Regulatory


Medical device recalls are on the rise. And, thanks to a number of high-profile cases, they’ve been making headlines – prompting calls for the process to be improved. One key aspect of this is ensuring the right information reaches the right people, as quickly as possible. Dan Cave speaks to Stephen Gilbert, professor for medical device regulatory science at EKFZ Digital Health, to find out how the process could be made smoother and safer.


hough he lived over 100 years ago, Austro- Czech author Franz Kafka’s work is still used as a reference point when depicting the failures of bureaucracy. One of his most impactful works, The Trial, follows the protagonist Josef K, who is arrested by authorities without ever knowing what he’s done wrong, how the justice system works or how to fight the outcome. By the end of the novel, with the state’s reasoning and processes still impenetrable to him, he’s executed.


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Critics of current medical device regulations might also say that today’s bureaucracy is failing patients and obscuring decision-making mechanisms in a similar manner. Especially when it comes to device recalls. Across the US, the UK and the EU, recalls are mostly down to the manufacturer. The process is usually voluntary: manufacturers are meant to receive and investigate complaints about their devices and inform the regulators if a defect that could result in a recall is


Medical Device Developments / www.medicaldevice-developments.com


Md Ayub Ali Khan/Shutterstock.com


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recalls


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