ERCP Endoscope Testing By Companies Flawed, Advisory Hearing Planned: FDA

Federal health regulators will convene an advisory panel of independent experts later this year, to discuss more stringent regulations concerning the cleaning of duodenoscopes used during endoscopic retrograde cholangiopancreatography (ERCP). The move comes after an outbreak of drug-resistent superbugs among patients who underwent the endoscopy procedure over the past several months in California. 

The FDA has criticized the instructions provided manufacturers’ following an outbreak of carbapenem-resistant enterobacteriaceae (CRE) that surfaced last month at UCLA Medical Center, which caused at least seven infections, two deaths and may have placed nearly two hundred others at risk.

The agency has suggested that even if the recommended steps are followed to clean ERCP endoscopes, flaws in the design may allow them to become easily contaminated.

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Stephen Ostroff, chief scientist of the FDA, plans to convene a panel of third party scientific advisors to review the safety of the medical scopes and make recommendations about what regulatory actions the agency may need to take.  No date has been set for the meeting, but it will be closely followed, as the agency usually follows the guidance of the advisory committees.

In the meantime, the agency has requested that the manufacturers of the ERCP scopes, such as Olympus, to test cleaning protocols again using a stricter methodology.

The results of those tests proved to be unsatisfactory, according to Ostroff, so the agency plans to convene the advisory council. The FDA asked manufacturers, including Fujifilm and Pentax to continue to test with the current protocols until reliable and safe procedures are found.

In addition, the design of the scopes will be examined, as the design of the ERCP endoscopes have been modified previously, with no conclusive improvements.

Ineffective Protocols And Design Flaws

The most recent outbreak of antibiotic-resistant bacteria surfaced last month at the UCLA Ronald Reagan Medical Center in California, after the facility confirmed that nearly 200 patients who underwent an ERCP between October 2014 and January 2015 needed to be tested for the deadly superbug CRE due to contaminated scopes.

The confirmed infections occurred despite the medical scopes being sterilized according to manufacturers specifications, leading the FDA to issue a warning to about duodenoscope cleaning problems last month.

During the ERCP procedure, the scope is sent through the mouth, down the throat to the stomach and small intestine to drain fluid from pancreatic and biliary ducts. These scopes have been linked to other infections for years.

A similar CRE superbug outbreak from infected duodenoscopes occurred in Chicago in 2014. The FDA called on manufacturers to submit test results for review, discovering in some cases the tests were poorly carried out.

In other instances, the cleaning and disinfecting protocol simply failed or was improperly conducted.

Under the 1996 FDA guidance, manufacturers were not required to submit data proving the cleaning protocols were effective and were allowed to set their own standards for effectiveness. The FDA is attempting to focus on this gap in oversight of regulation of medical scope cleaning protocols and potential design flaws.

The FDA imposed specific requirements following the Chicago outbreak, calling for the elimination of 99.999% of microbes at several ovations on the scope.

The outbreaks call into question the safety and reliability of the current cleaning procedures. Following the UCLA outbreak, the duodenoscopes were pulled and a heightened protocol was implemented, one going above and beyond that recommended by the manufacturers.

Several ERCP infection lawsuits have already been filed this month against Olympus, the manufacturer of the duodenoscopes linked to the UCLA outbreak. The complaints allege that design problems that make the scopes especially difficult to clean, placing patients at higher risk of contracting illness.

Exposure to the CRE superbug following an ERCP poses a serious risk of illness, as the bacteria kills 40% to 50% of patients after spreading to the bloodstream.


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