Legal News
MHRA alerts GPs over digital device used to assess risk of heart disease (16 May 2016)
Date: 16/05/2016
The Medicines and Healthcare products Regulatory Agency (MHRA) is investigating a digital calculator used by GPs to assess the potential risk of heart disease in patients.
The QRISK®2 Calculator is a predictive algorithm used to support medical practitioners – mainly in GP practices – to help assess the potential risk of cardiovascular disease in patients as part of their overall evaluation.
The issue which has been identified with the device has resulted in incorrect results being produced for a limited number of patients.
The MHRA is working with software provider TPP as a matter of urgency, to ensure an identified issue is resolved – and that any affected patients are identified.
The MHRA says that the risk to patients is low – and only a limited number of patients are potentially affected.
An alert has been sent to GPs, who will contact any individual patients if any further action is needed.
The MHRA says that patients should continue to take prescribed medicines –
and if they have any questions about their treatment, they should ask a nurse or doctor at their next routine review.
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