The Royal College of Physicians and Surgeons of Glasgow has responded to the Independent Medicines and Medical Devices Review, “First do No Harm”, chaired by Baroness Julia Cumberledge.
The review’s recommendations are as follows:
- The Government should immediately issue a fulsome apology on behalf of the healthcare system to the families affected by Primodos, sodium valproate and pelvic mesh.
- 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.
- A new independent Redress Agency for those harmed by medicines and medical devices should be created based on models operating effectively in other countries. The Redress Agency will administer decisions using a non-adversarial process with determinations based on avoidable harm looking at systemic failings, rather than blaming individuals.
- Separate schemes should be set up for each intervention – HPTs, valproate and pelvic mesh – to meet the cost of providing additional care and support to those who have experienced avoidable harm and are eligible to claim.
- Networks of specialist centres should be set up to provide comprehensive treatment, care and advice for those affected by implanted mesh; and separately for those adversely affected by medications taken during pregnancy.
- The Medicines and Healthcare products Regulatory Agency (MHRA) needs substantial revision particularly in relation to adverse event reporting and medical device regulation. It needs to ensure that it engages more with patients and their outcomes. It needs to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
- 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.
- Transparency of payments made to clinicians needs to improve. The register of the General Medical Council (GMC) should be expanded to include a list of financial and non-pecuniary interests for all doctors, as well as doctors’ particular clinical interests and their recognised and accredited specialisms. In addition, there should be mandatory reporting for the pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
- The Government should immediately set up a task force to implement this Review’s recommendations. Its first task should be to set out a timeline for their implementation.
The remit of the review is not within the general remit of the College. Sodium Valproate is however widely used for the control of Epilepsy by physicians. Implanted mesh is used for the repair of hernias. The particular elements are however more relevant to Obstetrics and Gynaecology which has its own Royal College.
However, the overall principles of the recommendations seem appropriate and reasonable to the issues discussed which could affect many branches of medicine (in its widest sense). The difficulty with some of the recommendations will be how they could be practically implemented.
The College wishes to respond to recommendations 6 and 7. We consider detection of adverse events from Medicines and Medical Devices to be of great importance and note that the UK in the past has been in the forefront of reporting such events (the Dunlop Committee, the Committee on the Safety of Medicines and the yellow card system and its successors). There have been previous issues with implant prostheses which led to the development of the orthopaedic prosthesis database (the National Joint Registry).
The College fully supports the creation of a database/ registry for all implanted devices. In the case of pelvic mesh implants, until recently, there was a lack of proper trials before registration of the such implants. The results with pelvic mesh implants varied from centre to centre and there was a lack of proper reporting of these results. The reporting of results was done on a voluntary basis, resulting in under-reporting of complications in many cases. The complications arising from the use or misuse of these meshes led to a significant negative impact on the patients’ quality of life as the review outlines. Similarly, mesh is commonly used in groin and other hernia repairs by general surgeons and has been in use for the past 30 years.
The aims of the registry should be:
- To improve upon the indications and use of the implants
- To achieve a standardization on the indications, surgical methodology and follow-up, with a proper assessment of quality and safety
- To allow the timely detection of poor and good results, if they appear more frequently than expected
Data submission should be compulsory, such as what is done in Sweden with the Swedish TVT Database and in Denmark with the Danish Hernia Database. The evaluation of the registry should be done by an independent committee under the auspices of national and international scientific societies. For example, in the case of hernia repair mesh this would be the ASGBI (Association of Surgeons of Great Britain and Ireland), the British Hernia Society and the Surgical Royal Colleges.
The College would recommend funding of the registry should be provided by the UK/EU medical device regulatory bodies rather than by the device manufacturer.