The U.S. Food and Drug Administration is working to speed label changes for medical devices linked to a "superbug" outbreak in California, possibly to include new warnings and more stringent cleaning and disinfecting instructions, a senior official said.
Last week the FDA warned that the complex design of the reusable duodenoscopes, which are threaded through the mouth, throat and stomach and used in a variety of gastrointestinal procedures, makes them difficult to disinfect properly, even when instructions provided by the manufacturers are followed. Pentax Medical, Fujifilm Holdings Corp and Olympus Corp are the leading makers of these endoscopes.
"We are working to expedite modifications to the label," Dr. William Maisel, chief scientist in the FDA's Center for Devices and Radiological Health, said in an interview. "We are also talking about updating the risk information."
The urgency comes as the FDA faces some criticism for taking more than three years to issue definitive guidelines on the instructions manufacturers must give for disinfecting the scopes, a delay that critics say may have contributed to the failure to keep the devices from causing infections.
The outbreak may have exposed 179 patients to a potentially deadly, drug-resistant strain of bacteria at UCLA's Ronald Reagan Medical Center in Los Angeles and contributed to two deaths. The FDA said last week that from 2013 to 2014 it received 75 reports, involving 135 patients, of possible contamination from reused duodenoscopes.
Maisel said that if a new cleaning method is established, the agency would expect companies to reflect that in their labels. One possible protocol is being developed by the U.S. Centers for Disease Control and Prevention and is close to being finalized, the CDC scientist leading the effort told Reuters on Friday.
Pentax Medical said in an e-mail it is talking to the FDA about updating its cleaning and sterilizing instructions, known as reprocessing. Fujifilm said it recommends strict adherence to the company's reprocessing instructions but "reserves the right" to make new recommendations in the future "whether as a result of new industry practices, FDA guidance, or Fujifilm-specific updates to best practices."
Olympus, whose devices were used in the UCLA outbreak, did not respond to questions about labeling changes.
CRITICS SAY FDA PROCESS TOO SLOW
Label changes, which can take months to complete, have been proposed in general terms before. But the latest outbreak has raised new issues that may require more specific measures to guard against infection from the flexible scopes, which are used to diagnose or treat disorders in about 500,000 procedures a year in the United States alone.
The FDA issued draft guidance on the labeling of reusable medical devices in May 2011, but such preliminary advice does not carry as much weight in the medical industry as its final guidance.
Among the draft recommendations: devices with "features that make them difficult to clean will need to be disassembled in order to be completely cleaned" and "instructions/diagrams for adequate disassembly should be included in the cleaning instructions."
The draft guidance said labels should include "any special warnings or precautions" about the reprocessing procedure. The FDA plans to release final guidance this spring.
Lengthy delays between the issuance of draft and final guidance are not uncommon at the agency, and critics say the slow process is not helping the situation.
"The draft guidance would have made a difference if it had been finalized," said Mark Duro, director of sterile reprocessing operations at New England Baptist Hospital in Boston.
“This was asking the manufacturers to give us more information about how to reprocess the (duodenoscopes), and every bit of additional information would be better than we have now."
The 2011 draft guidance may also prove to be out of date as bacteria become more virulent and drug-resistant.
The FDA has known of infections linked to reusable devices since at least 2009. The draft guidance was issued partly in response to those concerns.
But the latest outbreak is novel in that the bacteria are surviving even when manufacturers instructions are followed, Maisel said.
"In 2009 we weren't aware of outbreaks of multi-drug resistant bacteria in these scopes happening when proper cleaning was followed," he said.
Whatever the new labels say, some experts say they won't be enough to protect patients without additional safeguards.
“The devices need to be designed better, the instructions need to be more clear, the hospitals need better training, and adequate time needs to be given in hospitals to ensure sterility is top notch,” said Mary Logan, chief executive of the Association for the Advancement of Medical Instrumentation, an alliance of healthcare providers which helps develop standards for use.
AAMI will be issuing new guidelines on endoscope cleaning within the next two months.