PATI ENT SAFE T Y
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. This recommendation is critical to listening to patients and giving them a place where there is openness and transparency and not a culture of denial – which has been experienced by victims when they have sought information and answers from the NHS, as well as independent healthcare. The Patient Safety Commissioner would have authority to collect, collate data and research areas of care and treatment across the many different departments, regulators, companies and experts, where things appear to be going wrong.
Recommendation 3: The creation of 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. It will be set up so that it can provide remediation to victims of medical harm without forcing them to litigation.
Recommendation 4: Separate schemes should be set up for each of the interventions detailed in the report – Hormone Pregnancy Tests, 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. However, the Report also suggests that, in the future, there should be a scheme for each different issue that emerges further along, so that data can be collected and ongoing monitoring takes place.
Recommendation 5: 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 Report suggests that the centres should not only be interested in the continuing medical problems but be able to listen to the concerns and give constructive assistance for those looking for financial help for example, or social care.
Recommendation 6: The Medicines and Healthcare 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 should aim to raise awareness of its public protection roles and to ensure that patients have an integral role in its work.
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There is an opportunity currently, as we prepare for a post-Brexit world where EU medical device frameworks no longer apply. As reported last month, there is a Medical Devices Bill in front of parliament at present, equally providing a substantial potential for change. During the two years of listening, the Cumberlege team found that there was huge under-reporting of problems with medical devices and medicines in practice and have suggested a review and a fundamental upgrade or replacement of the Yellow Card Scheme for reporting faulty devices or side effects from medicines.
Recommendation 7: 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 is a great idea but contains some immense challenges. The National Joint Registry (NJR) is a useful parallel, which demands clinicians fill out details of orthopaedic implants into a separate national software system where the data is held. It is well supported by the majority of orthopaedic surgeons, although recent activity has focused on improving the quality of the data due to discrepancies between the NJR and hospital records.
The recommendation from the
Cumberlege Report possibly underestimates the complexity of perioperative data collecting with many hospitals still not reporting data digitally and, if they are, there are many different platforms in use which generally stand alone and do not share information across other digital systems, even within the hospital. There would be few surgeons who would support another separate system of data collection.
Recommendation 8: 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 pharmaceutical and medical device industries of payments made to teaching hospitals, research institutions and individual clinicians.
This is to be welcomed, although it is possibly not so warmly embraced by those whom it will feature. There are many questions to be answered related to this recommendation. Both of these databases would require constant updating to be comprehensive and useable and, in the light of GDPR, would need to be carefully designed.
Recommendation 9: 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 timing of this report in the light of COVID-19 means that the Department for Health and Social Care has its hands full with other more pressing matters. No commitment has yet been made to when the Government will respond to the Report and its recommendations, although it is essential that this is received sooner rather than later.
Discussion
The review identified that healthcare is resistant to acceptance or even
OCTOBER 2020
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