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France imposes conditions on ventilator product:

This article was originally published in Clinica

Executive Summary

The French healthcare products safety agency, AFSSAPS, has ruled that high frequency oscillation ventilators, SLE 2000 HFO and HFO manufactured by Eurocare (Italy) may only be sold if they are fitted with a compatible flow monitoring system. The new decision, published in the Journal officiel of January 13, follows a series of adverse incident events concerning the lack of reliability of pressure monitoring when the link for the intubation tube is accidentally diconnected and the lack of alarm system in this event.

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