It is intended to implement a design-based solution regarding fires of oxygen concentrators when revising ISO 8359. Currently, this standard only demands warning instructions.
BfArM has recommended implementing solutions to prevent encroachment of the fire from the tubing into the oxygen concentrator and to refit oxygen concentrators respectively until this problem will be solved by the revised standard.
Manufacturers are free to choose an adequate solution for their products, provided that the designated effect is achieved.
Queries concerning the costs of refitting are not within the jurisdiction of BfArM and the implementation of the corrective actions will be monitored by the local competent authorities.

In case of questions please contact:

Federal Institute for Drugs and Medical Devices
Medical Devices Division
Kurt-Georg-Kiesinger-Allee 3
53175 Bonn

Telephone: +49 (0)228 99 307-5306 (active medical devices and in vitro diagnostics)
Facsimile: +49 (0)228 99 307-5300
E-Mail: md-vigilance@bfarm.de