Confusion and concern have gripped New South Wales after the Therapeutic Goods Administration (TGA) suspended the sale of two defibrillators used in the state's ambulance fleet. The models, Corpuls 3 and Corpuls 3T, are central to emergency care in NSW, with the state holding a multiyear, multimillion-dollar contract for their use. Despite the suspension, the devices remain in active use, raising urgent questions about patient safety and regulatory transparency. The TGA announced the suspension late last month, citing potential safety, quality, or performance issues that needed addressing during the suspension period. However, the agency declined to specify the exact reasons behind the decision, leaving both paramedics and officials in the dark. This lack of clarity has fueled frustration among healthcare professionals, particularly those who have long reported malfunctioning devices in the field. Paramedics in NSW have described numerous incidents involving the Corpuls 3T defibrillators. According to Brett Simpson, president of the Australian Paramedics Association, members have encountered situations where the device unexpectedly shut down during critical resuscitations. Other reports include instances where the device failed to deliver shocks despite being charged, or discharged shocks without delivering them to the patient. These failures have led to concerns that life-saving interventions may be compromised. Data compiled by an investigative report, supported by artificial intelligence, reveals that since 2022, 117 adverse events related to the Corpuls 3 and 3T models have been reported to the TGA. Among these, 31 injuries, five deaths, and over 20 cases of the devices refusing to shock patients were documented. Such figures underscore the severity of the issue and highlight the urgency for a resolution. Despite the TGA's suspension, NSW Ambulance maintains that there is currently no impact on operations or patient care. A spokesperson stated that the organization will continue to monitor the situation and assess further developments. However, this stance has drawn criticism from medical experts and advocacy groups. Associate Professor Elizabeth Paratz, a cardiologist at St Vincent’s Hospital, emphasized the importance of using devices that have not been suspended by the TGA, underscoring the risks associated with continued reliance on potentially faulty equipment. The NSW government, represented by Health Minister Ryan Park, has expressed confidence in the ongoing safety of the devices, despite the high volume of reported failures. Park noted that not all reported failures constitute serious issues, such as a lead not functioning properly. He also mentioned that the TGA had not mandated the removal of the devices from circulation, though an incident management team has been formed to address concerns. Marty Nichols, associate director of clinical practice at NSW Ambulance, acknowledged the frustrations of paramedics but argued that the frequency of reported issues must be balanced against the scale of emergency calls, over 1.5 million annually. Similarly, Alan Morrison, executive director of clinical capability at NSW Ambulance, characterized the complaints as technical issues rather than outright failures, emphasizing the need for continued monitoring and improvement. Meanwhile, the South Australian ambulance union has also raised concerns about the performance of the Corpuls devices, indicating that the issue extends beyond NSW. Dr. Amanda Cohn, a Greens health spokesperson, warned that defibrillators are the most time-sensitive equipment in an ambulance, and any failure could result in preventable deaths. She urged the state to expedite the procurement of alternative devices rather than waiting until the current contract expires in six years. As the situation unfolds, the TGA has yet to provide detailed explanations for its decision, leaving stakeholders in limbo. With the suspension affecting the sale of the devices but not their usage, the debate continues over whether the current approach adequately safeguards public health. The coming months will likely determine whether the state can secure safer alternatives before the existing contract ends.
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