First Do No Harm: The report of the Independent Medicines and Medical Devices Safety Review

Report looking at Primodos (hormone based pregnancy test), sodium valproate and pelvic mesh, to examine how the healthcare system in England responds to reports of harmful side effects from medicines and medical devices and how it can respond to them more quickly and effectively.

SPS commentary:

It was noted that the system does not adequately recognise that patients are its raison d’etre and it has failed to listen to their concerns and is not good enough at spotting trends in practice and outcomes that give rise to safety concerns. Listening to patients is pivotal to that. One of its principal recommendations is the appointment of an independent Patient Safety Commissioner, accountable to Parliament, who would be the patients’ port of call, listener and advocate, who holds the system to account, monitors trends, encourages and requires the system to act.


In response, the MHRA has announced that it has been making changes to ensure that they listen to patients and involve them in every aspect of their work. It has already taking steps to strengthen collaboration with all bodies in the healthcare system and will strive to ensure the safety changes advised are embedded without delay in clinical practice.



Independent Medicines and Medical Devices Safety Review

Resource links:

MHRA response