Foreword
The role of medical equipment in hospital medical services has become increasingly important, as is the management of the technical status of medical equipment itself. At the same time, due to the large number of medical equipment and complex technology, it brings a series of management difficulties. Every year, medical accidents due to the quality and safety of medical equipment account for a certain proportion of medical accidents in hospitals, so the quality and safety control of medical equipment is bound to be implemented. The construction and application of the medical equipment "health" technical file system (referred to as the health file system) provide basic guarantee for medical equipment management, quality control, and safe operation.
1 Current status and difficulties of medical equipment technology management
(1) The technical application management of medical equipment is a complex and huge system project. Generally, the hospitals with more than two Class A hospitals in China have tens of millions to hundreds of millions of fixed assets of medical equipment. The number is quite huge and the variety is wide. Medical equipment such as CT and MRI, which cost more than one million yuan, also have medical equipment with a single price of less than 1,000 yuan; there are examination equipment such as radiation and ultrasound, and treatment medical equipment such as surgery. Some are in direct contact with the patient and used directly for the patient, and some are indirectly and indirectly used for clinical diagnosis and examination. As many of the above factors determine the complexity and difficulty of medical device technology management, due to human and material factors, the average medical institution only cares about how to purchase medical equipment and lacks how to manage medical equipment, but also how to carry out medical equipment safely and effectively In general, quality control can only manage the variety and property of medical equipment. Or only the maintenance and local maintenance management during the use, let alone the systematic quality management. How to manage the application of high-quality medical equipment technology under the current situation and conditions is a difficult problem that medical equipment management departments of medical institutions have been facing and troubled [1].
(2) As we all know, due to the large number and variety of medical equipment in various medical institutions, they will face many problems in the management process. Some hospitals are manually registered property when purchasing equipment, or some hospitals already have Computer information management system, but in most cases it is only the electronic asset account management of fixed assets, which does not have the function of technical management, and cannot provide dynamic technical data for technical problems in the process of equipment use, so dynamic Technical assessment of equipment safety status and usage status [2] [3].
The majority of medical workers and even medical engineering engineers do not understand the safety of medical equipment and do not grasp the specific meaning of how to control and evaluate the safety of medical equipment. Therefore, a lack of sufficient understanding of a medical equipment is objectively because The "health" file is set up for each device, so it is difficult to understand the operation status of the device, which may bring hidden dangers to medical treatment. On the other hand, whether it is a direct user of the equipment or the maintenance and management department of the equipment, relying on scattered and scattered equipment use maintenance file data cannot objectively and comprehensively evaluate the safe state of use of any equipment, nor can it provide enough Safety assessment data. Therefore, the establishment of a technical file system based on medical safety and quality management can solve many problems and difficulties in the current medical equipment management [4].
2 Construction ideas and contents of health file system
(1) The health file system is based on the normal operation and daily use of the equipment, which is different from the daily registration (use record) of the valuable equipment use department, because the user registers the status of the equipment every day, mainly whether it is turned on normally on the day of registration. What checks have been made, whether there are any simple contents such as failures, etc. The health files described in this article record more detailed technical operating status records of equipment failures, detections, measurements, repairs and maintenance after equipment acceptance and use begins. It is a file system that records the "health" status of medical equipment. Mainly provide support for medical equipment safety assessment, equipment investment, and hospital decision-making. The contents covered include the initial acceptance status, PM plan execution status records, fault maintenance status records, measurement status records, testing status records, and response maintenance costs. Records [5].
(2) Initial acceptance: After the purchase of medical equipment, the first installation and acceptance must be carried out. As a health file for a device, the purchase date of the device (installation date, after-sales service organization, price, use department, etc.) must be recorded. Information, these basic information can be entered through the system, or can be shared from the property registration information of the medical equipment management department). During the initial acceptance, the relevant technical parameters of the equipment shall be recorded in order to prepare important reference indicators for future equipment safety assessment.
(3) PM plan: Many equipment, especially valuable equipment and rescue equipment, should be developed according to the requirements of the PM plan in the early stage of purchase to ensure the normal use of the equipment after opening. Due to the current contradiction between the large number of medical facilities and relatively few engineering and technical personnel, we believe that it is possible to formulate a PM plan that is in line with the actual situation. Based on our actual experience, it is more appropriate to adopt a model of local pilot and comprehensive promotion.
(4) Measurement and testing: Some medical equipment requires periodic testing and measurement in accordance with the requirements of relevant management. For example, mandatory measurement equipment such as ultrasound, radiation, sphygmomanometer and other national measurement laws must be tested and measured accordingly. Periodic testing Both measurement and measurement must be included in the record range of the health file. Whether the measurement is passed or not can directly determine whether the medical device continues to provide medical services, and can provide an accurate basis for the risk assessment of the device.
(5) Equipment maintenance: equipment maintenance is an indispensable link in the entire service cycle of the equipment. In the entire service cycle of the equipment, each equipment may fail and require appropriate maintenance. The quality of maintenance and the number of repairs It can reflect the safe operation status of the equipment, so it is necessary to record the maintenance situation in real time. At the same time, the costs incurred during maintenance must also be recorded in the health file to provide a basis for determining whether the equipment is out of service and whether the same equipment or similar equipment is introduced.
3 Health file system design
3.1 Application Mode
EDMS (Electronical Document Management System) adopts C / S (client / server) structure application mode is more appropriate. DBMS (Data Base Management System, database management system) software is installed on the server side, which is specially responsible for the operation and maintenance of the database; the client side is installed with the front desk software of the health file system, which is responsible for the friendly interface and user interaction. In fact, only SQL (Structured Query Language) statements and result data are transmitted through the network, which improves the system throughput and response time. The C / S structure has better online transaction capabilities, openness, and expandability. Sex and safety [6].
3.2 Internet connection
The EDMS network should be established under the general planning of the hospital, either as a domain of the hospital network or as a working group under the domain. Due to the high degree of informatization in our hospital, it is sufficient to use existing resources for EDMS network networking. The network does not have a separate domain controller, but only establishes an EDMS working group that belongs to the HIS (Hospital Information Management System) domain. The EDMS working group has a database server and multiple workstations (clients). The workstations undertake tasks such as data reception, management, and query.
3.3 Main hardware equipment
The hardware devices used in the EDMS network mainly include database servers, workstations, HUBs (hubs), NICs (network interface cards), etc. It is recommended that EDMS be networked according to the Fast Ethernet standard.
The database server uses a disk storage system of RAID (Redundant Array of Independent Disks) technology, which can enhance fault tolerance and increase transmission rate. Considering the characteristics of large growth of EDMS data but without real-time backup, it is more appropriate to select the server hard disk to back up the data in the database server.
4 Application and experience of health file system
(1) Since there are already many device-related parameters and data in the health file, quality control (QC) and quality assurance (QA) control can be performed. Medical equipment serving medical services is mainly to provide medical data necessary for inspection, detection and measurement for medical treatment. According to the information recorded in the health file, it is possible to evaluate the use quality of the equipment, the use status, and the risk assessment.
(2) The information in the health record system can provide a basis for decision-making. For example, if there is important information about repairs and maintenance, repair times, repair costs, and measured values ​​in the health file, it can provide a reference for whether the equipment continues to service or is suspended. If the cost of comprehensive maintenance and repair is higher than the value generated by the operation of the equipment, you can decide whether to update it; if the measurement of a piece of equipment is not qualified, the service is forcibly suspended; if the products of a company have the same quality problems, then Pay attention to avoid risks when purchasing equipment in the future. The health file system can also save unnecessary expenses for the hospital. For example, some use departments need to purchase new equipment because of local interests, and the reason for applying for purchase is because the failure rate of the equipment in use is too high, and in fact the equipment is in use. The application situation is good, and the department only wants to use new equipment. With the accurate and comprehensive information provided by the health file system, the hospital decision-making layer can easily reject this unnecessary investment.
(3) Due to the establishment of the health record system, the competent department of equipment management can carry out scientific management. Statistical analysis of various data in the health file system, such as the difference in service life of different types of equipment, comparison of the differences between the equipment of the same type of different manufacturers, failure rate, intact rate, price and cost, on the one hand Provide decision support for repurchasing equipment, and at the same time can provide a quick and effective guarantee for the equipment management department how to formulate equipment maintenance programs, PM plan adjustments, and fault resolution, thereby providing first-hand for improving the technical service quality of the medical engineering department and conducting relevant research data. Example Table 1 is the statistical table of medical equipment failure classification in our hospital from 2003 to 2009. According to the statistical data results, we can make corresponding clinical engineering analysis results and solutions.
5 Results and discussion
(1) The establishment of the health record system is very positive. Through this system, the equipment management department can meet the requirements of scientific management. The system truly provides scientific data and effective methods for equipment quality control and quality assurance, completely changing the original equipment fuzzy management. The current situation has brought medical equipment technology management to a whole new level.
(2) During the construction of the health file system, it needs to be done step by step, from point to face, from part to all. The managers of the equipment management department and the clinical engineers of the hospital must have a new understanding of the equipment management. They must understand this problem from the height of medical engineering, and understand and master it with the development thinking. Through application and practice, the medical equipment health file system provided in this article meets the technical management requirements of hospital medical equipment and can provide reference for peers.
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