Some specialized surgical tools used to diagnose and treat various medical conditions can sicken and even worsen the odds of survival in some patients, according to Food and Drug Administration (FDA) Safety Alerts issued in recent months. Patients undergoing procedures with these surgical tools are advised to discuss with their doctors the risks and benefits of using these devices, and whether proper measures are being taken to ensure their safety.
Duodenoscopes – These specialized endoscopes have flexible parts that are fed down a patient’s throat to treat gallstones, cancers and other digestive system problems. More than 500,000 duodenoscope procedures are performed each year. Researchers have found the tools contain “microscopic crevices” which can harbor deadly drug-resistant bacteria even when manufacturer-provided cleaning and sterilizing procedures are followed. The tools are being blamed for hundreds of “superbug” bacterial infections and are considered a contributing factor in at least a dozen deaths in patients who have undergone duodenoscope procedures.
Brain surgery equipment – At least 33 people in four states were exposed to a deadly Mad Cow-type disease known as Creutzfildt-Jakob Disease, or CJD, after undergoing brain surgery using a guided imaging navigational system made by Medtronic. Much like the issue with the duodenoscopes, the sterilization process used to clean the navigational system was not efficient enough to remove CJD-infected tissue, exposing patients to the deadly disease. CJD is a rapidly degenerative and incurable neurological disorder that causes dementia, blindness, involuntary movements and coma. The disease kills 90 percent of infected patients within a year after symptoms begin. However, it can take years and even decades for the first symptoms to surface. There are no treatments for the disease.
Power Morcellators – Late last year, the FDA issued a Safety Communication strongly discouraging the use of laparoscopic power morcellators for the removal of uterine fibroids or entire uteruses in the majority of women because the tools could spread undetected uterine cancer, known as uterine sarcoma, and worsen the odds of survival. Power morcellators have a blade attachment that minces fibroids or uteruses inside the body and removes the tissue through a small incision. Procedures using these devices had been favored over open hysterectomies or myomectomies because they are less invasive, leave less scarring, and offer shorter recovery. More than 50,000 were performed each year, but that number is expected to drop dramatically following the FDA’s warning.