Question 11181 — human blood and organs

Summary

Mr. André Chassaigne questions the Minister of Solidarity and Health about the risks for donors and recipients of blood products following the malfunction of certain apheresis machines. During the treatment of certain diseases, apheresis machines make it possible to extract blood products (plasma, platelets) from a donor into extracorporeal circulation, then injected into the blood of the recipient-patient. Alerts have been issued since 2015 by managers of the Haemonetics company on the malfunction of their machines, which could contaminate the blood and affect the health of the donor, the recipient, or even the operator of the machine. For its part, the temporary specialized scientific committee, set up by the ANSM, affirmed that in the absence of a rapid assessment of the risks, “it will be necessary to consider the elimination of medical devices containing mobile joints”. On February 16, 2018, the ANSM revealed the trade names of the materials dispersed, then reinjected into the donor's blood: Hilox 882 and Plenco 05351. The product sheets for these materials, published on the websites of their manufacturers, show that they are made up of neurotoxic, carcinogenic, mutagenic and reprotoxic (CMR) molecules. In the absence of corrective action, a complaint was filed in May 2018 against the EFS, from the ANSM and Haemonetics for “risk of endangering the lives of others, aggravated deception and non-execution of a procedure for withdrawal or recall of a product harmful to health”. However, the ANSM has just declared that the benefit-risk remains positive, justifying the continued use of Haemonetics machines at the EFS. If the notion of benefit is certain for the patient-recipient, the benefit-risk is nonsense for the donors, who can be collected more than 250 times during their lifetime. However, there are other machines at EFS, with little or no risk, which could easily be substituted for Haemonetics machines. Furthermore, the CSST report cannot be consulted on the EFS website or on the information sheets intended for donors. Finally, the EFS did not implement the replacement plan aimed at ensuring the maintenance of production of plasma and platelets. He asks him for his opinion on the behavior and position of the ANSM and the EFS on this subject and on what today justifies the endangerment of donors, recipients and EFS staff.

Machine translation from French. The official text remains authoritative.

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