DePuy Spinal Implants being recalled in UK amid safety concerns
The lack of legislative safeguards in place for medical devices (as opposed to medicines) here in Ireland is again brought into focus by the recent recall of DePuy Spinal Implants in the UK by the Medicines and Healthcare products Regulatory Agency (MHRA).
DePuy advised that patients who have received affected devices could be at risk for poor spine biomechanics, pain, reversible or irreversible spinal nerve injuries and malunion/non-union.
We in Cantillons have already written about the need for strong regulation of the medical device industry in Ireland.
As set out in our November blog, the Health Product Regulatory Authority (HPRA) is responsible for the regulation of medical devices and for the monitoring of the safety of medical devices on the Irish market. However the HPRA is dependent on stakeholders such as patients and clinicians to make voluntary disclosures to it on adverse events pertaining to medical devices. On a search of the HPRA website, at the time of writing this blog, I can find no such recall here in Ireland of the DePuy spinal implants. It may be that they ( hopefully) were not used in Ireland. Only time will tell. In the meantime, it serves as yet another reminder that urgent, appropriate action needs to be taken to regulate the medical device industry.
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