It’s incorrect to say the regulatory environment in Australia has not changed. In 2014 an extensive review of Medicines and Medical Devices Regulation was undertaken by a panel of three eminent experts that included Emeritus Professor Lloyd Sansom AO.
That Panel made 58 recommendations, with the Government supporting 56 of them. Since then a series of legislative reforms has been put in place to regulate medical devices.
The TGA is regarded as one of the most thorough of any agency around the world and has undertaken extensive reforms of medical devices. Its rigorous premarket requirements for medical devices are aligned to international best practice.
ABC has now carried several biased and misleading articles questioning the value of the medical technology industry to the Australian healthcare system.
Global advances in medical technology over the past 20 years have resulted in a 56% reduction in hospital stays, 25% decline in disability rates, 16% decline in annual mortality and increased life expectancy of approximately 3.2 years.
The story failed to recognise doctors and other healthcare professionals are the primary users of medical technology and the industry provides physicians the tools they need to improve patient care. To ensure better outcomes for patients, surgeons need training and familiarity with medical devices.
The rapid innovation which is the hallmark of the medical technology industry – and which serves to benefit patients – would not be possible without the close collaboration between physicians and companies.
Indeed, some of the most significant medical technology breakthroughs in the last 50 years have originated with physicians who saw an unmet patient need or way to improve an existing procedure and brought their idea to a manufacturer to refine and produce for a wide patient audience.
Unlike pharmaceuticals, medical devices are implanted by surgeons and need to last for years, the more familiar a doctor is with a device, the better the outcome for the patient. That’s why medical technology companies provide extensive education and training (or retraining) of surgeons.
It’s also why technicians often support surgeons in the procession of instruments used ensuring they are all in place, and with their order of use. Technicians are highly trained specialists with intimate knowledge of the medical device being implanted and the tools used during that surgery.
PulseLine will continue to take a close look at the reporting of other media outlets and will call out errors, misrepresentation and bias.