In a new report, the HSSIB also asked the Association of British HealthTech Industries (ABHI) and the Association of the British Pharmaceutical Industry to bring manufacturers and people with lived experience together to support improvements in the design of insulin pens.

Nick Woodier, senior safety investigator at HSSIB, said: ‘Manufacturers have made real improvements to insulin pens, but patients and staff told us that current designs still do not work for everyone. Every person who uses a pen is different, and devices need to be designed with that in mind, including the risks that can arise from someone's physical, cognitive or mental health needs. We want manufacturers, the regulator and people with lived experience to work together so that pens are safe for everyone who relies on them.'

Industry and innovation stakeholders said recurring problems remain for some people, including those with learning disabilities, mental health needs or poor dexterity.

HSSIB heard multiple incidents involving insulin and devices occur each month.

The safety body also urged staff and patients to report problems with insulin pens through the MHRA's Yellow Card scheme, which it found is under-used.

Dominique Chu, deputy director, scientific data & insight, MHRA, said: ‘We welcome this report and will carefully consider HSSIB's recommendation.

‘Patient safety is our top priority. Medicines and medical devices should be safe and appropriate for everyone who uses them. We acknowledge the importance of ensuring the needs of people with different physical and cognitive abilities are properly considered. 

‘We will continue to work with relevant organisations to understand these issues and consider how the findings of this report can support the safe use of insulin devices.'

The MHRA said it was not part of the design process for medical devices which are approved by Notified and Approved Bodies. 

It said it can only influence the operation and performance of Approved Bodies, not Notified Bodies and this will only impact the devices that use the Approved Bodies route.

Ravi Chana, executive director, diagnostics, ABHI, said: ‘We welcome HSSIB's report and its focus on ensuring diabetes technologies are safe, accessible and meet the diverse needs of patients. Patient safety and user-centred design are fundamental priorities for our industry, and we recognise the importance of learning from lived experience to drive further improvements. Achieving this also requires a procurement environment that recognises the value of innovation and supports the development of technologies for diverse patient needs. We look forward to working with the life sciences industry, and wider partners, to take this recommendation forward.'