Issues with a high-tech appliance called an automated endoscope reprocessor (AER) may bear a large portion of the blame for a superbug outbreak that has killed and sickened patients in hospitals across the country and left the government scrambling to update its regulations for reusable medical devices.
AERs work like "a sort of specialized, high-tech dishwasher, pumping disinfectant through and around [devices like duodenoscopes]," USA Today reports.
Duodenoscopes are threaded down a patient's throat during gastroenterological procedures and have been blamed for passing the dangerous drug-resistant bacteria Carbapenem-resistant Enterobacteriaceae (CRE) from patient to patient in recent outbreaks in California, North Carolina, Seattle, Pittsburgh and Chicago.
When they enter a patient's bloodstream, CRE infections have a 50 percent fatality rate, the Centers for Disease Control and Prevention (CDC) has warned.
While the Food and Drug Administration (FDA) first issued a warning that the duodenoscope manufacturers' protocols for sterilization may not be adequate due to the devices' complicated design, and later issued new guidelines to the manufacturers, some thought the agency's response was too slow. The FDA also did not ask AER manufacturers to update decade-old test data about the performance of the machines until the past few weeks, according to USA Today.
A spokesman for one of the AER manufacturers, Medivators, told the newspaper that the appliance will "achieve high-level disinfection" of duodenoscopes if used properly. But Andrew Ross, head of gastroenterology at Virginia Mason Hospital in Seattle, where more than 30 patients were infected with CRE in 2013, was less than convinced.
"You either need a new design for the scope, which is known for being difficult to clean, or you need a better way to clean the instrument," Ross told USA Today.
Chris Lavanchy, engineering director for the nonprofit ECRI Institute, shared a similar view, and predicted that the FDA will at some point require AERs to be tested specifically for use on duodenoscopes, "one of the most difficult scopes to clean."
CRE isn't the only antibiotic-resistant superbug that poses a major threat to patients, however. Recent research has highlighted how easily Clostridium difficile can spread in hospitals and doctors' offices, FierceHealthcare has reported. The CDC grossly miscalculated the risk to patients by counting the number of death certificates that listed C. diff as the cause, when often the cause of death listed is the patient's initial diagnosis, according to an opinion piece in the Washington Times. What's more, the agency is "dragging its feet" to respond to the crisis, the piece argued, and "in the meantime, the needless deaths continue."