The antibiotic-resistant superbug outbreaks tied to a specialized device known as a duodenoscope has left hospitals across the country uncertain about how to safely sterilize the scopes absent any clear guidance from the government or device manufacturers, the L.A. Times reports.
An outbreak of deadly superbug carbapenem-resistant Enterobacteriaceae (CRE) first made major headlines when it killed two patients and sickened others at UCLA's Ronald Reagan Medical Center in Los Angeles. Similar duodenoscope-linked outbreaks had surfaced previously in Pittsburgh, Seattle and Chicago, before spreading to Cedars-Sinai Medical Center in Los Angeles and killing two patients in North Carolina. The Centers for Disease Control and Prevention has dubbed CRE a "nightmare bacteria" due to its 50 percent fatality rate and resistance to last-resort antibiotics.
The design of the duodenoscope may be to blame for the outbreaks, as the Food and Drug Administration (FDA) has warned hospitals that it can prevent effective sterilization even when following the manufacturers' instructions. This led to a cascade of criticism directed at the FDA and major manufacturer Olympus, as some claim they did not adequately warn hospitals about the infection risk until after the UCLA outbreak. Still others have questioned why hospitals are not required to report such outbreaks to their patients.
The FDA is meeting today and Friday to examine the use and cleaning of the scopes, according to the L.A. Times. Meanwhile, hospitals have had to make tough choices about how to handle their duodenoscopes, which are used for hundreds of thousands of gastroenterological procedures every year.
While UCLA previously told the newspaper that it has turned to an older method of cleaning known as gas sterilization, the Department of Veterans Affairs decided against the method out of concerns that it may harm patients. Seattle's Virginia Mason Medical Center, the site of one of the outbreaks, spent about $1 million to purchase a new set of scopes, while Beth Israel Deaconess Medical Center in Boston has begun to test three different cleaning methods to determine the best protocol.
The CRE outbreaks come amid an aggressive push against superbugs and antibiotic resistance by the federal government, which has pledged $1.2 billion to the initiative and asked a wide range of agencies to help cut the rate of these deadly infections.
Olympus waited to alert U.S. hospitals of scopes' superbug risk
Secrecy about superbugs could put patient safety in jeopardy
CDC looks to Chicago hospitals' example in battle against superbugs
Superbug outbreak spreads, but FDA won't take device off the market
FDA: Companies' tests of superbug-linked scopes flawed
Appliances used to clean superbug-linked scopes may be flawed
FDA tightens guidelines for superbug-linked medical scopes
What caused the CRE outbreak? The bottom line
Under-fire FDA rushes to respond to superbug outbreak
Antibiotic stewardship can curb rise of deadly superbugs
CRE superbug spreads to North Carolina, kills two
FDA issues warning about scopes linked to superbug outbreak
Superbug kills two patients in California
White House wants $1.2B to fight antibiotic resistance
White House plan calls for aggressive measures against superbugs