Medical Device Debris Left In Patients Poses Serious Risk
June 16th, 2008 amy
In case being implanted with recalled defective medical devices isn’t risk enough to take, patients having surgery also take the risk of catheters, scalpels, screws and more being left behind in their bodies after the operation.
Earlier this year, federal Food and Drug Administration 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.
“Patients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction and death,” is how the Journal of the American Medical Association recently summarized the problem in a cautionary article.
Even worse, some health workers don’t tell their patients about the broken devices, sending them home with pieces that have the potential to migrate throughout the body, or to interact with future procedures such as magnetic resonance imaging. One worry is that metal objects can overheat during MRIs, scorching patients from the inside.
Robert A. Fischer, an FDA nurse consultant who reviews adverse events, said he issued the public health notification after two years of informal reports showed problems involving more than 200 medical devices, MSNBC reports in a recent article. 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.
