{mosimage}Unretrieved device fragments (UDFs) can cause serious injury, the US Food and Drug Administration (FDA) warned healthcare professionals yesterday. According to a public health advisory, a UDF is a medical device fragment that has separated unintentionally and remains in the patient after a procedure.
More than 1000 adverse events each year are reported in association with more than 200 different devices and numerous medical specialties, the FDA said.
Patients are often unaware that a UDF may be the cause of their difficulty. Fragments have caused local tissue reaction, infection, perforation and obstruction of blood vessels, and even death.
Contributing factors may include biocompatibility of the device materials, location and potential migration of the fragment, and individual patient anatomy, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program. Also, magnetic fields present during magnetic resonance imaging (MRI) may cause metallic fragments to migrate, and radiofrequency fields can cause them to heat, leading to internal tissue damage and/or burns.
The FDA advises healthcare professionals to use medical devices only for labeled indications and according to manufacturer instructions, particularly during insertion and removal. Devices should be inspected for damage and defects before use and for breakage/fragmentation immediately on removal from the patient. Damaged devices should be kept for future study.
Patients should be advised of the potential risks and benefits associated with fragment retrieval and also the nature/safety of unretrieved fragments, including material composition, size, location, potential mechanisms for injury, and procedures that should be avoided (eg, MRI) to reduce the risk for serious injury.
Additional information regarding UDFs may be obtained by contacting the FDA's Office of Surveillance and Biometrics (HFZ-510) at 1350 Piccard Drive, Rockville, MD 20850. The agency may also be reached by fax at 240-276-3356, by email at [email protected], or by leaving a voicemail message at 240-276-3357.
