Intro to EAI
What does MDRO stand for?
Multidrug-resistant organism
Which scope manufacturers were looked at in the study?
Olympus & Pentax
True or False: Duodenoscopes have had more safety communications than any other medical device between 2013 and 2019.
True
True or False: There have only been documented outbreaks of CRE on the East Coast
False
What is the most urgent GI antibiotic resistant concern?
CRE
How many product recalls have there been on duodenoscopes since 2013?
3
(12 FDA safety communications, 7 guideline updates, 4 IFU updates, 3 product recalls)
Multiple rounds of ____ were recommended by the FDA to enhance scope reprocessing.
HLD
There are roughly ____ deaths each year related to antibiotic-resistant bacteria and fungi
A. 25,000
B. 31,000
C. 36,000
D. 40,000
C. 36,000
(2.8 million infections)
________ is a slang term for organisms that can’t be treated. A term used for all types of organisms. Usually sensationalized.
Super-Bug
Based on market surveillance studies, what percent of scopes were contaminated?
5% high concern
4.4% low concern
(assumed less than .4%)
In 2015, which major univiersity hospital had one of the most publicly known CRE outbreaks, impacting hundreds of patients?
UCLA - CRE MDRO
In 2015, NDM CRE was present in ___ states and in 2017 that number increased to ___ states.
In 2015, OXA-48 CRE was present in ___ states and in 2017 that number increased to ___ states.
21, 28
13, 24
There are over ____ strains of CRE
A. 50
B. 75
C. 100
D. 125
C. 100
What were the 2 factors looked at in the 522 Post Market Surveillance Study?
Human Factors
Sampling & Culture
There have been ___ FDA safety communications since 2013
A. 12
B. 7
C. 15
D. 9
A. 12
How long has it been since a new class of antibiotics has been introduced?
30 years
What is one impact of antibiotic resistance for patients in GI procedures?
Increase in complications/deaths
Longer length of stay in hospitals
Increased number of doctor visits
Assess the degree of contamination
Figure out how the contamination occurred
Find a way to fix it
The FDA believes the best solution to reducing the risk of disease transmission by duodenoscopes is through innovative device designs that make reprocessing easier, more effective, or __________.
Unnecessary
What product did Boston Scientific release that can make a significant impact on this issue?
Exalt!!