Linked Editorial by Kyushu University Senior Vice President Koji Todaka Published in The BMJ

Professor Koji Todaka, Senior Vice President of Kyushu University and Director of the Center for Clinical and Translational Research (ARO) at Kyushu University Hospital, has published an editorial in The British Medical Journal (The BMJ), one of the world's leading general medical journals.

The U.S. Food and Drug Administration’s (FDA) Manufacturer and User Facility Device Experience (MAUDE) database contains medical device reports (MDRs) of adverse events, product problems, and malfunctions. In an investigation published in The BMJ, Professor Rita F. Redberg and colleagues from the University of California, San Francisco (UCSF), found that the adverse event summary reports in the MAUDE database were frequently incomplete, inaccurate, and delayed. This includes missing malfunction details, undercounting of reported events, and submission delays by manufacturers. The study highlights substantial issues in current summary reporting, revealing limitations in the transparency and timeliness of early signal detection.

Unlike pharmaceutical products, medical devices are frequently cleared or approved and introduced into clinical practice based on smaller-scale and shorter-duration clinical trials. Their real-world performance and safety also depend heavily on the operator's experience and practical handling in routine care. Consequently, a robust postmarket surveillance framework, such as the MAUDE database, are therefore essential for rapidly identifying unexpected device malfunctions and emerging safety signals.

In an invited editorial accompanying the study, Professor Todaka examines the strengths and limitations of spontaneous reporting systems and clinical patient registries within medical device postmarket surveillance. He emphasizes their complementary roles and offers recommendations for future regulatory and systemic enhancements:

• Complementary roles of spontaneous reporting and clinical registries:
  Spontaneous reporting systems, such as the FDA's MAUDE database, excel at early signal detection, capturing previously unknown malfunctions or and potential safety risks quickly in a publicly accessible way. However, because the total number of patients exposed is unknown, calculating precise incident rates and conducting direct quantitative comparisons between devices remains challenging. Conversely, high-quality, large-scale clinical registries, such as those for cardiovascular disease or joint replacement, possess well-defined longitudinal follow-up data, enabling robust quantitative assessments of complication rates and rigorous long-term safety evaluations. 
• Data integration and ensuring transparency:
  Surveillance systems must not depend on a single data source. Instead, healthcare ecosystems should establish surveillance infrastructures that systematically integrate spontaneous reports, clinical registries, and real-world electronic health record (EHR) data. Nonetheless, even as summary reporting and data aggregation advance, public transparency must never be compromised. 
• Enhancing regulation and public trust:
  Professor Todaka welcomes the FDA’s efforts to improve transparency, including the transition toward standardized unique device identifiers (UDI) and public, near-real-time adverse event data disclosures. Transparent public reporting fosters societal trust, while rigorous evidence-based evaluation ensures device safety. Both elements are indispensable to safeguarding patient safety worldwide.

Original research paper:

“Evaluation of the accuracy, completeness, and compliance of current summary reporting of adverse events to the Food and Drug Administration using the manufacturer and user facility device experience (MAUDE) database: cross sectional study” Alyssa Zhou, Madris Kinard, Sarah Tingley, Rita F Redberg, The BMJ　10.1136/bmj-2026-100812
 URL: https://www.bmj.com/content/395/bmj-2026-100812

Editorial by Professor Todaka

“Postmarket surveillance of medical devices: Spontaneous reporting systems and clinical registries serve complementary purposes,” Koji Todaka, 10.1136/bmj-2026-101065
URL: https://www.bmj.com/content/395/bmj-2026-101065

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