BfArM’s updated assessment concerning oxygen concentrators
Case no. 2676/10
In September 2011, BfArM recommended corrective actions to prevent fires in oxygen concentrators http://www.bfarm.de/EN/medDev/riskinfo/recommend/oxygen_concentrators.html.
After discussion with a German hightech industry association as well as the German local Federal Competent Authorities we have concretised our recommendation:
From the first of July 2012 at the latest, devices should be equipped with installations for
- stopping encroachment of the fire into the device
- interruption of the delivery of oxygen in the accessory as close to the patient as possible, in case of ignition
From that date on, manufacturers also should offer respective refitting for devices that have been placed into the market before the first of July 2012. BfArM is of the opinion, that oxygen concentrators that have already been placed on the market should be refitted respectively. We would accept refitting during annual maintenance or other services, e.g. preparation for further use. Owners and users of these devices should realise this refitting.
Moreover, accessory should be designed that way (e.g. by using adequate material) that the fire extinguishes as soon as the supply of concentrated oxygen is interrupted.
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
Facsimile: +49 228 207-5300
Telephone: +49 228 207-5306 (Active and in vitro diagnostic medical devices)
Telephone: +49 228 207-5385 (Non-active medical devices)