The QMN Weekly Bulletin
Medical Devices / Regulatory Affairs

MHRA Issues Guidance on Infections from Heater Cooler Units

March 31, 2017

Heater cooler units used in cardiopulmonary bypass and extracorporeal membrane oxygenation can generate potentially infectious aerosols containing a range of harmful bacteria, some of which can be fatal, according to an ongoing UK investigation.

The UK’s Medicine’s and Healthcare Products Regulatory Agency has issued new guidance on how healthcare providers can lessen the risk of infection from the units.

NHRA said users should ensure that a full local risk assessment is conducted and a local quality assurance program is implemented for the use of HCUs that the units are monitored for harmful bacteria, and that suitable cleaning and disinfection regimes are used.

The MHRA or another appropriate agency should be notified of HCU-related issues, including problems encountered in cleaning and disinfection, patient harm, and new cases of M. chimaera infection, the agency said.

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