Publications

Technology Status Evaluation Reports

Technology status evaluation reports provide a review of existing, new, or emerging endoscopic technologies that have an impact on the practice of GI endoscopy. Reports are based on an evaluation of medical literature and a search of the MAUDE (U.S. Food and Drug Administration Center for Devices and Radiological Health) database to identify the reported adverse events of a given technology. When financial guidance is indicated, the most recent coding data and list prices at the time of publication are provided. Technology status evaluation reports are scientific reviews based on expert consensus and are provided solely for educational and informational purposes.

The members of the ASGE Technology Committee provide ongoing conflict of interest (COI) disclosures throughout the development and publication of all documents in accordance with the ASGE Policy for Managing Declared Conflicts of Interests.

If you have any questions or suggestions, please contact Customer Support at Info@asge.org.

The following information is intended only to provide general information and not as a definitive basis for diagnosis or treatment in any particular case. It is very important that you consult your doctor about your specific condition.

Newly Published
Upper Endoscopy
All assessments
RETs
PIVIs

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors
Colonoscopy
All assessments
PIVIs

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors
Bariatric Endoscopy
All assessments
RETs
PIVIs

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors
ERCP
EUS
All assessments
RETs

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors
Endoscope Design/Reprocessing
All assessments 
RETs

Automated endoscope reprocessors 2016

Jan 18, 2017, 21:50
Approximately 20 million GI endoscopic procedures are performed annually in the United States.1 Transmission of infectious agents by endoscopes is considered to be extremely rare, occurring with an estimated frequency of 1 in 1.8 million procedures.2 However, this infection rate may be an underestimate because of incomplete surveillance, under-reporting, asymptomatic infections, and infections with a long incubation period.3 GI endoscopes are semicritical medical devices and require at least HLD after each use.4 HLD is traditionally defined as complete elimination of all microorganisms in or on an instrument, except for small numbers of bacterial spores.5 It is operationally defined by the FDA as a 6-log reduction of mycobacteria.6 To minimize the risk of transmission of infectious agents, standardized guidelines have been developed for the reprocessing of endoscopes.7-11 The FDA defines reprocessing as validated processes used to render a contaminated medical device fit for a subsequent single use.
Title : Automated endoscope reprocessors 2016
URL :
Doi org link : http://dx.doi.org/10.1016/j.gie.2016.08.025
Volume : Gastrointest Endosc 2016;84:885–892
Select a choice : Keep
Content created : Oct 17, 2016, 00:00
ExternalPK :
File size :
Categories :
  • Endoscope Design and Care
  • Gastrointestinal Endoscopy Journal
  • Infection Control
  • Patient Care
Tags :
Automated_endoscope_reprocessors
Other Imaging Techniques
All assessments
RETs
Therapeutic GI Devices
All assessments
RETs
Miscellaneous
All assessments
RETs

Submucosal injection fluid and tattoo agents 2024

Nov 5, 2024, 11:24
Title : Submucosal injection fluid and tattoo agents 2024
URL :
Doi org link : https://www.giejournal.org/article/S0016-5107(24)03347-9/fulltext
Volume : Gastrointest Endosc 2024; Volume 100, Issue 5; p797-806 DOI: 10.1016/j.gie.2024.07.002
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  • misc

In Progress Technology Assessments

Endoscopic closure devices

2025

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Practice Guidelines

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