Objectives To highlight the need for a comprehensive risk assessment to be conducted prior to any decision on a possible high-volume product switch.

Methods A multi-disciplinary group of experts met to develop the content of this paper. They discussed their experiences and local Trust procedures and then wrote this paper. The content of this paper represents their consensus on the need to conduct risk assessments when considering a product switch, what parameters should be considered and which stakeholders.

Results This paper details the key elements of a comprehensive risk assessment and the consequences of not conducting one. It will encourage a new gold standard approach when assessing whether a high-volume product switch should be considered.

Conclusions Before a high-volume product switch is considered, a comprehensive risk assessment should be conducted. Numerous parameters should be included in any risk assessment. It is important that all of the necessary stakeholders, including representation from those who will be affected, are involved in varying degrees in the risk assessment process. Following comprehensive risk assessments, NHS Trusts would proceed with very few switches.