FDAnews
www.fdanews.com/articles/11262-nice-guidance-calls-for-more-data-on-body-composition-monitors

NICE Guidance Calls for More Data on Body Composition Monitors

February 17, 2017

New guidance from the UK’s National Institute for Health and Care Excellence (NICE) says there is currently not enough validation or clinical-outcome data to determine whether body composition monitors (BCMs) are effective for guiding fluid management in people on dialysis with chronic kidney disease.

The devices work by sending small, painless electrical signals through the body by way of electrodes. The electrodes also measure the opposition to the flow of the electric current from body tissues. The measurements are used to calculate hydration.

UK hospitals that are currently using BCMs should collect data, and those that are not should do so only as part of a research study, NICE said.

Currently, the fluid status of a person on dialysis is typically determined by clinical assessment, taking into account clinical features and symptoms that suggest overhydration or underhydration. However, individuals who are over- or underhydrated are often asymptomatic.

BCMs may help clinicians determine how much fluid to remove during dialysis. The guidance encourages BCM manufacturers to collect and publish data on both the validity of their device’s underlying fluid models to calculate fluid overload and the associated clinical outcomes.

NICE recommends additional research into the clinical effectiveness of BCM-guided fluid management in individuals with chronic kidney disease who are undergoing dialysis. Further research should collect clinical outcome data in the following populations: adults (aged 18 years and over) having peritoneal dialysis; babies, children and young people (aged 18 years and under) having haemodialysis; and babies, children and young people (aged 18 years and under) having peritoneal dialysis.

Read the guidance here: www.fdanews.com/02-17-17-BCMguidance.pdf.