Patient safety: the golden thread ‘tying the disjointed system together’

“We have found that the healthcare system – in which I include the NHS, private providers, the regulators and professional bodies, pharmaceutical and device manufacturers, and policymakers – is disjointed, siloed, unresponsive and defensive.”  Cumberlege review


The Independent Medicines and Medical Devices Safety Review, chaired by Baroness Julia Cumberlege, published its First Do No Harm report last month. This latest report is one of a number of high profile reviews focused on patient safety incidents, including: Bristol, Mid-Staffordshire, Morecambe Bay and Paterson. Indeed Paterson is referenced several times within the report.

Her covering letter to the Secretary of State pulls no punches. In addition to the quote above, she goes on to say that “ does not adequately recognise that patients are its raison d’etre and when….it has decided to act it has too often moved glacially.”

Other concerns she expresses are that the system is not good enough at spotting trends in practice and outcomes that give rise to safety concerns with listening to patients being pivotal to that.

In conclusion, in her letter, Baroness Cumberlege remarks that “We must ensure the risks of increasingly complex healthcare are understood and where the system is not sure of the risks it must say so.”

What the review covered

As readers will know the Independent Review was asked to look at three disparate interventions:

  • Hormone Pregnancy Tests
  • Sodium Valporate Use in Pregnancy
  • Pelvic Mesh

However, what became apparent was that far more bound them than separated them.  Pages 3 and 4 of the report list 16 common and compelling themes, including clinicians not knowing how to learn from patients and a lack of interest in / an inability to deliver the monitoring of adverse outcomes.

A summary of the recommendations and actions for improvement can be found at Chapter 8 (pages 187 -193).

The review covers a lot of ground (running to nearly 270 pages) so we are highlighting for you only some of the key points.


The review made nine recommendations. These are set out at pages 9 – 16 of the report:

  • Apology
  • Patient Safety Commissioner
  • Independent Redress Agency
  • Schemes to set up for each intervention to meet the costs of providing additional care and support
  • Networks of specialist centres to provide treatment
  • Substantial revision of the MHRA
  • Central Patient Identifiable Database for devices
  • GMC register to be expanded to include financial and non-pecuniary interests
  • Task Force to be set up immediately to implement recommendations

Central to improving patient safety is the recommended appointment of a Patient Safety Commissioner which is covered in detail at Appendix 2 of the report. However readers may be aware that the Parliamentary Health Service Ombudsman has warned of a system overcrowded with regulators

The proposed Redress Agency is covered in detail at Appendix 3. Specifically, Baroness Cumberlege states that “ in our view an open, honest culture in which mistakes are learned and barriers to disclosure are removed are overdue and essential...We consider this shift from individual culpability (blame) to systems based responsibility for harm (avoidable harm) as essential”. She is keen to encourage reporting and faster resolution.

Overarching themes

However, also of interest in this report is Chapter 2 which covers 12 overarching themes:

  • 'No one is listening' – The patient voice dismissed. It was interesting to read in this section that even Michael Mansfield QC did not take issue with a consultant on the spot when his partner was being treated
  • 'I’ll never forgive myself' – Parents living with guilt
  • 'I was never told' – the failure of informed consent.  This common themes section also highlights that the GMC are preparing new guidance on decision-making and informed consent so something to keep an eye out for. With regard to consent, the review recommend that talking to or hearing from others who have experienced the same intervention (whether face-to-face, through Skype or from a video recorded conversation) could be hugely beneficial.
  • Redress - 'We want justice'
  • Complaints – 'We do not know who to complain to'. The PHSO also reported the week after the publication of First Do No Harm. The review recommend that all organisations who take complaints from the public should designate a Non-Executive Director to oversee the complaints handling processes and outcomes and ensure that appropriate action is taken.
  • Duty of Candour - 'Preventing future errors'. Disappointingly, the review concludes that the statutory duty of candour has not been entirely effective…
  • Conflicts of Interest – 'We deserve to know'
  • Holding to Account – Guidelines and Quality
  • 'Collect once, use often'Data capture and the electronic record
  • 'Time to change focus' – Regulation of medicines and devices and potential reforms
  • Patient Safety – Doing it better

So a lot to take on board and worth a read in full.

Our content explained

Every piece of content we create is correct on the date it’s published but please don’t rely on it as legal advice. If you’d like to speak to us about your own legal requirements, please contact one of our expert lawyers.

Posted by


Mills & Reeve Sites navigation
A tabbed collection of Mills & Reeve sites.
My Mills & Reeve navigation
Subscribe to, or manage your My Mills & Reeve account.
My M&R


Register for My M&R to stay up-to-date with legal news and events, create brochures and bookmark pages.

Existing clients

Log in to your client extranet for free matter information, know-how and documents.


Mills & Reeve system for employees.