The trio of Japanese manufacturers include Olympus, Fujifilm Medical Systems, and Hoya Corp.’s Pentax subsidiary.
The companies have 30 days to submit plans to study how well healthcare professionals actually follow instructions for disinfecting the scopes between uses.
The studies must determine whether the cleaning instructions are adequate, what percentage of scopes remain contaminated after following those instructions, what factors contribute to persistent contamination, and how to adequately decontaminate the scopes.
Duodenoscopes are inserted down a patient’s throat to access the upper digestive tract. They are used to treat and diagnose gallstones, tumors, and blocked pancreatic or bile ducts.
Unfortunately, the complex mechanisms in the tip of the scope are hard to sterilize between uses. Several deadly outbreaks of antibiotic-resistant infections have been traced to scopes that remained dirty even after hospitals followed the manufacturers’ cleaning instructions.
Since 2013, at least eight infection outbreaks have been linked to the scopes. The problem has become more serious as antibiotic-resistant bacteria become increasingly common. The FDA cautions that the risk of infection is low and the scopes are used in life-saving procedures.
According to the agency:
“These studies will provide critical information about the effectiveness of current reprocessing instructions and practices that may provide additional information to inform the FDA’s actions to protect the public health and help reduce the risk of infections.”