Cumberlege Report into Patient Safety Published
An update has been issued on the Medicines and Medical Devices Bill’s journey through Parliament as well as new recommendations from the Cumberlege Review into the safety of medicines and medical devices. The Medicines and Medical Devices Bill is now to due to be examined by the House of Lords after the House of Commons stages were completed last month. Its Second Reading will take place on 21 July, and it is estimated (although not confirmed) that the further stages will take place in September i.e. Committee, Report and Third Reading stages.
The Independent Medicines and Medical Devices Safety Review, chaired by Julia Cumberlege, has issued a report surrounding the safety of medicines and medical devices. It makes nine recommendations, six of which will be briefly described below:
- It recommends the appointment of a Patient Safety Commissioner tasked with championing the value of listening to patient perspectives and the importance of seeking improvements to patient safety.
- A new independent Redress Agency should be established for those harmed by medicines and medical devices to administer decisions using a non-adversarial process with determinations based on avoidable harm, looking at systemic failings, rather than blaming individuals.
- MHRA’s system will need revision, especially around event reporting and medical devices. The review suggests increased patient engagement and greater awareness of its public protection roles.
- A new patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of operation. This can be connected to specifically created registers to research and audit these outcomes.
- Transparency of payments made to clinicians need to improve.
The Review also advised that a task force needs establishing to implement this Review’s recommendations. It remains to be seen what effects the Review may have on the next stages of the Medicines and Medical Devices Bill. A written statement about the Review will be published today along with the Chancellor releasing his Summer Statement.