Farmaci e dispositivi medici: è possibile un confronto? Il caso degli emostatici e dei sigillanti in chirurgia

Autori: Daria Bettoni

Introduction

The differences between drugs and medical devices are many. There is an increasing need for developing a common assessment process, which allows, in the same clinical setting, a comparison of efficacy, safety and cost, starting with the patient and its therapeutic needs.

Material and methods

It was carried out a general comparison between drugs and medical devices regarding regulatory pathways, surveillance, off label uses. These items were evaluated for the case of medical devices and hemostatic drugs and sealants.

Results

The drugs, compared to medical devices, have more strict rules, they are always the subject of extensive pivotal trials that allow a better understanding of the evidence and the potential side effects; mandatory clinical trials should also be provided for the medical devices, establishing clear and defined rules. Postmarketing surveillance of drugs is more structured, widespread and it allows more control both by users and regulatory authorities.

Conclusions

Drugs and medical devices with overlapping uses should always be compared, in order to obtain an appropriate choice in terms of effectiveness, risks and costs. This is particularly evident for the borderline medical devices for which the real differences in composition and mechanism of action often are not clear. The field of hemostasis, which is constantly expanding, is an example of the need for non-sectoral assessment of available options.

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