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

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DOI:

https://doi.org/10.20344/amp.13419

Keywords:

Equipment and Supplies, Patient Safety/legislation & jurisprudence

Abstract

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with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as ‘other’.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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Author Biographies

Carla Pires, Research Center for Biosciences and Health Technologies. Universidade Lusófona. Lisboa.

Carla Pires is Professor at Universidade Lusófona's Research Center for Biosciences and Health Technologies, Portugal, and invited collaborator Faculty of Arts and Humanities of the University of Lisbon, and Laboratory of Phonetics and Lisbon Baby Lab. Her research interests include health communication, social pharmacy, pharmacy practice, and other. http://orcid.org/0000-0003-4526-0271

Afonso Cavaco, Departamento de Sócio-Farmácia. Faculdade de Farmácia. Universidade de Lisboa. Lisboa.

Afonso Cavaco is PhD degree in Pharmacy Practice and Policy from the University of London (UK) in 2006. In 2007, he was a post-doctoral Fulbright Fellow at Johns Hopkins University, Bloomberg School of Public Health (USA), working with Prof. Debra Roter in Health Communication. Afonso holds presently an Associate Professor position at the Faculty of Pharmacy, University of Lisbon. He is responsible for undergraduate social pharmacy teaching as well as post-graduate courses (MSc and Doctoral Programs). He has more than 50 original full-papers published in indexed scientific journals with impact factor and, amongst other work, he has been the supervisor of 14 Master and 6 PhD students. In 2009, he was awarded with the Astra-Zeneca research grant. He was invited to be the course leader on health communication and qualitative research at the Faculty of Pharmaceutical Sciences, UNESP – São Paulo, Brazil. Other on-going international collaborations include Turkish (Ankara) and Polish (Lublin) universities.

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Published

2021-03-01

How to Cite

1.
Pires C, Duarte D, Cavaco A. Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations. Acta Med Port [Internet]. 2021 Mar. 1 [cited 2024 Mar. 28];34(3):201-8. Available from: https://www.actamedicaportuguesa.com/revista/index.php/amp/article/view/13419

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Original