FDA News

Endoscope manufacturer under investigation for modifications to device at center of CRE outbreak

The manufacturer of a duodenoscope involved in the recent carbapenem-resistant Enterobacteriaceae outbreak at Ronald Reagan UCLA Medical Center did not have 510(k) clearance, according to a statement from the FDA.

An FDA spokeswoman told Healio Gastroenterology in an email that Olympus made modifications to its TJF-Q180V duodenoscope (originally FDA-approved in 2010), but did not seek 510(k) clearance for that modification. A representative from Olympus told Healio Gastroenterology that the company “determined that the resulting TJF-Q180V did not require a new 510(k) application according to the FDA policy on modifications to 510(k)-cleared devices.”

In March 2014, the FDA requested a new 510(k) be submitted for the device. Olympus complied in October, after which the FDA requested additional data. That submission is currently pending and the Olympus spokesman said the company continues to cooperate with the FDA.

“It’s important to understand that we have received reports of infections associated with the duodenoscopes manufactured by all three device companies,” the FDA spokeswoman said.

The carbapenem-resistant Enterobacteriaceae (CRE) outbreak occurred in a small group of patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) between October and January, according to a UCLA Health press release. After an investigation with the Los Angeles County Department of Public Health, “it was determined that the routine cleaning of the ERCP scopes as recommended by the scope manufacturer does not completely eradicate CRE as it does for other bacteria and viruses,” the release said. “UCLA Health has instituted stricter sterilization procedures for the particular scopes that were used, so that we now have one of the most stringent scope protocols in the United States.”

The FDA recently issued a safety communication to raise awareness regarding the challenges for effective cleaning and disinfection caused by the complex design of ERCP duodenoscopes.

There are no alternative devices for ERCP, the FDA spokeswoman said, adding that only a fraction of the more than 500,000 ERCPs performed per year in the United States have been associated with transmitting antibiotic-resistant organisms due to inadequately processed duodenoscopes.

“While we are working to determine what more can be done to reduce the incidence even further, the risk of transmission of multidrug-resistant bacteria must be weighed against the consequences of not seeking necessary treatment,” the FDA spokeswoman said. “Pulling these devices from the market would prevent hundreds of thousands of patients from access to this beneficial and often life-saving procedure. The FDA believes at this time that the continued availability of these devices is in the best interest of the public health.”

The Olympus spokesman told Healio Gastroenterology the company “does not comment on active legal matters or speculation.”

“Olympus continues to monitor and investigate this issue. We are working with the FDA, relevant medical societies and our customers regarding these concerns including the consideration of alternative cleaning and reprocessing methods,” he said.

 “This is an issue for the FDA to address,” Dale T. Tate, executive director of communications and government relations at UCLA Health Sciences, told Healio Gastroenterology in an email. “As we have said from the outset, the UCLA Health System followed all the guidelines provided by the manufacturer and the FDA in cleaning the scopes used in these very complex endoscopic procedures.” – by Adam Leitenberger

Editor's Note: Headline was changed to more accurately reflect an ongoing investigation. Quotes were added to this story on March 5.

The manufacturer of a duodenoscope involved in the recent carbapenem-resistant Enterobacteriaceae outbreak at Ronald Reagan UCLA Medical Center did not have 510(k) clearance, according to a statement from the FDA.

An FDA spokeswoman told Healio Gastroenterology in an email that Olympus made modifications to its TJF-Q180V duodenoscope (originally FDA-approved in 2010), but did not seek 510(k) clearance for that modification. A representative from Olympus told Healio Gastroenterology that the company “determined that the resulting TJF-Q180V did not require a new 510(k) application according to the FDA policy on modifications to 510(k)-cleared devices.”

In March 2014, the FDA requested a new 510(k) be submitted for the device. Olympus complied in October, after which the FDA requested additional data. That submission is currently pending and the Olympus spokesman said the company continues to cooperate with the FDA.

“It’s important to understand that we have received reports of infections associated with the duodenoscopes manufactured by all three device companies,” the FDA spokeswoman said.

The carbapenem-resistant Enterobacteriaceae (CRE) outbreak occurred in a small group of patients who underwent endoscopic retrograde cholangiopancreatography (ERCP) between October and January, according to a UCLA Health press release. After an investigation with the Los Angeles County Department of Public Health, “it was determined that the routine cleaning of the ERCP scopes as recommended by the scope manufacturer does not completely eradicate CRE as it does for other bacteria and viruses,” the release said. “UCLA Health has instituted stricter sterilization procedures for the particular scopes that were used, so that we now have one of the most stringent scope protocols in the United States.”

The FDA recently issued a safety communication to raise awareness regarding the challenges for effective cleaning and disinfection caused by the complex design of ERCP duodenoscopes.

There are no alternative devices for ERCP, the FDA spokeswoman said, adding that only a fraction of the more than 500,000 ERCPs performed per year in the United States have been associated with transmitting antibiotic-resistant organisms due to inadequately processed duodenoscopes.

“While we are working to determine what more can be done to reduce the incidence even further, the risk of transmission of multidrug-resistant bacteria must be weighed against the consequences of not seeking necessary treatment,” the FDA spokeswoman said. “Pulling these devices from the market would prevent hundreds of thousands of patients from access to this beneficial and often life-saving procedure. The FDA believes at this time that the continued availability of these devices is in the best interest of the public health.”

The Olympus spokesman told Healio Gastroenterology the company “does not comment on active legal matters or speculation.”

“Olympus continues to monitor and investigate this issue. We are working with the FDA, relevant medical societies and our customers regarding these concerns including the consideration of alternative cleaning and reprocessing methods,” he said.

 “This is an issue for the FDA to address,” Dale T. Tate, executive director of communications and government relations at UCLA Health Sciences, told Healio Gastroenterology in an email. “As we have said from the outset, the UCLA Health System followed all the guidelines provided by the manufacturer and the FDA in cleaning the scopes used in these very complex endoscopic procedures.” – by Adam Leitenberger

Editor's Note: Headline was changed to more accurately reflect an ongoing investigation. Quotes were added to this story on March 5.