Information provided to heart surgery patients

Wednesday, 21 December 2016

SA Health says it is highly unlikely any South Australian cardiac surgical patient has been affected by an international manufacturing issue that has been linked to causing a rare infection.

One patient in Queensland is the only Australian that has contracted the infection linked to the Sorin 3T heater cooler machine, despite tens of thousands of patients having cardiac surgery in Australia.

Flinders Medical Centre’s Head of Cardiac and Thoracic Surgery, Associate Professor Jayme Bennetts, said there is no evidence of any cases in South Australia and the risk of infection is extremely low but around 1,000 public patients will receive information about the manufacturing issue in line with open disclosure policy.

“In June 2015, the Therapeutic Goods Administration (TGA) issued advice that certain heater cooler machines had been linked to infections from the rare Mycobacterium chimaera,” Associate Professor Bennetts said.

“Further TGA alerts in May and October 2016 recommended changes to protocols and testing but Cardiac Surgical Units in SA using the at risk devices had implemented changes prior to the updates, including testing all heater cooler devices and manufacturer disinfection of the Sorin 3T (now LivaNova) machines.

“Although the risk of infection is extremely low only affecting an estimated one in 10,000 cardiac surgery patients, following the latest advice from the TGA and the Australian Commission on Safety and Quality in Health Care the at risk devices are being decommissioned and replacement units will be delivered in the coming weeks.

“Last week, all states and territories met to discuss this issue and all recommended patient notification and therefore we are providing information about the symptoms, the infection and other FAQs to potentially exposed patients this week.”

Two units were located at Flinders Medical Centre, with additional affected Sorin 3T units at Flinders Private and Ashford Hospital. The Adelaide Community Healthcare Alliance Incorporated (ACHA) is also writing to patients.

Symptoms of Mycobacterium chimaera infection can include fever, weight loss, shortness of breath, night sweats, joint or muscle pains, nausea, vomiting or abdominal pain, and pain, redness, heat or pus around the surgical site, but these can come on long after surgery, hence we are providing this information to patients and GPs.

Anyone who had open heart surgery between July 2011 and July 2016 and is showing symptoms should contact their Cardiac Surgeon or their GP.

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