Article Text

Download PDFPDF
Original research
Medical devices that look like medicines: safety and regulatory concerns for children in Europe
  1. Suzy Huijghebaert1,
  2. Pauline De Bruyne2,3,
  3. Karel Allegaert4,5,
  4. Saskia Vande Velde2,
  5. Ruth De Bruyne2,
  6. Stephanie Van Biervliet2,
  7. Myriam Van Winckel2
  1. 1 Pharmacist, Brussels, Belgium
  2. 2 Department of Paediatric Gastroenteroloy, Ghent University Hospital - Ghent University, Gent, Belgium
  3. 3 Department of Paediatric Gastroenterology, Erasmus MC, Rotterdam, The Netherlands
  4. 4 Department of Paediatrics, Division of Neonatology, Sophia Children's Hospital, Erasmus MC, Rotterdam, The Netherlands
  5. 5 Department of Development and Regeneration, KU Leuven, Leuven, Belgium
  1. Correspondence to Dr Myriam Van Winckel, Paediatric gastroenterology, Ghent University Hospital 3K12D, Gent 9000, Belgium; myriam.vanwinckel{at}ugent.be

Abstract

Introduction Medical devices (MedDevs) and medicines are assessed (and monitored) differently before and after launch. There are products for repeated oral ingestion that are marketed in the European Union as MedDevs.

Objectives and methods To illustrate the consequences of these differences in assessment, we compared the leaflet information of three MedDevs with the standards for medicines and with published evidence at launch. As examples, gelatin tannate (GT), its combination with tyndalised probiotics (TP) (GTTP) for diarrhoea and a gel containing hyaluronic acid (HA)/chondroitin sulfate (CS)/poloxamer (Pol407) (HACSPol) for gastro-oesophageal reflux disease were examined.

Results Applying standards for medicines, product composition is insufficiently defined in the MedDev leaflet (eg, plant origin, polymerisation grade, dose and ratio of the relevant constituents). As no age limit is mentioned in the leaflets, all 3 products allow use in children from birth onwards, although published clinical documentation in children was poor (GT) or lacking (GTTP and HACSPol). MedDev leaflets do not mention adverse events (AEs), while literature search suggests safety concerns such as tannic acid (TA) cytotoxicity, potentially more diarrhoea/AEs with TP, use of doses higher than established safe (TA and HA) and lack of chronic toxicity studies for oral Pol407. None refers to interactions with medicines, although some ingredients may affect medicine absorption.

Conclusion Although these MedDevs require repeated oral intake as do medicines, their assessment and monitoring differ significantly from the standards for medicines. Compared with medicines, MedDevs for repeated oral use are poorly labelled and rely on very limited clinical information at market release.

  • Medical Devices legislation
  • paediatrics
  • clinical pharmacology
View Full Text

Statistics from Altmetric.com

Footnotes

  • Contributors SH conceived the idea of the work and presented a first draft; all

    authors contributed to the acquisition, analysis or interpretation of data for the work.

    All authors contributed to drafting the work or revising it critically for important

    intellectual content, approved the final version to be published and they agree to be

    accountable for all aspects of the work in ensuring that questions related to the

    accuracy or integrity of any part of the work are appropriately investigated and resolved.

  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.

Linked Articles