TBD Meeting (5257-21)

Disposable duodenoscopes have one irrefutable advantage over their reusable counterparts: They definitively solve the problem of scope-related multidrug-resistant organism (MDRO) infections. Yet they also come with trade-offs, such as increased cost and medical waste, which has triggered pushback from skeptical endoscopists. How endoscopists weigh their differing concerns will ultimately determine the uptake of these devices going forward, according to Andrew S. Ross, MD, medical director for strategic growth at Virginia Mason Medical Center, Seattle.

“What would you pay to not have to deal with the scope infection issue at all?” Dr. Ross asked during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “I think that x-factor is going to depend [on] who you’re talking to and how much they really believe in [duodenoscope-related infection] as an issue.”

Dr. Ross explained that some endoscopists doubt the clinical relevance of duodenoscope-related MDRO infections, possibly because of a lack of direct experience.

“There still is a prevailing sentiment among some endoscopists that duodenoscope infection is really not a problem,” Dr. Ross said. “Or [they may say,]: ‘We haven’t had that issue here in our medical center, so therefore it is not a problem.’ ”

In fact, the exact magnitude of the problem remains unknown.

“In the end, we have an unquantifiable risk to patients wherever [reusable duodenoscopes] are used,” Dr. Ross said.
 

Just how common are scope-related MDRO infections?

According to V. Raman Muthusamy, MD, AGAF, immediate former chair of the AGA Center for GI Innovation and Technology, and director of endoscopy at the University of California, Los Angeles Health System, scope-related MDRO infections are “relatively uncommon,” but they do occur.

MDRO infections are generally linked with contaminated endoscopes, but duodenoscopes are the most common culprit because they pose a unique risk.

“Traditionally, when outbreaks have occurred [with nonduodenoscopes], it has usually been due to a breach in the reprocessing protocol,” Dr. Muthusamy said in an interview. “But with duodenoscopes, we’ve found that that does not appear to be necessary, and that in many cases there are no identified breaches, and yet there are still outbreaks.”

Dr. Muthusamy, the first endoscopist to test a disposable duodenoscope in a human patient, noted that it’s challenging to definitively prove infection from a reusable scope. Citing an Executive Summary from the Food and Drug Administration, he said, “We know it’s happened 300-400 times over the past decade or so,” with infection rates peaking in 2014-2016 and steadily declining since then.

Approximately 5% of reprocessed duodenoscopes harbor pathogenic bacteria, according to Dr. Muthusamy, but the rate of infection is significantly lower.

“[The use of a contaminated duodenoscope] doesn’t mean a patient will actually get sick ... but it does mean the potential exists, obviously,” he said. “It just shows that these devices are hard to clean and a fraction of people have the potential of becoming ill. It’s our goal to improve on those numbers, and really try to eliminate the risk of this problem, as best we can.”
 

Infection isn’t the only concern

There are several potential ways to tackle the issue of scope-related infections, Dr. Ross said during his presentation, including designing devices that are easier to clean and optimizing the cleaning process; however, the only definitive solution is to eliminate cleaning altogether.

This is where disposable duodenoscopes come in.

At present, there are two such FDA-approved devices, the Ascope Duodeno from Ambu and the Exalt Model D from Boston Scientific, both of which Dr. Ross characterized as being “in their infancy.”

Studies testing the Exalt Model D suggest that performance compares favorably with reusable duodenoscopes.

“The scope works in a benchtop model, it works in a lab, and it seems to be functional in expert hands,” Dr. Ross said. “With inexperienced users, we also see that this device works, albeit with a rate of crossover that may approach up to 10%. So, a functional, disposable scope has been produced.”

Despite availability, several pain points may slow adoption, Dr. Ross said, including reluctance to use new technology, skepticism about the clinical impact of scope-related infections, environmental concerns of increased medical waste, and increased cost.

On this latter topic, Dr. Ross pointed out that the true cost of a reusable scope goes beyond the purchase or lease price to include repair costs, reprocessing costs, and, potentially, the cost of litigation from scope-related infection.

“If you have an outbreak in your medical center, you can rest assured that you will have some litigation exposure,” Dr. Ross said.
 

Fitting disposable duodenoscopes into routine practice

Currently, both FDA-approved disposable duodenoscopes are covered by outpatient pass-through reimbursement for Medicare, and in October, both will be covered on an inpatient basis, according to Dr. Ross.

“I think the big question regarding pass-through reimbursement is what happens when the codes get revalued,” he said. “How long will the additional reimbursement stay in place?”

For now, Dr. Ross suggested that endoscopists reach for disposable duodenoscopes in unique scenarios, such as weekend or night procedures, to avoid calling in a scope-reprocessing technician; or in operating room cases when the scope enters a sterile field. Disposable scopes should also be considered for patients with known MDROs, he added, and conversely, for patients who are immunocompromised or critically ill and “can least afford a scope-related infection.”

Ultimately, the role of disposable duodenoscopes may be decided by the patients themselves, Dr. Ross concluded.

“Certainly, patients know about this – they may come in and demand the use of a single-use scope in certain situations,” Dr. Ross said. “We have to remember when we’re bringing any new technology into the marketplace that while it’s important to understand the input and perspectives of multiple stakeholders, the single-most important stakeholder at the end of the day are our patients.”

Dr. Ross disclosed a relationship with Boston Scientific. Dr. Muthusamy disclosed a relationship with Boston Scientific and Medivators.

Disposable duodenoscopes have one irrefutable advantage over their reusable counterparts: They definitively solve the problem of scope-related multidrug-resistant organism (MDRO) infections. Yet they also come with trade-offs, such as increased cost and medical waste, which has triggered pushback from skeptical endoscopists. How endoscopists weigh their differing concerns will ultimately determine the uptake of these devices going forward, according to Andrew S. Ross, MD, medical director for strategic growth at Virginia Mason Medical Center, Seattle.

“What would you pay to not have to deal with the scope infection issue at all?” Dr. Ross asked during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “I think that x-factor is going to depend [on] who you’re talking to and how much they really believe in [duodenoscope-related infection] as an issue.”

Dr. Ross explained that some endoscopists doubt the clinical relevance of duodenoscope-related MDRO infections, possibly because of a lack of direct experience.

“There still is a prevailing sentiment among some endoscopists that duodenoscope infection is really not a problem,” Dr. Ross said. “Or [they may say,]: ‘We haven’t had that issue here in our medical center, so therefore it is not a problem.’ ”

In fact, the exact magnitude of the problem remains unknown.

“In the end, we have an unquantifiable risk to patients wherever [reusable duodenoscopes] are used,” Dr. Ross said.
 

Just how common are scope-related MDRO infections?

According to V. Raman Muthusamy, MD, AGAF, immediate former chair of the AGA Center for GI Innovation and Technology, and director of endoscopy at the University of California, Los Angeles Health System, scope-related MDRO infections are “relatively uncommon,” but they do occur.

MDRO infections are generally linked with contaminated endoscopes, but duodenoscopes are the most common culprit because they pose a unique risk.

“Traditionally, when outbreaks have occurred [with nonduodenoscopes], it has usually been due to a breach in the reprocessing protocol,” Dr. Muthusamy said in an interview. “But with duodenoscopes, we’ve found that that does not appear to be necessary, and that in many cases there are no identified breaches, and yet there are still outbreaks.”

Dr. Muthusamy, the first endoscopist to test a disposable duodenoscope in a human patient, noted that it’s challenging to definitively prove infection from a reusable scope. Citing an Executive Summary from the Food and Drug Administration, he said, “We know it’s happened 300-400 times over the past decade or so,” with infection rates peaking in 2014-2016 and steadily declining since then.

Approximately 5% of reprocessed duodenoscopes harbor pathogenic bacteria, according to Dr. Muthusamy, but the rate of infection is significantly lower.

“[The use of a contaminated duodenoscope] doesn’t mean a patient will actually get sick ... but it does mean the potential exists, obviously,” he said. “It just shows that these devices are hard to clean and a fraction of people have the potential of becoming ill. It’s our goal to improve on those numbers, and really try to eliminate the risk of this problem, as best we can.”
 

Infection isn’t the only concern

There are several potential ways to tackle the issue of scope-related infections, Dr. Ross said during his presentation, including designing devices that are easier to clean and optimizing the cleaning process; however, the only definitive solution is to eliminate cleaning altogether.

This is where disposable duodenoscopes come in.

At present, there are two such FDA-approved devices, the Ascope Duodeno from Ambu and the Exalt Model D from Boston Scientific, both of which Dr. Ross characterized as being “in their infancy.”

Studies testing the Exalt Model D suggest that performance compares favorably with reusable duodenoscopes.

“The scope works in a benchtop model, it works in a lab, and it seems to be functional in expert hands,” Dr. Ross said. “With inexperienced users, we also see that this device works, albeit with a rate of crossover that may approach up to 10%. So, a functional, disposable scope has been produced.”

Despite availability, several pain points may slow adoption, Dr. Ross said, including reluctance to use new technology, skepticism about the clinical impact of scope-related infections, environmental concerns of increased medical waste, and increased cost.

On this latter topic, Dr. Ross pointed out that the true cost of a reusable scope goes beyond the purchase or lease price to include repair costs, reprocessing costs, and, potentially, the cost of litigation from scope-related infection.

“If you have an outbreak in your medical center, you can rest assured that you will have some litigation exposure,” Dr. Ross said.
 

Fitting disposable duodenoscopes into routine practice

Currently, both FDA-approved disposable duodenoscopes are covered by outpatient pass-through reimbursement for Medicare, and in October, both will be covered on an inpatient basis, according to Dr. Ross.

“I think the big question regarding pass-through reimbursement is what happens when the codes get revalued,” he said. “How long will the additional reimbursement stay in place?”

For now, Dr. Ross suggested that endoscopists reach for disposable duodenoscopes in unique scenarios, such as weekend or night procedures, to avoid calling in a scope-reprocessing technician; or in operating room cases when the scope enters a sterile field. Disposable scopes should also be considered for patients with known MDROs, he added, and conversely, for patients who are immunocompromised or critically ill and “can least afford a scope-related infection.”

Ultimately, the role of disposable duodenoscopes may be decided by the patients themselves, Dr. Ross concluded.

“Certainly, patients know about this – they may come in and demand the use of a single-use scope in certain situations,” Dr. Ross said. “We have to remember when we’re bringing any new technology into the marketplace that while it’s important to understand the input and perspectives of multiple stakeholders, the single-most important stakeholder at the end of the day are our patients.”

Dr. Ross disclosed a relationship with Boston Scientific. Dr. Muthusamy disclosed a relationship with Boston Scientific and Medivators.

Disposable duodenoscopes have one irrefutable advantage over their reusable counterparts: They definitively solve the problem of scope-related multidrug-resistant organism (MDRO) infections. Yet they also come with trade-offs, such as increased cost and medical waste, which has triggered pushback from skeptical endoscopists. How endoscopists weigh their differing concerns will ultimately determine the uptake of these devices going forward, according to Andrew S. Ross, MD, medical director for strategic growth at Virginia Mason Medical Center, Seattle.

“What would you pay to not have to deal with the scope infection issue at all?” Dr. Ross asked during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology. “I think that x-factor is going to depend [on] who you’re talking to and how much they really believe in [duodenoscope-related infection] as an issue.”

Dr. Ross explained that some endoscopists doubt the clinical relevance of duodenoscope-related MDRO infections, possibly because of a lack of direct experience.

“There still is a prevailing sentiment among some endoscopists that duodenoscope infection is really not a problem,” Dr. Ross said. “Or [they may say,]: ‘We haven’t had that issue here in our medical center, so therefore it is not a problem.’ ”

In fact, the exact magnitude of the problem remains unknown.

“In the end, we have an unquantifiable risk to patients wherever [reusable duodenoscopes] are used,” Dr. Ross said.
 

Just how common are scope-related MDRO infections?

According to V. Raman Muthusamy, MD, AGAF, immediate former chair of the AGA Center for GI Innovation and Technology, and director of endoscopy at the University of California, Los Angeles Health System, scope-related MDRO infections are “relatively uncommon,” but they do occur.

MDRO infections are generally linked with contaminated endoscopes, but duodenoscopes are the most common culprit because they pose a unique risk.

“Traditionally, when outbreaks have occurred [with nonduodenoscopes], it has usually been due to a breach in the reprocessing protocol,” Dr. Muthusamy said in an interview. “But with duodenoscopes, we’ve found that that does not appear to be necessary, and that in many cases there are no identified breaches, and yet there are still outbreaks.”

Dr. Muthusamy, the first endoscopist to test a disposable duodenoscope in a human patient, noted that it’s challenging to definitively prove infection from a reusable scope. Citing an Executive Summary from the Food and Drug Administration, he said, “We know it’s happened 300-400 times over the past decade or so,” with infection rates peaking in 2014-2016 and steadily declining since then.

Approximately 5% of reprocessed duodenoscopes harbor pathogenic bacteria, according to Dr. Muthusamy, but the rate of infection is significantly lower.

“[The use of a contaminated duodenoscope] doesn’t mean a patient will actually get sick ... but it does mean the potential exists, obviously,” he said. “It just shows that these devices are hard to clean and a fraction of people have the potential of becoming ill. It’s our goal to improve on those numbers, and really try to eliminate the risk of this problem, as best we can.”
 

Infection isn’t the only concern

There are several potential ways to tackle the issue of scope-related infections, Dr. Ross said during his presentation, including designing devices that are easier to clean and optimizing the cleaning process; however, the only definitive solution is to eliminate cleaning altogether.

This is where disposable duodenoscopes come in.

At present, there are two such FDA-approved devices, the Ascope Duodeno from Ambu and the Exalt Model D from Boston Scientific, both of which Dr. Ross characterized as being “in their infancy.”

Studies testing the Exalt Model D suggest that performance compares favorably with reusable duodenoscopes.

“The scope works in a benchtop model, it works in a lab, and it seems to be functional in expert hands,” Dr. Ross said. “With inexperienced users, we also see that this device works, albeit with a rate of crossover that may approach up to 10%. So, a functional, disposable scope has been produced.”

Despite availability, several pain points may slow adoption, Dr. Ross said, including reluctance to use new technology, skepticism about the clinical impact of scope-related infections, environmental concerns of increased medical waste, and increased cost.

On this latter topic, Dr. Ross pointed out that the true cost of a reusable scope goes beyond the purchase or lease price to include repair costs, reprocessing costs, and, potentially, the cost of litigation from scope-related infection.

“If you have an outbreak in your medical center, you can rest assured that you will have some litigation exposure,” Dr. Ross said.
 

Fitting disposable duodenoscopes into routine practice

Currently, both FDA-approved disposable duodenoscopes are covered by outpatient pass-through reimbursement for Medicare, and in October, both will be covered on an inpatient basis, according to Dr. Ross.

“I think the big question regarding pass-through reimbursement is what happens when the codes get revalued,” he said. “How long will the additional reimbursement stay in place?”

For now, Dr. Ross suggested that endoscopists reach for disposable duodenoscopes in unique scenarios, such as weekend or night procedures, to avoid calling in a scope-reprocessing technician; or in operating room cases when the scope enters a sterile field. Disposable scopes should also be considered for patients with known MDROs, he added, and conversely, for patients who are immunocompromised or critically ill and “can least afford a scope-related infection.”

Ultimately, the role of disposable duodenoscopes may be decided by the patients themselves, Dr. Ross concluded.

“Certainly, patients know about this – they may come in and demand the use of a single-use scope in certain situations,” Dr. Ross said. “We have to remember when we’re bringing any new technology into the marketplace that while it’s important to understand the input and perspectives of multiple stakeholders, the single-most important stakeholder at the end of the day are our patients.”

Dr. Ross disclosed a relationship with Boston Scientific. Dr. Muthusamy disclosed a relationship with Boston Scientific and Medivators.

GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.

AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.

“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
 

The trouble with using risk scores

A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.

“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.

He pointed out that low implementation may also stem from poorly defined clinical responsibilities.

“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”

To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.

Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
 

Google Maps for GI bleeding

“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”

In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.

Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.

“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
 

The road to clinical implementation

With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.

In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.

“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”

In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.

“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”

The investigators disclosed no relevant conflicts of interest.

GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.

AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.

“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
 

The trouble with using risk scores

A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.

“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.

He pointed out that low implementation may also stem from poorly defined clinical responsibilities.

“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”

To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.

Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
 

Google Maps for GI bleeding

“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”

In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.

Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.

“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
 

The road to clinical implementation

With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.

In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.

“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”

In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.

“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”

The investigators disclosed no relevant conflicts of interest.

GI Genius recently became the first Food and Drug Administration–approved device to use artificial intelligence (AI) for endoscopy. Soon, similar technology may give gastroenterologists an edge before they even walk into the procedure room.

AI can provide highly accurate risk scores for patients with suspected upper GI bleeding, and make a recommendation for discharge or hospitalization, according to Dennis Shung, MD, MHS, a clinical instructor at Yale University, New Haven, Conn. And this could provide extensive benefit.

“Acute gastrointestinal bleeding is the most common gastrointestinal diagnosis requiring hospitalization. It costs around $19.2 billion per year,” Dr. Shung said, citing a study from Gastroenterology. He made these remarks during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Emergency department visits for upper GI bleeding increased 17% from 2006 to 2014, Dr. Shung added, suggesting a rising trend.
 

The trouble with using risk scores

A variety of conventional risk scores are presently available to help manage these patients. Generally, they use a composite outcome of hemostatic intervention, transfusion, or death to determine which patients should be hospitalized (high risk) and which patients can go home (low risk). Although these models can offer high sensitivity, they remain underutilized.

“[Clinical risk scores] are cumbersome, it’s difficult to calculate them, [and] you may not remember to do that in your busy workflow,” Dr. Shung said.

He pointed out that low implementation may also stem from poorly defined clinical responsibilities.

“[Observing] providers caring for patients with GI bleeding showed that there was a culture of not taking ownership,” he said. “Emergency department physicians thought that it was the gastroenterologists who needed to [perform risk scoring]. Gastroenterologists thought it was the ED [physicians’ responsibility].”

To overcome these pitfalls, Dr. Shung and colleagues are developing AI that automates risk analysis for upper GI bleeding by integrating the process into the clinical workflow. Like GI Genius, their strategy relies upon machine learning, which is a type of AI that can improve automatically without being explicitly programmed.

Their most recent study (Sci Rep. 2021 Apr 23;11[1]:8827) involved a machine learning model that could predict transfusion in patients admitted for acute GI bleeding. The model was developed and internally validated in a cohort of 2,524 patients, then shown to outperform conventional regression-based models when externally validated in 1,526 patients similarly admitted at large urban hospitals.
 

Google Maps for GI bleeding

“The future, as I envision it, is a Google Maps for GI bleeding,” Dr. Shung said, referring to how the popular web-mapping product analyzes real-time data, such as weather and traffic patterns, to provide the best route and an estimated time of arrival. “With the electronic health record, we have the ability to personalize care by basically using data obtained during the clinical encounter to generate risk assessment in real time.”

In other words, machine learning software reads a patient’s electronic health record, runs relevant data through an algorithm, and produces both a risk score and a clinical recommendation. In the case of suspected upper GI bleeding, the clinician is advised to either discharge for outpatient endoscopy or hospitalize for inpatient evaluation.

Because the quality and consistency of data in EHRs can vary, the most advanced form of machine learning – deep learning – is needed to make this a clinical reality. Deep learning converts simpler concepts into complex ones. In this scenario, that would mean deciding which clinical data are relevant and which are just noise. Taking this a step further, deep learning can actually “draw conclusions” from what’s missing.

“There are huge challenges in [irregular data] that need to be overcome,” Dr. Shung said in an interview. “But I see it as an opportunity. When you see things that are irregularly sampled, when you see things are missing – they mean something. They mean that a human has decided that that is not the way we should do things because this patient doesn’t need it. And I think there is a lot of value in learning how to model those things.”
 

The road to clinical implementation

With further research and validation, deep learning models for gastroenterology are likely to play a role in clinical decision-making, according to Dr. Shung. But to reach the clinic floor, developers will need to outsmart some more fundamental obstacles. “The main thing that’s really barring [AI risk modeling] from being used is the reimbursement issue,” he said, referring to uncertainty in how payers will cover associated costs.

In an interview, Sushovan Guha, MD, PhD, moderator of the virtual session and codirector of the center for interventional gastroenterology at UTHealth (iGUT) in Houston, pointed out another financial unknown: liability.

“What happens if there is an error?” he asked. “It’s done by the computers, but who is at fault?”

In addition to these challenges, some clinicians may need to be persuaded before they are willing to trust an algorithm with a patient’s life.

“We have to have community physicians convinced about the importance of using these tools to further improve their clinical practice,” Dr. Guha said. To this end, he added, “It’s time for us to accept and adapt, and make our decision-making process much more efficient.”

The investigators disclosed no relevant conflicts of interest.

William of Ockham would have been proud because, at this year’s American Gastroenterological Association’s Shark Tank pitch competition, one product clearly demonstrated Ockham’s razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Courtesy Dr. Toufic Kachaamy

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That’s it. A needle. But not like any other needle.


 

Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle

This EUS-guided access needle, invented by Dr. Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Dr. Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

“[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it,” Dr. Kachaamy said. “[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing.”

Dr. Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Dr. Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

“For people who are innovators, there’s nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”

Dr. Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.


 

A shark speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it “the highlight” of the AGA Tech Summit.

Dr. Muthusamy and four other “sharks,” including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

“We saw a full spectrum [of innovations],” Dr. Muthusamy said. “I think it was an enjoyable session.”

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.

“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Dr. Muthusamy also noted that several product designs previously failed to achieve what the EUS-guided access needle has the potential to do.

“I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we’ve had with earlier [attempts at solving this problem],” Dr. Muthusamy said.

For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.

“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. Muthusamy said.
 

Other fish in the sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. Gregersen said.

The balloon device, which contains multiple sensors, provides “real-time, quantitative, and mechanistic insights by simulating defecation.”

“It ... is inserted into the rectum,” Dr. Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device.”

According to Dr. Gregersen, Fecobionics has “diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation.” He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Dr. Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System (TAGSS)
TAGSS is a trans-abdominal gastric access device that “represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach,” Ms. Pattison said. “Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration.”

Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App
“At this time, most patient education is provided by Dr. Google,” Dr. Rajvanshi said, “and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis.”

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Dr. Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions
“I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally,” Dr. Karakurum said. “The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal.”

Dr. Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article was updated 5/14/21.

William of Ockham would have been proud because, at this year’s American Gastroenterological Association’s Shark Tank pitch competition, one product clearly demonstrated Ockham’s razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Courtesy Dr. Toufic Kachaamy

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That’s it. A needle. But not like any other needle.


 

Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle

This EUS-guided access needle, invented by Dr. Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Dr. Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

“[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it,” Dr. Kachaamy said. “[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing.”

Dr. Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Dr. Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

“For people who are innovators, there’s nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”

Dr. Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.


 

A shark speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it “the highlight” of the AGA Tech Summit.

Dr. Muthusamy and four other “sharks,” including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

“We saw a full spectrum [of innovations],” Dr. Muthusamy said. “I think it was an enjoyable session.”

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.

“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Dr. Muthusamy also noted that several product designs previously failed to achieve what the EUS-guided access needle has the potential to do.

“I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we’ve had with earlier [attempts at solving this problem],” Dr. Muthusamy said.

For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.

“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. Muthusamy said.
 

Other fish in the sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. Gregersen said.

The balloon device, which contains multiple sensors, provides “real-time, quantitative, and mechanistic insights by simulating defecation.”

“It ... is inserted into the rectum,” Dr. Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device.”

According to Dr. Gregersen, Fecobionics has “diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation.” He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Dr. Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System (TAGSS)
TAGSS is a trans-abdominal gastric access device that “represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach,” Ms. Pattison said. “Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration.”

Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App
“At this time, most patient education is provided by Dr. Google,” Dr. Rajvanshi said, “and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis.”

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Dr. Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions
“I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally,” Dr. Karakurum said. “The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal.”

Dr. Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article was updated 5/14/21.

William of Ockham would have been proud because, at this year’s American Gastroenterological Association’s Shark Tank pitch competition, one product clearly demonstrated Ockham’s razor – that sometimes the simplest solution is best – and came away as the winner at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.

Courtesy Dr. Toufic Kachaamy

Out of five innovative products, ranging from an educational app to a high-tech anorectal sensor, all aimed at improving outcomes in patients with gastrointestinal disorders, the winner was ... drumroll please ...

A needle.

That’s it. A needle. But not like any other needle.


 

Winner: Toufic Kachaamy, MD, FASGE, AGAF – An EUS-guided access needle

This EUS-guided access needle, invented by Dr. Kachaamy, enterprise clinical leader at Cancer Treatment Centers of America, Phoenix, is a simple device that overcomes a longstanding challenge presented by endoscopic retrograde cholangiopancreatography (ERCP): biliary access.

Many “ERCPs are considered difficult, and sometimes fail, depending on the center and the endoscopist,” Dr. Kachaamy said during a virtual presentation. “Most failures are due to failed initial access to the bile duct.”

Indeed, one study cited a failure rate in ductal cannulation of 5%-15% even among experienced hands.

Failure can have several consequences, Dr. Kachaamy noted, including increased complications, higher cost, delayed care, longer hospitalization, and greater likelihood of patient transfer.

He went on to explain why biliary access can be so challenging and how this EUS-guided access needle helps address these issues.

“[The] two main limitations [during endoscopic ultrasound–guided biliary access] are directing the wire into the narrowed areas and the wire shearing as we are manipulating the wire to get it to where we want it,” Dr. Kachaamy said. “[This EUS-guided access needle] is a 19-22 gauge, rotatable needle with a smooth, side exit for the wire to allow wire manipulation and direction without shearing.”

Dr. Kachaamy highlighted the simple design, which will keep the production cost below $300 per unit, and suggested that failed ERCPs are just the first potential indication of many. Future uses may include gallbladder access, peri-GI collection, gastrojejunostomy, and others.

In an interview, Dr. Kachaamy reacted to the win, which follows 2 years of collaborative development with Cancer Treatment Centers of America.

“For people who are innovators, there’s nothing that feels more rewarding than their ideas being recognized as adding something to the field and potentially helping people and patients,” Dr. Kachaamy said. “So [this is] very, very, very exciting. Very rewarding. Pride would probably be the best way I’d describe it.”

Dr. Kachaamy anticipates that this EUS-guided access needle will be commercially available within 1-2 years, pending regulatory approval. In the meantime, he and his colleagues are seeking a strategic partner.


 

A shark speaks

V. Raman Muthusamy, MD, AGAF, immediate past chair of the AGA Center for GI Innovation and Technology and director of endoscopy at UCLA Health System, moderated the Shark Tank session, calling it “the highlight” of the AGA Tech Summit.

Dr. Muthusamy and four other “sharks,” including a gastroenterologist, venture capitalist, regulatory device reviewer, and entrepreneur, scored the pitches using three equally weighted categories: the quality of the pitch, the level of innovation and impact on the field, and the quality of the business plan and overall feasibility.

“We saw a full spectrum [of innovations],” Dr. Muthusamy said. “I think it was an enjoyable session.”

Behind closed doors, the sharks narrowed the field to two top contenders. Ultimately, however, there could be only one winner: Dr. Kachaamy. Their decision aligned with a “Fan Favorite” audience poll.

“A lot of [Dr. Kachaamy’s win] had to do with the potential applications and commonality of the problem,” Dr. Muthusamy said in an interview. He highlighted how the EUS-guided access needle allows for an immediate response to ERCP failure without the need for a second procedure.

Dr. Muthusamy also noted that several product designs previously failed to achieve what the EUS-guided access needle has the potential to do.

“I think the feeling was that this seemed to be a way that may address some of the limitations and challenges that we’ve had with earlier [attempts at solving this problem],” Dr. Muthusamy said.

For innovators who didn’t make the cut this year, or those with products still in development, Dr. Muthusamy suggested applying next year.

“We encourage our colleagues and members of the AGA to continue to apply to this program,” Dr. Muthusamy said.
 

Other fish in the sea

Four other innovators entered the AGA Shark Tank this year. Here are snippets of their pitches:

Hans Gregersen, MD, PhD, MPH – Fecobionics
“Fecobionics is a simulated electronic stool with the consistency and shape of normal stool,” Dr. Gregersen said.

The balloon device, which contains multiple sensors, provides “real-time, quantitative, and mechanistic insights by simulating defecation.”

“It ... is inserted into the rectum,” Dr. Gregersen said. “It measures multiple pressures; it has gyroscopes that measure orientation; we can compute the bending of the device; and we can calculate the shape of the device.”

According to Dr. Gregersen, Fecobionics has “diagnostic potential for patients with fecal incontinence and for subtyping patients with constipation.” He highlighted fewer false-positives than current technology, alongside greater efficiency and lower cost.

Dr. Gregersen is a research professor at California Medical Innovations Institute, San Diego.

Mary J. Pattison, RN – Trans-Abdominal Gastric Surgical System (TAGSS)
TAGSS is a trans-abdominal gastric access device that “represents a novel and exciting means to address multiple gastrointestinal conditions that are without a standardized approach,” Ms. Pattison said. “Placed as simply as a [percutaneous endoscopic gastrostomy tube], TAGSS offers disruptive technology to address [gastroesophageal reflux disease], fundoplication, achalasia, gastroparesis, gastric tumors, and even obesity in a safe, efficient, and cost effective manner. TAGSS offers the first true hybrid approach for endoscopic/laparoscopic collaboration.”

Ms. Pattison is a nurse clinician and endoscopy assistant at WestGlen GI Consultants, Weston, Mo.

Pankaj Rajvanshi, MD, FAASLD – Healthswim App
“At this time, most patient education is provided by Dr. Google,” Dr. Rajvanshi said, “and we want to change that. We have built a platform which allows you, the physician, to create custom, curated, credible content that can be delivered seamlessly to your patients on an ongoing basis.”

Through the Healthswim app, patients subscribe to their providers, allowing access physician-approved content. Subscribers also receive provider updates through their social media feeds.

Dr. Rajvanshi is a gastroenterologist at Swedish Medical Center, Seattle.

Ali S. Karakurum, MD, FACP, FACG – A Device for Removal of Esophageal Food Impactions
“I would like to propose a device which consists of a clear overtube, a collapsible plastic cylindrical basket secured to the distal end of the overtube ... and a snare wire attached to the distal end of the basket which is controlled by the snare handle externally,” Dr. Karakurum said. “The device is ... gradually advanced over the scope for the basket to encompass the food bolus under direct visualization. Once the food bolus is within the basket, the wire loop at the end of the basket is closed via the external handle, securing the food bolus in the basket for safe removal.”

Dr. Karakurum is a gastroenterologist at Advanced Gastroenterology & Endoscopy, Port Jefferson, N.Y.

This article was updated 5/14/21.

Endoscopists are at high risk of musculoskeletal issues, and a multifaceted strategy is needed to reduce rates of injury, including better body posture and endoscopic suite layout, according to leading experts.

Andrey Shevchuk/iStock/Getty Images

Latha Alaparthi, MD, director of committee operations at Gastroenterology Center of Connecticut, Hamden, and assistant clinical professor at Yale University, New Haven, Conn., noted that female gastroenterologists are at particular risk because they often work with outsize equipment and suboptimal room setup.

“I think it’s something for us to recognize, and [we need to] find ways to protect ourselves,” Dr. Alaparthi said during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
 

Prevalence of musculoskeletal injuries in gastroenterology

Gastroenterologists spend 43% of their time performing procedures, Dr. Alaparthi said, and all those hours take a toll on the body. Up to 89% of gastroenterologists report musculoskeletal symptoms – most often back pain, followed by neck pain and hand pain.

Even newcomers to the field are at risk, she added, noting that 47% of gastroenterology fellows report injury in their first year of training. And with one out of three fellows now female, the issue may be a growing concern.

“As female gastroenterologists, we are even more at risk,” Dr. Alaparthi said. This is partly due to differences in equipment and room design, which “take into consideration 5% of female average measurements and 95% of that of males.”

The resultant injuries may be enough to drive female doctors from the field. Dr. Alaparthi recounted her colleague’s experience in leaving gastroenterology for the pharmaceutical industry after experiencing ongoing neck pain.

“She called me and said 1 week after she stopped doing endoscopies, her neck pain was gone.”

For gastroenterologists of any gender, musculoskeletal injuries can cause pain and suffering, reduced quality of life, lost or reduced work output, short-term or permanent disability, lost wages, and impediment to career advancement. Yet physicians aren’t the only stakeholders affected by these injuries. Employers stand to lose financially from decreased productivity and increased compensation costs.

“[Injuries have] implications not just to the individual but to the company and to patient care,” Dr. Alaparthi said.

She went on to suggest that an effective solution to the problem will require efforts from both gastroenterologists and institutions, including greater self-awareness of body positioning, access to anthropometrically suitable equipment, better room design, and a work culture that supports breaks during procedures, if needed.

“We definitely need programs to provide comprehensive work force injury prevention and protection specific to GI endoscopy – not just for gastroenterologists, but for the whole team involved.”

Ergonomics in endoscopy training

Presenting after Dr. Alaparthi, Katherine Garman, MD, associate professor of medicine and vice chief of research, gastroenterology, at Duke University, Durham, N.C., offered ways to incorporate ergonomics into an endoscopy training curriculum.

“Ergonomics evaluates how a job can best fit to an individual, instead of forcing an individual to fit into a job,” Dr. Garman said. “[This] is a really important concept when we think about training,”

Yet this concept may run counter to most fellows’ natural instinct to fit in and avoid being obtrusive, she noted.

“We need to think about empowering [fellows] from the very beginning to be proactive about how [they] interact with the equipment and the space,” Dr. Garman said. “[They should know] it is perfectly acceptable to adjust the monitor height, move the bed height to an appropriate level, and make the space comfortable ... at the beginning of what should be a long, productive career.”

Dr. Garman offered several more key points to include in a training program, including increased postural awareness, microbreaks during procedures, and early intervention for prior injuries that may increase risk.

“We’ve had fellows who’ve come in who’ve had fractures, wrist [injuries], shoulder injuries,” she said. “We advise early consultation with a physical therapist for those fellows.”

In a recently published study, Dr. Garman and colleagues invited a physical therapist into the endoscopy suite, allowing for real-time assessment of ergonomic positioning and posturing, as well as wellness planning. Out of eight participating endoscopists, all said that the posture education and procedure suite recommendations were helpful, 87.5% said that the pictures of their posture and movement analysis were helpful, 50% said that the pain education was helpful, and 25% found the personalized exercise plans helpful.

“Endoscopists are not always excited about doing exercises at home,” Dr. Garman said.
 

The ergonomically optimized endoscopy suite

In the next presentation, Mehnaz Shafi, MD, professor of medicine and ad interim chair of the department of gastroenterology, hepatology, and nutrition at MD Anderson Cancer Center, Houston, described how clinicians and institutions can create ergonomically optimized endoscopy suites.

She began by reviewing specific causes of injury, including repetitive motion, high pinch force, and awkward posture, the latter of which can lead to microtrauma, inflammation, and connective tissue injury.

According to Dr. Shafi, endoscopists should stand in a neutral position with back straight and knees slightly bent. The patient should be positioned at the edge of the bed, which should be 85-120 cm off the floor. Monitors should be 93-162 cm off the floor and 15-25 degrees below eye level. When interacting with multiple monitors, endoscopists should rotate their entire bodies to maintain a neutral position. Hands and elbows also should be kept neutral, with less than 10 degrees of angulation from the height of the bed. To ensure safer hand grip, Dr. Shafi suggested removing any cord loops that may increase tension and using a towel to more evenly distribute gripping force.

Finally, Dr. Shafi encouraged awareness of other room hazards, such as slippery floors and exposed wires and tubing.

The presenters reported having no conflicts of interest.

This article was updated May 5, 2021.

Endoscopists are at high risk of musculoskeletal issues, and a multifaceted strategy is needed to reduce rates of injury, including better body posture and endoscopic suite layout, according to leading experts.

Andrey Shevchuk/iStock/Getty Images

Latha Alaparthi, MD, director of committee operations at Gastroenterology Center of Connecticut, Hamden, and assistant clinical professor at Yale University, New Haven, Conn., noted that female gastroenterologists are at particular risk because they often work with outsize equipment and suboptimal room setup.

“I think it’s something for us to recognize, and [we need to] find ways to protect ourselves,” Dr. Alaparthi said during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
 

Prevalence of musculoskeletal injuries in gastroenterology

Gastroenterologists spend 43% of their time performing procedures, Dr. Alaparthi said, and all those hours take a toll on the body. Up to 89% of gastroenterologists report musculoskeletal symptoms – most often back pain, followed by neck pain and hand pain.

Even newcomers to the field are at risk, she added, noting that 47% of gastroenterology fellows report injury in their first year of training. And with one out of three fellows now female, the issue may be a growing concern.

“As female gastroenterologists, we are even more at risk,” Dr. Alaparthi said. This is partly due to differences in equipment and room design, which “take into consideration 5% of female average measurements and 95% of that of males.”

The resultant injuries may be enough to drive female doctors from the field. Dr. Alaparthi recounted her colleague’s experience in leaving gastroenterology for the pharmaceutical industry after experiencing ongoing neck pain.

“She called me and said 1 week after she stopped doing endoscopies, her neck pain was gone.”

For gastroenterologists of any gender, musculoskeletal injuries can cause pain and suffering, reduced quality of life, lost or reduced work output, short-term or permanent disability, lost wages, and impediment to career advancement. Yet physicians aren’t the only stakeholders affected by these injuries. Employers stand to lose financially from decreased productivity and increased compensation costs.

“[Injuries have] implications not just to the individual but to the company and to patient care,” Dr. Alaparthi said.

She went on to suggest that an effective solution to the problem will require efforts from both gastroenterologists and institutions, including greater self-awareness of body positioning, access to anthropometrically suitable equipment, better room design, and a work culture that supports breaks during procedures, if needed.

“We definitely need programs to provide comprehensive work force injury prevention and protection specific to GI endoscopy – not just for gastroenterologists, but for the whole team involved.”

Ergonomics in endoscopy training

Presenting after Dr. Alaparthi, Katherine Garman, MD, associate professor of medicine and vice chief of research, gastroenterology, at Duke University, Durham, N.C., offered ways to incorporate ergonomics into an endoscopy training curriculum.

“Ergonomics evaluates how a job can best fit to an individual, instead of forcing an individual to fit into a job,” Dr. Garman said. “[This] is a really important concept when we think about training,”

Yet this concept may run counter to most fellows’ natural instinct to fit in and avoid being obtrusive, she noted.

“We need to think about empowering [fellows] from the very beginning to be proactive about how [they] interact with the equipment and the space,” Dr. Garman said. “[They should know] it is perfectly acceptable to adjust the monitor height, move the bed height to an appropriate level, and make the space comfortable ... at the beginning of what should be a long, productive career.”

Dr. Garman offered several more key points to include in a training program, including increased postural awareness, microbreaks during procedures, and early intervention for prior injuries that may increase risk.

“We’ve had fellows who’ve come in who’ve had fractures, wrist [injuries], shoulder injuries,” she said. “We advise early consultation with a physical therapist for those fellows.”

In a recently published study, Dr. Garman and colleagues invited a physical therapist into the endoscopy suite, allowing for real-time assessment of ergonomic positioning and posturing, as well as wellness planning. Out of eight participating endoscopists, all said that the posture education and procedure suite recommendations were helpful, 87.5% said that the pictures of their posture and movement analysis were helpful, 50% said that the pain education was helpful, and 25% found the personalized exercise plans helpful.

“Endoscopists are not always excited about doing exercises at home,” Dr. Garman said.
 

The ergonomically optimized endoscopy suite

In the next presentation, Mehnaz Shafi, MD, professor of medicine and ad interim chair of the department of gastroenterology, hepatology, and nutrition at MD Anderson Cancer Center, Houston, described how clinicians and institutions can create ergonomically optimized endoscopy suites.

She began by reviewing specific causes of injury, including repetitive motion, high pinch force, and awkward posture, the latter of which can lead to microtrauma, inflammation, and connective tissue injury.

According to Dr. Shafi, endoscopists should stand in a neutral position with back straight and knees slightly bent. The patient should be positioned at the edge of the bed, which should be 85-120 cm off the floor. Monitors should be 93-162 cm off the floor and 15-25 degrees below eye level. When interacting with multiple monitors, endoscopists should rotate their entire bodies to maintain a neutral position. Hands and elbows also should be kept neutral, with less than 10 degrees of angulation from the height of the bed. To ensure safer hand grip, Dr. Shafi suggested removing any cord loops that may increase tension and using a towel to more evenly distribute gripping force.

Finally, Dr. Shafi encouraged awareness of other room hazards, such as slippery floors and exposed wires and tubing.

The presenters reported having no conflicts of interest.

This article was updated May 5, 2021.

Endoscopists are at high risk of musculoskeletal issues, and a multifaceted strategy is needed to reduce rates of injury, including better body posture and endoscopic suite layout, according to leading experts.

Andrey Shevchuk/iStock/Getty Images

Latha Alaparthi, MD, director of committee operations at Gastroenterology Center of Connecticut, Hamden, and assistant clinical professor at Yale University, New Haven, Conn., noted that female gastroenterologists are at particular risk because they often work with outsize equipment and suboptimal room setup.

“I think it’s something for us to recognize, and [we need to] find ways to protect ourselves,” Dr. Alaparthi said during a virtual presentation at the 2021 AGA Tech Summit sponsored by the AGA Center for GI Innovation and Technology.
 

Prevalence of musculoskeletal injuries in gastroenterology

Gastroenterologists spend 43% of their time performing procedures, Dr. Alaparthi said, and all those hours take a toll on the body. Up to 89% of gastroenterologists report musculoskeletal symptoms – most often back pain, followed by neck pain and hand pain.

Even newcomers to the field are at risk, she added, noting that 47% of gastroenterology fellows report injury in their first year of training. And with one out of three fellows now female, the issue may be a growing concern.

“As female gastroenterologists, we are even more at risk,” Dr. Alaparthi said. This is partly due to differences in equipment and room design, which “take into consideration 5% of female average measurements and 95% of that of males.”

The resultant injuries may be enough to drive female doctors from the field. Dr. Alaparthi recounted her colleague’s experience in leaving gastroenterology for the pharmaceutical industry after experiencing ongoing neck pain.

“She called me and said 1 week after she stopped doing endoscopies, her neck pain was gone.”

For gastroenterologists of any gender, musculoskeletal injuries can cause pain and suffering, reduced quality of life, lost or reduced work output, short-term or permanent disability, lost wages, and impediment to career advancement. Yet physicians aren’t the only stakeholders affected by these injuries. Employers stand to lose financially from decreased productivity and increased compensation costs.

“[Injuries have] implications not just to the individual but to the company and to patient care,” Dr. Alaparthi said.

She went on to suggest that an effective solution to the problem will require efforts from both gastroenterologists and institutions, including greater self-awareness of body positioning, access to anthropometrically suitable equipment, better room design, and a work culture that supports breaks during procedures, if needed.

“We definitely need programs to provide comprehensive work force injury prevention and protection specific to GI endoscopy – not just for gastroenterologists, but for the whole team involved.”

Ergonomics in endoscopy training

Presenting after Dr. Alaparthi, Katherine Garman, MD, associate professor of medicine and vice chief of research, gastroenterology, at Duke University, Durham, N.C., offered ways to incorporate ergonomics into an endoscopy training curriculum.

“Ergonomics evaluates how a job can best fit to an individual, instead of forcing an individual to fit into a job,” Dr. Garman said. “[This] is a really important concept when we think about training,”

Yet this concept may run counter to most fellows’ natural instinct to fit in and avoid being obtrusive, she noted.

“We need to think about empowering [fellows] from the very beginning to be proactive about how [they] interact with the equipment and the space,” Dr. Garman said. “[They should know] it is perfectly acceptable to adjust the monitor height, move the bed height to an appropriate level, and make the space comfortable ... at the beginning of what should be a long, productive career.”

Dr. Garman offered several more key points to include in a training program, including increased postural awareness, microbreaks during procedures, and early intervention for prior injuries that may increase risk.

“We’ve had fellows who’ve come in who’ve had fractures, wrist [injuries], shoulder injuries,” she said. “We advise early consultation with a physical therapist for those fellows.”

In a recently published study, Dr. Garman and colleagues invited a physical therapist into the endoscopy suite, allowing for real-time assessment of ergonomic positioning and posturing, as well as wellness planning. Out of eight participating endoscopists, all said that the posture education and procedure suite recommendations were helpful, 87.5% said that the pictures of their posture and movement analysis were helpful, 50% said that the pain education was helpful, and 25% found the personalized exercise plans helpful.

“Endoscopists are not always excited about doing exercises at home,” Dr. Garman said.
 

The ergonomically optimized endoscopy suite

In the next presentation, Mehnaz Shafi, MD, professor of medicine and ad interim chair of the department of gastroenterology, hepatology, and nutrition at MD Anderson Cancer Center, Houston, described how clinicians and institutions can create ergonomically optimized endoscopy suites.

She began by reviewing specific causes of injury, including repetitive motion, high pinch force, and awkward posture, the latter of which can lead to microtrauma, inflammation, and connective tissue injury.

According to Dr. Shafi, endoscopists should stand in a neutral position with back straight and knees slightly bent. The patient should be positioned at the edge of the bed, which should be 85-120 cm off the floor. Monitors should be 93-162 cm off the floor and 15-25 degrees below eye level. When interacting with multiple monitors, endoscopists should rotate their entire bodies to maintain a neutral position. Hands and elbows also should be kept neutral, with less than 10 degrees of angulation from the height of the bed. To ensure safer hand grip, Dr. Shafi suggested removing any cord loops that may increase tension and using a towel to more evenly distribute gripping force.

Finally, Dr. Shafi encouraged awareness of other room hazards, such as slippery floors and exposed wires and tubing.

The presenters reported having no conflicts of interest.

This article was updated May 5, 2021.