Medical devices: FDA ends secret reporting system that hid failuresBMJ 2019; 365 doi: https://doi.org/10.1136/bmj.l2097 (Published 08 May 2019) Cite this as: BMJ 2019;365:l2097
- Owen Dyer
The US Food and Drug Administration has announced that it will end the “alternative summary reporting” programme that has allowed millions of injuries caused by medical devices to escape public notice over the past two decades.
Much of the information that has been concealed from public view by the programme will be published within weeks, the agency said.
The programme itself went largely unnoticed for years, until it was unearthed by a Kaiser Health News investigation that reported its findings in March.1 This took “months of questions to the FDA,” Kaiser reported, before the FDA confirmed the existence of reporting exemption programmes and the thousands of incidents listed on secret databases, which in some cases were not shared with FDA expert advisory panels that review devices’ safety.