The government does not even require hospitals to track and disclose rates of a “superbug” known as CRE, which has a fatality rate of 40-50% because it is resistant to nearly all antibiotics.
Last month, UCLA hospital reported that 179 patients were exposed to CRE after undergoing procedures with a duodenoscope. The next day, the FDA warned that the scope’s complex mechanisms made it extremely difficult to sterilize. A similar outbreak that killed 11 people over the last two years was not disclosed publicly until this January.
In these cases, it took months or years for the hospitals to notify patients that they may be infected with CRE. The problem is that they could have been “colonized” — meaning the bacteria lives in their body without causing an infection right away.
Consumer advocates want hospitals to inform patients about the potential for infection, offer follow-up care, and treatment. They also want doctors to inform patients about the potential risk of disease-transmission on duodenoscopes before they undergo ERCP procedures, which are commonly used to treat gallstones and cancer.
The FDA has issued a warning, but has not recalled any products or recommended a more rigorous cleaning procedure. The scopes are used in about 500,000 procedures per year and the agency fears a recall would lead to a shortage of the scopes.
After the CRE outbreak at UCLA, the hospital started sterilizing the scopes using ethylene-oxide gas and they have not had any more cases of CRE. The FDA has not recommended this procedure because the gas is extremely toxic to people who are using it to clean the scopes. The scopes would also need to be thoroughly aired before they can be used again, which is impractical when they are needed for emergency procedures.