• Title/Summary/Keyword: Medical Device Management

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Conflict resolution and political tasks on the usage of beauty care devices by beauty artists (미용업종사자의 미용기기 사용에 대한 분쟁해결과 정책적 과제)

  • Kim, Ju-Ri
    • Journal of Arbitration Studies
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    • v.27 no.2
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    • pp.83-105
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    • 2017
  • In contemporary society interest in and consumption of beauty treatment are increasing, raising interest in health and beauty. However, beauty-related laws are becoming factors of hindrance of beauty development. Currently the Public Health Control Act plays a basic role in the beauty art business in Korea, However the contents are in discord with international laws and its definition is not clear. Therefore it is causing conflicts of different occupations and job associations which are similar to art business. Especially, because neither definitions nor policies on beauty care devices exist in the Public Health Control Act, beauty care devices using in foreign countries cannot be used in Korea due to classification as medical devices. Under this circumstance, therefore, beauty care device uses by beauty artists violate the law. The government has tried to solve these irrational regulations. Recently, the Small and Medium Business Administration announced 'the improvement plan of small business and young founders site regulation for public economy recovery' in a ministerial meeting on December 28, 2016. Regulations on policy preparation for skincare devices were inclusive in this announcement. It is the question whether the regulations will be executed or not. Even though beauty industrial competitiveness was presented in the 18th Presidential Council on National Competitiveness in 2009, it was not practiced. The proposal bills for beauty law improvement have been put forth several times since 2000 including an improvement plan for regulating beauty care devices. However, so far there have been no improvements. The damage on the regulation classifying beauty devices as medical devices is not only restricted to skincare. This develops beauty devices and the beauty industry which imports and exports beauty devices. When beauty devices are exported, complicated procedures are unavoidable and when beauty devices are imported, irrational problems like reregistration procedures and costs occur. The reason why an improvement plan has not gone into practice is the resistance of the dermatologists' association. Dermatologists tend to stand positively against harming public health by saying that beauty devices used by beauty artists cause people to suffer side effects. In contrast, anyone who has a licence to use beauty devices is able to use them in foreign countries. It is not only infringement of one's right as a beauty artist but also people's right to receive beauty care services. With this reason, Korean's current law under which beauty devices are ruled as medical devices should be revised with accordance to domestic surroundings. Therefore in order to advance and globalize the beauty industry, the support and cooperation of the Korean government and relevant associations is needed to legislate and revise the beauty devices laws. The relevant associations abandon regional self-centeredness and cooperate to define ranges, size and management of beauty devices for safe use. If no collaboration exists, an arbitration agency should be established to solve the problem.

New techniques for wound management: A systematic review of their role in the management of chronic wounds

  • Bekara, Farid;Vitse, Julian;Fluieraru, Sergiu;Masson, Raphael;De Runz, Antoine;Georgescu, Vera;Bressy, Guillaume;Labbe, Jean Louis;Chaput, Benoit;Herlin, Christian
    • Archives of Plastic Surgery
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    • v.45 no.2
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    • pp.102-110
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    • 2018
  • Debridement is a crucial component of wound management. Recent technologies such as hydrosurgery (Versajet), ultrasound therapy (the MIST therapy device), or plasma-mediated bipolar radio-frequency ablation therapy (Coblation) seem to represent interesting alternatives for wound debridement. The purpose of this systematic review was to describe, evaluate, and compare these three recently developed methods for the management of chronic wounds. In January 2016, an electronic database search was conducted of MEDLINE, PubMed Central, and Embase for articles concerning these three innovative methods for the management of chronic wounds. A total of 389 references were identified by our search strategy, and 15 articles were included. We extracted data regarding the number and age of patients, indications, operating time, number of procedures, costs, wound healing time, decrease in exudation, perioperative blood loss, bacterial load, and the occurrence of complications. The 15 articles included studies that involved 563 patients who underwent hydrosurgery (7 studies), ultrasound therapy (6 studies), or Coblation (2 studies). Six randomized controlled trials were included that compared the use of a scalpel or curette to hydrosurgery (2 studies) or ultrasound therapy (6 studies). Hydrosurgery, in addition to being a very precise and selective tool, allows significantly faster debridement. Ultrasound therapy provides a significant reduction of exudation, and improves the wound healing time. No comparative study dedicated to Coblation was identified. Despite the obvious clinical interest of the topic, our review of the current literature revealed a lack of prospective randomized studies comparing these devices with each other or with standard techniques, particularly for Coblation and hydrosurgery.

The Role of Health Committee for Health Management of Rural Residents in the COVID-19 Epidemic (코로나19 유행 상황에서 농어촌지역 건강마을 건강위원의 역할)

  • Kim, Yunyoung;Kim, Keonyeop;Hong, Nam-Soo;Kang, Soo Jin;Kim, Eunhwi;Kim, Jong-Yeon;Park, Min-Ah
    • Journal of agricultural medicine and community health
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    • v.46 no.4
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    • pp.218-229
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    • 2021
  • Objectives: The purpose of this study was to suggest the direction of the Healthy Village project for rural residents in accordance with the prolonged COVID-19 by investigating the digital environment for major health problems, the role of a health leader, necessary projects, and non-face-to-face projects for Healthy Village members in the COVID-19 epidemic. Methods: Telephone interview surveys were conducted with 585 residents from November 30, 2020 to December 21, 2020. Results: Health problems perceived by residents were in the order of concerns about infection (48.5%), depression (32.5%), difficulties in using medical services (9.4%), and lack of exercise (7.7%). The role of the health committee in the COVID-19 situation was "encouraging people to follow quarantine rules" with 91.3%. As a necessary health village project, there was a high demand for the provision of health products and mental health projects. 17.9% said that there is a computer or smart device connected to the Internet in their home, and 42.2% said that there is someone in the village who can easily get help if there is a problem in accessing and using Internet information. 36.9% were able to watch videos, and 22.2% were able to use the Internet through public facilities. Conclusion: In a public health crisis, where the provision of public health and medical services to rural residents is not smooth, it is necessary to manage health and quarantine through health leaders in the village, and it is required to establish a digital environment infrastructure that can conduct community participatory health village projects in a non-face-to-face environment.

The Jurisdictional Precedent Analysis of Medical Dispute in Dental Field (치과임상영역에서 발생된 의료분쟁의 판례분석)

  • Kwon, Byung-Ki;Ahn, Hyoung-Joon;Kang, Jin-Kyu;Kim, Chong-Youl;Choi, Jong-Hoon
    • Journal of Oral Medicine and Pain
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    • v.31 no.4
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    • pp.283-296
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    • 2006
  • Along with the development of scientific technologies, health care has been growing remarkably, and as the social life quality improves with increasing interest in health, the demand for medical service is rapidly increasing. However, medical accident and medical dispute also are rapidly increasing due to various factors such as, increasing sense of people's right, lack of understanding in the nature of medical practice, over expectation on medical technique, commercialize medical supply system, moral degeneracy and unawareness of medical jurisprudence by doctors, widespread trend of mutual distrust, and lack of systematized device for solution of medical dispute. This study analysed 30 cases of civil suit in the year between 1994 to 2004, which were selected among the medical dispute cases in dental field with the judgement collected from organizations related to dentistry and department of oral medicine, Yonsei university dental hospital. The following results were drawn from the analyses: 1. The distribution of year showed rapid increase of medical dispute after the year 2000. 2. In the types of medical dispute, suit associated with tooth extraction took 36.7% of all. 3. As for the cause of medical dispute, uncomfortable feeling and dissatisfaction with the treatment showed 36.7%, death and permanent damage showed 16.7% each. 4. Winning the suit, compulsory mediation and recommendation for settlement took 60.0% of judgement result for the plaintiff. 5. For the type of medical organization in relation to medical dispute, 60.0% was found to be the private dental clinics, and 30.0% was university dental hospitals. 6. For the level of trial, dispute that progressed above 2 or 3 trials was of 30.0%. 7. For the amount of claim for damage, the claim amounting between 50 million to 100 million won was of 36.7%, and that of more than 100 million won was 13.3%, and in case of the judgement amount, the amount ranging from 10 million to 30 million won was of 40.0%, and that of more than 100 million won was of 6.7%. 8. For the number of dentist involved in the suit, 26.7% was of 2 or more dentists. 9. For the amount of time spent until the judgement, 46.7% took 11 to 20 months, and 36.7% took 21 to 30 months. 10. For medical malpractice, 46.7% was judged to be guilty, and 70% of the cases had undergone medical judgement or verification of the case by specialists during the process of the suit. 11. In the lost cases of doctors(18 cases), 72.2% was due to violence of carefulness in practice and 16.7% was due to missing of explanation to patient. Medical disputes occurring in the field of dentistry are usually of relatively less risky cases. Hence, the importance of explanation to patient is emphasized, and since the levels of patient satisfaction are subjective, improvement of the relationship between the patient and the dentist and recovery of autonomy within the group dentist are essential in addition to the reduction of technical malpractice. Moreover, management measure against the medical dispute should be set up through complement of the current doctors and hospitals medical malpractice insurance which is being conducted irrationally, and establishment of system in which education as well as consultation for medical disputes lead by the group of dental clinicians and academic scholars are accessible.

The Effects of Customer Rude Behaviors on Organizational Deviance, Life Violations, and Creativity using Emotional Dissonance and Job Stress as Mediators (고객무례행동이 감정부조화와 직무스트레스를 매개로 조직일탈, 생활침해, 창의성에 미치는 영향에 관한 연구)

  • Han, Na-Young;Kang, Mi-Young;Park, Sang-Bong
    • Management & Information Systems Review
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    • v.39 no.2
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    • pp.127-143
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    • 2020
  • As customers' irrational, rude behaviors are often covered by media recently, the issue is becoming a more serious social issue. Workers' stress in the service industry is very severe because they have to face and interact with customers with rude behaviors in-person due to the nature of the job. As a result of customers' rude behaviors, workers even desire to leave their organization because they feel doubts about their job and have negative emotions such as unpleasantness, depression, and fear. Considering that customers' rude behaviors directly impact service industry workers' ability to offer proper service, it is necessary to have appropriate measures against their rude behaviors. This research examined the impact of customers' rude behaviors on service industry workers' emotional dissonance, its impact on job stress, and the impact of job stress on organizational deviance, life violations and creativity. The study also analyzed the moderating effects of stress management education in emotional dissonance and job stress relationship to device ways to manage job stress more positively. To collect data, the study conducted a survey on medical service workers in the customer service sector of large general hospitals and small or medium-sized hospitals in Busan, and the results were as follows. First, rude behaviors had a significant positive(+) effect on emotional dissonance, which had a significant positive(+) effect on job stress. Third, job stress had a significant positive(+) effect on both organizational deviance an life violations. Fourth, job stress had a negative(-) significant effect on creativity. Fifth, there was no moderating effect of stress management education in the relationship between emotional dissonance and job stress.

A Performance Evaluation of Diagnostic X-ray Unit Depends on the Hospitals Size (병원 규모별 진단용 X선 발생장치의 성능 평가)

  • Park, Ju-Hun;Im, In-Chul;Dong, Kyung-Rae;Kang, Se-Sik
    • Journal of Radiation Protection and Research
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    • v.34 no.1
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    • pp.31-36
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    • 2009
  • The purpose of this study is to measure the tube voltage, the tube current/volume, exposure time and exposure dose of diagnostic X-ray unit in each doctor offices, hospitals and general hospitals for evaluating the performance of such device, to learn the method and technology of its measurement and to suggest its importance. Research subjects were total 30 X-ray units and divided into groups of 10 X-ray units each. The tube voltage, the tube current/volume, exposure time and exposure dose were measured using percentage average error, and then reproducibility of exposure dose was measured through calculating coefficient of variation. The results are like followings; The tube voltage correctness examination showed that incongruent devices among total 30 X-ray units were 5 devices (16.7%). The tube current correctness examination showed that incongruent X-ray units were 3 devices (10.0%). The tube current volume correctness examination showed that incongruent X-ray units were 4 devices (13.3%). Finally, according to exposure time correctness examination, incongruent X-ray units were 5 devices (16.7%) and according to reproducibility examination of exposure dose, incongruent X-ray units were 7 devices (23.3%). Above results showed serious problem in performance management based on management regulation of diagnostic X-ray unit; it means that regular checkout and safety management are required, and as doing so, patients will be able to receive good quality of medical service by the reduction of radiation exposure time, image quality administration, unnecessary retake and etc. Therefore, this study suggests that the performance of diagnostic X-ray units should be checked regularly.

Concentration of elemental ions released from non-precious dental casting alloys (치과주조용 비귀금속 합금의 금속 용출 수준)

  • Sakong, Joon;Park, Soo-Chul
    • Journal of Technologic Dentistry
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    • v.35 no.1
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    • pp.1-17
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    • 2013
  • Purpose: This study was to assess the extents of the release of metals from the non-precious alloys used for dental casting by measuring the differences in the extents of the release of metals by types of alloys, pH level and elapsed time. Methods: Uniform-sized specimens(10 each) were prepared according to the Medical Device Standard of the Korea Food and Drug Administration(2010) and International Standard Organization(ISO22674, 2006), using four types of alloys(one type of Ni-Cr and one type of Co-Cr used for fixed prosthesis, and one type of Ni-Cr and one type of Co-Cr used for removable prosthesis). A total of 12 metal-release tests were performed at one-day, three-day, and two-week intervals, for up to 20 weeks. The metal ions were quantified using an Inductively Coupled Plasma-Atomic Emission Spectrometer. Results: The results showed that the extent of corrosion was higher in the ascending order of Jdium-$100^{(R)}$, Bellabond-$Plus^{(R)}$, Starloy-$C^{(R)}$, and Biosil-$F^{(R)}$. The lower the pH and the longer the elapsed time were, the greater the increase in metal corrosion. At pH 2.4, the release of Ni from Jdium-$100^{(R)}$, a Ni-Cr alloy, was up to 15 times greater than the release of Co from the Co-Cr alloy from two weeks over time, indicating that the Ni-Cr alloy is more susceptible to corrosion than the Co-Cr alloy. Conclusion: It is recommended that Co-Cr alloy, which is highly resistant to corrosion, be used for making dental prosthesis with a non-precious alloy for dental casting, and that non-precious alloy prosthesis be designed in such a way as to minimize the area of its oral exposure. For patients with non-precious alloy prostheses, a test of the presence or absence of periodontal tissue inflammation or allergic reaction around the prosthesis should be performed via regular examination, and education on the good management of the prosthesis is needed.

A Case of Intramuscular Abscess in the Sternocleidomastoid Muscle after Intramuscular Stimulation (IMS) (근육내 자극요법 후 목빗근내 농양의 치험례)

  • Kim, Jae-In;Choi, Hwan-Jun;Choi, Chang-Yong;Yang, Hyung-Eun
    • Archives of Plastic Surgery
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    • v.37 no.2
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    • pp.182-186
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    • 2010
  • Purpose: Intramuscular stimulation (IMS) shows good results in the treatment of chronic pain patients who did not respond to other treatments such as oral analgesics, trigger point injection, nerve block and epidural steroid injection. But, IMS procedure especially, patients with diabetes mellitus (DM) has sometimes serious problem. So, we present a very rare case of intramuscular abscess in the sternocleiomastoid muscle after IMS with literature review. Methods: A 66 year old male visited our department 7 days after IMS in the neck. His premorbid conditions and risk factors of deep neck infection was DM and old age. Computed tomographic scans of the head and neck region were performed in this patient: signs of deep neck infection, were seen enhanced abscess in the sternocleidomastoid muscle, cellulitis overlying tissue of the neck, and air bubbles involved muscle. Necrotic wound was excised serially and we treated this with the Vacuum-assisted closure (VAC, Kinetics Concepts International, San Antonio, Texas) system device. After appropriately shaping the sponge in the pockets, continuous negative pressure of 125 mmHg was applied. The VAC therapy was utilized for a period of 12 days. Results: We obtained satisfactory results from wide excision, drainage of the abscess with the VAC system, and then primary closure. The postoperative course was uneventful. Results: We suggest that many of the infectious complications may be preventable by strict adherence to aseptic techniques and that some of the other complications may be minimized by refining the techniques with a clear understanding of the medical disorders of patients. And, the refined technique using the VAC system can provide a means of simple and effective management for the cervical intramuscular abscess, with better cosmetic and functional results.

An Integrated Training Aid System using Personalized Exercise Prescription

  • Jang S. J.;Park S. R.;Jang Y. G.;Oh Y. K.;Kwak H. M.;Diwakar Praveen Kumar;Park S. H.;Yoon Y. R.
    • Journal of Biomedical Engineering Research
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    • v.26 no.5
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    • pp.343-349
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    • 2005
  • Continuously motivating people to exercise regularly is more important than finding a way out of barriers such as lack of time, cost of equipment, lack of nearby facilities, and poor weather. Our proposed system presents practicable methods of motivation through a diverse exercise aid system. The Health Improvement and Management System (all-in-one system which saves space and maintenance costs) measures and evaluates a diverse body shape analysis and physical fitness test and directs users to automated personalized exercise prescription which is prescribed by the expert system of three types of exercise templates: aerobics, anaerobics, and leisure sports. Automated personalized exercise prescriptions are built into XML based documents because the data needs to be in the form of flexible, expansible, and convertible structures in order to process various exercise templates, BIOFIT, a digital exercise trainer, monitors and provides feedback on the physiological parameters while users are working out in the gymnasium. If these parameters do not range within the prescribed target zone, the device will alarm users to control the exercise and make the exercise trainer adjust systemically the proper exercise level. Numeric health information such as the report of the physical fitness test and the exercise prescription makes people stay interested in exercising. In addition, this service can be delivered through the Internet.

Dementia Response Technology Development Strategy through PEST-SWOT Analysis

  • Yu, Tae Gyu
    • International journal of advanced smart convergence
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    • v.9 no.1
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    • pp.185-192
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    • 2020
  • The number of dementia patients in Korea is expected to increase to 3.30 million in 2050, and the cost of dementia management will increase sharply to KRW 106.5 trillion of GDP. In August 2017, the Moon Jae-in government announced the 'Dementia National Responsibility System' through a five-year plan for government operation and expanded the Dementia Peace Center nationwide. However, for this, strategic dementia-related technology development strategies should be established and given the role of government and the role of the private sector. Therefore, in order to derive the corresponding strategy, this study developed the government's 'dementia' response technology development strategy through the situation analysis from the political, economic, social, and technological perspective and the environmental (PEST) analysis of the strengths, weaknesses, opportunities, and threats (SWOT). As a result, the direction of technology development in the dementia-related medical device market is expected to become a trend of developing dementia self-measurement by developing low-cost and high-efficiency diagnostic technology products. It has been shown that the development of various products for consumers should begin. As a result, the dementia market approach strategy should be premised, the related technical support and legal restrictions should be minimized, and the education of related experts should be strengthened to solve the government's development of dementia technology and the social problems of dementia. In addition, by developing joint projects with major companies around the world and actively participating in the technology platform, it is important to naturally build up skills accumulation for the development of dementia technology and competence skills of dementia technology experts in the long term.