Heater-coolers in surgery have got warnings from the FDA

A recent warning issued by the FDA has highlighted potential risks involved with the use of heater-cooler devices within surgery settings.

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According to the authority, the most commonly utilised devices for warming or cooling a patient within open-heart surgery may potentially create additional risks to the patient through the transmission of harmful bacteria.  The best thing to do in any hospital setting is to look at Aluminium Radiators UK as they will keep the room warm and will not not loose heat as the aluminium works as a kind of blanket.  You can find out more about this from experts at sites including apolloradiators.co.uk/designer-radiators

The bacteria risk is thought to increase dangers of infection for vulnerable patients, which may create serious injury or even result in death. The FDA are calling for enhanced recognition of the potential dangers, in order to address and mitigate any potential risks associated with using the devices.

Researchers’ Recommendations

While the water that is used within these heater-cooler devices never comes into direct contact with the patient, the medical community and CRO researchers have been investigating the potential for NTM (nontuberculous mycobacteria) organisms to develop within the reservoirs of the devices. The issue is thought to potentially affect all such devices, without being focused upon one or two single manufacturers or brands.

The heater-cooler devices are neither sealed nor airtight, which can allow harmful bacteria to enter the system and be passed through the vents used within the devices. In cardiopulmonary procedures, contaminated water may potentially enter the operating environment, compromising the sterility of the bypass procedures.

Maximising Patient Safety

In normal clinical settings, these organisms pose no threat to patients as they are commonly located within soil and water and are not usually considered to be harmful. However, in bypass scenarios, breathing in these organisms may result in serious pulmonary infection for those individuals with compromised immune systems and health vulnerabilities. As a result, the FDA have issued the following guidelines for healthcare providers who may currently be deploying these devices:

• Be rigorous in following manufacture guidelines for the disinfection and cleaning of the device, and ensure that a regular schedule of maintenance cleaning and disinfecting is adhered to.
• Never use water from a tap source to clean the machines, for refilling, topping off or rinsing the device. Instead, use sterile water or filtered water which does not pose any risk of harbouring potentially harmful organisms.
• Direct the exhaust vent of the device well away from the surgical field, to minimise the risk of bacteria being inhaled during the surgical process.

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