The selection and insertion of vascular grafts in haemodialysis patients

This investigation was carried out by the Healthcare Safety Investigation Branch (HSIB). Find out more about HSIB legacy.

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.

Dialysis is a procedure to remove waste products and excess fluid from the blood when a person’s kidneys stop working properly. Almost 30,000 people in the UK receive regular dialysis. The most common type of dialysis is haemodialysis, during which a patient’s blood goes through a tube into a machine to be filtered, and is then passed back into the patient’s body. To carry out haemodialysis, access is required to the bloodstream; one option for this is a vascular graft. This is a synthetic implant used to connect an artery and vein, to create a larger and stronger opening through which the blood can travel.

There are numerous types of vascular grafts produced by different manufacturers. Vascular grafts are available in different diameters and lengths, and may be either tapered or non-tapered in shape. Some vascular grafts are for delayed use, needing around 2 weeks between insertion and first use, and others are for rapid access and can be used approximately 72 hours after insertion.

This investigation used a real patient safety incident, referred to as ‘the reference event’, to examine aspects of the selection and insertion of vascular grafts, including measures to ensure the correct type is inserted. The reference event involved Teri, who had to undergo an additional procedure after the incorrect type of vascular graft was inserted for haemodialysis treatment.

The investigation’s 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.

Teri had chronic kidney disease (a long-term condition resulting in a gradual loss of kidney function) and needed regular haemodialysis.

Teri 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. This was identified by the sticker from the graft’s packaging which had been placed on Teri’s medical records, and confirmed by checking the empty box that the graft had been taken from.

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. The further procedure was required to enable Teri to have haemodialysis during the interim period (approximately 2 weeks) before the delayed use graft could be used.

This incident was referred to HSIB by the Trust where the reference event occurred. This was following a serious incident investigation by the Trust; a referral to the manufacturer of the vascular graft concerning the packaging; and a notification to the Medicines and Healthcare products Regulatory Agency, due to other incidents involving similar packaging at the Trust.

HSIB’s Chief Investigator authorised a national investigation, which 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.

• 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.