March 12--The Food and Drug Administration, criticized for its slow response to tainted scopes infecting patients, said for new reusable devices it will require manufacturers to submit test results showing they can be cleaned reliably.
Until now, device makers could simply attest that their cleaning instructions would work.
Federal officials also announced Thursday new recommendations for hospitals and medical providers to routinely test medical scopes for bacterial growth after they have been disinfected.
But FDA officials stood by their earlier decision not to recall any of the ERCP duodenoscopes at the center of deadly superbug outbreaks at U.S. hospitals, including UCLA and Cedars-Sinai Medical Center.
Regulators also said they had no authority to require manufacturers such as Olympus Corp. to redesign the duodenoscopes.
On Thursday, the FDA was finalizing its draft guidelines for cleaning duodenoscopes and a wide range of other reusable medical devices. They were first published in 2011.
Dr. Stephen Ostroff, the FDA's chief scientist, said the agency had been working on the proposed guidelines since 2011 but "accelerated" its work after the recent outbreaks in California.
Under the finalized guidelines, manufacturers will now have to validate that reusable medical devices can be successfully cleaned before they get FDA approval.
Companies will have to perform tests that show the devices can be disinfected or sterilized according to the manufacturers' instructions.
Last month, the FDA warned medical providers that following manufacturers' instructions does not ensure that the duodenoscopes are free of bacteria, which can become trapped in tiny crevices near the tip of the devices.
The FDA has already imposed these new guidelines on makers of the duodenoscopes.
In spring 2014, agency officials asked Olympus and two other scope makers, Pentax Medical and Fujifilm, for test results showing that their scopes could be cleaned of bacteria effectively.
All three companies have failed twice to submit adequate data and the FDA has said it's awaiting more information from the firms.
"This guidance is an important step toward further enhancing the safety margin by outlining for manufacturers the steps they should undertake to make their reprocessing instructions effective," said Dr. William Maisel, chief scientist at the FDA's Center for Devices and Radiological Health.
Some hospitals have complained that they cannot easily get the cleaning instructions from manufacturers. Health officials have also said the instructions are difficult to follow.
Maisel said the FDA was working with the companies to make sure the instructions "are usable and freely available."
There have been a series of deadly superbug outbreaks at U.S. hospitals since 2012, most recently at UCLA's Ronald Reagan Medical Center and Cedars-Sinai hospital.
At those two Los Angeles hospitals, 11 patients were infected with CRE and 246 more people were possibly exposed to the lethal superbug after being treated with an ERCP duodenoscope.
Carbapenem-resistant Enterobacteriaceae, or CRE, is highly resistant to antibiotics and can kill up to 50% of infected patients.
Critics have faulted the FDA for not responding sooner to numerous red flags about the difficulty of cleaning these medical scopes of antibiotic-resistant bacteria.
FDA has come under intense criticism for allowing the biggest manufacturer of these duodenoscopes, Olympus, to sell a device without the necessary government approval since 2010.
Olympus has said the company didn't believe further regulatory approval was necessary for the 2010 redesign of its TJF-Q180V duodenoscope. At the FDA's request, the company subsequently filed for approval, which is pending.
Nationally, about half a million patients a year undergo ERCP, in which a fiber-optic scope is threaded down the person's throat to diagnose and treat problems in the digestive tract such as gallstones, cancers and blockages in the bile duct.
These instruments are not the same type used in more routine endoscopies and colonoscopies.
This week, Sen. Patty Murray (D-Wash.) expressed her continued concern about the agency's handling of the matter and urged FDA Commissioner Margaret Hamburg to fully investigate the scopes at the center of the outbreaks.
At a Senate hearing Tuesday, Hamburg assured Murray that a full review was already underway.
Murray has been pressing the FDA for answers since January when an outbreak that sickened more than 30 patients was disclosed at Virginia Mason Medical Center in Seattle.
Ten House members have also sent a letter to the FDA wanting to know what regulators knew about this infection risk beforehand and for how long.
Hamburg is stepping down at the end of March and Ostroff, the agency's top scientist, will serve as interim commissioner.
