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Objective:The standardized medical device clinical trials in China began in a short time, and the quality of trials needs to be improved.This article intends to explore possible ways for the improvement of quality management of the medical device clinical trials.Methods:Through working practice and literature review, analyze the current status of medical device clinical trials and in vitro diagnostic reagent in China; put forward targeted improved measures for the quality management system; as well as verify its feasibility through practice.Results:This article summarizes three factors that limit the improvement of the quality of medical device clinical trials, including the insufficient research and development strength of sponsors, the limited professional level of research teams, and the differences in verification and drugs, based on the risk-based quality management concepts, puts forward improved measures from three aspects, which including building risk-based quality certification system, making full use of electronic information systems to ensure the trial quality, and strengthening training of clinical trial capacity of researchers, and verifies the feasibility of these measures via the practical experience of our hospital since 2016.Conclusions:The application of risk-based quality management system, electronic information system and clinical trial capacity training can improve the management quality for medical device clinical trial centers.
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Objective To evaluate the cleaning quality of different cleaning methods for laparoscopic instruments, ensure the cleaning quality of instruments.Methods The used laparoscopic instruments were classified into two categories: non-lumen instruments and lumen instruments. Three cleaning methods, traditional manual cleaning (A), manual cleaning + ultrasonic cleaning (B), manual cleaning + automatic cleaning disinfector (C), were adopted respectively for treating instruments. Cleaning quality of instruments were detected with ATP bioluminescence assay.Results The qualified rates of laparoscopic non-lumen instruments cleaned by methods A, B, and C were 78.75％, 95.71％, and 96.00％ respectively, difference was significant (χ2=16.453, P＜0.001);qualified rate of methods B and C for cleaning non-lumen instruments was higher than that of method A (P＜0.016), there was no significant difference between methods B and C (P＞0.016). Qualified rates of laparoscopic lumen instruments cleaned by methods A, B, and C were 76.47％, 98.75％, and 91.55％ respectively, difference was significant (χ2=21.087, P＜0.001); qualified rates of methods B and C for cleaning lumen instruments were both higher than that of method A (P＜0.016), there was no significant difference between methods B and C (P＞0.016). Conclusion Effect of manual cleaning + ultrasonic cleaning and manual cleaning + automatic cleaning disinfector on used laparoscopic instruments are both better than that of traditional manual cleaning method, can effectively guarantee the cleaning quality of instruments and help to ensure the operation safety of patients.
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The aim of the development course in university is to expand the multidisciplinary knowledge.The students,who choose development course,are coming from many subjects.Therefore,the design and teaching methods of this course should have their own characteristics.This study introduces the exploration of medical instrument course with defense features and talent training mode.The core ideas of curriculum reform include the following.The course contents should be professionally subdivided,so that all the students from different majors can obtain the knowledge.Teaching methods should be guided by the national defense requirements using lectures and discussions.Multiply assessment modes,such as speech,discussion,paper poster,and creative exhibition,can be used to evaluate the students.The present reforms have been implemented in the reality of course teaching practice.The reform contents in this paper have a great significance to the creation of development courses based on the integration of preponderant disciplines in the university.
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Objective To study the application of quality control circle (QCC) in reducing the damaging rate of ophthalmic instruments.Methods A QCC group was established,and a QCC knowledge training themed by reducing the damaging rate of ophthalmic instruments was conducted,then a series of measures were taken,such as making an activity plan,grasping the current situation,setting up a goal,executing analysis,making a countermeasure,implementing the countermeasure and verifying effectiveness.Results After implementing QCC activity,a scientific and reasonable flow chart of ophthalmic instruments management was made,and the damaging rate of ophthalmic instruments was reduced from 9.80％ to 5.20％ (P ＜ 0.05),improved by 46.94％.The control rate reached 94.66％;and still was kept higher than 90％ in the effectiveness maintenance period.Also,8 kinds of abilities of QCC members were improved as well.Conclusion Damaging rate of ophthalmic instruments could be greatly reduced by carrying out QCC activities,and the utilization rate of ophthalmic instruments is increased;meanwhile,the satisfaction degree of doctors and patients is enhanced,and abilities of members of QCC also are promoted.
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Objective To explore the practicability and feasibility of the oxygen humidification bottle drying rack for drying wet bottle and inner core.Methods Totally 600 sets of recovered humidification bottles and inner cores were cleaned and sterilized,and then divided equally into an experimental group and a control group.The experimental group used the oxygen humidification bottle and the control group applied the basket.The bottles and inner cores in the experimental group were placed upside down on the drying rack,and then underwent 3-h drying in the electric thermostatic drying cabinet (45 ℃).The bottles in the control group were placed in the plastic basket closely,and the inner cores were inserted in the gap between the bottles,then the bottles and inner cores went through 3-h drying in the electric thermostatic drying cabinet (45 ℃) as well.The two groups had 30 sets of bottles and inner cores dried at each time.Results The experimental had the drying rate (96％) significantly higher than that (68％) in the control group (x2=79.675,P＜0.005),while the rollover rate (0％) statistically lower than that (17.67％) in the control group (x2=58.14,P＜0.005).It's indicated that the experimental group behaved obviously better than the control group in drying rate and rollover rate.Conclusion The oxygen humiliation bottle drying rack has a good effect on fixing and drying wet bottles.The device can ensure the quality of disinfection,shorten the drying time and improve the working efficiency.
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Objective To study the application of quality control circle (QCC) in reducing the damaging rate of ophthalmic instruments.Methods A QCC group was established,and a QCC knowledge training themed by reducing the damaging rate of ophthalmic instruments was conducted,then a series of measures were taken,such as making an activity plan,grasping the current situation,setting up a goal,executing analysis,making a countermeasure,implementing the countermeasure and verifying effectiveness.Results After implementing QCC activity,a scientific and reasonable flow chart of ophthalmic instruments management was made,and the damaging rate of ophthalmic instruments was reduced from 9.80％ to 5.20％ (P ＜ 0.05),improved by 46.94％.The control rate reached 94.66％;and still was kept higher than 90％ in the effectiveness maintenance period.Also,8 kinds of abilities of QCC members were improved as well.Conclusion Damaging rate of ophthalmic instruments could be greatly reduced by carrying out QCC activities,and the utilization rate of ophthalmic instruments is increased;meanwhile,the satisfaction degree of doctors and patients is enhanced,and abilities of members of QCC also are promoted.
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Objective To explore the practicability and feasibility of the oxygen humidification bottle drying rack for drying wet bottle and inner core.Methods Totally 600 sets of recovered humidification bottles and inner cores were cleaned and sterilized,and then divided equally into an experimental group and a control group.The experimental group used the oxygen humidification bottle and the control group applied the basket.The bottles and inner cores in the experimental group were placed upside down on the drying rack,and then underwent 3-h drying in the electric thermostatic drying cabinet (45 ℃).The bottles in the control group were placed in the plastic basket closely,and the inner cores were inserted in the gap between the bottles,then the bottles and inner cores went through 3-h drying in the electric thermostatic drying cabinet (45 ℃) as well.The two groups had 30 sets of bottles and inner cores dried at each time.Results The experimental had the drying rate (96％) significantly higher than that (68％) in the control group (x2=79.675,P＜0.005),while the rollover rate (0％) statistically lower than that (17.67％) in the control group (x2=58.14,P＜0.005).It's indicated that the experimental group behaved obviously better than the control group in drying rate and rollover rate.Conclusion The oxygen humiliation bottle drying rack has a good effect on fixing and drying wet bottles.The device can ensure the quality of disinfection,shorten the drying time and improve the working efficiency.
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Objective To investigate the current situation of medical instrument cleaning in Central Sterile Supply Departments(CSSD),in order to identify problems and provide references for further improvements of equipment cleaning.Methods Questionnaire survey was adopted,data of 127 CSSDs in five coastal provinces or cities in China in 2017 were collected,and status of each link of medical instrument cleaning was analyzed.Results The allocation rate of ultrasonic cleaner and spray cleaner were 96.6％ and 78.7％,respectively;62.2％ of hospitals used tap water to pre-rinse,and 10.2％ used normal saline or sterile water to pre-rinse,11.0％ used tap water for finial rinsing;78.7％ of hospitals did not perform continuous humidification in transit,and 18.1％ of hospitals did not perform continuous humidification and their time of transit was more than 2 hours;66.9％ of CSSDs only used multi-enzyme detergent.More than half of the hospitals did not record time for manual rinsing/manual final rinsing.Conclusion The configuration of medical instrument cleaning equipment of 127 CSSDs is good.However,it is necessary to pay more attention to cleaning details.Specifications for instrument cleaning water should be established;continuous humidification during transportation of medical instruments should be promoted;cleaning methods and cleaning detergents should be selected reasonably;standardized rinsing should be enhanced to ensure quality of medical instrument cleaning.
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Objective To improve the quality of medical device clinical trial.Methods To analyze medical device clinical trials conducted in our hospital from 2006 to 2010,and proposed the strategy to strengthen medical device clinical trial management.Results Most of the medical devices clinical trials were class Ⅲ medical devices clinical validation in our hospital,Surgical departments undertook most of the clinical trials.Until July 2013,49 trials were done only 56％ of undertake the project.96％ of completed trials were approved for medical device registration certificate.Conclusions The quality of clinical trials must be improved,andthe quality control process in medical device clinical trial should be reinforced.
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Objective To improve the cleaning quality of reusable medical instruments continuously through root cause analysis,reduce healthcare-associated infection(HAI)and the wear and tear of instruments.Methods The major factors influencing the cleaning quality of instruments were analyzed and clarified by fishbone diagram,contin-uous quality improvement was carried out based on 5 terminal factors,the rate of rusting,stain,repeated cleaning, damage,and clinical department satisfaction before and after the implementation of continuous improvement were compared.Results The qualified rate of instrument clean increased from 94.24% before implementing measures to 97.60% after implementing measures,the rate of rusting,stain,repeated cleaning,damage decreased from 3.39%, 2.37%,5.76%,and 2.08% to 1 .55%,0.85%,2.40%,and 0.48% respectively,there were significant difference among different groups(all P <0.001 );the score of satisfaction rate to central sterile supply department elevated from(93.87±3.87)before implementing measures to (98.08 ±0.59)after implementing measures(t =6.80,P <0.001).Conclusion Root cause analysis is important in improving cleaning quality of reusable instruments continu-ously,as well as reducing HAI and the wear and tear of instrument,it can save medical cost.
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Objective:The role of the medical instruments in clinical diagnosis and treatment is getting more and more important, especially the application of new technologies and equipment promote and improve the level of clinical diagnosis and treatment, and the advantages bring the gospel to the patients. However, due to the limitations of technologies, tools, design and lack of materials, the medical instruments introduced to the hospital existing defects. Meanwhile, operation staff’s inadequate knowledge poses potential hazard to the health care’s quality. Methods: So now days when referring to the medical quality control, we should and must concern about the quality control of medical equipment to improve health care quality control standards. The essay comes forward preliminary method to carry out medical equipment quality control system established work with the dissecting of the present health care quality situation. Results:These jobs are the basic, whether to carry out the job and promote health care quality management depend on the practice of competent departments and professionals. But most hospitals are reusing and repurchasing and ignoring the medical equipment control quality, these situations need to be correct immediately. Conclusion:Otherwise, the development of medical technologies will increased the risk and damage to the improvement of health care, even the price of life.
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Objective To study the effectiveness of alkaline electrolyzed water (AEW)in the cleaning of medical instruments and its corrosive effect on metal. Methods Medical instruments of solid smooth,solid with gear or tube were cleaned with AEW adding ultrasonic washing,cleaning efficacy were compared with conventional method, AEW without pulsing ultrasonic washing and control group,corrosive effect of AEW on metal immersed in AEW was tested. Results Cleaning efficacy of solid smooth,solid with gear or tube instruments were significantly differ-ent among four groups(F= 10.868,14.268,6.146,respectively,all P0.05). AEW had no corrosive effect on stainless steel and copper. Conclusion The cleaning efficacy of AEW on solid smooth,solid with gear instruments is su-perior to conventional cleaning method,and can achieve better effectiveness if ultrasonic cleaning is added.
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In 2008, Korea has enacted new ordinances about the role of estheticians, but this law can be interpreted ambiguously, restricting hiring of estheticians in medical clinics. The purpose of the study is to obtain information about medical-esthetic systems in other countries. We have taken a survey of this object from 30 OECD & Asian countries, and the questionnaires returned from a total of 22 countries (Australia, Austria, Canada, Denmark, Finland, France, Germany, Hungary, Japan, Netherlands, New Zealand, Norway, Portugal, Slovak Republic, Spain, Switzerland, Turkey, United Kingdom, United States, Singapore, Israel, and Thailand), were used for the final analysis. The results are summarized as follows. In most countries, estheticians working independently deal with only healthy, normal skin. In most countries, estheticians working independently have no right to operate any medical instruments. In all 17 countries that returned the questionnaires medical clinics can employ estheticians, and only theses estheticians who belong to the medical clinics can handle the non-invasive medical instruments under the supervision of doctors. In 17 countries that have related legal regulations, nurses, under the control of doctors, can perform wider range of duties in various settings than estheticians. The survey concludes that the duties of estheticians are closely related with medical skin care services and estheticians can perform various non-invasive medical procedures only under the control of doctors. From consulting a variety of medical-esthetic systems in other countries, we propose that the estheticians be allowed to work in medical clinics to provide better medical services for the patients and to make more chances of employment for themselves.
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Humans , Asian People , Austria , Canada , Denmark , Employment , Finland , France , Germany , United Kingdom , Hungary , Israel , Japan , Jurisprudence , Korea , Netherlands , New Zealand , Norway , Organization and Administration , Portugal , Surveys and Questionnaires , Singapore , Skin , Skin Care , Slovakia , Social Control, Formal , Spain , Switzerland , Turkey , United StatesABSTRACT
OBJECTIVE To analyze situation of clearence of rust in the surgical operation apparatus.METHODS 300 surgical operation apparatus were choosed,divided into the A,B,C groups.For group A,soak method was taken to clear the rust,group B with soak and hand scrub in method,group C with soak.hand scrub and lubricant method.RESULTS The method for group C was most effective.The qualified rate and re-rust rate were 99.0% and 2.0%,respectively.CONCLUSIONS Clearence is a better method for operation apparatus maintanance,but daily cleaness is also important to avoid rusting.
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OBJECTIVE To explore an effective cleaning method to improve the washing quality of contaminated complicated medical instruments.METHODS The used puncture needles were washed by three methods(ultrasonic wave only,ultrasonic wave + polyenzyme detergent,ultrasonic wave + spray washing with special washing-rack designed by ourselves,while artificial washing group as control group,3 pieces per group).After washing,the samples were further assayed with HemoCheck-s swab to compare the washing effect.RESULTS The color of cotton swabs was turned blue or light blue.CONCLUSIONS Our results have demonstrated that ultrasonic cleaning plus spray washing with special washing-rack can improve the cleaning quality.
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OBJECTIVE To transfer the dispersing management non-disposable medical instrument packages into the centralized management by the supply department,to improve its quality and save the medical cost.METHODS The centralized management adopted the step by step implementation strategy,standardized recycling,cleaning,and packaging procedure for key instruments.The cleanliness and integrity of the packaging sheet,the in-packet indicator cards and the out-packet label,and instrument and their human and material resources consumption were compared each other.RESULTS Under the centralized management,the cleanliness and integrity of packaging sheet,the wholeness indicator cards in packet and outside packet of instrument label were obviously better than dispersing management(P
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OBJECTIVE To discuss the quality management of the recycled medical instrument.METHODS We executed the routine of recycled instrument seriously during our daily work,and gave strict measures during quality management such as callback,washing,classification,packaging,sterilization,handout,and inspection.RESULTS The recycled medical instrument had been used and managed for more than one year and the clinical work was ensured in progress smoothly and achieved satisfied results.CONCLUSIONS Actualizing the measure of quality control,perfecting the method of management and improving quality control could assure the safe and efficient use of recycled medical instrument and reach the standard of controlling hospital infection,and advancing medical nursing level.
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OBJECTIVE To explore the impact factors on the process of washing and disinfection for medical instruments.METHODS The reasons that tend to cause bad washing quality were analyzed in the process of washing for medical instruments and corresponding measures were taken.RESULTS Efficient washing procedures should be installed in the process of washing for medical instruments and washing effects should be affirmed.CONCLUSIONS Efficient washing methods should be taken to guarantee successful sterilization and control hospital infection.
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OBJECTIVE To study the medical instruments,packs,and textile goods disinfected and sterilized in a hospital. METHODS Totally 432 of surgical instruments were randomly divided into 4 groups.They were washing by hands and machines and detected their blood residue. RESULTS Using the multi-enzyme detergent was more effective than unused.It was helpful for the contaminated medical instruments clean by multi-enzyme detergent for(2 min). CONCLUSIONS It is important for assure the quality of the disinfection and sterilization to proper cleaning and the care of the medical instruments.
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OBJECTIVE To study and improve the washing methods for the metal piping medical instruments. METHODS Some contaminated metal uteroventral scraping and drawing instruments were randomly divided into group A(by the ultrasonic vibration with proteinase washing method)and group B(by the traditional manual washing method). The effects of two washing methods were studied. RESULTS The qualified rate of experimental samples in the group A was higher than that in the group B(P