Multiple black particles were found in the plasma collected by the machines of the American company Haemonetics. It would be a dysfunction of the seal that isolates the plasma from the blood.
Half of the French fleet of plasma collection machines is now unusable. The decision, made by the Agency for Drug Safety (ANSM) on Thursday 12, concerns 300 machines manufactured by the American company Haemonetics. This suspension comes after two particularly suspicious incidents, during which "a multitude of particles visible to the naked eye" were observed inside the machine and the plasma bag.
In France, only two suppliers share the market for these so-called apheresis machines. Apheresis is a technique that allows to collect, via a machine, one or more blood components (red blood cells, plasma, platelets). To do this, the machine collects the donor's blood, removes the desired component (s), and then reinjects the blood thus filtered into the donor.
The source of these particles would be a seal, which wears due to its rotational movement. "These seals are present in single-use medical devices (DMUs), which are discarded after collection. The donor is only in contact with this DMU, ​​never directly with the machine, "says Dr. François Boulanger, director of collection and production of labile blood products at the French Blood Establishment (EFS). The DMUs have a rotating system, in which it appears that the seal rubs abnormally during the three-quarters of an hour of sampling, producing these particles. "But that does not mean that the particles go into the donor," reassures the doctor. In contrast, deposits were found in the plasma collected. More and more reports
 This is not the first time that these machines have worried the health authorities. In February 2017, two whistleblowers had already warned the ANSM and the EFS about the risks of poisoning that donors run. Between February and October 2017, nine reports of visible black particles were made. But after the study of these cases, the ANSM concluded in December that "the risk / benefit balance of apheresis remains extremely positive", speaking of "rare phenomena" and "health risks considered as weak".
But since the beginning of 2018, reports continue to increase. 49 of them report abnormal noises during collections. It is in front of "the recurrence and the atypical character of the last incidents in spite of the security measures already taken" that the ANSM made its decision. "Although a priori there is no deleterious effect on health," says Dr. Boulanger, "it is not normal that a joint deteriorates so quickly. The supplier was already under surveillance, so that was too much. We had to act ». Voltage plasma stocks
This brutal reduction in the means for plasma collection is a blow to the EFS. 90% of the plasma collected is for the manufacture of blood-derived drugs, and the remaining 10% is used for transfusions. "For drugs derived from blood, we can survive with plasma bought in other countries," says the doctor, "but basically, it is amputated by 20%." For transfusions, the problem comes mainly from the blood group AB, a universal donor whose plasma can be transfused to all patients. "The AB group must necessarily be removed apheresis," says the doctor. "Half of the plasma we have left will be enough but just enough. We will be in slight tension. But redeployment measures have already been taken, and the EFS is thinking about the renewal of the machines. .


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