31 August 2016
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Medsafe is alerting health care professionals and facilities about a potential link between the use of heater-cooler devices, particularly in open cardiac surgery, and infections with non-tuberculous mycobacteria (NTM).
This alert provides information and recommendations to health care professionals about the use and maintenance of these devices and their component parts.
One case of a surgical site infection with non-tuberculous mycobacteria (NTM) has been reported in New Zealand in a patient that had previously undergone open chest cardiothoracic surgery and where a heater-cooler device was used during surgery. Similar cases have been reported internationally,
Heater-cooler devices are used to warm or cool a patient to optimise medical care and improve patient outcomes. In cardiothoracic surgery, heater-cooler devices are used within the operating theatre to control a patient’s temperature.
Heater-cooler devices contain water tanks that provide temperature controlled water to external heat exchangers or warming / cooling blankets through closed circuits. Although the water in the circuits does not come into direct contact with the patient there is the potential for contaminated water to enter other parts of the device or to aerosolise, transmitting bacteria through the air via the device’s exhaust vent into the environment and to the patient. The exact route of transmission, however, is unknown.
NTMs are wide spread in nature and although not known to be harmful to healthy individuals, have been found to cause infections in very ill or immunocompromised patients or in situations where prosthetic material was implanted. One of the NTM organisms identified – Mycobacterium chimaera – has recently been linked to infections with heater-cooler devices. The organism is slow-growing, so infections may present some months (or years) after exposure.
All brands of heater – cooler devices may be affected by this issue.
If you, or someone you provide care for, has had open cardiac surgery and you are concerned about this issue, please consult a health care professional.
There have been reports internationally of surgical site infections with the unusual mycobacterial species, Mycobacterium chimaera, in patients who have undergone cardiac surgery. This surgery has involved open cardiac procedures where medical devices such as cardiac valves have been implanted. Investigations have linked these infections with contaminated heater-cooler devices.
Non-tuberculous mycobacteria (NTM) include a number of different bacterial species many of which are widespread in nature and can be found in water, including tap water. They are not usually a major cause of infection in the community, however, in rare cases may cause infection in very ill or immunocompromised patients or in situations where prosthetic material was implanted. The organism is slow-growing so may present as an infection some months or years after exposure.
The exact route of transmission is unknown, however, studies suggest that if bacterial contamination of the water within the device occurs, there is potential for the device to transmit bacteria through the operating environment air by aerosol via the device's exhaust vent.
Other regulators have received reports of infections, but the overall number of cases is unclear. The United States FDA had received 40 reports of NTM infections potentially associated with these devices by 1 April 2016, the majority of these reports were made in 2015.
Some suppliers of heater-cooler devices used in cardiothoracic surgery have updated their instructions for use and provided recommendations on how to reduce the risk of water contamination and on testing for the presence of the organism.
In addition to standard procedures, Medsafe recommends the following:
Currently there are no evidence-based guidelines available on the follow-up of patients who have been exposed to a contaminated device.
Implementing a 'look-back' may be complex because of the slow-growing nature of the organism. Screening of asymptomatic patients for NTM is not currently indicated. Medsafe recommends liaising with infection prevention and control services in your area to determine the most appropriate approach.
For patients who have undergone open cardiac surgery, especially those who have had heart valve replacements, consider:
The advice provided in this alert has been adapted from Australian advice provided by the TGA (Therapeutic Goods Administration) and peer-reviewed for New Zealand application.
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