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Journal of Korean Society for Quality Management 2008;36(2): 59-. |
| 의료기기에 대한 임상모니터링 기반의 지속적 품질개선: 치과용 임플란트의 사례 |
| 김명덕1, 엄태관1, 김영진2 |
1오스템임플란트㈜ 임플란트연구소
2부경대학교 시스테경영공학과 |
| Continuous Quality Improvement of Medical Equipments Based on Clinical Monitoring: A Case Study of Dental Implants |
| Myung-Duk Kim1, Tae-Gwan Eom1, Young-Jin Kim2 |
1Implant R&D Center, Osstem Implant Inc.
2Department of Systems Management and Engineering, Pukyong National University |
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| ABSTRACT |
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Dental implant has recently become one of the most viable treatment options for regaining the oral function and dental aesthetics compared with conventional fixed or removable dentures. Dental implants vary in material, dimensions, geometries, surface properties, and interface geometries. It has been reported that there has been a proliferation of manufacturers who produce implants using various materials and surface treatments, and the dentist needs to select from over 2,000 different dental implants and abutments in a specific treatment situation. Unfortunately, however, no metrics have been specifically identified for the purpose of quality assessment and selection of an appropriate dental implant. This study aims to provide practical guidelines for quality assessment of dental implant based on clinical data. Like other medical devices and materials, the superiority related to specific characteristics of the dental implant needs to be verified through extensive clinical studies. The procedures of clinical monitoring for dental implants have been proposed along with a case study to exemplify the usefulness of clinical monitoring for the purpose of continuous quality improvement in medical industry. |
| Key Words:
Quality Assessment;Dental Implant;Clinical Study; |
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