Sustainability through Repair: Empowering Biomedical Engineers to Keep Medical Devices Running
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As medical devices in our healthcare system are becoming more and more sophisticated with embedded software, robotics, and AI technologies, it is becoming more and more challenging to keep these devices operational when problems arise. Often, the biomedical engineers who are tasked with maintaining and servicing these devices face legal and practical barriers to the repair of medical devices, despite their high level of qualification and skills. Intellectual property protections asserted by the manufacturers often mean that manuals, schematics and diagnostic software are not available. Training and certification for these devices can be prohibitively expensive. The Australian Productivity Commission has found that medical device manufacturers routinely restrict access to repair information and spare parts, leading to detrimental impacts for patients as well as increased costs, shorter device lifespans.
To move to a sustainable health care system, we need to keep our devices in operation for longer. This paper argues whether an Australian ‘right to repair’ law for medical devices could help achieve this. The push for the right to repair across a wide range of industries recognises that legal, regulatory and policy reform is needed to ensure access to repair information and tools. However, the issues are complex, involving intellectual property, competition law and safety regulations. There is little scholarship available in Australia about the experiences of people at the front line, such as biomedical engineers.
Many medical device manufacturers oppose the idea of a medical device right to repair outright, arguing that the potential risk of patient harm is too high. However, official reports have found that these concerns are likely overstated: there is still scope to improve access to repair information and tools, thus enabling in-house and independent repa