Evaluation Of Current Medical Device Manufacturers And Anti-bacterial Medicines Application On The In-patients In A District, Shanghai

Rapid response to public health crisis or emergency depends on an intact system for the disease control and prevention. Components of this system compose of reserves of some medical apparatus, medicine and manufacturing capacity as well as professionals. Manufacturers of medical devices and application of antibiotics and other anti-bacterial agents are key elements for the control of infectious disease epidemic and immediate response to the public health crisis. In this study, the two key elements for the infrastructure construction of the system were extensively evaluated in a district, Shanghai.Part I Evaluation of current medical device manufacturers in a District, ShanghaiTo grasp the current circumstances of the medical device manufacturers in a District, Shanghai, discover existing problems, and provide evidences for the supervision and infrastructure for immediate response to emergent public health events. Cross-sectional study was employed to investigate the general situation of the medical device manufacturers, professional capacities, hardware facilities and administrative mechanism. Indicators concerning those manufacturers were evaluated by systemic scoring. Educational background of the personnel at administrative levels were qualified. Majority of them held Bachelor degree and were appointed as engineers. Professionals got high score. Average comprehensive score of those manufacturers investigated was above 90%, reaching the level of"fine". But relatively low score was obtained in the administrative mechanism. Significant difference in the comprehensive scores was also determined between manufacturers for class II medical device and class III medical device. The medical device manufacturers in this District have good technical potency. But current administrative regulations need to be improved and regulations need to be strictly followed. The manufacturers for class II medical devices need to improve own requirement. Strict supervision should be enforced. Part II Epidemiological survey of anti-bacterial medicines application on the in-patients in a district, ShanghaiSeventeen hospitals were selected for the survey of anti-bacterial medicines application on 4089 case/times of the in-patients in 2004. Contents of the investigation included the purpose of antibiotics application, name of anti-bacterial medicines, therapeutic course, administered pathway, side effect and cost of medicine. The participants were mainly of self-paid patients and similar in gender ratios. Departments of hospitals covered Internal Medicine, Surgery, Gynecology and Pediatrics, mainly Department of Internal Medicine and Surgery. The results were stated as followed.1. Basic situation of anti-bacterial medicines application. Major purpose of anti-bacterial medicines application was for the treatment of bacterial infection, accounting for 60.5%. The rest was for the prevention of infection, mainly for the prevention of infection after surgery. Those anti-bacterial medicines covered 17 categories including cephalosporin (33.16%), fluoroquinolones (13.84%), aminoglycoside antibiotics (13.12%) except furane. Antibiotics like chloromycetin, tetracycline were rare. Average categories of anti-bacterial medicines during the in-hospital period was 1.95±0.95 days, the most 8 days. Those who were administered more categories of anti-bacterial medicines were for therapeutic purpose, female patients, middle-aged group and medical insurance covered patients. Average duration of the anti-bacterial medicines application was 6.28±4.72 days, with median interval 5 days. The shortest was 1 day and the longest 71 days. Those with long term usage of the anti-bacterial medicines were male, for therapeutic purpose and treated in primary hospitals and cooperative medical survices. Average duration of the anti-bacterial medicines application was shortest in the 3rd grade comprehensive hospitals (6.06±4.34 days) and longest in the primary community hospitals (6.77±3.53 days) (F=4.871, p= 0.002). Administration pathway was mainly intravenous (85.11%), and then oral (11.95%). Side effect (ADR) was reported in 33 cases with incidence rate of 3.6‰, including penicillin 7.83‰(9 cases), cephalosporins 14.1‰(10 cases), and fluoroquinolones 5.37‰(7 cases). Expense of anti-bactrial medicines accounted for 31.07% of entire medicine expense.2. Analysis of reasonable anti-bacterial medicines application: In therapeutic administration, 1841 case/times (31.2%) were determined to be unreasonable, including 1248 cases/times unreasonable duration (extended or shorten), 494 wrong selection of anti-bacterial medicines and 99 lack of necessity. In the preventive administration after surgery, 548 of 1904 cases/times (28.78%) were determined to be unreasonable including 508 case/times extended administration and 40 cases/times wrong selection. In other preventive administration, 470 of 1636 case/times (28.72) were determined to be unreasonable, including 317 case/times extended duration, 153 wrong selection. In the evaluation of specific population, application rate of aminoglycoside in the infants under 5 years old was 6.28%, the rate of fluoroquinolones in the adolescents under 18 years old was 3.87%. Some renal toxic antibiotics like aminoglycoside were administered for 328 case/times (27.06%) to the aged population with renal function deficiency.Combined administration had been used for 936 case/times, 5.90% of which was determined to be unreasonable combination including combination of different aminoglycoside antibiotics. Serious problems, including anti-bacterial medicines administration in the aged, the infants and renal toxic aminoglycoside uasage, still existed in the primary and private hospitals.In summary, over and unreasonable usages of abti-microbacterial medicines existed in those in-patients in a District, Shanghai, especially in those primary and private hospitals.3. Suggestions:(1) Extensive training of the local doctors on pharmacological knowledges and the regulation of administration is very necessary to increase the professional levels of the doctors and prescription level of local hospitals in medical services. It is also necessary to guide reasonable usage of anti-microbial medicines in local community and then subsequently entire society.(2) Public health education of anti-bacterial medicines usage, basic knowledge of anti-bacterial medicines as well as medical policy will help in changing some traditional customs, idea and attitude of anti-bacterial medicines usage, and increase reasonable administration of these medicine.(3) Health department of local government need to enforce the anti-bacterial medicines management, especially in those primary and private hospitals.(4) Self-management in hospital need to be enforced accordint to the Indictive Regulation of Clinical Application of Anti-bacterial Medicines, issued by local government, to enforce the management of clinical application of anti-bacterial medicines and drug-resistance surveillance of the anti-bacterial medicines.Conclusion: From this study, current situation and existing problems were revealed in the medical device manufacturers and application of anti-bacterial agents in a District, Shanghai, which provides information for the improvement of our ability for the emgent response to public health crisis.