Abstract
In recent years, medical device regulatory bodies have recognised software-as-a-medical-device (SaMD) as a distinct subgroup of devices. The field of SaMD has been rapidly evolving and encompasses a range of different digital solutions. Many organisations have now started to look into digital healthcare, as a way to solve key global challenges. However, there remains uncertainty regarding how many of these SaMD products are entering the market and to what extent these systems achieve a desired level of general safety once they are in the market. In this study, we utilise data collected from publicly available databases. The data are evaluated for trends and a descriptive analysis is performed of the recall and adverse events associated specifically with SaMD. We find that there is a significant positive trend (p < 0.05) of SaMD registrations, although the number of SaMD registrations remains relative low compared to non-SaMD. This rise in SaMD registrations coincides with increasing levels of recalls and adverse events. More importantly, it becomes apparent that adverse events notification is not yet fit for purpose with regards to SaMD.
Highlights
The inclusion of software into medical devices is a long established practice, stand alone software offerings that provide diagnostic and therapeutic functions is relative new
In 2020, the Therapeutic Goods Authority (TGA) released a study on the harms caused by software [2], outlining recalls and adverse events related to software through a literature review
We focus on the following three research questions; (1) Has SaMD registrations been growing in Australia and what is the origin? (2) What types of recall events are associated with SaMD? (3) What are the types of adverse events associated with SaMD? We conclude with a discussion on results and the nature of regulatory actions for SaMD
Summary
The inclusion of software into medical devices is a long established practice, stand alone software offerings that provide diagnostic and therapeutic functions is relative new. Software applications are an increasingly fundamental feature of clinical practice and regulators around the world have responded to recognise this rise in interest within this area. Certain regulators, such as the one in Australia, have even made data available that can be used for further analysis. Consideration of software in medical devices has long been a concern for the TGA, which had evaluated means by which to address software through its essential principles as early as 2001 [1]. The TGA report did not distinguish in its analysis between medical devices that have software and software as a stand alone medical device
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