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Emotional decision, additional burden: Is it beneficial?
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The European Commission’s decisions on approval procedures for medical devices have been dictated and formalized in the very emotional context of the breast prosthesis scandal; regulatory demands have since then increased and lengthened Notified Bodies’ tasks. In our specialty, in which a number of relatively small and creative European companies strive for innovation and medical cooperation, this additional burden could be deleterious.
European scientific societies, national scientific societies, medical unions and associations have not been consulted, before or after the technocratic decision. Scientific bodies and professional organizations are aware of both patient satisfaction or dissatisfaction and medical device outcomes; benefit-risk ratio evaluation is our routine, together with continuous updates of technical improvements in long-term evaluations. We have permanent access to critical analysis of our data, and our meetings are mainly based on data collection. EUREQUO, for instance, is one of the world’s most important databases on cataract outcomes, and any unwanted or unpredicted event can be evaluated and compared with this huge number of results.
None of us, of course, would question our patients’ safety, and none of us would question the need for innovation. EU creativity in ophthalmology has long been recognized worldwide and is envied by many of our foreign colleagues. The continuous benefit to patients is not achieved through risky ways. Today, alternative techniques are replacing more costly and irrelevant animal models. Potential allergy and toxicity have to be analyzed with these techniques. In ophthalmology, for instance, testing molecules or materials with mice fibroblasts is no longer necessary because automated microplate kits can test a much larger panel of situations. On the other hand, considerable improvements in clinical results assessment have been achieved in recent years; imaging, biological tests and comprehensive examination techniques have modified, shortened and strengthened our conclusions. In all fields of ophthalmology, preoperative and postoperative evaluations have led to more precise, safer diagnoses and prognoses. Informed consent relies more on both medical will to inform and scientific basis. Medical performance evaluations benefit from this situation, and we do not need as much time as we did years ago to ensure optimal service and safety for our patients.
Additional regulatory demands should be weighed in relation to our current evaluation techniques because the latter already create the conditions of continuously improved results.
We ophthalmologists are part of the process and campaign aimed at enhancing safety. Therefore, our propositions have to be heard and forwarded to the commission, and we should be involved in the decision-making process thorough our medical and professional representative bodies. Nothing is as permanently changing as “state of the art” in biology and medicine. We share the demand for safer evaluation, provided this demand is consistent with our good clinical practices and the creativity and innovation that are intrinsic to European culture.
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- Philippe Sourdille, MD, is an OSN Europe Edition Board Member. He can be reached at philippe.sourdille@wanadoo.fr.
Disclosure: No products or companies that would require financial disclosure are mentioned in this article.