• Journal of Biomedical Engineering Research
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• v.40 no.5
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• pp.197-205
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• 2019

The existing Extracorporeal membrane oxygenation(ECMO) and Cardiopulmonary bypass system(CPB) have been developed and applied to various devices according to their respective indications. However, due to the complicated configuration and difficult usage method, it causes inconvenience to users and there is a risk of an accident. Therefore, smart all-in-one cardiopulmonary circulation device is being developed recently. The smart all-in-one cardiopulmonary assist device consists of a blood pump for cardiopulmonary bypass, a blood oxidizer for cardiopulmonary bypass, a blood circuit for cardiopulmonary bypass, and an artificial cardiopulmonary device. It is an integrated cardiopulmonary bypass device that can be used for a variety of purposes such as emergency, intraoperative, post-operative intensive care, and long-term cardiopulmonary assist, combined with CPB used in open heart surgery and ECMO used when patient's cardiopulmonary function does not work normally. The smart all-in-one cardiopulmonary assist device does not exist as a standard and international standard applicable to advanced medical devices. Therefore, in this study, we will refer to the International Standard for Blood Components, the International Standard for Blood, the Guideline for Blood Products, and prepare applicable performance and safety guidelines to help quality control of medical devices, and contribute to the improvement of the health of people. The guideline, which is the result of conducted a survey of the method of safety and performance test, is based on the principle of all-in-one cardiopulmonary aiding device, related domestic foreign standards, the status of domestic and foreign patents, related literature, blood pump(ISO 18242), blood oxygenator (ISO 7199), and blood circuit (ISO 15676) for cardiopulmonary bypass.The items on blood safety are as follows: American Society for Testing and Materials ASTM F1841-97R17), and in the 2010 Food and Drug Administration's Safety Assessment Guidelines for Medical Assisted Circulatory Devices. In addition, after reviewing the guidelines drawn up through expert consultation bodies including manufacturers / importers, testing inspectors, academia, etc. the final guideline was established through revision and supplementation process. Therefore, we propose guidelines for evaluating the safety and performance of smart all-in-one cardiopulmonary assist devices in line with growing technology.

• Korean journal of food and cookery science
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• v.17 no.6
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• pp.542-548
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• 2001

Hazard Analysis Critical Control Point(HACCP) is becoming an important component of food safety worldwide. The aim of this study was to investigate comprehensively the education and knowledge level of food service managers on HACCP as well as applying HACCP system to industrial foodservice. Total 247 foodservice managers participated in the survey and 159 responses were used for analysis. The results were as follows: 1) 89% of foodservice managers were educated about HACCP, and 40.9% felt they did fully understand HACCP and 47.8% did half. 2) The score for the implementation of HACCP was in the order of apparatus and facility sanitation, personal sanitation, and time-temperature/etc. sanitation. 3) Foodservice managers who were taught HACCP kept a deep attention to food and personal sanitation, compared with those without education(p＜0.05). However, the education time on HACCP affected conducting safety management. The results suggest that education and understanding of HACCP are positively related, and understanding of HACCP has a positive influence on conducting safety management.

• Journal of the Korean Society of Food Science and Nutrition
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• v.42 no.3
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• pp.464-477
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• 2013

There is a great need to develop a training program proven to change behavior and improve knowledge. The purpose of this study was to evaluate employee hygiene knowledge, hygiene practice, and cleanliness, before and after HACCP system implementation at one small-size restaurant. The efficiency of the system was analyzed using time-temperature control after implementation of u-HACCP$^{(R)}$. The employee hygiene knowledge and practices showed a significant improvement (p<0.05) after HACCP system implementation. In non-heating processes, such as seasoned lettuce, controlling the sanitation of the cooking facility and the chlorination of raw ingredients were identified as the significant CCP. Sanitizing was an important CCP because total bacteria were reduced 2~4 log CFU/g after implementation of HACCP. In bean sprouts, microbial levels decreased from 4.20 logCFU/g to 3.26 logCFU/g. There were significant correlations between hygiene knowledge, practice, and microbiological contamination. First, personnel hygiene had a significant correlation with 'total food hygiene knowledge' scores (p<0.05). Second, total food hygiene practice scores had a significant correlation (p<0.05) with improved microbiological qualities of lettuce salad. Third, concerning the assessment of microbiological quality after 1 month, there were significant (p<0.05) improvements in times of heating, and the washing and division process. On the other hand, after 2 months, microbiological was maintained, although only two categories (division process and kitchen floor) were improved. This study also investigated time-temperature control by using ubiquitous sensor networks (USN) consisting of an ubi reader (CCP thermometer), an ubi manager (tablet PC), and application software (HACCP monitoring system). The result of the temperature control before and after USN showed better thermal management (accuracy, efficiency, consistency of time control). Based on the results, strict time-temperature control could be an effective method to prevent foodborne illness.