The Baroness Cumberlege Report – First do no harm (Published 8th July 2020)
Published: 22 Jul 2020
The report of the Independent Medicines and Medical Devices Safety Review (IMMDs)
- The Cumberlege review has reported on three important clinical areas where harm has occurred; Primodos, sodium valproate and surgical mesh insertion for female urinary incontinence. The review has helped us identify a direction of travel in assuring new medical devices being introduced to treat a wide variety of conditions. The principals are generalisable and I believe we should use these as we develop additional devices registries.
2. This review into the treatment of female incontinence with surgical mesh is specific. It has given us interesting insights into the various vehicles that, in some respects, we take for granted, when holding patients’ data for review purposes; namely data bases and registries. In the course of this work, Cumberlege has defined databases and registries. These definitions, if accepted, can be extrapolated out into other areas where medical devices are implanted and further into other areas of healthcare.
3. Cumberlege states that a Database can be legally mandated, in the public interest, to hold a limited patient-related dataset which should include the patient’s NHS number, their date of birth and gender, the unique device identifier (assuming a device is being implanted), the name and GMC registration number of the operating surgeon, the health care provider and identifier and the date of the procedure.
4. There are important considerations made specifically in relation to the surgical treatment of urinary incontinence and, in particular, the implantation of mesh devices. These are that this is routinely recorded data which should form part of every operation procedure record and is, therefore, routine data with no associated burden to collect.
5. In addition, to ensuring complete data collection, Cumberlege argues that the “collection of this data to be mandated by the Secretary of State for Health and Social Care. As this mandate or direction overrides a patient’s right to opt out of their personal data being shared it is only reasonable that the data collected for the database is the least necessary to fulfil its legitimate purpose”.
6. Stating that there is no burden to collecting this data is somewhat overstating the case. It presupposes that all operation notes are collected electronically with a direct feed of administrative data into them and a software package which extracts the relevant data out feeding into a programme set up to interpret the data and produce a meaningful record, both for the purposes of recording the event but also so that the data base is completed and will be stored for subsequent use. All this is possible, yet it will take time and effort to ensure that this takes place. This is currently in the hands of NHS X and NHS Digital to enact.
7. Why would such rules apply only to the limited area of urinary incontinence, albeit that there has been inappropriate management of many such patients? It could be argued that the collection of such data would apply across the board of all patients having interventional procedures where devices are implanted? NHS X have taken on this challenge and we, in the clinical community, need to understand that this is a very important positive step forward.
8. Cumberlege goes onto outline how a database is expanded out into a Registry which she defines “as a repository for more complex patient related information datasets enabling research and investigation into patient outcomes”.
9. One of the important differences between a database and a registry, that Cumberlege draws out, is that consent should be required for the latter. Given that consent is required for the implantation of any device, that should not be a problem. However, obtaining consent under current information governance rules requires many areas to be covered including gaining consent for a multitude of subsequent uses that will extend out into the future. Some of these uses may not be apparent when the device is implanted and therefore, much thought is required in obtaining comprehensive consent.
10. There will be additional demographics that will be worth recording in a registry. For instance, we have learnt during the COVID-19 pandemic that ethnicity and deprivation appeared to be important factors in the development of the disease and its complications, and should not these characteristics also be recorded in creating a registry data set?
11. NHS X have already planned to learn from the National Joint Registry (hosted by HQIP) and other existing registries (for example the National Vascular Registry commissioned by HQIP) which hold a lot of information. These include data pertaining to prostheses, to the patient, including their sympathology, comorbidity and clinical outcomes. In addition, some have recorded patient reported outcomes, compared with pre-operative state.
12. HQIP held a workshop in 2019 where these topics were discussed, and the report ( https://www.hqip.org.uk/wp-content/uploads/2020/03/Final-HQIP-Proposal-for-a-medical-devices-registry-FULL-report.pdf ) has been used both in setting up the mesh registry but will be of use for the wider work into registries. One thing that became apparent is the large discrepancy that exists between introducing a new medicine versus introducing a new medical device. There is intense scrutiny for new medicines, not so for devices. Post introduction of new medicines and devices is somewhat sparse on both sides.
13. We are encouraged by these recommendations. As the NHS becomes more digital with electronic patient records, and the collection of digital data these databases and registries become more feasible. What we must aim at is to have a comprehensive device surveillance system. That way we will not need to wait for the next scandal and the need to have to react quickly to recover a situation, and all the while patients suffering as a consequence.