• 근관절건강학회지
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• 제31권1호
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• pp.42-52
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• 2024

Purpose: This study aimed to identify the factors affecting compliance with personal protective equipment (PPE) use among medical device reprocessing staff. Methods: This descriptive cross-sectional study included 163 cleaning staff members from ten general hospitals in Seoul and Gyeonggi. Data were collected using self-report questionnaires administered between July and September 2023. Analysis included t-tests, ANOVA, Pearson's correlation coefficient, Bonferroni correction, and multiple regression, conducted using SAS ver.9.4. Results: Statistically significant differences in compliance with PPE were found based on department and exposure to contamination within six months (t=-2.82, p=.007). Attitudes toward PPE (r=.22, p=.006) and awareness of the safety climate (r=.22, p=.006) showed a statistically significant positive correlation with PPE compliance. Factors influencing use of personal protective equipment by cleaning staff during medical device reprocessing were department, compliance with PPE, and awareness of the safety climate. The explanatory power of these factors was 58.0%. Conclusion: Improving PPE compliance and creating a safe cleaning environment entails fostering a supportive safety climate. Additionally, regular training that takes into consideration the characteristics of the cleaning staff, alongside continuous monitoring, is required.

• 무역상무연구
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• 제75권
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• pp.159-177
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• 2017

In this paper, we examined trends and regulations of the global medical equipment industry through literature search. The medical equipment industry is attracting attention as a new growth engine in the Fourth Industrial revolution. However, the medical device industry is a highly competitive field due to product diversity, short product life cycle and technological advances. In addition, Medical equipment are related to human health and safety. Therefore, it can only be exported if it is approved by national or international standards. Therefore, from the development stage of the product, the medical equipment should designate the country to be exported and develop a medical equipment that meets the requirements for licensing the medical equipment in the country. Therefore, In this paper, In this paper, we will present the practical considerations of the medical equipment exporting company by examining the global medical equipment market trends and the regulations related to medical equipment in major countries.

• 대한의용생체공학회:의공학회지
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• 제31권2호
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• pp.123-128
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• 2010

The thermometers is widely used in diagnostic medical devices, and the safety and accurate performance of these devices are important in the diagnosis and monitoring of personal health. Especially, the accuracy of infra-red thermometer is highly emphasized. Here two typical thermometers are utilized for this purpose: the electronic thermometers measure body temperature by contacting to subject while infra-red thermometers measure by no contacting to subject. Therefore, the evaluating items of each thermometer are different, and the standard for each temperature is highly needed. But, there have been no international standards of each thermometer such as IEC. In this paper, we developed the standards of electronic and infra-red thermometer based on national standards such as KS, ASTM, EN, JIS and FDA guidance. The new standards focused on the safety and suitable performance for health care. This standards were applied to enact and revise the electronic medical device standards. So it can be applied to evaluate the safety and performance on technical file review. We predict that this standard will improve the quality of diagnostic medical devices (thermometers) and increase the international competitive power of domestic product.

• 대한한의학회지
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• 제43권3호
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• pp.150-163
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• 2022

Objectives: This research aimed to develop a guideline for evaluating safety and performance of electronic warm-acupuncture apparatus. With the development of medical devices like electronic warm-acupuncture apparatus with improved performance, convenience and safety measures compared to traditional warm-acupuncture needling, safety and performance guideline is a necessity. Methods: By referring to existing standards and guidelines of other electronic devices for Korean medicine with heating function, guideline for safety and performance assessment of electronic warm-acupuncture apparatus was drafted Results: The guideline, presents explanation for adequate temperature and settings of the apparatus, and safety measurements providing against thermal runaway situations along with guidelines for the manual. Guideline for detailed test method for the performance of the apparatus such as accuracy of temperature increase and the timer, and safety unit was also provided. The test items and suggested test methods for the requirements of biological, electrical and electromagnetic safety were referred to Korean approval documents of ministry of Food and Drug Safety. Conclusion: We proposed the relevant items to verify performance and safety of warm-acupuncture apparatus to assure patient safety and improve the quality of currently developing devices for application in clinical field.

• 대한의용생체공학회:의공학회지
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• 제42권6호
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• pp.259-267
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• 2021

Recently, the market for personal health care and medical devices based on Bluetooth Low Energy(BLE) has grown rapidly. BLE is being used in various medical data communication devices based on low power consumption and universal compatibility. However, since data errors occurring in the transmission of medical data can lead to medical accidents, it is necessary to analyze the causes of errors and study methods to reduce data error. In this paper, the minimum communication speed to be used in medical devices was set to at least 800 byte/sec based on the wireless electrocardiography regulations of the Ministry of Food and Drug Safety. And the data loss rate was tested when data was transmitted at a speed higher than 800 byte/sec. The factors that cause communication data error were classified, and the relationship between each factor and the data error rate was analyzed through experiments. When there were two or more activated peripherals connected to the central, data error occurred due to channel hopping and bottleneck, and the data error rate increased in proportion to the communication distance and the number of activated peripherals. Through this experiment, when the BLE is used in a medical device that intermittently transmits biosignal data, the risk of a medical accident is predicted to be low if the number of peripherals is 3 or less. But, it was determined that BLE would not be suitable for the development of a biosignal measuring device that must be continuously transmitted in real time, such as an electrocardiogram.

• 대한의용생체공학회:의공학회지
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• 제36권5호
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• pp.162-168
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• 2015

In this study, we suggested the performance and safety testing guideline for low intensity pulsed ultrasound (LIPUS) represented by the ultrasound fracture treatment device and cartilage treatment device and low intensity focused ultrasound (LIFU) represented by ultrasonic face lifting device. For these study, the international standards and management regulations of Korea, Japan and United State were analyzed. And the usefulness and applicability were evaluated by testing with commercial equipment and reflecting the views of the industry and experts. As a result of this study, the safety and performance test guidelines for low intensity therapeutic ultrasound device were proposed by presenting the 10 items for LIPUS and 12 items for LIFU. The suggested guidelines are considered a high utilization in the domestic testing and approval authorities. And they are also thought to be useful to new technology development.

• 한국임상수의학회지
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• 제41권3호
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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.

• 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.

• 대한의용생체공학회:의공학회지
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• 제43권3호
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• pp.147-152
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• 2022

This research is to measure real-time temperature distribution inside a tissue-mimicking phantom for the safety and effectiveness evaluations of focused ultrasound (FUS) device capable of linear scanning stimulation. Since the focusing area of the FUS stimulation device is smaller than diameter of conventional thermal probe and keeps moving, it is impossible to monitor temperature distribution inside the phantom. By using the phantom with a thin film temperature sensor array inserted, real-time temperature change caused by the FUS device was measured. The translation of the measured temperature peak was also tracked successfully. The present phantom had been experimentally proven to be applicable to validate the performance and safety of the therapeutic ultrasound devices.

• 한국산업융합학회 논문집
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• 제26권1호
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• pp.15-26
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• 2023

In this study, an end-effector robot which is a two-axis delta robot type for upper-limb rehabilitation is designed. It is not only rehabilitation functions that has designed robot but also mechanical and electrical safety devices were constructed to ensure patient safety. By constructing the two-axis delta robot is combined with an LM guide, the operating range and rigidity required for rehabilitation were secured. The electrical safety system which is required for the medical robot was designed, and a safety strategy was established to ensure patient safety and it is applied in the integrated safety circuit. The safety is considered in whole design process from the robot's mechanical design to the electric control unit.