• Journal of the Korea Safety Management & Science
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• v.12 no.3
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• pp.37-52
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• 2010

This study is aimed at proposing the national policy for medical device control system in Korea as deeply analysed the present status of the system. On 1979, Korean government had started to inspect 24 kinds of the medical devices such as X-ray diagnostic equipments, medical sterilizer and etc. mostly imported from advanced countries which USA, Germany and Japan for the first time according to the Pharmaceutical Affairs Law. However medical devices were becoming consideration as an important partner of diagnosis, curing and alleviation of diseases by medical doctors and also much important keeping the health at home. Furthermore medical devices industry can be designated as a national growth engine industry. So it is necessary not only to harmonize to international standards but also the harmonization of the system including pre-market application and post-market surveillance, is strongly needed by the Korea Food and Drugs Administration(KFDA).

• Journal of Service Research and Studies
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• v.4 no.1
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• pp.109-121
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• 2014

Used medical equipment utilized in medical technology, most are not human or environmental risks likely to in normal medical technology. Therefore, the risk is close to zero so that medical devices are classified into Class 1 medical device, such as little or no risk by treating. It can be minimized without arising unnecessary and waste of time. As handlers in the medical device vendors are expanding the area of the business, we can uplift operators' commitment to the business and for the people's choice. In this paper, our research are presented to improve the legal and regulatory directions for the distribution of used medical devicesin in order to establish and promote a fair deal of diversity.

• Journal of Korean Ophthalmic Optics Society
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• v.1 no.1
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• pp.41-51
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• 1996

According to Korean pharmaceutic law, spectacles is a kind of medical device or instrument that is composed of a front and two temples with a pair of lenses. If the spectacle is not worn, it is a kind of optical device, but if it were worn, it will makes a new optical system to correct ametropia. Therefore, spectacles must be carried on by dispensing opticians.

• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.185-210
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• 2021

On September 24, 2021, the new provisions(Article 38-2 of the Medical Service Act) mandatory CCTV installation in operating rooms where the unconscious patient is operating such as general anesthesia. The revised medical law aims to effectively prevent illegal activities that may occur in the operating rooms and to promote appropriate resolution to medical dispute. According to the law, medical institutions operating unconscious patients, such as general anesthesia, must install CCTVs in the operating rooms by September 25, 2023, and film surgical scenes only at the request of patients and their guardians, regardless of the consent of the medical personnel. The bill delegated the legislative device to minimize infringement of fundamental rights to subordinate statutes without stipulating it in the law.(Article 38-2(10)) The most realistic policy plan to minimize the infringement of the fundamental rights of patients is to prepare specific regulations. Therefore, this study examines the legislative background and main contents of the amended CCTV installation bill, and suggests issues to be reviewed when preparing subordinate statutes by analyzing major issues. It was reviewed based on compliance with the principle of minimizing infringement of fundamental rights of information subjects in the operating rooms. The information subjects of CCTV are health professionals and patients. Suggesting issues should be considered when preparing subordinate statutes so that the purpose of the CCTV installation law can be achieved while minimizing infringement of right of self-determination of personal information, personality rights, and human rights. It is hoped that this paper will be referred when discussing subordinate statutes and regulations to contribute minimizing infringement of fundamental rights.

• The Journal of Internal Korean Medicine
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• v.40 no.4
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• pp.597-611
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• 2019

Objective: The goals of this study were to analyze each of the reasons adopted by the Constitutional Court or the Courts for Decisions determined to permit the use of medical devices by Korean medicine doctors and to look at the medical devices from a Korean medical perspective. Materials and Methods: For this study, several judicial precedent databases were used for searching judicial precedents that handle the usage of medical devices by Korean medicine doctors. Prior studies on similar issues were considered. The Korean medicine textbooks and related research studies were also used in this study. Results: From 2000 to 2018, a large number of lawsuits were filed regarding the legality of Korean medicine doctors using medical devices; approximately 20 final judgments or decisions were made. Among them, only two cases determined that Korean medicine doctors could legally use medical devices. Conclusion: The decisions in both cases could be interpreted as the judgments that Korean medicine doctors were allowed to use a medical device whose use or operating principles were commonly incorporated with Korean medical principles. That was provided that training was sufficient in the use of the medical device, to the extent that it could be used and that such use of the medical device was not feared to pose a health hazard.

• The Korean Journal of Emergency Medical Services
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• v.11 no.3
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• pp.17-30
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• 2007

Accidents occur frequently and that the date of the emergency situation and the people a good quality of life to actively respond to the emergency scene in the line of business activities and given their lives silently. 1st EMT's is currently the most jobs in the ability to work within a hospital that can be verified by expanding employment opportunities than the rate of youth unemployment and a sharp alleviate part of the current emergency medical institution performing the duties within the contents of this communication in a Emergency patients reflected in the rates for schools that can be revitalized as part of the emergency medical system(part of the emergency medical workers) for the completion of the law concerning emergency care, if you want the current laws and enforcement rules are to be improving. Under the current provisions in law concerning emergency care, and enforceable rules on enforcement issues and identify practical issues for consideration and improvements to enumerate the reasons for the demotion, the following conclusions can be sure until they improve. In addition, the National Assembly recently passed a bill AED use, and enforceable rules to enforce party that can teach AED necessarily a grade, including 1st EMT's to protect people's lives and to actively deal with the emergency situation so that it can be. Resolving these issues in the country where the emergency medical system can create a foundation for the advancement of emergency patients can get a good length of life, opens.

• The Korean Society of Law and Medicine
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• v.24 no.1
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• pp.3-42
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• 2023

The Supreme Court en banc decision on December 12, 2022 (docket number 2016Do21314) ruled that the diagnosis of endometrial hyperplasia by an oriental medical doctor using a diagnostic ultrasound device was not an unlicensed medical practice for an oriental medical doctor, which shall be scrutinized by the article 27 (1) of the Korean Medical Service Act. This ruling did not determine that a specific medical practice, especially diagnosis, based on the radiology, which is a part of western medicine, was not an unlicensed medical practice for an oriental medical doctor. Rather, it intended to clarify that the prosecutor should specify and prove the way of diagnosis and he should not prosecute mere the use of a diagnostic ultrasound device itself. To that extent, the ruling is agreeable because, as the oriental medicine community has argued, there is no regulation prohibiting the use of certain devices. It is probable, however, that the way of diagnosis established in radiology, which is a part of western medicine, was actually used in the case. In that case, there is undeniably an unlicensed medical practice for an oriental medical doctor. While many of the cases where the demarcation between (western) medicine and oriental medicine have been problematized thus far have been experimental treatment in nature, the above practice of using ultrasound appears to be frequently done in many oriental clinics, and so it is necessary to cope with the possibility of a disguised unlicensed medical practice. Another problem is the prevention of unfair practice or the protection of medical consumers. In fact, many oriental medical clinics' practice appear to have a tendency of inducing medical consumers' misunderstanding that a diagnosis based on radiology, which is a part of western medicine, were provided. It is hard to respond to this problem with demarcation between (western) medicine and oriental medicine. A new regulation against unfair practice might be necessary to implement.

• The Korean Journal of Emergency Medical Services
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• v.25 no.1
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• pp.23-36
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• 2021

Purpose: The purpose of this study was to determine how the use of level D personal protective equipment (PPE) and cardiopulmonary resuscitation (CPR) feedback equipment affects chest compression (CC). Furthermore, this study provides basic data for developing Korean CPR guidelines that can be applied to patients with suspected or confirmed COVID-19. Methods: This randomized, single-blinded, crossover simulation trial included 26 student paramedics who performed 2-minute chest compressions using three different methods: Method A involved performing traditional CC for two minutes without donning level D PPE, Method B involved performing CC while donning level D PPE, and Method C involved performing CC with a CPR feedback device while donning level D PPE. Results: The use of a CPR feedback device during the 2-minute CC increased the exercise intensity of the subjects, but donning level D PPE didn't affect the quality of CC and the exercise intensity. The results of methods A and B showed changes in the quality of compression 80 seconds after the start of CC. No significant changes occurred in 2-minute CC when using the CPR feedback device. Conclusion: Using a CPR feedback device could prevent deterioration in the quality of CC while donning level D PPE.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.125-144
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• 2016

All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

• The Journal of the Korean dental association
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• v.57 no.9
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• pp.514-522
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• 2019

In accordance with Article 33(8) of the Korean Medical Law, it is stated that a medical person cannot open or operate a medical institution by borrowing the name of another medical person. However, the publicity of medical care is threatened by the recent illegal network dental clinics. The purpose of this study is to investigate the actual condition of illegal network dentistry and to analyze the cases and to find out the reason why the prohibition of double opening & operating of medical institution. As a result, the illegal network dental clinics treated less health care insurance treatment such as dental caries and periodontal treatment than general dental hospitals. In contrast, the rate of implementation of illegal network dentistry was high in endodontics treatment and extraction, which could lead to uninsured treatments such as crowns and implants. As a result of Supreme Court precedent analysis, it is concluded that illegal act is not only the opening of a medical institution by borrowing the name of other medical personnel, but also the duplicated operation which has the authority to make decision about management matters of medical institutions. The results of the patient's case survey also showed that excessive dental treatment due to such as dental staff incentive system. In conclusion, the illegal network dental clinics not only threatens the oral health of the public, but also causes leakage of health insurance premiums. In other words, the ban on opening and operating the multiple medical institution should be strictly applied as a strong protection device for protecting the patient in dental case.