Plasma and platelet collection machines are suspected of exposing donors to toxic substances, report Bastamag and the cell investigation of Radio France. The two media evoke dozens of reports in France of suspicious particles observed in devices in surveys published Friday. According to them, the manufacturer of the defective devices, the American company Haemonetics, like the French health authorities, would not, for a long time, have taken the measure of the risk.
When it is not a classic blood donation, the plasma and platelets are sorted by a centrifuge. The donor receives what the machine does not need. It is during this stage that particles from the material (more precisely, joints) could be reinjected into the body of the donors.
About 3000 reports of visible particles in devices, including 84 in France, have been identified by Haemonetics since 2005, a list that would be far from exhaustive according to Radio France and Bastamag. In a first report published on the subject by Haemonetics in 2011, the company claims that the observed deposits are dried blood particles.
"Endangering the lives of others", "aggravated deception"
But in 2017, the French Blood Establishment (EFS), which is concerned internally about the problem from 2015, is the recipient of a study explaining that the particles are the same as those found during the analysis of the joints of Haemonetics devices. The same year, the National Agency for Drug Safety (ANSM) seized a committee of experts who obtained the official composition of the seal, which includes carcinogenic or mutagenic components. In its conclusions, the Committee notes that "the toxic risk" is "possible".
According to ANSM, quoted by Bastamag, these substances would pose, on the contrary, no problem since they can be eliminated by blood macrophages.
While the authorities have still not reacted, the three elders of Haemonetics who alerted them at the end of 2015 lodge a complaint in May 2018 for "endangering the lives of others", "aggravated deception" and "failure to comply. withdrawal or recall procedure for a product detrimental to health ". The complaint concerns the French Blood Establishment, the ANSM and any co-author of the facts.
In September 2018, the use of Haemonetics plasma sampling machines is finally suspended in France, after new incidents. Those that allow the removal of platelets, however, are still in circulation …