In early December, the National Medicines Safety Agency (ANSM) issued an alert on a product used for dialysis. This product, a citrate-based dialysate marketed in 2012, is believed to be responsible for an excess mortality of 40% in patients treated with this product compared to those treated with a product without citrate. Following this alert, many dialysis centers changed their practices and favored the use of citrate-free dialysates pending further investigations.
Also, the ANSM has decided to set up, until next March 31, a national medical device vigilance survey with healthcare professionals and patients.
A two-step survey
First, the ANSM will collect all the adverse events that have occurred during or during a dialysis session. To this end, it has put in place effect declaration forms. accessible online.
Secondly, the dialysis centers will be asked to inform the ANSM about the types of dialysates used in their centers in November 2018 and March 2019 to measure the effects of changes in practice.
But even before the results of this survey, the ANSM promises to put in place, as of January, new recommendations for the treatment of ichronic renal failure.
Read also :
Infographic: get to know your kidneys
Chronic renal failure: improving management
