Medical devices often enter clinical practice on the basis of premarket studies that are smaller and shorter than those required for medicines, while device performance may depend on operator experience and real world use. Postmarketing surveillance is used to identify emerging hazards and determine whether they represent genuine increases in risk.Individual medical device reports are important in identifying hazards, providing public visibility and alerting regulators, clinicians, and researchers to previously unrecognised problems. Direct reports to the US Food and Drug Administration’s (FDA’s) Medical Device Reporting programme have provided the initial signal for many FDA medical device safety communications.1 However, spontaneous reporting systems are limited by underreporting, incomplete information, uncertain causality, and a lack of reliable information on how many patients received each device.23 These systems can generate hypotheses but cannot reliably estimate incidence or compare device performance.In the linked study (doi: 10.1136/bmj-2026-100812),4 Zhou and colleagues identify important shortcomings in adverse…
