Mandatory Reporting of Medical Device Adverse Events

The Therapeutic Goods Administration (TGA) has called for comment on whether healthcare facilities should report adverse events caused by medical devices.

In its submission to the TGA, Painaustralia firmly supported mandatory reporting for medical related adverse events by healthcare facilities to ensure optimum patient safety.

Medical devices play a critical role in the diagnosis, prevention, monitoring, treatment, alleviation of disease or injury, investigation, replacement and modification of the anatomy or physiological process. Many people with chronic pain benefit from the use of medical devices for a range of chronic and debilitating conditions both pain and non-pain related.

However, they need to be regulated and any adverse events, including near misses must be reported. Millions of people worldwide have suffered injury and even death because of a poorly regulated and conflicted industry in areas such as breast implants, heart valves and surgical vaginal mesh which has had a devastating impact on thousands of Australians.

More effective communication with consumers about the types of devices being considered by health professionals and timely follow up when failures occur is also a critical component of a well-functioning regulatory system.

Improving these areas will ensure consumers can have confidence in the regulatory system to protect their safety and make more informed choices around their treatments and subsequent outcomes.

We will keep you informed of the outcomes of the TGA’s consultation.