Australia’s Therapeutic Good Administration issued an update on its product review investigation of heater-cooler devices after more patients were found to be infected with Mycobacterium chimaera infections following heart surgery.
The TGA has narrowed the investigation to heater-cooler devices intended to be used for cardiac bypass surgery, where blood is circulated outside the body and infused with oxygen and returned to the patient. The devices are used to control blood temperature during surgery.
Initial product safety reviews suggest the water tanks could become contaminated with bacteria, and patients were likely infected when bacteria in the water tank became airborne. The water is not intended to come in contact with patients.
The six confirmed cases in Australia were associated with Stockert Heater-Cooler 3T heater-cooler units manufactured before September 2014.
The following heater-cooler devices were withdrawn from the Australian market: Zoll Circulation’s Coolgard; Chalice Medical’s Paratherm; Medos Medizintechnik’s DeltaStream; and Sorin Group’s Stockert Heater-Cooler 3T and Stockert Heater Cooler 1T (IDDM, May 19).
The Australian Commission on Safety and Quality in Health Care issued a notice to health care facilities in October 2016 on the proper cleaning and disinfection procedures to mitigate risk of infection. It instructed hospitals to keep records and perform routine maintenance on the heater-cooler devices. At the time, roughly 50 individuals worldwide had become infected following surgery.
The UK’s Medicine’s and Healthcare Products Regulatory Agency also issued guidance calling on users to ensure that a full local risk assessment is conducted and a local quality assurance program is implemented for the use of heater-cooler units. The agency requested that HCUs be monitored for harmful bacteria, and that suitable cleaning and disinfection regimes are implemented (IDDM, Feb. 24).
The TGA said in its recent update that more than 100 individuals have been severely infected globally since 2013. In fact, more than one-third of the devices used to control blood and organ temperatures during open heart surgery may
LivaNova, which manufactures one of the most commonly used heater-cooler units, responded to the research by developing a three-part plan to resolve the issue. The company said it would modify the device design to include internal sealing and a vacuum system, implement a no-charge deep disinfection service and loan users a new device at no charge (IDDM, June 19).
Read the TGA update here: www.fdanews.com/08-22-17-Australia.pdf.