Is There Really No Kit for Kids? Quantification of Manufacturer Recommendations Regarding Paediatric Use For High-Volume IR Devices.

ABSTRACT

AIMS: The development of paediatric specific devices appears to lag behind advancements in our specialty. Children could therefore be limited in the number of procedures available to them unless we continue to use and modify adult devices 'off-label'. This study quantifies the proportion of IR devices in which paediatric use is indicated by the manufacturer. MATERIALS & METHODS: Cross-sectional analysis of device instructions for use (IFU), assessing inclusion of children was performed. Vascular access, biopsy, drainage, and enteral feeding devices, from 28 companies who sponsored BSIR, CIRSE and SIR (2019-2020) as determined by the meeting websites, were included. Devices for which the IFU was not available were excluded. RESULTS: 190 (106 vascular access, 40 biopsy, 39 drainage and 5 feeding) devices with IFU's from 18 medical device manufacturers were assessed. 49/190 (26%) IFU's referenced children. 6/190 (3%) explicitly stated the device could be used in children and 1/190 (0.5%) explicitly stated the device was not for use in children. 55/190 (29%) implied they could be used in children through caution notes. The most common caution was a reference to the size of the device that could be accommodated in a child (26/190, 14%). CONCLUSIONS: This data identifies an unmet need for paediatric IR devices and could be used to support the future development of devices intended for the children we treat. There is potentially a larger proportion (29%) of devices suitable for paediatric use, but which lack manufacturer explicit support. LEVEL OF EVIDENCE Level 2c, Cross-Sectional study.