|
KMID : 1142220170120010021
|
|
Regulatory Research on Food, Drug & Cosmetic
2017 Volume.12 No. 1 p.21 ~ p.28
|
|
|
A Study on Development of Guideline to Establish Safety and Performance Evaluation for the Antibiotic Loaded Bone Cem
|
|
Kim Sang-Hun
Kim Seol-Hee
Lee Chae-Won
Na Heung-Bok
Han Ji-Man
|
|
|
Abstract
|
|
|
|
Antibiotic loaded bone cements acts primarily as a preventive agent that can prevent infection that can occur in surgical and bone implants involving antimicrobial agents and implants. In Korea, we apply a common reference to biological safety standards for antibiotic loaded bone cements, and we assess the performance of each manufacturer for each production company. Since there is no separate guideline for medical device standards or separate guidelines, it is necessary to set up an evaluation guideline for rapid authorization, evaluation support, and appropriateness of quality control. Therefore, the study analyzed the characteristics of antibiotic loaded bone cements, through an investigation into antimicrobial types and the requirements of antimicrobial agents suitable for bone marrow cement. In addition, we examined market trends and international organizations such as ISO, ASTM, and FDA guidelines. In order to develop the guideline for the antibiotic loaded bone cement, detailed test methods were selected and validated for physical chemistry, performance evaluation, biological evaluation, sterilization test, and drug evaluation. We presented standard guideline for the evaluation of antibiotic loaded bone cement based on the above review. In the future, this will provide a basis for providing high quality health care technology to the people by strictly managing the quality of antibiotic loaded bone cement. Through the safety and performance evaluation guideline of antibiotic loaded bone cement developed in this study, we propose differentiation from existing bone cement to support the approval and examination of antibiotic loaded bone cement. We hope that this report will help promote public health and strengthen the industrial competitiveness of domestic medical devices.
|
|
|
KEYWORD
|
|
|
Antibiotic, Antibiotic Loaded Bone Cement, Bone Cement, Guideline, Standardiz
|
|
|
FullTexts / Linksout information
|
|
|
|
|
|
Listed journal information
|
|
|
|
|