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FDA Webinar: FDA Innovation Challenges: Identify Sterilization 

Alternatives and Reduce Ethylene Oxide Emissions

Moderator: Irene Aihie

August 13, 2019

3:00 pm ET

Coordinator: Welcome and thank you for standing by. At this time all participants will be 

on a listen-only mode until the question-and-answer session. At that time 

please press Star followed by number 1, unmute your line and record your 

name clearly to be introduced. Today’s conference is being recorded and if 

you have any objections you may disconnect. I’d like to introduce Irene Aihie. 

Ma’am you may begin.

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

Office of Communication and Education. In response to the February 2019 

closure of a large device elevation facility the FDA is taking steps to ensure 

that hospitals, healthcare providers and patients have access to medical 

devices that are safely and effectively sterilized. On July 15, 2019, the FDA 

announced the launch of two public innovation challenges to encourage 

innovation in medical device sterilization.

Challenge one focuses on identifying alternatives to ethylene oxide 

sterilization methods. And challenge two is focused on developing strategies

to reduce ethylene oxide emissions. The FDA Center for Devices and
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Radiological Health will accept applications for both of these challenges 

through October 15, 2019. The FDA encourages participation in these 

challenges from organizations such as medical device companies or 

distributors, technology manufacturers including startup companies or labs, 

academic and research institutions, healthcare facilities, professional societies, 

foundations and other nonprofits.

Today Chris Dugard and Steven Elliott both from the Office of Surgical and 

Infection Control Devices here in CDRH will discuss both innovation 

challenges. Following the presentation we will open the line for your 

questions related to the information provided during the presentation. 

Additionally there are other subject matter experts here to assist with the Q&A

portion of our Webinar. Now I give you Chris.

Chris Dugard: All right thank you and good afternoon everyone. This is Chris Dugard. And 

as Irene mentioned I’m a reviewer in the (sterilization) devices team in the 

Office of Health Technology. And I’m joined by Steve Elliott who is also a 

reviewer in the same team. And today we’re going to be talking about FDA’s 

innovation challenges to identify sterilization alternatives to ethylene oxide 

and reduce ethylene oxide emissions.

So here’s an overview of the agenda. I’m going to start with an overview of 

ethylene oxide sterilization in general. Then I’ll go into FDA’s efforts to 

address issues associated with ethylene oxide sterilization. Then I’ll provide 

an overview of the innovation challenges, tips for potential applicants and 

then we have a page of resources and we’ll have time for questions at the end.

Sterilization is defined as a process intended to render devices free of viable 

microorganisms in order to prevent patient exposure to pathogenic 

microorganisms. Sterilization is a binary consideration, the device is sterile or 
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it is not. But there is no way to prove with 100% certainty that a product is 

sterile. Since microbial activation is expected to be exponential we express 

how thorough a cycle is through probability in what we call the sterility 

assurance level or SAL. For example a typical SAL for medical devices is 

expressed as an SAL of ten to the minus 6 or a probability that only one in 1 

million devices is contaminated following exposure to the cycle. This is 

calculated by exposing either bioburden that’s been characterized or 

biological indicators which I will refer to as BIs from now on with a known 

population and resistance to the intended cycle determining the SAL based on 

whether the BIs or bioburden are successfully inactivated or killed.

There are several common types of sterilization modalities used to process 

medical devices and these are thermal which includes steam sterilization and 

dry heat sterilization, chemical which includes ethylene oxide gas, vaporized 

hydrogen peroxide, chlorine dioxide, et cetera and irradiation which includes 

gamma, x-ray and E-beam. Sterilized medical devices are critical to our 

healthcare system and patient safety to prevent infections through the use of 

these devices. As you all probably can tell the focus on this talk will be on

ethylene oxide.

Ethylene oxide is a common if not the most common sterilant used for 

medical devices. Discovered in the 1800s it was originally used for fumigation 

until the military began using it as a sterilant in the 1940s. It was eventually 

patented for sterilization of medical devices in the late 1950s and since then it 

has achieved roughly 50% of the market share for medical devices provided 

sterile to healthcare. The reason for this is its great material compatibility as it 

is compatible with most common medical device materials, its ability to 

penetrate multiple layers of packaging with only metal and glass really 

providing any sort of effective barrier against it and scalability on an industrial 
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scale that is large quantity of devices and mixed loads can be sterilized at 

once.

Liquids would be one of the primary kinds of products that are not suitable for 

ethylene oxide sterilization. EO mode of action is alkylation of microbial 

DNA preventing further division. An ethylene oxide cycle involves exposure 

of product to ethylene oxide gas under vacuum in a sealed chamber with

defined temperature and humidity conditions. And despite EO’s effectiveness 

for sterilizing medical devices it also has its disadvantages. There are more 

variables that are critical parameters such as time, temperature, ethylene oxide 

gas concentration and relative humidity that need to be addressed to ensure a 

reproducible cycle. As ethylene oxide concentration goes up the more lethality 

there is in the cycle but this may impact material compatibility. The longer the 

cycle the more lethality but again this may impact throughput and material 

compatibility.

The higher the temperature the more lethality but ethylene oxide is a low 

temperature process ideal for temperature sensitive products. So this may be a 

limiting factor. Humidity adds moisture to hydrate spores which makes them 

more susceptible to the lethal effects of ethylene oxide but this may require 

preconditioning to ensure consistent lethality. Aeration of devices post 

sterilization to remove ethylene oxide residuals adds even more time. 

Compare this to irradiation where the only critical parameter is the dose of 

radiation delivered.

So those are considerations on cycle design but in terms of safety there are 

also disadvantages as ethylene oxide is highly flammable and explosive. 

Ethylene oxide emissions during the sterilization process can be both an 

environmental and worker health concern as ethylene oxide is identified as a 

hazardous air pollutant and is classified as a carcinogen. To date we are aware 
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of one industry ethylene oxide sterilization facility that has been closed on the 

basis of emissions. As a result there are concerns associated with 

manufacturing and processing of devices historically sterilized with ethylene 

oxide not just in terms of safety but also in terms of finding a suitable 

alternative to EO if more facilities are closed. If more were to be closed this 

may severely impact availability of devices typically sterilized with ethylene 

oxide.

While these safety concerns present challenges that need to be mitigated,

unavailability of ethylene oxide would have an impact on public health. Its 

effectiveness against a broad spectrum of microorganism has been wellestablished. As I noted earlier an ethylene oxide sterilization cycle is scalable 

allowing for large amounts of devices to be sterilized at once. This ensures the 

supply chain medical devices is preserved and removing ethylene oxide as an 

option may create delays getting these devices to market. I also noted earlier 

that ethylene oxide has excellent material compatibility. As a result this is the 

only current option for a large number of complex medical devices. For 

example ethylene oxide is one of the only modalities used for electronic 

medical devices.

So this brings us to FDA’s efforts to address these concerns. We have been 

working with sterilization experts, medical device manufacturers and other 

government agencies to both advance current methodologies using ethylene 

oxide for medical device sterilization and to prevent the potential for medical 

device shortages due to a lack of alternative to ethylene oxide. This also 

includes discussion of other methods that may be used instead of ethylene 

oxide. These issues are important because while we are interested in 

alternative modalities for devices that may not necessarily need to use 

ethylene oxide we recognize that there will likely always be a place for 

ethylene oxide in medical device sterilization but further mitigating its risks is 
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of great interest to the agency. These concerns tie into our innovation 

challenge which I’ll expand on just a bit. But the FDA is also planning on 

holding an Advisory Committee Panel on November 6 and 7 of this year to 

obtain stakeholder feedback regarding challenges and opportunities for 

ethylene oxide reduction and the use of alternative strategies to inform the 

FDA’s decision making. There will be more on that in the coming weeks.

Now more about the innovation challenges themselves. The FDA is reaching 

out to anyone involved in sterilization to foster innovative new sterilization 

technologies and methods both based around ethylene oxide and not to 

mitigate the risks associated with ethylene oxide as well as ensure there is no 

interruption of medical device availability. The first challenge is to identify 

new sterilization methods or technologies to EO sterilization. This means any 

method or technology that demonstrates compatibility with the largest crosssection of materials used to make medical devices or packaging materials or 

sterile barriers is scalable, allows for high capacity, and demonstrates 

quantifiable reduction in viable microorganisms to an acceptable sterility

assurance level.

The second challenge is asking for any methods that can reduce the level of 

ethylene oxide emissions. As noted earlier we recognize the prevalence and 

usefulness of EO sterilization for medical devices and realize that even if an 

alternative modality is found there will likely always be a need for ethylene 

oxide sterilization in some capacity. 

However given the risks I mentioned there is room for innovation to modify 

existing practices to reduce ethylene oxide emissions as close to zero as 

possible. We are looking for methods that still achieve an acceptable validated 

sterility insurance level and reduces the amount of emissions typically seen in 

the process. This may include strategies to reduce EO concentration, control 
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bioburden, using a bioburden approach, reduction in the amount of ethylene 

oxide used, capture of emissions and transformation into harmless 

bioproducts, emission containment and abatement, et cetera.

So I talked about some of this on the last slide but eligibility for these 

challenges includes any safe and effective alternative methods or technologies 

to ethylene oxide sterilization for medical devices as well as any innovative 

strategies and procedures in any stage of ethylene oxide sterilization process 

that is demonstrated through reduced ethylene oxide emissions to near zero.

We are casting a wide net so if you have anything that fits these criteria we 

encourage you to submit an application.

I will now go into a bit more detail about what is expected in these challenges. 

For challenge one, that is identifying new methods and technologies other 

than ethylene oxide, we are looking for methods that can sterilize a wide range 

of polymeric materials without a change in the chemical and physical 

properties of the polymers by degrading them for example through oxidation,

chain scission, or other unfavorable reactions or by generating unacceptable 

levels of toxic byproducts such as leachables. There may be some materials 

that have been traditionally sterilized using ethylene oxide that may have 

alternatives. We are looking for methods where these materials could be 

diverted to a different modality.

We are looking for methods that can or have the potential to sterilize bulk 

volumes or large loads of products at an industrial scale. While we would not 

rule out methods that sterilize smaller loads, industrial level methods would 

have the best chance of mitigating the concerns I discussed earlier. We are 

also looking for methods that have the potential to be adapted to existing 

infrastructure and can be rapidly deployed to medical device manufacturers 
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and sterilization providers in the US. Again no method will be ruled out but if 

it has the potential to be adapted to current infrastructure that would be a plus.

For challenge two, that is reducing emissions of existing ethylene oxide 

processes to as close to zero as possible, we are looking for methods that do 

not negatively impact throughput of current ethylene oxide sterilization 

processes. Like challenge one, we are also interested in methods that are able 

to use existing infrastructure and can be rapidly deployed. This includes 

strategies to control and reduce bioburden prior to sterilization. We would like 

to see strategies that use lower levels of ethylene oxide in general while still 

maintaining an acceptable sterility assurance level. 

We would like to see methods that capture ethylene oxide emissions and 

transform them into harmless byproducts. This includes methods of detection, 

measurement, tracking and containment of emissions or byproducts to 

minimize or prevent dissemination into the sterilization facility and

environment. Methods that can minimize exposure to workers in nearby 

communities will also be looked at.

As for who can apply, we are looking for applications from any companies 

involved in sterilization: medical device companies, startups, academic 

researchers, healthcare facilities, professional societies, foundations or anyone 

else I haven’t listed that is involved in sterilization to look at any safe and 

effective alternative methods or technologies to ethylene oxide sterilization 

and any innovative strategies in any stage of ethylene oxide sterilization that 

are demonstrated to reduce EO emissions to close to zero as possible. I will 

note however that review of these challenge submissions does not constitute 

regulatory acceptance or endorsement of a process associated with a 

premarket submission. Following the challenge these methods or technologies 

would still have to be reviewed through the relevant premarket pathway.
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So now I’ll get a little more into what we expect in your actual application. 

For either submission we would like to see the development plan for the 

method or technology, how far is it from being able to be implemented at an 

industrial level? Is it still in a conceptual stage? What is the supporting 

science or evidence? We would like you to list the development team 

including names of essential team members and prior experience of each team 

member in sterilization methods or technologies. We would like the scientific 

basis and/or preliminary data to support the proposed method or technology 

and as much detail as you have available while still meeting our submission 

criteria. You should also describe the anticipated benefit and the impact of the 

method or technology on public health.

Compatibility of the method or technology with medical device materials 

should also be discussed. For example if it’s a new method, are there materials 

that are compatible with this method that EO is not and then vice a versa. Also 

we would like to see the capability of the method or technology to ensure 

scalability and high throughput for safe and effective sterilization of large 

volumes of devices. If the method or technology is still at more of a 

conceptual stage but you can envision that it might eventually be scalable to 

an industrial level we would like to learn about that.

So while I did note that review of these submissions does not constitute 

regulatory acceptance there is the - there are incentives to participating in this 

innovation challenge. There is the obvious potential benefit of positively 

impacting public health. You will be receiving more interaction with the FDA 

and as a result potentially accelerate the development and review of your 

technology or you may also receive FDA recognition for a successful 

application. All right so here is the timeline for the innovation challenges. The 

challenge began July 15 of this year and it - the submission period started July 
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15 and will end October 15. You can submit your application to the email 

address on this page which is also on our Web site. And the judging period

will be from October 16 to November 16. And we will be announcing 

applicants selected for the challenge in December 2019.

When reviewing the challenge submissions a panel of subject matter experts 

within the agency will be considering the anticipated benefit of the strategy or 

technology. And just to emphasize the criteria I noted earlier some of what we 

will be considering include is it easier or more difficult to implement that 

existing practices, does it introduce additional concerns even if it eliminates 

some of the concerns associated with ethylene oxide. We will be looking at 

the impact on public health compared to other alternatives. Since EO is 

compatible with most commonly used medical device materials we will be 

comparing compatibility with the proposed method or technology in every 

submission as well.

A new method or technology that is highly effective on only a small number 

of materials may not address the challenges we are facing. As I mentioned 

several times before we will be considering scalability, how feasible is it to 

implement the proposed change and we will be considering whether further 

interaction with the FDA would help foster a potentially beneficial method or 

technology.

All right here is the application format. We are asking that these submissions 

be no longer than 20 pages and include a cover page with a company name, 

address and primary contact with name, phone number and email, name of the 

alternative sterilization method or technology, FDA regulatory history if 

appropriate and name of the challenge that you are addressing. Please also 

include an executive summary limited to one page with a summary of the 

method or technology, the significance of the problem it will solve and a 
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summary of the proposed development plan. So you may submit more than 

one application and there is no official application form and the format is 

outlined of the Web page. The link for this page and other resources are listed 

at the end of this presentation.

If your application is selected, expect confirmation from FDA and instructions 

on next steps. There may also be the potential for Web presentations to 

evaluate finalists. Please note that we will confirm receipt of every application

so if you submit one and you don’t hear from us please reach out. Also note 

that even if we do not select your application as a finalist or if you have 

technology or a new method that is in early stages we encourage you to 

continue to reach out to the agency through our typical channels including 

pre-submissions or breakthrough device designation outside of this challenge. 

Please note that all communications with the FDA will be considered 

confidential and will not be released by us. Any announcement to be made 

about a particular application will be vetted through the applicant prior to 

announcing. As I noted here are the resources and now we will have time for 

questions.

Irene Aihie: While we get started or get ready to prepare for questions I do want to make a 

note that if we do have any members of media listening in our press officers 

will follow up with you separately. And if you have any questions please send 

those media related questions to the following email address that is 

fdaoma@fda.hhs.gov.

Chris Dugard: And now we have time for questions.

Coordinator: And thank you. At this time to begin the question and answer session you may 

press Star followed by number 1 to ask a question. Star 2 that will withdraw 
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the question. Again please unmute your line and record your name clearly as 

prompted to be introduced. Again with questions please press Star followed 

by number 1. Please standby.

Irene Aihie: So we have a few questions that we feel may come up. I believe Steven?

Steven Elliott: Okay so...

Coordinator: And the first question comes from (Darren Demetric). Your line is open.

(Darren Demetric): Yes, hi. With regard to reduction of EtO emissions I work for a company 

called (Renew Medical). We’re a processor of single-use medical devices. 

Most of the reprocessing industry utilizes EO sterilizers as part of their 

process to reprocess these single-use devices. They do this even though only 

critical medical devices are defined by CDC requires sterilization where semicritical devices or non-critical device is deemed necessary to do a high level 

disinfection. Does FDA or more importantly could FDA consider putting 

emphasis on high level disinfection for reprocessing semi-critical and 

noncritical medical devices in lieu of sterilization? This could significantly 

reduce the impact of EO gas in the reprocessing industry?

Steven Elliott: That is a very interesting question. Right now I’d say that there is potential to 

do that and reevaluate the appropriate classification for certain devices be they

critical or semi-critical. However it does raise potential concerns. There’s 

already confusion and debate over the appropriate classification under the 

Spaulding Classification system. So that might be a potential strategy that we 

could explore in detail if you intended to put in a submission along those 

lines.

(Darren Demetric): Great, thank you.
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Coordinator: Thank you. Our next question is from Edward Life Sciences. Your line is

open. The company with Edward Life Science your line is open. You may 

want to check your mute button.

Irene Aihie: We’ll take our next question.

Coordinator: All right our next question is from (Ayanna Alexander). Your line is open.

(Ayanna Alexander): Hi. Can you all hear me?

Irene Aihie: Yes, we can hear you.

(Ayanna Alexander): Okay, just making sure. I am a part of the media but I do have a clarifying 

question. I know you guys are looking for substitutes to ethylene oxide but if 

you - you’re saying if you find one there is probably still going to be a good 

chance that EtO is still going to be used to clean devices?

Irene Aihie: If you wouldn’t mind sending that question to the mailbox that I mentioned 

earlier so that we can have...

(Ayanna Alexander): Got you.

Irene Aihie: ...a member of our press team get that answer for you.

(Ayanna Alexander): Thank you.

Irene Aihie: You’re very welcome.

Coordinator: Thank you. Next question is from (Brent Ashton). Your line is open.
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(Nicole McCleaf): Hi. Actually it’s (Nicole McCleaf) from 3M. Can you hear me?

Irene Aihie: Yes, we can hear you.

(Nicole McCleaf): So I actually have two questions one for challenge one, are you looking for 

alternatives to EO that aren’t already known, you know, like nitrogen dioxide, 

hydrogen peroxide. There is some data out there on that. Are you looking to -

looking for alternatives beyond that?

Steven Elliott: Yes, that’s another excellent question. With that it could be either way. So I’d 

say that it could be an alternative that we do not have a sterilization history 

with or it could be utilizing an existing sterilization technology such as 

vaporized hydrogen peroxide, nitrogen dioxide, chlorine dioxide anything like 

that in a broader application than we’ve seen. One of the issues we have is that 

when we see some of these sterilization modalities we’re seeing them in a 

device specific processing context. 

So we don’t know the greater capability of the process and that’s something 

that could be explored with the challenge. Again in this case we’re looking for 

a fix for compatibility and processing of devices that were historically 

sterilized with ethylene oxide so that’s a much broader usage than some of the 

submissions we’d see for doing, or using those processes and a much more 

narrow or limited sense.

(Nicole McCleaf): Okay. Thank you. And then my second question is kind of related to that but 

it’s for challenge two. Are you looking for methods other than the methods 

that are currently in the ISO 11135? For example the BI bioburden or cycle 

calculation approach will likely help with EO concentration but I guess if you 

can clarify if you’re looking for alternatives to those methods?
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Steven Elliott: Okay. We are looking for alternatives that will result in a reduction of 

ethylene oxide emission. However you get there with, as indicated previously,

hitting those, you know, defined process sterility assurance levels to assure a 

sterile specification for advice, so absolutely. The approaches that are less 

conservative as defined by the ISO 11135 standard would be an appropriate 

point but if there’s alternate methodology that is worth considering we would 

absolutely love to see that come in, in the form of a challenge submission.

(Nicole McCleaf): Okay great, thank you.

Coordinator: Thank you. Our next question is from (Sumner Barenburgh). Your line is 

open.

(Sumner Barenburgh): Hi. This is (Sumner Barenburgh). I have two questions. How do 

you plan to coordinate with the EPA and the EPA registrations that will be 

required? That’s part one. And then part two with this innovation will the

FDA be underwriting any of the work in developing this alternative?

Steven Elliott: Okay can you please clarify underwriting? So you mean subsidizing some of 

your costs?

(Sumner Barenburgh): Yes.

Steven Elliott: Okay, that unfortunately, would be outside of the scope of the challenge 

incentives. In terms of our work with the EPA, this challenge is an 

independent FDA venture. There are certain steps that are required for 

addressing chemical sterilants with the EPA registering as pesticides and such. 

And for those I would refer you to EPA’s Web site to address those regulatory 

requirements. Those are a little bit outside of the scope of the challenge.
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(Sumner Barenburgh): No, the question I’m asking because I was involved with chlorine 

dioxide as controlling bio contamination and for sterilization. And so we get 

FDA approval on a couple of applications but we also needed concurrently as 

an antimicrobial or a sterilant we had to get EPA registrations historically.

Steven Elliott: Yes, and with any challenge incentives or proposed ideas that would not 

negate any other regulatory requirements from a different agency.

(Sumner Barenburgh): Okay, thank you.

Irene Aihie: We’ll take our next question.

Coordinator: One moment please. Our next question is from (Thomas Rickel). Your line is 

open.

(Thomas Rickel): Well yes I’m speaking on behalf of Medtronic this afternoon. Can FDA share 

their thoughts on the differences in engaging innovation challenge versus 

maybe a more traditional presubmission? That’s the first part of the question. 

And the second part of the question would be how many submissions does 

FDA intend to support say they get numerous bid applicants how many would 

FDA intend to support?

(Afton): Let me just start with the second part of the question with regard to how many 

applications do we intend to support. So as both Steve and Chris mentioned 

we are looking for very innovative ideas. And if we get several challenge 

applications that have that we can definitely accept multiple applicants into 

the challenge itself. So really we’re going to focus on the quality of the ideas

and we will support those high quality ideas.
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(Thomas Rickel): Thank you.

((Crosstalk))

Coordinator: (Phil Coghill), your line is open.

(Phil Coghill): Yes thank you, (Phil Coghill) from Medtronic. Is the FDA collaborating with 

other medical device regulatory bodies such as Notified Bodies, Health 

Canada, PMDA or, you know, with these challenges?

(Afton): Good afternoon. So FDA is not currently collaborating with our OUS 

regulators on this particular challenge but we are aware of other activities. 

And so that is the challenge is as one of several components that we’re doing 

as we address this issue. We have other stakeholder engagement and outreach 

in a forthcoming Advisory Committee Meeting on that. And so that might be a 

more appropriate area to think about some of those other jurisdictions.

(Phil Coghill): Thank you.

Coordinator: At this time I’m seeing no further questions. As a reminder that is Star 

followed by 1 with any questions.

Steven Elliott: Actually I did want to reach back just briefly because I - we realize we didn’t 

respond fully to one of the questions regarding incentives and how the 

interaction for the innovation challenge would differ from a typical interaction 

with FDA along the lines of presubmission process. And I’m sure that this 

would be of interest and I think it is important to note that the type and nature 

of interactions that we would be having with companies would be dependent 

on the content of the submission. Obviously, we want to gauge the efficacy of 
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us providing significant interaction. Some processes we could offer more in 

the way of help, some processes less.

And obviously being a challenge winner would not replace or remove any 

need for objective review in a medical device submission. Processes would

obviously need to be able to support a sterile specification for a medical 

device. And there might be some outstanding concerns that would need to be 

addressed prior to implementation of a sterilization process for a specific 

medical device. Having considered all of those caveats we definitely will be 

looking for I’d say more frequent interaction potentially iterative review of a 

process. In this case we would recognize that at this point we have incentive 

and interest in developing solutions to our outstanding processes which is a 

little bit different than a presubmission process where we’re looking at just 

answering questions and concerns based on something that’s of interest to a 

sponsor or a company coming in.

Definitely we want to help identify and provide suggestions to any, to address 

any scientific and regulatory concerns that would facilitate the use of this 

process. And we would also be trying to facilitate our own internal training 

and education to address any potential review challenges we’d get with a new 

process coming in. So those are elements we just wanted to point out to 

distinguish and address an earlier caller’s question.

Irene Aihie: Operator, are there any other questions?

Coordinator: I’m sure no questions at this time. As a reminder please Star 1 if you do have 

a question. And I’m showing no questions at this time. We do have a couple 

of questions that just came in. (Thomas Rickel) your line is reopened. You 

may ask your question.
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(Thomas Rickel): Great, Steve thanks for clarifying the answer to the question. I think that was 

Steve. One additional question that has to do with disclosure of innovation 

challenge I think Chris covered it briefly and I wonder if you could perhaps 

just go over it one more time. I think I heard Chris mention that any 

announcements FDA intends to post with regard to progression in the 

challenges particular submissions would be reviewed with the company 

before being posted. Maybe just talk through the way in which FDA intends to 

communicate on progress along the way both through vetting and then also 

through interacting with an applicant?

Steven Elliott: Okay. I think it might be helpful at this point if we can get just a little bit of 

clarification at this stage you’re speaking. Are you speaking during the review 

or judging process or are you speaking to post-selection of a winner or 

meritous submission?

(Thomas Rickel): I think clarification of both stages probably once FDA has landed on the 

selected applicants then the way in which they intend to communicate on 

about the population of submissions. And then secondarily, you know, I’m 

presuming that perhaps FDA would like to discuss the progression of the 

challenge and if there’s any sort of discussion points along the way as they’re 

working with applicants?

Steven Elliott: Okay, with that, in terms of process, the level of interaction required might be 

determined at this point. Some of these elements are not firmly decided and 

that will - that was – that’s based on the number and I’d say consistency and 

quality of applications we’re getting. And if there’s any elements in those that 

would require us to reach out and have some potential additional interactions 

would definitely take place with that. But it’s – if it’s a case of if we’re 

receiving an enormous multitude of these things obviously our selection 

process needs to be a little bit more cutthroat in terms of how we’re going 
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through and reviewing these things so resources might come into play for that 

as well.

(Aftin): And then this is (Aftin). To add on with to what Steve is saying with regard to 

communications. So FDA would certainly have interest in announcing those 

applicants that were selected into the challenge because they would have been 

selected because they have novel ideas that we think could have a positive 

impact on public health. But as Chris indicated in his statements a little earlier 

in the presentation we would work with those that are selected into the 

challenge with regard to what will be communicated as well as when so that 

goes also to your timing question as well.

(Thomas Rickel): Great, thank you.

Coordinator: Thank you. Our next question is from (Bill Cavell). Your line is open.

(Phil Coghill): Thank you, (Phil Coghill) Medtronic again. My question is that the two 

challenges are quite different. And the second challenge for reducing ethylene 

oxide there may be a lot of companies coming in with very similar ideas. Has 

there been a thought to try to combine those and have companies work 

together since they’re really industry wide benefits versus the alternatives to 

EO may be unique and really dependent on the particular company. Have you 

thought about combining applications or methods that come in on the 

reduction of ethylene oxide?

Steven Elliott: Okay. That is a very interesting thought. We would welcome any designated 

collaborative submissions from industry to address this problem. Again, our 

angle on this is advancing and supporting public health. So in terms of that 

we’d absolutely welcome those things. Unfortunately, one of the concerns 

with that as we just mentioned would be that we can’t share independent,
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Page 21

similar submissions between companies due to the existing confidentiality that 

we would have to maintain. But we would welcome that coming in from an 

external perspective, if any companies or interested parties would like to 

collaborate on that, we would definitely welcome that type of pursuit.

(Phil Coghill): So thank you for the clarification.

((Crosstalk))

Coordinator: Excuse me, (Brad Dumpke) joined.

(Brad Dumpke): Oh thanks. Could you elaborate on industrial level throughput or scalability 

please?

Steven Elliott: Okay. Yes essentially with the concerns associated with use of ethylene oxide 

we’re definitely all aware that ethylene oxide is a major contributor to 

industrial sterilization of medical devices. So with that, it’s something that has 

a high throughput, large volume processing infrastructure in place. 

And while we don’t expect something to come out tomorrow at the exact 

same capacity and replace it [EtO sterilization], that would be one of our 

desired outcomes would be trying to identify or, you know, see processes 

coming in that could be potentially in the future scalable to work at a similar 

capacity to, you know, an ethylene oxide or gamma radiation sterilization. So 

we understand that it’s not there for a lot of modalities yet but that’s one of the 

purposes of the challenge would be encouraging back going forward.

(Brad Dumpke): Thank you.

Coordinator: Thank you. And our next question is from (Al Tillia). Your line is open.
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(Al Tillia): Hello. So my question is about challenge number two, does this challenge also 

cover conversion of the emitted EtO to others safer gases or just reducing it?

Steven Elliott: That is an excellent point. For clarification any process that is going to reduce 

ethylene oxide emissions be it a change to the actual sterilization process itself 

or some sort of external abatement, cleanup or chemical conversion all of 

those things would be considered relevant.

(Al Tillia): Okay, thank you.

Coordinator: And thank you. I’m seeing no further questions at this time. I’d like to turn the 

meeting back over to Irene Aihie.

Irene Aihie: Thank you. This is Irene Aihie. And 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 Wednesday, August 21. 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 today’s Webinar please complete a short 13 

question survey about your FDA CDRH Webinar experience. The 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: And thank you. This does conclude today’s call. You may disconnect your 

lines and thank you for your participation.
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END