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The Food and Drug Administration on Dec. 13 cleared Boston Scientific’s single-use duodenoscope, the Exalt Model D, for endoscopic retrograde cholangiopancreatography.
It’s the first disposable duodenoscope to hit the market in the wake of the agency’s August call for manufacturers and health care facilities to move to partially or fully disposable duodenoscopes. The goal is to eliminate the risk of spreading infections between patients from incomplete sterilization of traditional, multi-use scopes. The FDA also recently approved a Pentax duodenoscope with a disposable elevator, the most difficult part to clean.
The agency reported in April that 5.4% of samples from multi-use scopes test positive for Escherichia coli, Pseudomonas aeruginosa, or other “high-concern” organisms.
Boston Scientific spokesperson Kate Haranis said the Exalt Model D will be available in the first quarter of 2020, but the company is still working out how much it will charge.
Cost effectiveness will depend largely on the degree to which the price of the device is offset by the infections it prevents. It might prove particularly attractive to high-volume centers with higher than usual infection rates. It might also be of interest to smaller practices where the price of a multi-use scope doesn’t make sense for only a few procedures a year, said Gyanprakash Ketwaroo, MD, an interventional endoscopist and assistant professor of gastroenterology at Baylor University, Houston.
AGA is working with FDA to ensure physicians continue to have access to ERCP as new devices are introduced to the market and will continue to update members on the latest developments. The GI societies believe that device transitions can be incorporated over the life cycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology. Review the GI societies’ guiding principles for continued scope evolution at https://www.gastro.org/news/gi-societies-advise-fda-on-duodenoscope-reprocessing.
Dr. Ketwaroo had no relevant financial disclosures.
The Food and Drug Administration on Dec. 13 cleared Boston Scientific’s single-use duodenoscope, the Exalt Model D, for endoscopic retrograde cholangiopancreatography.
It’s the first disposable duodenoscope to hit the market in the wake of the agency’s August call for manufacturers and health care facilities to move to partially or fully disposable duodenoscopes. The goal is to eliminate the risk of spreading infections between patients from incomplete sterilization of traditional, multi-use scopes. The FDA also recently approved a Pentax duodenoscope with a disposable elevator, the most difficult part to clean.
The agency reported in April that 5.4% of samples from multi-use scopes test positive for Escherichia coli, Pseudomonas aeruginosa, or other “high-concern” organisms.
Boston Scientific spokesperson Kate Haranis said the Exalt Model D will be available in the first quarter of 2020, but the company is still working out how much it will charge.
Cost effectiveness will depend largely on the degree to which the price of the device is offset by the infections it prevents. It might prove particularly attractive to high-volume centers with higher than usual infection rates. It might also be of interest to smaller practices where the price of a multi-use scope doesn’t make sense for only a few procedures a year, said Gyanprakash Ketwaroo, MD, an interventional endoscopist and assistant professor of gastroenterology at Baylor University, Houston.
AGA is working with FDA to ensure physicians continue to have access to ERCP as new devices are introduced to the market and will continue to update members on the latest developments. The GI societies believe that device transitions can be incorporated over the life cycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology. Review the GI societies’ guiding principles for continued scope evolution at https://www.gastro.org/news/gi-societies-advise-fda-on-duodenoscope-reprocessing.
Dr. Ketwaroo had no relevant financial disclosures.
The Food and Drug Administration on Dec. 13 cleared Boston Scientific’s single-use duodenoscope, the Exalt Model D, for endoscopic retrograde cholangiopancreatography.
It’s the first disposable duodenoscope to hit the market in the wake of the agency’s August call for manufacturers and health care facilities to move to partially or fully disposable duodenoscopes. The goal is to eliminate the risk of spreading infections between patients from incomplete sterilization of traditional, multi-use scopes. The FDA also recently approved a Pentax duodenoscope with a disposable elevator, the most difficult part to clean.
The agency reported in April that 5.4% of samples from multi-use scopes test positive for Escherichia coli, Pseudomonas aeruginosa, or other “high-concern” organisms.
Boston Scientific spokesperson Kate Haranis said the Exalt Model D will be available in the first quarter of 2020, but the company is still working out how much it will charge.
Cost effectiveness will depend largely on the degree to which the price of the device is offset by the infections it prevents. It might prove particularly attractive to high-volume centers with higher than usual infection rates. It might also be of interest to smaller practices where the price of a multi-use scope doesn’t make sense for only a few procedures a year, said Gyanprakash Ketwaroo, MD, an interventional endoscopist and assistant professor of gastroenterology at Baylor University, Houston.
AGA is working with FDA to ensure physicians continue to have access to ERCP as new devices are introduced to the market and will continue to update members on the latest developments. The GI societies believe that device transitions can be incorporated over the life cycle of current instrumentation, to eliminate the potential for gaps in accessibility of care and to ensure that there is adequate efficacy and safety data to support the adoption of new technology. Review the GI societies’ guiding principles for continued scope evolution at https://www.gastro.org/news/gi-societies-advise-fda-on-duodenoscope-reprocessing.
Dr. Ketwaroo had no relevant financial disclosures.
