Design and application of "healthy" technical archive system for medical equipment

Preface

The role of medical equipment in hospital medical services has become increasingly important, and the technical status management of medical equipment itself is also becoming increasingly important. At the same time, due to the large number of medical equipment and complex technology, a series of management difficulties are brought about. Every year, medical accidents caused by 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 must be implemented. The construction and application of the medical equipment "health" technical archive system (referred to as the health archive system) provides a 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. In my country, hospitals above the second-class level generally have medical equipment fixed assets worth tens to hundreds of millions of yuan. The number is quite large and the variety is wide. There are medical equipment with a unit price of more than one million yuan, such as CT and MRI, and medical equipment with a unit price of less than 1,000 yuan. There are inspection equipment such as radiology and ultrasound, and there are also treatment equipment such as surgery. Some are directly in contact with patients and used for patients, while others are indirectly used for clinical diagnosis and examination. Due to the above factors, the complexity and difficulty of medical equipment technical management are determined. Due to the factors of manpower and material resources, general medical institutions only care about how to purchase medical equipment but lack how to manage medical equipment, and even lack how to safely and effectively control the quality of medical equipment. In general, they can only manage the variety and quantity of medical equipment. Or they can only manage the repair and local maintenance during use, let alone systematic quality management. How to manage the high-quality technical application of medical equipment under the current situation and conditions is a problem that the medical equipment management departments of medical institutions have always faced and troubled [1].

(2) As we all know, due to the large number and variety of medical equipment in various medical institutions, there are many problems in the management process. For example, some hospitals manually register property when purchasing equipment, or some hospitals already have computer information management systems, but in most cases, they only manage electronic property accounts for fixed assets, without technical management functions, and cannot provide dynamic technical data for technical problems during the use of equipment. Therefore, it is impossible to conduct dynamic technical evaluation of equipment safety status and usage status [2][3].

The majority of medical workers, even medical engineering engineers, do not understand the safety of medical equipment, and do not understand the specific meaning of how to control and evaluate the safety of medical equipment. Therefore, they lack sufficient understanding of a medical device. Objectively, because there is no "health" file for each device, it is difficult to understand the operating status of the device, which may bring hidden dangers to medical care. On the other hand, whether it is the direct user of the equipment or the equipment maintenance and repair management department, it is impossible to objectively and comprehensively evaluate the safety status of any equipment based on scattered equipment use, repair and maintenance file data, nor can it provide sufficient safety evaluation data. Therefore, establishing 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 record system

(1) The health record system is based on the record of normal operation and daily use of equipment. It is different from the daily registration (usage record) of the department using expensive equipment, because the user registers the status of the equipment every day, mainly recording whether it is normally turned on on that day, what inspections have been done, whether there are any faults, etc. The health record described in this article records the more detailed technical operation status of the equipment after the equipment is accepted and put into use, such as the fault status, detection status, measurement status, repair and maintenance. It is an archive system that records the "health" status of medical equipment. It mainly provides support for medical equipment safety assessment, equipment investment, and hospital decision-making. The contents covered include the initial acceptance status, PM plan execution status record, fault repair status record, measurement status record, detection status record, and corresponding maintenance cost records [5].

(2) Initial acceptance: After the medical equipment is purchased, the first thing to do is to conduct the initial installation acceptance. As a health record of a piece of equipment, the purchase date of the equipment must be recorded first (basic information such as installation date, after-sales service agency, price, and using department. This basic information can be entered through the system or shared from the property registration information of the medical equipment management department). The relevant equipment technical parameters should be recorded during the initial acceptance so as to serve as important reference indicators for future equipment safety assessment.

(3) PM plan: For many equipment, especially expensive equipment and rescue equipment, a PM plan should be formulated according to the requirements at the initial stage of purchase to ensure the normal use of the equipment after it is turned on. Due to the contradiction that there are many medical institutions with equipment but relatively few engineering and technical personnel, we believe that a PM plan that conforms to the actual situation can be formulated according to the specific situation. According to our actual experience, it is more appropriate to adopt a model of local pilot and comprehensive promotion.

(4) Measurement and testing: Some medical equipment needs to be regularly tested and measured in accordance with relevant management requirements. For example, ultrasound, radiology, sphygmomanometers and other mandatory measurement equipment stipulated by the National Measurement Law must be tested and measured accordingly. Regular testing and measurement must be included in the record scope of the health record. Whether the test and measurement pass or fail can directly determine whether the medical equipment continues to provide medical services, and can also provide an accurate basis for equipment risk assessment.

(5) Equipment maintenance: Equipment maintenance is an indispensable part of the entire service life of the equipment. During the service life of the equipment, each device may fail and require appropriate maintenance. The quality and frequency of maintenance can reflect the safe operation of the equipment. Therefore, it is necessary to record the maintenance status in real time. At the same time, the costs incurred during maintenance must also be recorded in the health record to provide a basis for determining whether the equipment should be discontinued and whether the same or similar equipment should be introduced.

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3 Design of health record system

3.1 Application mode

The application mode of C/S (client/server) structure is more suitable for the health record system EDMS (Electronical Document Management System). The server side is installed with DBMS (Data Base Management System) software, which is responsible for the operation and maintenance of the database; the client side is installed with the health record system front-end software, 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 throughput and response time of the system. The C/S structure has good online transaction capabilities, openness, scalability and security [6].

3.2 Network connection

The EDMS network should be established under the overall planning of the hospital. It can be a domain of the hospital network or a workgroup under the domain. Due to the high degree of informatization of our hospital, the EDMS network is sufficient to use existing resources. The network does not have a separate domain controller, and only establishes an EDMS workgroup subordinate to the HIS (hospital information management system) domain. The EDMS workgroup has 1 database server and multiple workstations (clients). The workstations are responsible for data reception, management, query and other tasks.

3.3 Main hardware equipment

The hardware equipment used in the EDMS network mainly includes database servers, workstations, HUBs, NICs, etc. It is recommended that EDMS be networked according to the Fast Ethernet standard.

The database server uses a disk storage system with RAID (Redundant Array of Independent Disks) technology, which can enhance fault tolerance and increase transmission speed. Considering the characteristics of EDMS data growth but no real-time backup, it is more appropriate to choose a server hard disk to back up the data in the database server.

4 Application and experience of health record system

(1) Since the health record already has many equipment-related parameters and data, quality control (QC) and quality assurance (QA) control can be performed. Medical equipment serves medical care mainly by providing medical data necessary for inspection, testing, and measurement. Based on the information recorded in the health record, the quality of equipment use, the status of use, and risk assessment can be evaluated.

(2) Information in the health record system can provide a basis for decision-making. For example, if there is important information such as maintenance status, maintenance frequency, maintenance cost, and measurement value in the health record, it can provide a reference for whether the equipment should continue to serve or terminate service. If the comprehensive maintenance and repair costs are higher than the value of the equipment, it can be decided whether it needs to be updated; if a piece of equipment fails to meet the measurement requirements, it will be forced to stop service; if a company's products all have the same quality problems, it should be noted that when purchasing equipment in the future, it should be careful to avoid risks. The health record system can also save hospitals unnecessary expenses. For example, some departments need to purchase new equipment for local interests, and the reason for applying for purchase is that the failure rate of the equipment in use is too high. In fact, the equipment in use is in good condition, and the department only wants to use the new equipment. With the accurate and comprehensive information provided by the health record system, the decision-making level of the hospital can easily reject such unnecessary investment.

(3) With the establishment of a health record system, the equipment management department can carry out scientific management. Statistical analysis of various data in the health record system can be performed, such as statistically analyzing the service life differences of different types of equipment, comparing the differences, failure rates, intact rates, price costs and other factors between the same type of equipment from different manufacturers. On the one hand, it can provide decision support for repurchasing equipment, and on the other hand, it can provide a quick and effective guarantee for the equipment management department on how to formulate equipment maintenance plans, PM plan adjustments, and troubleshooting, thereby providing first-hand information for improving the technical service quality of the medical engineering department and conducting related research. For example, Table 1 is a statistical table of medical equipment failure classification in our hospital from 2003 to 2009. Based on this statistical data, we can make corresponding clinical engineering analysis results and solution strategies.

5 Results and Discussion

(1) The establishment of the health record system is of great positive significance. 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, which completely changes the status quo of fuzzy equipment management and raises the technical management of medical equipment to a new level.

(2) In the process of building the health record system, it is necessary to proceed step by step, from point to surface, from part to whole. Managers of the equipment management department and clinical engineers of the hospital should have a new understanding of equipment management, understand this issue from the perspective of medical engineering, and understand and master it with the idea of ​​development. Through application and practice, the medical equipment health record system provided in this article meets the technical management requirements of hospital medical equipment and can provide reference for peers.