• 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 Biosystems Engineering
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• v.39 no.3
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• pp.158-165
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• 2014

Purpose: The objective of this paper was to compare test standards regarding the performance and safety of agricultural tractors to identify the differences in test conditions, measurement tolerances, and test procedures. Based on the comparison, some recommendations were proposed for possible revisions or improvements to current tractor test standards. Methods: The test standards and codes of major standards development organizations (SDOs), such as the Organization for Economic Cooperation and Development (OECD), the International Organization for Standardization (ISO), the American Society of Agricultural and Biological Engineers (ASABE), EC type approval, and the board of actions of the Nebraska Tractor Test Laboratories (NTTL), were selected and analyzed. Comparison of the test standards: The ISO provides references for fuel and lubricants for tractor tests, and the OECD provides additional measurements for calculating fuel consumption characteristics during the power take-off (PTO) tests. The ISO, EC type approval, and the ASABE provide PTO protective device and the safety requirements. During drawbar power tests, seven transmission ratios are selected for fully automatic transmissions, according to the OECD. In case of hydraulic lift tests, ISO 789-2 and OECD Code 2 advise the use of a static lift force, while SAE J283 advises the use of additional dynamic lift capacity tests for a better representation of in-field operations. The OECD, the ISO, and EC type approval determine the seat index point (SIP), whereas the ASABE determines the seat reference point (SRP) for roll-over protective structure (ROPS) tests. Diversified measurement tolerances were among the braking performance test standards. The European Union (EU) has developed daily limits for vibration exposures with adaptations from ISO 2631-1. Electromagnetic compatibility evaluations are emerging of high-efficiency tractors due to the long-term conformance to electromagnetic emissions and interferences. Comparisons of tractor test standards discussed in this paper are expected to provide useful information for tractor manufacturers and standards development personnel to improve the performance and safety test standards of tractors.

• The Transactions of the Korean Institute of Electrical Engineers P
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• v.66 no.4
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• pp.177-181
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• 2017

Auxiliary power supply for railway vehicle is a equipment that focuses on the service of passengers in a vehicle. It supplies power to controllers used in heating and cooling devices, fluorescent lamps, batteries and many other electrical equipments. Most of the auxiliary power supply for railway vehicle are mainly used for the round trips and circulation routes within the metropolitan area and have a capacity of 170~200 kVA. In this study, we developed the auxiliary power supply capacity to 240kVA for 200km/h class. As such, the auxiliary power supply is an important device for securing the reliability and safety of the railway vehicle and improving the passenger convenience, so the performance verification of the performance must be ensured. In this paper, 240kVA auxiliary power supply is developed. Also, performance of the auxiliary power supply manufactured through the analysis of various characteristics related to the auxiliary power supply was confirmed while operating the actual line.

• The Journal of KAIRB
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• v.5 no.1
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• pp.14-20
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• 2023

Purpose: To obtain fundamental data on selection tools for an internal audit and develop a new guideline. We scored the indicated points from the internal audit, identified the research progress and problems that occurred, and confirmed the validity of the risk factors involved. Methods: Of the 63 internal audits conducted by Keimyung University Dongsan Hospital from 2014 to 2021, we analyzed 55 clinical trials with an inspection checklist. We excluded 8 that failed to transfer data and refused to comply with the internal audit. The statistical summary of the collected data was verified and interpreted by using frequency analysis and a chi-square test. Result: Of total 55 cases included in the internal audit, sponsor-initiated trial (SIT) was 63.6% (vs. investigator-initiated trial [IIT]), clinical trial for investigational drug was 71.0% (vs. nonclinical or clinical trial for investigational device), domestic multicenter trial was 60.0% (vs. single center or multinational multicenter trial), and trial requisition for MFDS approval was 69.1% (vs. exception for MFDS approval). The 10 areas of the clinical trial inspection checklist (reports, protection of subjects, compliance with protocols, records, management of investigational drug and/or device, delegation of duties, qualification of investigators, management of specimen, contract-agreement and approval of protocols, and preservation of recorded documents) were weighted between 2 to 5 points. The average of the total points was 16.09±13.2 and 20 clinical trials were above the average. As a result of comparing the average of the total points weighted by year, the highest score was in 2020. The 4 factors that play significant roles in determining the internal quality were (1) principal subjects that initiated the clinical trials (p=0.049), (2) type (p=0.003), (3) phase of clinical trials (p=0.024), and (4) number of registered subjects reported at the time of continuing deliberation (p=0.019). Of the 10 areas of the clinical trial inspection checklist, 'record' was the most inappropriate and insufficient. We found more indicated points; the quality of performance declined in IIT, nonclinical trials, and other clinical trials that were not in phase I1-IV4, and the study of more than 30 registered subjects at the time of continuing review. Conclusion: If an institution has an internal audit selection tool that reflects the aforementioned risk factors, it will be possible to effectively manage high-risk studies; thereby, contributing to an efficient internal audit and improving the quality of clinical trials.

• Journal of the Korean Society of Safety
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• v.33 no.5
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• pp.21-27
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• 2018

The purpose of this study is to develop a SOP (Standard Operating Procedure) for a distribution board that can monitor the leakage current of a load distribution line in real time. The developed distribution board was fabricated by applying IEC 61439-1. It consists of the distribution board and an alarm device. The work process for making the distribution board was compliant with the KEMC (Korea Electrical Manufacturers Cooperative) regulations. And the AC distribution board range is 1,000 V. In addition, the voltage in DC is less than 1500 V. The distribution board receives a 3-phases and 4-wires power supply system and can supply power to the load of a maximum of 32 single or three phase distribution circuits. Also, leakage current measured on the power distribution board was used by sensors installed. The SOP of the developed distribution board consists of the installation standards for the short circuit alarm device and sensor, the surge protection device, switches and indication lamps, and other devices. The operation procedure was prepared so that each manufacturing step of the distribution board must be confirmed by the persons in charge of preparation, production, quality control and approval before moving forward to the next step.

• Genomics & Informatics
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• v.12 no.4
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• pp.151-155
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• 2014

In November 2013, the US Food and Drug Administration (FDA) sent a warning letter to 23andMe, Inc. and ordered the company to discontinue marketing of the 23andMe Personal Genome Service (PGS) until it receives FDA marketing authorization for the device. The FDA considers the PGS as an unclassified medical device, which requires premarket approval or de novo classification. Opponents of the FDA's action expressed their concerns, saying that the FDA is overcautious and paternalistic, which violates consumers' rights and might stifle the consumer genomics field itself, and insisted that the agency should not restrict direct-to-consumer (DTC) genomic testing without empirical evidence of harm. Proponents support the agency's action as protection of consumers from potentially invalid and almost useless information. This action was also significant, since it reflected the FDA's attitude towards medical application of next-generation sequencing techniques. In this review, we followed up on the FDA-23andMe incident and evaluated the problems and prospects for DTC genetic testing.

• The Journal of Korean Institute of Communications and Information Sciences
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• v.39C no.10
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• pp.896-908
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• 2014

The electrical medical device market have been expanded since the public interest in healthy living that has deepened together with the global health trend of the aging population. The external hand-held ultrasonic probe is a frequently approved medical device and it is commonly used in the clinical field. However, there is no obvious standard or a guideline in Korea on regarding evaluation of performance of such external hand-held ultrasonic probe for approval and quality management. In this study, local and foreign reference standards were reviewed to propose performance test standards and methods after conducting characteristic of probe, market, and permission status. In addition, such proposed test items were validated to develop a draft guideline that is internationally harmonized for performance evaluation. This study is expected not only improve the quality and performance of the external hand-held ultrasonic probe but also contribute to securing consistency of permission and evaluation works for approval.

• 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.31 no.6
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• pp.434-437
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• 2010

For approval of medical devices manufactured or imported, submission of technical documents as well as the application form is required. The manufacturer (or importer) should properly identify the raw materials the applied product is made of and the manufacturing processes the product undergoes before it is shipped in the application form. In the technical documents, scientific data to evaluate the efficacy, safety, and quality of the applied product that has been described in the application form should be provided. Therefore, identifying the raw materials that were used for the parts of the applied product and describing the physical and chemical characteristics of the raw materials are quite important and essential in ensuring the efficacy, safety, and quality of the applied product. To describe the physical and chemical characteristics of the raw materials correctively, the applicant is required to have broad knowledge in the scientific fields such as chemical, polymer, metal, and ceramic science and engineering. But most of the applicant are not experts in these fields, so that the description in the application form often includes wrong and improper descriptions. Thus, we developed a guideline which explains the raw materials for medical devices, show the their examples. The purpose of this description guideline is to help the applicant properly completing the "Raw materials or constituents and their volumes" part in the application form.

• Journal of Dental Anesthesia and Pain Medicine
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• v.16 no.4
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• pp.303-307
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• 2016

Background: In dental intravenous sedation, continuous intravenous infusion of a low-dose drug requires an infusion pump such as a syringe pump. To develop a new syringe pump for clinical use, the functions of the pump must meet certain international standards. Various safety and efficacy tests must be performed on the syringe pump, as stipulated by these standards, and an approval must be received from the approving agency based on such test results. Methods: The authors of the present study developed a novel syringe pump and performed efficacy evaluation by testing its infusion speed at 1 and 25 ml/h, and infusion performance testing at 2 and 24 h. Moreover, performance evaluation was conducted by comparing the novel pump to an existing pump with the infusion speed varied from 1 to 5 ml/h. Results: In the efficacy testing on the newly developed syringe pump, infusion with the infusion speed initially set to 1 ml/h resulted in infusion speeds of 1.00 and 0.99 ml/h in the 2- and 24-h assessment, respectively. Changing the infusion speed setting to 25 ml/h resulted in an infusion speed of 25.09 and 23.92 ml/h in the 2- and 24-h assessment, respectively. These results show no significant differences when compared with other commercially available pumps. Conclusions: The efficacy testing of the newly developed syringe pump showed the accuracy to be within tolerance. Based on these findings, we believe that the newly developed syringe pump is suitable for clinical use.