Deadly bacteria outbreak inflames disinfection concerns

The contaminated medical scopes linked since 2013 to a series of deadly superbug outbreaks in at least eight hospitals across the country all had been cleaned and disinfected using high-tech appliances cleared by the government to kill the bacteria behind such infections.

The outbreaks in Los Angeles, Seattle, Chicago and other cities infected scores of paCatients with antibiotic-resistant bacteria, mostly a strain called CRE that has nightmarish mortality rates of 40% or more. And in each case, the hospital relied on an automated endoscope reprocessor, or AER, to disinfect the scopes between uses, an ongoing USA TODAY investigation finds.

Many of the AERs were cleared a decade ago by the Food and Drug Administration as meeting requirements that they remove 99.9999% of the bacteria the scopes might retain after being snaked down a patient's throat. Yet the FDA, which has been reviewing the scopes' infection risks for more than a year, did not approach manufacturers of the reprocessors until the past few weeks to ask for updated test data validating that the machines perform as required.

"If it turns out that hospitals are following manufacturers' instructions and (the AER) doesn't work, then shame on the manufacturers and shame on the FDA," says Mark Duro, who heads sterile processing operations at New England Baptist Hospital in Boston and lectures nationwide on proper reprocessing techniques.

The regulatory system must ensure that both the scopes, known as duodenoscopes, and the reprocessors are effective and compatible because they have to work in tandem to meet the FDA's safety requirements, Duro adds. "These (scopes) are a nightmare to clean, so somebody needs to be checking that data."

So far, the FDA has focused its investigation mainly on the duodenoscopes themselves, aiming to determine whether the instruments' crevices trap bacteria that are passed from patient to patient.

Like the AER manufacturers, the companies that make the scopes — Olympus, FUJIFILM and Pentax — also must run validation tests on their devices to ensure they are free of bacteria when cleaned according to manufacturer guidelines. The FDA requested the test results last April, and all three companies' data were found to be inadequate, FDA Chief Scientist Stephen Ostroff said in an interview. The companies were asked to try again, he said, but still have not provided acceptable results.

The FDA's examination of test data for the automatic reprocessing machines is another step in the agency's review, adds William Maisel, deputy director at the agency's Center for Devices and Radiological Health. The FDA has old data from testing done at the time each reprocessor was cleared for use, he adds, "and we have requested additional validation data" from more recent tests.

WIDENING THE INVESTIGATION

Manufacturers of the reprocessors say their data will show that the machines are tested thoroughly — and proven effective if used precisely as directed.

"Our validations with these particular (scopes) look very strong," says Craig Smith, senior vice president of regulatory affairs and quality assurance at Medivators, a leading AER manufacturer. "If you follow the instructions and do all the necessary pre-cleaning and put a scope in a Medivators AER, it's going to achieve high-level disinfection."

The FDA's position is less certain.

In a safety alert last month, the agency confirmed that duodenoscopes have caused infections in hospital patients "even when manufacturer reprocessing instructions are followed correctly" and that "effective cleaning of all areas of the duodenoscope may not be possible."

The alert underscored the increasingly urgent questions about the validity of the agency's safety clearances for both the scopes and the automated reprocessors used to clean them.

"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," says Andrew Ross, head of gastroenterology at Virginia Mason Hospital in Seattle, where more than 30 patients were infected in 2013 with a CRE-related bacteria linked to contaminated duodenoscopes. Seven died within weeks of being diagnosed, followed by four more, but all had underlying illnesses that also may have contributed to their deaths.

In that case, investigators confirmed that the scopes were being brushed and cleaned properly before disinfection in a Medivators AER.

"We use equipment sold to us by device manufacturers that have been approved and evaluated by the FDA, and we have to rely on those providing oversight to make sure we have instruments that are actually safe to use on patients," Ross says. "It's very clear that the current (methods) for reprocessing are not having the desired outcome."

THE CLEANING CHALLENGE

Duodenoscopes are especially complex devices, typically used to treat blockages of the bile and pancreatic ducts in a procedure called ERCP, or endoscopic retrograde cholangiopancreatography, which is performed about 500,000 times a year. The flexible tubes have an "elevator" at their tip, which controls tiny tools that can insert stents or cut away tissue, gallstones and other obstructions.

The AERs are a sort of specialized, high-tech dishwasher, pumping disinfectant through and around the scopes, and the machines are far more effective if material caked inside of the instruments is removed beforehand. AERs typically are cleared for all sorts of endoscopes — not just duodenoscopes — so there are various sets of specific guidelines for how technicians should use custom brushes to clean different models of scopes so they're free of biological debris ahead of reprocessing.

But a USA TODAY investigation revealed in January that CRE outbreaks in at least three hospitals — Virginia Mason, Advocate Lutheran in Chicago, and the University of Pittsburgh Medical Center — had been tied to scopes that reportedly were brushed and reprocessed as directed. Reports of more scope-related CRE cases followed, at UCLA and Cedars-Sinai medical centers in Los Angeles, the Medical College of Wisconsin and other hospitals. At each, investigations found that reprocessing was done properly.

Despite the FDA's subsequent safety advisory, the agency has not sought to have the scopes pulled from use, citing the low infection threat and the scopes' importance as the safest option for treating certain digestive disorders. Since 2013, roughly 1 million people have had ERCP procedures, and the FDA has received reports of 135 related infections. (The agency acknowledges that many cases may go unreported.)

But the FDA did finalize new guidance — waiting in draft form since 2011 — that gives manufacturers more detailed instructions for how to test and validate the effectiveness of cleaning and disinfection procedures for both the scopes and the AERs used to reprocess them. Agency officials also adopted a new policy that no new duodenoscopes will be cleared for use until data from those tests are submitted, reviewed and approved by the FDA.

NEW DESIGNS, NEW CONCERNS

The policy changes follow a period in which increasingly complex duodenoscope designs have come into use with no FDA review of manufacturers' data to validate that they could be cleaned. One revised Olympus model was introduced in 2010 with no new FDA clearance, agency officials say, because Olympus believed the changes were too minor. The scope was sold for years before the FDA demanded a new clearance application, which remains under review while the scope still is in use.

"The (changing) endoscope designs have complicated the cleaning and disinfection process both for the user and the AER manufacturer," says Alicia Nakonetschny, president of Custom Ultrasonics, a leading maker of reprocessors. The more complex designs "may allow organic debris and microorganisms to accumulate," she adds, so scope manufacturers must provide updated guidance on the need for additional manual brushing to ensure the devices can be reprocessed effectively.

The University of Pittsburgh Medical Center Presbyterian Hospital was using Custom Ultrasonics reprocessors when CRE cases started cropping up among patients treated with duodenoscopes in 2012. The hospital's investigators tried a different reprocessing machine, says Carlene Muto, the hospital's director of infection control, but they ultimately concluded the problem was that disinfectant from the washer was not reaching isolated crevices in the redesigned Olympus scope's elevator mechanism.

"These (AERs) probably were certified before the new scope design and I don't know that anyone would necessarily say, 'Oh, 10 years have gone by, let's recertify those washers for the scopes that are available today,' " says Muto. "It does seem reasonable that when there's a major change in the scope design, if you're saying the washer can clean the scope, it is important to prove that it can."

And those questions don't just apply to older reprocessors.

A handful of newer AER models have been cleared for cleaning scopes with far less pre-treatment and manual brushing than conventional reprocessors, but those clearances also are raising questions. When asked whether hospitals should expect the new, "brushless" AERs to work on duodenoscopes, the FDA's Maisel said the agency now is recommending that those scopes still should get the same rigorous brushing that would be done if they were being run through a conventional reprocessor.

The problem is that most AERs are designed to work with all sorts of endoscopes — from relatively simple devices that just guide a camera through someone's body to far more advanced instruments, such as duodenoscopes, that require much more intricate cleaning. And manufacturers are not expected to validate their reprocessors on every model of every type of scope on the market — rather, they are required to demonstrate that their devices work on a representative sample.

"I have to question whether that (generalized) testing is sufficient for something like a duodenoscope," says Chris Lavanchy, engineering director at the ECRI Institute, a non-profit research organization that seeks to bring sound, scientific scrutiny to medical issues. "I think it's reasonable to assume that going forward FDA would, for example, require the (AER) validation process to specifically include testing on a duodenoscope, just because it's one of the most difficult scopes to clean."

Follow investigative reporter Peter Eisler on Twitter @bypetereisler