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TGA is lax on device safety

Date

Richard McGee

Despite a range of government reports urging improved transparency, Australia's medical device regulator, the Therapeutic Goods Administration, still fails to help doctors and patients make informed decisions about the safety of medical devices.

As highlighted by the recent recalls of metal-on-metal hip replacements and PIP breast implants, medical devices have the potential to do much harm. These recalls have helped to focus attention on two important and frequently neglected issues. The first, how medical devices reach the market. The second, what happens once medical devices are on the market.

To understand how devices are regulated in Australia, we first need to look overseas. Most healthcare workers and the general public may be surprised to know that medical devices are subject to far less scrutiny than prescription drugs before being approved. Prescription drugs must be tested for safety and efficacy in several stages from small pilot studies to large-scale multicentre randomised trials, while medical devices are often approved without any clinical trial data.

In the US, many devices are approved because of their similarity to devices already available on the market. This leads to a ''daisy chain'' effect where one device is approved based on a previous older device and so on, despite the fact that new devices may pose substantially greater risks to patients.

In Britain and the rest of Europe, devices are approved in the same way as toys and household appliances, that is, using the Conformité Européenne (CE) mark, which is supposed to show that a device is safe and fit for its purpose. In reality, the bodies assessing devices and awarding CE marks are wholly funded by the device industry. Recent research and subsequent media investigations have raised questions about how impartial this process can be. Once a medical device is on the market in the US and Europe, safety is often only assessed through an ad hoc system of reporting.

So what about Australia? Worryingly, once a European CE mark is obtained, the device manufacturer can apply for their device to be placed on the Australian register of therapeutic goods for use in Australia without further restrictions.

Similar to both the US and Europe, once a device is on the market, safety in the most part is only assessed through an ad hoc system of reporting adverse events. Since 2009, a series of government reports have sought to improve TGA processes and in response the TGA released a blueprint for the future in December 2011.

This prompted a research investigation, which I led, to find out whether any recent changes have improved what doctors and patients could learn about medical device safety. The results showed that there have been nearly 300 unexplained deaths and 2500 unexplained serious injuries due to medical devices since 2000, but this may be underestimated because there were large gaps in the data available. In addition, the number of device failures appears to be increasing while device recalls and alerts remain static. The TGA website, the source of this data, is difficult to use, sometimes inconsistent and mostly uninforming. This lack of transparency risks jeopardising public confidence in our regulatory system.

What needs to change? First, the registration process needs reform so that a list of devices used in Australia becomes available and any safety or effectiveness data is simply accessed. Second, the TGA needs to improve the transparency of its activities in response to device problems such that doctors and patients can track TGA decisions. Third, there needs to be a culture change among patients and doctors who use devices, so that potential device problems are reported as a matter of routine rather the current ad hoc system.

It is clear the potential for large-scale health gains, and unintended harms through device failure, are substantial. At a time when the device industry has seen large-scale device failures, it is troubling that our national regulator still lacks transparency. While reforms have been proposed, they may not yet go far enough. It is a matter of great public interest that the TGA rise to this challenge.

Dr Richard McGee is a final year PhD candidate at the Sydney School of Public Health, University of Sydney.

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