• Journal of Korean Society for Quality Management
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• v.46 no.2
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• pp.211-224
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• 2018

Purpose: It can easily be understood that more rules and regulations need to be imposed on the medical device industry due to its impact on public health and hygiene. Domestic medical device manufacturers are thus required to comply with the requirements specified in the good manufacturing practice (GMP) system, and it is essential to abide by the international standards as well to sustain their global competitiveness. The main purpose of this study is to review the guidelines of the medical device GMP system in Korea and propose future directions for further enhancement of the GMP system. Methods: Specific requirements prescribed in international standards, such as ISO 9001:2015, ISO 13485:2016, ISO 14971:2012, and ISO 14155:2011, are analyzed and compared with the domestic GMP system. Results: It has been observed that the generic international standard related to quality management system, ISO 9001:2015, lays out the foundations for the development of quality management system relevant to medical device industry, ISO 13485:2003, with which the domestic GMP system is fully compatible. Further, several important aspects of risk management and clinical trials of medical devices are also recognized and included in the domestic medical device GMP system. Conclusion: Even though specific requirements of individual ISO standards are slightly different from each other, their overall structure and framework may contribute to the development and enhancement of globally competitive GMP system of the domestic medical device industry.

• Journal of the Korea Convergence Society
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• v.11 no.2
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• pp.147-154
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• 2020

This study is about the development of ICT-based wearable devices for vision recovery that can cause functional myopia improvement through accommodation training. Vision Training Device(OTUS) is a head mount type wearable device, which naturally stimulates the contraction and relaxation of the ciliary muscles of eye. Users can conduct customized vision training based on personal vision information stored through the device. In the experiment, the effects of improvement of the symptoms by the accommodation training were compared and analysed for the two groups (16 comparative group and 16 accommodation training group) after causing functional myopia. The result showed the functional myopia improved average 0.44D±0.35 (p<0.05) at the accommodation training group compared to the comparative group. This study proved the effectiveness of vision training device(OTUS) on functional myopia, but further clinical trials are judged necessary to prove the possibility of long-term control of the functional myopia.

• Medical Lasers
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• v.9 no.2
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• pp.150-158
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• 2020

Background and Objectives Low-level laser therapy (LLLT) is used widely to promote hair growth in androgenetic alopecia (AGA). This study examined the clinical efficacy and safety of a home-use LLLT device with a newly designed array of light sources and software optimized for individual types of AGA. Materials and Methods The study was a randomized, double-blind, sham device-controlled trial. Forty-eight subjects (39 men and nine women) were assigned randomly in a 2:1 ratio to use either the test device (LG Pra'L HGN1, LG electronics, Korea) or sham device. The subjects used the LLLT device three times a week for 16 weeks. Phototrichogram was used to measure the hair density and hair thickness at 0, 8, and 16-weeks. Adverse events were closely monitored. Results After 16 weeks of using the device, the test group showed a significant increase in hair density and hair thickness compared to the control. In the test group, the hair density increased 6.96 counts/cm² at eight weeks and 13.67 counts/cm² at 16 weeks from the baseline. The hair thickness increased 7.21 ㎛ at eight weeks and 11.80 ㎛ at 16 weeks compared to the baseline. Conclusion The home-use LLLT device with a novel array of light sources and an individualized program according to the types of hair loss appears to be an effective and safe treatment modality for both male and female AGA patients.

• Journal of Korean Neurosurgical Society
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• v.46 no.5
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• pp.425-430
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• 2009

Objective : The present study analyzed the risk factors, prevalence and clinical results following revision surgery for adjacent segment degeneration (ASD) in patients who had undergone lumbar fusion. Methods : Over an 8-year period, we performed posterior lumbar fusion in 81 patients. Patients were followed a minimum of 2 years (mean 5.5 years). During that time, 9 patients required revision surgery due to ASD development. Four patients underwent autogenous posterolateral arthrodesis and extended transpedicle screw fixation, 4 patients underwent decompressive laminectomy and interspinous device implantation, and 1 patient underwent simple decompression. Results : Of the 9 of patients with clinical ASD, 33.3% (3 of 9) of patients did not have radiographic ASD on plain radiographs. Following revision surgery, the clinical results were excellent or good in 8 patients (88.9%). Age > 50 years at primary surgery was a significant risk factor for ASD development, while number of fusion levels, initial diagnosis and type of fusion were not. Conclusion : The incidence of ASD development after lumbar surgery was 11.1% (9 of 81) in this study. Age greater than 50 was the statistically significant risk factor for ASD development. Similar successful clinical outcomes were observed after extended fusion with wide decompression or after interspinous device implantation. Given the latter procedure is less invasive, the findings suggest it may be considered a treatment alternative in selected cases but it needs further study.

• Nutrition Research and Practice
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• v.12 no.4
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• pp.291-297
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• 2018

BACKGROUND/OBJECTIVES: This study evaluated the effects and molecular mechanisms of the Schisandra chinensis fruit extract (SC) and its major compound gomisin A (GA), on the contractility of rabbit penile corpus cavernosum smooth muscle (PCCSM). MATERIALS/METHODS: PCCSM was exposed to SC or GA after appropriate pretreatment with nitric oxide synthase (NOS) blocker, guanylate cyclase blocker, adenylyl cyclase blocker or protein kinase A blocker. Subsequently, we evaluated the cyclic nucleotide in the perfusate by radioimmunoassay, protein expression level of neuronal NOS (nNOS) and endothelial NOS (eNOS) by western blot, and the interaction of SC or GA with udenafil and rolipram. RESULTS: Both SC and GA induce PCCSM relaxations in a concentration-dependent manner. Pretreatment with NOS blocker, guanylate cyclase blocker, adenylyl cyclase blocker or protein kinase A blocker result in significantly decreased relaxation. SC and GA also induce the levels of cyclic nucleotide in the perfusate in a concentration-dependent manner. Perfusion with GA also showed significantly higher levels of eNOS protein. Furthermore, the udenafil and rolipram induced relaxations of PCCSM were enhanced after exposure to SC and GA. Our results indicate that SC and GA induce the relaxation of PCCSM via the nitric oxide (NO)-cGMP and cAMP signaling pathways. CONCLUSIONS: The SC and GA are potential alternative treatments for men who want to consume natural products to ameliorate erectile function, or who do not respond to the commercially available medicines.

• Natural Product Sciences
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• v.23 no.3
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• pp.169-174
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• 2017

The aim of this study was to investigate the effect and action mechanism of quercetin on penile corpus cavernosum smooth muscle (PCCSM). PCCSM precontracted with phenylephrine (Phe) was treated with four different concentrations of quercetin ($10^{-7}$, $10^{-6}$, $10^{-5}$ and $10^{-4}M$). PCCSM were preincubated with N-Nitro-L-arginine methyl ester hydrochloride (L-NAME) and 1H-[1,2,4]oxadiazolo[4,3-a]quinoxalin-1-one (ODQ) to block nitric oxide synthase and guanylate cyclase, respectively. The changes in PCCSM tension were recorded, and cyclic nucleotides in the perfusate were measured by radioimmunoassay. The interactions of quercetin with phosphodiesterase type 5 inhibitors (PDE5-Is) such as sildenafil, udenafil and mirodenafil, were also evaluated. PCCSM relaxation induced by quercetin occurred in a concentrationdependent manner. The application of quercetin to PCCSM pre-treated with L-NAME and ODQ significantly inhibited the relaxation. Quercetin significantly increased cGMP in the perfusate. Furthermore, quercetin enhanced PDE5-Is-induced relaxation of PCCSM. Quercetin relaxed the PCCSM by activating the NO-cGMP signaling pathway, and it may be a therapeutic candidate or an alternative treatment for patients with erectile dysfunction who do not completely respond to PDE5-Is.

• Biomedical Science Letters
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• v.27 no.2
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• pp.45-50
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• 2021

Coagulase-negative staphylococci (CoNS) are a typical group of microorganisms, and the recent advances in laboratory technology and medicine has dramatically modified their significance in medical practice. CoNS, which were previously classified as normal bacterial flora, have recently been reported to be associated with serious infectious diseases, such as surgical wound infection or periprosthetic joint infection. Representative CoNS include Staphylococcus epidermidis, S. haemolyticus, and S. saprophyticus, which are known to cause serious problems in biomaterial-based and prosthetic device infections, as well as to cause simple urinary tract infections in sexually active women. Over the last decade, the clinical isolation rate of CoNS has been increasing, and antibiotic resistance has also been occurring. This review aimed to investigate the incidence of CoNS infection and to use the results as basic data for the management of CoNS, with a focus on the isolation rate and antibiotic resistance in clinical surgery.

• Journal of the Korean Medical Association
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• v.61 no.12
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• pp.765-775
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• 2018

With growing interest in novel digital healthcare devices, such as artificial intelligence (AI) software for medical diagnosis and prediction, and their potential impacts on healthcare, discussions have taken place regarding the regulatory approval, coverage, and clinical implementation of these devices. Despite their potential, 'digital exceptionalism' (i.e., skipping the rigorous clinical validation of such digital tools) is creating significant concerns for patients and healthcare stakeholders. This white paper presents the positions of the Korean Society of Radiology, a leader in medical imaging and digital medicine, on the clinical validation, regulatory approval, coverage decisions, and clinical implementation of novel digital healthcare devices, especially AI software for medical diagnosis and prediction, and explains the scientific principles underlying those positions. Mere regulatory approval by the Food and Drug Administration of Korea, the United States, or other countries should be distinguished from coverage decisions and widespread clinical implementation, as regulatory approval only indicates that a digital tool is allowed for use in patients, not that the device is beneficial or recommended for patient care. Coverage or widespread clinical adoption of AI software tools should require a thorough clinical validation of safety, high accuracy proven by robust external validation, documented benefits for patient outcomes, and cost-effectiveness. The Korean Society of Radiology puts patients first when considering novel digital healthcare tools, and as an impartial professional organization that follows scientific principles and evidence, strives to provide correct information to the public, make reasonable policy suggestions, and build collaborative partnerships with industry and government for the good of our patients.

• 순환기질환의공학회:학술대회논문집
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• 2006.10a
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• pp.34-35
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• 2006

• Journal of Biomedical Engineering Research
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• v.33 no.4
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• pp.202-206
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• 2012

In this study, we developed transdermal direct drug delivery device using micro-needle painlessly. We has fabricated micro-needle that is 130 ${\mu}m$ thickness and 250 ${\mu}m$length with 10 ${\mu}m$ spiral groove for rolling down drug. Head part of micro-needle device is composed of 20ea micro-needles, an on-off valve and a protective cap. Glass bottle for containing drug is connected to head part of micro-needle device. We examined the puncture characteristic testing using porcine skin and drug delivery testing using porcine, rat skin with Indian Ink.