Medical Device Vigilance Research Articles

Preliminary feasibility assessment of CDM-based active surveillance using current status of medical device data in medical records and OMOP-CDM

In recent years, there has been an emerging interest in the use of claims and electronic health record (EHR) data for evaluation of medical device safety and effectiveness. In Korea, national insurance electronic data interchange (EDI) code has been used as a medical device data source for common data model (CDM). This study performed a preliminary feasibility assessment of CDM-based vigilance. A cross-sectional study of target medical device data in EHR and CDM was conducted. A total of 155 medical devices were finally enrolled, with 58.7% of them having EDI codes. Femoral head prosthesis was selected as a focus group. It was registered in our institute with 11 EDI codes. However, only three EDI codes were converted to systematized nomenclature of medicine clinical terms concept. EDI code was matched in one-to-many (up to 104) with unique device identifier (UDI), including devices classified as different global medical device nomenclature. The use of UDI rather than EDI code as a medical device data source is recommended. We hope that this study will share the current state of medical device data recorded in the EHR and contribute to the introduction of CDM-based medical device vigilance by selecting appropriate medical device data sources.

The establishment of the Korean medical device safety information monitoring center: Reviewing ten years of experience

Medical devices may revolutionize healthcare delivery but can lead to serious adverse events for treated patients and users. While reporting of adverse events related to medical devices is an essential starting point for post-market surveillance, underreporting of medical device adverse events is a global problem. Korea introduced a voluntary medical device adverse event reporting system in 2010, called the Medical Device Safety Information Monitoring Center, which has led to an increase in adverse event reports. For 10 years, the Medical Device Safety Information Monitoring Center has analyzed medical device adverse events systematically and has provided active feedback to the manufacturers and education on safe use. Recently, the Medical Device Safety Information Monitoring Center contributed to harmonization of international medical device vigilance through the sharing of adverse events. This experience of Korea might contribute to improvements in medical device vigilance, which is a critical prerequisite for improving medical device policies and regulations.

Vigilance System Requirements Across US and EU for Medical Device

Medical device vigilance is concerned about device problems (incidents) their analysis and mitigation to ensure that device performance is good and that patient safety are maintained. The main aim of this is to outline the criteria of the medical device vigilance program and to highlight the requirements that still remain in the state laws of regulated markets (US and EU) and to increase access to safe, reliable and therapeutic benefits. The severity of the Subject, risk assessment should carried out by the manufacturer prior to marketing. In US, Medical Device surveillance deals with post-marketing monitoring where the manufacturer or importer is required submit reports to regulatory authorities; same as in the EU. US medical device tracking system involved with different sections to update adverse event. The user or manufacturer has to report incidents to member states where necessary actions are to be taken as early as possible to protect or reduce hazard of casualty or severe decline in terms of safety and quality by implementing the CAPA for risk analysis.

Medical device active surveillance of spontaneous reports: A literature review of signal detection methods.

The collection and analysis of real-world data for the active monitoring of medical device performance and safety has become increasingly important. Spontaneous reports, such as those in the Food & Drug Administration's (FDA's) Manufacturer and User Facility Device Experience (MAUDE), provide early warning of potential issues with marketed devices. This review synthesizes the current literature on medical device surveillance signal detection and provides a framework for application of methods to active surveillance of spontaneous reports. Ovid MEDLINE, Ovid Embase, Scopus, and PubMed databases were systematically searched up to January 2019. Additionally, five methods articles from pharmacovigilance were added that had potential applications to medical devices. Among 105 articles included, the most common source of data (84%) was registries; median time between data collection and publication was 8 years. Surgical procedure outcome signal detection articles comprised 83% while 14% were on device outcome signal detection. The most common family of methods cited (70%) was Sequential Probability Ratio. Application of any signal detection algorithm requires careful consideration of influential factors, data limitations, and algorithmic assumptions. We recommend approaches using disproportionality, statistical process control, and sequential probability tests and provide R packages to further development efforts. The small number of published examples suggest that further development of statistical methods and technological solutions to analyze large amounts of data for device safety and performance is needed. Fundamental differences in products, data infrastructure, and the regulatory landscape suggest that medical device vigilance requires its own body of research distinct from pharmacovigilance.

Comparative Study of Medical Device Vigilance in Canada, USA, Australia

The medical device vigilance system was set up to minimize risks to the safety of patients, users and others by detecting the possible adverse reactions in patients, the medical device safety issues are identified and reported manufacture or health professional through identification and reporting of issues by members of the public or through information sharing with other competent authorities. Medical device reporting is important from the processing and reporting of single adverse incidents through to the removal of products from the market as part of a Field Safety Corrective Action, Manufacturers are obliged to maintain robust medical device vigilance and post-marketing surveillance systems for the maintenance of the marketing authorization in the country were the product is marketed.

Differences in Perspectives of Medical Device Adverse Events: Observational Results in Training Program Using Virtual Cases.

BackgroundMedical device adverse event reporting is an essential activity for mitigating device-related risks. Reporting of adverse events can be done by anyone like healthcare workers, patients, and others. However, for an individual to determine the reporting, he or she should recognize the current situation as an adverse event. The objective of this report is to share observed individual differences in the perception of a medical device adverse event, which may affect the judgment and the reporting of adverse events.MethodsWe trained twenty-three participants from twelve Asia-Pacific Economic Cooperation (APEC) member economies about international guidelines for medical device vigilance. We developed and used six virtual cases and six questions. We divided participants into six groups and compared their opinions. We also surveyed the country's opinion to investigate the beginning point of ‘patient use’. The phases of ‘patient use’ are divided into: 1) inspecting, 2) preparing, and 3) applying medical device.ResultsAs for the question on the beginning point of ‘patient use,’ 28.6%, 35.7%, and 35.7% of participants provided answers regarding the first, second, and third phases, respectively. In training for applying international guidelines to virtual cases, only one of the six questions reached a consensus between the two groups in all six virtual cases. For the other five questions, different judgments were given in at least two groups.ConclusionFrom training courses using virtual cases, we found that there was no consensus on ‘patient use’ point of view of medical devices. There was a significant difference in applying definitions of adverse events written in guidelines regarding the medical device associated incidents. Our results point out that international harmonization effort is needed not only to harmonize differences in regulations between countries but also to overcome diversity in perspectives existing at the site of medical device use.

Thrombosis of Surgical Bioprosthetic Heart Valves-Insights from Reports to International Medical Device Vigilance Systems

Thrombosis of Surgical Bioprosthetic Heart Valves-Insights from Reports to International Medical Device Vigilance Systems

Knowledge, Attitudes and Practices of Dentists on Medical Devices: Study in the Region of Dakar, Senegal

The aim of this study was to test the level of knowledge, attitudes and practices of the dental surgeon on medical device in the region of Dakar. This was a descriptive and cross-sectional study covering 130 dental surgeons practicing in the region of Dakar, selected following stratified sampling. One stratum grouped 60% of the sample that worked in dental public structures. Another stratum gathered 40% of the sample who were dentists working in private dental structures. More than half of the dental surgeons (53.8%) have at least observed once an adverse effect case with a predominance of allergy (42%). The prevailing attitude was to stop or removal of the material. However, more than 86% of the sample have never reported or notified any adverse effects following use of any material. Almost 9/10^th of the surveyed sample (88.5%) have never been trained on medical device vigilance. These results strongly advocate for the integration of medical device vigilance in the current health monitoring system and for an improved awareness in notifying and spontaneously reporting adverse effects observed in the use of medical device. More than half of the dental surgeons (48.40%) do not define the medical device vigilance.

PRM200 - Development of A Web-Based Tool To Elicit the Opinion of Regionally Dispersed Health Care Professionals Responsible for Medical Device Vigilance

PRM200 - Development of A Web-Based Tool To Elicit the Opinion of Regionally Dispersed Health Care Professionals Responsible for Medical Device Vigilance

Reporting standards for adverse events after medical device use in the peripheral vascular system

New York, NY;Phoenix, Ariz; Houston, Tex; London, Ontario, Canada; Delhi, India; Silver Spring, Md; and Lewiston, MeAdverse event reporting after medical device implanta-tion is essential to understanding the safety and perfor-mance of a device. Standardization of reporting attainsgreat importance when comparing different devices andfor the ongoing surveillance of a marketed device.Although some work has been done to standardize adverseevent reporting for medical devices, a single reference withrecommendations that span investigational and postmarketuse does not exist.Standardization of nomenclature for reporting vascularconditions is one of the objectives of the Society forVascular Surgery (SVS) in its Bylaws.

Medical device vigilance systems: India, US, UK, and Australia

The term medical device includes a wide category of products ranging from therapeutic medical devices exerting their effects locally such as tissue cutting, wound covering or propping open clogged arteries, to highly sophisticated computerized medical equipment and diagnostic medical devices. To achieve uniformity among the national medical device regulatory systems and increase the access to safe, effective, and clinically beneficial medical technologies, the Global Harmonization Task Force (GHTF) was conceived in 1992 by five members: European Union, United States, Australia, Japan, and Canada. All regulated countries have clearly defined medical devices, as has the GHTF. Although GHTF has tried to achieve harmonization with respect to medical devices, some differences still exist in the national laws of the countries of GHTF. Further, regulated countries have classified medical devices on the basis of their associated risk. In the Indian regulatory system, medical devices are still considered as drugs. In 2006, the Medical Device Regulation Bill was recommended to consolidate laws for medical devices and to establish the Medical Device Regulatory Authority of India. In addition, medical devices are not classified by any Indian regulatory authority. Although India has moved towards harmonizing its medical device regulations with those of regulated countries, this study aims to identify whether India should have a vigilance system in harmony with those of GHTF or develop its own system for medical devices.

Il rischio tecnologico in sanità

An overall risk management process in healthcare should involve the evaluating of potential risk related to medical devices and technology. The importance of this analysis is undelined by many legislative measures of both the Italian Country and the European Community. This article describes the importance of a medical devices vigilance system and the analysis that can be conducted to establish the baseline hazards associated with a device, evaluating its potential hazards. To improve patients safety, the risk analysis should include any risks associated with the manufacture and delivery of the device.

Vorkommnismeldungen bei mechanischen Herzklappenprothesen

The purpose of this study was to collect the experience gained from risk assessment of incidents associated with mechanical heart valves as reported to the German Medical Devices Vigilance System. All events in connection with the use of prosthetic heart valves which had been reported to the Federal Institute for Drugs and Medical Products were identified in the Institute's anonymized database. Subsequently all information that had been obtained and the reports of investigations by the various responsible manufacturer of medical products were retrospectively analysed. Of 53 incident reports the aortic valve position was involved 32 times, the mitral valve position 21 times. 17 cases of leaflet breakage, 12 of leaflet dysfunction, 6 of valve thrombosis, 4 of paravalvular leakage, 4 of damage to the suture ring, 3 of endocarditis and 7 of various other singular defects were reported. The outcome was mostly very serious (re-surgery, prolongation of surgery, death). Corrective actions taken by the manufacturers consisted of recalls, advisory notices and stoppage of production. The Medical Devices Vigilance System is able to detect product failures of mechanical heart valves and to initiate corrective action. As the reporting rate over more than 10 years is relatively low, it can be assumed that in general mechanical heart valves are safe medical devices. The quality of incident reporting by manufactures and users of medical devices should be improved to reduce the number of undetected and unsolved incidents.

Matériovigilance

Within the French Agency for Health Products (AFFSSAPS), there is a section for evaluating medical devices, separate from drug and biological product monitoring. Medical devices vigilance monitors incidents or incident hazards that may result from use of medical devices after they have been put on the market. Anyone, manufacturer, user, or third party who observes or knows of voluntary accident(s) or risk(s) or incidents caused by a medical device, should immediately report to the agency. The dermatologist, for example, is concerned as much by small instrumentation such as lasers and sterilizers, but also implantable medical devices. Each type of report indicates the capacity of the informant, the name of the medical device, as well as its batch and series number, and specifies the incident (date, consequences, and measures taken).

Nutrition parentérale à domicile : prise en charge et suivi des incidents ; mise en œuvre des vigilances. Enquête sur la France métropolitaine

For Home Parenteral Nutrition (HPN), pharmacy had to deliver some medical devices and drugs. It comes up the following and taking care of incidents that's occurring at home with those products. The aim of the survey was making and inventory on vigilance's organization, incident's management and assessment, about HPN in France. A questionnaire was send to the main characters of HPN (by law authorized centres, services providers, custom-made makers, laboratories.) They were asked to describe their organization and to grade incidents according to their frequency. Organizations are varied and specific to each centre. The data process shows that the most registered incidents are: blended tubing of infusion sets, problems linked to industrial sets, occlusion or air bubble alarms with pumps. There are very few internal medical devices vigilance reports. An improved management would be done with generalization of a patient declaration form, a patient's practice assessment and a permanent quality improvement.

Enquête sur la perception de la matériovigilance par les médecins dans les services hospitaliers publics français de médecine physique et de réadaptation

With the European policy towards medical safety becoming increasingly regulated, the medical device vigilance enables France to remain abreast of incidents involving medical devices. Practices within the Physical Medicine and Rehabilitation services are of particular concern. A national mail survey was conducted of the doctors practicing in these services in order to evaluate their knowledge of the vigilance system and its implementation. An additional study was performed among the non respondents. The results show that less than half of the practices surveyed conveyed a relative knowledge of the vigilance system, while 21% were completely unaware of its existence. The education on the system is scant at best. Only one doctor out of two knows his local correspondent who receives the incident reports from public health establishments. In France, the system must be utilised more within the medical practices. The use of medical devices and the rules and regulations of the vigilance system should be integrated into the medical education. Other actions proposed to the health establishment include developing a plan of communication for circulating information, improving management regarding incidents that occur on weekends and public holidays, and lastly, reorganising the local structure by creating a specific committee with a designated representative for each care unit.

Quality analysis of medical device vigilance reports

The quality of the notifications issued within the European Medical Device Vigilance system were retrospectively reviewed and the adequacy of the recommended guidelines evaluated. The study material comprised all 589 vigilance notifications the Finnish competent authority received from manufacturers and other national competent authorities during 1997, 1999, and 2001. The number of vigilance reports, particularly the reports issued by national competent authorities, has increased from 82 in 1997 up 166 in 2001 while the proportion of reports with demonstrated bearing on health risk has decreased from about 40% down to 20% during the last five years. The number of manufacturers' reports has also increased from 28 in 1997 up to 98 in 2001 while the information given in the reports have become somewhat more incoherent. The time needed to close a device-related incident has increased, too. It is obvious that the present vigilance guidelines provide adequate guidance for both the manufacturers and competent authorities to manage vigilance cases efficiently and appropriately. It is crucial that all pertinent parties should adopt the recommended procedures and act accordingly. The vigilance system underpinned with high quality notifications only assures the continuous enhancement of patient safety, the bottom line.

Innovation and regulation in human implant technologies: developing comparative approaches

Human implant technologies are subject to continual innovation and proliferation, raising important issues for technology testing, healthcare sciences, clinical performance and risk assessment, and regulation. The regulatory environment of medical devices is being shaped by harmonisation of standards in the European Union. The aim of this paper is to compare the histories and current regulatory environment of two technologies, breast implants and artificial hips, and to consider the implications of this comparison for a sociological healthcare research agenda to investigate the issues raised. The main focus is upon developments in the United Kingdom. Major points of contrast between the two technologies include the institutional contexts in which clinical evidence has been marshalled for government attention; the relative importance of strategic alliances between clinicians and manufacturers in the innovation process; the degree of public controversy evident; the varying definitions of an ‘adverse incident’ within medical device vigilance systems; and in the UK the presence of a national register for breast implants but not for hip implants. Inter-national contrasts in these dimensions are noted. The analysis suggests that improved understanding is required of the institutional, organisational and professional processes involved in implant technology innovation and regulation. A comparative research agenda is proposed, focusing upon: innovativeness and proliferation; safety and technological standards; clinical and social outcomes; and consumer/user information and choice. It is concluded that research in these areas will enhance the ‘evidence-base’ for the evaluation of human implant technologies in the context of their innovatory and regulatory environments.

Traçabilité pharmaceutique intégrée au dossier patient. Développement d'une application informatique hospitalière

The Clinical Pharmacy Department (CPD) of the Gustave Roussy Institute, has developed a traceability software package that is integrated with the patient file. The Traceability & Medical Devices Functional Unit manages the Blood Derivative Medicinal Product traceability circuits, the circuits of over 400 Sterile Medical Devices and, generally speaking, those for all pharmaceutical goods for which traceability is imperative. The SIMBAD-TRACE ® software package has been developed in situ and was first open for access in March 1999. It enables pharmaceutical traceability data to be accessed from 500 networked workstations. The references tracked generated about 10,000 movements per year. In terms of performance, the system achieves three complementary objectives: 1) reporting traceability scores which reflect the ability of CPD and the establishment to pertinently respond to a complex regulatory requirement on a daily basis; 2) the contribution of the tool to cost containment with respect to allocating rare goods; the contribution of the software package to the implementation of medical device vigilance inquiries, particularly descending inquiries. Finally, SIMBAD-TRACE ® is one of the pillars of our Quality Assurance Program (QAP).

Les désinfectants de dispositifs médicaux: marquage CE et normalisation

EC marking, medical devices vigilance and Europan standardisation will contribute to improve quality level of medical device disinfectants. Users and buyers shall have reasoned strategies that may guarantee quality and safety of medical devices disinfection procedures. Le marquage CE, l'exercice de la matériovigilance et la normalisation européenne vont contribuer à augmenter le niveau de qualité des désinfectants de dispositifs médicaux mis sur le marché. Les utilisateurs et les acheteurs de ces produits doivent établir des stratégies raisonnées d'achat et d'utilisation afin de garantir la sécurité et la qualité des procédures de désinfection des dispositifs médicaux.