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Part 1: Model text of medical testing scheme
According to the national medical care This work plan is formulated in accordance with the spirit of the device supervision work conference and the regional drug supervision work conference, and in combination with the key work points of the Tibet Autonomous Region Drug Administration in 2021, in order to effectively prevent and control the quality and safety risks of medical devices in our region and improve the quality and safety assurance level.
1、 Guiding ideology
2021 is the first year of the "14th Five Year Plan". To do a good job of medical device supervision in our district this year, we should adhere to the guidance of Xi Jinping Thought on Socialism with Chinese Characteristics for a New Era, comprehensively implement the 19th National Congress of the Communist Party of China, the 2nd, 3rd, 4th, 5th Plenary Sessions of the 19th Central Committee, the 7th Tibetan Work Forum of the Central Committee, the 8th Session of the 9th District Party Committee The spirit of the Ninth Plenary Session of the Ninth National People's Congress and the Economic Work Conference of the District Party Committee, based on the "four strictest" requirements of General Secretary Xi Jinping, and in accordance with the requirements of basing on the new development stage, implementing the new development concept, and building a new development pattern, keeps the bottom line to ensure safety, pursues the high line to promote development, and effectively guarantees the safety and effectiveness of people's equipment, Celebrate the 100th anniversary of the founding of the Party and the 70th anniversary of the peaceful liberation of Tibet with outstanding achievements.
2、 Job responsibilities and requirements
The drug regulatory functional departments at all levels should improve their awareness, implement their local management responsibilities, and follow the relevant laws and regulations such as the Regulations on the Supervision and Management of Medical Devices, the Measures for the Supervision and Management of Medical Device Production, the Measures for the Supervision and Management of Medical Device Business, and the Measures for the Supervision and Management of the Use Quality of Medical Devices, Pay close attention to the potential risks and prominent problems existing in the production, operation and use of medical devices, take the initiative to prevent and resolve various risks, standardize the in-process and post supervision, severely crack down on violations of laws and regulations, further compact the main responsibility for the quality and safety of medical devices of the production, operation and use units of medical devices, and ensure that the work of medical device supervision is carried out orderly and effectively.
3、 Key points
（1） Strengthen epidemic prevention and control, and serve the overall situation
At present, the COVID-19 epidemic is still spreading globally, and there are still sporadic cases in many places in China. The drug regulatory functional departments at all levels should not relax to pay attention to the normalization of epidemic prevention and control. According to the requirements of the Notice on the Quality Supervision of Medical Devices for Epidemic Prevention and Control under Normalization testing Focus on five categories of products, including reagents, medical masks, and medical protective clothing, and focus on checking whether the products used in their production and operation have been registered and approved and have qualification certificates, whether the purchase and sales channels are legal, whether the records of purchase inspection and sales are true, complete, and traceable, and whether the transportation and storage conditions meet the labeling requirements of labels and instructions, Whether appropriate facilities and equipment are equipped, whether the quality management system is effectively operated, etc., continue to strengthen the supervision of all links of medical devices for epidemic prevention and control, crack down on counterfeiting and selling, and consolidate the hard won prevention and control achievements. Among them, the supervision and inspection of COVID-19 detection reagents should be reported to the Food and Drug Administration of the autonomous region every quarter (see annex).
（2） Deepen the "release and management service" and carry out the review and approval work in an orderly manner
We will continue to improve the review and approval system, continue to release the dividend of the reform of "release, regulation and service", adhere to the fundamental standard of safety and effectiveness, strengthen communication and exchange, serve the development of the medical device industry, and constantly improve the public's attention and satisfaction rate on medical device supervision.
1. Improve the quality of variety registration and filing review and approval. The Food and Drug Administration of the autonomous region is responsible for the review and approval of the registration of Class II medical devices in the region. The Medical Device Registration and Supervision Management Office and the Tibetan Medicine Evaluation and Certification Center strengthen cooperation, improve the communication mechanism, summarize the experience and practices of emergency approval and product review in 2020, and continue to do a good job in the quality assessment and evaluation of medical device review and approval. Encourage enterprises to apply for registration of medical device varieties, and strengthen technical guidance in accordance with the Procedures for Priority Examination and Approval of Class II Medical Devices in the Tibet Autonomous Region. All municipal bureaus should actively encourage enterprises within their jurisdiction to apply for variety filing, standardize the filing work in strict accordance with the requirements of relevant laws and regulations on medical device filing, implement the requirements of the Notice of the State Food and Drug Administration on Carrying out the Standardized Work of Class-I Medical Device Filing, and strictly prohibit the occurrence of "high class low batch" and non medical devices filed as medical devices, The Food and Drug Administration of the Autonomous Region will supervise and inspect the filing of Class I medical devices in relevant municipal bureaus by the end of March, and inspect the implementation of the cleaning and standardization of Class I medical devices on the spot.
2. Carry out the registration of medical device production and operation license. The autonomous region's Food and Drug Administration, in accordance with the Measures for the Supervision and Administration of the Production of Medical Devices and other relevant laws and regulations, orderly carried out various administrative approvals for medical device production license, clinical trial filing, Internet information service qualification certificate approval, medical device network third-party platform filing, and medical device operating enterprises in the Tibetan Green Industrial Park. All municipal bureaus shall carry out business license filing work in strict accordance with relevant laws and regulations, such as the Measures for the Supervision and Administration of Medical Device Business, the Detailed Rules for the Implementation of On site Inspection of Medical Device Business Quality Management Norms in the Tibet Autonomous Region (for trial implementation), and it is strictly prohibited to set access conditions in violation of laws and regulations.
（3） Inherit and carry forward Tibetan medicine therapy and promote the standardization of Tibetan medical equipment
Tibetan medical instruments are widely used in Tibetan medical institutions in our region, such as the traditional Tibetan medical bleeding knife, Zamai Chongguo and many other Tibetan medical instruments play an important role in Tibetan external treatment. In order to inherit and carry forward the Tibetan external medical treatment method and standardize the clinical use of Tibetan medical devices, the autonomous region's drug administration submitted 25 applications for classification and definition of commonly used clinical Tibetan medical devices to the State Food and Drug Administration. In 2021, the State Food and Drug Administration will actively coordinate with the State Food and Drug Administration to issue the classification catalog of Tibetan medical devices and start the development of Tibetan medical device standards.
（4） Strengthen bottom line thinking and strictly control risks
Keeping the safety bottom line is always the top priority and the most fundamental responsibility. Drug regulatory functional departments at all levels should strengthen regulatory measures, further sort out the potential risks in the field of medical device supervision, increase the accuracy and effectiveness of supervision and inspection, and ensure that the quality and safety situation of medical devices in our region continues to be stable and good. All municipal bureaus should strengthen supervision and inspection according to their respective functions, strengthen the targeting and effectiveness of inspection, urge enterprises to implement the main responsibility of product quality and safety, establish and improve the quality management system suitable for the medical devices involved and ensure its effective operation, and require enterprises to regularly conduct a comprehensive self inspection of the quality management system and submit a self inspection report as required, Timely rectify the problems found in the self inspection report and the supervision department's spot check and inspection, and take control measures and seriously investigate and deal with the violations found in the inspection.
First, we should do a good job in the supervision of production links. According to the regulations of the State Food and Drug Administration on classified and hierarchical supervision of medical device manufacturers, the autonomous region Food and Drug Administration regularly issues the Catalogue of Key Medical Devices under Supervision in Tibet Autonomous Region according to the risk level of medical device varieties, and implements classified and hierarchical supervision and management of medical device manufacturers in the region. The Tibetan Drug Evaluation and Certification Center organizes the implementation of the second Class III medical device manufacturer inspection. In 2021, in accordance with the relevant requirements of the State Food and Drug Administration, on the basis of full research, we will explore the unique identification of medical devices for implantable medical device manufacturers. The Tibetan Medicine Evaluation and Certification Center of the Autonomous Region will be responsible for the full coverage inspection of manufacturers of implantable and epidemic prevention and control products, and the dynamic tracking inspection of newly registered category II medical devices in 2020. Each municipal bureau shall, in combination with the actual situation in its jurisdiction, implement classified and hierarchical supervision on the filed Class I medical devices, and be responsible for formulating and implementing the supervision and inspection plan for Class I medical device manufacturers in its jurisdiction.
The second is to strengthen the supervision of operation and use links. The drug regulatory functional departments at all levels shall, in accordance with their statutory duties, actively complete the tasks of the superior drug regulatory departments, consolidate the results of each special inspection, and formulate and organize the implementation of the supervision and inspection plan for the operation and use of medical devices in combination with the actual situation in their respective jurisdictions. In 2021, the Tibetan Medicine Evaluation and Certification Center of the Autonomous Region will be responsible for the supervision and inspection of medical device operating enterprises in the Tibetan Youth Industrial Park. In combination with this year's centralized renewal work, the supervision and inspection ratio will not be less than 50%. The inspection coverage rate of each municipal bureau for medical device operating enterprises within its jurisdiction is: if the number of operating enterprises is more than 200, the inspection proportion shall not be less than 20%; 100-200, the inspection proportion shall not be less than 30%; If there are less than 100, the inspection proportion shall not be less than 40%. Full coverage inspection shall be carried out for key medical institutions such as public hospitals above Level II (including Level II) and large private hospitals in the jurisdiction, and other medical institutions shall limit the inspection coverage rate in combination with the actual situation in the jurisdiction.
1. Deeply carry out special supervision and inspection of sterile implantable medical devices. According to the unified arrangement and deployment of the National Bureau, the autonomous region's drug administration formulates the region wide sterile and implantable medical device action based on the actual situation programme The municipal bureaus are specifically responsible for carrying out special inspection of sterile and implanted medical devices in the operation and use link, continuing to carry out the governance of illegal behaviors, and focusing on the rectification of illegal operation and use of medical devices.
2. Continue to carry out special supervision and inspection on decorative color flat contact lenses and condoms. The Food and Drug Administration of the autonomous region will no longer issue these two work plans separately. According to the requirements of the General Office's Notice on Cracking Down on the Illegal Operation of Decorative Colored Flat Light Contact Glasses (SFJBJJ [2015] No. 48) and the Notice on Strengthening the Quality and Safety Management of Condoms (SFJBJJ [2015] No. 30) issued by the former State Food and Drug Administration, Formulate a special inspection plan for the jurisdiction in combination with the actual supervision. For the key areas around the school, supermarkets, hotels and so on, efforts should be made to investigate and deal with illegal acts such as unlicensed operation, non-standard purchase inspection, and illegal production and sales, and products should be supervised and sampled when necessary. At the same time, with the help of new media and traditional media platforms, scientific publicity and education on decorative colored flat light contact lenses and condom products will be strengthened to further enhance the public's awareness of safe use of equipment and gradually create a good atmosphere of social governance.
3. Strengthen the supervision of online sales of medical devices. In accordance with the work deployment of the State Food and Drug Administration for "clearing the Internet" action in 2021 and the Measures for the Supervision and Administration of Online Sales of Medical Devices, the autonomous region Food and Drug Administration plans to reach a cooperation agreement with China Health Media Group, build a scientific monitoring mechanism by relying on information technology, and actively monitor the online sales of medical devices in our region. All municipal bureaus should highlight the problem orientation, strictly investigate and deal with illegal behaviors of online sales of medical devices, clean up illegal enterprises, illegal products and illegal information, and purify the marketing environment of medical devices. Deepen the implementation of responsibilities, further consolidate the main responsibility of medical device online sales enterprises, and enhance the awareness of law-abiding and integrity of enterprises. Strengthen the treatment of both symptoms and root causes, strengthen communication and cooperation with relevant departments, jointly crack down on illegal behaviors of online sales of medical devices, and form a long-term regulatory mechanism. The data monitored by the national Internet medical device information and transaction monitoring platform should be checked, processed and fed back in a timely manner.
4. Strengthen the inspection of use links. All municipal bureaus, according to the arrangement and deployment of special inspections and the requirements of the Notice on Strengthening the Quality Management of Medical Oxygen (TIYJ [2021] 2) jointly issued by the Market Bureau, the Health Commission and the Food and Drug Administration of the Autonomous Region, strengthen the supervision and inspection of medical device users with special inspections as the entry point, and urge users to strictly implement the Regulations on the Supervision and Administration of Medical Devices The Measures for the Supervision and Management of the Use Quality of Medical Devices and other laws and regulations require us to strengthen the annual reporting system of users, implement the main responsibilities of users, and constantly improve the quality management level of medical devices.
（5） Use spot check and inspection to enhance supervision effect
To effectively implement the tasks of national and provincial sampling, all municipal bureaus should actively cooperate with the autonomous region drug administration to implement the supervision and sampling inspection of medical devices, supervise and inspect the operating and using units at the same time of sampling inspection, and deal with problems found in a timely manner.
1. Implement the national sampling task. The Drug Administration of the autonomous region implements the national sampling work in accordance with the 2021 medical device sampling plan of the State Food and Drug Administration, and organizes various work such as supervision sampling, data entry, report delivery, and disposal of nonconforming products.
2. Carry out provincial sampling work. The Food and Drug Administration of Tibet Autonomous Region formulated the "2021 Provincial Medical Device Supervision and Sampling Plan of Tibet Autonomous Region" based on the sampling inspection situation in 2020. The Food and Drug Inspection Research Institute of Tibet Autonomous Region formulated and implemented specific sampling and inspection plans, and the municipal bureaus cooperated in the supervision and sampling work.
All municipal bureaus should pay attention to the application of sampling inspection results in the supervision work, further strengthen the inspection and disposal of unqualified medical device inspection products sampled by large countries and provinces, report the investigation results in time, complete the inspection and disposal tasks on time according to laws and regulations, and shall not affect the progress of national and provincial sampling work. Those who do not report the inspection and disposal results on time will be notified.
（6） Strengthen system concept and improve supervision ability
Adhere to the idea of "one game of chess for the whole district", strengthen the overall planning, coordinate and improve the ability level of medical device inspection and detection, supervision and inspection, case verification and disposal, promote the overall improvement of supervision ability, pool strong joint forces of supervision, and comprehensively consolidate the medical device supervision work according to the requirements of the new development stage, new development concept, and new development pattern.
1. Carry out legal business training. With the implementation of the newly revised Regulations on the Supervision and Administration of Medical Devices this year, the Food and Drug Administration of the Autonomous Region will carry out training on medical device laws and regulations and supervision practice for all municipal bureaus and 74 county (district) bureaus to continuously improve the level of supervision business.
2. Strengthen the top-level system construction. In combination with the current situation of our region's wide range of medical device use supervision, complex product categories involved, many regulatory risk points, weak regulatory measures, etc., the Autonomous Region Food and Drug Administration plans to organize the formulation of the Guidelines for the Inspection of Medical Device Users in Tibet Autonomous Region in 2021, to provide the basis for the drug regulatory authorities at all levels to carry out the use link supervision. In combination with the guidance of the State Food and Drug Administration on the third-party logistics of medical devices and the development trend of the industry, the Detailed Rules for the Implementation of the Operation Quality Management Standards of Medical Device Third Party Logistics Enterprises in Tibet Autonomous Region was formulated.
3. Enhance the inspection and detection support capability. The Food and Drug Inspection Research Institute of Tibet Autonomous Region undertakes the national sampling, provincial sampling, supervision and sampling inspection of medical devices. It shall report the sampling information in time and hand over the unqualified report as soon as possible. Focusing on the expansion of registered products and epidemic prevention devices in medical molecular sieve oxygen production and other areas, we continued to improve the inspection and detection capability of medical devices.
4. Improve the quality of monitoring and evaluation. The ADR Monitoring Center for Drugs and Cosmetics of the Autonomous Region organized the monitoring of adverse reactions of medical devices throughout the region, improved the monitoring system of adverse events of medical devices in the region, established and improved the working organization of the monitoring system, comprehensively promoted the construction of the monitoring system, and focused on medical devices and key risk products for epidemic prevention and control such as medical masks and protective clothing, Effectively improve the monitoring, evaluation and risk early warning capabilities of medical devices in our district. In 2021, the National Bureau will continue to incorporate the monitoring of municipal medical device adverse events into the year-end assessment. All municipal bureaus should attach great importance to it, equip and strengthen relevant institutions and personnel, and solidly carry out medical device adverse event monitoring and risk signal discovery within their jurisdiction.
（7） Innovate supervision methods and improve supervision means
The Fifth Plenary Session of the 19th Central Committee of the Communist Party of China (CPC) and the Seventh Central Working Forum on Tibet pointed out that innovation is the core of China's overall modernization drive. The drug regulatory functional departments at all levels should fully analyze the risks, blind spots and weaknesses existing in the regulatory process, actively explore innovative regulatory means, and introduce a number of practical regulatory policies that conform to the regulatory reality, so as to ensure the implementation of medical device supervision in the region. All municipal bureaus are encouraged to explore and study new working modes and formulate systems and regulations suitable for their own jurisdictions in combination with the actual conditions and risk points of their jurisdictions.
（8） Strive hard and continue to strengthen law enforcement
The Drug Administration of the Autonomous Region will improve relevant supporting systems and regulations in accordance with the case investigation mechanism established by the National Bureau, and continue to purify the order of medical device production and circulation. The municipal and county drug regulatory departments should strive for the financial support of the local government for the investigation and handling of cases, implement the regulatory responsibility, enrich the regulatory force, and timely detect and investigate violations in the field of medical device safety. It is necessary to strengthen the management of case source information, dig deeply into illegal clues, and strengthen the verification and handling of case clues. The Food and Drug Administration of the Autonomous Region will further strengthen the supervision and guidance of administrative law enforcement of medical device cases at the city and county levels, and organize the investigation and treatment of trans regional medical device violations. All municipal bureaus focus on contact lenses, condoms and household medical devices, investigate and deal with violations of medical devices with high public concern and wide application scope, and strictly investigate illegal behaviors such as using experiential marketing methods to operate and use beyond the scope, operating and using unlicensed medical devices. We will strengthen coordination and cooperation with public security organs and other departments, strengthen the connection between punishment and execution, strictly implement the requirements of individual punishment, and crack down on all kinds of illegal and criminal acts.
Appendix: Supervision and Inspection of New Coronavirus Test Reagent
Part 2: Model text of medical testing scheme
[Key words] Portable; Embedded system technology; miniaturization
introduction
Clinically important physiological parameters include electrocardiogram (ECG), blood pressure, blood oxygen saturation, etc. These basic physiological parameters contain rich information about human health status, which has extremely important clinical significance for the treatment of patients.
In the traditional detection of physiological parameters, doctors use separate instruments such as electrocardiograph, sphygmomanometer and blood oximeter to obtain these indicators of patients. These examination steps make doctors spend more time in the examination of patients, and too many examination steps tend to make patients have a sense of resistance, reducing the detection efficiency. Although multi parameter monitors have emerged in the market for the problem of multi physiological parameter detection, the problem with multi parameter monitors is that they are mainly targeted at large hospitals and ICU wards for the purpose of monitoring critical patients. Although they have complete functions and complete monitoring of various physiological indicators, they are large and expensive. It is not suitable for promotion in primary medical institutions.
In order to solve this problem, according to the characteristics of basic medical institutions, and for the purpose of detecting the basic physiological indicators of the general public, a detection system integrating the functions of electronic sphygmomanometer, blood oxygen saturation meter and electrocardiograph is proposed. Compared with the traditional multiple discrete instruments, the appearance of the detector will reduce the cost of the instrument, reduce the volume, shorten the detection time, and facilitate doctors to diagnose patients on the basis of ensuring the complete detection of physiological parameters. At the same time, it is also helpful for doctors to master the situation of patients when blood pressure, ECG, heart rate, blood oxygen and other parameters change at the same time, which is more helpful for doctors to diagnose and treat.
Compared with traditional multiple independent detection instruments, this detector has the advantages of fast detection speed, low cost, small size, light weight, etc. Its detection object is mainly targeted at the grass-roots public, simple to use, convenient to carry, and highly intelligent, which can fully meet the needs of community medical institutions, township hospitals, and even field operations for multiple physiological parameters detection, In order to improve the medical and health conditions at the grass-roots level, help doctors improve their diagnosis and treatment methods, and enhance the diagnostic level of community medicine in China, so the promotion and application of this instrument has good social benefits. According to the current market situation, the total cost of a single blood pressure meter, blood oxygen meter, multi-channel electrocardiograph, and thermometer is about 40000 yuan, while the cost of an integrated micro blood pressure, blood oxygen, and electrocardiograph multi parameter detector is about 10000 yuan. This price is far lower than the current total price of many instruments, making these community medical institutions All township hospitals can be equipped with this instrument. If it is popularized, it will greatly reduce the purchase cost of medical instruments, thus reducing the medical cost, with considerable economic benefits.
Although the detection technologies of blood pressure, blood oxygen saturation, electrocardiogram, temperature and respiration involved in this detector are relatively mature, there are still many technologies that need to be further studied. However, the miniaturized integrated blood pressure, blood oxygen saturation and electrocardiograph measuring instrument has not yet appeared at home and abroad. If it is successfully developed, it will fill in the gaps at home and abroad, and also provide better options for detection and diagnosis of families and community medical institutions
1. Research scheme and technical route:
1.1 Overall research scheme:
In the design of portable multi physiological parameter instrument, reasonable hardware design scheme is the key to system integration and miniaturization design. Since the multi parameter detector needs to complete multiple functions, the number of interfaces, processing speed, and system power consumption are all problems that need to be solved. At the same time, the portable multi physiological parameter instrument needs to meet the requirements of multi-channel acquisition, small size, low power consumption, low cost, etc., so the system design is proposed to adopt the solution shown in Figure 1.
As shown in Figure 1, physiological parameters of human body such as blood pressure, blood oxygen and electrocardiogram can be input into special chips for physiological signal acquisition through piezoelectric sensors, photoelectric sensors, ECG dry electrodes, etc. Thus, the pressure signals of blood vessels, light intensity signals of human finger tips, and weak biological ECG signals can be converted into detectable electrical signals. Through these sensors and acquisition chips, different types of signals are converted to electrical signals. Further processing and calculation shall be carried out, and the results shall be output to the LCD screen, or data transmission shall be carried out through USB, printer and telemedicine communication interface.
1.2 Hardware system solution:
According to the system structure of the above portable multi physiological parameter detector, the block diagram of its hardware system is shown in Figure 2:
This hardware system takes ARM processor as the core to meet the needs of multi interface and low power consumption. At the same time, processor chips of ARMV5TE and above systems, such as ARM926EJ-S and Cortex-A9 core chips, and the enhanced DSP instruction set in the core are used to complete the requirements of a large number of complex digital operations in signal processing and recognition, further improving the system processing speed. In terms of software, the embedded operating system is used to uniformly schedule and manage the whole system, simplify the software development process of the tester, and increase the reliability and portability of the product. The excellent GUI in the embedded operating system is used to simplify the user interface design of the instrument and simplify the operation of the detector.
After the ARM processor gets the analog signal, the embedded operating system running on it calls the on-chip A/D conversion program to perform analog-to-digital conversion on the signals of each channel, and then calls each signal processing task to perform software filtering, analysis, threshold comparison, recognition and other functions on their respective data. Finally, the ECG waveform and the measurement results of blood pressure, blood oxygen, heart rate, body temperature and other parameters are displayed on the touch screen through the GUI interface, and certain judgment results and suggestions are given, so as to provide medical staff or patients with reference. If you need to print the results, you can print the report through the printer. If you need to get specific data, you can get the results through the USB interface. In addition, the system also designs a telemedicine communication interface, which can send data to the remote workstation in real time to complete telemedicine services.
2. Market efficiency and economic indicators
The detector meets the market demand and has broad market prospects. There are more than 40000 villages and towns in China. According to 1/3 of the villages and towns equipped with equipment, a total of 13000 instruments are needed. If the cost of each instrument is 5000 yuan and the sales price is 10000 yuan, the total profit generated by the instrument will be 65 million yuan.
Compared with traditional multiple independent detection instruments, this detector has the advantages of fast detection speed, low cost, small size, light weight, etc. Its detection object is mainly targeted at the grass-roots public, simple to use, convenient to carry, and highly intelligent, which can fully meet the needs of community medical institutions, township hospitals, and even field operations for multiple physiological parameters detection, In order to improve the medical and health conditions at the grass-roots level, help doctors improve the means of diagnosis and treatment, enhance the diagnostic level of community medical care in China, and effectively solve the problem of "difficult and expensive medical treatment". Therefore, the promotion and application of this instrument has good social benefits.
reference:
[1] Yang Chunyan, Xiao Jilin. Single chip microcomputer with ADC, PWM and comparator - EM78P458 [J] Foreign electronic components, 1999, (11)
[2] Chen Zhencheng; Jinxingliang; Xu Xiaowen; Zhu Jianming; Wang Diya;; Preliminary study on a non-invasive blood glucose detector [J]; Journal of Sensing Technology; Issue 07, 2008
Part 3: Model text of medical testing scheme
The knowledge of medical genetics is updated rapidly, and the content of theoretical textbooks is classic, but they cannot keep up with the situation. With the continuous development of science and technology, various new ideas, new technologies and new approaches are emerging. If we still follow the script, we cannot teach students the latest cutting-edge content, so that theory can be separated from practice. Therefore, in the teaching of medical genetics, according to the development of precision medicine, we have timely added the corresponding cutting-edge content, so that students can contact and understand the development trend of precision medicine at the first time. For example, in the chapter of Chromosomes and Chromosome Diseases, when we talk about the detection methods of trisomy 21 syndrome, besides the traditional B ultrasound and amniocentesis to detect chromosomes, we also introduce the rapid development of peripheral blood gene detection methods in recent years to students. The detection is non-invasive, does not cause abortion risk, and has high accuracy. In the chapter of molecular diseases and enzyme protein diseases, students were told that molecular diseases such as thalassemia and phenylketonuria could also be diagnosed in advance by means of gene sequencing. These are the most basic practical applications of precision medicine. In addition, in the introduction, the second generation sequencing, exon sequencing, RNA seq and other knowledge are added. Through optimizing the teaching content, more advanced ideas and technologies are provided for genetic counseling, so that students can have a deeper understanding of the specific content of precision medicine [5].
2 Improve teaching methods and deepen understanding of precision medicine
In order to better carry out the teaching of precision medicine, we adopt the case teaching method to guide students to establish the concept of precision medicine. Through typical cases, clinical content is integrated into classroom teaching, so that students can learn with interest and improve their initiative in classroom teaching. For example, in the teaching of oncogenetics, we put forward a case: Angelina Jolie has a family history of breast cancer. She detected BRCA1 gene defects through genetic technology, which means that she has 87% probability of suffering from breast cancer and 50% probability of suffering from ovarian cancer. According to the analysis and suggestions of doctors, she accepted mastectomy. Introduce precision medical cases in the classroom, so that students can fully understand the concept, process and technology of precision medical, and then further combine and expand with theoretical knowledge. In combination with the above cases, ask the question: Why did Angelina Jolie undergo excision? Then it is derived that BRCA1 gene is a tumor suppressor gene. If the mutation of this gene will lead to the loss of tumor suppressor function, the incidence of breast cancer and ovarian cancer will increase significantly. The concept of tumor suppressor gene and proto oncogene is introduced to help students systematically review the knowledge of genetics, cell biology, molecular biology and other disciplines, and comprehensively apply it to the analysis of specific diseases, so as to inspire students to understand that precision medicine can predict possible diseases through gene sequencing technology, and take corresponding preventive measures. In the teaching of pharmacogenetics chapter, we put forward a case of personalized drug use: William Elder Jr was diagnosed with cystic fibrosis at the age of 8, and was found to be caused by G551D mutation through gene sequencing. Because of the use of Kalydeco (the drug is only effective for patients with G551D mutation), his condition was effectively controlled. Through this case, students will be guided to realize the problem of drug targeting after the disease is diagnosed. It is clear that gene sequencing technology can guide patients to choose the best dose and the most effective drug at the right time to produce the best therapeutic effect.
In teaching, teachers use the case teaching method, based on typical cases, to guide students to use theory to analyze clinical problems, combine clinical problems with basic knowledge, master the pathogenesis and detection principles and methods of genetic diseases in combination with textbooks, stimulate students' interest in learning, deepen their understanding of precision medicine, and promote students to think deeply.
3. Improve assessment methods and improve students' innovation ability
The evaluation methods are mainly divided into summary evaluation and formative evaluation. In recent years, formative assessment has been widely concerned. Formative assessment refers to the assessment of teachers' teaching process and learners' learning process and results by diagnosing problems existing in educational programs, educational processes and activities, and combining learners' feelings, attitudes, methods, etc. reflected in the learning process. Formative evaluation pays more attention to students' comprehensive quality and innovative ability. For medical genetics, we have adopted formative assessment, focusing on the assessment of students' learning process, such as teachers' arrangement of challenging tasks, students' group discussion, group members' access to information after class, and class presentation, so as to cultivate students' innovation ability and team cooperation ability.
The development of precision medicine is the cross and comprehensive application of genetics, biology and bioinformatics. In clinical work, facing many complex medical links, it is difficult to rely on individuals to make a clear diagnosis of genetic diseases. The realization of precision medicine requires good communication between genetic consultants and bioinformatics personnel, clinicians, gene testing companies and patients, and effective analysis and integration of data from various disciplines, so as to finally achieve the goal of precision medicine. Therefore, in the usual training, we should pay attention to cultivating students' ability of organization and coordination and innovation.
4. Actively carry out the second class to cultivate students' genetic data retrieval skills
Develop students' medical genetics data retrieval skills through the second class. In the research of genetic diseases, OMIM database is known as the bible of medical genetics, OMIM includes all known genetic diseases, genetically determined traits and their genes. In addition to briefly describing the clinical characteristics, diagnosis, differential diagnosis, treatment and prevention of various diseases, OMIM also provides the linkage relationship, chromosome location, composition structure and function, animal model and other data of known pathogenic genes, and is attached with carefully screened relevant references. The numbers of various genetic diseases, traits and genes formulated by OMIM are universally recognized. The second class is held to teach students how to retrieve genetic information of a disease through OMIM database, including basic description, clinical characteristics, gene location, genetic mode, molecular genetics, animal model knowledge, etc.
At present, the rapid development of genomics technology and the continuous development of new technologies such as second-generation sequencing and bioinformatics are constantly promoting the development of medical genetics and promoting the adoption of new teaching ideas and new thinking in medical genetics. Precision medicine is one of the development directions of modern medicine and has important strategic significance. The future medical development will enter the era of 3P medicine to predict, prevent and individualize. As an educator of medical genetics, it is necessary to integrate the new frontiers of genomic biology and integrate new concepts and technologies into clinical medical teaching according to the future development of basic biomedical science and clinical science, Through gradually cultivating students' innovative thinking in teaching, strengthening students' awareness of precision medical treatment, and promoting the cultivation of high-quality composite medical talents. However, achieving the penetration of precision medicine in medical genetics teaching also poses a high challenge to teachers. Teachers are required to deeply understand the connotation and laws of precision medicine and master multidisciplinary knowledge in order to design teaching methods and apply them to teaching practice. In the future teaching, we will continue to strengthen learning and thinking, strive to explore innovative thinking training methods for medical students in the context of precision medicine, further improve the teaching level, and improve the training quality of composite medical talents.
reference
[1] Tang Bikui, Hu Mingjie, Huang Yinjiu, et al. Practical exploration of precision medical thinking in medical genetics teaching [J]. Journal of Qiqihar Medical College, 2017, 38 (1): 91-92
[2] Tang Bikui, Hu Mingjie, Zhang Jing, et al. Exploration of medical genetics teaching reform based on Internet thinking [J]. Basic Medical Education, 2016, 18 (5): 400-401
[3]Vinay Prasad. Perspective:The precision oncology illusion[J]. Nature, 2016 (37) :63.
Part 4: Model of Medical Testing Scheme
Supervision Bureau:
Your bureau conducted a double random inspection on our hospital on May 26, 2020, and found the following problems in our hospital: 1. The pre examination triage system has not been established and implemented; 2. Legal practice is not in place; 3. Inadequate radiation protection; 4. The radiation workers did not receive physical examination, radiation protection training and personal dose detection.
After receiving the written notice of rectification, President Lin attached great importance to it and immediately supervised the rectification of the problems in all aspects of our hospital against the supervision opinion. The rectification measures are reported as follows:
1、 Establish and implement the pre examination triage system to separate the pre examination triage and guidance; Carefully improving the outpatient log requires that the registration content must be complete. Strengthen the internal management of the hospital, establish and improve various rules and regulations, and implement various core medical systems and infectious disease prevention and control systems. Standardize personnel management, improve professional and technical personnel files, strengthen legal practice, and require medical, nursing, pharmaceutical and technical personnel to work with certificates in accordance with the requirements of laws and regulations such as the Law on Licensed Doctors and the Law on Licensed Nurses.
2、 Normalized management of medical waste disposal and infectious disease prevention;
1. Establish and improve the medical waste management organization and management system.
Establish a leading group for medical waste management in the hospital. The group members include the heads of medical departments, nursing departments, infection management departments, general logistics and clinical and medical technology departments. Clarify the work responsibilities of each department and implement the hierarchical management responsibility system. Reorganize all links and details of medical waste management, and further improve the medical waste management system of our hospital. Establish a responsibility system for medical waste management, clarify that the hospital president is the first person responsible for medical waste management in our hospital, and take full responsibility for the leadership of medical waste management in the hospital.
2. Improve the medical waste disposal workflow.
According to the requirements of relevant laws and regulations in the Regulations on the Management of Medical Wastes, and in combination with the actual situation of our hospital, the Flow Chart of Medical Wastes Disposal in Yanshan Weidong Hospital was formulated and posted at a conspicuous position in each medical waste generation department. Standardize and guide all departments to classify, collect and dispose medical wastes according to the requirements of the Classification Catalog of Medical Wastes. The medical waste disposal staff shall be provided with protective articles such as work clothes, gloves, masks, hats, etc. to ensure the occupational health and safety of relevant staff.
III. Rectification measures for radiation management
1. Strengthen leadership and improve management organization and management system.
A leading group for radiation safety and protection has been established. The president is fully responsible for the leadership of radiation safety protection, further strengthening leadership and implementing responsibilities; Formulate radiation security system, designate special personnel to be responsible for the management of radiation devices, and implement the safety responsibility system; Formulate and timely revise radiation safety management regulations, X-ray machine operation safety operation procedures, protection and safety equipment maintenance and repair system, personal dose monitoring regulations, radiation worker training management system, radiation worker personal dose management system, radiation accident emergency plan, etc. Establish a radiation protection management organization with full-time (part-time) management personnel to be responsible for the quality assurance and safety protection of radiation diagnosis and treatment, develop and implement the radiation diagnosis and treatment and radiation protection management system, and timely record and manage the personal dose monitoring, occupational health examination and other project information in the unit's Radiation Worker Certificate.
Part 5: Model of Medical Testing Scheme
In the first half of 2019, under the correct leadership of the County Health and Family Planning Bureau and the Municipal Health Supervision Bureau, we further strengthened law enforcement and actively maintained the people's health by focusing on medical and health supervision, drinking water hygiene, public place hygiene and infectious disease prevention and control. The work of our institute in the first half of 2019 is summarized as follows:
1、 Health administrative licensing
1. Acceptance: In the first half of this year, 25 public place health licenses were accepted, 7 kindergartens health care service licenses, 4 medical institutions practice licenses, and 1 radiology license. 2. Distribution: 24 new public place sanitation licenses were issued in the first half of this year. 8 accommodation places, including 1 guesthouse and 7 hotels; 14 beauty salons, including 10 barber shops and 4 beauty salons; 1 bathtub; One waiting room. In the first half of this year, there was a total of one change of public place sanitation license (bookstore) in the county. In the first half of this year, 6 nurseries and kindergartens in Heilongjiang Province were newly issued with health care certificates, and 1 nurseries and kindergartens in Heilongjiang Province were reviewed with health care certificates. A total of 4 new medical institution practice licenses were issued. A total of 1 new radiology license was issued.
2、 Comprehensive supervision and law enforcement of health and family planning
1. At present, there are 164 public places (392 people with qualified valid health certificates) in our county, including 59 accommodation places, 92 beauty salons, 5 bathing places, 4 dance halls, 1 bookstore, 1 swimming pool, 1 theater and 1 waiting room. We actively carried out the quantified and graded management of health supervision in public places. 109 public places in our county were under the quantified and graded management of health supervision, and the health credit rating was C. Among them, there are 59 accommodation places, 47 should be managed quantitatively, 47 have been managed quantitatively, with a management rate of 100%, 92 beauty salons, 53 should be managed quantitatively, 53 have been managed quantitatively, with a management rate of 100%, 5 bathing places, 5 should be managed quantitatively, 5 have been managed quantitatively, with a management rate of 100%, and 4 concert halls, There are 4 enterprises that should be managed in a quantitative way, and 4 enterprises that have been managed in a quantitative way, with a quantitative management rate of 100%. A total of 164 public places were supervised and managed throughout the year, 170 people were supervised and inspected in various public places, and the supervision and management coverage rate reached 72.5%. 161 quantitative and hierarchical management files of public place health supervision were established, with a filing rate of 100%. To carry out supervision, monitoring, filing and quantitative management of municipal centralized water supply, secondary water supply units and rural small centralized water supply units, at present, there is one municipal centralized water supply unit in the area under its jurisdiction. The water purification plant has been filed and quantitatively rated. Its credit rating is C, and the quantitative grading management rate is 100%, The 14 water supply personnel directly in charge of water supply in the water purification plant are employed with qualified and effective health certificates, and the certificate holding rate is 100%. The water purification plant is equipped with a water quality testing laboratory to test the ex factory water on time every month, and report the test results to the Health Supervision Institute for filing. The water related products they use have health permit approval documents. There are 43 secondary water supply units, 43 files have been established, and the filing rate is 100%. As the sanitary facilities of 43 secondary water supply units do not conform to the national sanitary standards and specifications, they do not meet the conditions for obtaining a license, so no sanitary license has been obtained at present. Actively carry out supervision, inspection and monitoring of small centralized water supply facilities in rural areas, supervise and inspect 34 natural villages of small centralized water supply units in rural areas, and issue 34 rectification opinions. Among them, there are 3 natural villages with centralized water supply units of more than 100 tons and less than 1000 tons. The sanitation supervision of small rural centralized water supply units has been included in the scope of sanitation supervision and coordination.
2. The medical administration and health supervision has 80 medical institutions that normally carry out diagnosis and treatment activities in our county, including 4 county-level medical institutions, 11 township level medical institutions (hospitals), 44 village health centers (clinics), 7 private clinics, 1 community health service center, and 13 enterprise clinics. Supervision and inspection: First, implement the requirements of the provincial, municipal and county Blue Shield Action Implementation Plan, further strengthen the efforts to rectify the medical market and crack down on illegal medical practice. In the first half of the year, two cases of unlicensed medical practice were filed and investigated, and one case is now closed with a fine of 23 hundred yuan only; The other one was handed over to the Security Bureau for punishment. Second, supervision and inspection of medical institutions were carried out: in the first half of the year, supervision and inspection were carried out on 4 county-level medical institutions, 11 township level medical institutions (hospitals), 27 village health centers (clinics), 7 private clinics, 1 community health service center, 13 enterprises and institutions clinics, a total of 63. In the supervision and inspection, illegal behaviors of medical institutions using non health technicians and exceeding diagnosis and treatment were found, According to the spirit of the Bureau, 13 illegal medical institutions were given warning punishment. Third, we severely cracked down on illegal blood collection and supply, and no illegal blood collection and supply was found in the supervision and inspection. Fourth, we carried out the supervision and inspection of the "health care" 100 day action. 82 health supervisors were dispatched in this inspection. According to the work requirements, the supervisors checked a total of 40 (homes) in various clubs, communities, squares, parks and other crowded places, and found no behavior of carrying out TCM and TCM diagnosis and treatment activities.
3. In the first half of the year, the health supervision of infectious disease prevention and control inspected 63 medical institutions of all levels and types, and 1 disease prevention and control center. Implementation of disinfection and isolation system
The disinfection and isolation organization and system have been established. The County People's Hospital, the County Hospital of Traditional Chinese Medicine and the County Maternal and Child Health and Family Planning Service Center have carried out the monitoring of disinfection and sterilization effects. The disinfection and sterilization effects have met the requirements, and the qualification rate of disinfection effect monitoring has reached 100%. The medical staff shall be trained on disinfection and isolation knowledge, and the incoming inspection and acceptance system of disinfection products shall be strictly implemented, so that the medical devices can be sterilized or sterilized one person for one use. Supervision of medical waste The medical waste generated by the Center for Disease Control and Prevention and all medical institutions can be classified and collected according to the requirements of the Regulations on the Management of Medical Waste. The handover, transportation, temporary storage and disposal of medical waste are completely registered. A monitoring department and full-time and part-time personnel for medical waste management are set up, and a management responsibility system is established, Medical waste management system and emergency plan shall be formulated, special yellow packaging bags and sharp tool boxes with marks shall be used, and temporary storage facilities for medical waste shall be established and meet the requirements. No medical waste was discarded in the hospital or stacked at non storage sites. The County People's Hospital and the County Hospital of Traditional Chinese Medicine have temporary storage rooms for medical waste. The medical waste generated by the County Maternal and Child Health Care and Family Planning Service Center, the Disease Control Center, the Urban Neighborhood Community Health Service Center, Xixing Township Health Center, Sunwu Town Health Center, four private clinics and 13 enterprise and public health centers are transferred to the County People's Hospital or the County Hospital of Traditional Chinese Medicine for temporary storage, The People's Hospital of the county and the Hospital of Traditional Chinese Medicine will transfer the collected medical waste to the Heihe Jingcheng Medical Waste Treatment Plant for treatment, and strictly implement the transfer triple bill system. Other medical institutions have built their own medical waste disposal facilities and can burn them in time. In the supervision and inspection, it was found that a health center of an enterprise or institution failed to put disposable syringes and disposable oral instruments into a special sharp tool box after use, and it was given an administrative punishment of warning and fine of 2000 yuan. The People's Hospital of our county and the Traditional Chinese Medicine Hospital of our county have built disinfection and treatment facilities for iatrogenic sewage. The sewage treatment facilities of the county hospital of traditional Chinese medicine operate normally, have established a sewage treatment management system and an emergency plan for sewage treatment accidents, are equipped with sewage treatment staff, and have received relevant training. However, due to the lack of relevant equipment, no sewage disinfection effect monitoring has been carried out. The sewage treatment facilities of the County People's Hospital operate normally. A sewage treatment management system and an emergency plan for sewage treatment accidents have been established. Sewage treatment staff have been allocated and have received relevant training. However, due to the lack of relevant equipment, sewage disinfection effect monitoring has not been carried out. There are no local sewage disinfection equipment and facilities in infectious disease clinics, observation rooms and wards.
4. Occupational radiation health supervision There is one occupational health inspection institution in our county, which did not conduct random double random inspection, but carried out normal daily supervision, and the supervision coverage rate reached 100%. During the inspection, it was found that the occupational health monitoring files were kept by special personnel and counters, and the occupational health inspection equipment operated normally; 11 persons have obtained the training certificate of occupational disease diagnosis doctors in Heilongjiang Province. On April 25, 2019, a publicity campaign was held in the People's Square with the theme of healthy China, occupational health and the same behavior, and a brochure was distributed. In the first half of 2019, there were 2 radiology diagnosis and treatment units in our county, with 100% supervision coverage and 100% certificate application rate (due to the backward equipment in each township and other reasons, no radiology diagnosis and treatment work was carried out this year, and certificates were issued). Radiation workers wear 100% personal dose, and the filing rate of personal health records is 100%. All medical institutions have allocated protective articles (lead aprons, etc.) for staff and protective articles for examinees to radiation diagnosis and treatment places.
5. In the first half of the year, 12 health supervision stations were inspected. The health supervision stations in Sunwu County were fully listed, established and improved the health supervision and management organization system, and all had office space. Some of the health supervision stations were less than 20 square meters. The station head and deputy station head met the job requirements, and there were 2 assistants. None of them was equipped with computers and other special equipment for health supervision. The work responsibilities of the twelve health supervision and coordination stations have been basically implemented, and they have established and improved the year beginning plan, quarterly plan and summary, can carry out the health supervision and coordination patrol work according to the time limit, and timely report the patrol illegal information. The information reporting rate of health supervision, coordination and inspection is 100%. Some health supervision assistant stations failed to carry out patrol inspection work in accordance with the filing situation and supervision frequency of each industry.
6. There are 17 schools in the county, including 8 in urban areas and 9 in rural areas; 21 kindergartens. In order to improve the level of health care work in educational institutions and ensure the physical and mental health of children, on May 20, 10 units including the Health and Family Planning Comprehensive Supervision and Law Enforcement Bureau and the Education and Sports Bureau carried out a joint inspection of health care in 21 kindergartens in the county. In combination with the actual work in the high incidence period of infectious diseases in spring, especially the abnormal weather in this spring, they arranged work and carefully inspected one by one, Avoid missing items, missing items and dead corners, and ensure that all work is implemented. The inspection found that all kindergartens attached importance to the prevention and control of infectious diseases and the safety of drinking water. The health organization is established and improved, and the health management system is standardized. The cleaning and disinfection system has been formulated, and the infectious disease emergency plan, the infectious disease epidemic situation reporting system, the absence system due to illness, and the recovery diagnosis and morning check system have been established. The system has been strictly implemented, and the infectious disease epidemic situation reporter and the public emergency reporter have been determined, and relevant records have been made. Effective disinfectant is available to sterilize classrooms, stairs, toys and door handles according to the disinfection ratio. The health management of infectious diseases is well implemented. Strengthen health publicity and health education for kindergartens, establish good health awareness, and urge them to develop good health habits of "washing hands, drinking boiled water, eating cooked food, frequent ventilation, drying clothes and quilts". During the daily morning check-up, it is important to observe whether the students have fever, cough, and herpes in the hands, feet, and mouth. Once found, they should be isolated immediately, and parents should be notified to take the students away from school for treatment. And make registration and report to the county CDC and the county health and family planning supervision bureau. This inspection has made the formulation of various rules and regulations of various kindergartens more standardized, the implementation of rules and regulations more conscious and active, the learning and living environment of teachers and children more safe, comfortable and beautiful, and the occurrence of infectious diseases in spring is minimized.
7. Health supervision of family planning
According to the requirements of the 2019 Heihe City Family Planning Technical Service Supervision and Spot Check Plan issued by the Municipal Health Commission, health supervision was carried out for the family planning work in the whole county. During the inspection, it was found that Sunwu County People's Hospital and Maternal and Child Health Care Hospital carried out family planning technical services and obtained the license for mother and child health care; The number of employees who have obtained the examination certificate of maternal and infant health care is 14 and 7 respectively. Comply with the national requirements, carry out family planning services according to the family planning service items and business scope approved by the superior competent department, post the slogan of "fetal gender identification for non-medical needs, and artificial termination of pregnancy for non-medical needs" in a conspicuous position, and go to the county people's hospital and maternal and child health care center for inspection, There is no non-medical need for fetal sex identification and non-medical need for artificial termination of pregnancy. Strengthen the management and use of legal documents such as Birth Medical Certificate and Premarital Medical Examination Certificate.
8. Publicity and training of laws and regulations, strengthening health supervision and law enforcement
In the first half of the year, our bureau organized supervision and law enforcement personnel to systematically learn laws and regulations such as the Administrative Compulsory Law and the Administrative Punishment Law by means of centralized learning and individual self-study, defined the scope and functions of supervision and law enforcement, and mastered the knowledge of supervision and law enforcement procedures, medical service supervision and management, supervision and law enforcement investigation and evidence collection. Carry out training and learning of laws, regulations and business knowledge for all supervisors for 4 times. Actively carried out the "Law on the Prevention and Control of Occupational Diseases" publicity week and other publicity activities to distribute more than 1000 leaflets and more than 500 brochures to the society, and received more than 100 people's consultations from the masses. In the first half of the year, two cases were punished according to the general procedure, with a fine of 4300.00 yuan.
3、 Work arrangement in the second half of the year
1. Timely report the information according to the superior's deployment..
2. We will intensify the fight against illegal medical practice and illegal blood collection and supply, and continue to seriously investigate and deal with illegal medical practice. Strengthening the work of health supervision and management was comprehensively promoted.
3. Carry out the scoring management of bad practice behavior of medical institutions. Special Inspection on Medical Waste Disposal shall be carried out for medical institutions at all levels within the jurisdiction.
4. We will strengthen health supervision and law enforcement in public places. First, strengthen the daily supervision and inspection of public places; Second, carry out health monitoring; Third, carry out quantitative and hierarchical management of health supervision in public places.
5. We will strengthen supervision over medical radiation clinics.
Part 6: Model of Medical Testing Scheme
1、 Guiding ideology
Guided by the important thought of "Three Represents" and the Scientific Outlook on Development, and based on laws and regulations such as the Drug Administration Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China, and the Regulations on the Supervision and Administration of Medical Devices, We will comprehensively rectify and standardize the order of the development, production, circulation and use of drugs and medical devices to ensure the safety of drug use by the people.
2、 Overall objectives
Through special actions, we will further standardize the order of the drug and medical device market, constantly improve the administrative capacity of drug regulatory departments according to law, enhance the integrity and self-discipline awareness of drug and device related enterprises, and enhance the awareness of law-abiding business, comprehensively improve the level of rational drug use, and severely crack down on illegal criminal activities in the production and sale of counterfeit drugs, so as to cause adverse reactions (incidents) of drugs and medical devices It is monitored and managed effectively to ensure the safety of drug use by the people.
3、 Work measures
In accordance with the principle of "comprehensive rectification and highlighting the key points", achieve comprehensive coverage of all regulatory links, and focus on rectification of key varieties, important links and prominent problems with potential safety hazards.
（1） Strengthen the supervision and inspection of the production of drugs and medical devices, and urge enterprises to implement the quality management system.
1. To organize a comprehensive inspection of the implementation of the Good Manufacturing Practice for Drugs (hereinafter referred to as GMP) by pharmaceutical manufacturers. Strengthen daily supervision and inspection in accordance with the Measures of * Municipality on Supervision, Inspection and Grade Evaluation of Drug Manufacturing Enterprises. The inspection focuses on the quality of personnel in key positions of drug manufacturing enterprises and the implementation of quality management responsibilities, the purchase of raw and auxiliary materials, and the quality inspection. The inspection focuses on enterprises with more problems in the recent daily inspection and drug manufacturing enterprises with major changes in management personnel. Strengthen the management of preparation production and dispensing of medical institutions, and focus on the inspection of whether the preparation room of medical institutions meets the allocation management measures and whether the preparation dispensing meets the requirements. From June 1, 20 *, the medical institutions that have not renewed the approval number shall not make preparations, and the behaviors of making preparations without certificates and not according to standards shall be strictly investigated and dealt with.
2. We will strengthen the supervision of medical device manufacturers and high-risk, special medical device operators. Fully implement the construction of safety credit system for medical device manufacturing enterprises, take credit rating as the starting point, further strengthen enterprise self-discipline, and improve long-term supervision mechanism. Standardize the order of medical device registration and declaration, and crack down on fraud in medical device registration and declaration; Focus on the inspection of medical device enterprises with complaints, problems found in the inspection and other potential safety hazards, conduct a comprehensive inspection of the quality system of key supervised varieties and high-risk product production and operation enterprises, and focus on the inspection of whether their products are legal, whether the purchase channels are standardized, and whether the relevant records are complete; An inspection shall be carried out on the operating enterprises of hearing aid fitting, focusing on whether the operating conditions have been lowered without authorization, whether the key personnel are on duty, and whether the corresponding fitting management specifications have been implemented. Strictly enforce the market access of contact lens business enterprises to ensure the objectivity and impartiality of license issuing work.
3. Strengthen the inspection of the raw and auxiliary material supplier audit, raw and auxiliary material purchase and quality inspection, storage and safekeeping, quality control of intermediate and finished products, product audit and release of pharmaceutical manufacturing enterprises and medical institutions' preparation rooms.
（2） We will standardize the behavior of drug distributors and accelerate the reform of the drug distribution system.
1. Strengthen the supervision and inspection after the certification of the Good Supply Practice for Pharmaceutical Products (hereinafter referred to as GSP) for pharmaceutical trading enterprises. In combination with the Implementation Plan for Graded Supervision of Quality and Credit of Drug Retailers in * County, the key personnel and pharmacists' attendance, purchase and sales channels, purchase and sales records, storage conditions, etc. were inspected, and the operating enterprises that violated the GSP regulations were ordered to rectify; If the circumstances are serious, it is suggested that the Drug Trade License be revoked according to law. If any form of unlicensed operation, lease or lending of licenses is found in the follow-up inspection, the case must be filed and investigated according to law. Organize the surprise inspection of drug wholesale and retail enterprises, and organize the inspection, supervision and inspection of drug distributors who report that they do not operate in accordance with GSP regulations. Standardize the practice behavior of pharmaceutical technicians, seriously investigate and deal with the illegal behaviors of pharmacists such as multiple hanging of one certificate, false hanging of one certificate and off post, and practically improve the pharmaceutical service level of resident pharmacists.
2. Strengthen the drug quality inspection of medical institutions, focusing on whether the drug procurement channels of medical institutions are standardized, whether the storage conditions are available, whether the personnel qualifications meet the requirements, whether the relevant systems are sound, and whether the purchase and sales records are complete. We will continue to promote the standardized construction of pharmacies in medical institutions, standardize drug quality management in medical institutions, and constantly improve the quality of drug use.
3. Strengthen the construction of special drug monitoring information network, realize real-time monitoring of the flow of special drugs, and prevent the flow of special drugs into illegal channels while ensuring medical needs.
4. Accelerate the construction of a long-term drug safety supervision and management mechanism. Establish an enterprise behavior verification information base, check and record the quality system, drug safety, internal management, sales behavior, storage and transportation conditions, advertising behavior and other illegal behaviors, and expose the illegal behaviors to the public.
5. Integrate existing resources, actively cultivate modern drug distribution enterprises, improve logistics concentration and efficiency, and accelerate the development of drug logistics industry. Make full use of the existing rural medical and health resources, and combine with the pilot work of the new rural cooperative medical system and the food safety "One Hundred Counties and Ten Thousand Villages Safe Store Project", guide and encourage chain stores in rural areas of our county to set up drug counters, and further promote the construction of the rural drug supply network and supervision network.
（3） Strengthen the quality supervision and management of drugs and medical devices in medical institutions, and improve the adverse reaction monitoring system.
1. Strengthen the quality supervision of drugs and medical devices in medical institutions. In accordance with the requirements of the Measures of * Municipality for the Supervision and Administration of the Quality of Drug Use in Medical Institutions (Municipal Government Order No. 222) and the Opinions of * Municipality on the Supervision and Administration of the Use of Medical Devices in Medical Institutions (for Trial Implementation) (HSYJX [20 *] No. 89) formulated and issued by the Municipal Food and Drug Administration, focus on the inspection of the purchase channels, storage conditions, personnel qualifications Implementation of purchase records and other management systems.
2. We should attach great importance to the supervision of listed drugs, find and handle problems in time, and prevent and reduce the occurrence of drug accidents. Strengthen the publicity, education, management and supervision of clinical rational drug use, and improve the level of clinical rational drug use. Active measures should be taken to deal with adverse reactions caused by drugs. The health department should do a good job in medical identification in time, and the drug supervision department should organize supervision and sampling inspection in time to make technical identification of the legality and eligibility of drugs.
3. We will strengthen the monitoring and re evaluation of adverse drug reactions and medical device adverse events, accelerate the establishment of county adverse drug reaction monitoring workstations, focus on monitoring adverse drug reactions (events) of chemical drug injections, traditional Chinese medicine injections, multi-component biochemical injections, vaccines, medical devices and other products, and deal with mass adverse reaction events in a timely manner.
（4） We will strengthen the monitoring and investigation of drug and medical device advertisements, and vigorously punish false and illegal drug and medical device advertisements.
We will increase the frequency of inspection of advertisements for drugs and medical devices, and focus on the daily supervision of mainstream media, drug and medical device retail stores, outdoor drugs, medical device advertisements, and small print advertisements. In particular, we will strengthen the monitoring of advertising content in information services and TV shopping programs, and prevent repeated illegal and false advertisements Supervise and spot check the varieties with many complaints and potential quality hazards; Strengthen the supervision of the advertising behavior of the news media, establish the accountability system for false and illegal advertising of the news media and the industry self-discipline mechanism; Establish the illegal advertising announcement system and the market withdrawal mechanism of advertising activity subject, announce the varieties of illegal and false advertisements and enterprises in the main media of the county for many times, and timely warn the society.
（5） Strengthen law enforcement, and always maintain the high pressure situation of cracking down on counterfeits and dealing with inferiors.
Strengthen the inspection and law enforcement work, and strictly investigate and deal with major cases of drugs and medical devices that seriously endanger public safety, involve a wide range of areas, have bad circumstances, and have serious consequences. If a crime is constituted, it shall be promptly transferred to the public security department for handling. We will continue to carry out the special rectification work of cracking down on counterfeit drugs in rural areas, strengthen the inspection of the medical equipment market in the suburban fringe, severely crack down on the illegal operation and sale of fake and inferior medical equipment, increase the sampling inspection of specialized drugs and advertising drugs, and strengthen the sampling inspection of the quality of injection drugs with high use risks. Open the channels for complaints and reports, effectively sort out the clues for reports, give full play to the role of the Public Security Liaison Office, and strictly investigate and deal with major drug and equipment cases that seriously endanger public safety, involve a wide range of people, have bad circumstances, and have serious consequences. Improve the joint law enforcement and transfer mechanism with the public security, health, quality supervision, industry and commerce departments.
4、 Job requirements
（1） Establish organizations and strengthen leadership. The county government decided to take this special action as the key work of rectifying and standardizing the market economic order this year and next, and set up a leading group for the special action of * county to rectify and standardize the drug market order, with the deputy county head in charge of the county government as the leader, the director of the county food and drug administration as the deputy leader, the county party committee publicity department, the county supervision bureau, the county public security bureau, the county finance bureau, the county health bureau The relevant heads of the County Administration for Industry and Commerce, the County Administration for Quality Supervision and other departments are members. The leading group office is located in the County Food and Drug Administration to undertake specific daily work. In accordance with the working pattern of "unified leadership, departmental cooperation and interaction of all parties" and the policy of "addressing both the root causes and the root causes", further strengthen the responsibilities of all departments at all levels, and ensure that the special action to rectify and standardize the order of the drug market is implemented.
（2） Clear division of labor and close cooperation. This special action focuses on food and drug supervision departments, and all relevant departments should closely cooperate and strengthen cooperation. The food and drug regulatory authorities should give full play to the main force role and strengthen the guidance and supervision of special actions; The health department should strengthen the standardized management of medical institutions' pharmacies, improve the quality and rational use of drugs and medical devices in medical institutions, and ensure the safety and effectiveness of patients' use of drugs and devices; The industrial and commercial departments should further strengthen the investigation and punishment of illegal advertisements of drugs and medical devices, so that false illegal advertisements of drugs and medical devices can be investigated and dealt with in a timely and effective manner; The public security organ should dig deep into the criminal network of manufacturing and selling fake and inferior drugs and medical devices, and increase the efforts to crack down on the criminal activities of manufacturing and selling fake and inferior drugs and medical devices; The supervision department shall strengthen supervision according to law, and seriously investigate the responsibility of relevant leaders and personnel for those who refuse to implement national laws and regulations, approve in violation of laws and regulations, and have serious problems in manufacturing and selling fake and inferior drugs and medical devices; The financial department should actively provide guarantee for the implementation of the special action, strive to improve the administrative law enforcement and technical support conditions, and ensure the smooth completion of various tasks of the special action; The press and publicity department should give full play to the role of correct public opinion guidance, cooperate with the government and relevant departments to do a good job in relevant publicity work, widely carry out the publicity campaign of "safe drug use and rational drug use", publicize the public drug laws and regulations and knowledge of rational drug use, publicize the special action to rectify and standardize the drug market order, and timely report the achievements and experience of the special action, Create a good atmosphere of public opinion.
（3） Strictly enforce the law and administer according to law. We will strictly enforce the responsibility system for administrative law enforcement, further standardize administrative law enforcement, promote administration in accordance with the law, and severely punish illegal and criminal acts in administrative law enforcement, such as non-compliance with the law, lax law enforcement, impunity for violations of the law, and. We will strictly investigate and deal with major cases of drugs and medical devices that seriously endanger public safety, involve a wide range of people, have serious circumstances, and have serious consequences.
（4） Improve the mechanism and promote self-discipline. While vigorously carrying out special rectification, we should pay attention to the construction of long-term regulatory mechanism. We will vigorously promote the construction of a credit system for the pharmaceutical and medical device industries, accelerate the formation of an industry self-discipline mechanism, and actively encourage pharmaceutical and medical device production and operation units to operate honestly and legally. Further strengthen the punishment of dishonesty, expose the illegal and dishonest pharmaceutical and medical device manufacturing and operating enterprises to the public in a timely manner, and order them to rectify within a time limit. Strengthen the supervision and sampling inspection of the quality of drugs and medical devices, actively play the role of technical support of drug and medical device quality inspection and testing institutions, reasonably arrange funds, and increase the batch of supervision and sampling inspection. We will improve the emergency response system for the safety of drugs and medical devices, improve emergency response capabilities, and ensure the health and life safety of the people.
5、 Work steps
This special action is carried out in three stages:
（1） Mobilization and deployment phase (October 20 *). The County Food and Drug Administration shall take the lead in formulating the work plan for drug development, production and circulation, the County Health Bureau shall take the lead in formulating the work plan for drug use, and the County Industry and Commerce Branch shall take the lead in formulating the work plan for rectifying false and illegal drug advertisements. The implementation plan formulated by relevant departments shall be copied to the County Food and Drug Administration.
Chapter 7: Model of Medical Testing Scheme
Municipal Health and Family Planning Commission:
According to the requirements of the Municipal Health and Family Planning Commission on the health and family planning work arrangement for the prevention and control of avian influenza, and the work meeting on the prevention and control of avian influenza, the leaders of our bureau attach great importance to the prevention and control of the epidemic situation, quickly convene the prevention and control work meeting of medical units, and seriously deploy the prevention and control measures for the epidemic situation in our district. The report of self inspection and self inspection on avian influenza prevention and control in our region is as follows:
1、 Strengthen the organization and leadership, improve the emergency plan,
We improved the Emergency Response Plan for Human Influenza Epidemic Situation in the Economic and Technological Development Zone, established a H7N9 influenza leading group, a clinical treatment group for human infection with H7N9 influenza, and a prevention and control group for human infection with H7N9 influenza, and defined the responsibilities of each group. At the same time, strengthen emergency preparedness and improve the ability of prevention and control. Adhere to the leadership shift system and maintain smooth communication. The staff, work and responsibility are in place. Be prepared for emergencies at any time.
2、 Carry out supervision and inspection and implement the epidemic reporting system
Supervise and inspect all kinds of medical institutions under the jurisdiction, focus on the implementation of fever clinics and pre examination triage, and require all medical institutions to implement the epidemic reporting system in strict accordance with the requirements of the National Plan for Monitoring, Screening and Management of Unidentified Pneumonia and the Plan for Diagnosis and Treatment of Human Infection with H7N9 Avian Influenza (the first version in 2017), and report the epidemic situation immediately, No delay, concealment or omission is allowed.
3、 Strengthen personnel training and ensure emergency response
In the afternoon of March 7, 2017, we organized all medical staff of the Economic Development People's Hospital to carry out the prevention and control knowledge training of "human infection with H7N9 influenza". The main contents include: first, the surveillance program for pneumonia of unknown cause; Second, hospital infection prevention and control of human H7N9 avian influenza; The third is the diagnosis and treatment of human infection with H7N9 avian influenza. To make all medical staff fully aware of H7N9 influenza, so as to achieve early detection, early report, early isolation, early referral, early treatment, and improve the emergency response capability against the epidemic.
4、 Strengthen the work of pre examination and triage, and do a good job in medical treatment
In strict accordance with the Administrative Measures for the Pre examination and Triage of Infectious Diseases in Medical Institutions, our District Economic Development People's Hospital strengthened the body temperature measurement in the outpatient department and the pre examination and triage of fever patients, so as to achieve early detection, early report, early isolation and early treatment of flow sensitive cases. A pre examination triage table and a temperature measuring point for fever patients are set up in the outpatient hall of the hospital. Nurses measure the temperature of fever patients, distribute masks, and make pre examination triage registration. Divert fever patients to fever clinic. At the same time, health education should be carried out, and a leaflet of H7N9 influenza prevention and control knowledge should be issued at the triage counter to correctly guide the masses to prevent, control and seek medical treatment. At the same time, it is required that the fever clinic requires doctors to sit down for consultation and do a good job of registration. The first doctor attaches great importance to fever patients. Suspected cases with poultry contact history within a week should be isolated as soon as possible, reported as soon as possible, and transferred to other hospitals. All efforts should be made to cut off the route of infection.
5、 Strengthen material reserve to ensure adequate supply of emergency disposal materials
Chapter 8: Model of Medical Testing Scheme
[Key words] High frequency electric knife; Performance test; Risk Management
With the continuous improvement of the number of operations in hospitals, the safe use of surgical equipment has attracted the attention of operating departments and equipment management departments. High frequency electric knife, due to its high frequency, small contact area and high current density, may easily cause accidental injury and injury to patients if used improperly. However, long-term use will reduce the output power performance and circuit detection performance, resulting in poor safety assurance performance, which will seriously endanger the life safety of surgical patients [1]. Therefore, in order to ensure the safety and effectiveness of the use of high-frequency electric knife, it is very necessary to carry out risk management on its use.
1. Principle and composition of high-frequency electric knife
The working principle of the high-frequency electric knife is to generate high-frequency current of specific frequency, waveform and specific load power curve, act on human tissues with the help of corresponding surgical tools, and heat them intensively to volatilize and burst tissue components to produce cutting, burning and hemostasis effects, so as to achieve the purpose of surgery. High frequency electric knife generally includes: host, surgical electrode, neutral electrode, bipolar electrode and other main parts, foot switch, various knife heads, tweezers, power line, protective grounding wire and other joint accessories [2].
2 Risk control scheme of high-frequency electric knife
In order to effectively control the risk of clinical use of high-frequency electrotomes in the operating room of our hospital, a preventive plan for high-risk medical equipment was formulated. The specific inspection contents include appearance and accessories, electrical safety performance, replacement, repair and maintenance, and performance test. According to the clinical risk assessment standard for medical equipment jointly completed by Vermont University and Fluke Company, the performance test of high-frequency electric knife is required to be conducted at least twice a year to ensure that the performance parameters of the electric knife, especially the safety standards, always comply with the national standards [3]. Combined with the test results in previous years, the performance indicators of the high-frequency electric knife in our hospital are in good condition, and the failure rate during daily maintenance is not high. At the same time, combined with the specific work of the technicians in the Equipment Department, the risk control scheme for the high-frequency electric knife is finally formulated: the electrical safety and performance test cycle: once a year, the appearance and accessories inspection cycle: once every half a year, Items include equipment cleaning, whether the box is damaged, whether the power cord and foot switch are normal, whether there is correct and clear asset number, and whether the electrode connection is damaged.
3. Risk control implementation of high-frequency electric knife
According to the risk control plan, the quality of high-frequency electric knife shall be tested regularly, and the implementation results shall be input into the medical equipment information management system.
3.1 Testing equipment and environment
The reference standards for testing are: Technical Specification for General Electric Safety Quality Testing of Medical Electrical Equipment and JJF1217-2009 Calibration Specification for High Frequency Electric Knife. Test location: operating room; Temperature: 20 ℃; Humidity: 54% RH. Testing equipment: (1) FLUKE electrical safety detector, model ESA620, was purchased by our institute in 2011 for electrical safety testing. (2) The quality performance test adopts FLUKE's high frequency electric knife quality detector, the model is QA-ESII. Since our institute has not purchased this equipment, it is jointly completed with Ningbo Institute of Measurement and Testing.
3.2 Test results
Basic information of the tested objects: There are 14 high-frequency electric knives in the operating room of our hospital, including 6 Kangmei and 8 Elsa. In June 2015, the electrical safety test was carried out on 14 high-frequency electric knives in the operating room. The test items include protective grounding impedance, insulation impedance, leakage current to ground, shell leakage current (normal state), shell leakage current (disconnection to ground). In July, we jointly tested the performance of high-frequency electrotome with Ningbo Institute of Metrology and Testing. The test items include output power, high-frequency leakage current and wave crest factor. In the electrical safety inspection, 2 sets were unqualified, which showed that the protective grounding resistance was too large. One set failed in the performance test, which is shown by the output power deviation of 11.1% in the electrocoagulation mode, exceeding the allowable value by 10%.
3.3 Treatment measures
For two high-frequency electric knives with excessive grounding resistance, their grounding terminals shall be de oxidized, the surface of the grounding terminals shall be polished off with sandpaper, and the copper sheet of the power line and ground wire shall be filed smooth with a file. The test was carried out again. The grounding resistance of one electric knife dropped to 200 Ω, and another one still exceeded the standard. It was normal after the new power cord was replaced. For high-frequency electrotomes with high output power, on the one hand, notify the clinic to suspend or selectively use them, and at the same time contact the manufacturer to calibrate them. After calibration, the output power of the modified high-frequency electric knife was tested again, and the final error was less than 10%.
4 Conclusion
Through the development and implementation of the risk control scheme for the use of high-frequency electric knife, the performance deviation in the use process can be found, and timely calibration can be carried out to eliminate potential safety hazards, ensure the safety and effectiveness of the use of high-frequency electric knife, thus improving the level of medical quality. At the same time, the limitation of equipment should be tested, and the relevant performance test of high-frequency electric knife after maintenance has not been carried out. This content will be added to the risk control plan in the future, and will be gradually carried out in combination with the actual situation.
[References]
[1] Peng Zhifang, Yang Jun. Analysis and discussion on the quality control test results of high-frequency electric knife [J]. Medical and Health Equipment, 2012, 33 (8): 110-111
[2] Chen Yanyang, Zhang Hongyan. Some issues on the safe use of high-frequency electric knife [J]. China Medical Equipment, 2008, 23 (1): 111-113
Chapter 9: Model of Medical Testing Scheme
In order to implement the spirit of relevant laws and strengthen the management of laboratory biosafety, Shanghai Songjiang District Health Bureau started to carry out the registration and filing of primary and secondary pathogenic microorganisms (BSL-1, BSL-2) laboratories in November 2006, and on this basis, carried out several special biological safety inspections and daily supervision and inspection. In order to objectively evaluate the regulatory effect of the laboratory after filing, and promote the exploration of the "controllable and measurable" management model of health supervision, from June to July 2008, we conducted disinfection effect testing and the first on-site testing of biosafety cabinets in 14 secondary pathogenic microorganism clinical laboratories in the area under our jurisdiction, providing scientific basis for strengthening the biosafety management of pathogenic microorganism laboratories.
1 Object and method
1.1 Object
14 registered secondary pathogenic microorganism clinical laboratories in 7 private medical institutions (above outpatient department) and 7 public medical institutions (including primary and secondary medical institutions) within the jurisdiction were selected as the monitoring objects.
1.2 Test content
The sampling test of disinfection effect includes the determination of bacterial contamination conditions and ultraviolet lamp irradiation intensity on the surfaces of objects in the laboratory, disinfectants in use, indoor air, staff hands, staff gloves, biosafety cabinet operating surfaces (before and after disinfection), etc. The objects on the surface of objects include laboratory cleaning area, semi polluted area, polluted area (detection instruments, centrifuges, refrigerators, water bath box handles, door handles, telephones, computer keyboards, display switch parts, faucet outlets) and other key parts.
The on-site detection of Class II biosafety cabinet includes temperature, relative humidity, vertical airflow velocity section measurement, noise measurement, smoke test, and ultraviolet lamp irradiation intensity measurement inside the cabinet.
1.3 Test methods and evaluation basis
Natural sedimentation method is adopted for air sampling. Smear method is adopted for sampling of object surface, staff hands and gloves, biosafety cabinet operating surface, etc. 1 mL of disinfectant in use is sampled plus 9 mL of corresponding neutralizer to detect total bacteria and pathogenic bacteria. Methods and results were evaluated according to the relevant provisions of the Technical Specifications for Disinfection (2002) and the Hygienic Standards for Hospital Disinfection (GBl5982-1995).
The irradiation intensity of the ultraviolet lamp is measured by the ZDZ-l automatic shift ultraviolet irradiance meter. Methods and results evaluation refer to the relevant provisions of "Evaluation and Standard of Disinfection and Sterilization Effect" (GBl5981-1995).
ZRQF series intelligent anemometer, HS5660A precision pulse acoustic meter, CENT310 digital thermometer and hygrometer are used for on-site detection of Class II biological safety cabinet. Methods and results evaluation refer to the relevant provisions of General Guidelines for Biosafety of Microbiological and Biomedical Laboratories (WS233-2002) and Technical Code for Building Biosafety Laboratories (GB50346-2004).
1.4 Quality control
In order to unify the testing standards, clarify the testing requirements, and improve the overall quality of testing, the testing personnel shall be trained on the basis, sampling and testing methods, document preparation, precautions, result evaluation and other knowledge. The inspection results and work quality shall be evaluated uniformly.
1.5 Data processing
Excel 2003 software was used to input data and check, and SPSS11.0 software was used for statistical analysis.
2 Results
A total of 197 samples were tested in this disinfection effect test, 191 of which were qualified, with a total qualification rate of 96.95%. Among them, the laboratory qualification rate of private medical institutions is 92.86%, and that of public medical institutions is 100.00% (Table 1).
The number of biosafety cabinets tested on site was 69, and 60 were qualified, with a total qualification rate of 86.96%. Among them, the laboratory qualification rate of private medical institutions is 85.29%, and that of public medical institutions is 88.57% (Table 2).
3 Discussion
3.1 Disinfection effect test
The results of this disinfection effect test show that the disinfection and health status of the secondary pathogenic microorganism clinical laboratory in this area is good, and the overall qualification rate is slightly higher than the qualification rate of medical institutions' microbiological laboratories reported in the literature. The results also show that the disinfection effect of public medical institutions' laboratories is better than that of private medical institutions' laboratories, which is related to the lack of professionals in private medical institutions' laboratories reported in the literature, and the more BSL-2 pathogenic microorganism detection projects carried out in some medical institutions.
The results also show that some private medical institutions in this area still have some weak links in medical environment and disinfection of goods. The reason why the bacteria in the hands of medical staff exceed the standard is related to irregular hand washing, short hand washing time, and unqualified hand sanitizer; The qualification rate of laboratory air is low, the main reasons are poor air circulation and poor disinfection; The qualification rate of ultraviolet lamp in laboratory is low, which is related to the lack of testing, inspection and updating in long-term use; The ultraviolet lamps in the biosafety cabinet are newly installed, and the qualification rate is low, which is related to the lack of comprehensive grasp of the relevant performance and common sense of the biosafety cabinet by the professionals in the laboratory, resulting in the purchase, installation and testing of the biosafety cabinet not meeting the relevant requirements.
Among the large number of pathogenic microorganisms detected by the secondary pathogenic microorganism laboratory, there are quite a number of unknown samples and operations on uncultured infectious materials, so that medical institutions may also be exposed to microorganisms with biosafety protection level above Class II, so the biosafety problem cannot be ignored. Some private medical institutions put profit first, and often do not pay enough attention to biosafety issues in order to reduce costs. For this reason, medical institutions should strengthen the study of "Technical Specifications for Disinfection", "Hygienic Standards for Hospital Disinfection" and "Evaluation and Standards for Disinfection and Sterilization Effects", carry out self-monitoring of disinfection effects in strict accordance with national standards and norms, timely correct problems found, and promote the biosafety management of clinical laboratories. Laboratory operators should strengthen disinfection knowledge training, improve biosafety awareness, correctly operate disinfection technology, and ensure the biosafety of clinical laboratories. While actively promoting education, the health administrative department should strengthen supervision and punishment.
3.2 Field test of biosafety cabinet
In the microbiological laboratory, mixing, oscillation, centrifugation, ultrasound, crushing, blowing and knocking and other operations can produce a large number of microbial aerosols, and the installation and correct use of biosafety cabinets is one of the important biosafety measures to prevent the diffusion of microbial aerosols. At present, most users do not know enough about the detection performance of biosafety cabinets, and there is no qualified organization to uniformly carry out the detection work of biosafety cabinets. Some users will continue to use the biosafety cabinets as long as they can rotate, which has become a great hidden danger.
