This week the International Consortium of Investigative Journalists (ICIJ) has launched The Implant Files: a global examination of the medical devices industry and its regulators.
ICIJ journalists and a team of more than 250 reporters and data specialists from 58 news organisations in 36 countries have examined cases from all over the globe, and the campaign builds on reporting that started in the Netherlands.
The ICIJ has built a global resource for recalls and safety notices; the International Medical Devices Database (IMDD) gathers recalls, safety alerts and field safety notices to create a searchable portal that anyone can access. This has been built using the data they have extrapolated during their investigations.
It is expected that the stories released this week will form part of a sustained campaign.
AusBiotech CEO Lorraine Chiroiu said: Medical devices are invented and used with the purpose of increasing and improving patients’ health and their quality of life. Risk is a part of all medical procedures, and it is the management of this risk that is key to patient safety and, therefore, our regulations.”
AusBiotech continues its support of Australian regulations that are commensurate to the level of risk,” she said.
“Australia’s TGA is a world-class regulator and - like industry - take their role in adverse event reporting very seriously. Industry is cognisant of its responsibilities and reporting risks associated with medical device products.”
While the reported stories lightly acknowledge the positive role medical devices play in quality of life improvement, they suggest that our Australian regulations are based on “lenient” European and American approvals – and omit any mention of where medical devices are saving lives.
Regulation of medical devices is dependent on global collaboration, and as such, it is imperative that Australian regulations remain closely aligned with the EU regulations and international best practice that enables the world-wide exchange of medical device data.