US FDA Issues warnings on device fragments
This article was originally published in Clinica
Executive Summary
The US FDA has issued a warning about the dangers of fragments of medical devices that can become unintentionally separated and remain in a patient after a surgical procedure. In a public heath notification, the agency says that these fragments, referred to as unretrieved device fragments (UDFs), can cause local tissue reaction, infection, perforation and obstruction of blood vessels, and death. During MRI procedures, magnetic fields can cause metallic fragments to migrate and radiofrequency fields can cause the fragments to heat, causing internal tissue damage or burns.