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The federal government is cracking down on dirty duodenoscopes. In a publicly issued safety notice from the U.S. Food & Drug Administration, or FDA, the federal agency outlines some dangers of these reusable medical devices. Duodenoscopes are incredibly valuable medical devices, used in a common procedure to diagnose and treat potentially life-threatening problems in the […]
The federal government is cracking down on dirty duodenoscopes. In a publicly issued safety notice from the U.S. Food & Drug Administration, or FDA, the federal agency outlines some dangers of these reusable medical devices.
Duodenoscopes are incredibly valuable medical devices, used in a common procedure to diagnose and treat potentially life-threatening problems in the pancreas and bile ducts. But when they are not properly disinfected between use on different patients, deadly infections can result. The recent FDA notice makes it clear that the nationwide problem of dirty duodenoscopes, apparent for several years, is still a huge public health issue.
Duodenoscopes are flexible tubes, with lights at the end, used for the medical procedure known as endoscopic retrograde cholangiopancreatography (ERCP). In an ERCP, the duodenoscope is used to diagnose problems in the bile ducts, duodenum (top of the small intestine), and pancreas, as well as to perform medical therapies in these areas. The duodenoscope is inserted in the patient’s mouth, then threaded through the throat and stomach and into the duodenum. Duodenoscopes are used in over 500,000 ERCPs nationwide each year.
The duodenoscope is a complex instrument with many small working parts. Due to the high cost of these instruments, up to $40,000, they are reused with different patients. Between patients, the duodenoscope must be cleaned and disinfected, which is known as “reprocessing.” If the reprocessing is inadequate, tissue or fluid from one patient can remain in the duodenoscope, then cause an infection in a subsequent patient. Dirty duodenoscopes have been linked to numerous infections within the last several years, including outbreaks of the deadly CRE bacteria in the United States and Europe.
The FDA’s recent safety notice is directed at patients considering ERCP, physicians using duodenoscopes, and reprocessing facilities. The purpose of the notice is to report interim results from studies performed by the three manufacturers of duodenoscopes – Fujifilm Medical Systems USA, Inc.; Olympus Medical Systems Corporation; and Pentax of America- regarding the reprocessing of duodenoscopes in real-world settings. The studies, known as post-market surveillance studies, were ordered by the FDA in October 2015.
The post-market surveillance studies are ongoing but based on an analysis of ten percent of samples collected, the FDA states that contamination rates on reprocessed duodenoscopes are higher than expected. For example, up to three percent of the reprocessed duodenoscopes tested positive for disease-causing bacteria, such as E. coli, which are known as “high concern organisms.” The manufacturers are currently conducting studies, or “root-cause analyses,” to determine the reason for these infection rates. But the FDA does note some factors that might cause the infection rates, including damage to the device and errors in reprocessing the scopes.
The FDA notice also notes problems with labels and instructions for the duodenoscopes. Studies have shown that the reprocessing instructions in the user manuals are difficult to understand and follow. Some reprocessing staff had insufficient training and missed one or more steps in the process. Furthermore, the user manual descriptions of some reprocessing steps were unclear.
The FDA notice also notes that the risk of contamination from inadequate reprocessing is relatively low. The agency recommends that patients refrain from canceling or postponing ERCP procedures until they have discussed the issue with their physicians. This recognizes the fact that duodenoscopes are crucial for the diagnosis and treatment of diseases which are severe and often life-threatening.
If you or a loved one has been exposed to an infected duodenoscope, contact the experienced attorneys at Parker Waichman LLP right away at 1-800-YOURLAWYER. With a free consultation, our dedicated Duodenoscope infection injury attorneys can determine your legal rights for injury or death resulting from an infection suffered during an ERCP or other medical procedure.