Following the publication of a report by the Independent Medicines and Medical Devices Safety (IMMDS) Review in July, NICE has outlined action it will take to further reinforce the use of its guidance among regulators and professional organisations.
The IMMDS Review, entitled First Do No Harm, had highlighted that had NICE guidance been followed more closely then much of the subsequent harm suffered by patients could have been avoided.
Led by Baroness Julia Cumberlege, the review set out to examine how the healthcare system in England responded to reports about harmful side effects from three products: hormonal pregnancy test Primados (which was withdrawn from sale in the UK in 1978), sodium valproate’s use in pregnancy and surgical mesh used for pelvic organ prolapse and stress urinary incontinence.
NICE updated all of its Interventional Procedures guidance relating to mesh used in the treatment of pelvic organ prolapse and stress urinary incontinence during 2016 and 2017, prior to the announcement of the IMMDS review.
The primary aim of Interventional Procedures guidance is to look at the safety of a procedure or operation.
In response to the review, the NICE board has agreed more work will be carried out with system partners to reiterate the importance of collaborative working to ensure a more integrated approach to safety recommendations made in the guidance.
Led by chairman Sharmila Nebhrajani, the NICE board also agreed to the following steps:
- To consider how to facilitate the production of a single and collaboratively produced patient decision aids
- To work with NHSX and other system partners to co-create databases and registries which could be used to inform our guideline development
- For an exceptional review to be carried out on its guideline on the management of urinary incontinence and pelvic organ prolapse in women
Professor Gillian Leng, Chief Executive at NICE, said: “I am pleased the NICE board has approved a series of actions as a result of our internal review of the report.
“As an organisation, NICE fully engaged with the IMMDS review and provided oral and written evidence. We welcome the publication of the review team’s report and thank Baroness Cumberlege for the opportunity to take part in the process.
“We have studied the report carefully and assessed where we can take further action. During the review we worked with partners from across the health and care system to implement improvements and ensure a more integrated approach to patient safety. This work will continue.”
