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Cleaning and disinfection of heater-cooler-units (HCUs): possible influence on oxygenator integrity

Ref. no.: 03103/16

BfArM refers to our recommendation of 2016-12-22 regarding the possible mycobacteria infection risk (only available in German) during heart surgery. Particular emphasis was placed on cleaning and disinfection of heater-cooler-units (HCUs).

Recently, BfArM has received notification suggesting that the cleaning and disinfection procedure of heater-cooler-units may affect the integrity of the involved disposable oxygenator, possibly resulting in direct blood-water contact.

Thus, BfArM recommends that user shall conduct the cleaning and disinfection of heater-cooler-units strictly according to the IFU of the HCU manufacturer. Additionally, users should obtain confirmation from the oxygenator’s manufacturer that the oxygenator will tolerate when the cleaning and disinfection procedure of the heater-cooler-unit is done as prescribed in the HCU IFU.

Distributors and manufactorers are advised to provide any information to the user that are necessary for the safe use within the intended purpose of the medical devices, especially with respect to the foreseeable combination of devices from different manufacturers.

In case of questions please contact:

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

Telephone +49 228 207-3202 (Non-active medical devices)
Facsimile +49 228 207-5300
e-mail: md-vigilance@bfarm.de

Date 2016.12.22