In the past 30 years, enormous advances in interventional medical devices have affected health care, just as pharmacological innovation did the generation before. Gastric bands, coronary stents, intrauterine devices, and prosthetic joint replacements have greatly improved quality of life for millions. But nothing comes without a cost. Cunlin Wang and colleagues1 noted some of the risks in a study of the paediatric section of the US National Electronic Injury Surveillance System All Injury Program database. More than 144000 adverse events were recorded over 2 years, and during this time nearly 1% of all unintentional injuries to children were caused by implantable or interventional medical devices. These unwanted effects were often unforeseen, bringing into question the processes that develop, evaluate, and regulate such devices.
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