Medical devices and “reviews”: the need for transparency begins in the United States

The Food and Drug Administation (FDA) has been appointed to provide “reviews” to accompany medical devices to help patients and guide them in purchasing the right equipment.

Written Tuesday, by Emanuele Mortarotti

Welcome back to Dispotech, your disposable excellence. The news item we will be discussing today, which appeared on the American website Washington Examiner, could seriously revolutionise the world of medical devices, their proper use and competition between companies.

When shopping online, when we want to see a film or go to a restaurant, we often rely on customer reviews; we might not be aware of it, but certain websites and/or applications have changed our habits and condition us enormously.

But if we are looking online for information on a pacemaker, a hip replacement or other medical devices, it is truly difficult to find opinions and testimonials on usage; the ones we find are often bad or not true. They are called “adverse event reports”: stories of malfunctions, breakdowns and failures of medical equipment presented by manufacturers, doctors and patients who are witnesses to negative experiences or problems with the purchased equipment. Deposited in an FDA database – the pace is approximately 2000 reviews daily – these reports are often so difficult to access and unavailable for reading that it becomes almost impossible, even for the FDA, to diffuse customer opinions and do justice (or injustice) to devices registered with the United States governmental agency.

What’s more, according to dedicated studies, it seems that only about 1% of the real problems enter the database. Various American journalists have concretely tried to find reviews for determined devices made by specific brands: surfing the web and finding useful (as well as truthful) results is a veritable nightmare. "All over the world there are companies with the same name and often, we find more than 1000 companies sharing the same name that sell similar products: navigating amongst them is a truly arduous task", the report reads.

Former FDA employee Madris Tomes conceptualised and opened her own company, Device Events, in 2014, which allows users to search for news and reviews on medical devices registered with the FDA thanks to keywords – just as you would with Google, but in a much more focused and sector-based context. Tomes’s customers are insurance companies, hospitals and large corporations.

In 2012, the FDA promised to “modernise the system of positive and negative reviews”; since then, relatively little or nothing has been done. Device Events has therefore filled a real void and sparked a trend that might even reach the old continent.

What do you think of a system like this? Would it also be useful in Italy? Have your say by contacting Dispotech, your disposable excellence.

Emanuele Mortarotti
Author Emanuele Mortarotti


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