- Electro-Mechanical Safety Testing of Portable ECG Devices for Home Healthcare Usage
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Kim JH, Cho EJ, Lee CK, Park SK, Lee BC, Yoo SK
- KMID: 2166563
- Healthc Inform Res.
- 2010 Mar;16(1):30-35.
- doi: 10.4258/hir.2010.16.1.30
OBJECTIVES: This paper suggests the experimental guidelines to evaluate the electro-mechanical safety of belt type equipment. The electro-mechanical safety was determined by using the International Electrotechnical Commission guidelines, which are... -
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- Medical device adverse effects
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Kwon BS
- KMID: 2459157
- J Korean Med Assoc.
- 2019 Sep;62(9):480-485.
- doi: 10.5124/jkma.2019.62.9.480
This study aimed to describe adverse effects or reactions by medical devices. There may be unexpected effects caused by medical devices that can often be harmful to the patient. This... -
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- Review of regulatory management on standards and specifications for veterinary medical devices in Korea
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Kang KM, Kim TW, Kwon OR, Park HJ, Cho SM, Kim CH, Lee MH, Moon JS
- KMID: 2386847
- Korean J Vet Res.
- 2017 Jun;57(2):71-78.
- doi: 10.14405/kjvr.2017.57.2.71
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... -
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- Effects and Satisfaction of Medical Device Safety Information Reporting System Using Electronic Medical Record
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Jang HJ, Choi YD, Kim NH
- KMID: 2378517
- Healthc Inform Res.
- 2017 Apr;23(2):94-100.
- doi: 10.4258/hir.2017.23.2.94
OBJECTIVES: This paper describes an evaluation study on the effectiveness of developing an in-hospital medical device safety information reporting system for managing safety information, including adverse incident data related to... -
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- Arrangements of the intravenous parallel infusions with anti-reflux valves decreasing occlusion alarm delay
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Joe HB, Moon BK, Lee YJ, Min SK
- KMID: 2236218
- Korean J Anesthesiol.
- 2014 Apr;66(4):300-305.
- doi: 10.4097/kjae.2014.66.4.300
BACKGROUND: The methods of arrangement of combined intravenous parallel infusions using anti-reflux valve (ARV), with and without anti-syphon valve (ASV) that could decrease occlusion alarm delay were investigated. METHODS: Occlusion challenge... -
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- An evaluation of the Manufacturer And User Facility Device Experience database that inspired the United States Food and Drug Administration's Reclassification of transvaginal mesh
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Sandberg J, Gray I, Pearlman A, Terlecki R
- KMID: 2404982
- Investig Clin Urol.
- 2018 Mar;59(2):126-132.
- doi: 10.4111/icu.2018.59.2.126
PURPOSE: To assess the utility of the Manufacturer And User Facility Device Experience (MAUDE) database in objectively capturing adverse events for transvaginal mesh in the United States. MATERIALS AND METHODS: We... -
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- The Incidence of Riata Defibrillator Lead Failure: a Single-Center Experience
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Gwag HB, Hwang JK, Park KM, Park SJ, On YK, Kim JS
- KMID: 2400432
- J Korean Med Sci.
- 2017 Oct;32(10):1610-1615.
- doi: 10.3346/jkms.2017.32.10.1610
Riata defibrillator leads were recalled due to a high failure rate. This study measured the incidence of externalized conductor (EC) and electrical dysfunction (ED) and sought to determine the predictors... -
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- A comparative clinical study on the accuracy and efficacy of Accumate(R) 1100, an infusion pump for patient-controlled analgesia
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Kim KM, Noh GJ
- KMID: 2169068
- Anesth Pain Med.
- 2016 Jan;11(1):36-41.
- doi: 10.17085/apm.2016.11.1.36
BACKGROUND: The accuracy and efficacy of patient-controlled analgesia (PCA) devices are crucial because malfunction of the devices may lead to fatal outcomes. The aim of this study is to evaluate... -
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- Assessment of Factors Affecting the Usefulness and Diagnostic Yield of Core Biopsy Needles with a Side Hole in Endoscopic Ultrasound-Guided Fine-Needle Aspiration
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Inoue T, Okumura F, Mizushima , Nishie H, Iwasaki H, Anbe K, Ozeki T, Kachi K, Fukusada S, Suzuki Y, Sano H
- KMID: 2382343
- Gut Liver.
- 2016 Jan;10(1):51-57.
- doi: 10.5009/gnl14249
BACKGROUND/AIMS: A barbed puncture needle with a side hole was recently developed to improve sample quality and quantity in endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA). In this study, we retrospectively assessed... -
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- Cardiac Implantable Electronic Device Safety during Magnetic Resonance Imaging
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Hwang YM, Kim J, Lee JH, Kim M, Nam GB, Choi KJ, Kim YH
- KMID: 2355456
- Korean Circ J.
- 2016 Nov;46(6):804-810.
- doi: 10.4070/kcj.2016.46.6.804
BACKGROUND AND OBJECTIVES: Although magnetic resonance imaging (MRI) conditional cardiac implantable electronic devices (CIEDs) have become recently available, non-MRI conditional devices and the presence of epicardial and abandoned leads remain... -
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- A Prospective, Randomized, Controlled Comparative Study of Three Energy Devices in Open Thyroid Surgery: Thunderbeat, Harmonic, and Ligasure
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Back K, Hur N, Kim MJ, Choe JH, Kim JH, Kim JS
- KMID: 2466236
- J Endocr Surg.
- 2019 Dec;19(4):106-115.
- doi: 10.16956/jes.2019.19.4.106
PURPOSE: Energy devices, such as Harmonic Focus Plus (Ethicon; ultrasonic scalpel; Harmonic) and Ligasure Small Jaw (Covidien; bipolar sealer; Ligasure) are widely used in thyroid surgery as substitutes for Bovie... -
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- Safety and Efficacy of Ultrasound-Guided Fiducial Marker Implantation for CyberKnife Radiation Therapy
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Kim JH, Hong SS, Kim JH, Park HJ, Chang YW, Chang AR, Kwon SB
- KMID: 1372850
- Korean J Radiol.
- 2012 Jun;13(3):307-313.
- doi: 10.3348/kjr.2012.13.3.307
OBJECTIVE: To evaluate the safety and technical success rate of an ultrasound-guided fiducial marker implantation in preparation for CyberKnife radiation therapy. MATERIALS AND METHODS: We retrospectively reviewed 270 percutaneous ultrasound-guided fiducial... -
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- Usefulness of a Guiding Sheath for Fluoroscopic Colorectal Stent Placement
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Song HY, Nam DH, Lee H
- KMID: 1372872
- Korean J Radiol.
- 2012 Feb;13(Suppl 1):S83-S88.
- doi: 10.3348/kjr.2012.13.S1.S83
OBJECTIVE: To investigate the technical feasibility, clinical usefulness, and safety of a guiding sheath in fluoroscopic stent placement for patients with malignant colorectal obstructions. MATERIALS AND METHODS: Between June 2007 and... -
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- National Endoscopy Quality Improvement Program Remains Suboptimal in Korea
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Cha JM, Moon JS, Chung IK, Kim JO, Im JP, Cho YK, Kim HG, Lee SK, Lee HL, Jang JY, Kim ES, Jung Y, Moon CM, Kim Y, Park BY
- KMID: 2412065
- Gut Liver.
- 2016 Sep;10(5):699-705.
- doi: 10.5009/gnl15623
BACKGROUND/AIMS: We evaluated the characteristics of the National Cancer Screening Program (NCSP) and opinions regarding the National Endoscopy Quality Improvement Program (NEQIP). METHODS: We surveyed physicians performing esophagogastroduodenoscopy and/or colonoscopy screenings... -
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