Children are not simply miniature adults, a common saying in pediatrics. However, due to the lack of significant financial incentives for companies to create kid-specific treatments, pediatricians frequently have to rely on using adult medications and medical devices off-label for their young patients or provide no treatment at all.

Pediatricians' Dilemma with Off-Label Use

In the past decade, as medical devices powered by artificial intelligence and machine learning have witnessed a rapid growth, Ryan Brewster, a pediatrics resident at Boston Children’s Hospital, expressed concerns that the same pattern of limited pediatric-specific devices would emerge. This situation poses a significant challenge for the well-being of pediatric patients.

Analysis of FDA-Approved AI and ML Devices

In a detailed new analysis of AI and ML-enabled devices authorized by the Food and Drug Administration, Brewster and his colleagues at Boston Children’s and Harvard Medical School made a crucial discovery. After spending half a year delving into FDA documents, they found that only a minority of these devices, specifically 149 out of 876, were clearly labeled for use in kids under 18. Among the pediatric devices, there were notable gaps in the data used to validate the algorithms, raising doubts about their efficacy in younger patients. This lack of proper labeling and data validation highlights the urgent need for more focused research and development in the field of pediatric AI and ML devices.

Implications for Pediatric Care

The implications of this finding are far-reaching. Pediatricians are constantly faced with the dilemma of having to make do with adult medications and devices that may not be suitable for their young patients. The absence of dedicated pediatric-specific AI and ML devices not only limits the treatment options available but also poses risks to the health and well-being of children. It is essential that the medical community and industry work together to address this issue and invest in the development of safe and effective pediatric AI and ML technologies. This will ensure that children receive the best possible care and have access to treatments tailored specifically to their needs.

Call for Action

The situation demands immediate attention and action. There is a clear need for increased research and development efforts to create AI and ML devices that are specifically designed for pediatric use. Companies should be incentivized to invest in this area to meet the growing demand for pediatric-specific treatments. Additionally, regulatory bodies like the FDA need to play a more active role in ensuring that these devices are properly evaluated and labeled for pediatric use. Only through collaborative efforts can we hope to improve the care provided to pediatric patients and address the current shortcomings in the field of pediatric AI and ML.