Software Package for Tracking Status of Inspection Dates and Reports of Medical Devices in Healthcare Institutions of Bosnia and Herzegovina Lejla Gurbeta, Almir Badnjević Verlab Ltd Sarajevo, Medical Device Verification Laboratory, Sarajevo, Bosnia and Herzegovina
[email protected] ,
[email protected]
Emir Žunić
Nejra Pinjo, Fahira Ljumić
Info Studio Ltd, Sarajevo, Bosnia and Herzegovina
International Burch University, Sarajevo, Bosnia and Herzegovina
Abstract— This paper presents software package solution for tracking the status of medical devices inspection dates in verification laboratory. Software package is implemented by the Engineers from Medical Device Verification Laboratory Verlab as necessary tool for tracking dates of inspection of all measuring devices in 3 Clinical Centres, 26 Hospitals, 63 Primary Care Units and more than 350 Private Clinics in Bosnia and Herzegovina (BH). This software is offering possibility to check and download certificates, measuring reports, working reports and calculated errors for each medical device in each healthcare institution. The software is working online and access is possible through Verlab’s web site. Inspection of medical devices in BH is defined by the National Metrology Institute of BH based on directive MDD 93/42/EEC, ISO 60601 and more than 20 different manufacturer’s user and service manuals. The results of this paper is software package which is available to Engineers from verification laboratory, to management and technical stuff in healthcare institutions and National Metrology Institute of BH for planning, tracking and checking inspection dates and all reports of medical devices in healthcare institutions of BH Keywords— verification; measuring errors; metrology
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I. INTRODUCTION With the beginning of the last century, technology became more and more used in everyday medicine practice. According to Joel D. Howell [1], term medical technology at the beginning of the nineteenth century had an entirely different meaning than it has today. Then it referred to the devices that were necessary for the daily operation of healthcare facilities such as laundry, kitchen, telephone system and furniture for hospital rooms. It was at the end of the ninetieth century, that the concept of medical technology gained todays meaning as devices that are directly or indirectly used for the diagnosis, prevention of disease and the provision of their care to patients. Medical devices are considered to be any instrument, apparatus, appliance,
software or other article, whether used alone or in combination, including software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic [2-6] purposes. The development of new medical technology has given physicians a more comprehensive database for the relevant decision-making and transformed the patient-doctor relationship. Measuring is the bedrock of medical research and clinical practice now-days. Today, a person who comes to the hospital for a routine checkup goes under a series of tests and the results of the tests are used in making a diagnosis. The doctor, the patient, family members and other medical staff relies on test results - the numbers, graphs or images gathered using all sorts of medical devices, from simple electrocardiograph (ECG) devices to highly sophisticated computer topography (CT) scanner or Magnetic Resonance Imaging (MRI). Any medical device with measuring function having at its output some SI unit or derived SI unit, is observed as a legal measure and becomes a part of legal metrology and it falls within the jurisdiction of National Metrology Institutes (NMI). Metrology is defined as the science of measurement, embracing both experimental and theoretical determinations in any field of science and technology [7]. The diversity and innovativeness of this sector contributes significantly to improving the quality and effectiveness of health care. In ideal situation, devices used in medical measurement would have perfect reliability and repeatability without any spread of measured values and there wouldn't be any deviations from applicable standards. Depending on internal and external factors, errors are not rare. It is important to notice which factors can cause deviations as soon as possible before any harm is done. Precision and performance of medical devices became an important part in determining appropriate diagnosis and treatment for patients [8]. Medical devices are controlled during the process of production [9], but their surveillance and functionality check latter on is usually omitted especially because all further inspection is performed by those who sell the same equipment and in the whole process there is a big
influence of subjectivity and monopoly. In order to ensure impartiality, increase accuracy and precision in therapy and diagnose, it is necessary to do annual verification of medical devices in authorized laboratories which possess equipment that comply to measuring standards with proven traceability up to international standards. II. INSPECTION OF MEDICAL DEVICES A. Legal metrology in Bosnia and Herzegovina Verification (inspection) is a set of procedures used to determine whether certain device meets metrological requirements [10]. By performing verification regularly it is possible to detect if there are some serious breaks in medical devices and in this way it is possible to decrease expenses of health care institutions. Verification of medical devices with measuring function in BH is defined by law in Official Gazette [11]. Law implementation started on the 1st January, 2015. According to research conducted by National Metrology Institute of BH [12] it is founded that many healthcare institutions in BH have very old equipment. Some of medical devices are aged over 20 years and lot of that equipment has not been verified for many years. According to the above mentioned study [11] it was proposed to introduce several medical devices in legal metrology. Since 22nd September, 2014 following medical devices with the measuring function became part of legal metrology: electrocardiogram (ECG), defibrillator, patient monitor, respirator, neonatal and paediatric incubators, infusion pumps, perfusors, anaesthesia machine, dialysis machine and therapeutic ultrasound. In BH, Medical Device Verification Laboratory is authorized to work in accordance with the ISO 17020 standard [10]. All equipment used for verification is previously calibrated in accredited laboratories in accordance with the ISO 17025 [13], to ensure traceability up to international measuring standards. B. Documents of inspection A set of documents are issued after each verification: certificate, report of error (absolute and relative) for each output parameter that is checked and work order for staff authorized to perform verification of medical devices. In total every year for verification of single medical device, three documents are submitted. There is no specific data about number of used medical devices in Bosnia and Herzegovina but it is assumed that there are around 300,000 medical devices used in Bosnia and Herzegovina on a daily basis. Based on previous, it was necessary to implement a certain software solution that will enable tracking of verifications, performed and upcoming and also enable easy access to data obtained by verification of medical devices for authorized laboratory staff and staff in healthcare institutions.
III. SOFTWARE PACKAGE FOR TRACKING STATUS OF INSPECTION DATES AND REPORTS OF MEDICAL DEVICES IN HEALTHCARE INSTITUTIONS OF BOSNIA AND HERZEGOVINA A. Information technology in business Information technology had changed the way of doing business. There is a huge number of data that are easily accessed by internet in a matter of moments. Online application for tracking status of verification for each medical device, therefore, has a lot of advantages. First, and, foremost clients are able to see verification status of medical devices they poses (how many devices they verified, reports of verification, certificates). In that way they are able to plan the timeline of verification so that budget plan is distributed more efficiently and conveniently. By using online application client is able to contact laboratory at any time and also express their opinion through online survey and give suggestions how to ameliorate service. By creating online databases of verification of medical devices efficient planning of services, repairs or modernization of equipment is enabled that is essential part of clinical engineering. The verification of medical devices consists of several phases: request, reconsideration of request related to the verification, contract and verification of medical device. Online application represent an easy way for submitting requests since for every verification client must define manufacturer, type, model, serial number of device that is object of verification. Once the device is introduced in online database, submitting request becomes very easy to perform and also it becomes very easy to check status of verification for that medical device. For certificated laboratory for inspection of medical devices it is very important to offer a quality service to its clients. Online application provides good data management and analytics of verifications creating database of used medical devices in Bosnia and Herzegovina, for the first time. Also, it provides a tool for creating plans of verifications for staff. B. Application Software application used for tracking of verification in laboratory Verlab is made in Oracle ADF (Application Development Framework) technology. Java Platform Enterprise Edition (Java EE) is defined as basis for many now- days applications and fulfillment of the Oracle ADF framework enables using many Java EE applications. This technology is based on Model-View-Control (MVC) architecture. This architecture helps in structuring application and assigning tasks to each part of application. The main idea of this architecture is delegation of tasks to different layers of application. Model contains program data and it process them, View represents user interface and it shows data obtained from model while Controller controls interaction between View and Model [13]. As a development tool Oracle JDeveloper 11g is used. This tool offers end-to-end development which includes process from design to coding. It is important to
collect, store, and retrieve data and to do this database is required.
reports for Institute of metrology of Bosnia and Herzegovina as well as for clients of verification laboratory.
Database which used is Oracle XE (Express Edition) 11g. As a reporting server Jasper Reports server is used. It is free, therefore it is the most commonly used reporting server. It provides us with reports and analytics that should be used into web or mobile applications.
Fig. 3. Verification tracking
Fig. 1. Oracle ADF, architecture
As an application server Oracle GlassFish Server Open Source Edition is used, which delivers a flexible, lightweight and production-ready Java EE platform. IV. RESULTS AND CONCLUSION Verlab’s online application, software for tracking status of verification of medical devices started running in June, 2015. Since then, 64 health care institutions are registered to use the software and around 500 verifications are recorded in the database. Up to July, 2015 there are around 1500 documents in the online database.
The health care institution in Europe and world have made step toward introducing IT technologies in health care system. [15] Health information technology (HIT) is in general increasingly viewed as the most promising tool for improving the overall quality, safety and efficiency of the health delivery system. [16] This software could be the first step into introducing the IT technologies in every day practice in health care institutions regarding maintenance of medical devices, as a support service. This software is a promising tool since it is very easy to use and there is no need for some additional education on how to use it. The process of making orders and tracking verification status is made very simple. Also, the software can be a useful tool to show how introducing information technologies in health care institutions can be used to optimize management and reduce the cost of bureaucracy and maintenance of medical devices.
Fig.4 . Report example, number of inspected medical devices
REFERENCES [1] Fig. 2. Online application
For a client and staff of verification laboratory, easy access to data is enabled. Search engine allows search by several parameters: serial number, group of medical devices, manufacturer, number of certificate and date of verification. Good organization of data is accomplished by color coding, fig. 3. A free tool is used to implement efficient way of creating reports offer an easy way for creating monthly and yearly
[2] [3]
[4] [5]
D. Joel., “Technology in the Hospital: Transforming Patient Care in the Early Twentieth Century.”, Johns Hopkings University Press; 1995. European Commission DG Health and consumer Directorate B, 2012 International Standard IEC 60601-1 , Third edition 2005-12; Medical electrical equipment – Part 1: General requirements for basic safety and essential performance Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1) Medical devices: Guidance document; Guidelines Relating To The Application Of: The Council Directive 90/385/EEC On Active Implantable Medical Devices
[6]
The Medical Device Indsutry, Science ,Technology and Regulation in a Competitive Enviroment; Edited by Norman F.Estrin; Marcel Dekker INC publisher; 1990 [7] JCGM 200:2008 International vocabulary of metrology - Basic and general concepts and associated terms (VIM), 3rd edition. [8] World Health Organization (WHO) at: http://www.who.int/medical_devices/en/, last accessed on 11th July, 2015. [9] Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (OJ L 169, 12.7.1993, p. 1), at: http://eurlex.europa.eu/LexUriServ/LexUriServ.do?uri=CONSLEG:1 993L0042:20071011:en:PDF), last accessed on 7th July, 2015. [10] BAS EN ISO/IEC 17020, 2nd edition; September 2013; Conformity assessment – Requirements for the operation of various types of bodies performing inspection. [11] Official Gazette of Bosnia and Herzegovina, no. 75/14.
[12] Badnjević, Gurbeta, Džemić, Bošković et al. Measurement in medicine – Past, present, future. Folia Medica; 2015: 50(1). [13] EN ISO/IEC 17 025:2005; 2nd edition; 15th May 2005; General requirements for the competence of testing and calibration laboratories. [14] Srdjan Maravic,”Edukacija, MVC, Programiranje”; 27 th August 2014 at: https://srdjanmaravic.wordpress.com/, last accessed on 7th July, 2015. [15] Agency for Health Care Research and Technology at: http://healthit.ahrq.gov/program-overview , last accessed on 11th July, 2015. [16] Chaudhry, B. Wang, J., & Wu, S. et al., (2006). Systematic review: Impact of health information technology on quality, efficiency, and costs of medical care, Annals of Internal Medicine, 144(10), 742– 752.
