A Hazardous Mistake

The progression we have achieved as a society gives us an umpteenth number of things to take great pride in. After all, what’s the norm today was once well beyond anyone’s thinking capacities. This generation of go-getters have reformed the way our growth has usually occurred throughout our history. While the natural growth process that we had stuck with for centuries was painfully slow to deliver any noticeable changes, today, the world can change overnight. So, what is influencing such disparity between our time and the ones our predecessors lived through? Well, every ounce of progression we have experienced over the years has had some sort of drivers. Such is the importance of these drivers that without them there can be no growth whatsoever. The modern crop of visionaries seem to have been aware of that, as they concluded that in order to integrate certain improvisations in our growth, there have to be a necessary change in what’s driving as well. The search to find an improvised driver ended up guiding us towards technology, and all of a sudden the world received something like a turbo boost.

To say technology reinvented the wheel would be an understatement, but the transition period was worthwhile as we witnessed historical improvements across various sectors. However, despite the excellence of technology, we have realized that some of its by-products require a level of supervision, especially within a sensitive field like medicine. The importance of proper supervision was reinforced when concerning reports regarding FDA’s Manufacturer and User Facility Device (MAUDE) database were published recently.

Basically, FDA constantly reviews adverse event medical device reports to ascertain the safety level of a device, so when errors like patients’ death getting mislabelled as ‘injury’ started to pop up in these reports, it caused somewhat of a crisis in the FDA. As per the sources, a natural language processing algorithm was used to review over 1,000 medical device reports. The study revealed that over 23% of reports were wrongly labelled as injury, mere malfunction, or something in similar vicinity. FDA’s lack of knowledge in relation to the life-threatening potential of some devices out there in the market right now has caused uproar. It’s not the first time that FDA’s MAUDE system has faced the heat of medical experts. The system’s opaque nature has been questioned time and again, thus the latest fiasco demands an action.

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