• Asian Pacific Journal of Cancer Prevention
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• v.17 no.9
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• pp.4341-4347
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• 2016

Background: Patient safety is one of the key components of nursing care for cancer cases. Valid and reliable context-based instruments are necessary for accurate evaluation of patient safety in oncology units. The aim of the present study was to develop and evaluate the psychometric properties of the Patient Safety Violation Scale in medical oncology units in Iran. Materials and Methods: In this methodological study, a pool of 58 items was generated through reviewing the existing literature. The validity of the 58-item scale was assessed through calculating impact score, content validity ratio, and content validity index for its items as well as conducting exploratory factor analysis. The reliability of the scale was evaluated by assessing its internal consistency and testretest stability. Study sample consisted of 300 oncology nurses who were recruited from thirteen teaching hospitals affiliated to Tehran University of Medical Sciences, Tehran, Iran. Results: Sixteen items were excluded from the scale due to having low impact scores, content validity ratios, or content validity indices. In exploratory factor analysis, the remaining 42 items were loaded on five factors including patient fall, verification of patientidentity, harm during care delivery, delay in care delivery, and medication errors. These five factors explained 62% of the total variance. The Cronbach's alpha of the scale and the test-retest interclass correlation coefficient were equal to 0.933 and 0.92, respectively. Conclusions: The 42-item Patient Safety Violation Scale is a simple and short scale which has acceptable validity and reliability. Consequently, it can be used for assessing patient safety in clinical settings such as medical oncology units and for research projects.

• The Korean Society of Law and Medicine
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• v.23 no.2
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• pp.97-118
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• 2022

The use of diagnostic radiation in medical institutions is rapidly increasing. Accordingly, the collective effective dose is on the rise every year. Therefore, it is necessary to reduce the radiation exposure of the person undergoing the radiation examination as low as reasonably achievable. And we must establish a legal system to perform the safe management of radiation for diagnosis efficiently. In this way, I went over the problems of the Act and Subordinate Statutes regarding radiation safety management for diagnosis. As a result, the main contents are as follows. First, in the 「Medical Service Act」, there is no basis for the Safety Inspection Institute of Radiation and Radiation Exposure Measuring Institutes. And there are no provisions concerning delegation of administrative disposition. Therefore, it is necessary to secure legal justification by providing the basis for the Safety Inspection Institute of Radiation along with Radiation Exposure Measuring Institutes and the basis for administrative dispositions against these institutions in the 「Medical Service Act」. Second, the 「Rules on the Installation and Operation of Special Medical Equipment 」 should be integrated with the 「Rules on the Safety Management of Radiation Generators for Diagnostics」 to unify administrative procedures such as reporting for radiation special medical equipment for diagnosis. Third, in the case of violating the diagnostic radiation safety management standards in the 「Rules on the Safety Management of Radiation Generators for Diagnostics」, it is necessary to supplement the insufficient sanctions such as administrative disposition. Fourth, regulating diagnostic radiation and therapeutic radiation used in medical institutions with the dual legal system of the 「Medical Act」 and the 「Nuclear Safety Act」 is not efficient in the safety management of diagnostic radiation. Therefore, it is necessary to uniformly regulate diagnostic radiation and all medical radiation, including therapeutic radiation and nuclear medicine, in the 「Medical Service Act」 system.

• Proceedings of the Safety Management and Science Conference
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• 2010.11a
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• pp.103-112
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• 2010

This study was done to provide basic data on the safety of professionals in medical imaging system by measuring the electromagnetic waves generated in the medical imaging system being used in medical organization. The studied medical imaging systems were general X-ray system, computed tomography(CT), ultrasonographic system, magnetic resonance imaging(MRI), PET-CT and fluoroscopic system, and through these devices, electric field and magnetic field were measured and analyzed. As a result of the analysis, the measured values classified by the medical organizations were not much significant, but in the measurement by the medical imaging systems, there were high hazard elements in the sequential order of electric field PET-CT($17.7{\pm}22.9$)v/m, CT($10.3{\pm}8.7$)v/m, general X-ray system ($8.8{\pm}8.8$)v/m, magnetic field general X-ray system($5.06{\pm}8.26$)mG, CT($2.71{\pm}4.53$)mG and PET-CT($0.74{\pm}0.34$)mG, the systems that adopted X-ray as main ray source, and the more aged the medical imaging systems, the greater the effects of electro-magnetic waves($10.6{\pm}15.93v/m$ for 5 years or more, $6.14{\pm}5.60v/m$ for 5 years or less). The effects of electromagnetic waves on medical imaging systems or facilities were not much when the notification of ministry of knowledge economy is considered, but in the overall perspective considering all the equipments and facility of the medical organization, such effects were significant. It is determined that sustainable safety managements of electric field and magnetic field must be done during process from medical imaging system installation to maintenance to rule out such factors.

• Journal of the Korea Safety Management & Science
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• v.12 no.4
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• pp.67-72
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• 2010

This study was done to provide basic data on the safety of professionals in medical imaging system by measuring the electromagnetic waves generated in the medical imaging system being used in medical organization. The studied medical imaging systems were general X-ray system, computed tomography(CT), ultrasonographic(USG) system, magnetic resonance imaging(MRI), PET-CT and fluoroscopic(R/F) system, and through these devices, electric field and magnetic field were measured and analyzed. As a result of the analysis, the measured values classified by the medical organizations were not much significant, but in the measurement by the medical imaging systems, there were high hazard elements in the sequential order of electric field PET-CT($17.7{\pm}22.9$)v/m, CT($10.3{\pm}8.7$)v/m, general X-ray system($8.8{\pm}8.8$)v/m, magnetic field general X-ray system($5.06{\pm}8.26$)mG, CT($2.71{\pm}4.53$)mG and PET-CT($0.74{\pm}0.34$)mG, the systems that adopted X-ray as main ray source, and the more aged the medical imaging systems, the greater the effects of electro-magnetic waves($10.6{\pm}15.93v/m$ for 5 years or more, $6.14{\pm}5.60v/m$ for 5 years or less). The effects of electromagnetic waves on medical imaging systems or facilities were not much when the notification of ministry of knowledge economy is considered, but in the overall perspective considering all the equipments and facility of the medical organization, such effects were significant. It is determined that sustainable safety managements of electric field and magnetic field must be done during process from medical imaging system installation to maintenance to rule out such factors.

• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.215-221
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• 2019

The respiratory medical device is a medical device that delivers optimal oxygen or a certain amount of humidification to a patient by delivering artificial respiration to a patient through a machine when the patient has lost the ability to breathe spontaneously. These include respirators for use in chronic obstructive pulmonary disease and anesthesia or emergency situations, and positive airway pressure devices for treating sleep apnea, and as the population of COPD (chronic obstructive pulmonary disease) and elderly people worldwide surge, the market for the respiratory medical devices it is getting bigger. As the demand for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, the boundaries between the items are blurred due to the purpose, intended use, and method of use overlapping similar items in a respiratory medical device. In addition, for both airway pressure devices, there is a problem that the ventilator standard is applied because the reference standard has not been established. Therefore, in this study, we propose clear classification criteria for the respiratory medical devices according to the purpose, intended use, and method of use and provide safety and performance evaluation guidelines for those items to help quality control of the medical devices. And to contribute to the rapid regulating and improvement of public health. This study investigated the safety and performance test methods through the principles of the respiratory medical device, national and international standards, domestic and international licensing status, and related literature surveys. The results of this study are derived from the safety and performance test items in the individual ventilator(ISO 80601-2-72), the International Standard for positive airway pressure device (ISO 80601-2-70), The safety and performance of humidifiers (ISO 80601-2-74) and the safety evaluation items related to home healthcare environment (IEC 60601-1-11), In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers and importers, certified test inspection institutions, academia, etc., the final guidelines were established through revision and supplementation. Therefore, in this study, we propose guidelines for evaluating the safety and performance of the respiratory medical device in accordance with growing technology development.

• The Korean Journal of Emergency Medical Services
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• v.17 no.3
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• pp.149-168
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• 2013

Purpose: The purpose of this study is to develop a safety health education program for the upper graders of elementary school children and to evaluate the program. Methods: The study was designed for learner centered safety education and heath education based on a theory of lifelong education. After a model development of the program was set up, five major units were selected after five stages of program planning, design, acting, evaluation and feedback: school safety, traffic safety, home safety, life safety, and first-aid. Twenty things were selected as what to teach, and a lesson plan of 12 sessions was mapped out by arranging what to teach. The subjects in this study were 114 elementary school students who were in five different sixth-grade classes. Each class received education for five days, in four sessions each, according to the program. Results: The learners showed improvement in safety consciousness, safety knowledge, self-efficacy and safety behavior after they received education according to the safety health education program, and they expressed a lot of satisfaction with the program. Conclusion: It is important to develop the lifelong education for safety health education for the elementary school children.

• Journal of the Korean Institute of Illuminating and Electrical Installation Engineers
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• v.25 no.5
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• pp.61-66
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• 2011

An accidental disconnection of power supply for operating theatres may result in fatal accidents. Thus, it is necessary to import the electric safety system in medical locations. This paper shows an analysis of simulation for the safety in medical IT system based on KS C IEC 60364-7-710(Electrical Installations of Buildings - Requirements for special installations or locations - Medical locations). The analysis was progressed by measuring leakage currents according to variation of volts, circuits and loads. And it was made database for calculation the reasonable length of branch circuit.

• Journal of Biomedical Engineering Research
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• v.41 no.1
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• pp.35-41
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• 2020

In this study, we examined whether the systematic literature review method used in the field of evidence-based medicine could be used for post-market clinical evaluation of medical devices by modifying them to fit the regulatory perspective of medical devices in Korea. For this purpose, systematic literature review was modified and applied to conduct a clinical literature survey on the ophthalmic electrosurgical system(Trabectome^®, NeoMediX Corp) used for the treatment of glaucoma. A total of six documents were finally selected, and clinical safety and efficacy information on the indications of the ophthalmic electrosurgical system were effectively presented. In addition, general safety information and unexpected safety information could be distinguished through comparison with medical device adverse event reporting cases. The method used in this study is expected to be used in various ways throughout post-market medical device safety management system and for the purpose of regulation improvement, especially in the field of ophthalmic electrosurgical system.

• Journal of the Korea Safety Management & Science
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• v.10 no.3
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• pp.55-62
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• 2008

This is to prevent accidents that can be caused during the process of hospital logistics and accidents in relation to the traceability of medical wastes. And this is also to set up the logistic management system of medical wastes is hospital where the safety of patients shall to regard as the first priority. through these case studies effective operating plans shall be provided.

• Journal of Applied Reliability
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• v.16 no.3
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• pp.216-223
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• 2016

Purpose: This paper suggests the procedure to enhance the reliability of the software of the medical device that is to cure, treat, diagnose, and prevent a disease or an abnormal health conditions. Methods: After test requirements are classified by the software requirements specification for safety and backgrounds, reliability assessment methods are suggested. Results: Verification and validation for function and safety can be performed whether the medical device software are implemented as intended. Conclusion: Procedure on the static analysis, unit test, integration test, and system test are provided for the medical device software.