Medical equipment "health" management system design and applications (1)

Preface

Medical equipment in hospitals in the role of the medical services have become increasingly important, the medical equipment of its own technology in management is increasingly important.

At the same time, due to the large number of medical equipment, technical complexity, the brought a series of management difficulties. Each year due to the quality of medical device safety medical incidents arising in the Hospital of medical accident in occupies a certain proportion, thus the quality of the medical device security control is bound to perform. Health medical equipment "," technical archives system (hereinafter referred to as health records system) on the construction and application of the medical device management, quality control, provide the basis for safe operation.

1 medical device technology management situation and the difficulties

(1) medical device technology management is a complex and large systems engineering, dimethyl hospitals generally have tens to several million of fixed assets, the amount of medical equipment is fairly large and wide variety, both monomers expensive million above such as CT, MRI and other medical equipment, also has a single price below $ 1000 of medical equipment, and emission class, ultrasonic inspection machine class, etc., also have the surgery, therapeutic class medical equipment.

There is direct contact with patients directly to patients, and patient non-directly or indirectly for the clinical diagnosis, examination, etc. Due to the large number of factors determine medical device technology management complexity and difficulty, general medical institutions because of human and material factors only care about how to purchase medical equipment and lack of how to manage medical equipment, how safe is the lack of effective quality control of medical devices, typically can only do the number of varieties of medical equipment asset management. Or only in the course of maintenance and local maintenance management, much less systematic quality management. How in the existing circumstances and conditions, the high quality of medical device technology application management is the management of medical institutions and medical device sector has been facing and distress challenge [1].

(2) it is well known, due to medical institutions and medical equipment to the number, variety, so in the management of the process will face many problems, such as a hospital in the purchase of equipment are artificial registration property, or the hospital already have computer information management system, but the vast majority of cases are fixed by the management of electronic records, property does not have the technical management of the function, you cannot use the device in the process of technical issues to provide dynamic technical data and therefore cannot be dynamically device security status, using state of the technology assessment [2] [3].

The majority of medical workers, even medical engineering engineers failed to understand the medical device security, did not grasping how to control and evaluate the safety of medical devices, so the specific meaning of a medical device lacks adequate understanding, because each device has to designate a "healthy" files, it is difficult to understand the operational status of the device, you may bring about hazards to health.

On the other hand, regardless of the device directly to the consumer or equipment maintenance management departments, by relying on decentralized sporadic equipment maintenance records data can not be objective and comprehensive evaluation of the use of any device, security status also cannot provide sufficient security assessment data. Therefore establish a safety and quality management based on medical technology filing system, in order to address the current medical equipment management problems and difficulties [4].

2 health records system construction and content covered

(1) health records system based on equipment uptime and daily use of records, distinct from the valuable equipment using the daily registration Department (using records), because users registered on the status of every device, mainly whether the normal power on the day of registration, do check whether there is a failure, and so simple content, this article describes health records is the device after the device is used for acceptance of fault condition, detection, measurement conditions, maintenance, and other more detailed technical running record.

Is the record medical equipment "healthy" condition of the archival system. Major security assessment for medical equipment, equipment, hospital decision-making support, the content is covered by the initial acceptance status, PM plan implementation records, fault repair records, record measurements, detection, and response of the maintenance cost of records [5].

(2) initial acceptance: purchase of medical equipment, the first thing to do the initial installation and acceptance, as a unit of health records, it is first necessary to record the date purchased the device (installation date, service agencies, price, using the Department and other basic information, these basic information can be input through the system, or from the medical device management property registration information sharing).

Initial acceptance record related equipment specification parameter for for future equipment safety assessment of important reference index.

(3) PM plans: many devices, especially valuable equipment and rescue equipment, purchased early should be based on requirements developed PM plans to ensure that the device is turned on after normal use.

Since the current medical institutions equipment and engineering and technical personnel to relatively little contradiction, we think we can make a case-by-case basis in line with the actual PM plans according to our actual experience, the use of local pilot, comprehensive open mode is more appropriate.

(4) Metrology test: some medical equipment in accordance with the requirements of the relevant management required for regular inspection and measurement, such as ultrasonic, radiographic, sphygmomanometers and other national metrology law enforcement measuring equipment must be appropriate for the detection and measurement, periodic inspection and measurement must be integrated into health records the range of records, inspection measurement passed or not can directly determine whether the medical equipment for medical services, as well as for equipment provide accurate risk assessment.