Heater-cooler devices used during cardiothoracic and other surgical procedures to warm or cool a patient have been linked with infections from bacteria called M. chimaera. Between 2010 and 2015, the FDA received 32 Medical Device Reports of patient infections associated with heater-cooler devices.
More than 250,000 heart bypass procedures using heater-cooler devices are performed in the U.S. every year. The 3T device linked to these infections represents about 60% of all heater-cooler devices in the country.
Proactive steps to manage the risk include:
- Maintain documentation of biomedical inspections of equipment; include the date, time and name of the inspecting technician.
- Notify the FDA via Med Watch report and the unit manufacturer If a contaminated heater-cooler device is identified.
- Require the manufacturer to perform its inspection at the hospital and monitor the inspection. Establish a chain of custody for any tubing, connectors or parts that are replaced. Do not release the device to the manufacturer.
- Develop a plan to transition away from the 3T device.
- Ensure perfusionists and staff follow FDA recommendations for the use and maintenance of 3T devices.
- Establish a team to develop the hospital’s plan of action to notify patients and physicians and conduct training for physicians and employees. Include the hospital risk manager on the planning and implementation team.
- Develop the patient notification letter and a plan for notifying patients and the public. Maintain a database that identifies patients notified. Determine how returned, undelivered mail will be addressed and additional measures the hospital will take to notify potentially exposed patients.
- Notify risk management of all patients identified infected with M. chimaera.
- Submit a notice of potential loss report to the facility’s professional liability insurance claim representative for all M. chimaera infected patients identified. Report any threat of legal action regardless of infection.
- Notify the facility’s directors and officers and errors and omissions carrier(s) of all M. chimaera infected patients identified as well as any threats of legal action regardless of infection.