The Cumberlege Review and The Medicines and Medical Devices Bill – what next?

During the months that have followed the publication of Baroness Cumberlege’s Independent Medicines and Medical Devices Safety Review (IMMDR, or The Cumberlege Review), the UK government have been steadily putting plans in place in response to the recommendations outlined in the report.

In a release published yesterday, The Minister for Patient Safety, Suicide Prevention and Mental Health – Ms Nadine Dorries MP, provided an update on the implemented measures.

There are two key measures that stand out in this regard. The first lies in reference to the seventh recommendation in the IMMDR: “a central patient-identifiable database should be created by collecting key details of the implantation of all devices at the time of the operation. This can then be linked to specifically created registers to research and audit the outcomes both in terms of the device safety and patient reported outcomes measures”.

This will come into play as part of the amend to the forthcoming legislation of The Medicines and Medical Device Bill (The Bill) – “to create the power to establish a UK-wide medical device information system” which had been set into motion ahead if the publication of the IMMDR. Such a database will provide the means to achieve full traceability of all medicines and medical devices supplied to the UK health service, with record of which patient the medicine was provided to, or which patient a particular medical device has been implanted into”.

For this, there will need to a be standardised approach for the unique identification of each medicine and/or medical device available for clinical use in the UK, as well as the capacity to be able to unambiguously identify every patient. Without either of these elements to standardise the capture of this information, achieving full traceability as a patient safety measure will forever be one of healthcare’s most formidable challenges.

The second in fact refers to the second recommendation: “the appointment of a Patient Safety Commissioner who would be an independent public leader with a statutory responsibility. The commissioner would champion the value of listening to patients and promoting users’ perspectives in seeking improvements to patient safety around the use of medicines and medical devices”, and this poses food for thought.

As part of the amendments made to The Bill, the government confirms a tabled amendment “to establish the role of an independent Patient Safety Commissioner”, to “act independently on behalf of patients”. This is where the evidence collated by the database will provide great benefit and valuable insight, notably for the post-market surveillance of products to prevent instances, such as those highlighted in the IMMDR, from arising in future.

These changes, among the others, will present a significant step change for healthcare – in that it equates traceability in a clinical setting with improved quality of care – and that step is one that is both necessary and perhaps, long overdue.