US Congress considers new tracking system for medical devices after excessive recalls

BMJ 2012; 344 doi: (Published 23 April 2012) Cite this as: BMJ 2012;344:e2915
  1. Keith Epstein
  1. 1Washington, DC

The recall of thousands of medical devices in the United States, some of which pose grave threats to patients’ health, has prompted Congress and the Food and Drug Administration to call for improved surveillance of all devices and stronger international safety standards.

Congressional committees plan to consider a measure on 25 and 26 April that would require a regulation “as soon as practical” to track devices through a unique device identifier (UDI) system by the end of 2012. Each medical device would be linked by lot or serial number to medical records, enabling the FDA to find faulty devices and notify patients and hospitals about safety problems or recalls.

More than three quarters of all high risk medical devices are now given a “fast track” review by the FDA. Of the devices that are approved, more than 90% pass without requiring any clinical testing and can be approved even if they are “substantially equivalent” to a similar device that has been recalled.

The agency, often regarded as the “gold standard” for regulation worldwide, lacks authority to …

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