A computerised solution for medical device tracking: an Australian experience

Many industries, including motor vehicle and aviation, maintain sufficient records and tracking systems to ensure post marketing surveillance is effective. When a part fails these industries are able to contact the appropriate parties and recommend a course of action. In contrast, the medical device industry has lacked the appropriate tracking systems. The Australia and New Zealand Heart Valve Registry was established in 1994 to retrospectively and confidentially identify, locate and track patients implanted specifically with a Bjork-Shiley Convexo/Concave (C/C) heart valve. From 1979 to 1987, 35 surgeons implanted approximately 900 C/C valves, at 11 implanting centres in 5 Australian states. Of the 14 valves reported to have experienced a mechanical failure such as outlet strut fracture or single leg separation, only three patients survived beyond 24 hours of medical intervention. All facets of locating these patients have been difficult. Identifying each patient through their original hospital record was time consuming and complex due to different, multiple or absent manual record systems. It became evident that a computerised database was needed to manage the volume and complexity of interrelated data held by the Registry. To track these valves it was necessary to collect, store and retrieve patient data from three main sources; device identifiers, implantee demographics and current attending physician demographics. An analysis of the few available systems in Australia and overseas highlighted the lack of a suitable product. Working in conjunction with a local software provider, a system was designed to manage Registry data and automate the production of various reports, lists and statistical functions. This paper will describe the difficulties encountered in the manual collection of retrospective data, the development of an electronic solution and the potential use of this system in prospective patient tracking through a centralised Registry.