The drug agency (ANSM) has recalled two disinfectants, Surfa'safe premium and Opaster are recalled as a precaution, because of the presence of bacteria in several batches of these products. Health establishments, medical offices, dental offices or other health and medico-social structures must no longer use them, says the ANSM.
The germs detected in these products for professionals are naturally present in the environment (in water in particular). But they are "opportunistic", that is to say, likely to cause an infection in immunocompromised people, explains the ANSM. On the other hand, "the risk of infection for the general population is very low".
Disinfectants used on medical devices
In several batches of Surfa'safe premium and its variations, the presence of bacteria Burkholderia cepacia was highlighted as well as Pseudomonas oryzihabitans in batches of Opaster.
Surfa'safe premium is a disinfectant widely used in the medical environment (hospitals, medical practices, etc …) for the disinfection of surfaces and non-invasive medical devices (stethoscope, blood pressure monitor …). Opaster, of very limited use in France, is a disinfectant for invasive medical devices including surgical equipment.
ANSM asked Anios laboratories to carry out microbiological tests on other products in their range of disinfectants. The first results of the tests carried out on twenty lots did not highlight the presence of these bacteria in these other products. Tests continue on products in stock.
The contamination is linked to the water network
Nevertheless, "pending the end of the investigations on the other Anios products, the agency recommends as a precaution and as far as possible, to favor the use of other brands for patients with weakened immune systems (under chemo, grafted, cystic fibrosis, prolonged stay in intensive care or neonatology …), "says Thierry Sirdey, director of medical devices at the ANSM.
The origin of the contamination would be related to the water network of the plant. Anios laboratories, which disinfect the water circuits, stopped the production and distribution of all their products. The restart of the plant can be considered only after verification of the resolution of the problem by the ANSM.