NCPA - National Center for Policy Analysis


June 19, 2008

Hundreds of patients have learned the hard way about a growing but under-recognized problem: medical devices that break or malfunction, leaving behind potentially deadly debris, says JoNel Aleccia of MSNBC.

Earlier this year, federal Food and Drug Administration (FDA) officials warned clinicians about the danger of devices that litter patients' bodies with broken stents, torn balloons, fractured wires and stray parts ranging from catheter tips to drill bits.

These devices can lead to complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction and death, according to a cautionary article by the Journal of the American Medical Association.


  • Since 2003, reports of 72 deaths and 4,675 injuries associated with "unretrieved device fragments," or UDFs, have been logged in the FDA database that tracks adverse events.
  • Sponges and other instruments inadvertently left behind after surgery occur in perhaps 1 of every 1,000 to 1,500 abdominal operations, according to a 2003 estimate.

Doctors usually know that a UDF is there, but they don't tell the patients about the broken devices, make no attempt to retrieve the devices, or are unsuccessful when they try, says Aleccia.  Some doctors may not want to worry their patients unnecessarily, while others may fear legal consequences.  Devices can break for a variety of reasons ranging from significant manufacturing defects to gross operator error, according to a review of FDA reports of adverse events.

Tackling the issue of UDFs will require recognizing broken devices and fragments as problems as serious as any of the adverse events now used as measures for patient safety and performance, says Aleccia.

Source: JoNel Aleccia, "Medical Litter: Device Debris Poses Serious Risk," MSNBC Interactive, June 16, 2008

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