March 9, 2015 — Hospitals do not have to inform patients when they are exposed to antibiotic-resistant “superbugs” on dirty medical scopes, which may explain why it took years for some recent outbreaks to come to light, according to Bloomberg.
There are no laws requiring hospitals to track or disclose cases of a “superbug” known as CRE, which is resistant to nearly all antibiotics and has a fatality rate of up to 50%.
Not everyone who is exposed to CRE develops an infection — many are “colonized,” which means the bacteria lives inside the patient’s body but does not cause any symptoms right away. Patients who are colonized can transmit CRE to other patients on duodenoscopes that are difficult to sterilize.
The FDA has warned that a particular scope sold by Olympus has a complex mechanism at the tip that is hard to clean. The scope has been linked to an outbreak of CRE at a hospital in Los Angeles. The outbreak began last summer, but was not disclosed until February. The scopes were also linked to a similar outbreak in Seattle that began two years ago, but was not disclosed until January.
Consumer advocacy groups are now demanding action from the FDA. The agency has not recalled any duodenoscopes, fearing a shortage. The agency also has not recommended a more rigorous sterilization procedure involving ethylene-oxide gas, likely because the gas itself is toxic and the procedure takes much longer.
At the very least, advocates want hospitals to inform patients about the risk of disease-transmission on duodenoscopes. The scopes are primarily used in ERCP procedures, which are used to treat gallstones, blocked bile ducts, and cancers in pancreas.