Quality processes surrounding the maintenance of medical equipment have developed enormously over the years. Decades ago, people started performing maintenance on medical equipment and measuring electrical safety. The hospital’s technical staff did this in general according to their own insights and sometimes recorded the relevant information in a file. Fixed procedures did not yet exist at that time.
Maintenance process
The automation and safeguarding of the maintenance process is a development that we can no longer ignore today. Consider, for example, reporting, traceability, uniformity in maintenance procedures, and efficiency. These are topics that are part of the quality systems that are used in the hospital, but also at suppliers and manufacturers of medical products. Many hospitals work with quality systems such as those of NIAZ or JCI. For suppliers and manufacturers, this is often ISO 13485. A continuous development here is the improvement in work processes, efficiency, and effectiveness. Hospitals, suppliers, and manufacturers must have their maintenance processes set up in such a way that all maintenance information is traceable. What matters here?
Traceability
It is important to be able to trace which measuring instrument or simulator with which firmware was used when performing maintenance on the device in question. If it later turns out that a measuring instrument deviates, it must be easy to trace which devices have been tested with it. The revision and revision date of maintenance procedures are also important to keep track of. Software for test automation records this information.
Reporting
Software for test automation measures, analyzes, and reports the relevant information. This can be saved or entered manually. A link between the test automation program and a maintenance management program such as Ultimo ensures greater efficiency in the workflow. This is also a good example of risk management.
Risk management
Automating processes contributes to risk management. This way you can ensure that maintenance procedures are fully carried out as the manufacturer intended. Standardization of procedures also contributes to better risk management. The measurement data is stored in a standardized manner, reducing the chance of human errors.
The properties that test automation brings with it make it an almost indispensable link in the maintenance process of medical devices.
