cyclic voltammetry.

스크린인쇄 작업 환경개선을 위한 대체 세정공정

강경묵,이수영,유승교 서울産業大學校 1998 논문집 Vol.47 No.1

The field if printing to use pressurized ink using screen gossamer that is called screen printing. Existing cleaning solvents for the screen printing have a bad effect to the environment which are the organic solvents containing aromatic compounds and stench. Also, cleaning method of screen printing affect the human body which are for the most part mixed cleaning method of dipping and polish. In this study, we measured the cleaning efficiency by gravimatric analysis and the property change of gossamer by image analyzer using existing cleaning solvent for the betterment of screen printing working environment. Also, we investigated an alternative cleaning process showing excellent cleaning efficiency using the ultrasonic and vibration cleaning method instead of the exsiting mixed cleaning method.