Regulation to keep pace with medical technology

Latest News

"Global advances in medical technology over the past 20 years have resulted in a 56 per cent reduction in hospital stays, 25 per cent decline in disability rates, 16 per cent decline in annual mortality and increased life expectancy of approximately 3.2 years, according to United States health industry figures," says CEO of the Medical Technology Association of Australia, Ian Burgess.

Mr Burgess has contributed to the Consumers Health Forum publication, Health Voices, which also includes contributions from TGA head Dr John Skerritt and AusBiotech deputy CEO Lorraine Chiroiu.

The latest edition of the publication is focussed on medical devices.

"...we are strengthening the post-market monitoring systems for devices," writes Dr Skerritt.

"New approaches for gathering safety 'signals' for devices are possible through analysis of large sets of de-identified patient data from hospital admissions and discharges, Medical Benefits Schedule item claims, and increasingly, electronic health record data.

"All results from TGA’s laboratory testing of devices are now publicly reported and we have stepped up information-sharing with overseas regulators. For companies and individuals that do not do the right thing, TGA will have stronger compliance and enforcement powers to protect the public, and graduated penalties that allow us to respond appropriately to the full range of non-compliant behaviours."

According to CHF CEO, Leanne Wells, “While the Therapeutic Goods Administration is introducing reforms to strengthen regulatory safeguards, more needs to be done to encourage doctors to report adverse outcomes with medical devices. Medical specialists need to take more responsibility for protecting the interests of their patients.  It is disturbing that there is no mandatory requirement for health professionals to report adverse events with medical devices."

She continues, “Australia’s experience with the pelvic mesh tragedies has been the latest episode to indicate the shortcomings of our regulatory system. Earlier episodes of regulatory deficiencies including with metal-on-metal hip prostheses and breast implants demonstrate the difficulties in keeping track of the safety and quality of biotechnology developments in Australia and overseas."

"Safety and efficacy are the highest priority and the MTAA has been an active participant of TGA consultations over the years," says MTAA's Ian Burgess.

"During the recent Senate inquiry into transvaginal mesh implants we read and heard harrowing stories about how the lives of some women have been negatively impacted. We look forward to the recommendations of the inquiry to identify improvements. Medical device companies have in place robust adverse event reporting systems and comply with the TGA’s mandatory reporting requirements. However, the inquiry heard evidence pointing to potential improvements in the processes and awareness of adverse event-reporting by healthcare professionals and also by patients.

"Most medical devices are incremental improvements of previous versions with an established history of safe and effective use. Also, some adverse events related to implanted devices become evident only after many years of use. The current regulatory system does recognise the data challenges unique to devices and therefore mandates that adverse event data be reported every six months for the first three years following the marketing approval of a device.

"The key challenge is adapting the clinical evidence requirements to take into account the unique circumstance of medical devices whilst recognising the pace of change in healthcare technology.  The advent of 3D printing, combination devices, the internet of medical things, mobile health, Artificial Intelligence, and personalising healthcare through Big Data will fundamentally change healthcare delivery in the future. Concurrently, our regulatory, reimbursement and funding models will need to quickly adapt."