Technological development, over the last two decades has had a tremendous impact on the health care sector. Advances in medical device technology and manufacturing practice have led to a significant impact on the accuracy and efficacy of medical procedures and a remarkable influence on health care services at all associated levels. This evolution, driven by intense and productive applied biomedical research, as well as the rapid progress in health care telematics, is expected to dramatically change the shape of health care delivery within the next decade.
These innovations are also causing a shift of focus to technology assessment and risk management, provided by governmental agencies and regulatory bodies. New improved methods are implemented in equipment design and manufacturing practice, with emphasis on reliability and safety for both patients and users. Monitoring systems for adverse incidents are also introduced, to provide surveillance for safety during use.
The need for appropriate reporting systems, in order to collect information concerning adverse incidents, has been recognised world-wide. Many countries have already established their own user reporting systems for medical devices. Within the EU a series of Directives and guidelines have been put into force, in order to provide the legal framework for the implementation of a medical device vigilance system through which Member States will be able to exchange information.
The implementation of the medical device directives has resulted in a considerable amount of information to be exchanged between Competent Authorities, Notified Bodies, Manufacturers, Users and the Commission. The potential of utilising telematics to facilitate a harmonised approach to regulatory information exchange, in order to increase the effectiveness and efficacy of the relevant procedures, has been investigated within the framework of EUROMEDIES (European Medical Device Information Exchange System), a Concerted Action supported by DG XIII under the AIM (Advanced Informatics in Medicine) programme. The most important consensus statements, which have emerged, concern the elaboration of the data model and the basic data set to be exchanged amongst the involved parties, the definition of the necessary mechanisms for data security, integrity and confidentiality as well as the identification of Electronic Data Interchange (EDI) technology as the most appropriate means to meet the relevant requirements.
This book presents the current issues concerning information exchange in the field of Medical Device Vigilance and expands on the influences and trends introduced by the application of telematic technologies. It consists of two parts. The first provides an extensive overview of the activities and initiatives undertaken, by all parties involved in the medical device vigilance, in the EU and world-wide. The main objective is to provide and disseminate information to the international community, on the actions planned, in progress or already implemented, in order to facilitate collaboration and promote global harmonisation. The issues concerned were extensively discussed during the second Euromedies workshop, in September 1995, in Athens and the first part is primarily based on the relevant contributions. The second part of the book, deals with the telematics aspects concerning the medical device vigilance, as they have been negotiated within the framework of Euromedies Concerted Action. This Action has facilitated a common approach to the relevant regulatory information exchange, based on consensus of all actors involved; this has subsequently provided the basis for the elaboration of the requirements for a telematics facility that would serve the purposes of this exchange, expected to be used in the implementation of the vigilance system in the European Union.
The positive results achieved through this action have to be attributed to the high level of expertise, but also to the good willingness of all participants and contributors. Of course, the positions expressed in their papers do not necessarily engage their organisations, reflecting their own points of view. I would like to express my deep appreciation for their efforts. Nicolas Pallikarakis Associate Professor, University of Patras
The protection of health and safety of patients and users, is the main objective of the comprehensive, harmonised legislation created in the EU, in the area of medical devices. In this paper, a brief description of the legislative programme is presented, giving details on the three medical device directives, as well as their transposition. A detailed analysis of the directives context follows, with the steps and actions that all involved parties have followed or need to follow to ensure their uniform application.
Post market procedures have been foreseen within the medical device directives. This in turn, led to the preparation of the guidelines on a medical device vigilance system, which is actually the establishment of a recommended procedure to deal with reported adverse incidents. The medical device vigilance system provided a most valuable service to enhance safety of medical devices in the EU. However, a number of potential problems can arise during its implementation. Proper use of the vigilance system improves the protection of health, by reducing the likelihood of repeating the same type of incident.
This overview of medical device vigilance at the U.S. Food and Drug Administration (FDA) discusses the basic reporting regulation and program at FDA. The FDA program has grown to the point where we now receive over 100,000 reports per year. How FDA examines the data patterns in overall reporting, to identify signals in the database, and the potential actions FDA takes to respond to these problems are also presented. New initiatives include, for example, new methods to triage reports and the move developing an internationally harmonised nomenclature.
Since its inception, in 1986, the Australian Vigilance System has had voluntary and compulsory components. The voluntary component is the Therapeutic Device Problem Reporting Scheme and the compulsory one is requirements on sponsors to report as a condition of entry on the Australian Register of Therapeutic Goods. In addition, reports produced worldwide are actively monitored for their applicability to Australia.
A significant number of patient injuries and deaths are associated with the use of medical devices. After several decades of experience in device evaluation and accident investigation, ECRI believes that many of these adverse effects could not be predicted in advance, even with the most sophisticated design validation techniques. Reporting networks with investigational capability that identify problem devices and provide feedback about adverse effects to manufacturers and medical device users are essential to meet the health communities obligation to provide safe and effective products and patient care.
Effective and efficient medical device vigilance information exchange requires addressing several organizational and technical issues in a harmonized way. This paper describes a conceptual data model that has been derived within the scope of the EUROMEDIES project and accepted by project participants as a meaningful representation of data requirements on medical device vigilance. A possible scenario of a distributed implementation of the model is also discussed.
The implementation of appropriate security mechanisms for an effective and efficient medical device vigilance information exchange is very important, as the system handles sensitive information. These mechanisms have to be designed in such a way that they maintain confidentiality, integrity and availability of the data of medical devices. In this paper the security aspects of the information exchange on medical device vigilance is examined in detail.
K. Pramataris, G. Doukidis, G. Giaglis, J. Raptakis
62 - 68
EDI is expected to be the dominant form of business communication between organisations moving to the Electronic Commerce era of 2000. The healthcare sector is already using EDI in the hospital supply function as well as in the clinical area and the reimbursement process. In this paper, we examine the use of EDI in the healthcare administration sector and move specifically its application to the Medical Devices Vigilance System. At a first place, the potential of this approach is examined, after an initial brief presentation of the EDI concept and its application in healthcare. This presentation is followed by an overall description of the EDI prototype system, which was developed in the context of the EUROMEDIES Concerted Action, in order to facilitate the requirements definition phase.
Recent research work on feasible solutions for electronic data exchanges in the european pharmacovigilance domain (EPhV) has facilitated a better understanding on strategic and operational factors inherent to such a class of transnational vigilance information systems. Most of the material presented here has resulted from the CARE - Pharmacovigilance Pilot project of the ENS-Telematics Programme, and from other subsequent research activities like the IDA feasibility study and the TEDIS-EuroSCape project. Attention has been paid to design principles and features of a communication scheme that must be used to support cooperative problem solving within a network of loosely connected autonomous and hetereogeneous agents. Experience confirmed two key-success factors : a) the users leading role, and b) the Pilot approach putting the focus on standardized electronic data interchange for communicating existing different local systems.
The adoption of the directives 71/316/EEC on measuring instruments and 90/384/EEC on non-automatic weighing instruments has resulted in a considerable quantity of certificates to be exchanged between the Central Metrological Authorities and the Local Metrological Authorities, in the member states. This requirement to exchange data, prompted the setting up of the WELMEC working group, to explore how computerisation could help the member states perform their tasks.
Finland, as a member state of the European Union, has taken all necessary actions to implement the medical device directives. This paper presents the current situation in the area of manufacturers' registration as well as adverse incident notification. The establishment of a trans-european network between member states is strongly supported, as it could provide an efficient tool for the information exchange.
A decentralised approach on the enforcement's' responsibility of the medical devices act, which includes the directives and the guidelines for the vigilance system, has been adopted in Germany. DIMDI under this act, had been nominated to set up a database - supported information system, that would ensure secure usage of medical devices in Germany. The necessary measures taken in order to fulfil the German legislation as well as DIMDI's points of view for the international data exchange on medical devices are being discussed in this paper.
Ireland is one of the countries in the European Union, that have transposed both directives on medical devices into national legislation. A detailed discussion on issues regarding the transposition of the directives, the implementation of the vigilance system, the registration requirements in Ireland as well as the Department's view in current developments, particularly the potential use of EDI for the information exchange between all Competent Authorities, is presented in this paper.
An overview of the Dutch competent authority activities and measurers in the area of medical devices directives, is presented in this paper and covers the following topics: the transposition of the directives into national legislation, the notification of manufacturers, the postmarket surveillance system and the implementation of the vigilance system.
In Spain, only the Active Implantable Medical Device Directive has been transposed into national legislation, with the Medical Device Directive relevant Decree still in a draft edition. However, the notification of serious adverse incidents is compulsory for manufacturers and users, both for CE-marked devices and non CE-marked devices. Manufacturers of all medical devices classes must be registered at the national competent authority, though the directives do not require it.
Wolfgang Ecker, R. De Roo, Mads Frellsen, Antonio F. Gomes, Richard Gutowski
119 - 123
This paper comprises a compilation of five papers, originating from Austria, Belgium, Denmark, Portugal and the United Kingdom. It discribes the actions and measures taken for the transposition of the medical devices directives as well as the implementation of a vigilance system. It also includes aspects of the implementation of a trans-European system for data exchange in the field of medical device vigilance system.
To facilitate access to medical information, ECRI has developed and promulgated a hierarchical medical device nomenclature system containing over 4,800 valid terms and 3,100 cross-references. The Universal Medical Device Nomenclature System (UMDNS) is appropriate for a wide range of applications. It is used world-wide and is available in 5 languages (7 additional translations are in progress).
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