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FDA Webinar: Duodenoscope Sampling and Culturing

Moderator: Irene Aihie

March 22, 2018

1:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants are in a

listen-only mode. During the question and answer session please press Star 1

and record your name. Today’s conference is being recorded. If you have any 

objections you may disconnect at this time. I would now like to turn today’s

meeting over to Irene Aihie. Thank you. You may begin.

Irene Aihie: Hello and welcome to today’s FDA Webinar. I am Irene Aihie of CDRH’s

Office of Communication and Education. On February 26, 2018 the US Food 

and Drug Administration, Centers for Disease Control and Prevention and 

American Society for Microbiology along with other endoscope culturing 

experts announce the availability of voluntary standardized protocols that 

were developed for duodenoscope surveillance sampling and culturing. These 

protocols are an update to the interim duodenoscopes surveillance protocols 

released by CDC in 2015.

Today’s presenters are Dr. Shani Haugen, Microbiologist here at the FDA 

Centers for Devices and Radiological Health, Dr. Michelle Alfa, an 

Independent Researcher Professor for the University of Manitoba, Dr. Kevin 

Alby, representing the American Society for Microbiology and Clinical 

Microbiologist at the University of Pennsylvania and Dr. Judith Noble-Wang,

a Microbiologist at the CDC’s Division for Healthcare Quality Promotion.

The group will review the voluntary duodenoscope surveillance sampling and 

culturing protocol. This can be leveraged by facilities to help monitor the 
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quality of their reprocessing features. Following the presentation, we will 

open line for your questions related to the information provided during the 

presentation. Now I give you Dr. Haugen.

Dr. Shani Haugen:Thank you. On this slide I’m showing the outline for today’s Webinar on the 

recently released protocols from the FDA, CDC and ASM on duodenoscope

surveillance sampling and culturing. I’ll be providing an overview of the 

document, Dr. Alfa will walk through the sampling method, Dr. Alby will 

discuss the options for culturing samples and Dr. Noble-Wang will provide a

comparison to CDC’s 2015 interim recommendations for duodenoscope

sampling which have been replaced with the current method. After our

presentation we will be taking your questions about duodenoscope

surveillance sampling and culturing.

The protocols we’ll be talking about today were released on February 26, 

2018. On this slide I’ve included the Web site where you can download the 

document. These protocols were developed by a working group comprised of 

staff from the FDA and CDC, representatives from ASM, duodenoscope

manufacturers in the US and other experts in endoscope sampling, culturing 

and reprocessing. The recommendations in the document are largely based on 

expert opinion and experience with sampling and culturing including 

benchtop validation of these methods by the duodenoscope manufacturers, but 

they also draw upon scope sampling and culturing guidelines from Australia 

and Europe. During the development we received helpful feedback from 

multiple professional societies which are listed at the beginning of the 

document. These protocols are meant to be used as a tool for healthcare 

facilities that voluntarily choose to conduct surveillance sampling and 

culturing of duodenal scopes. This document was developed to provide 

validated methods for surveillance sampling and culturing of duodenoscopes 
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that would address some of the concerns that have been previously raised 

about duodenoscope sampling and culturing.

You may be wondering why would a healthcare facility conduct surveillance 

sampling and culturing of duodenoscopes and use these protocols? The 

answer is this type of surveillance is the only way to monitor with testing the 

quality of start-to-finish endoscope reprocessing procedures in a clinical 

environment. While there are methods to assess the quality of cleaning 

processes such as ATP and other assays, those methods are not intended to be 

used after high level disinfection of clinically-used devices and they are not a 

substitute for microbiological testing.

Surveillance sampling and culturing was discussed at FDA’s May 2015 

Advisory Committee meeting and is included as a supplemental measure to 

enhance duodenoscope reprocessing as noted in FDA’s August 2015 safety 

communication on this topic. We want to emphasize that the use of this 

protocol is voluntary and FDA, CDC and ASM are not requiring its use. 

Healthcare facilities should check their state and local requirements regarding 

sampling and culturing endoscopes. As you’ll see in the document, conducting 

surveillance sampling and culturing requires specific resources, training and 

expertise. It also requires cooperation within the healthcare facility to identify 

resources and designate responsibilities for different staff members and

different departments within a facility.

Surveillance sampling and culturing is not a substitute for complete adherence 

to the endoscope manufacturer’s recommendations for reprocessing and 

maintenance. Results after following these protocols cannot be used to certify

that an endoscope is sterile.
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On this slide I’m showing an excerpt from the table of contents from the 

protocols. You can refer to the table of contents to provide a snapshot of the 

entire document and to get a sense of how the document is organized with 

multiple subsections and options in each section.

The document is divided into three sections. The first section provides an 

overview and introduction to surveillance sampling and culturing. This section 

includes topics such as the goals and limitations of testing, references, 

definitions, and a discussion of how the document was developed. The second 

section describes the actual handling and sampling of duodenoscopes which 

Dr. Alfa will discuss in more detail. And the third section provides the four 

options for microbiological culturing of samples and include suggestions for 

microbial limits. Dr. Alby will be discussing this section of the document.

One of our goals for the document was to write the protocols in a way that 

would allow them to be widely adopted. To that end there are duodenoscope

model specific options in the sampling method. And as Dr. Alby will discuss 

there are four options for culturing. Healthcare facilities should select the 

appropriate method for sample collection, culture and interpretation that best 

suits their needs.

Please note that the methods themselves such as a flush brush flush method 

for sampling the instrument channel were validated in benchtop testing and 

are not intended to be modified. We recognized that different facilities will 

have preferences for protocols and standard operating procedures such as 

organization of the document, placement of illustrations and the level of detail 

and terminology used. To address this we included many details in a strict 

organizational structure with the understanding that healthcare facilities could 

adapt the content to suit their own institutional formatting preferences,

simplifying the language and structure of the document based on their 
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preferences and remove options that are not relevant for the healthcare 

facility.

Because there are options, healthcare facilities that choose to conduct 

surveillance sampling and culturing will need to make a number of decisions. 

Those decisions will be based on the facility’s individual needs and resources. 

Examples of the types of decisions that must be made include the frequency of 

surveillance sampling and culturing, endoscope handling after sampling, 

clinical use of duodenoscopes during culturing and before results are 

available, selection of a microbiological laboratory to conduct culturing, and 

the microbial limits, results reporting an action plan. I’ll now turn the 

presentation over to Dr. Michelle Alfa.

Dr. Michelle Alfa:Well thank you Shani. As you can see on this slide for the sampling method 

two staff are required for the sampling. And this is an important aspect 

because it ensures maintenance of aseptic technique during the sample 

collection process. The staff who do sampling should be familiar with 

duodenoscope handling and they should also be trained in aseptic technique 

and duodenoscope sampling.

And I think it’s important to remind people that as in all staff functions an 

endoscopy reprocessing proficiency assessment of the duodenoscope

sampling capabilities is recommended. The easiest way to do this would be to 

have a visual audit of the individual to make sure they’re actually following 

the appropriate steps and maintaining aseptic technique Sampling should be 

conducted on patient ready duodenoscope. And I’d like to point out as Shani

mentioned that the sampling methods described in this protocol have been 

validated by the three duodenoscope manufacturers and have been 

demonstrated to have recovery efficiency between 65% to 100% of inoculated 

organisms.
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If we can go to the next slide please, in terms of the actual sampling method 

there was a long committee discussion of how to do this. And there’s different 

ways of doing it in different countries but we opted to take an approach that 

would reduce the workload but ensure that we are targeting the key 

duodenoscope components. So the protocol describes a sampling method that 

is one combined sample which is collected from the elevator recess, the 

instrument channel and also the elevator wire channel if it is an unsealed 

channel. The idea being that pooling all of these three samples together will 

reduce the workload in terms of the sample collection and also in terms of the 

microbiology laboratory that’s doing the culture.

Now you can see that the three sites are indicated on the diagram shown on 

this slide. The elevator recess is at the very end of the duodenoscope and 

there’s a red circle around it. And it includes the elevator lever and the recess 

itself. The second sample is the instrument channel and it is collected from the 

biopsy port to the distal end. So that channel has a flush-brush-flush 

methodology. And finally the elevator guide wire channel opening is shown 

on the control head. And if it’s unsealed a sample would be collected from 

that as well. Now if there is a need to sample other types of endoscopes or 

there is other situations the protocol guideline does provide information in 

Appendix 1 regarding collection of samples from other types of endoscopes 

based on the approximate channel dimensions. So there’s some help if sites 

want to culture endoscopes other than their duodenoscopes.

If we can go to the next slide, I’m just going to spend a few minutes to go 

over the sampling method. So where the elevator recess, this seam between 

the distal end cap when that cap is present and the distal end should be 

sampled with a swab moistened with sterile water. And that’s because we 

want to make sure that not just the lever recess but also the area around it that 
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had been shown to have problems is also being sampled. When that swab has 

completed sampling the swab head should be cut off into the sample 

collection container. And then the elevator recess should undergo a flush -

brush and final flushing sample collection. The appropriate brush to use for 

this is indicated in the protocol. Essentially the protocol refers to the 

manufacturer’s recommendation for the appropriate brush that would 

normally be used for cleaning of those tiny areas in the lever. And because of 

the differences in device design, sampling the elevator recess for Fujifilm and 

Olympus duodenoscopes will differ from the method used for Pentax 

duodenoscopes. That’s because there are design differences in the elevator 

recess area.

If we can go to the next slide. In terms of sampling method for the 

instrument channel, the channel from the biopsy port to the distal end is 

flushed with sterile water. It is then brushed with a sterile brush using a single 

pass of the brush down the channel. The brush end is cut off into the sample 

container. The wire shaft of the brush is removed and the channel is flushed 

again.

Now the step where the brush is introduced into the channel is the one that’s 

most prone to introducing external contamination. Care is needed to ensure 

that the sterile brush shaft doesn’t accidentally get contaminated during the 

brushing step. And it’s important also to realize that the brush that’s used 

should follow the correct dimensions provided the duodenoscope 

manufacturer in terms of the dimensions of a brush that will fit properly 

through that channel.

If we go to the next slide, this is dealing with the sampling method for the 

elevator wire channel. And it’s only sampled of course when it’s not a sealed 

elevator guidewire and there is an accessible port on the control head. So 
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when it is accessible this channel should be flushed with sterile water 

following the instructions in the protocol.

Please go to the next slide. In terms of sample handling; the extracts 

including the swab and the brush heads from the elevator recess, from the 

instrument channel and from the elevator wire channel are combined in one 

sample for microbiological culturing. As soon as the sample is collected an 

appropriate neutralizing media (for example Dey-Engley Broth) should be 

added to the sample in a one-to-one ratio. The use of neutralizer is very 

important because published data have shown that addition of neutralizer 

helps damaged organisms be able to grow on the cultured media. And this is 

especially important if the organisms present are viable but non-culturable

organisms within biofilm or build a biofilm in the duodenoscope.

The sample once it’s collected should be kept on ice or refrigerated prior to 

microbiological culturing. And this refrigeration and ice step during 

transportation is important to ensure that there isn’t replication of low concern 

organisms because if they replicate and get to the level that’s high it may lead 

to unnecessary action. So in many ways it’s very similar to the transport of 

biological samples such as a urine sample that also require refrigeration to 

ensure that the organisms in the sample do not replicate and become a false 

positive.

If we can go to the next slide, one of the issues after the samples are collected 

is what do you do with that endoscope that’s been sampled? Because the 

device was handled with sterile implements and sterile water only reconducting the complete manual cleaning is not necessary. Sites can choose to 

take one of the following three actions. They can, after sampling repeat 

manual high level disinfection without the complete manual cleaning. They 

can choose to process the endoscope again in an automated endoscope 
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reprocessor again without doing the manual cleaning before that. And also 

they can undertake simple drying and then send the scope for sterilization. I 

think that covers everything I’m going to talk about so I’d like to pass it on to 

Dr. Kevin Alby.

Dr. Kevin Alby: Thank you. As was mentioned I will cover in the next few slides which focus 

on culturing of the sample that was obtained from the duodenoscope. Now the 

goal of the working group was to create a method that could be conducted by 

any lab environmental or clinical that had experience with standard 

microbiological culturing.

Next slide. In order to achieve a protocol that was accessible to a large 

number of labs the working group actually came up with four different but 

related culturing protocols that could be implemented. The four methods are 

membrane filtration with culture on solid media, centrifugation with culture 

on solid media, membrane filtration with liquid culture and finally 

centrifugation with liquid culture. It is important to note that membrane 

filtration with culture on solid media is the protocol that was validated by the 

duodenoscope manufacturers. For healthcare facilities trying to decide which 

of the four methods to use key stakeholders such as members of infection 

control and the microbiology laboratory should evaluate which option best 

matches their goals with the available equipment and resources in the 

laboratory.

Next slide. For solid media cultures the entire sample needs to be concentrated 

for use. The filter or concentrate - the filter of the concentrate should be 

placed onto a single blood auger plate and incubated for 72 hours at 35

degrees to 37 degrees Celsius. Cultures should be monitored daily for growth. 

And it is important to note that these are the conditions for routine 

surveillance to detect a large number of relevant organisms however 
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incubation media, temperature and/or time may need to be adjusted if the goal 

of sampling and culturing is to detect a specific organism.

Next slide. For the liquid culture media again the entire sample should be 

concentrated for use. The protocol recommends utilizing a neutralization 

culture brought such as Dey-Engley Broth. And that broth is incubated for 

three days at 35 degrees to 37degrees. Similar to the solid media cultures the 

liquid culture should be monitored daily for growth and subculture when 

growth is detected. Again this method should recover a large number of 

relative organisms but modifications may need to be made for the recovery 

specific organisms. And we leave it up to the individual healthcare facility to 

determine those modifications.

Next slide. If growth is detected in either culture method it is important that 

the laboratory identify the organism or organisms present to an extent to be 

able to develop an action plan based on the classification of that organism. 

This workup should be documented as any other culture would within the 

laboratory or healthcare information system to allow for review at a later date. 

It is important that the healthcare facility develop a plan of notification that is 

important with institutional as well as local regulations and policies.

Next slide. This slide offers some insight as to how the working group 

classifies different organisms. Those organisms that are commonly associated 

with disease such as Staphylococcus aureus or the enteric gram-negative rod 

were classified as high concern organisms. Organisms less commonly 

associated with disease and more likely to be contaminants from the 

processing and/or sampling and culturing process are considered low concern 

organisms. Common examples include skin and environmental organisms 

such as coagulase-negative staphylococci and bacillus species.
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The final group is the moderate concern organisms which are similar to the

low-concern organisms in that they are less often associated with disease but 

because of their prevalence in the oral cavity and gastrointestinal tract their 

detection may more likely represent failure of reprocessing than that of the 

detection of low concern organisms. Importantly the group does not offer 

specific recommendations for any other groups of organisms leaving the

decisions of what to do for a positive result in the hands of the healthcare 

facility and its key stakeholders.

Next slide. While the group does not provide any specific feedback and link 

any specific action to a recovery of a particular organism we do provide a 

number of suggestions for action. These include things such as removing the 

duodenoscope from use, notifying patients, reviewing reprocessing as well 

sampling and culturing methods. Note this is not an exhaustive list and 

facilities are encouraged to come up with action plans that best meet the needs 

of their patients. Responses may different organisms recovered and again the 

decision is entirely up to the discretion of the healthcare facility with input 

from key stakeholders. With that I will pass a presentation over to Dr. NobleWang for a discussion of the differences between this protocol in the interim 

CDC guidance.

Dr. Judith Noble-Wang: Thank you Dr. Alby. In the next few slides I will compare the new 

protocol to the 2015 CDC interim protocol. In March 2015 CDC released an 

interim duodenoscope surveillance protocol that included duodenoscope 

sampling and culturing methods. A revision to the methods were also 

published in August 2015. The interim methods were intended to provide 

facilities considering culturing with a starting point for a protocol that could 

be adapted for their use to assess the adequacy of their duodenoscope 

reprocessing. However, the interim protocol had not been validated and was 

one approach to culturing duodenoscopes. Since then the 2018 methods
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produced by the FDA/CDC/ASM workgroup have been validated by the 

major duodenoscope manufacturers.

This slide shows the major differences between the 2015 CDC interim and the 

new 2018 protocols. For sampling three locations (the instrument channel, 

elevator recess and distal cap seam) were identified by the 2018 protocols 

compared to two locations in the interim method. For the instrument channel 

location, the 2018 protocol directs a flush-brush-flush method using a 20 

milliliter flush of the channel with sterile water, followed by a brushing step 

and a second 20 milliliter flush with water. The interim method specified

flushing the channel with 50 milliliters of sterile water.

For the elevator recess location, the 2018 protocol specifies brushing with 

sterile water and then flushing with water. The interim method specified

brushing with a phosphate buffered saline with a very low concentration of 

tween-80 to act as a surfactant. For the sample from the distal cap seam, a 

moistened swab is used to swab the seam between the distal end cap in the 

distal end. This location was not specified in the interim protocol. 

Now let’s move the sample handling. The 2018 protocol directs combining all 

the samples from the three locations in one container whereas the interim 

protocol directed submission of four samples for each duodenoscope, the 

instrument channel flush, elevator recess and three controls. The facility could 

choose to combine the instrument channel flush and distal end recess samples.

And finally let’s cover the neutralization methods specified in 2018 protocols. 

The protocol validated the addition of a neutralizer to the sample extract. The 

Dey-Engley Neutralizing Broth as suggested is added after the samples are 

combined at an equal volume of the samples to facilitate outgrowth of 

microorganisms that have been potentially damaged by reprocessing. It was 
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not known how a disinfected neutralizer would impact cultures when the CDC 

interim protocol was developed in 2015. A suggested laboratory internal 

process positive control was included as a proxy.

Next slide please. In this slide we’re comparing the culture methods specified 

by the two protocols. As shown, the culturing options are similar between the 

two methods for plating after membrane filtration and centrifugation; as well 

as liquid enrichment culture after membrane filtration and centrifugation. The 

methods do differ in the volumes that are handled and culture. The 2018 

filtration and plating culturing methods have been validated to demonstrate 

that the new method can extract between 65% to 100% of bacterial cells that 

were placed on the device.

For agar plating, the 2018 protocol specifies one blood agar plate after the 

samples are combined and processed by membrane filtration or centrifugation. 

The interim protocol specified a blood and MacConkey agar for each 

duodenoscope. Dilutions were also suggested in some cases.

For controls, none are specified in a 2018 protocol other than what are 

indicated for normal laboratory practices. Three controls were identified in the

2015 interim protocol: an internal process positive control I mentioned earlier 

and two negative controls which were the water stock solution used for 

irrigating the channel flush and the Saline/ Tween 80 solution used for 

sampling the elevator recess.

Moving on to culture incubation conditions: the conditions specified in both 

protocols are intended to detect the most common highconcern organisms on 

reprocessed duodenoscopes. The 2018 protocol specify incubation at 35 

degrees centigrade for 72 hours compared to 48 hours in the 2015 CDC 

interim protocol.
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Next slide please. In summary, the key components in the new validated 2018 

protocol specify: firstly, friction for sampling the instrument channel on the 

duodenoscope with the use of the flush-brush-flush method and sterile water. 

Secondly, the addition of a liquid neutralizer to the sample extract to inhibit 

carryover of disinfectants and allow stressed organisms to grow thereby 

reducing false negatives. And thirdly, concentration of the sample by 

membrane filtration for culture. These key components of the new protocol 

were validated to show optimum growth of high-concern microorganisms 

from ready-to-use duodenoscopes.

Next slide please. And thank you for your attention. The line is open now to 

answer your questions about duodenoscope surveillance sampling and 

culturing methods discussed in our presentation.

Coordinator: Thank you. We will now begin the question and answer session. And we will 

be taking questions only from the phone. To ask a question or make a 

comment you may press Star 1, make sure your phone is unmuted and record 

your name to introduce your question. And to withdraw that request you may 

press Star 2. Once again for a question or a comment from the phone please 

press 1 and record your name and it is Star 2 to withdraw that request.

Judith Noble-Wang: While that is going on -- this is Judith Noble-Wang again -- I will answer 

the first question which is, "Why make changes to the interim protocol?" At 

the time the interim protocol was released in 2015 there was a pressing need 

for standardized sampling and culturing protocols. The previous protocol 

filled that gap, but it was interim, meaning it was always intended to be a 

placeholder until appropriate testing could be conducted to validate a

surveillance sampling and culturing protocol.
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Without a validation, the performance of the interim sampling and culturing 

methods was unknown. Shortly after the release of the interim protocol, the 

working group was initiated to address the lack of validation. The new 2018 

sampling methods and the filtration andplating culturing methods were 

modified to streamline the sampling and culturing processes and have been 

validated to demonstrate that these methods can extract between 65% to 100% 

of the bacterial cells that were placed on the device. We can now move on to 

other questions.

Coordinator: Thank you. Our first question or comment comes from (Noreen Johnson). 

Your line is open. (Noreen) please check your mute feature. Did you have a 

question or comment? 

(Noreen Johnson):No I did not have a question. Thank you.

Coordinator: Thank you. Our next question or comment comes from (Lynn Pasquale). Your 

line is open.

(Lynn Pasquale) Yes we were wondering do you have a recommendation on the brushes? The 

current brushes we buy are disposable. They're clean but they’re not packaged 

sterile.

Dr. Michelle Alfa:In terms of the brush choice that you would use for the channel or the lever 

recess cavity you are correct the brushes used in clinics are not sterile. You 

do need to use sterile brushes. One way to do that is to steam sterilize them. 

And they would be used once for sample collection, the end cut off and then

the remainder of the brush should be disposed of. An alternative would be to 

use sterile brushes available from the manufacturer because some of them do 

provide that type of brush. These sterile brushes could be used as long as the 

dimensions match the channel dimensions that you’re putting it through.
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(Lynn Pasquale): Thank you.

Irene Aihie: We'll take our next question.

Coordinator: Thank you. Our next question or comment comes from (Chris Bungle). Your 

line is open.

(Chris Bungle): Yes. I would like to know if unless I missed it -- and I apologize if I did --

once all of the specimens are collected into one container, you know, from the 

different areas of the scope and we go to culture it what is the 

recommendation of culture it? Aspirating 1 cc. You centrifuge it first then you 

take the sediment? I mean how does that go onto the plate?

Dr. Kevin Alby: This is Kevin. I’ll take that one. So it depends on which method you choose. 

So if you are using a membrane filtration method so you will use essentially a 

membrane filter packet to concentrate the sample so you’ll take the 100 or so 

mils that you'll have after collection, you’ll vortex to make sure you get 

everything off the brushes and you’ll put that entire sample on the filter and 

let the vacuum essentially concentrate it onto that piece of filter paper which 

is that piece of filter paper would then go on to the blood agar plate or into the 

liquid broth. If you do a centrifugation concentration then you do like you 

suggested you would take that sample, you’d put it in conical tubes, you'd 

centrifuge it and then take the sediment.

(Chris Bungle): Okay so the sentiment will be taken with a sterile pipette 1 cc or does it matter 

or, you know?

Dr. Kevin Alby: You know, let me pull up sorry, it’s in - the specific amount is in the protocol.
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(Chris Bungle): Oh it is in the protocol...

Dr. Kevin Alby: Yes.

(Chris Bungle): ...because that will dictate - I guess you’re - I guess you’ll do a colony count 

right?

Dr. Kevin Alby: You could do colony count if you are doing solid media or you would do just 

turbidity if you were doing liquid media.

(Chris Bungle): Okay. So you can use either liquid or so all right.

Irene Aihie: Thank you. We'll take our next question.

Coordinator: Thank you. The next question or comment comes from (Mehran). Your line is 

open.

(Mehran): Hi, thank you. So what is the recommendation for the cultured scopes while 

we're waiting for culture results? Is it to take them out of service or...

Dr. Michelle Alfa:It's a very good question and that is one of the decisions that we think the site 

should actually be making. Ideally the expectation would be that the scope 

would be quarantined until the culture results are available. But obviously as 

we're incubating the culture for 72 hours that is a long time for a 

duodenoscope to be in quarantine. The committee discussed a lot regarding 

this issue and in the end settled on the approach that if the culture results at 48 

hours are negative then it would be fine to take the scope out of quarantine 

and be able to use it again.
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And then when the final result comes at the 72-hour mark, hopefully it would 

also be negative. If it was positive at 24 or 48 hours obviously there might 

have to be some action taken depending on the organism and colony count. 

This type of approach is probably not much different from many other 

diagnostic samples where you get an interim report and action is taken 

pending the final report.

If sites choose to sample their scopes and then continue to use them and not 

quarantine them obviously the risk is if the duodenoscope ends up being 

contaminated it makes action a lot more complex in terms of how to deal with 

the patients that might have been exposed to a contaminated duodenoscope. 

Now we do realize that by quarantining a scope there might be inventory 

issues in terms of the number of duodenoscopes available because once a 

duodenoscope is cultured it will be out of circulation until the at least the 48

hour result is available. So again it’s a decision that I think the committee that 

is struck at the site that’s doing culture needs to address. They must make a 

decision about whether they’re going to quarantine duodenoscope after being 

cultured or not. However, the recommended approach is to quarantine 

because this ensures the least risk of using a contaminated scope on another 

patient.

(Mehran): Okay thank you so much.

Dr. Michelle Alfa:No problem.

Coordinator: Thank you. Our next question or comment comes from (Elise). Your line is 

open.

(Elise): Hi. Is there a recommended time frame before the sample gets iced or 

refrigerated?
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Dr. Michelle Alfa:The intent would be that once the sample is collected it would be refridgerated 

or held on ice. If you’re in a healthcare facility and you've got a 

microbiology lab on site that’s going to be doing the culture the sample would 

be held in refrigeration until such a time as the sample is actually transported 

to the lab. The lab would then put it in the refrigeration as well.

If you’re sending it to an off-site laboratory it may take up to 24 hours to get 

that sample transported to the off-site microbiology laboratory. And again 

using ice packs, or temperature-controlled transport containers or refrigeration 

truly is needed because there are published data to show that if you transport a 

non-refrigerated sample at room temperature many organisms in the sample

will replicate to fairly high levels over the 24 hour time period. 

So to recap the expectation is that if you’ve got an on-site lab you would – it 

would follow the transport conditions of your facility and you would get to 

your diagnostic micro lab as quickly as possible, and while it’s waiting keep it 

refrigerated until such a time as it gets to the lab.

If you’re sending it to an off-site lab the expectation is that definitely the

sample should arrive at the lab within 24 hours. During the 24-hour period it's 

really important that it is held on ice or refrigerated.

Coordinator: Does that conclude your question or comment?

(Elise): Yes thank you.

Coordinator: Thank you. Our next question or comment comes from (Joline Fedorov). Your 

line is open.
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(Joline Fedorov): Thank you. I have a question about the use of Tween versus the neutralizer. Is 

Tween a neutralizer?

Dr. Michelle Alfa:Tween is a component that often is in the neutralizers. The problem is that 

depending on the concentration Tween can have a negative effect on some of 

the gram-negative organisms that are exposed to this component.

There’s a number of different neutralizers. Iff you look at the components of 

Dey-Engley broth you will see that there are components like Tween and 

lecithin. Although Tween will give you some level of neutralization it’s not 

one that will cover all of the aspects that need neutralization and that’s why 

the committee recommended the Dey-Engley Broth rather than just Tween by 

itself.

(Joline Fedorov): So the expectation then is that Tween is now not a part of the culturing as 

we're used to it?

Dr. Michelle Alfa:No Tween would not be part of sample collection (Judith may want to 

comment on this as well). The sample collection for the new protocol that's 

being recommended is sterile water which is either deionized sterile water or 

reverse osmosis sterile water. This sample collection fluid doesn’t contain any 

tween in it whereas you're correct in that for the CDC protocol a part of the 

sample collection protocol related to the lever cavity did have Tween in it.

(Joline Fedorov): Perfect.

Dr. Michelle Alfa:And what we’re recommending in the new FDA/CDC/ASM protocol is that 

you don’t need to use Tween because you’re going to be adding the DeyEngley neutralizer in a one to one ratio to the sample. The Dey-Engley 
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neutralizer covers many more aspects of neutralization compared to just 

Tween alone.

(Joline Fedorov): Okay thank you.

Dr. Michelle Alfa:Judith did you have anything else you wanted to add to that?

Dr. Judith Noble-Wang: Yes. I would just add that the Tween80 was included as a 

surfactant just for sampling. It was felt that Tween-80 would help to remove 

any sticky biofilmsthat would be in the distal recess area. Validation showed –

that use of water for sampling performed well. Essentially, we don’t need to 

use the Tween-80 for the sampling.

(Joline Fedorov): Okay. Thank you.

Coordinator: Thank you. And again as a reminder at this time they're taking questions only 

from the phone. So ask a question or make a comment you will need to press 

Star 1, make sure your phone is unmuted and record your name to introduce 

your question. Again for questions there from the audio portion only please 

press Star 1 and record your name. Our next question or comment comes from 

(Peter). Your line is open.

(Peter): Hi, just a question on culturing. We missed it or maybe we didn’t hear it 

correctly. We're just wondering what method is validated, the solid plate with 

centrifusion or the solid plate with membrane filtration or both?

Dr. Kevin Ably: The solid plate with membrane filtration is the validated method. So that was 

the method that the manufacturers would spike scopes and looked at recovery 

percentages. The other methods are kind of expert opinion based off of – that 

they should work because of - based off of expert opinion.
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(Peter): Thank you.

Coordinator: Thank you. Our next question or comment comes from (Greg Pennington). 

Your line is open.

(Greg Pennington): Yes. The question I have is about the brush. You said sterilize the brush 

but is that brush cleared through the 510(k) for sterile processing?

Dr. Michelle Alfa:I will comment on the brush and then pass it over to Shani for comments 

regarding the FDA component of it. The expectation is that it would be a 

sterile brush that’s used. The brush can be purchased as a sterile brush if, you 

know, there is one available for the size that you need for the sites that you're 

sampling. An alternative would be the steam sterilization of a traditional 

non-sterile bruh.

The sample collection protocol is basically one that is facilitating the ease of 

collection of these samples. So obviously the easiest way is to actually buy a 

sterile brush. And beyond that I’ll pass it over to Shani because in terms of 

510(k) issues she could address those best.

Dr. Shani Haugen:Yes this is Shani Haugen from FDA. Brushes for cleaning endoscopes are 

Class 1 510(k) exempt medical devices. And so 510(k)s are not needed for 

cleaning brushes for endoscopes. For specific questions about models and 

brushes you can refer to the - you should be able to contact the duodenoscopes 

manufacturer to address what types of brushes to use.

(Greg Pennington): So, you know, if we’re going to - if they're exempt from the 510(k) on the 

reprocessing what parameter do you use so you don’t melt the brush, melt the 

bristles so you have a functioning brush that you can use?
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Dr. Michelle Alfa:In terms of that I think the standard steam sterilization cycles that hospitals 

have would be appropriate. In my research lab we’ve steam sterilized the 

traditional cleaning brushes. But I think the important thing is that for 

healthcare facilities the ideal solution is actually to buy a sterile brush itself 

because then you don’t have to worry about that aspect.

If you are going to sterilize the brush the key thing it would be for one-time 

use. It would have to be appropriately packaged and put through a routine 

health care sterilization cycle. You would have to assess the brush after 

sterilization to ensure that the brush was not obviously damaged. But in our 

hands we found that most of the brushes that we used were steam sterilizable. 

But again I really want to reiterate if there are sterile brushes available 

commercially that is a better option.

(Greg Pennington): Okay thank you.

Coordinator: Thank you. Our next question or comment comes from (Kathy Mullaney). 

Your line is open.

(Kathy Mullaney):Yes. Are there any kits available for sampling available at this point?

Dr. Michelle Alfa:In terms of endoscope sample collection kits - yes there are some commercial 

vendors that have put together sample collection kits. I’m not going to 

mention any company names because I will maybe mention some and forget 

others. If you do a Google search you will find that there are some 

manufacturers that have sample collection kits designed specifically for 

sampling flexible endoscopes. And they usually have all the types of 

connectors that are needed, and the sterile water, etc. The may also include the 

appropriate sterile brush or they may advise what brushes could be used. 
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(Kathy Mullaney):Thank you.

Coordinator: Thank you. Our next question or comment comes from (Palmer). Your line is 

open.

(almer): Good afternoon. We have a couple of questions. So we do this on every scope 

for duodenoscopes?

Dr. Michelle Alfa:Okay I can start this response but the others on the panel may want to chip in 

as well. If you recall from Shani's presentation the idea of the frequency with 

which the samples would be taken was one of the decisions that we believe 

the site committee probably needs to meet and discuss. Ideally you would like 

the samples to be done on every duodenoscope before it’s actually used on a 

patient. But the reality is that I don’t think it is feasible to sample each 

duodenoscope after each use. So the frequency of duodenoscope culture from

published documents indicates that sometimes sites will choose to do 

duodenoscope culturing at least once a week or they will ensure that within a 

given period of days that all of their duodenoscopes have actually had culture 

done on them. And it depends on how you’re disinfecting them because if 

you’re sending them for sterilization like ethylene oxide, that scope is going to 

be out of use for a number of days.

And so the slate of patient procedures has to be correlated with the number of 

duodenoscopes available and the impact of the quarantine approach after a 

sample has been collected for culture. So really it is a question the site needs 

to determine and to be honest I have not seen a lot in the published literature 

talking about the frequency of sampling. But, generally speaking, the idea of 

once a week is something that is discussed in the literature. I’ll ask if maybe 

Shani can comment on this as well.
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Dr. Shani Haugen:Sure. So when it comes to frequency of sampling Michelle is completely 

accurate that the group didn’t feel that this was a decision that could be made 

at such a high level and that each healthcare facility would need to evaluate 

their own needs and resources to determine what frequency of sampling is 

appropriate for their site. When it comes to using this protocol for other types 

of endoscopes, this protocol was written for duodenoscopes but as Michelle

pointed out earlier there is an appendix that includes the appropriate flush 

volumes for other types of endoscope channels. So healthcare facilities that

wish to conduct surveillance on other types of endoscopes should consider 

how endoscope designs and the organisms that may be present affect various 

aspects of the protocols including the extraction flush volume and the culture 

method.

Key aspects that should be considered include the use of a flush brush flush 

collection of channel samples where possible, adding neutralizer to the 

samples collected, whether each sample should be independently cultured or 

all samples should be pooled prior to culture and concentration of sample to 

ensure optimal sensitivity of the culture method.

Dr. Michelle Alfa:And I'll just add one other point on to that just for information. In Australia 

they tend to indicate that culture samples taken once a month for other types 

of flexible endoscopes is adequate. They usually recommend once a week for 

duodenoscope cultures - just to give you an idea of what some other countries 

are doing.

(Palmer): All right. And we currently use Hygiena here to check for the ATP. Will this 

take the place of it or will that be in conjunction with it?
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Dr. Michelle Alfa:The ATP testing is actually designed and there is a lot of published 

information on it for evaluating the cleaning stage. In addition there are some 

research laboratories that have actually done testing to assess ATP levels after 

disinfection. And as Shani mentioned in her presentation the expectation is 

that if you’re trying to test an endoscope post HLD, (i.e. a patient ready 

endoscope) then really the only way to assess the contamination that's in the 

duodenoscope is by culture. There is no ATP test at this point that is sensitive 

enough to detect down to one to ten organisms and therefore it's not 

appropriate to use ATP as a substitute for culture. 

However, ATP testing is appropriate for monitoring the cleaning efficacy so at 

that stage any rapid ATP test kit could certainly could be used. However, post 

HLD ATP is not sensitive enough to replace culture as it requires thousands of 

organisms to generate one relative light unit on ATP. So in answer to your 

question ATP is not a replacement for culture. Culture would be the test you 

would do to assess a patient ready scope to determine if it’s contaminated or 

not.

(Palmer): Thank you.

Coordinator: Thank you. And for further questions please limit yourself to one question. If 

you have a follow-up question you’ll need to press Star 1 again. Again please 

limit yourself to one question. If you have a follow-up question you’ll need to 

press Star 1 again to bring yourself back into the queue. Our next question or 

comment comes from (Jennifer Lightner). Your line is open.

(Jennifer Lightner): Thank you. I think my question was answered earlier by Michelle but I’m 

just going to bring it up for clarification. So is it okay to assume that we get 

preliminary readouts at 48 hours because when we did the 48-hour quarantine 
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we would get preliminary at 24. So now is it okay to have a 48-hour 

preliminary readout?

Dr. Michelle Alfa:I’ll ask Kevin to comment on this as well but the expectation is that the plates 

would be read at 24, 48 and 72 hours. The committee felt it would be 

important that if there's growth after 24 hours incubation of the culture, you 

would get that positive culture report. If there's no growth at 24 hours and 

there's no growth at 48 hours, the idea of sending a preliminary no growth 

report indicating that further results of the final report will follow - was 

thought to be a practical approach. And so the expectation would be that if the 

culture shows growth at 24 hours you will get notified of this result. If there's 

no growth up to 48 hours incubation you would get that information and then 

you would receive a final report after 72 hours of incubation. Kevin do you 

have any additional comments?

Dr. Kevin Alby: Yes this is Kevin. A couple of additional comments is that this is something to 

work out with your facilities between the lab and the key stakeholders, 

infection control, perioperative processing in terms of when preliminary 

reports should be issued and what preliminary reports should be issued but 

that the lab should be looking at these cultures every day.

(Jennifer Lightner): Okay thank you.

Coordinator: Thank you. Our next question or comment comes from (Diane Miller). Your 

line is open.

(Diane Miller): Yes hi. This is a question regarding culturing. Based on the methods that were 

presented today it doesn’t look like there is any recommendation to do a 

quantitative by dilution culture over a qualitative. Is that correct?
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Dr. Kevin Alby: Yes that’s correct. And that’s one of those things that if – this is Kevin again 

and that if there were a specific problem and you were trying to monitor a 

specific problem is that you would potentially do dilution series to determine 

exactly how many colonies are present. The filtration method does offer some 

quantitation for low levels because you know that what your import volume is 

and how many colonies grow, how many colonies grow if it’s a low number 

of qualities colonies. So there is some level of quantification from that 

perspective if you do the filtration method onto solid media or the 

centrifugation method onto solid media.

(Diane Miller): Okay great thank you.

Coordinator: Thank you. Our next question or comment comes from (Dorothy). Your line is 

open.

(Dorothy): Hi. I think my question's already been answered but I was a little confused 

when you said patient ready scope in some other dialogue I had with 

something, you know, we had storage ready and patient ready. So when you 

were saying patient ready I thought you meant right before we use the scope 

on the patient but you mean – okay the way we do it now we call for it after 

we disinfect the scope.

Dr. Michelle Alfa:Yes and that’s a good question and it’s good to get some clarification on it. 

The expectation is that the culture would be done after the disinfection phase. 

But there is some published data to suggest that if you allow the scope to be 

stored overnight or over a couple of days you sometimes will get better 

sensitivity in actually detecting organisms because if you sample it right after 

the high level disinfection process is finished the levels may be so low or so 

damaged that it's difficult for those organisms to grow and be detected.
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(Dorothy): Okay thank you.

Coordinator: Thank you. Our next question or comment comes from (Donald). Your line is 

open.

(Donald): Yes question on the swabbing of the distal seam, what swab do you 

recommend and how is the sample collected in the container?

Dr. Michelle Alfa:I would expect that any swab that is currently available for collecting patient 

samples could be used. It is wetted before it is rubbed across the area that’s 

indicated in the protocol. And I’m sorry the last part of your question if you 

could repeat it?

(Donald): How do we then include that sample from the swab into the container?

Dr. Michelle Alfa:For swabs there's two ways to do it. One is there's often a snap portion 

indicated on the shaft of a regular diagnostic swab that allows you to easily 

break it off into the tube aseptically. And the alternative approach if you want 

to just cut the head off using sterile scissors. Since sterile scissors are needed 

for cutting off the channel brush head you could use the sterile scissors for 

both the brush head and the swab or you could use the snap feature of a 

diagnostic swab.

(Donald): Okay great. Thank you.

Coordinator: Thank you. Our next question or comment comes from (Deborah). Your line 

is open. (Deborah) please check your mute feature. All right we'll go to our 

next question. Our next question or comment comes from (Kate McGuire). 

Your line is open.
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(Kate McGuire): Hi. I think my question has been answered by a previous participant. Thank 

you so much.

Coordinator: Thank you. Our next question or comment is from (David Michelvitch). Your 

line is open.

(David Michelvitch): I was wondering what was the thinking of having controls in the 2018 

protocol but not in the interim protocol previously?

Dr. Judith Noble-Wang: Hi. This is Judith Noble-Wang. Just to clarify the controls were in 

the interim protocol. And other than your regular laboratory controls that you 

do there are no additional controls listed in the 2018 protocol. The new

protocol has been validated and shown to be effective to extract most, but not 

necessarily all, microbes on the device. In contrast, the interim protocol was 

not validated, and for that reason several controls were included to account for 

unknown factors that may impact recovery of the microorganisms.

(David Michelvitch): Thank you. 

Coordinator: Thank you. Our next question or comment comes from (Jan Tibbit). Your line 

is open.

(Jan Tibbit): Yes I wondered who actually did the sampling of the hospitals or facilities 

that have already implemented or trialed these protocols? Is it the endoscope 

processing staff that do them or does microbiology or other people do the 

sampling?

Dr. Kevin Alby: Hi. This is Kevin. As a facility that has done some of the sampling we leave it 

to the people who are professionals at handling the scope so the perioperative 
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processing staff. We recommend - and that’s in the recommendations is to 

have people who are familiar with handling the scopes do the sampling not 

laboratory staff.

(Jan Tibbit): Okay thank you.

Coordinator: Thank you. Our next question or comment comes from (Lawrence). Your line 

is open. (Lawrence Muscarelli) your line is open. Please check your mute 

feature. Our next question or comment comes from (Marlon Williams). Your 

line is open.

(Marlon Williams): Can you hear me?

Coordinator: Yes.

(Marlon Williams): Can everyone hear me? All right how are you doing? I have a question 

about the flush brush flush method. I’m wondering in the - of the necessity for 

it because it seems like it is more movements and it leads us to the position of 

possibly actually contaminating a scope?

Dr. Michelle Alfa:That’s a very good comment. And the reason for the flush...

(Marlon Williams): Can you speak up? I can barely hear you.

Dr. Michelle Alfa:Okay. Sorry I’ll put the phone a little closer to my mouth. The reason for 

using friction is that there is published data that shows that for very low levels 

of organisms it is important to have a friction component in the sample 

collection and that fluid flow alone won’t be adequate or not as good as fluid 

combined with friction. You're correct that the brushing step is most prone to 

introducing external contamination. 
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But it was felt that it was still important to have that friction because 

otherwise the sample may not be as sensitive. The use of friction outweighs 

the risk of contamination. As long as you use aseptic technique you shouldn't 

be introducing external contaminants and it is important to have the friction 

component present in the channel. For the lever recess the same reason 

reasons are relevant for sample collection. Those little brushes can actually get 

under some components of the lever and the combination of flushing up and 

down with the fluid and brushing really does facilitate improving the 

sensitivity of sample collections.

Woman: Thank you.

(Marlon Williams): Thank you.

Coordinator: Thank you. Our next question or comment comes from (Eric Walters). Your 

line is open.

(Eric Walters): Oh thank you. I think you’ve already answered my question so thank you.

Coordinator: Thank you. Our next question or comment is from (Linda Lawrence). Your 

line is open.

(Linda Lawrence):Yes my question is with the brushing do you actually brush down and bring 

the brush back out before you cut the tip or do you bring it through the scope 

once and cut the tip before the rest of the brushes fall back through?

Dr. Michelle Alfa:In the FDA/CDC/ASM protocol it actually does clearly spell out the 

instructions for that. During this webinar presentation we just mentioned that a 

brushing step is needed. The details are that the brush is inserted through the 
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biopsy port, and by pushing the brush down the channel it will come out the 

distal end. When it emerges from the end of the duodenoscope it's then cut 

off into the sample container. So it’s not put down and then pulled up through 

the channel. It’s actually just passed through the channel and once it emerges 

from the end it’s cut off aseptically into the specimen container.

(Linda Lawrence):Thank you.

Coordinator: Thank you. Our next question or comment comes from (Byron Fernandez). 

Your line is open.

(Byron Fernandez): Thank you. My question is regarding the culturing and subsequent 

observation and gram staining of any recovered organisms. I understand that 

there is a requirement to check incubating plates at 24-hour period 24, 48 and 

72 hours. Should grant gram stain of those observed isolates be occurring at 

those time points or after the 72-hour period?

Dr. Kevin Alby: This is Kevin. That’s going – so they should have some type of work up at 

that time that growth is observed. It depends on your facility if you choose 

liquid or solid culture method and what equipment you have available to you 

to do your workup. So if you are a laboratory that is a MALDA-TOF 

spectrometry and you’re doing a solid culture technique you would likely be 

able to go straight to organism identification on day one or as a post if you’re 

doing liquid culture then you would do a gram stain of the liquid culture and 

then look at the subculture.

(Byron Fernandez): Okay. We are currently taking advantage of the membrane filtration 

method which is why I ask because at each time period there is a potential 

points of contamination in terms of recovering a gram stain subculture.
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Dr. Kevin Alby: Yes. So the idea would be to provide as much information as you could as 

quickly as you could.

(Byron Fernandez): Okay thank you.

Coordinator: Thank you. Our next question or comment comes from (Holly). Your line is 

open.

(Holly Holmig): Hi. This is (Holly Holmig). I guess my question sort of has been answered. It 

was about sterile brushes. And I think I need to clarify the full guidelines from 

the FDA so that I can compare them to ARN and AMI guidelines for 

sterilization a single use items because I don’t know that those brushes have 

an instruction for use to sterilize them. So I’m going to have to do some more 

research but thank you for answering the questions thus far.

Coordinator: Thank you. Our next question or comment comes from (Nihan). Your line is 

open. (Nihan) please check your mute feature. Your line is open for your 

question or comment.

Woman: Oh yes hold on one second. We're here. She stepped out and I believe she's -

she asked her question on the line.

Coordinator: Okay. 

Man: Thank you. 

Coordinator: If she has an audio question she can press Star 1 to get herself back into the 

queue. Our next question or comment comes from (Jaclyn Daily). Your line is 

open.
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(Jaclyn Daily): Yes I wanted to ask related to not recleaning the scope but going straight to 

high level disinfection or sterilization. And it ties back to the participant who 

asked the question about flushing and brushing and flushing again being that it 

could loosen some organisms from the biofilm. Would it not be prudent then 

to do a clean and then go towards the high level disinfection? You may not 

necessarily need to do leak testing but the manual cleaning to me sounds like 

it would be apropos.

Dr. Michelle Alfa:That’s a good question and hello, good to hear from you.

(Jaclyn Daily): Yes Dr. Alfa.

Dr. Michelle Alfa:I think the key thing is that if you are collecting it aseptically properly and you 

are using sterile water then you do have the choice to re-clean and then 

disinfect or just to go straight to disinfection. Theoretically you should be 

able to go right to the disinfection. But we definitely leave it to the site 

because your point is valid it depends on how the collection is done as to 

whether anything might be introduced. So, in terms of sites that are worried 

about that by all means there's no problem, you can reclean it and then send it 

for the disinfection or sterilization process again. But the expectation would 

be if the sample is collected aseptically that going directly to the disinfection 

or sterilization step would be an adequate process.

(Jaclyn Daily): Okay thank you.

Coordinator: Thank you. Our next question or comment comes from (Linda Kane). Your 

line is open.

(Linda Kane): Hi. Thank you. Can you hear me?
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Dr. Michelle Alfa:Yes.

(Linda Kane): Oh good thank you. My question is that this is a voluntary protocol at this 

time. Are there any states in the United States that it’s mandatory, mandated? 

And are there any ideas when it will become mandatory versus voluntary? 

Thank you.

Dr. Shani Haugen:This is Shani Haugen from FDA. So your question was whether there are any 

states that require use of this protocol? We’re not aware of any states that do 

require the use of this protocol but again this is something that each healthcare 

facility should check with both their state and local requirements. It is not 

required by FDA, CDC, or ASM.

(Linda Kane): Thank you.

Coordinator: Thank you. Our next question or comment comes from (Katy Godsey). Your 

line is open.

(Katy Godsey): Thank you. My question was just answered.

Coordinator: Thank you. Our next question or comment comes from (Atosha Richards). 

Your line is open.

(Atosha Richards): Is there any plan to make a video to ensure accuracy for the staff to 

perform this procedure?

Dr. Shani Haugen:This is Shani Haugen from FDA. At this time know there are no plans from 

the FDA, CDC ASM Working Group to develop a video for this protocol. 

Thank you.
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Coordinator: Thank you. Our next question comes from (Fran Hixson). Your line is open.

(Fran Hixson): My question happens to be very similar to the previous question about 

training. And videos with the little caveats that you’re sharing would be very 

beneficial for us as we're trying to implement the protocol. In regards to 

training can you tell me for those who perform the task the time it takes to 

really perform the procedure and sampling accurately?

Dr. Michelle Alfa:I actually agree with you that having some tools and a video is actually an 

excellent way of doing it. And we were hoping that maybe some of the sites 

may actually choose themselves to create a video because it facilitates the 

training process and also facilitates the ensuring that the individuals know 

exactly what’s supposed to be done.

I think it’s really important that there's a committee that involves, infection 

control specialists because they can review specific aseptic handling of 

devices and clinical microbiologists who can help review the aseptic handling 

of samples to avoid accidental introduction of environmental contaminants. In 

addition the site committee makeup would also endoscopy reprocessing, 

endoscopy nursing staff and facility educators to determine the best way to 

provide appropriate training for the duodenoscope sample collection. So your 

point is very well taken and I think it might be worthwhile for some of the 

sites or maybe some of the other organizations or educational groups to create 

a video that would go through all the duodenoscope sample collection steps so 

that people can actually see it being done in the appropriate way.

Corey Ofstead’s publication does mention some of these things but I think the 

key thing is that this is a new protocol and I think the concept of having a 

video made to show exactly how that brush is put through the channel and 
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underneath the lever mechanism in the recess as a training tool a video would 

be quite helpful.

Dr. Shani Haugen:And just to add to that this is Shani Haugen from FDA. There has been 

literature indicating that when initially incorporating this type of procedure 

within the healthcare facility it does take quite a bit of time those first few 

times for sample collection. But then once sufficient practice has been gained 

then the time for sample collection can be reduced substantially.

Coordinator: Thank you. Does that conclude the question or comment?

(Fran Hixson): Well I just wanted - the degree of training how long does it take for one to 

become competent when you were implementing your process?

Dr. Michelle Alfa:So maybe I’ll start that one off. I think the first decision that has to be made is 

related to one of the previous questions that were asked as to who is going to 

do the sample collection? Ideally it makes sense that individuals who are 

competent at handling duodenoscopes be trained in the aseptic technique part 

of sample collection. So in terms of how long it takes it really depends on who 

you select be the person to collect the sample. If that person doesn’t have 

experience with handling duodenoscopes it’s going to take you longer to get 

them up to speed than somebody who does. And even the person who has 

expertise in handling duodenoscopes you then need to get them up to speed in 

terms of this particular protocol and the use of the aseptic technique. So sorry 

I’m being vague on this but it really does depend on who you actually select 

to collect those samples.

(Fran Hixson): Thank you.
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Coordinator: Thank you. Our next question or comment comes from (Jaclyn Daly). Your 

line is open.

(Jaclyn Daly): Yes thank you. I had a second question related to the culturing. Being that in 

the document under regulatory requirements it says sampling the endoscope 

for microbial culturing is the quality indicator. So if we're using it as a quality 

indicator and we get some of the high concern organisms there was mention 

of notifying the patient. But if the patient is healthy and fine and depending on 

how long between the use on the patient and when the culturing was done how 

do you go about notifying the patient and offering some constructive feedback 

as to what to do? How would you do that?

Dr. Kevin Alby: This is Kevin. So we don’t offer specific guidance as to what exactly a 

healthcare facility should do in terms of when they should contact a patient 

and the type of information they should provide. That is the sort of decision to 

have with that kind of core team that is hopefully developed. That includes 

infection control, maybe someone from risk management, you know, to kind 

of assess what happens in each of those situations. So the idea is that it’s an 

example of something that our facility can do but it’s really up to the facility 

to determine what to do in each representative situation.

(Jaclyn Daly): And I just was – it’s the same question but just to follow up why not all 

organisms because depending on your immune state any of these organisms 

could become problematic? And I realize it’s a GI thing but it seems that 

we're kind of establishing two levels here. If you’ve got these organisms that 

are considered high concern and you’ve got ones that are moderate to low 

how do you decide which patients get notified other than what you had stated?

Dr. Kevin Alby: Again that comes down to what your patient population is, the kind of opinion 

of the experts at your facility as to who they think is at risk for infection with 
FDA 

Moderator: Irene Aihie

03-22-18/1:00 pm ET

Page 40

coagulase-negative staphylococcus because as you said it really depends on 

your patient population. And your patient population may be susceptible to 

infection with those organisms whereas other facilities may not have a patient 

population that would be susceptible to infection with those organisms. And 

so it’s really again going to be a facility by facility decision.

(Jaclyn Daly): Okay. Thank you.

Coordinator: Thank you. Our next question or comment comes from (Kevin). Your line is 

open.

(Kevin): Hi. You said that the proper technique for sampling the working channel is to 

advance the brush all the way through and when it comes out the end to cut 

off the end of the brush. Did you investigate whether there was any possibility 

for microscopic damage from cutting that and then pulling it back to the 

channel with maybe a bore scope of something of that type?

Dr. Michelle Alfa:Well in answer to your question I can’t speak for the manufacturers when they 

did the validation. But in terms of putting the brush through and cutting it off 

from a research lab perspective we’ve actually done that for years and we’ve 

not encountered any instance of failure of leak testing where there was scrapes 

inside the channel the perforated it. In terms of using a borescope we 

ourselves did not use borescope examination. I can’t speak for the 

manufacturers when they did their assessment but for the years that we’ve 

done sample collection from endoscopes and we’ve passed sterile brushes 

down and cut the end off we haven’t experienced anything that we could

recognize as major damage from the shaft being pulled back up.

(Kevin): Okay. Thank you very much.
FDA 

Moderator: Irene Aihie

03-22-18/1:00 pm ET

Page 41

Coordinator: Thank you. I would not like to turn it back over to Irene Aihie for any closing 

remarks.

Irene Aihie: Thank you. This is Irene Aihie. We appreciate your participation and 

thoughtful questions. Today’s presentation and transcript will be made 

available on the CDRH Learn Web page at www.fda.gov/training/cdrhlearn 

by Friday, March 30. If you have additional questions about today’s 

presentation please use the contact information provided at the end of the slide 

presentation.

As always we appreciate your feedback. Following the conclusion of the 

Webinar please complete a short 13 question survey about your FDA CDRH 

Webinar experience. This survey can be found at www.fda.gov/cdrhwebinar 

immediately following the conclusion of today’s live Webinar. Again thank 

you for participating. This concludes today’s Webinar.

Coordinator: Thank you. That concludes today’s conference call. Thank you for your 

participation. You may disconnect at this time.

END