The recent recalls of metal-on-metal hip replacements and PIP breast implants highlight the potential for widely used medical implants and devices to cause serious harm, despite having passed all the required checks and balances.
This failure prompted my colleagues and I to investigate the safety of medical devices – which includes a range of items such as bandages and thermometers, to breast implants and prostheses – using data provided by Australia’s medical regulator, the Therapeutic Goods Administration (TGA).
We wanted to know: how frequently consumers, health professionals and manufacturers reported concerns about the safety of devices; how the TGA investigated these complaints and; how effectively the TGA communicated this information to those who could potentially be at risk from the faulty devices.
Our findings are published in the current edition of the Medical Journal of Australia – and they’re not pretty. Perhaps most alarming is the TGA’s failure to investigate almost half (47.5%) of the safety complaints it received after initial enquiries. Another 25% of complaints resulted in no further action being taken.
Based on data from the TGA website, there have been nearly 300 deaths and 2,500 serious injuries related to medical devices since 2000. Unfortunately the TGA doesn’t provide any further data about how these deaths or injuries occurred. It’s also important to note that these figures may be an underestimate because almost half the data was missing from this period (between 2000 to 2011).
Despite the increasing number of device complaints and the large number of deaths and injuries, the amount of recalls and alerts issued by the TGA has remained static. Out of a total of 35 device recalls during this period, only 12 device recalls were considered to be life-threatening or pose a serious health risk.
Comparing the number of complaints to recalls, there were 585 reports of device failures in 2001, which resulted in one recall. By 2009 there were 926 reports of device failures and again, there was only one recall. The TGA hasn’t provided any more data on rates of device failures since mid-2009.
Not all device recalls are initiated by the TGA. The metal-on-metal hip replacements, for example, were recalled by the manufacturer before a recall was issued by the TGA. In these situations (known as company-initiated device recalls), the TGA doesn’t routinely list the recall on its website. This creates all sorts of problems with transparency because the public isn’t readily informed about the latest developments in device safety.
The TGA website should act as a central repository for safety information about medical devices. But, in its current state, it’s impossible for patients or doctors to assess the safety or effectiveness of any given device. And it’s not clear where patients or doctors can turn to for better advice.
Despite these criticisms, some positive changes are occurring within the TGA. After a series of government reports urged the agency to improve its transparency and communication with consumers, the TGA has planned to include more information on some of its websites. The question is whether this will go far enough.
So where to from here?
Firstly, we need to promote cultural change within the medical community so that potential problems with devices are reported consistently and rapidly.
Doctors, nurses and allied health professionals are well aware of the processes for reporting problems with medications. But device reporting is much more fragmented. Complaints about potentially faulty devices are sometimes reported to the device manufacturer, sometimes to the TGA and, in some cases, not at all.
Secondly, medical devices must go through more rigorous testing before they hit the market. Once they are available to consumers, their effectiveness should be tracked with robust surveillance systems, so potential faults can be quickly detected.
Thirdly, the TGA needs to improve its transparency and communication so doctors and patients can track TGA decisions.
With Australia’s ageing population and a growing reliance on hip-replacements and other medical devices, it’s increasingly important that the TGA helps patients and clinicians make informed decisions about the safety and effectiveness of medical devices. I hope the TGA will rise to the challenge.