Concerns over a rare infection have prompted NSW health authorities to replace cardiac surgery equipment at four Sydney hospitals as a precaution, and advise recent open heart surgery patients to consult their doctors.
An Australian patient has potentially contracted Mycobacterium chimaera (M. chimaera) from a piece of contaminated surgical equipment during open heart surgery, the Therapeutics Goods Administration advised.
The same equipment – surgical heater-cooler units – have been removed from Prince of Wales and St George hospitals, as well as the Sydney Children's Hospital at Randwick and the Children's Hospital at Westmead as a precaution. There have been no reported patient infections to date in NSW, NSW Health said.
NSW Health advised patients to see their doctors if they had undergone open heart surgery at the hospitals in the last five years.
The department also recommended doctors consider whether their open heart surgery patients may have contracted the infection.
M. chimaera infections in cardiac surgery patients overseas have been linked to the heater-cooler units made by medical equipment manufacturer Sorin. It is thought that the units were contaminated during their manufacture.
The contaminated units, which control the temperature of the blood during the procedure, transmit the infection to the formerly sterile surgical area and the heart's new implanted valve and graft.
The first identified case of the infection linked to the units was in Switzerland in 2012.
Internationally, 56 patients have been identified as having the infection after undergoing the procedure where the contaminated equipment was used, the US Food and Drug Administration reported in 2015.
The infections were identified between three months and five years after surgery.
Several independent studies reported open heart surgery patients had developed postoperative prosthetic-valve endocarditis caused by the mycobacteria.
Symptoms of the infection could include fever lasting more than a week, pain, redness, heat, pus around a surgical incision, night sweats, joint and muscle pain, loss of energy and failure to gain weight, or failure to grow in children.
NSW Health assured the public that M. chimaera infections were rare and risk to patients was very low and there was no ongoing risk in NSW public hospitals.
Infectious disease specialist at the NSW Clinical Excellence Commission, Dr Kate Clezy said the contamination risk was only associated with the one brand of heater-cooler units.
"We've contacted all facilities using this device to ensure they were being rigorously cleaned or replaced," Dr Clezy said.
"The risk of infections to an individual patient is very small, but it's important that we've alerted clinicians to the risk and put systems in place to reduce the risk further."
NSW Health formed an expert panel of clinicians and representatives from the Clinical Excellence Commission, chief executives of Local Health Districts and Health Protection NSW once it was alerted to the potential infection risk.
The contaminated units were either cleaned and verified as clear of contamination or have been replaced with new units, NSW Health said.
A safety notice was issued to public and private health facilities on July 8, and updated on August 4, to notify clinicians of the very low risk of infection, the department said.
More detailed information was provided to cardiologists, cardio-thoracic surgeons, clinical microbiologists and laboratories, and a fact sheet for open-heart surgery patients was prepared.
NSW Health and other jurisdictions are working with the Australian Commission for Safety and Quality in Health Care to develop a national infection control guideline on minimising the risk of infection relating to the use of heater-cooler units.
