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Reviews / 2020

Independent reviewPublishedMedicines and devicesEngland

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

Baroness Cumberlege · work from 2018 · published 2020

What this was

Review of harm from hormone pregnancy tests, sodium valproate in pregnancy, and pelvic mesh. It found that patients, mostly women, were not listened to, and that the system was not set up to spot harm from a product once it was in use. The review made nine recommendations.

Why it sits in the hub

The Patient Safety Commissioner exists because of this review. The redress agency it asked for was not created. The Hughes report in 2024 returned to compensation for valproate and mesh.

Findings

  1. Finding 1

    Women were dismissed when they reported harm from a medicine or a device.

    InequalitiesListening to patients and familiesMedicines and devices

  2. Finding 2

    The regulator and the NHS did not have the data to see a pattern of harm.

    Data and early warningMedicines and devicesRegulation and oversight

Recommendations in this hub

The source reports 9 recommendations or essential actions. The notes below are a paraphrase, not the official text.

  1. 1AcceptedGovernment

    Apologise to the families affected.

    CandourListening to patients and families
  2. 2AcceptedGovernment

    Appoint a Patient Safety Commissioner.

    The role was created. Dash later recommended moving its medicines work to the MHRA and its wider work into a patient-experience function.

    Listening to patients and familiesRegulation and oversight
  3. 3Not implementedGovernment

    Create an independent redress agency.

    Hughes later set out options for valproate and mesh. A single redress agency was not established.

    Complaints and redressMedicines and devices
  4. 4Partly doneMHRA and NHS

    Build registries for devices and a clearer record of conflicts of interest and industry payments.

    Data and early warningMedicines and devices
  5. 5Partly doneMHRA

    Reform the MHRA so that it looks harder for harm after a product is in use, with patients in the work.

    Medicines and devicesRegulation and oversight