• 대한의용생체공학회:의공학회지
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• 제39권6호
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• pp.268-277
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• 2018

With drastic change in the market and technology of medical devices, a comparative analysis is necessary in advanced systems internationally in order to prepare domestically applicable plans for improvement in classification and differential grade management for items of medical devices. This research examines and analyzes the differences of definition and legal systems of medical devices among Korea, United States, EU, Japan and China, and investigates classification and grading system of each country to identify disadvantages of classification and grading structures for medical device in Korea. This research suggests ways to supplement the disadvantages of domestic classification and grading system of medical devices, and elicits differential management plans for medical devices.

• 재활복지공학회논문지
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• 제11권4호
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• pp.287-297
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• 2017

본 연구는 의료기기 안전성에 관한 의료인들의 인식(지식, 태도)과 행동에 관한 기초현황을 파악하여 보고, 직종 간 차이를 평가해보기 위한 탐색적 조사연구이다. 인천광역시에 소재한 900병상 규모의 상급종합병원을 대상으로 설문지를 배포하여 220명의 응답 자료를 분석에 사용하였다. 연구결과, 연구대상 의료인들은 대체적으로 의료기기 종류에 따른 잠재적 위험성에 대한 인식이 갖춰져 있고, 의료기기 안전성 교육의 필요성을 느끼고 있었다. 또한 의료진들의 직종 간 의료기기 안전성에 관한 인식의 차이를 살펴봤을 때, 등급 높은 의료기기를 주로 사용하지만 의료기기 안전에 관한 인식이 가장 낮은 전공의를 대상으로 하는 의료기기 안전교육의 필요성이 크다는 것을 알 수 있었다. 향후 전국규모의 연구를 통하여 자료의 질을 향상하고 결과의 수준을 높이며, 이를 바탕으로 의료기기 안전성 관리에 있어 정책적, 교육적 기반으로 활용할 필요가 있다.

• 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.

• Journal of Korean Neurosurgical Society
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• 제46권1호
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• pp.16-22
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• 2009

Objective : This study was designed to investigate automated pressure-controlled discography (APCD) findings, to calculate the elastance of intervertebral discs, and to assess the relationship between the calculated elastance and disc degeneration. Methods : APCD was performed in 19 patients. There were a total of 49 intervertebral discs treated. Following intradiscal puncture, a dye was constantly injected and the intradiscal pressure was continuously measured. The elastance of the intervertebral disc was defined as unit change in intradiscal pressure per fractional change in injected dye volume. Disc degeneration was graded using a modified Dallas discogram scale. Results : The mean elastance was 43.0${\pm}$9.6 psi/mL in Grade 0, 39.5${\pm}$8.3 psi/mL in Grade 1, 30.5${\pm}$22.3 psi/mL in Grade 2, 30.5${\pm}$22.3 psi/mL in Grade 3, 13.2${\pm}$8.3 psi/mL in Grade 4 and 6.9${\pm}$3.8 psi/mL in Grade 5. The elastance showed significant negative correlation with the degree of degeneration ($R^2$=0.529, P=0.000). Conclusion: APCD liberates the examiner from the data acquisition process during discography. This will likely improve the quality of data and the reliability of discography. Elastance could be used as an indicator of disc degeneration.

• 한국표면공학회지
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• 제51권3호
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• pp.164-171
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• 2018

In this study, we have fabricated pure titanium (Ti)/hydroxyapatite (HA) double layer coating on medical grade PEEK from magnetron sputtering system, an investigation was performed whether the surface can be had more improve bio-active for orthopedi/dental applications than that of non-coated one. Pure Ti and HA coating layer were obtained by a radio-frequency and direct current power magnetron sputtering system. The microstructures surface, mechanical properties and wettability of the pure Ti/HA double layer deposited on the PEEK were analyzed by scanning electron microscopy (SEM), energy dispersive X-ray spectroscopy (EDS), X-ray diffraction (XRD), nano-indentation, and contact angle test. According to the EDS and XRD results, the composition and crystal structure of pure Ti and HA coated surface were verified. The elastic modulus and hardness value were increased by pure Ti and HA coating, and the pure Ti/HA double layer coating surface has the highest value. The contact angle showed higher value for pure Ti/HA double layered coating specimens than that of non-coated (PEEK) surface.

• 대한방사선기술학회지:방사선기술과학
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• 제42권1호
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• pp.31-37
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• 2019

Investigate the adequacy awareness of accuracy control of CT apparatus Questionnaire survey and statistical analysis in the analysis according to age, there is a difference between familiarity with accuracy management items (F = 14.187, p<0.001) and necessity of accuracy control (F=8.109, p<0.001), depending on academic background and work history, There is a difference only in familiarity (F=5.103, p<0.05, F=13.394, p<0.001), and according to the scale of the medical institution analysis shows that if you are more interested than senior general hospital grade hospital grade or less It was analyzed. In order to advance the accuracy control level, we have introduced our comprehensive and efficient comprehensive and efficient integrated medical image quality management operation system of the whole medical image equipment including CT device, It is thought that it is necessary to develop human resources capable of doing.

• 임상간호연구
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• 제20권2호
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• pp.147-161
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• 2014

Purpose: This study was aimed to modify and adapt the previously developed, high-quality enteral tube feeding guidelines for the usage in clinical settings in Korea. Methods: Guideline adaptation process was undertaken according to the guideline adaptation manual version 2.0 developed by NECA (Kim, et al., 2011) and the standardized methodology for nursing practice guideline adaptation (Gu, et al. 2012). Results: The modified and adapted enteral tube feeding guidelines were consisted of 11 domains and 95 recommendations. The domains and numbers of recommendations in each domain were: 4 on general issues, 2 on enteral nutrition indication and discontinue, 6 on enteral nutrition device selection, 12 on enteral tube feeding device insertions, 3 on enteral nutrition formular and choices, 16 on enteral tube feeding start and progress, 20 on enteral tube feeding maintenance and management, 15 on monitoring enteral tube feeding administration, 10 on prevention of error, 5 on medication administration, and 2 on documentation and report. There were 16.1% of the recommendations marked as A grade, 17.8% of B grade, and 66.1% of C grade. Conclusion: The adapted enteral tube feeding nursing practice guideline is to be added to the evidence-based practice guidelines for fundamentals of nursing practice. The guideline is hoped to be disseminated to nurses nationwide in order to improve the efficiency of enteral tube feeding practice.

• Journal of Korean Neurosurgical Society
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• 제48권1호
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• pp.46-52
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• 2010

Objective : In cervico-thoracic junction (CTJ), the use of strong fixation device such as pedicle screw-rod system is often required. Purpose of this study is to analyze the anatomical features of C7 and T1 pedicles related to screw insertion and to evaluate the safety of pedicle screw insertion at these levels. Methods : Nineteen patients underwent posterior CTJ fixation with C7 and/or T1 included in fixation levels. Seventeen patients had tumorous conditions and two with post-laminectomy kyphosis. The anatomical features were analyzed for C7 and T1 pedicles in 19 patients using computerized tomography (CT). Pedicle screw and rod fixation system was used in 16 patients. Pedicle violation by screws was evaluated with postoperative CT scan. Results : The mean values of the width, height, stable depth, safety angle, transverse angle, and sagittal angle of C7 pedicles were $6.9{\pm}1.34\;mm$, $8.23{\pm}1.18\;mm$, $30.93{\pm}4.65\;mm$, $26.42{\pm}7.91$ degrees, $25.9{\pm}4.83$ degrees, and $10.6{\pm}3.39$ degrees. At T1 pedicles, anatomic parameters were similar to those of C7. The pedicle violation revealed that 64.1% showed grade I violation and 35.9% showed grade II violation, overall. As for C7 pedicle screw insertion, grade I was 61.5% and grade II 38.5%. At T1 level, grade I was 65.0% and grade II 35.0%. There was no significant difference in violation rate between the whole group, C7, and T1 group. Conclusion : C7 pedicles can withstand pedicle screw insertion. C7 pedicle and T1 pedicle are anatomically very similar. With the use of adequate fluoroscopic oblique view, pedicle screw can be safely inserted at C7 and T1 levels.

• 한국정보전자통신기술학회논문지
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• 제15권2호
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• pp.164-177
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• 2022

의료기기 사용적합성 평가란 최종 시제품 제작 완료이전 실제 사용자를 통한 의료기기의 평가를 말한다. 국제전자의료기기 안전규격 중 하나인 IEC 62366은 유럽 및 미국 등 주요 선진국의 의료기기 인허가 획득을 위해 반드시 적용해야 하는 규격이다. 국내의 경우 식약처 고시를 통하여 2021년 1월부터 등급별로 순차적 적용을 시행하고 있다. 본 연구에서는 (주)이끌레오에서 개발 중인 집중형초음파자극시스템의 사용자 적합성 평가 중 형성평가를 인천 G 대학 병원 의료기기융합 센터를 통하여 참가자 전문의 15인을 모집하였고, 공동 시나리오 개발을 통하여 시험을 진행하였다. 작업 수행 여부 결과에서는 90.67%의 수행율을 보였으며, 수행 완료 후 참가자 설문 조사결과 문항별 결과 분석에서 '사용자 인터페이스의 용이성' 86.67%, '정보의 식별성/가독성/이해도' 문항에서 94%의 보통 이상의 응답 비율을 보였다.

• 임상간호연구
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• 제19권1호
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• pp.128-142
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• 2013

Purpose: This study was conducted to adapt the previously developed intravenous infusion guidelines with good quality for development of the evidence-based intravenous infusion nursing practice guideline in Korea. Methods: Guideline adaptation process was conducted according to guideline adaptation manual version 2.0 developed by NECA (Kim, Kim et al., 2011) which consisted of three main phases, 9 modules including a total of 24 steps. Results: Adapted intravenous infusion nursing practice guideline was consisted of 19 domains and 180 recommendations. The domains and number of recommendations in each domain were: general guide, 4; assessment, 1; vascular access device selection, 4;site selection, 14;site preparation, 5;site care, 29; maintaining patency, 11; blood sampling via vascular access, 4; vascular access device exchange and removal, 9; add-on device selection, 27; infusion related complications, 63; education, 7; and documentation and report, 2. There were 11.9% of A, 28.4% of B, 58.7% of C in grade of recommendations. Conclusion: Adapted intravenous infusion nursing practice guideline is expected to contribute providing an evidence based practice guides for intravenous infusion. The guideline is recommended to be disseminated to nurses nationwide to improve the efficiency of intravenous infusion practice.