Updated advice on the recent Stockert 3T heater-cooler issues

The Stockert 3T heater-coolers used during certain surgeries have been linked to a dangerous microorganism, Mycobacterium chimaera.

The manufacturers of the ‘deadly device’ have now issued advice in relation to managing and cleaning the device as part of ongoing investigations.

Heater-coolers

On 11 June 2015, the Medicines and Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert (MDA). MDA’s are given out as a means of communicating safety information to Health and Social Care (HSC) organisations as well as patients and users of medical products. These alerts may come about as a result of an investigation by any U.K. administration or from other Competent Authorities around the world.

Risks associated with the heater-coolers

The specific MDA highlighted an infection risk called non-tuberculous Mycobacterium to patients who have had open-heart surgery. The heater-coolers use temperature-controlled waters in tanks to regulate a patient’s blood or body temperature during surgery, and the reported issues came about when the water was found to be contaminated, which then meant that the machine could potentially spread bacteria in the open-air.

With bacteria circulating in the air, it can enter a patient’s open chest, consequently causing an infection, which can be fatal.

The MHRA details that, where disinfection and maintenance procedures aren’t strictly followed, organisms could multiply in heater-cooler devices, and a group of microorganisms can form which can cause chronic infections and potential fatalities.

Advice from device manufacturers

Manufacturers of the device, including LivaNova and Maquet, have issued further advice and actionable points. The medical device manufacturers have said to contact the manufacturer and the MHRA if:

It’s also important that individuals or patients who are, or might be, infected with Mycobacterium chimaera notify Public Health England and the MHRA.

Field safety notices

LivaNova issued an updated field safety notice for the 3T heater-cooler devices, emphasising the importance to follow additional guidance, such as:

Maquet has also issued a field safety notice for the heater-coolers too. The medical manufacturers has revised its instructions for use in relation to the cleaning, descaling, and disinfecting of the HU 35 heater-coolers. They’ve suggested a new weekly high-level disinfection routine in a bid to reduce the build-up of microorganisms, and the MHRA notes that Maquet will shortly update cleaning and disinfecting instructions for the following models: HCU20, HCU30 and HCU40.

We’re keeping a close eye on this one – anyone affected is asked to come forward to speak to us as soon as they can. Legal claims have been launched by our counterparts in the United States.

Sources:

https://www.gov.uk/drug-device-alerts/heater-cooler-devices-used-in-cardiac-surgery-risk-of-infection-with-mycobacterium-species-update

https://www.ncbi.nlm.nih.gov/pubmed/23635385

https://www.health-ni.gov.uk/articles/medical-device-alerts-mdas

http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/CardiovascularDevices/Heater-CoolerDevices/ucm492590.htm