Report recommends packaging and labelling change to prevent implant ‘never event’

In this investigation, the implant is a vascular graft and is one option for haemodialysis treatment – it is designed to connect an artery to a vein and create a larger and stronger opening for blood to travel. There are different types of vascular grafts (different diameters, lengths and may be tapered or non-tapered). Some grafts are for delayed use (needing 2 weeks between insertion and first use) and others for rapid use (used approx. 72 hours after insertion.)  

The national investigation explored the factors that influence the selection and insertion of vascular grafts and highlighted the risk that a graft could be mis-selected and lead to another surgical procedure for the patient. This increases risk of infection and can be distressing for the patient as well as placing extra demand on surgical teams. These issues were illustrated in the case of Teri, a patient with chronic kidney disease, who needed regular haemodialysis. She was referred to her local hospital for a rapid access type of graft. However, she was fitted with a delayed use graft. As the wrong type of graft was fitted, Teri needed to have another surgical procedure and an overnight stay which may have otherwise not been needed. 

HSIB’s findings are centred on human factors and design, and highlighting what makes errors more likely to occur. They have focused on the current packaging and labelling of grafts, the reliability of checklists, the implementation of national standards for invasive procedures and how the safety culture within an organisation impacts the implementation of such standards. 

Key findings in full 

• The packaging of rapid access and delayed use vascular grafts may be very similar, resulting in an increased risk of staff selecting and inserting the wrong type of graft. 
• The wording used on packaging and labels to describe vascular grafts does not reflect the terminology used by clinicians in the operating theatre. 
• There is Medicines and Healthcare products Regulatory Agency (MHRA) guidance for the labelling and packaging of medicines, but not for medical devices such as vascular grafts. 
• There was a lack of standardisation and therefore variation in how checklists and ‘team briefs’ (procedures that aim to ensure patient safety) were completed/conducted and recorded in different operating theatres.
• The incorporation of national safety standards alone may not be successful without an embedded safety culture being in place. 

In relation to the findings on packaging and labelling and checklists, HSIB have made four recommendations focused on reviewing system requirements for barcode scanning technology; updating the applicable standard/s to state that medical device labelling and packaging should detail the specific use of an item; amending the assurance processes for designated approved bodies to consider context of use and usability guidelines; and the publication of guidance on the labelling and packaging of medical devices.

The report notes that technology-based safety measures are considered more effective than ‘those that rely on the actions of people.’ In the context of the physical selection of vascular grafts, they also explored the use of automation and computerisation. They looked at the use of barcode scanning technology to mitigate the risk of mis-selection errors. The report specifically refers to the ‘Scan4Safety’ programme. The Department for Health and Social Care (DHSC) carried out a two-year trial on the programme from 2016 at six ‘demonstrator’ NHS Trusts. Some of the examples at the trial sites showed the promising features of the programme – for example, unique barcode on a patient wristband which could be used to confirm the correct implant had been selected at point of care. 

However, the investigation heard that since the trial ended the programme has continued, but with reduced momentum. Due to the reduced central management, Trusts have been developing applications and using adaptations of the scanning technology, resulting in inconsistent use and variable effectiveness. HSIB have recommended that a review is carried out on the system requirements for barcode scanning technology to support local organisations to adopt and use the technology in the most effective way.  

Helen Jones, National Investigator says: “Wrong implant procedures are classified as a never event and are a recognised safety risk. When it comes to an implant like a vascular graft, inserting the incorrect one could result in a further surgical procedure for a patient who may already be unwell, suffering from a long-term chronic condition that requires regular treatment. 

“Our investigation highlighted that there are reasons, in relation to vascular grafts, why the risk of error may be increased. It was clear to see from our evidence that simplification and standardisation is needed when it comes to packaging and labelling to ensure that the rapid access and delayed grafts are not mixed up. We have also put emphasis on technology and automation as this is often the most effective way to mitigate against incorrect insertion. There is the drive to implement technology-based measures, however more work needs to be done to ensure its longevity and consistency, reducing the patient safety risks and easing pressure on the teams carrying out invasive procedures. 

“Overall our findings, safety recommendations and safety observations aim to prevent the selection and insertion of incorrect vascular grafts from happening in the future and to improve care for patients across the NHS.”