AGA statement: How to stop duodenoscope infections

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”

SAN FRANCISCO — A growing number of antibiotic-resistant infections have been reported following use of duodenoscopes, which are used in the advanced procedure endoscopic retrograde cholangiopancreatography, or ERCP. The American Gastroenterological Association (AGA) Center for GI Innovation and Technology convened a meeting on March 23, 2015, “Getting to Zero,” with experts in gastroenterology, epidemiology and infectious disease; the endoscope manufacturers Fuji and Pentax; and representatives from the U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and ECRI Institute to discuss how to prevent these infections.

“More than 500,000 ERCPs are performed each year throughout the U.S., saving the lives of hundreds of thousands of patients with very serious illnesses,” said AGA President Dr. John I. Allen, MBA, AGAF. “The value of these procedures can not be understated. AGA is committed to finding a path forward to remove the risk of device-transmitted infections and ensure safe patient care.”

“We must stop device-associated infections. It’s a complex issue without an easy solution, but first we need to protect our patients,” added Dr. Michael Kochman, AGAF, chair of the AGA Center for GI Innovation and Technology, explaining this means educating patients, redesigning the endoscopes, and finding new ways to clean them.The problem of this infection transmission lies in the complex design of the elevator channel in duodenoscopes, which can allow bacteria to remain after cleansing, even if reprocessing follows currently accepted procedures developed and approved by the manufacturers and FDA. Meeting participants also acknowledged other potential sites of failure in the design.

AGA supports current FDA and CDC guidance and suggests the following additional recommendations to improve patient safety.

Short-term recommendations for physicians

1. Treat all elevator-channel endoscopes the same, including both FNA echoendoscopes (EUS) and duodenoscopes.

2. Continue to follow the recently enhanced manufacturer reprocessing guidelines. Currently, FDA is working with each endoscope manufacturer to validate their enhanced reprocessing protocols.

3. Elevator-channel endoscopes should be tracked by patient and by device serial number to facilitate retrospective identification in case of infection.

4. Establish a two-phase infection surveillance program: a) track all patients who have had a procedure with an elevator-channel endoscope and b) periodically collect culture surveillance of all elevator-channel endoscopes.

5. Baseline culturing of all elevator-channel endoscopes is prudent; the sensitivity is unknown at this time. Importantly, a positive culture should trigger a thorough review of your reprocessing technique.

6. Develop a standard device reprocessing training program and ensure reprocessing staff demonstrate competency every 6 months, as well as with the introduction of new model endoscopes.

7. If you suspect a breach or infection, contact CDC immediately to aid in investigation.

Long-term recommendation: Device redesign

Further study of the failure modes resulting in the transmission of infection will inform the necessary components of a device redesign. FDA has committed to expeditiously review validation data for alternative scope designs that mitigate the risk of transmitting infection.

What Patients Need to Know

Most people will never have an ERCP. But for patients who need it, ERCP is a critical and life-saving procedure. ERCP is the least invasive way for doctors to diagnose and treat problems in the bile duct and pancreatic ducts, including infections, stones, tumors and blockages. Experts all agree that there is no demonstrable infection transmission risk related to upper endoscopy or colonoscopy. Patients should not defer or avoid these procedures, which include colon cancer screening tests.

To put the issue in perspective, the infectious complication rate for theses specific types of infections is about 150 out of more than 1 million procedures over the last two years. The therapeutic benefits of this procedure far outweigh the potential low risk of infection.

For more information about these bacteria, visit the CDC website.

AGA appreciates the involvement of CDC, FDA, Fuji, Pentax, ECRI Institute, and the GI and infectious disease experts in developing these recommendations and for their commitment to “Getting to Zero.”