HSIB: The selection and insertion of vascular grafts in haemodialysis patients (27 July 2023)

Summary

This investigation aims to improve patient safety by supporting healthcare staff in a surgical setting to select and insert the appropriate type of implant (vascular graft) for haemodialysis treatment.

The Healthcare and Safety Investigation Branch (HSIB) explored the factors that affect the ability of staff to safely select and insert vascular grafts for haemodialysis treatment. The national investigation focused on:

• The identification of factors within the healthcare system as a whole that influence patient safety risks associated with the selection and insertion of vascular grafts in an operating theatre environment.
• Exploration, using a systems approach, of the design of labelling and packaging used for the different types of vascular grafts for patients on haemodialysis treatment.
• Exploration of the impact on operating theatre teams of staff redeployment and repurposing of working environments in response to the COVID-19 pandemic.

Content

Reference event

Teri had chronic kidney disease and needed regular haemodialysis. He had previously received haemodialysis via a connection between an artery and a vein. However, this connection was failing due to narrowing of the blood vessels and she needed to have a vascular graft implanted so that her treatment could continue.

Teri was referred to her local hospital for insertion of a ‘rapid access’ type of vascular graft, to enable her haemodialysis treatment to be carried out as planned. Before Teri’s operation, a consultant vascular surgeon and members of the operating theatre team went to the store cupboard to look at the types of vascular grafts stocked. The consultant vascular surgeon was not sure which size would be needed, so two different sized vascular grafts were selected. However, it was not recognised at the time that they were different types of vascular graft, with one being the intended rapid access type and the other a delayed use graft.

Following surgery, the consultant vascular surgeon immediately realised that a delayed use vascular graft had been inserted instead of a rapid access graft.

Because the wrong type of vascular graft was inserted, Teri needed to have another surgical procedure and an overnight stay in hospital, which may not have otherwise been needed.

Findings

• 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.
• Barcode scanning technology (Scan4Safety) can be used to mitigate the risk of an incorrect medical device being selected/inserted. Due to the reduced central management of the Scan4Safety programme, trusts have been developing applications and using adaptations of the scanning technology, resulting in inconsistent use and variable effectiveness.

Safety recommendations

HSIB made four safety recommendations as a result of this investigation.

1. HSIB recommends that NHS England reviews system requirements for barcode scanning technology, in order to support local organisations to reduce the risk of incorrect selection and insertion of prostheses/implants.
2. HSIB recommends that the British Standards Institution updates the applicable standard/s, and raises with the International Organization for Standardization, to state that medical device labelling and packaging should detail the specific use of an item. This should be developed with user input to drive consistency in the terminology used on medical device labelling/packaging.
3. HSIB recommends that the Medicines and Healthcare products Regulatory Agency ensures the assurance processes for designated approved bodies (to check medical device manufacturers conform to packaging standards) are amended to consider context of use and usability guidelines, to reduce the risk of selecting and inserting the incorrect device.
4. HSIB recommends that the Medicines and Healthcare products Regulatory Agency publishes guidance on the labelling and packaging of medical devices, to promote best practice and reduce selection of the incorrect item.

Safety observations

HSIB makes the following safety observations:

• It may be beneficial if the term ‘user’ in the context of medical devices was defined in international and national standards to incorporate all staff who interact with the device, including those who select the device, check it before use and use it.
• It may be beneficial for healthcare organisations to deliver multi-disciplinary team training on the key principles of the revised ‘National safety standards for invasive procedures’ to support the implementation and embedding of these standards.
• It may be beneficial for trusts to assign experienced operating theatre clinicians to lead on the implementation of the ‘National safety standards for invasive procedures’, to address the cultural issues hindering implementation.

Related resources on the hub: 

• NatSSIP2 sequential steps: The NatSSIPs Eight – Flow chart
• Error traps gallery