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[Promotion for medical devices; what is actually allowed?]
Jeroen F Schouten1,2, Loes M Schepers3, John A Lisman4
1Bravis ziekenhuis, afd. Apotheek, Bergen op Zoom en Roosendaal.
None:
Medical devices are increasingly promoted to healthcare professionals for both onlabel and offlabel uses, often on the basis of limited or selectively presented evidence. In contrast to the strictly regulated advertising rules for medicinal products, oversight of promotional claims for medical devices appears less consistent. The article illustrates this issue with examples. CytoSorb is a hemoadsorption device certified for cytokine removal and several additional indications. It is actively promoted for treating acute intoxications despite lacking clinical studies and showing pharmacokinetic implausibility. Catheterbased interventions for venous thromboembolism (VTE) and vacuum therapy, although onlabel, are increasingly encouraged despite limited evidence and contested guideline recommendations. These examples highlight the need for a critical approach among healthcare professionals when evaluating new technologies.
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