Objective:To investigate the medical equipment quality control work which need to be improved in Shanghai medical institutions, and evaluate the acceptability of hospital management team on regional medical equipment quality control checks and standard, so as to seek the corresponding solutions.Methods: The 92 copies of self-designed medical equipment management standard questionnaire was distributed, 76 valid questionnaires were reveived, the received rate of 83%.Results: Only 70% of the people thought the major difficulty is the shortage of medical equipment management staff; 97% thought the quality control has great impact on improvement of medical equipment management. Quality control center determined the annual topics about the problems and needs to form the problem oriented, team based, expert resource collaborative working model. And studied and formulated three specifications and recommendations templates. We carried out a four-month intensive training and received critical acclaim.Conclusion: Medical equipment management staff proposed new requirements. Questionnaire objectively reflected the difficulties in the quality control inspection work, but also pointed out the direction for the future management of the quality of promotion. It provided the thought to improve the quality management and to enhance management methods and training models in the future.

OBJECTIVE:To investigate the correlation of blood concentrations of tamoxifen (TAM) and its metabolites with endometrial hyperplasia in estrogen receptor(ER)-positive breast cancer patients. METHODS:A total of 69 patients with ER-posi-tive breast cancer selected from our hospital during Mar. 2015-Apr. 2016 received TAM (twice a day,one tablet each time) for more than 6 months. According to endometrial thickness,they were divided into abnormal hyperplasia group(40 cases)and normal group(29 cases). The steady state concentrations of TAM and its metabolites [4-OH-tamoxifen(OHT),N-demethylation tamoxifen (DMT),Endoxifen] were determined by HPLC-FLU. The correlation of blood concentration and other factors with endometrial thickness were investigated by Pearson test and multiple regression analysis. RESULTS:The medication time and Endoxifen steady state concentration in abnormal hyperplasia group were both significantly longer or higher than normal group,with statistical signifi-cance (P<0.05). There was no statistical significance in age,BMI,complication and steady state concentrations of TAM,OHT and DMT between 2 groups(P>0.05). The endometrial thickness was positively correlated with Endoxifen steady state concentra-tion and medication time(r=0.447,0.460,P<0.05). Using endometrial thickness(y)as dependent variable,medication time(x1) and Endoxifen steady state concentration(x2)as independent variable,multiple regression analysis was conducted. Multiple regres-sion equation was calculated as follows:y=2.436+0.123x1+0.082x2(F=12.610,r=0.526,P<0.05). CONCLUSIONS:Medication time and Endoxifen steady state concentration may be related to endometrial hyperplasia,which can provide reference for predicting TAM induced endometrial abnormal hyperplasia in ER-positive breast cancer patients.

Objective:Along with general hospital assessment opportunity, we explore to optimize ventilator management processes to reduce security risks by using the advanced quality management tools. Methods:Based on the ventilator maintenance statistical data in year 2012, we applied Pareto chart, Pareto curves and fishbone diagrams etc. quality management tools, and conducted PDCA cycle analysis on safety factors of ventilator clinical application. At the end, we summarized the results and provide improvements recommendations. Results:The cumulative proportions fell from 23.6%to 80%range, the human operator, compressor inlet;pipeline leaks and consumables management are a major are major factors. Through fishbone diagram analysis, we categorized them into 4 aspects:personnel, operations, equipment and supplies management. We optimized existing systems and processes from three areas:the device management, supplies management and training. By implementing these improvements plans, the security risk caused by supplies management was basically solved, the effect is very obvious. Conclusion:By using quality management tools, the safety problems during clinical application of ventilator can be reflected directly and clearly, and protect ventilator safe and stability to next level, so that it helps medical equipment management be more scientific, effective and normative.

The hydrogen peroxide low temperature plasma sterilization technology solved the problems of thermo-sensitive materials' disinfection and sterilization based on its development and unique characteristics. This paper introduced the researches of clinical application quality control, and showed the hydrogen peroxide low temperature plasma sterilizers were being widely used in hospitals and highly recognized. According to the clinical data and the literatures of the domestic equipment in preliminary application, it could be concluded that the technology maturity of domestic hydrogen peroxide low temperature plasma sterilizers was in a high level. The advantages of using domestic hydrogen peroxide low temperature plasma sterilizers to do disinfection and sterilization included lower cost, safer, faster and non-toxic, etc. Also the management system should be improved and the clinical staff should master the technical essentials, obey the procedures strictly, verify periodically and offer full monitoring to upgrade the quality of sterilization.
Cold Temperature ; Disinfection ; instrumentation ; Hydrogen Peroxide ; chemistry ; Plasma Gases ; chemistry

Objective:To study the correlation between plasma concentration and clinical efficacy in newly diagnosed type 2 diabe-tes treated with nateglinide. Methods:On the basis of diet control and exercise, 73 cases of newly diagnosed type 2 diabetes received nateglinde therapy for 2 months. Adverse events were routinely monitored during the therapy. Fasting blood glucose(FBG), 2h post-prandial blood glucose(2h-PG), fasting C-peptide(F-CP), 2h C-peptide(P-CP) and glycosylated hemoglobin (HbA1c) were ob-served before and after the treatment. LC-MS was used to determine the plasma concentration of nateglinide on the last day of treat-ment. Results:FBG, 2h-PG, HbAlc and P-CP after the treatment had significant changes when compared with those before the treat-ment (P<0. 05). There was no significant difference in F-CP in spite of minor increase (P>0. 05). The difference in HbA1c and P-CP before and after the treatment both showed a significantly positive correlation with plasma concentration of nateglinide (P<0. 05). Conclusion:Nateglinide displays good clinical efficacy and safety in newly diagnosed type 2 diabetes, and its plasma concentration can be used to evaluate the pancreatic islets function and glucose-lowing effects.

The quantity of medical equipment in hospital rise quickly recent year. It provides the comprehensive support to the clinical service. The maintenance of medical equipment becomes more important than before. It is necessary to study on the orientation and function of clinical engineer in medical equipment maintenance system. Refer to three grade health care system, the community doctors which is called General practitioner, play an important role as the gatekeeper of health care system to triage and cost control. The paper suggests that hospital clinical engineer should play similar role as the gatekeeper of medical equipment maintenance system which composed by hospital clinical engineer, manufacture engineer and third party engineer. The hospital clinical engineer should be responsible of guard a pass of medical equipment maintenance quality and cost control. As the gatekeeper, hospital clinical engineer should take the responsibility of "General engineer" and pay more attention to safety and health of medical equipment. The responsibility description and future transition? development of clinical engineer as "General Engineer" is discussed. More attention should be recommended to the team building of hospital clinical engineer as "General Engineer".
Engineering ; Equipment Safety ; Equipment and Supplies, Hospital ; Humans ; Maintenance and Engineering, Hospital ; Safety Management ; organization & administration

In 2011, Shanghai Medical Equipment Management Quality Control Center launched the fifth after-sale service satisfaction survey for medical devices in Shanghai area. There are 8 classes medical devices involving in the survey. This paper demonstrates the investigation results of monitoring devices which are from different manufacturers.
Consumer Behavior ; Equipment and Supplies ; Product Surveillance, Postmarketing ; Quality Control

To improve the manufacturer's medical equipment after-sale service, the fifth Shanghai zone customer satisfaction survey was launched by the end of 2011. The DSA/X-ray equipment was setup as an independent category for the first time. From the survey we can show that the DSA/X-ray equipment's CSI is higher than last year, the customer satisfaction scores of preventive maintenance and service contract are lower than others, and CSI of local brand is lower than imported brand.
Consumer Behavior ; Product Surveillance, Postmarketing ; statistics & numerical data ; Quality Control ; Radiography ; instrumentation ; standards

This study based on the technology evolution theory, S-curve and bibliometrics, verified product evolution was accompanied by the evolution and transition of a number of sub technologies. It judged MRI was in the stage of underdevelopment and a new round of technology was being developed. It was found that the value of MRI equipment in scientific research or clinical application in foreign countries was higher than that in China by comparing the literatures at home and abroad. And there was a gap between China and the world scientific center in the independent R&D capability. The study verified the applicability of the technical evolution theory and the evaluation empirical laws in the medical devices evaluation, and explored the operability of the assessment tools. This paper not only provided a reference for equipment configuration, but also showed the gaps of key technologies in home and abroad and provided a reference for upgrading China's independent innovation and industrial technology.
China ; Industry ; Magnetic Resonance Imaging ; instrumentation ; Technology ; trends

OBJECTIVEEstablish a regional cloud account of hospital medical equipment based on dynamic two-dimensional code link.

METHODSEstablish a medical equipment data platform based on B/S architecture. Combined with mobile internet means such as WeChat and try the industrial 4.0 designed intelligent boxes.

RESULTSThe problem of no interface transmission and integration of the regional medical equipment account information is solved. It dynamically collects equipment data, operation cost and efficiency. The real-time operation data is visualized.

CONCLUSIONSThe dynamic management platform of regional medical equipment helps to standardize the management of large medical equipment and improve the utilization ratio of medical equipment. The platform provides basis of management decisions and equipment allocation for relevant departments.