• 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.

• The Journal of the Society of Stroke on Korean Medicine
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• v.10 no.1
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• pp.1-7
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• 2009

Objectives : This Study was prepared for investigating the safety of oriental medicine and continuous intravenous urokinase combined therapy in acute cerebral infarction. Methods : We prospectively estimate safety of hemorrhagic transformation occurred in oriental medical therapy and continuous intravenous urokinase combined therapy. We estimate National Institute of Health Stroke Scale Score and Modified Barthel Index. Results : Hemorrhagic transformation was not noted. and Others are not fatal complication. Conclusions : oriental medical therapy and continuous intravenous urokinase combined therapy are safety method in treatment of acute cerebral infarction. We think this can be a good model of Oriental and western cooperative therapy.

• Journal of Biomedical Engineering Research
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• v.44 no.1
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• pp.1-10
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• 2023

With the announcement of MEDICAL DEVICE REGULATION 2017/745 (MDR) on April 5 2017, medical device manufacturers shall apply ISO 14971:2019 (3^rd) revised in December 2019. However, there is not much related information and guidance available to medical device manufacturers, especially single use medical device. Risk management process basically follow 5 steps which are Risk Analysis, Risk Evaluation, Risk Control, Evaluation of overall residual risk and post-production activities. The purpose of this study is to provide a guidance of from risk analysis with Failure Mode and Effects Analysis (FMEA) table to overall residual risk evaluation for the single use medical device and to reflect it in a Periodic Safety Update Reports (PSUR) to satisfy with MDR requirements with single use medical device which are widely used and manufactured FDA class 2 or CE class IIb as examples. For this study, single use medical device manufacturer can adopt ISO 14971:2019 in accordance with MDR requirements and it can be extended to the PSUR. But there are still limitations to adopt to the all-single use medical device especially high class, private device and implantable device. So, Competent Authority (CA) shall publish more guidance for the single use medical device.

• Quality Improvement in Health Care
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• v.22 no.2
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• pp.75-90
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• 2016

Objectives: This study measures the level of cognition of employee's patient safety culture and evaluates the current level through comparing the results to external levels. Ultimately it is performed to construct a strategic improvement plan through the basic database for patient's safety culture. Methods: A questionnaire survey of self reporting type was carried out using structured questionnaire of the patient's safety culture for employees currently employed in a hospital. Total responders was 1,129 and a response rate was 54.6%. The survey results were calculated with a percent positive response, and the current level was evaluated by comparing with the survey results of a hospital (2009 and 2014) and the survey result of The Agency for Healthcare Research and Quality(2014). Results: Sub-dimension of high percent positive response for each area were 'teamwork within hospital units' (80%), 'feedback & communication about error' (73%) and 'supervisor/manager expectations & actions promoting safety' (67%). Meanwhile, 'teamwork across hospital units' (31%), 'hospital management support for patient safety' (29%), 'staffing' (27%) and 'non-punitive response to error' (17%) were relatively low percent positive response. Compared to the survey results of AHRQ (2014) for each area, 'teamwork within hospital units' (80%), 'feedback & communication about error' (73%), 'frequency of event reporting' (66%) were at the top 50% percentile level and the remaining sub-dimensions showed a very low level in the lower 10% percentile area. Conclusion: In order to establish a system for patient safety culture within the hospital and evaluate the effect on this, it is necessary to periodically evaluate the patient's safety culture and establish regulations on hospital safety culture to comply with this.

• Safety and Health at Work
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• v.10 no.1
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• pp.54-60
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• 2019

Background: Increasing the establishment of integrated management systems (IMSs) is done with the purpose of leaving traditional management methods and replacing them with modern management methods. Thus, the present study sought to analyze the events and investigate the impact of IMS on health and safety performance indices in an Iranian combined cycle power plants. Methods: This case study was conducted in 2012 in all units of the Yazd Combined Cycle Power Plant on accident victims before and after the implementation of IMS. For data analysis and prediction of indices after the implementation of IMS, descriptive statistics and Kolmogorov-Smirnov test, Chi-square, linear regression, and Cubic tests were conducted using SPSS software. Results: The number of people employed in the power plant in an 8-year period (2004-2011) was 1,189, and 287 cases of work-related accidents were recorded. The highest accident frequency rate and accident severity rate were in 2004 (32.65) and 2008 (209), respectively. Safe T-score reached to below -3 during 2010-2011. In addition, given the regression results, the relation between all predictor variables with outcomes was significant (p < 0.05), except for the variable $X^1$ belonging to the accident severity rate index. Conclusion: The implementation of safety programs especially that of IMS and its annual audits has had a significant impact on reducing accident indices and improving safety within the study period. Accordingly, health and safety management systems are appropriate tools for reducing accident rate, and the use of regression models and accident indices is also a suitable way for monitoring safety performance.

• Korean Journal of Radiology
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• v.25 no.8
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• pp.695-697
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• 2024

• Journal of Preventive Medicine and Public Health
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• v.50 no.2
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• pp.68-82
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• 2017

Objectives: We performed a systematic review to assess and aggregate the available evidence on the frequency, expected effects, obstacles, and facilitators of disclosure of patient safety incidents (DPSI). Methods: We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines for this systematic review and searched PubMed, Scopus, and the Cochrane Library for English articles published between 1990 and 2014. Two authors independently conducted the title screening and abstract review. Ninety-nine articles were selected for full-text reviews. One author extracted the data and another verified them. Results: There was considerable variation in the reported frequency of DPSI among medical professionals. The main expected effects of DPSI were decreased intention of the general public to file medical lawsuits and punish medical professionals, increased credibility of medical professionals, increased intention of patients to revisit and recommend physicians or hospitals, higher ratings of quality of care, and alleviation of feelings of guilt among medical professionals. The obstacles to DPSI were fear of medical lawsuits and punishment, fear of a damaged professional reputation among colleagues and patients, diminished patient trust, the complexity of the situation, and the absence of a patient safety culture. However, the factors facilitating DPSI included the creation of a safe environment for reporting patient safety incidents, as well as guidelines and education for DPSI. Conclusions: The reported frequency of the experience of the general public with DPSI was somewhat lower than the reported frequency of DPSI among medical professionals. Although we identified various expected effects of DPSI, more empirical evidence from real cases is required.

• The Korean Journal of Nuclear Medicine Technology
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• v.15 no.2
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• pp.104-110
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• 2011

Purpose: The object evaluation method about medical institutes of these days increases credibility of consumers about medical services by conducting a certification system about medical institutes. In addition, as nuclear medicine test rooms and diagnosis test medicine room adopt many kinds of international certification systems, the matters regarding safety management of test rooms are being regarded as important. Since the blood test rooms of nuclear medicine are exposed to many harmful factors such as infection from clinical specimen and radioactive isotope reagent, there is a need to pay lots of attention to the safety management of staff and patients. Therefore, this study discusses safety management activities of staff and patients, which are conducted in the blood test rooms of the nuclear medicine department in Asan Medical Center. Materials and Methods: In the blood test rooms of the nuclear medicine department in Asan Medical Center, the matters regarding comprehensive safety management by the person in charge of safety management are offered and all staff members of the test rooms apply them into work. Safety management education is regularly conducted according to established regulations, and infection is prevented through implementation of wearing personal protectors and hand sanitation during test work. In addition, technical safety guides and accident guides for interruption of electric power are provided against emergencies. Through infection management guides, infection prevention and preparation methods for infection are learned and radioactive isotope management, safety management about reagent use and safety guides about harmful chemical substances are being applied to work. Results: The blood test rooms of the nuclear medicine department apply safety management regulations to work. Under the situation where hand sanitation should be conducted, hands are washed to prevent infection between staff and patients, and for preventing infection from clinical specimen, personal protectors are worn. The reagent, which is classified as harmful substance, is separately stored to be easily recognized, radioactive wastes and general medical wastes are also safely managed. Through these lots of safety management activities, safety management awareness of staff members is enhanced, and patients are protected from many dangers. Conclusion: Staff members of the blood test rooms of the nuclear medicine department should be fully aware of safety management regulations and apply them to work. When better safety management suggestions are made, they need to be examined and applied for increasing quality of safety management for staff and patients.

• Korean journal of aerospace and environmental medicine
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• v.29 no.2
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• pp.67-71
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• 2019

The health of licence holders (flight crew members and air traffic controllers) is recognized as an important element of aviation safety. The medical emergency symptoms that occur during the flight duty period without prior notice can interfere with human performance capabilities and threaten aviation safety. To prevent this, ICAO has been required to conduct a periodic medical assessment process of licence holders including routine analysis of in-flight incapacitation events and medical findings during medical to identify areas of increased medical risk and continuous reevaluation of the medical assessment process to concentrate on identified areas of increased medical risk. The supply and demand of licence holders have become a major issue due to the increase in air traffic around the world, and the pilot retirement age has been extended to 65 years. But, there is no significant change in the aviation medical assessments process. The follow up of the result of medical examination discovered through aviation medical examination is a very important part, but it has not been properly implemented, and the sick leaves and medical inflight incapacitation reporting system should be improved. The management of health risk factors for licence holders must be implemented to prevent aircraft accidents or aviation safety problems caused by health problems. In this paper, we propose the development plan and concrete improvement plan of the health risk management system of licence holders in Korea in terms of aviation safety.