Preventing ‘never events’

The Healthcare Safety Investigation Branch’s (HSIB) latest report recommends changes to the packaging and labelling of implants used in patients undergoing haemodialysis, to reduce the risk of the incorrect implant being inserted.

The implant is a vascular graft and is one option for haemodialysis treatment. It’s designed to connect an artery to a vein and create a larger and stronger opening for blood to travel and there are different types.

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.

HSIB’s findings are centred on human factors and design, and highlighting what makes errors more likely to occur. They focused on the 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.

In relation to the findings on packaging and labelling and checklists, HSIB made four recommendations focused on: reviewing system requirements for barcode scanning technology; updating the applicable standard 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 and looked at the use of barcode scanning technology to mitigate the risk of mis-selection errors.

The report specifically refers to the ‘Scan4Safety’ programme, a two-year trial carried out from 2016 at six ‘demonstrator’ NHS Trusts. Some of the examples at the trial sites showed the promising features of the programme, for example, a unique barcode on a patient wristband which could be used to confirm the correct implant had been selected at the 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 has 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.