Chapter IV Management System of Medical Devices
File name The basic task of hospital equipment management
Electronic file code ZYGL-04-00 1 Page 2-1
First, according to the principle of advanced technology, reliable quality, economic rationality, convenient application and maintenance, the hospital equipment development plan, purchase plan, purchase system, management measures and maintenance plan are formulated to provide qualified technical equipment for diagnosis and treatment and meet the needs of medical treatment, teaching, scientific research and preventive health care.
The second is to formulate management system, do a good job in departmental services, guide, supervise and inspect the use, repair and maintenance of medical instruments and equipment in clinical and medical technology departments, ensure that instruments and equipment are in good technical condition, have high equipment integrity rate and utilization rate, give full play to the effectiveness of instruments and equipment, and avoid backlog and waste.
Third, take the initiative to serve the next department, do a good job in maintenance, ensure the replenishment of spare parts, pay attention to cultivating technical strength and improve medical engineering knowledge and skills.
Fourth, promote the construction of key disciplines in hospitals, help key departments to carry out technical evaluation and feasibility demonstration of equipment, provide equipment information, and provide basis for hospital leaders to make decisions.
5. Strictly standardize management, adopt advanced management methods, conscientiously do a good job in equipment classification and code application, do a good job in scientific management of equipment, and improve post responsibility system.
Six, efforts to improve the economic benefits of equipment, strengthen the financial management of equipment, fixed capital management, liquidity management, cost accounting, cost-effectiveness and cost-effectiveness analysis and evaluation.
Seven, in accordance with the regulations, conscientiously do a good job of upgrading and eliminating equipment.
File name The basic task of hospital equipment management
Electronic file code ZYGL-04-00 1 Page 2-2
Eight, pay attention to the measurement work, regular quality supervision and management of equipment, to ensure that the equipment meets the requirements of legal measurement standards.
Nine, abide by the law, it is strictly forbidden to appear illegal acts and unhealthy practices in the process of equipment procurement, and consciously accept supervision and restraint.
Principles of file name management of medical devices
Electronic document code ZYGL-04-002 Page number 1- 1
I. Principles of Dynamic Management
That is, according to the actual situation, different management methods are adopted for different types, different departments and different performances of instruments and equipment. Sometimes it is even necessary to formulate different management methods and policies according to different needs (such as the needs of clinical diagnosis and treatment, research work or discipline construction), and there should be a guiding principle for the management of medical equipment, and its guiding ideology is the strategic goal of medical development.
Second, the principle of system management
In order to establish the overall concept and overcome the narrow concept of departmental ownership (even individual ownership), we should evaluate the effectiveness of equipment management from the perspective of overall function and overall benefit (rather than local function and local benefit). At the same time, when deciding whether to buy and equip a piece of equipment, we must consider the overall resource conditions, technical conditions, management conditions and market conditions, and analyze the advantages.
Three. Principles of economic management
It is necessary to act according to the laws of economy and value, so that the management of hospital equipment, including purchase, use, storage, collection, maintenance and renewal, should be economically accounted, pay attention to economic benefits, give full play to the role of resources, and serve to improve the quality of diagnosis and treatment.
Fourth, the principle of openness and coordination.
Adhere to the concept of openness in the management of instruments and equipment, fully improve the utilization rate of resources, attach importance to the information exchange and feedback of the use of instruments and equipment, advocate the enjoyment of resources, and never adopt the backward policy and closed measures of "behind closed doors", especially to prevent and reverse a few departments or personnel from purchasing advanced medical equipment as a tool to seek the interests of small groups or individuals.
File name, the main function of the equipment department
Electronic document code ZYGL-04-003 Page number 1- 1
First, according to the goal of hospital development planning and the needs of medical treatment, teaching and scientific research, the hospital equipment allocation plan and phased implementation plan are formulated.
Two, according to the clinical and medical departments of the procurement plan and reserves, prepare the annual procurement plan, submitted to the dean for approval before implementation.
Three, formulate rules and regulations of hospital equipment management and specific management measures, implementation details.
Four, the specific organization and implementation of hospital equipment planning, and earnestly do a good job in the process of equipment management procurement, ordering, acceptance and warehousing, installation and commissioning, delivery, maintenance, transfer, renovation, loss reporting and scrapping, measurement inspection, statistical reporting and a series of daily business work.
Five, strive to improve the comprehensive benefits of hospital equipment, and constantly strengthen the scientific management of hospital equipment.
6. Organize the collection, collation, synthesis, analysis, preservation and retrieval of information related to hospital equipment management, and provide relevant decision-making basis for hospital leaders.
Seven, organize and help medical staff to master the methods and essentials of using instruments and equipment, and improve medical engineering knowledge of medical staff.
Eight, cooperate with medical staff to carry out technical innovation and scientific research on equipment, and promote the development of hospital technology and new equipment.
File name, the main function of the equipment department
Electronic document code ZYGL-04-003 Page 2-2
Nine, strictly implement the rules and regulations, abide by the hospital professional ethics construction norms, prevent unhealthy practices in equipment procurement, and strive to improve economic efficiency.
Ten, do a good job in the daily affairs of the hospital equipment management committee.
File name: Quality requirements of medical equipment managers
Electronic document code ZYGL-04-004-004 Page number 1- 1
Improving the quality of medical equipment management personnel is an important condition for hospital equipment management. Quality requirements include two aspects:
1.* * * Same-sex quality requirements, including ideological and political quality, cultural and technical quality, scientific management quality and so on. , requires dedication, integrity, skilled technology, skilled operation, know how to manage, and have certain organizational planning ability.
The second is the specific quality requirements, including having certain basic medical knowledge and the most basic medical equipment professional knowledge, operating ability, maintenance technology and so on. , to achieve the technical requirements of "one expert and many abilities", especially to abide by professional ethics and code of conduct.
File name: principle of staffing for medical device management.
Electronic file code ZYGL-04-005 Page 2-1
I. The principle of having both ability and political integrity
It is necessary to have the professional ethics of dedication, loyalty, obedience to needs, diligence, honesty and selfless dedication, as well as the technical requirements of diligent study, assiduous study, rigorous scholarship and Excellence.
Second, the principle of streamlining administration.
Staffing should proceed from the actual situation of the hospital, be practical and realistic, be efficient and effective, and prevent overstaffing.
Third, the principle of stabilizing the team.
We should attach great importance to and care for equipment management personnel and engineering and technical personnel. We should not only be strict with them, but also pay attention to stabilizing them. Care should be taken not to make them feel neglected and "inferior" to medical staff, and to fully mobilize their enthusiasm, initiative and creativity.
Fourth, the principle of consistency of power and responsibility.
We should give full play to their talents and responsibilities and their intelligence.
Five, the principle of reasonable structure
According to the situation of hospital equipment management, all kinds of engineering and technical personnel are equipped, and their professional structure, knowledge structure, education structure, ability structure, age structure, education background and regional structure are fully considered to give full play to the complementary role of disciplines.
Attached:
Hospital equipment management personnel assessment scale
Unit name and position
Category evaluation content score My evaluation department evaluates the final evaluation score of the superior evaluation.
Political and ideological expression 15% 1. The attitude and performance of implementing the line, principles and policies of the party and the state and participating in political study.
2. Integrity and professional ethics.
3. Work style and ideological style performance 5
five
five
Work attitude 15% 4. Enterprising, enthusiastic, brave to shoulder heavy burdens and work actively.
5. Can you take the initiative to think, innovate and create and its achievements at work?
6. Abide by labor discipline, attendance and sick leave, obey the organization and distribution, and abide by the law. five
five
five
Business ability 10% 7. Can you do your job well?
8. Business technical knowledge and ability 5
five
Job performance 60% 9. Formulate, establish and abide by the implementation rules and regulations
10. Observe the safety operation rules. Is there any accident?
1 1. Make a plan and achieve the planned indicators.
12. The storage of instruments and equipment is consistent with the account card in use.
13. Storage and loss of instrument and equipment warehouse
14. Collect and sort out relevant information to provide decision-making basis for leaders.
15. Maintenance and utilization of equipment, thrift.
16. Economic management and fund management and economic benefit analysis
17. Help clinical medical departments to engage in scientific and technological development and promote discipline construction in hospitals.
18. Technological innovation and innovation achievements, published papers and award-winning achievements
19. Quality inspection and measurement assessment approved by superior units
20. Engage in or assist in teaching and scientific research.
five
five
five
five
five
five
five
five
five
five
five
File name equipment principle
Electronic file code ZYGL-04-006 Page 2-1
Equipment management of medical equipment refers to the whole process management from procurement to planning, and then through selection, ordering, arrival, installation and acceptance of equipment. In order to provide the most suitable technical equipment for clinical medical treatment, teaching and scientific research, the following equipment principles should be followed when making plans and schemes:
I. Economic principles
1. Make the hospital equipment plan according to the actual economic capacity, so as to make the equipment layout reasonable.
2. According to the predicted source of patients and predicted economic and social benefits, equipped with departments.
3 in accordance with the principle of doing more with less money and the principle of intensive growth with less input and more output.
Second, practical principles.
That is, the equipment plan should be formulated in combination with the scale, task, present situation and the actual situation of the medium and long-term development plan of the unit, and the following relations should be handled well here:
1. In terms of the relationship between purchasing large-scale instruments and equipment and purchasing conventional instruments and equipment, priority should be given to purchasing conventional instruments and equipment.
2. In highlighting the key points and ensuring the overall situation, we should highlight the key points, form a situation in which people are lacking and areas are lacking, give full play to the characteristics and advantages of hospitals, and do not engage in comprehensive egalitarianism in the allocation of funds.
3. The introduction of large-scale instruments and equipment should have a certain sense of being ahead of the times, and introduce world advanced equipment with reliable performance and advanced technology for at least five years.
4. For a large number of popular instruments and equipment or instruments and equipment with no characteristics in clinical application, the relationship between high performance indicators and practicality should be based on the principle of practicality to avoid the waste of equipment resources.
5. In terms of the relationship between imported instruments and domestic instruments and equipment, domestic instruments and equipment should be used as much as possible if they can meet the clinical requirements.
File name equipment principle
Electronic file code ZYGL-04-006 Page 2-2
Third, the standards of grade hospitals.
Hospital equipment should not only meet the clinical needs, but also meet the requirements of the Ministry of Health and the provincial (city) health department (bureau) in hospital grading evaluation.
Principles of purchasing archival instruments and equipment
Electronic file code ZYGL-04-007 Page 3-1
First, the principle of evidence
Medical device products to be purchased (including imported and domestic products) must have a medical device product registration certificate. These products should be examined by the medical device management department before they can enter the market. Can't buy unlicensed products.
Second, the economic principle.
1. Determine the price.
To buy equipment, we must first determine the price, that is, how much it costs to complete the equipment work.
2. Choose domestic products first
If domestic products can meet the requirements in terms of performance and quality, there is no need to introduce foreign products. Where only the key mainframe needs to be imported, its supporting auxiliary equipment can be purchased at home.
3. Pursuing high cost performance and low cost consumption.
(1) When choosing a model, the performance and price of the machine are contradictory, and high performance will inevitably lead to high price. In order to evaluate the quality of products between manufacturers, the ratio of performance to price is an important index. On the premise of meeting the requirements of clinical use, try to keep the price of the machine low, that is, to pursue high cost performance.
(2) After the instrument is put into use, there are startup costs, such as water, electricity, steam, labor and material consumption. The main consumption to be considered here is the consumption of materials necessary for the operation of instruments and equipment, such as reagents (paper) and catheters. Therefore, when purchasing instruments and equipment, we should pay attention to the source and dependence of materials, introduce foreign equipment and use domestic consumables, which is the principle of low cost consumption.
4. There are preferential payment methods
The ordering of instruments and equipment inevitably involves the payment method, is it installment payment or lump sum payment? Should the deposit be paid in advance or in full, or after the goods are installed, debugged and accepted? Among all these methods, the method with the latest payment time should be chosen to minimize the risk of equipment investment funds.
Principles of purchasing archival instruments and equipment
Electronic file code ZYGL-04-007 Page 3-2
Third, the principle of advanced technology, mature products and high quality.
1 advanced technology
Advanced technology means that the principle and structure adopted by this product are scientific and advanced, and its technical parameters are outstanding and leading among similar products. It is necessary to prevent the introduction of outdated products due to invalid information.
2. Mature products
Product maturity means that the product is not a trial product, but has been tested by a large number of clinical practices and has a broad user base. Don't easily adopt the trial products launched by manufacturers for the first time, and don't trust the advertising of manufacturers.
3. Excellent quality
High quality means that the reliability, safety and durability of products are ahead of similar products.
4. Believe in famous brands
Brand-name products are the results obtained by brand-name production enterprises through continuous development, improvement and improvement of the performance, quality, technology and reliability of their products and strict management of all aspects of production, and after fierce market competition. So buying a famous brand means believing in the internal quality of the factory. In addition, brand-name manufacturers pay more attention to after-sales service, so they can buy with confidence. Of course, the price of brand-name products will be more expensive than ordinary products, and will be weighed according to the set price.
Fourth, the principle of functional application.
Functional application is to make the best use of equipment resources, make full use of them, and choose more practical functions from clinical practice, rather than too many functions that are not commonly used. For example, the choice of instruments for general examination in outpatient department should be such a situation. However, for all kinds of instruments and equipment used in research and development in clinical laboratories, in addition to selecting the functions needed in the current work, it is also necessary to consider the functions that need to be added in the development of disciplines, that is, selecting relatively perfect functions.
Principles of purchasing archival instruments and equipment
Electronic document code ZYGL-04-007 Page 3-3
Five, the principle of quality service
1. Training
Manufacturers should do a good job in training operators and maintenance personnel to ensure normal start-up and daily maintenance.
2. The manufacturer shall provide detailed drawings, operation manuals and maintenance manuals for the instruments and equipment purchased by users. Ensure that maintenance spare parts can be provided in time.
3. After-sales service
We should try to extend the free warranty period. In terms of after-sales maintenance, we should have fast response time and strong troubleshooting ability to achieve the goal of high startup rate.
File name equipment use management system
Electronic document code ZYGL-04-008 Page 4- 1
I. Purpose
In order to ensure the normal operation of instruments and equipment in a long period of time, give full play to their diagnosis and treatment functions and maximize social and economic benefits, it is necessary to do a good job in the use and management of instruments and equipment.
Second, the task
1. Be prepared before use.
(1) Prepare for installation of instruments and equipment before arrival.
Before the equipment arrives, it is necessary to do a good job in supporting preparations such as housing, electricity, water supply, air conditioning, sewage discharge and self-prepared accessories outside the relevant contract to ensure that the equipment can settle down under the specified environmental conditions.
(2) Do a good job in operator training.
Operators of large-scale medical equipment or valuable instruments should go to the superior hospital or factory for technical training before the equipment arrives, and should obtain the operation license or qualification certificate so that the equipment can be put into use after installation.
(3) Do a good job in installation, debugging and acceptance.
This step is very important, which is related to whether the ordered equipment meets the contract requirements, whether its function and performance indicators reach the theoretical value and the best state, so it is also related to the service life of the equipment. In short, it is directly related to the interests of users. To this end, we should carry out this work in an organized, step-by-step and standardized manner:
(1) Organize special personnel to open the box for acceptance, and make original records. This step is mainly to check and count the outer packaging, appearance, variety, specification and quantity of the products, and record the acceptance site and physical objects by photography when necessary. Participants should include equipment management personnel, procurement personnel and maintenance personnel. When unpacking large-scale medical equipment or expensive instruments, representatives of user departments, heads of equipment departments, hospital leaders in charge of equipment and representatives of manufacturers are required to attend. If the manufacturer's representative
File name equipment use management system
Electronic file code ZYGL-04-008 Page 4-2
If you can't be present, you can only open the box with the authorization of the manufacturer's representative, so that the unpacking action is effective. If problems are found in the unpacking acceptance, we should negotiate with the manufacturer to solve the problems, claim compensation or even return the goods.
② Installation, debugging and acceptance. For small and medium-sized instruments and equipment, this work is generally completed by maintenance personnel, and the installation, commissioning and acceptance report is written for the record. For large medical equipment or expensive instruments, manufacturers usually send engineers to complete them. The maintenance personnel of the unit cooperated with the personnel on duty, thus getting a field technical training. The installation and debugging work should be careful, and debugging and testing should be carried out one by one according to the technical conditions of the products. We must never look at these images and try them.
For the performance acceptance of large medical equipment or expensive instruments, it is also necessary to organize specialized personnel. Participants should include leaders in charge of equipment, heads of equipment management departments, heads of user departments, specific operators and maintenance engineers. When necessary, experts who have used equipment from superior units should be invited to check and accept the functions, characteristics and clinical application effects of the equipment. After acceptance, the manufacturer shall write a report on installation, debugging and acceptance, and the instrument and equipment can be put into use only after the report is signed by the representatives of the supplier and the supplier, and the warranty period starts from this time.
2. Do a good job in the long-term management of the use period.
(1) management means
After the equipment is installed, debugged and accepted and delivered to the department for use, it begins a long service life until it is scrapped. So how does the equipment management department manage the service life well? Generally, the establishment of account books, files, rules and regulations is the main management means.
① Accounting: After the acceptance of equipment procurement, the warehouse establishes accounting according to the classification of fixed assets or consumables, and implements unified financial management.
② Filing: Equipment files should be established for instruments and equipment. Specifically, full-time or part-time archivists are responsible. After the installation, debugging and acceptance of instruments and equipment are qualified, the archivist will collect the following three aspects of information.
File name equipment use management system
Electronic file code ZYGL-04-008 Page 4-3
Data, set out to establish instruments and equipment files, purchase data: application report, demonstration form, order card, contract, acceptance record, product samples, etc.
Random materials of instruments and equipment: operation and maintenance manuals, circuit diagrams and other related materials.
Management information: operating procedures, maintenance system, application quality inspection, measurement, use and maintenance records, adjustment and scrapping records, etc.
③ Establishment of operating rules and regulations: In order to prevent man-made damage to instruments and equipment, give full play to the functions and characteristics of instruments and equipment, and prolong the service life, the user department should do the following work: a. Before starting the machine for the first time, the operating rules of instruments and equipment should be formulated.
B. The operators shall strictly abide by the operation procedures.
C. establish a usage file to record the daily or every usage.
D. regular maintenance.
E. Any fault or abnormal phenomenon shall be reported to the equipment management department immediately for timely treatment and maintenance.
F. accept the assessment of equipment utilization rate.
(2) Management methods
In order to improve the utilization of instruments and equipment, we should choose different ways to manage different types of instruments and equipment.
(1) Specialized management or centralized public use: it is managed by specialized personnel in specialized departments, operated and used by specialized personnel, users do not use computers, and operators provide testing, diagnosis and treatment reports, which is a form of resource sharing.
② Special * * * use: special * * use, that is, managed by a special person, so that the performance of instruments and equipment can be kept in good condition at any time for users with operation certificates to operate on the computer. Hospital operating room equipment belongs to this type and is also a form of resource sharing.
③ Special use: Some conventional ward equipment, such as monitors, aspirators and first-aid instruments, are equipped in all departments, and their application scope is limited to their own departments.
File name equipment use management system
Electronic document code ZYGL-04-008 Page 4-4
(4) Lease mode: Let users pay part of the rent to get the right to use for a period of time, so as to avoid the idle waste of medical equipment.
File name equipment maintenance and repair management system
Electronic file code ZYGL-04-009 Page 3-1
I. Purpose
Ensure that the instruments and equipment are always in normal and good condition, so as to meet all kinds of clinical requirements for instruments and equipment.
Second, the task
Do a good job in daily maintenance, maintenance or metrological verification of trouble-free instruments and equipment, and do everything possible to troubleshoot those instruments and equipment that cannot operate normally in the shortest time.
Three. Institutions and personnel
Under normal circumstances, the equipment management department should have a professional maintenance room or full-time maintenance personnel, which is the organizational guarantee for completing the equipment maintenance task through scientific and reasonable division of labor and organic combination.
Four. measure
1. arouse the enthusiasm of maintenance personnel and do a good job in equipment maintenance.
(1) In medical institutions, they should be treated equally with technicians from other business departments, and participate in the assessment and promotion. Those who have made outstanding contributions can be promoted without exception.
(2) Pay attention to and strengthen the training, training and re-education of medical engineering technicians, so that the comprehensive theoretical knowledge learned by the school can be transformed into professional technical knowledge and practical work skills, and constantly adapt to the development of new technologies in clinical medical engineering through knowledge updating. It is necessary to regularly participate in the maintenance training courses and academic seminars equipped with instruments in this unit to learn more direct maintenance knowledge from them.
(3) Study the law of equipment failure, and change passive maintenance into active maintenance. The law of equipment failure is the law of development and change of equipment failure in its life cycle. The development and change of equipment failure rate is very similar to the section of a bathtub, so it is also called "bathtub theory". According to the faults in different periods, corresponding countermeasures should be taken.
File name equipment maintenance and repair management system
Electronic file code ZYGL-04-009 Page 3-2
(4) Establish a performance appraisal system for maintenance personnel, and record their usual work attitude, maintenance workload, technological innovation achievements, papers, etc. in personal files, so as to improve the enthusiasm and sense of responsibility of maintenance personnel.
2. Establish a complete maintenance management system to ensure the normal routine maintenance.
(1) Reasonable division and combination of personnel
It is a contradiction that hospitals have more equipment and fewer maintenance personnel. The solution to this contradiction is to divide the maintenance personnel into different jobs first, so that they have their own job responsibilities and their own professional direction, so that each maintenance personnel has their own expertise in the maintenance of a certain type of equipment. The so-called combination means that the maintenance tasks undertaken by each maintenance personnel overlap with the categories of maintenance instruments, so that the overlapping and repetitive instrument maintenance can be carried out in the form of cooperation, which can not only give full play to the collective wisdom, but also avoid the phenomenon that no one is maintaining when someone is away.
(2) Establish the post responsibility system for maintenance personnel.
Maintenance should be registered, parts should be written off, maintenance reports and personal workload records should be kept, spare parts should be planned, and reports should be requested in time during work, so that the work can be carried out in an orderly manner, and the equipment integrity rate of instruments and equipment responsible for individual division of labor should be assessed.
(3) Spare parts supply
The procurement of special personnel should be combined with the procurement of maintenance personnel, and the equipment warehouse should be equipped with general maintenance accessories, such as light bulbs of various light sources, various parts of sphygmomanometers, and various parts of oxygen inhalers. Spare parts that fail during maintenance should be considered as spare parts.
(4) Preventive maintenance system
Preventive maintenance should be carried out regularly for key equipment that is prone to mechanical wear and screw loosening, such as shadowless lamp, operating table and pressure steam sterilizer.
(5) establish a safety inspection system
File name equipment maintenance and repair management system
Electronic document code ZYGL-04-009 Page 3-3
Regularly check the safety of key equipment such as electricity safety and surrounding environment safety to ensure the safety of medical equipment.