MEDEMAS –Medical Device Management and Maintenance System Architecture Ülkü Balcı Doğan, Mehmet Uğur Doğan, Yekta Ülgen and Mehmed Özkan Bogazici University, Biomedical Engineering Institute, 34342, Bebek - Istanbul, Turkey E-Health 2009 İstanbul

Aim Design and development of a medical device maintenance management software to keep and assign record of medical devices, their information, maintenance protocols and repair/maintenance histories; the foregoing maintenance dates, and the technician responsible for them; to inform the technician about the maintenance; to carry out and complete the maintenance process remotely using proper maintenance protocol(s). It is critically important that the safety and performance of medical devices are continually assessed when they are in use, as these characteristics can only be proven if one measures how a device stands up in these conditions. No amount of rigour in the pre-marketing review process can predict all possible device failures or incidents arising from device misuse. It is through actual use that unforeseen problems related to safety and performance can occur.

Design and Implementation Layout MEDEMAS will provide a pool of medical devices, all required information about these devices, and the maintenance protocols for the devices. will also contain complete repair and maintenance history of a specific device. will create optimal maintenance schedule for devices. will enable the service technician to carry out and report maintenance/repair processes via remote access. thus will prevent/minimize possible future failures . The most comprehensive and challenging side of the study is optimization of maintenance scheduling. We intend to make the study a well constructed preventive maintenance: all actions carried out on a planned, periodic, and specific schedule to keep an item/equipment in stated working condition through the process of checking and reconditioning

Design Considerations While planning maintenance scheduling, the number and the availability status of maintenance equipment should be taken into consideration. Similarly, the number, status, and expertise of technicians; availability of medical device to be maintained and its maintenance history are also required. In case of failure, the action to be taken is to adjust a new maintenance schedule after approximating repair period; meanwhile the technician/user will be directed to a repair request form for the medical device. These operations will not be done manually; an underlying software will run after each newly entered/updated maintenance document and will make maintenance scheduling

Design Considerations Maintenance frequency is affected by medical device related factors like: recommendations of the manufacturer and advisory bodies, age of the device, past history of the device, experience and knowledge of the user, and frequency, environment and nature of use

Design Considerations The application will have a powerful evaluating facility. Evaluation of the medical devices, the technicians and the maintenance processes will be made automatically using scoring databases. These databases will contain grading of processes/properties which will be added up to make evaluations. Keeping information of and evaluating the technical staff is especially important as a significantly large proportion of total human errors occur during the maintenance phase.

System Architecture The proposed nature of the study is a main server remotely accessed by technicians with PDAs through GPRS/WLAN. Main server will also be accessed by hospital personnel and directives for data entry, management and reporting facilities. This will be done by computers through internet or intranet.

The Management System Topology

Operation Modes Remote maintenance access is used by the technician on process. The access is limited with technician’s authorities. Main process is filling out the maintenance form and sending it to the main server. The technician is supplied with the maintenance protocol and the maintenance history of the device. Besides, he is informed about the jobs ahead he is responsible for and is alerted for incomplete jobs.

Operation Modes Direct application management is the other access type. Both internet and intranet can be used, and almost all data manipulation, reporting, display, evaluation and tracking are via this type. It can be further divided into three: The first process is forming databases of all devices, maintenance protocols, technicians, trainings, maintenance equipment, maintenance calendar, etc. Recording, update and deletion are main processes in terms of data management.

Operation Modes The second process is the display of the database; it includes construction of many reports. Preparing proper reports, it will be able to track the devices in the hospital, the status of devices, the most problematic devices, the problems experienced (frequency and reasons either), the cost of individual devices in terms of maintenance, etc. The reporting process will help the directors in: following the medical equipment, finding out which devices are most problematic, which are most expensive to maintain, finding out the most experienced problems and the reasons of problems etc.

Operation Modes The third process is designing and implementing an optimal maintenance schedule. An underlying program will be run in cases of maintenance entry or update (like case of failure). A change in technician record or maintenance accessory record (i.e. ammeter is impaired) will also cause the program to run. The program will make a new schedule, optimizing many parameters like technician, maintenance device, medical device availability, recommended device maintenance period, approximate repair duration, historical data about maintenance activity of the medical device, etc. The beginning to manage this is creating and maintaining of database files required for optimization. The rest is to implement a well built algorithm for optimizing maintenance schedule. Since the technician will be previously assigned with the maintenance process, when maintenance time is close enough, he will be informed again via e-mail. The technician will have remote access to main server. He will be able to carry out the maintenance form and send it to the main server at the (same) time of completion.

Operation Modes A new test record / maintenance form will be created for each maintenance process, which will contain: instructions, a to do list which will be checked out by the technician as the process goes on, and some information space to be filled by the technician, like the nature of the problem, the work carried out, the measurement values, the results of the work done i.e. succeeded or not, etc. These maintenance records will be associated with the device being processed, and will totally constitute the repair and maintenance history of the device.

Design and implementation of the maintenance process software The measurements and controls will be made for compliance with International/European Medical Device Standards. Some standard values and test values are given below; the tables mirror related database files. Since the technician will be previously assigned with the maintenance process, when maintenance time is close enough, he will be informed again via e-mail. The technician will have remote access to main server. He will be able to carry out the maintenance form and send it to the main server at the (same) time of completion.

A Sample Form Criteria* Allowed/Recommended Values* Measured Values Maximum mains voltage 250 V Maximum touch leakage current 100 A Maximum patient leakage current Below 320 nm Maximum earth leakage current 5 mA Operating Temperature 5° to 45°C * Values and criteria are derived from ISO 8835-5 and IEC 60601-1 Anaesthetic ventilator Standard and Measurement Values, a section from maintenance form

Project Status The application architecture of MEDAMAS is carefully built. Database creation and data management modules are completed. Databases are supplied with the flexibility to allow automatic processes. Underlying automation and remote-connection applications are still under construction.