Call for implant tracking system

The Therapeutic Goods Administration has heard renewed calls for a national system for tracking the safety of critical implants and devices.

ABC Radio's Health Report today highlighted problems with regulating and monitoring critical implants such as heart valves, pacemakers and other devices which, if they fail, will result in serious injury or death to the patient. Other implanted devices such as artificial joints were not exempt -- major surgery is often required to replace faulty devices.

The TGA has systems in place for reporting of adverse events, but there is no national systems for post-market surveillance of devices, and no easy way to track devices implanted in patients.

Consultant Arthur Brandwood, who spent five years working for the TGA in the medical devices division, said the issue was complicated. The TGA's responsibilities are to regulate the industry, not the medical system, he said, and most implanted devices in Australia come from overseas, adding to the logistical complications.

"To make device tracking work, you need to track through the entire supply chain, from the supplier and distributor to the hospital and the patient," Brandwood said.

While attempts have been made to set up various device tracking systems, they haven't been entirely successful, he said. But improved hospital quality systems have improved things. A National Joint Replacement Registry was established recently to track hip and other joint replacements, and a heart valve registry is also in place.

The Australian Council of Safety and Quality in Healthcare, a national body that reports to the Federal, State and Territory Health Ministers on issues of healthcare safety and quality, said it was aware of the issue. "It's been slated as a possible action area but it's still in the embryonic stages," a spokesperson said.