Since 2003, the US Food and Drug Administration (FDA) received reports of 72 deaths and 4,675 injuries linked to â€œunretrieved device fragments,â€ or UDFs.Â <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">Medical devices that break or malfunction is a growing and under-recognized phenomenon and earlier this year, the Federal Food and Drug Administration officials warned clinicians about the danger of such devices left in patientsâ€™ bodies such as broken stents, torn balloons, fractured wires, and stray parts ranging from catheter tips to drill bits.
â€œPatients who harbor such material may subsequently experience complications such as local tissue rejection, inflammation, perforation, blood vessel obstruction, and death,â€ according to a Journal of the American Medical Association summary.Â Exacerbating the issue, some health workers never advise patients about the broken devices, leaving them with pieces that can either move through the body or dangerously interact with future procedures such as magnetic resonance imaging (MRI) where metal can overheat and scorch patients from within.Â Robert A. Fischer, an FDA nurse consultant who reviews adverse events, said he issued the public health notification after two years of â€œinformal reportsâ€ indicating similar problems involving over 200 medical devices.Â â€œWe decided that the best way to approach this was to say: â€˜This is a problem and be careful,â€™â€ Fischer said.
The biggest problem is not just that devices break or doctors opt to leave them in the patient, but that doctors often don’t tell their patients over concerns about worrying their patients or fear of legal consequences.Â The FDA reports likely underestimate the magnitude of the problem, said Dr. Mark Estes, president of the Heart Rhythm Society, a research and advocacy agency that has pushed for better enforcement of cardiac device standards.Â â€œThe monitoring system is a passive system,â€ Estes said. â€œThe FDA accepts what comes in from doctors and manufacturers. There is tremendous under-reporting of devices.â€
The problems often stem from catheter wire guides breaking or fracturing or orthopedic bone screws.Â According to Dr. John R. Clarke, medical director of the ECRI Institute, a patient safety and research agency in Pennsylvania, UDF incidents are probably occurring with the same frequency as medical mistakes such as when sponges and instruments are left behind in surgery.Â In these cases, objects are inadvertently left behind in about 1 in every 1,000-1,500 abdominal operations, according to 2003 estimates.Â The issue with UDFs differs because doctors usually know the UDF is in the patientâ€™s body but either does not, or is unable to, retrieve the UDF.Â â€œIn some cases, finding a 10/0 [gauge] needle would be like looking for a contact lens in a shag rug carpet,â€ Clarke said.Â â€œOr, you know exactly where it is, but medically retrieving it would not be worth the risk.Â Youâ€™re not going to dig apart the femur to get a quarter-inch screw.â€
Devices can break for a many reasons such as manufacturing defects; operator error; improperly stored catheters that have been exposed to light and have become brittle and fracture; or doctors having to use unfamiliar devices or tools when vendors switch styles without notice.