FDA: ERCP Endoscopes Pose Unique Reprocessing Challenges

Veronica Hackethal, MD

May 18, 2015

Effective reprocessing of endoscopes that are used in endoscopic retrograde cholangiopancreatography (ERCP) procedures requires continued vigilance to prevent dangerous infections, according to a US Food and Drug Administration (FDA) advisory panel that met today and yesterday.

The Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee met to discuss the unique challenges associated with reprocessing ERCP endoscopes.

At least six outbreaks ― some lethal ― have occurred within recent years despite proper adherence to manufacturers' instructions and recommendations from professional organizations about the reprocessing of duodenoscopes. Most concerning is that infections have been linked to rare bacteria, especially multidrug-resistant organisms.

More than 600,000 ERCP procedures are performed in the United States each year. In ERCP, a specially trained physician threads a duodenoscope through the esophagus, stomach, and duodenum, then injects contrast media directly into the biliary tree to visualize the biliary and pancreatic duct anatomy. This allows the physician to assess for obstruction or narrowing of the ducts caused by cancer, gallstones, inflammation, infection, or other disorders. The procedure can enable immediate and sometimes life-saving treatment.

The duodenoscope is a reusable, flexible, lighted tube with a hollow channel that enables other instruments to be inserted through it for tissue sampling and treatment of some abnormalities. Its unique features make it difficult to reprocess so that it can be used in subsequent patients. Duodenoscopes have many small parts that are hidden and can be difficult to reach; therefore, meticulous reprocessing is necessary to avoid transmitting infections to subsequent patients.

Several reasons may account for why outbreaks have occurred. Insufficient manual cleaning, failure to follow the manufacturer's recommended cleaning instructions, or failure to use enough disinfectant may be to blame. Some infections have been linked to contamination from tap water or irrigating solutions. Finally, improper use of automated endoscope reprocessors (AERs), inadequate drying, and defective equipment may all play roles.

One issue is that the design of duodenoscopes may make it difficult to properly reprocess them. Some hospitals use high-level disinfection, which involves use of chemical disinfectants that may not necessarily kill all organisms. Duodenoscopes can be damaged by the high heat commonly used with steam sterilization. Some hospitals use chemical sterilization with ethylene glycol, which raises the issue of toxicity and worker safety.

Even when duodenoscopes are cleaned properly, they may be rinsed improperly with tap water or other liquids, introducing new bacteria. Another issue concerns storage and transfer of the duodenoscopes to the operating room after cleaning, also potential sources of contamination. A third issue concerns proper drying of duodenoscopes and the potential for biofilm formation. Biofilms need water for survival and could potentially contaminate duodenoscopes.

At least six outbreaks have occurred despite proper adherence to manufacturers' instructions and recommendations from professional organizations about reprocessing of duodenoscopes. Most concerning is that infections have been linked to rare bacteria, especially multidrug-resistant organisms.

Regulatory Action

The FDA reviewed reports of infections associated with all duodenoscope devices between January 1997 and February 2015. During this time, there were 433 endoscope reports of patient infection, exposure to an infectious agent, or device contamination. Of these, 146 were linked to duodenoscopes, with 142 reports received between 2010 and early 2015 (patient infection: n = 119; patient exposure to an infectious agent: n = 18; contamination: n = 5). Among AERs, 152 reports were associated with patient infection (n = 109), exposure to an infectious organism (n = 6), and device contamination (n = 37).

The FDA issued a joint safety communication with the US Centers for Disease Control and Prevention (CDC) in November 2009 cautioning about the consequences associated with improper cleaning of endoscopes, including duodenoscopes, and making recommendations.

The FDA further convened a public workshop in 2011 that addressed factors affecting reprocessing of reusable medical devices.

In 2011, the FDA also published draft guidelines entitled, Processing/Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling (Reprocessing Medical Devices Guidance). After considering almost 500 comments on this document, the FDA provided the final guidance.

In Fall 2013 to Winter 2014, the CDC alerted the FDA to a potential association between multidrug-resistant bacteria and duodenoscopes, despite proper cleaning, disinfection, and sterilization. Since then, the FDA has communicated with federal partners, manufacturers, and other stakeholders to investigate how this is happening and how best to mitigate it. In February 2015, the FDA published another safety communication, which was updated in March 2015, warning that the design of duodenocopes could interfere with effective cleaning and disinfection of duodenoscopes.

One model in particular, the widely used Olympus TJF-180V, had been marketed without premarketing notification submission. After the company provided proper documentation, and upon FDA review, the FDA issued new reprocessing instructions for this model in March 2015.

In another document issued in March 2015, the CDC issued interim guidance for surveillance of bacterial contamination of duodenscopes after reprocessing.

Six Conclusions

After 2 days of discussion and deliberation, the advisory panel reached conclusions to questions posed by the FDA in six broad topic areas.

1. Safety of duodenoscopes and AERs

The benefits of ERCP procedures far outweigh the risks of contracting a rare infection from a contaminated device, the panel advised. Two thirds of the panel strongly favored sterilization over high-level disinfection, as well as reclassification of duodenoscopes as critical devices. The majority felt that manual cleaning is critical, but that it needs improvement, including some level of competency testing, validation, and training.

2. The role of premarket human factors in developing reprocessing instructions

The panel felt that premarketing human factors testing is important in the development of reprocessing instructions, but that testing may need to be evaluated differently for manual cleaning, AERs, and sterilizers. There was a split vote over whether certification of technicians should be required. There was a universal call, however, for a set of best practices and means of assessing competency in cleaning.

3. Ensuring adequacy of brushes and flushing aids, which are not FDA regulated

The panel did not reach definitive conclusions on this issue. They did recommend, however, that devices be used in accordance with manufacturer specifications, and they called for making available as much information as possible to understand the adequacy of certain brushes, flushing aids, etc. The panel was of the opinion that the FDA does not have a responsibility to ensure that these types of products perform as intended.

One unresolved issue is that Olympus released new brushes in May 2015. Data about these new brushes have not yet been reviewed. Whether they could improve reprocessing of duodenoscopes is currently unknown.

4. Should hospitals be mandated to follow the CDC interim guidance issued in March 2015?

The CDC interim guidelines are not sufficient in their current form to be implemented as best practices guidelines, and hospitals should not be mandated to follow them. The concept of developing a best practices document is desirable, but such a document does not yet exist.

5. Ensuring patient safety during ERCP procedures

Hospitals need to have processes in place to ensure patient safety. Diagnostic ERCP is no longer necessary, because noninvasive alternatives exist. Therapeutic ERCP is still important, and patients need to be appropriately selected for this procedure. The panel emphasized the importance of informed consent and of educating patients about alternatives to ERCP and the risks involved.

6. Advice on sharing information with the public

The FDA needs to work with societies and respond to outbreaks early with interim advice in order to instill confidence in the public and healthcare providers.

Abdelmonem Afifi, PhD, UCLA Fielding School of Public Health, in Los Angeles, California, summed up the panel's conclusions regarding the safety of reprocessing procedures for duodenoscopes:

"Whether the current procedures that we use are safe enough, my [assessment is] no. Whether the high level disinfection is good enough, I think no. From a potential patient's point of view, I would like to see sterilization also added to the procedure, as well as surveillance culture. I want to know that this is safe for me, and my body."

The committee members have disclosed no relevant financial relationships.


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