The article provides an overview of the existing regulatory framework for heater-cooler devices.
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a set of notices dedicated to heater-cooler devices. The publications highlight the most important aspects related to the use of such devices, as well as the regulations these products are subject to.
Heater-Cooler Devices: Overview
According to the guidance, heater-cooler devices are often necessary for use during surgeries to warm or cool patients as part of their care; they are especially important tools for surgeries involving the heart and lungs (cardiothoracic surgeries). As further explained by the FDA, such devices are composed of tanks with fluid (in most cases it is water) and external heat exchangers. The authority provides the following image illustrating the principal mode of action of such devices:
Blue arrows and lines stand for cold water, and red ones for warm respectively.
According to the applicable legislation, heater-cooler devices described by the FDA are Class II medical devices. The regulatory aspects associated thereto are addressed in the following regulations:
- 870.4250 Cardiopulmonary Bypass (CPB) Temperature Controller; and
- 870.5900 Thermal Regulating System.
As further explained by the authority, the aforementioned products are intended to be used as follows:
- The CBP Temperature Controller is intended to supply temperature-controlled fluid to heat exchangers associated with devices (for example, blood oxygenators) intended to keep circulating blood and organs at a specific temperature best suited to the type of surgery performed.
- Thermal Regulating Systems are generally cleared for use with warming/cooling blankets.
It is also stated that even though such devices are covered by cardiovascular classification regulations, they could be used for various medical purposes.
Recommendations for Use
The authority further provides recommendations to be considered when using water-based heater-cooler devices. In particular, the FDA pays special attention to the risks associated with microorganisms that could grow in fluid tanks. This could potentially result in infection in patients due to the contaminated water. However, the authority states that in appropriately selected patients, the benefits of temperature control during open-chest cardiothoracic procedures generally outweigh the risk of infection transmission associated with the use of these devices.
The recommendations provided by the authority include, inter alia, the following ones:
- The instructions provided by the manufacturer should be strictly followed for the cleaning and disinfecting procedures.
- Tap water should not be used for devices of this type due to the risk of contamination, only sterile water should be used instead. Alternatively, a special filter could be used to ensure the proper quality of the water used to refill the tanks of a device.
- The exhaust ventilation of the device should be directed away from sterile fields to reduce the risk of contamination with the air.
- The device should be subject to regular cleaning and disinfection following the appropriate instructions provided by the manufacturer. Furthermore, it is important to follow the maintenance requirements and procedures to ensure proper operations of the device and prevent damage. In certain cases, the appropriate written procedures should be applied.
- The device that does not operate as intended should be immediately removed from service, as it exposes patients to additional risks.
- It is also advised to conduct air and water sampling regularly to monitor their quality and be able to identify the issues related to the operations of the device.
- All suspected contamination cases should be duly investigated by the appropriate procedures to be developed and implemented by a healthcare facility.
- Any issues and adverse events associated with heater-cooler devices should be duly reported to the authority by the medical device reporting requirements.
Infections Associated With Water-Based Heater-Cooler Devices
The authority has also published a separate notice dedicated to the ongoing evaluation and continued monitoring of reports of Nontuberculous Mycobacteria (NTM) infections associated with water-based heater-cooler devices. As described before, since heater-cooler devices include tanks with temperature-controlled fluid, they could be subject to infection developed inside of these tanks, which could potentially result in contamination of patients. Even though the fluid is not intended to come into direct contact with a patient during the normal use, bacteria could still reach the surrounding aid through a ventilation system of the device. This creates a situation when a patient is exposed to additional risks associated with potential contamination. However, as was mentioned before, clinical benefits arising from the use of the device outweigh the aforementioned risks, provided that the patients are selected properly.
According to the guidance, the risks associated with NTM infections are especially important in the case of patients subject to cardiothoracic surgical procedures. To develop an approach to be followed when mitigating such risks, the authority performs continuous analysis of all the information which becomes available concerning the safety and performance of water-based heater-cooler devices allowed for marketing and use in the US. The sources analyzed by FDA include, inter alia, scientific publications, and incident reports.
In summary, the present FDA guidelines highlight the most important aspects related to heater-cooler devices used to control temperature during surgery procedures. The document outlines the key points to be considered by medical device manufacturers, as well as by healthcare professionals using such devices in order the ensure the proper operations of the equipment and the safety of patients.
How Can RegDesk Help?
RegDesk is a next-generation web-based software for medical device and IVD companies. Our cutting-edge platform uses machine learning to provide regulatory intelligence, application preparation, submission, and approvals management globally. Our clients also have access to our network of over 4000 compliance experts worldwide to obtain verification on critical questions. Applications that normally take 6 months to prepare can now be prepared within 6 days using RegDesk Dash(TM). Global expansion has never been this simple.
Want to know more about our solutions? Speak to a RegDesk Expert today!