In about half a million procedures annually, surgeons use devices known as duodenoscopes to diagnose and treat blockages of the bile and pancreatic ducts. These scopes have a specialized tip and a flexible tube, and surgeons guide them into the patient’s digestive tract. Physicians use the scope to drain fluids from the body.
The FDA recently acknowledged that not all hospitals have the proper resources, expertise, and staff to correctly sterilize the scopes after use. As a result, the bacteria is not necessarily killed from the previous patient before use on the next patient. This increases the risk of transmitting infection from one patient to the next. In fact, there have been eight reported outbreaks in the last two years of antibiotic-resistant bacteria, known as “superbugs,” linked to the use of the scopes. Though this number may seem low, it is certainly not negligible – these bacterial outbreaks are sometimes deadly.
The FDA still believes the scopes should be available, since they benefit “appropriately selected patients.” While the FDA cannot require manufacturers to change the design of the scopes, the agency is recommending several changes to the scopes’ design. For example, the FDA suggested using disposable parts for the areas of the scope that are difficult to clean. Additionally, hospitals could consider testing the scopes for bacteria after they have been cleaned, or using ethylene oxide gas to kill all the bacteria on the scopes. Hopefully, these changes will reduce the risk of contamination and infection. As of now, most scopes are either manually cleaned by hospital staff or automated machines used to disinfect the devices.
If you think you may have a medical malpractice claim, contact Paul M. da Costa, Esq. at Sarno da Costa D’Aniello Maceri LLC. The attorneys at Sarno da Costa D’Aniello Maceri LLC are experienced in handling all kinds of medical malpractice cases. Call us today at 973-274-5200.
