Evaluation of the unique device identification system and an approach for medical device tracking

Bayrak, Tuncay; Çopur, Funda Özdiler

doi:10.1016/j.hlpt.2017.04.003

Cited by 10 publications

(3 citation statements)

References 3 publications

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“…Os autores também apontaram que estabelecer o sistema UDI no ambiente digital é desafiador e que há dificuldades na implementação do sistema de rastreamento baseado em UDI por dois motivos: a legislação pertinente não fornece informações detalhadas sobre como o sistema UDI será implementado, e cada tipo de dispositivo médico tem suas próprias dificuldades de rotulagem UDI. Em particular, na Turquia, os autores observaram que as partes interessadas na indústria de dispositivos médicos, especialmente fabricantes, ainda não estão prontos para o rastreamento baseado em ID e que o sistema de registro atual não é eficaz para rastrear dispositivos médicos e compartilhar dados 25 .…”

Section: Discussionunclassified

A rastreabilidade de dispositivos médicos implantáveis e o sistema único de identificação de dispositivos: um estudo bibliométrico

Cabral

Machado

Bridi

et al. 2021

GANJ

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ARTIGO DE REVISÃO A rastreabilidade de dispositivos médicos implantáveis e o sistema único de identificação de dispositivos: um estudo bibliométricoThe traceability of implantable medical devices and the unique device identification system: a bibliometric study Trazabilidad de dispositivos médicos implantables y sistema único de identificación de dispositivos: un estudio bibliométrico Resumo Objetivou-se sistematizar e analisar a produção científica nacional e internacional sobre a rastreabilidade de dispositivos médicos implantáveis e a utilização do Sistema Único de Identificação de Dispositivos em 126 artigos acadêmicos. Os dados foram recuperados da base de dados Scopus e analisados à luz da estatística inferencial, a fim de se chegar a conclusões sobre um grupo maior. Assim, foram adotados o coeficiente de determinação e o teste de aderência do qui-quadrado, utilizando o software Microsoft Excel® e o programa estatístico R para avaliar a atividade de produção científica relacionada com os termos rastreabilidade e identificação única do dispositivo. Foi gerado um mapa no software VOS, que proporcionou a análise dos parâmetros de comportamento e algumas apresentações dos resultados em forma de tabelas e gráficos, examinados de acordo com a estatística descritiva. Verificou-se que houve crescimento teórico e empírico no campo da rastreabilidade de dispositivos médicos implantáveis e na utilização do Sistema Único

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Section: Discussionunclassified

A rastreabilidade de dispositivos médicos implantáveis e o sistema único de identificação de dispositivos: um estudo bibliométrico

Cabral

Machado

Bridi

et al. 2021

GANJ

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“…25 In this sense, a unique ID code for each MD in the EU market would be an important step to ensure traceability and to establish causality in both positive and negative patient outcomes. 26…”

Section: Portuguese Safety Alerts On Mds and Actions Taken By The Regulatory Authoritymentioning

confidence: 99%

Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations

Pires

Duarte

Cavaco³

2021

Acta Med Port

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Introduction: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations.Material and Methods: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany.Results: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices.Discussion: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts.Conclusion: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens’ access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.

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“…All these types of monitoring can be computerized by injecting the collected data into databases, a fact wich helps provide standardized reporting and fully completed forms for initiating and tracking security alerts and reminders [22].The databases can be accessible to the public via a search or private web portal under the authority of a regulatory body. The computerization of MD vigilance system also concerns UDI coding, which allows an addition to the existing labeling requirements, and concerns MDs traceability in order to strengthen their safety, reduce medical errors linked to MDs misuse and combat counterfeiting [4].In fact, UDI is an alphanumeric code, which makes it possible not only to identify the device (ID) by affixed sequence, bearing the manufacturer and model's definition, or device variation, but also to identify the product (PI) by referring to the production batch, batch number, serial number, manufacturing date or expiry date [23]. The UDI is presented on the device label as a bar code or radio frequency identification label [24].…”

Section: Active Monitoringmentioning

confidence: 99%

Development and implementation of a system for medical devices monitoring in Morocco

et al. 2021

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Given the importance of medical devices in improving health, a system of monitoring their use is necessary to ensure an acceptable benefit/risk ratio. The present study focuses on the post-marketing monitoring system, of which the aimis to develop, a national strategy for the establishment of a multidimensional vigilance system to monitor medical devices in Morocco. Methods : The study is based on a systemic review selected by the PRISMA method for the period between [2011-2021] and on the Scopus, Pubmed, Science direct and Web of science databases. Results: A preliminary analysis of the data identified some challenges such as under-reporting and lack of standardization of adverse reaction coding, standard nomenclature problem for international trade, lack of clarity of requirements for manufacturers, and insufficient regulation and significant incentives for the use of unique device identifiers. Recommendations for a more effective national system are put for ward which address the regulation and computerization of the system for the development of medical devices monitoring mechanisms.

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Evaluation of the unique device identification system and an approach for medical device tracking

Cited by 10 publications

References 3 publications

A rastreabilidade de dispositivos médicos implantáveis e o sistema único de identificação de dispositivos: um estudo bibliométrico

A rastreabilidade de dispositivos médicos implantáveis e o sistema único de identificação de dispositivos: um estudo bibliométrico

Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations

Development and implementation of a system for medical devices monitoring in Morocco

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