AUSTRALIA'S medical device regulator will announce sweeping reforms to improve public safety, including device cybersecurity risks, in the wake of a series of scandals and a damning Department of Health review of its device failure monitoring system.
The Therapeutic Goods Administration will release an Action Plan for Medical Devices today that includes toughening device assessments before approval and strengthening monitoring, after health consumer groups that will meet in Melbourne on Friday announced a campaign to make device regulatory failure a federal election issue.
The TGA will examine ways to better monitor device cybersecurity risks and provide "clearer guidance to industry on cybersecurity requirements for medical devices and the IT systems they connect with".
"With the fast-paced increase in the numbers of medical devices with software or digital components, the coverage of regulation in Australia will be broadened to ensure new and emerging technology such as 3D printed devices and software apps are safe and provide reliable information to consumers," the plan said.
The TGA will establish a specialist unit to evaluate emerging technology such as 3D printed devices and software apps because "poorly performing apps may pose a significant consumer risk".
The TGA announcement follows confirmation it has only initiated four device criminal prosecutions in the past decade, and no pelvic mesh device prosecutions, despite nearly 2000 women pursuing class actions against two multinational mesh manufacturers and a Senate inquiry hearing up to 15,000 women could have mesh injuries, some "catastrophic".
The action plan also follows publication of a federal Department of Health report in the European Medical Journal in January estimating only 0.5 per cent of medical device adverse events, including life-saving devices, are captured by the TGA's device monitoring scheme.
This is despite device manufacturers being the only mandatory reporters under the scheme, subject to prosecution for failing to report adverse events relating to their products.
The Action Plan for Medical Devices: The Safety of Australian Patients Comes First report acknowledges transparency about medical devices released onto the Australian market can be "significantly improved" and more information about individual devices is required so that patients can make informed decisions about their use.
The plan anticipates possible law changes and closer links with consumer groups after a Senate inquiry into the pelvic mesh scandal heard damning evidence about the TGA's failure to respond to rising concerns about the devices for more than a decade from women patients, some doctors and consumer groups.
"The TGA will ensure that all perspectives, but particularly those of consumers who use medical devices, are taken into account," the action plan said.
The action plan acknowledged the failure of its monitoring system to pick up emerging problems with pelvic mesh devices.
"Recent incidents involving medical devices such as transvaginal mesh (pelvic mesh devices implanted through the vagina) have highlighted the need to access more complete data on adverse events and rapidly share information about emerging safety issues to more promptly address threats to patient safety and to take quicker action," the TGA said in the report.
The TGA acknowledged "many incidents are not currently reported by private or public hospitals or by individual healthcare professionals".
The regulator will review the system that allows manufacturers to self-certify devices they deem low risk and whether more devices deemed medium risk should be subject to TGA audits before they are registered for use in Australia.
Under the current system many pelvic mesh devices were cleared for use in Australia as medium risk devices not subject to audits, and based on overseas assessments not subject to independent scrutiny in Australia.
"For higher risk devices the TGA will consult on whether the government should require greater levels and scrutiny of clinical evidence for certain groups of devices," the action plan said.
"These devices include spinal implants, devices that make diagnoses, diabetes management devices, medical devices used for IVF, and companion diagnostics (tests used to guide the choice of medicines for particular cancers or rare diseases)."
The TGA will introduce systems to "improve its ability to identify problem medical devices earlier and to take action quicker", allowing it to "confirm with other international regulators whether they have also had significant reports of adverse events with particular products".
"The TGA's IT systems and analysis capability for adverse events will be enhanced to improve our assessment and investigation processes.
"Together with health consumer organisations, we will also develop simpler ways for consumers to report adverse events (including using smartphone apps) and publicise how reporting of adverse events can improve the safety of products."
The action plan is being released as women left with permanent and serious pelvic mesh complications meet in Melbourne on Thursday for a screening of the film, The Bleeding Edge, about American regulatory failures that contributed to the mesh scandal, and a conference in Melbourne on Friday organised by consumer health groups from across Australia.