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The Future of Endoscopy Starts Now

Sterile Single-use Endoscopy

We want to simplify endoscopy

The single most important question in healthcare today is how to improve patient outcomes with the resources available. And as the world population increases and life expectancy expands, the pressure mounts on hospital budgets, workflow efficiency and, ultimately, patient safety.

Flexible endoscopes raise specific problems because they are costly to purchase, reprocess and repair, they are not always available when you need them, and their use risks exposing patients to infections.

We believe that the challenges in flexible endoscopy should be addressed with single-use devices, and for more than a decade we have been harnessing the technology. 

Single-use endoscopy is the future

  • check No reprocessing

  • check No cross-contamination

  • check No availability issues

  • check Transparent contracts

  • check Cost-effective setup

Increasing concern of cross-contamination is led by outbreaks

There is a need for a change in endoscopy

Mar 2015

FDA guidance on reprocessing

FDA issues final guidance on reprocessing of medical devices

 

Aug 2015

FDA WARNING LETTERS ISSUED

FDA issues warning letters to Olympus, Pentax and Fujifilm for failing to report MDRs to FDA on reusable scopes

 

Sep 2015

FDA WARNING STATEMENT

FDA issues safety communication regarding infections caused by reprocessing process on flexible bronchoscopes

 

Nov 2015

IMPROPER CLEANING SPREADING DISEASES

Inadequate “Cleaning of Flexible Endoscopes Before Disinfection Can Spread Deadly Pathogens” is #1 on ECRI Top 10 Health Technology Hazards for 2016

 

Jan 2017

CDC SAFETY ALERT ISSUE

CDC releases “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPAC

 

Mar 2018

FDA WARNING LETTERS ISSUED

FDA warns Olympus, Pentax and Fujifilm to prevent infections associated with the transmission of bacteria from contaminated duodenoscopes

 

Reusable endoscopy

A complex and costly setup putting patients at risk

Single-use endoscopy

A simple and cost-effective setup eliminating infection risks

Risk of Cross-Contamination

Despite increased reprocessing requirements, crosscontamination remains a major issue.

Eliminating Risk of Cross-Contamination

Sterile out of the pouch. Personal scope for each patient, never been in contact with other patients.

Extensive Reprocessing Setup

100+ steps of cleaning, major surveillance and documentation burden..

No Reprocessing

Scopes are discarded after use – no cleaning, documentation,surveillance or auditing on proper reprocessing.

Availability Issues

Procedure delay or even cancellation due to unavailable scopes.

No Availability Issues

No more “where is my scope?” Always a new scope at hand ensuring a fully functional scope for each patient.

High Cost-in-Use

High capital investment plus repair and reprocessing costs.

Low Cost-in-Use

Minimal upfront investment. No cost for repair, reprocessing or added investment when guidelines change.

Complex Contracting

Complex and non-transparent contracts on scopes, repair, etc. binding the hospital.

Transparent Contracting

Increased flexibility and simplicity for the hospital.

In 2009, Ambu launched the world’s first single-use flexible endoscope

Worldwide representation

Ambu’s single-use visualization products are used in more than 3,000 hospitals worldwide

Many has already converted

More than ⅓ of our aScope customers already use aScope more than reusable scopes

Fully disposable

Several major facilities have gone fully disposable on selected procedures

By 2020, Ambu will provide single-use across all flexible endoscopy areas

Ambu will offer scopes within all flexible endoscopy areas including sterile, single-use HD duodenoscopes, colonoscopes and gastroscopes

Single-use bronchosopes 

Read more about Ambu's single-use, high quality bronchoscope; the Ambu® aScope™ 4 Broncho, which comes in three sizes.

Our latest proof of ideas that work for life.
 

Explore now

 

 

The convenience and the safety of having the scopes right here has been a game changer for us.

The two main advantages are: it is so quick, efficient and available that it allows us – in the patient who has a suspected pulmonary infection – to get in and get the appropriate microbiological sampling – often before the time the first dose of antibiotic is administered.

The second advantage, which is probably equally important, is it’s a disposable scope. In the ICU, we’re dealing with resistant organisms, and reusable scopes can be colonized. They can have their channels contaminated. With single-use scopes, you use it and throw it away. And you have a sterile new scope for the next patient. It’s great from an infection prevention point of view, as far as we’re concerned, as well.


Eric C. Feucht, MD
Critical Care Medicine and Medical Director of Respiratory Therapy
at Metro Health Hospital in Ann Arbor

Comprehensive reprocessing is complex, time-consuming, and costly 1,2,3,4,5,6,7

$350

Average cost burden for reusable scopes

$300

Cost of Ambu aScope for every procedure

Steps in reprocessing
 

1

Pre-Cleaning at Site of Use

2

Transport

3

Leak testing

4

Manual cleaning

5

High Level Disinfection

6

Inspection

7

Drying & Storage

8

Control

9

Use

10

Back to cleaning

 

The basic design of the reprocessed endoscope has remained virtually unchanged for over half a century since the advent of the first flexible endoscope in the 1960s. The endoscopist, and device manufacturers, have been
limited by the physical constraints of the endoscope working channel. A disposable platform can change this by enabling the development of endoscopes tailored to the requirements of the accessory. This can open new frontiers of endoscopic intervention.

Kenneth F. Binmoeller, MD, FACG, FASGEDirector
Interventional Endoscopy Services California Pacific Medical Center

 

I believe disposable endoscopy will play a very important role in gastroenterology. Patients are understandably concerned about recent reports of infection transmission. We need to explore the possibility of using disposable devices in GI endoscopy.

Klaus Mergener, MD, MBA, FASGE, FACG, AGAF, FACP, FACPE
Affiliate Professor of Medicine, University of Washington, Seattle, WA

 

A cost-effective, sterile, single-use endoscopic portfolio for the GI space will instantly change the entire practice of gastroenterology. All the concerns with reprocessing and potential cross-contamination would be eliminated. When utilization begins, sterile, single-use endoscopes will represent a classic example of the term “disruptive technology” as applied to endoscopy.

Bergein (Gene) F Overholt, MD,
Past President ASGE, Co-Founder of Gastrointestinal Associates, Knoxville, US

Want to know more?

Do you want to now more about the portfolio of single-use products in Ambu?
Fill in your contact information in the form and we will contact you.

 

References

  1. J. Kovaleva et al. 2013; Review “Transmission of Infection by Flexible Gastrointestinal endoscopy and Bronchoscopy” Clinical Microbiology Revives April 2013 vol. 26 no. 2 231-254

  2. ECRI institute https://www.ecri.org

  3. CDC Guideline 2008.Disinfection and Sterilization in Healthcare Facilities

  4. FDA Reprocessing of Reusable Medical Devices: Information for Manufacturers https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ReprocessingofReusableMedicalDevices/

  5. AAMI Releases ‘Must-Have’ Guide for Endoscope Reprocessing http://www.aami.org/newsviews/newsdetail.aspx?ItemNumber=2468

  6. CDC safety alert September 11, 2015 “Immediate Need for Healthcare Facilities to Review Procedures for Cleaning, Disinfecting, and Sterilizing Reusable Medical Devices” https://emergency.cdc.gov/han/han00382.asp

  7. CDC release from the Healthcare Infection Control Practices Advisory Committee (HICPAC) January 25, 2017. “Essential Elements of a Reprocessing Program for Flexible Endoscopes – Recommendations of the HICPAC” https://www.cdc.gov/hicpac/recommendations/flexible-endoscope-reprocessing.html

  8. Cori L. Ofstead et al 2017. “A GLIMPSE AT THE TRUE COST OF REPROCESSING
    ENDOSCOPES: RESULTS OF A PILOT PROJECT” In International Journal of Healthcare Central Service Material Management (www.iahcsmm.org

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