Clinicians should take special precautions to prevent fragments of medical devices from breaking during procedures and being left in patients, potentially causing serious adverse events, the Food and Drug Administration (FDA) warned in an advisory aimed at reducing such complications (http://www.fda.gov/cdrh/safety/011508-udf.html).
When a medical device breaks during a procedure, fragments may be left in the patient either because the physician is unaware of the break or because attempts to retrieve the fragments have failed. Patients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction, and death.
The agency's Center for Devices and Radiological Health receives about 1000 adverse event reports related to unretrieved device fragments each year. The reported events have involved more than 200 medical devices used by clinicians in various specialties.
Patients and their treating clinicians are often unaware of the presence of unretrieved . . . [Full Text of this Article]
