鶹ýӰ

FDA: Unapproved Duodenoscope OK to Use

— Agency notes that "superbug" infections have occurred with approved devices as well.

MedpageToday
image

Although one of the duodenal endoscopes implicated in recent "superbug" infections was never cleared by the FDA, that physicians should continue to use it because otherwise there wouldn't be enough devices available to meet patient needs.

Also, the FDA pointed out that infections have occurred with other duodenoscopes that had been approved, reiterating that the designs of all these devices made them hard to disinfect thoroughly after use.

The problem , when two deaths and several other infections at a UCLA hospital were attributed to duodenoscopes contaminated with carbapenem-resistant Enterobacteriaceae (CRE) bacteria. Afterward, the FDA acknowledged that it had received 135 reports of such infections in conjunction with duodenoscopic exams since January 2013 but hadn't taken action.

Since then, "FDA has received inquiries from healthcare providers about whether they should cancel ERCP [endoscopic retrograde cholangiopancreatography] procedures, based on the fact that one specific model duodenoscope manufactured by Olympus (the TJF-Q180V) does not currently have a 510(k) clearance," the agency said in an update posted Wednesday.

"FDA is not recommending that healthcare providers cancel ERCP procedures for their patients who need them," it said. "[W]e believe that that removal of the device from the market could lead to an insufficient number of available duodenoscopes to meet the clinical demand in the U.S. of approximately 500,000 procedures per year."

Also, the FDA said, "the reported duodenoscope-associated infections have occurred in patients who have had procedures with duodenoscopes from all three manufacturers."

Olympus has applied for 510(k) clearance for the TJF-Q180V device, which the FDA is now reviewing, the agency said.

It said it planned no action against Olympus, although marketing a medical device without approval or clearance is a clear violation of FDA regulations.

For providers planning to perform ERCP procedures, the agency issued the following recommendations:

  • Thoroughly clean and disinfect duodenoscopes, pursuant to the manufacturers' instructions
  • Have a comprehensive quality program in place for reprocessing duodenoscopes
  • If you suspect that a duodenoscope may be associated with a patient infection, take it out of service and meticulously clean and disinfect it until it is verified to be free of pathogens
  • Inform patients of the benefits and risks associated with ERCP procedures, including the risk of possible infection
  • Discuss with your patients what they should expect following the ERCP procedure and what symptoms (such as fever or chills, chest pain, severe abdominal pain, trouble swallowing or breathing, nausea and vomiting, or black or tarry stools) should prompt additional follow-up

Any infections that could be related to such procedures should be reported to the FDA .