abbreviated_fda_510k_pathway

As medical device developers, it is our responsibilities to make sure that our products are safe and effective.

Unfortunately, the recent high profile cases of antibiotic-resistant superbugs spread by tainted endoscopes that have sicken many have called into questions whether there needs to be new regulations to prevent future infections.

If you have a device that is designed to be cleaned or reused, should not some of the design inputs include reprocessability requirements?” - Mike Drues

Today we are speaking with a familiar guest Michael Drues, Ph.D. about the recently published guidance document released by FDA for reprocessable medical devices.

Mike was one of several people who was invited to present at the panel meeting at FDA on this topic last year.

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What good is the regulation if it’s not realistic?” - Mike Drues

Mike is the president of Vascular Science, as well as a consultant for the FDA, Canada Health and other worldwide regulatory organizations and medical device companies.

Due to his work with these organizations, Mike can see the issue from both sides: He understands the regulations and why they must exist, and he also knows that they need to be approached and implemented with real-world scenarios in mind.

On today’s podcast, some of the topics we discuss include:

  • What happened in a landmark endoscope case from UCLA, and how it affects everyone in the medical device industry.

  • Who must be considered and included as the end users of a product.

  • The specifics of some of the new regulations, including new rules pertaining to UDI labels.

  • Thoughts on who should be handling the reprocessing validation.

  • Why over-complicated reprocessing manuals can do more harm than good.

  • Best practices for device development companies to keep in mind when following the new regulations.

Links and Resources:

Vascular Sciences

Mike on LinkedIn

USA Today article about the UCLA case

New reprocessing guidance document from the FDA

Jon and Mike's previous podcast on the reprocessing tragedy

 


Transcription:

Announcer: Welcome to the Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.

Jon Speer: If you can make sure that your medical device that you're designing and developing and manufacturing, if you can make sure that that product was safe and effective, wouldn't you do so? Isn't that our obligation in the medical device industry? Don't we have a responsibility to make sure that the products that we're designing and developing and manufacturing are safe and effective for their indications and intended uses? I think that that is... We would all agree that that is absolutely the purpose, but something has happened recently where maybe we're not doing everything that we need to do. It really has surfaced with respect to reusable products, things that need to be reprocessed and cleaned in between uses. There obviously has been a lot of press, a lot of news about that. And today, on this episode of The Global Medical Device Podcast, familiar guest, Mike Drues from Vascular Sciences, and I talk about how these dirty devices are impacting, actually, policy and guidance documents coming from the FDA, that are now gonna trickle down and affect many, many of us in the medical device industry. So be sure to listen to this episode of the Global Medical Device podcast.

Jon Speer: Hello. This is Jon Speer, the founder and VP of Quality and Regulatory at greenlight.guru and welcome to another episode of the Global Medical Device podcast. Today, we're gonna talk about something that is suddenly now impacting a lot of medical device companies around the world and, you know what? These medical device companies may not even realize that this is happening. My guest today is Mike Drues. Mike Drues is with Vascular Sciences, and he consults with FDA Health Canada, as well as medical device companies all over the world, from coast to coast, from continent to continent. Mike, welcome back to the program today.

Mike Drues: Well, thank you so much for the invitation to come back, Jon. It's always a pleasure to speak with you and your audience.

Jon Speer: Mike, you're welcome. Absolutely. I love our conversations. We sometimes get pretty deep. And today is another one of those topics that it's certainly possible and I'm gonna remind the audience that a few months ago, you and I had a conversation about reprocessing of devices. There were some issues with some duodenoscopes in the marketplace and some super bugs that had cropped up at a couple of major medical institutions, and a big hubbub that was happening in the industry about reprocessing. Obviously, that topic hasn't gone away. I'm sure you're staying on top of reprocessing and this issue about "super bugs and dirt devices" and all that sort of thing. What is the latest and greatest from your perspective?

Mike Drues: Well, first of all, Jon, just to recap the situation for your audience, for anyone that either may not remember or hadn't heard, but much of this stemmed from the tragedy that happened just this past year at UCLA, as well as several other medical institutions, where several people were infected and seriously impacted by infections caused by a certain type of endoscope, as you said it, duodenoscope, that were not cleaned and reprocessed property. That's the topic of our conversation today. And this has generated an awful lot of discussion in the medical device world. Since then, in the interest of full disclosure, I was one of several people that were invited to present at the panel meeting at FDA on this topic just last year. And maybe we can get into some of those issues today.

Jon Speer: Yeah, yeah, absolutely. I'm sure we'll talk about that. I love to pick your brain a little bit about... Not only that panel discussion, but also the outcome of that, but it's always interesting to me whenever you see headlines and the news about Congress wanting to jump in and take some action that impacts the medical device industry. And sometimes there are these events and certainly tragic and certainly there needs to be some sort of action taken, of course, but now, all of a sudden, when it becomes national news, and headline news, and Congress is getting involved, how does that impact all the rest of us, all the rest of these companies who may be doing the right thing? What does that mean? How does that impact is?

Mike Drues: Well, that's a terrific question, Jon. And quite frankly, one of the things that bothers me about some folks in this industry, a number of people have said to me, "Well, I don't work in gastroenterology" or "I don't work on duodenoscopes. Why should I care about this particular case?" And quite frankly, as we're gonna talk about, everybody in the medical device industry should be aware of this, because this is now one of those small number of medical device cases that are truly a watershed moment, because it is reaching out and impacting every medical device in this industry, certainly, all the devices that are being labeled for reusability or reprocessing.

Mike Drues: And unfortunately, back to your comment a moment ago about the impact, these are not new issues. We've been talking about these issues since, actually, the early 1990s. Unfortunately, it sometimes takes bodies to pile up on the side of the road before anybody, including our industry, or Congress, starts to pay attention. Simply put, one of the changes that has happened since this strategy is that now, every single medical device that is being labeled for reusability and reprocessing is now required as part of the 51 K or PMA or whatever kind of submission to have validated cleaning protocols, and so on. That is certainly a good thing, but I think we should have been doing that a long time ago.

Jon Speer: Yeah, absolutely. You and I have talked both on podcast and just on one-on-one conversations in the past about the premise behind design and development, and design controls, and just being prudent engineering, and I think this is certainly a case, if you know that your product and you label your product to be reused, reprocessed over and over again, that those are certainly things that should be captured as user needs. Those are certainly things that you should define with specific design inputs and you should definitely be verifying and validating those things as well.

Mike Drues: I agree, and one of the things that I would love to hear your opinion on, Jon, I know that you and your audience are very into the design controls and some people have suggested that we need new regulation to prevent these kinds of problems from happening, but some people would argue that we already have that regulation in the design controls. As you and your audience are well aware, one of the underlying tenets of the design controls is to make sure that you meet the needs of your intended user. Well, who is your user? Most people think of it as the physician, or a surgeon, but if your device is specifically labeled to be reused at reprocessed, is not one of your users the actual reprocessor? And if so, isn't that already included in our current regulation? What do you think, Jon?

Jon Speer: [chuckle] Yeah, I do a lot of, we'll say coaching and teaching, especially companies that are very, very new to the medical device process and product development efforts, and in many times, going through their first medical device product development process ever, trying to bring a novel technology to the market. And we usually pause and spend a lot of time when we're talking about design inputs. And I think it's the FDA design control guidance document that even comes out and says that you should spend something like 30% of your product development timeline focusing on your design inputs. And a lot of people... You know how this goes. Everybody's trying to hurry up, hurry up, hurry up. Check the boxes, get the document, move to the next phase, and so on and so forth.

Jon Speer: And I think when you get to design inputs, that's one of those areas where I tell people, "Hey, we need to take our time. We need to get this right." And we need to think of all, and I'll use ALL, with underline and capital letters, we need to think of all the design inputs that can impact this particular product, all the requirements, basically. And you raise an excellent point. If I know that my end user is certainly the physician, certainly the patient, but sometimes we forget about all these other end users.

 

Jon Speer: What about the nurse who's bringing the product to the physician to use? What about the person who is, like you said, cleaning the product after it's been used, or that reprocessor? Those people are definitely end users as well, and there are definitely requirements that we need to be capturing as part of that. And I think, by and large, we do, as an industry, I think we do a very poor job of doing that right now and I don't think that we need additional regulations. I think we just, like you say, follow what's already in place. Just make sure we're actually capturing all of the design input requirements.

Mike Drues: Well, I would agree with you, Jon. And just picking up on that all design inputs theme, just a step further, how in your experience in working in devices that are designed to be reprocessed and reused, how many companies, as part of their design inputs, include reprocessability as an input? In other words, we're all very familiar with the concept of design for manufacturing. Well, a couple of years ago, and this is one of the many things I talked about at my FDA panel presentation. I sort of coined the phrase 'design for reprocessability'. In other words, if you have a device that is designed to be cleaned and reprocessed and reused, should not some of those design inputs include the reprocessability requirements? What do you think?

Jon Speer: I think absolutely. The absolute... The thing that, Mike, that still blows my mind sometimes is I get asked questions about packaging and labeling, if they should even, if a medical device company should capture design input requirements for how the product should be packaged and how it should be labeled. And we're still struggling with packaging and labeling, and making sure that those are captured from a design control perspective. We still got a lot of work to do as an industry. We still need to do a much better job of certainly of addressing packaging and labeling, but absolutely. If I know that my device is gonna be used, and then after the procedure, it needs to be reprocessed, there's all sorts of ramifications.

Jon Speer: I need to make sure that I define things like, how does it need to be reprocessed? What are the cleaning agents that are compatible? What cleaning agents are not compatible? There might be something that I'm gonna use in the effort to clean and reprocess the device that could actually have a negative effect on that. And if there are different nooks and crannies, which, that's... As you read about the duodenoscopes, you read there's a lot of stuff that's out there. Of course, how much of it is true or false, I'll let you all draw your own conclusion. But there were some... Let's just say, some of the things that I read indicated that there were some very hard to get to nooks and crannies within these products that were really difficult to clean, and require maybe some disassembly in order to properly do so, and that wasn't always happening. And chances are, that wasn't very well-defined as part of a requirement.

Mike Drues: Well, you're right, Jon. And again, I'm glad that you brought up the labeling issue, because one of the things now that companies are being asked to think about, and again, this is just basic engineering to me. Everybody in your audience is familiar with the UDIs, the unique device identifiers, now that are becoming part of the labeling requirements. Well, in the new reprocessing guidance, as well as several of the other related guidances, now, FDA is reminding everybody that we have to design our UDIs to be reprocessable as well. In other words, depending on how you actually attach that label, if you have a device that is designed to be reused X number of times, the label needs to be able to survive the ETO or the autoclave or the sterilization of, whatever method. And so, not only just does the label have to be designed to withstand those requirements, but we also need some way to track the number of times that a device is reused, like the odometer on your car that will tell you when you need an oil change. These are basic things, but as an industry, it's amazing sometimes how we have gotten to now 2016 and we're still just trying to figure this stuff out.

Jon Speer: Yeah, you just said a couple of things that I wanna dive a little bit deeper on a couple of those things. You asked me the question about, do we need increased regulation? And then you reminded me and the audience that there is a new reprocessing guidance document from the FDA. I guess, a little tongue in cheek, I'll flip it back at you. Isn't a new guidance document, isn't that really new regulation?

Mike Drues: Well, in a sense. I mean, technically speaking, as you know, Jon, as a professional, guidance is only guidance, but I like to look at it as reminding people of what they should be doing. Ideally, they wouldn't need guidance from FDA but none of us are perfect. So I guess I try to look at it from a positive perspective in just reminding people, and especially newer people to this industry, that might not have the historical perspective that you and I have, so that we do not continue to repeat the same mistakes over again.

Jon Speer: Right. Right, and I know you've scoured and read every line of that guidance document inside and out, so...

Mike Drues: It's a great cure for insomnia, if anybody has any difficulty sleeping.

Jon Speer: Well, yeah, and if that guidance document doesn't do it, just there's a whole bunch of others that you can find. [chuckle]

Mike Drues: Absolutely. And listen, one other thing that I would like to bring up here for you and your audience 'cause I would love to hear your thoughts on this, Jon. Obviously, the validation is part of any good design control professional's vocabulary, when it comes to reprocessing, and this is where the guidance, in my opinion, does not go far enough. It says that we need to have a validated reprocessing protocol, which makes sense, but the question becomes, Who does that actual validation?

Jon Speer: Right.

Mike Drues: In other words, should a medical device company, who is not in the business of cleaning and reprocessing instruments, most the time, that's done in the hospital or perhaps by a third party company. Should the medical device company be writing and validating that protocol? In my opinion, that makes no sense, even though that's what many people do. It should be validated in the hospital by whoever is going to be doing that reprocessing. So from a validation perspective, Jon, what's your thoughts on who actually should be doing that validation?

Jon Speer: Yeah, and I'm glad you asked that because I kinda got at the second point that you reminded me of a few minutes ago. And, the device company that's making the device to be reprocessed and reused, what is their responsibility? And I guess it's really what you're getting at here. And so, from a validation standpoint, I'm gonna look at it... I know, generically, this is how I always think about validation from a process perspective, and I'll use the acronyms IQ, OQ, PQ. And I think if we... For the audience to understand, I guess I'll give you a few words. Installation qualification, Operational qualification, Performance qualification. I will say on that particular topic, there are a couple of guidance documents that you can review.

Jon Speer: If you search GHTF process validation, Global Harmonization Task Force process validation, they have a pretty good guidance document. I realize that GHTF is no longer the entity, it's now IMDRF. But anyway, segue here. [chuckle] I think that a device company cannot fully validate because unless the device is coming back to them after use, and the device is being reprocessed by the company at their facility with their equipment, that's not, it's not pragmatic or even practical. You can't even validate the reprocessing if the actual cleaning and the reprocessing is happening at another facility, 'cause a lot of times, these things are being reprocessed and cleaned at the hospitals, right?

Mike Drues: That's exactly, right, Jon. And taking that a half a step further, the question of who does the validation. As we both agree, it's important for whoever is gonna be doing the the reprocessing, the hospital, or the third party reprocessing company, to actually do that validation. But what about the individual? I do not mean to be unkind or to be patronizing here, but the people that are actually doing the actual reprocessing work, these people are not exactly PhDs in engineering. For example, when a company, like some of the endoscope companies now have come out with a 160-page manual.

Jon Speer: Yeah, that's not gonna cut it.

Mike Drues: On how to reprocess their device and a 60 to 90 minute video on how to reprocess their device, with all due respect, is that realistic? If you go to Walmart and you buy a toaster and it comes with 160-page manual, how many people are gonna read that? It comes down to the fundamental question, What good is the regulation and following the regulation of the guidance if it's not realistic? What do you think, Jon?

Jon Speer: Yeah. As you described that, our industry is classic at using IFUs and operator manuals and labeling and in an attempt to be CYA. And if you don't know what CYA means, you can look that up. [chuckle]

Mike Drues: Google it.

Jon Speer: Google it. Yeah. But I think about just the car, you mentioned the car example earlier. I know, just because I have a car, that every so often, I have to go in and do some routine maintenance. I may have to change my oil, as a great example. And I got a little sticker on my window, that's my label that reminds me of that. [chuckle] Right? Or a little light that pops up on my dash that reminds me of that. I also have in my car a manual for my vehicle. Now, I'm gonna confess, folks, I've never read that manual from cover to cover. I only...

Mike Drues: I don't even think I've opened the manual, Jon.

Jon Speer: I only get the manual out when there's a question about something, that either pops up on my dash, or I'm really trying to figure out something that it's been bothering me. I scan it real quickly, but let's just say that manual is probably 160 pages and I've never read it and I drive my car every single day. And...

Mike Drues: And perhaps, I should not say this in a podcast that's gonna be going out to the rest of the world, but as a PhD in engineering myself, my philosophy is, if I have to read the user manual for any product, then some engineer did not do their job.

Jon Speer: Right, absolutely. I think, for a company to come out and say, "Here is our 160-page manual on how to reprocess our device, and watch this video." I understand it's a knee jerk reaction, it's a knee jerk response. It's an attempt to try to mitigate the issues that have been surfaced on the topic, but that's not... You and I both know that that approach is gonna be largely ineffective.

Mike Drues: It is, and listen, as we approach the end of this recording for today, I do think it's important to leave this on as positive a note, and as a pragmatic of a note as we can. Maybe we can wrap this up by sharing with our audience some best practices or some suggestions, and some things to keep in mind. And one or two things that I would say is... Obviously, the regulation is important, the guidance is important. We need to be familiar with all of that, that is applicable to whatever devices that we're developing. But beyond that, consider the real world scenario, the real life scenario. How exactly is your device going to be used in the real world? Not just by the physician or surgeon user, but as you said earlier, by the nurse, by the reprocessor, by whoever else is going to be in contact with your device.

Mike Drues: Think about things like, for example, if and when it comes to labeling and your UDI. Your UDI label needs to be able to survive the reprocessing environment. Think about coming up with some sort of a tracking system for a reusable device so that we know how many times that device has been reprocessed. Think about who should do the actual validation. Is it the people in the hospital? And if so, work with them directly. Get out into the hospital reprocessing center, and actually ask them for their suggestions on how to make the reprocessing easier. Bottom line, I think if we just simply keep thinking about how our devices are used in the real world, that will take us many steps in the direction of trying to minimize or perhaps even eliminate these kinds of problems in the future.

Jon Speer: Yeah, I definitely agree with that. And I guess, a bit of a kind of a personal twist that I want you all to think about, as well, on this topic and frankly, any other topic that you're dealing with when it comes to medical device product development and manufacturing. And that's to remember a few things about what you're doing. You're making medical devices that are intended to save and improve the quality of life. And I think my personal twist on it is this. All of our family, we have people in our lives who have all benefited from medical technologies and devices. And in my own personal situation, I have some family members who have gone through some health concerns and issues, as I'm sure all of you have, as well.

Jon Speer: One example, my parents are getting a little bit older and they're going through and trying to prepare for their golden years of their lives and going through physicals and tests and all that sort of thing, as we all do as we get a little bit older. And sometimes, things are discovered, and there needs to be medical procedures that, guess what, require medical devices. And I, personally, I want some assurance to know that everything that my parents, my family, my sister, my kids, all of the people that I love and care about, I want great assurance to know that the products, the medical devices that are gonna be used on me and my family have been, are safe and effective and have been tested and reprocessed properly, and all of those things. We should all bring that back to what we're doing in the medical device industry, and think about those things.

Mike Drues: Well, Jon, I could not agree with you more to that last point,and let me just share one last thought with your audience as we wrap this up. As you mentioned in my introduction, I not only consult for a wide variety of medical device companies, but I also work as a consultant for the FDA, so I see a lot of these issues from both sides. One of the most common questions that I get from people in medical device companies across the board, they say to me, "Mike, you work with all these different companies, as well as the FDA. If we come to the FDA with our new medical device, what do you think they're gonna wanna see in terms of safety, efficacy, performance?" Dot dot dot. And I often say to them something like this. "Look, I understand that's an important question to you and why you're asking that question, but let's think about this a slightly different way."

Mike Drues: "Sooner or later, a family member, a friend, perhaps even ourself, is going to be on the receiving end of one of these devices. When that day occurs, what would we, as individuals, want to see in terms of safety, efficacy, performance, and so on, to put our personal stamp of endorsement, if you will, to say that this product is okay to use in my spouse, in my child, perhaps even in myself? Then and only then should we go to FDA and have a discussion as to what needs to be done."

Mike Drues: This is something... This is the way that it used to work a long time ago, when I first did it and started out in this business almost 25 years ago. But it doesn't really happen as much as it does today. Yes, the regulation is important, whether we're talking about reprocessing, design controls, or anything else, but we have to take a bigger look. I view the regulatory requirements, including the design controls, as just a starting point, not an ending point, just sort of reminders of the things that we should be doing anyway, but it is by no means a complete or an exhaustive list. Keeping in mind that we might be on the receiving end of one of our products is, quite frankly, when you think about it, a humbling thought, and it's an awesome responsibility.

Jon Speer: Yeah, that's well stated. Well, Mike, as always, I appreciate the opportunity to chat with you and thanks for finding time between your airport journeys [chuckle] to join us on today's episode.

Mike Drues: Well, thank you so much, Jon. I always enjoy our conversations, and I appreciate the invitation to come back. And if there's anything that I can do to help anybody in the audience, feel free to contact me.

Jon Speer: Absolutely. You can find more about Mike Drues, the best place that I find that I learn all kinds of things about Mike Drues, is frankly, it's on LinkedIn. Look him up. Mike, actually, you're gonna can look up Michael Drues D-R-U-E-S. And he's with Vascular Sciences, and he consults with FDA, he consults with Health Canada, he consults with medical device companies, as well. Send him a note. Let him know that you have a question and I'm sure he's happy to help you solve all of your medical device woes and problems, or at least, get you on the right path.

Jon Speer: This is Jon Speer and I wanna tell you a little bit about greenlight.guru. Greenlight.guru is developing, or has actually developed, and is in 12 countries all over the world at the time of this podcast, in our software solution. Our software solution helps medical device companies manage and maintain their entire quality management system, as well as optimize workflows around capturing and managing design controls, in an ISO 14971 compliant approach to risk management. Check us out. Go to greenlight.guru, request the demo, learn more about our software solution.

Jon Speer: Last thing that I wanna say is thank you for listening to the Global Medical Device Podcast. Tell your friends. We're on iTunes, we're on SoundCloud, and of course, you can find it on greenlight.guru and you can find all episodes that Mike and I have been on, by following Mike and/or myself on LinkedIn as well. This has been Jon Speer, the founder and VP of Quality and Regulatory, and this has been The Global Medical Device Podcast.

 


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