Safety of medicines and medical devices will come under closer scrutiny03/02/22
This article is published as part of Capsticks’ Medical Malpractice Forward View 2022.
Safety of two medicines (Primodos and Sodium Valproate) and one device (pelvic mesh) was at the heart of 'First Do No Harm', the report of the Independent Medicines and Medical Devices Safety Review. Creation of a new role of Patient Safety Commissioner (PSC) was a central plank of the Review Committee’s desire to strengthen both the voice and influence of patients in patient safety. Scoping of the role has been completed and the job advertised, with interviews taking place on 23 March 2022. The PSC will have statutory powers to make report/recommendations to the Secretary of State and any relevant person/organisation, and to request information.
A trial date is awaited for the High Court group litigation by Claimants who are suing the manufacturer Johnson and Johnson, alleging injury from trans-vaginal mesh. They are likely to have been buoyed by the 2021 decision of the Australian Federal Court to dismiss the Defendant’s appeal against a finding of liability.
What the new PSC means for you: Although the PSC will not be under a statutory duty (unlike a Coroner considering Prevention of Future Death), the PSC’s power is likely to highlight patient safety issues to a wider audience and further enable learning from error to prevent harm. There is also scope for reputational damage. Healthcare organisations should be ready to respond to requests from the PSC with as much care as they give to their responses to PFD reports.
Medical Malpractice Forward View 2022
This article is part of Capsticks’ Medical Malpractice Forward View 2022.
Read the other articles featured in this publication below:
- Spotlight on two liability decisions to watch out for in 2022
- Fixed recoverable costs in low value clinical negligence claims are on the horizon
- Concussion injury in elite sport will remain in the headlines
- Inquests: failures of care during the pandemic may be scrutinised more closely, but ‘following the science’ will likely continue to be the dominant theme on causation
- Procedures and policies, including national policy decisions, will be central to the defence of Covid-related claims
- The latest on the Covid-19 Public Inquiry
- Learning from the Paterson Inquiry: new legislation on regulation, co-operation between regulators and more
- The rollout of technology to support the delivery of care will continue apace, with data security coming into ever sharper focus
- There is likely to be an increase in the number of clinical trials
- Safety of medicines and medical devices will come under closer scrutiny
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