The United States Senate investigated cases of hospital acquired infections across the US and the world and found at least 25 outbreaks caused by dirty surgical instruments, specifically duodenoscopes. Many patients infected by the dirty scopes died. The Senate specifically placed the blame of the scope manufacturers who produced the scopes and failed to warn of the design flaw making them difficult to properly disinfect, the FDAs ineffective medical device regulators and the hospitals who failed to properly clean and disinfect the instruments, failed to properly report hospital acquired infections, and also failed to warn and protect patients.
Duodenoscopes are used in more than 500,000 procedures each year in the United States. This scope is used in the endoscopic retrograde cholangiopancreatography (ERCP) procedure, performed commonly to diagnose and treat gallstones and other problems related to the gallbladder, biliary ducts and pancreas. The duodenoscope can be more difficult to clean and disinfect than other endoscopes. Many hospitals have inadequate policies for sterilizing the instruments, or they fail to even follow the policy for sterilization.
The link to review the FDAs recommendation for proper cleaning, disinfecting and sterilization of these instruments can be found at: http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm253010.pdf
If you or a loved one has acquired an infection after undergoing an ERCP procedure, you should contact an experienced medical malpractice attorney, immediately.