• The Journal of the Korean dental association
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• v.56 no.9
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• pp.479-490
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• 2018

3D printing technology supporting the specific patient medical services is actively being implemented in dentistry. The purpose of this study is to introduce the legal and institutional considerations to the medical practitioners in dentistry who must observe when they manufacture medical devices using 3D printers, and to provide a ways to activate and enhance their utilization in the domestic approval point of view for medical devices. Through the public data of government agencies and related organizations, the statutory system and compliance matters related to the manufacture of 3D printing medical devices have been examined and reviewed for the government's improvement efforts. Through the study, the government has been actively improving the system and making policy, but the active interest and participation of medical professionals and related workers are continually required to solve the problems which are scattered. 3D printing technology is expected to be more frequently utilized in the field of dentistry in near future. Therefore, it is essential to establish measures to improve the regulation through continuous cooperation with the related ministries with the long-term point of view enhancing smooth entry to the market for the medical devices by taking data from the continued research.

• Journal of Biomedical Engineering Research
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• v.42 no.6
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• pp.277-286
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• 2021

The global market size of AI based SaMD for medical image in 2023 will be anticipated to reach around 620 billion won (518 million dollars). In order for Korean manufacturers to efficiently obtain CE marking for marketing in the EU countries, the paper is to introduce the recommendation and suggestion of how to reclassify SaMD based on classification rules of MDR because, after introducing the Regulation EU 2017/745, classification rules are quite modified and newly added compared to the Directive 93/42/EEC. In addition, the paper is to provide several rules of MDR that may be applicable to decide the classification of SaMD. Lastly, the paper is to examine and demonstrate various secondary data supported by qualitative data because the paper focuses on the suggestion and recommendation with a public trust on the basis of various secondary data conducted by the analysis of field data. In conclusion, the paper found that the previous classification of SaMD followed by the rule of MDD should be reclassified based on the Regulation EU 2017/745. Therefore, the suggestion and recommendation are useful for Korean manufacturers to comprehend the classification of SaMD for marketing in the EU countries.

• The Korean Society of Law and Medicine
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• v.15 no.2
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• pp.63-89
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• 2014

In 1976, the Dalkon Shield-intrauterine device injured several thousand women in U.S.A. which caused the changes of medical deivce regulation. The Medical Device Regulation Act or Medical Device Amendments of 1976 (MDA) was introduce. As part of the process of regulating medical devices, the MDA divides medical devices into three categories. The class II, and III devices which have moderate harm or more can use the section 510 (k), premarket notification process if the manufacturer can establish that its device is "substantially equivalent" to a device that was marketed before 1976. In 21 U.S.C. ${\S}$ 360k(a), MDA introduced a provision which expressly preempts competing state laws or regulations. After that, the judicial debates had began over the proper interpretation and application of Section 360(k) In February 2008, the U.S. Supreme Court ruled in Riegel v. Medtronic that manufacturer approved by the Food and Drug Administration (FDA)'s pre-market approval process are preempted from liability, even when the devices have defective design or lack of labeling. But the Supreme Court ruled in Medtronic Inc. v. Lora Lohr that the manufactures which use the section 510 (k) process cannot be preempted and in Bausch v. Stryker Corp. that manufactures which violated the CGMP standard are also liable to the damage of patient at the state courts. In 2009, the Supreme Court ruled in Wyeth v. Levine that patients harmed by prescription drugs can claim damages in state courts. This may cause a double standard between prescription drugs and medical devices. FDA Preemption is the legal theory in the United States that exempts product manufacturers from tort claims regarding Food and Drug Administration approved products. FDA Preemption has been a highly contentious issue. In general, consumer groups are against it while the FDA and pharmaceutical manufacturers are in favor of it. This issues also influences the theory of product liability of U.S.A. Complete immunity preemption is an issue need to be more declared.

• Journal of Biomedical Engineering Research
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• v.43 no.3
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• pp.153-160
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• 2022

As new types of medical devices are emerging through convergence with advanced technology, innovative technologies are becoming hot issues in health policy because of their disruptiveness. This study analyzed the innovative medical device management systems in the US, China and Korea. Innovative medical devices have been defined differently depending on the country's management system, but in common, they are defined as products that do not exist or have dramatically improved performance compare to existing products by applying innovative technologies. Innovative medical devices have been supported by regulatory authorities during product development and approval processes. While the US and China have more than 300 products designated as innovative medical devices with diverse functions, application fields, and manufacturing countries considering the initial situation of the implementation for the system, Korea has only 16 products, mainly radiology and diagnostic devices and made in Korea only as innovative medical device. In addition, Korea shows the highest market approval rate of innovative medical devices compare to the US and China, and it is necessary to prepare the approval process in consideration of product diversity.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.19-24
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• 2023

Due to the spread of COVID-19, many patients with severe respiratory diseases have occurred worldwide, and accordingly, the use of mechanical ventilators has exploded. However, hospitals do not have systematic risk management, and the Medical Device Regulation also provides medical device risk management standards for manufacturers, but does not apply to devices in use. In this paper, we applied the Failure Mode Effects Analysis (FMEA) risk analysis technique based on the International Standard ISO 14971 (Medical Devices-Application of risk management to medical devices) for 85 mechanical ventilators of a specific model in use in hospitals. Failure modes and effects of each parts were investigated, and risk priority was derived through multiplication of each score by preparing criteria for severity, occurrence, and detection for each failure mode. As a result, it was confirmed that the microprocessor-based Patient Unit/Monitoring board in charge of monitoring scored the highest score with 36 points, and that reliability management is possible through systematic risk management according to priority.

• Journal of Cardiovascular Imaging
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• v.31 no.4
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• pp.180-187
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• 2023

BACKGROUND: Two-dimensional (2D) transesophageal echocardiography (TEE) is commonly used for assessing patients undergoing transcatheter atrial septal defect (ASD) device closure. 3D TEE, albeit providing high resolution en-face images of ASD, is used in only a fraction of cases. We aimed to perform a comparative analysis between 3D and 2D TEE assessment for ASD device planning. METHODS: This was a prospective, observational study conducted over a period of one year. Patients deemed suitable for device closure underwent 2D and 3D TEE at baseline. Defect characteristics, assessed separately in both modalities, were compared. Using regression analysis, we aimed to derive an equation for predicting device size using 3D TEE parameters. RESULTS: Thirty patients were included in the study, majority being females (83%). The mean age of the study population was 40.5 ± 12.05 years. Chest pain, dyspnea and palpitations were the common presenting complaints. All patients had suitable rims on 2D TEE. A good agreement was noted between 2D and 3D TEE for measured ASD diameters. 3D TEE showed that majority of defects were circular in shape (60%). The final device size used had high degree of correlation with 3D defect area and circumference. An equation was devised to predict device size using 3D defect area and circumference. The mean device size obtained from the equation was similar to the actual device size used in the study population (p = 0.31). CONCLUSIONS: Device sizing based on 3D TEE parameters alone is equally effective for transcatheter ASD closure as compared to 2D TEE.

• Journal of Cerebrovascular and Endovascular Neurosurgery
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• v.25 no.3
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• pp.275-287
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• 2023

Objective: Flow diverting stents (FDS) are a validated device in the treatment of intracranial aneurysms, allowing for minimally invasive intervention. However, after its approval for use in the United States in 2011, post-market surveillance of adverse events is limited. This study aims to address this critical knowledge gap by analyzing the FDA Manufacturer and User Facility Device Experience (MAUDE) database for patient and device related (PR and DR) reports of adverse events and malfunctions. Methods: Using post-market surveillance data from the MAUDE database, PR and DR reports from January 2012-December 2021 were extracted, compiled, and analyzed with R-Studio version 2021.09.2. PR and DR reports with insufficient information were excluded. Raw information was organized, and further author generated classifications were created for both PR and DR reports. Results: A total of 2203 PR and 4017 DR events were recorded. The most frequently reported PR adverse event categories were cerebrovascular (60%), death (11%), and neurological (8%). The most frequent PR adverse event reports were death (11%), thrombosis/thrombus (9%) cerebral infarction (8%), decreased therapeutic response (7%), stroke/cerebrovascular accident (6%), intracranial hemorrhage (5%), aneurysm (4%), occlusion (4%), headache (4%), neurological deficit/dysfunction (3%). The most frequent DR reports were activation/positioning/separation problems (52%), break (9%), device operates differently than expected (4%), difficult to open or close (4%), material deformation (3%), migration or expulsion of device (3%), detachment of device or device component (2%). Conclusions: Post-market surveillance is important to guide patient counselling and identify adverse events and device problems that were not identified in initial trials. We present frequent reports of several types of cerebrovascular and neurological adverse events as well as the most common device shortcomings that should be explored by manufacturers and future studies. Although inherent limitations to the MAUDE database are present, our results highlight important PR and DR complications that can help optimize patient counseling and device development.

• Journal of Sensor Science and Technology
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• v.29 no.5
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• pp.279-282
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• 2020

In this study, body pressure was quantitatively detected using built-in optical sensors, inside an air cushion seat. The proposed system visualizes the effect of the body pressure distribution on the air cushion seat. The built-in sensor is based on the time-of-flight (ToF) optical method, instead of the conventional electrical sensor. A ToF optical sensors is attached to the bottom surface of the air-filled cells in the air cushion. Therefore, ToF sensors are durable, as they do not come in physical contact with the body even after repeated use. A ToF sensor indirectly expresses the body pressure by measuring the change in the height of the air-filled cell, after being subjected to the weight of the body. An array of such sensors can measure the body pressure distribution when the user sits on the air cushion seat. We implemented a prototype of the air cushion seat equipped with 7 ToF optical sensors and investigated its characteristics. In this experiment, the ToF optical pressure sensor successfully identified the pressure distribution corresponding to a sitting position. The data were accessed through a mobile device.

• Journal of Veterinary Clinics
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• v.41 no.3
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• pp.157-164
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• 2024

The standard radiation protection method in the angiography suite involves the use of a thyroid shield, a lead apron, and lead glasses. However, exposure to substantial amounts of ionizing radiation can cause cataracts, tumors, and skin erythema. A newly developed curtain-type radiation protection device consists of a curtain drape composed of a five-layer bismuth and lead acrylic head-shielding plate, with both bearing an equivalent 0.25 mm lead thickness. In this study, a quality assurance phantom was used as the patient to create radiation scatter from the radiographic source, and an anthropomorphic mannequin phantom was used as the interventionalist to measure the radiation dose at seven different anatomical locations. Thermoluminescent dosimeters were used to measure the radiation dose. The experimental groups consisted of all-sided or one-sided curtain set-ups, the presence or absence of a conventional shielding system, and the orientation of beam irradiation. Consequently, the curtain-type radiation protection device exhibited better radiation protection range and capabilities than conventional radiation protection systems, especially in safeguarding the forehead, eyes, arms, and feet, with minimal radiation exposure. Moreover, the mean shielding ratios of the conventional shielding system and curtain-type radiation protection device were measured at 51.94% and 93.86%, respectively. Additionally, no significant decrease in the radiation protection range or capability was observed, even with changes in the beam orientation or one-sided protection. Compared with a conventional shielding system, the curtain-type radiation protection device decreased radiation exposure doses and improved comfort. Therefore, it is a potential new radiation protection device for veterinary interventional procedures.

• Journal of Biomedical Engineering Research
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• v.45 no.3
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• pp.109-117
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• 2024

We developed a device that integrates digital otoscope and stethoscope for telemedicine. The integrated device was utilized for the collection of tympanic membrane images and cardiac auscultation data. Data accumulated on the platform server can support real-time diagnosis of heart and eardrum diseases using artificial intelligence. Public data from Kaggle were used for deep learning. After comparing with various deep learning models, the MobileNetV2 model showed superior performance in analyzing tympanic membrane data, and the VGG16 model excelled in analyzing cardiac data. The classification algorithm achieved an accuracy of 89.9% for eardrums data and 100% for heart sound data. These results demonstrate the possibility of diagnosing diseases without the limitations of time and space by using this platform.