Why do the same types of problems show up again and again in FDA medical device inspections? In today’s episode, Michael Drues, PhD joins the podcast to talk about the FDAs Fiscal Year Report for 2022 Inspections and discusses the most common problems found during these inspections.
Recurring guest Michael Drues is the President of Vascular Sciences where he works to educate the industry and offers help to bring medical devices to market in the most effective way possible. Dr. Drues is a medical device professional possessing regulatory expertise who understands the ins and outs of the regulation systems in the medical device industry and is passionate about helping others better understand it as well.
Listen to the episode to learn more about the most common mistakes companies make that result in Form 483s, what companies can do to avoid these mistakes, and how you should be thinking about root cause analysis.
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Some of the highlights of this episode include:
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Common reasons why companies get in trouble during FDA inspections
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Why CAPA is specifically at the top of reasons for 483s and how to prevent that
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Examples of design control problems and how to avoid them
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The root causes of these issues and root cause analysis
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What complaint handling problems look like
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What causes people not to handle complaints correctly
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Whether anything about these problems is new or trending
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What the FDA does when they find these problems
Links:
Memorable quotes from Michael Drues:
“The emphasis should be on prevention, not correction.”
“I consider myself to be a medical device professional, and I do not use the word “professional” lightly. Along with it comes the responsibility, including knowing what the heck you’re doing.”
“What is the point of getting complaints or post-market surveillance or anything else if you’re not going to act on it?”
“I hate to say it, but we are the poster children for Einstein’s definition of insanity.”
Transcript:
Etienne Nichols: Hey everyone. Welcome back to the Global Medical Device Podcast. Today with us is Mike Dreus, a voice you've heard on the podcast many times before. Familiar voice. Good to have you.
Good to have you with us today, Mike.
Mike Drues: Thank you as always, Etienne, and for the opportunity to have this discussion with you and your audience.
Etienne Nichols: We talked a little bit about today's topic.
The title may change. We'll see how the conversation goes. But common problems found during FDA medical device inspections, particularly looking at 483s and whether or not the past is destined to repeat itself.
I'm curious, looking over the last year, what are some of the common reasons why companies get in trouble during these FDA inspections?
Mike Drues: Yeah, great question, Etienne. And as always, thank you for the opportunity to have this discussion on this very important topic with you and your audience. And let me just start out by prefacing this by I really wish that we would not have to talk about these kinds of topics.
You know, I really wish that we worked in an industry where we wouldn't need the FDA telling us to do things that if we're going to call ourselves medical device professionals, we really should know to do them.
And then the other thing that I just wanted to point out as we get started here, Etienne, is my intent here is not to criticize or not to bash on either individual companies or even on the FDA.
We have way too much that already. It's really to learn, learn from others past mistakes so that we hopefully won't repeat them in the future.
Etienne Nichols: So, if I could just kind of interject one thing as we were kind of talking through this. You make a really good point because the industry, it is regulated. We do see problems come up.
But I almost see it as two halves of one industry. You know, the upper half may not need the regulation per se. I've heard you talk about this as well.
True engineering, true biological research. If you're doing what you should do, maybe you don't need those regulatory requirements. Those are for the people maybe who aren't doing quite enough. And so, I do think if we look at it and refocus the conversation to educate the bottom half, the newer to the industry, I don't know, that makes me feel a little better.
I don't know about you.
Mike Drues: Well, good. And your point is certainly well taken.
Some people might say well, Mike, gee, that might work in the ideal world.
What Plato would the ideal plane. But I will acknowledge I didn't just fall off the turnup truck yesterday. We don't live in that kind of a world. And for whatever reasons, either on purpose or because of, of lack of knowledge, people don't always do these things. So, let's, let's dig into it and let's talk about some of the most common reasons why companies get in trouble with FDA during inspections.
Specifically, 43 observations or sometimes even warning letters. So the top three are CAPAs, design, controls and complaints.
Those are the top three reason why companies get either 43s or warning letters. CAPAs, design, controls and complaints. And in total, that represents about 35%. A little over 1/3 of all 43s are because of those three things. CAPAs, design, controls and complaints. And we'll dig into these further as we go.
The next three in the top 10 list are purchasing controls, process validation, and medical device reports, or MDRs. So, purchasing controls, process validation and medical device reports.
Those three combined add up to about 20% of all 43 observations.
And just rounding out the top 10 are non-conforming products, production and process controls, and acceptance activities, and finally, quality audits.
So, the top 10 that I just mentioned, in total, those top 10 reasons represent 75% of all of the 43s that were issued in the last calendar year, 2022. That's sort of at the, at the high level.
Now. We can dig a little deeper editing if you want to.
Etienne Nichols: Yeah.
So CAPA, it's interesting. Capa design, controls, complaints. I looked through the FDA's website. I think since 2006 they've been putting out the Excel file and you can just go, and you can see all of those different things.
CAPA is consistently at the top.
And I know you've talked in the past about this, but what are your thoughts on not only why this might be, but how we can prevent this in the future?
Mike Drues: Well, so let's dig into CAPA in particular as our first topic of discussion.
About 12% of all of the 43s are specifically related to CAPAs. And as you just pointed out, this is a trend that's been going on not just for months or years, but decades.
And I hope Etienne, and that you as well as our audience appreciates the irony, if not the hypocrisy of CAPA corrective action, preventative action. And yet we seem to do the same mistakes over and over.
Einstein's definition of insanity, doing the same thing over and over and expecting different results.
So CAPAs represent about 12% of foreign.
So, let's dig into that a little bit deeper. So first of all, as our audience knows, CAPAs in general are the process that we try to use for correcting and most importantly, preventing problems.
And as I've talked about in earlier podcasts, I think that the whole approach to CAPA is backwards. We shouldn't call it a CAPA, we should call it a PACA. The emphasis should be on prevention, not correction.
But that's a topic of a different discussion. So, what are the most common reasons why companies get in trouble because of CAPAs?
One example, a manufacturer either did not document their procedures, or they did not adequately capture their capita activities.
To me, that's such a fundamental problem.
You know, there's the adage in GMP training, if it wasn't documented, it didn't happen,
right? So that's one of the most common reasons why companies get in trouble on the CAPA side.
So, taking it a step further, one of the things that I see missing in a lot of companies’ quality management systems, is having any kind of established criteria of when a complaint becomes a CAPA, you should definitely have criteria. It's not required in the QSR. Maybe it should be. But when I review companies’ quality management systems, I make recommendations not simply based on what's required.
Because remember Etienne, and as we've talked about before, when a company is meeting the requirements, that's like being a C student. We can do better than that.
So having criteria to determine in what circumstances a complaint or complaints plural, go on to initiate a CAPA is very important.
And those criteria should not be static. In fact, your entire quality management system should not be static. It should be a living, breathing document.
You should go back periodically and make sure that those criteria are still current. As a matter of fact, another and I'm trying to make as many tangible suggestions here as I can,
you should take some of your past complaints or perhaps even make up a fictitious complaint and put it into your system and see if the criteria that you have to determine whether a campus should be initiated addresses that particular complaint.
If it does, terrific. If it doesn't, maybe you need to update that criteria and then finally back to the documentation piece. Because it's stunning to me how so many companies, they don't have the demonstration that they've actually done this document. The fact that you developed your criteria and that you tested your criteria and that you evaluated or updated the criteria.
And even in those situations where you don't have to Update it because your criteria are sufficient. Okay, terrific. But put a note in there. Hey, on such and such a day, we revisited this.
We made up a fictitious complaint and we applied it and we saw that our criteria were sufficient and therefore no additional action was taken.
Document that. That way when somebody comes months or years later, you can point to it and say, hey, this is not something that we did, you know, five years ago and never touched since then.
But just like a risk management plan, anybody that creates a risk management plan and sticks it in there in their three-door file cabinet, and I know I'm dating myself here, it never touches it again.
They might be meeting the letter of the law, but they're certainly not meeting the spirit of the law. Does that make sense?
Etienne Nichols: It makes, makes total sense. And I love how you talk about documenting even that you reviewed it. That's a, that's a great recommendation. What I've actually not heard very much.
The other thing you mentioned was, you know, there's a regulatory requirement and meeting that, you know, meeting that requirement might make you a C student, maybe you pass a grade.
But we've talked in the past about almost, I think, if I remember right, three different things to appeal to. We want to obviously be legally and regulatorily compliant as a business. We want to be economically, you know, viable. But then there's a third one which is ethical. We want to be ethical. We want to be providing, you know, very safe and effective devices to help our patients. There’re three different aspects you can be looking at this through.
We don't. We think about the business side of CAPA. You know, a lot of people look at it as a drag on the business, but it should be lifting the business up, streamlining those processes, making things better.
Mike Drues: I agree 100%. And that's going back to the documentation example is a perfect illustration of what you just said, Etienne. And because I remember years ago when I started out in this business as an R and D engineer, I, I loathed documentation. And still to this day, even as a regulatory consultant, I know it sounds kind of ironic, I loathe documentation because most of it is a complete and total and utter waste of time.
Let's be honest.
But when I talk about documentation here, like for example, document that we visited this, but no additional action was necessary. I'm not talking about creating a 300-page PhD dissertation.
I'm talking about maybe a couple of sentences, maybe even one sentence might be sufficient that just, you know, synopsis summarizes rather what, what we did. That's all, you know, the reality is we're spending more time talking about what it would take to create, you know, two sentences of documentation here than what would actually, you know, the time to do it.
Etienne Nichols: It sounds really trivial when we just break it down like that, but I actually think it's a really powerful point you're making because a lot of procedures I've seen in the past were written not to help the business be efficient.
They were more written to impress.
You know, we, we have our flowery engineering speak, but perhaps maybe we.
Mike Drues: Or in some cases to cover your.
Etienne Nichols: You know what, there's that. Yes, absolutely. You know, so early in my career I worked in the FAA. Some, some people know this. I was in the aerospace. We were doing, we were creating new materials for custom aircraft interior, and I was producing a report for my boss. It was one of my first jobs out of, out of, out of college.
I turned around, hidden my report. He started flipping through it and he turned around and gave it immediately back to me and said, Etienne, I don't want any fluff in my reports.
And I thought, well, what was. I just.
It was great.
Mike Drues: In medicine, we call that the bullet. You know, what's the bottom line? What's the takeaway?
Etienne Nichols: Yeah. Okay. So, we talked a little bit about CAPA. Anything we're missing here so far?
Mike Drues: No. I think we can move on to the next one.
Etienne Nichols: Okay. Design control problems, you said 12%. 43 observations pretty close to the same as CAPA's occurred in 2022. Can you provide some specific examples of these design control problems and how maybe we can avoid them?
Mike Drues: Yeah, great, great question. So, CAPA's 12%.
Design controls is another 12%. Now, obviously design controls is a very, very broad topic.
So, let's, you know, start to peel that onion back further and, you know, look at some specific examples.
So, to start, the most common source of a 483 observation under the category of design controls is under design validation.
Now, I hope somebody doesn't need a PhD in engineering to appreciate that design validation is one of the most important parts of the entire design process.
A design validation essentially means demonstrating that your device conforms to the defined user need and its intended uses. I mean, to me, basic, basic, basic. And if somebody doesn't do that, this might sound harsh to some people. I have no more polite way to describe that as a boneheaded mistake. I have other words I could use to describe it that are not so politically correct with the polite.
And again, I'm not trying to be harsh here, but I'M just trying to be honest. You know, it goes back to, I think I mentioned earlier, I consider myself to be a medical device professional and I do not use that word professional lightly. Along with it comes the responsibility, including knowing what the heck you're doing.
So, the most frequent cause of 483s under the design controls, as I said, is design validation and oftentimes, you know, linking that to risk management.
So, for example, not performing a risk analysis that happened 30 times in 2022 that we know of. Right? Not performing a risk management, not documenting the results of a risk analysis. So once again, we're back to if it isn't documented, you know, it didn't happen.
Basic, basic, basic. And don't just think from a regulatory or a quality perspective. Edian, as you and some of your audience probably know, I spend some of my time working as an expert witness in medical device product liability cases.
Just imagine if I as an expert witness, if your company gets sued because a patient is injured using one of your devices. And I as an expert witness am able to point out that, oh by the way, this company did not seem to do a risk analysis, you know, as part of the development and didn't periodically update that risk analysis through complaints and post market surveillance and all that kind of stuff.
I hope it doesn't take a JD from Harvard after your name to appreciate ka ching ka ching ka ching.
Other causes other reasons why companies got 43 observations under that same category of design controls, specifically design validation, lack of or inadequate procedures that happened almost 20 times.
Not validating software, not using production equivalent devices in validation studies. Think about that editing.
Not using a production equivalent device in a validation study. What are you validating? Are you validating a prototype? You know, I mean, that doesn't make any sense now to be fair.
And again, all of these things we can dig into probably as individual podcast discussions themselves. So, I don't want to over generalize the design control is one of the most basic tenets of your design controls is that you want to do your final VNV testing on your final device to be marketing.
Yeah, correct. But in other words, a production, you know, representative model. But that's not always realistic and that's not always necessary. There are ways that you can get around it.
But here are examples where FDA specifically pinged companies for not doing that. And I'm assuming that the reason why they got pinged is because they didn't have a justification for why they didn't use the production quality device.
Or maybe their justification was not sufficient.
So, I think it's important that we look beyond just these numbers, beyond these statistics and start, you know, thinking about the causes. Just a few other quick examples of design validation problems.
Not establishing acceptance criteria prior to the validation.
So how do you do a validation if you don't know if you're going to pass or not? Because you haven't defined the criteria. And I'm not talking about just one-off kind of thing, or here's one example of one company that's operating in somebody's garage or basin.
I'm talking about multiple examples of the same problems throughout the industry.
Not documenting the results in the design history file, the DHF, okay, that doesn't bother me as much, but it's still a problem.
And finally, not confirming that the device conforms to defined user needs and intended purposes. Isn't this the entire purpose of the design validation process? That happened multiple times, you know, about a dozen times that one specific thing happened.
So together, design validation and design controls account for about half of all the design control related site citations in 43 observations. So once again, I want to illustrate that we're not talking about, you know, one off kind of events here.
You know, we're talking about, for whatever reasons that I quite frankly cannot completely understand, these, these problems seem to be endemic throughout our industry.
Etienne Nichols: Yeah, when, when you talk, we're talking about the risk management side. I was thinking about why, you know, why would we have this problem with risk management? And I think one of the things I've, I've seen this in multiple companies where you throw together some sort of risk management file for your design and you go on and you move through the engineering, they say, oh, we got to finish that risk management file.
And you put a team on that and it's a reverse engineered document. You look at your, your design and you reverse engineer the risk analysis so that it meets what you want.
It's, it's embarrassing to say that, that that's been the case, but I think that's part of the problem. The other problem is some of the, some of the ways we produce these risk documents, they don't inform the design because they don't have to inform the design.
There's no mechanism to, to force that. And maybe this goes to, you know, one of the main issues that we see from the reference of Part 820.30, which is not establishing some of the procedures for some of these activities.
Mike Drues: I don't know. I think you're right, Etienne. And before we move to the third of the top three most common reasons for 483s, I'll give you one or two very recent examples. Just in the news a week ago from when we did this podcast, was an example of a company that got pinged by FDA for failure to verify that its washing procedure sufficiently removes foreign material from the manufacturing process.
I mean, this might sound harsh to somebody, to some people, but I'm sorry, professional, you know, if we're going to call ourselves professional, that should mean something. How does somebody get out of engineering school and work in this industry without knowing such a, such a basic thing? And I would argue that if they don't know that, they have no business working in this, in this industry.
Failure to address. It's that same example, failure to address the residual sterilite levels.
This is on a catheter, after the catheter is washed and sterilized. So, who knows? This is a catheter that's going into a patient, possibly into their cardiovascular system or their urinary system or their GI system.
At the end of the day, it doesn't matter. It's going into the patient.
Don't you think it might be a good idea to make sure that, gee, we don't want to have a lot of gunk or other stuff on there that's going to get into the person.
I mean, does it really take. Take a PhD in engineering to appreciate that?
So that was just last week that that happened. So, these are recurring problems, regrettably.
Etienne Nichols: And so, I think about.
I know we have a third one that we need to get to, but I think about CAPA Design Controls.
And I was just driving through, thinking through some of these different reasons why this might be consistently an issue.
And there's two things that come to my mind when I think of why this might have happened, because a lot of it, a lot of the reasons you go again, is not establishing the documentation or not performing whether it's risk analysis and connecting those things.
One of them might be the laziness with documentation. You know, you mentioned I don't like documentation. I get that, and that makes sense. But the other is I wonder sometimes,
well, with CAPA, particularly, how much of our industry truly knows how to do root cause analysis. I don't want to, you know, root cause this whole situation today, death. But root cause analysis, what is the root cause at some of these issues?
Mike Drues: Indeed. And I know you’ve; you're offering that probably as a rhetorical question, but I can't help but, you know, comment briefly on that because I see, a lot of people talk about the root cause of the problem, but rarely, rarely do I see anybody get anywhere remotely close to the actual real root cause. They're oftentimes dancing around the surface, you know, superficial manifestations or symptoms of much deeper problems.
And so, in my opinion, Etienne, and again, I know this is going to sound harsh to some people, I think what is the root cause of many, if not most of the problems that we run into, not just the ones we're talking about today, but in our industry in general, is what's up here, you know, what's between the ears. I mean, how can you overlook some of these most basic things?
Etienne Nichols: I want to add one thing to the root cause thought too. So that makes sense. For CAPA, it's an easy connection there, but. But for design controls, it may not be quite as easy a connection, but I still think the root cause analysis or the ability to root cause an issue is part of the problem.
And I want to see what you think about this, because when we talk about process validation, or not process validation, but the design validation, validating those user needs, I user need itself requires a certain amount of root cause thinking to get to the true, true problem you're trying to solve for a product.
So, it just, I think it's another.
Mike Drues: Way of thinking, are you solving the right problem? Are you asking the right questions? These are all riffs on the same overall theme.
So, closing the loop on the last portion of our discussion, I just want to remind our audience, because I may have misspoke a moment ago, that what we just talked about, design validation and design change, these two things together represent half of all of the reasons why companies get pinged by the FDA under the topic of design control.
Half of them, yeah.
Etienne Nichols: So, we go round out with the top three. The last one, complaint handling, led to 11% of the 43 observations. Do you have some specific examples for complaint problems?
Mike Drues: Absolutely. And just as a preference to my response here, I teach entire courses in some of these areas and one of them in particular is on complaint handling and post market surveillance.
So, let's start out at the beginning here.
What's the definition of a complaint?
Well, it turns out that in the regulation itself, there are at least three or four different definition of complaints.
So, one of the recommendations that I have to companies is come up with your own definition of complaint. You're not necessarily forced to choose one of the ones that are in the regulation.
Those are a good place to start.
But take that definition, or in this case take these combination of definitions and tailor them to your particular kinds of devices, your particular kinds of technologies. Because remember, one of the challenges with regulation and guidance, one of the challenges with the quality system regulation is that it's written for a very, very broad audience. You know, the medical device industry is a very broad industry, from band aids to artificial hearts and everywhere in between.
So, we can't take this one size fits all approach.
So come up with your own definition.
And then here are some of the most common examples that FDA pinged. Companies in this particular area of complaint handling did not document their procedures 140 times. This happened in last year 140 times.
Did not document their complaint handling procedures, did not maintain their complaint files.
That, that also was a, was a pretty common one.
The next two are just, are just stunning to me.
Complaints of devices. Sorry, let me start again. Complaints of device failures were not investigated.
Complaint of device failures were not investigated. This happened almost 25 times.
What is the point of having a complaint handling system? In other words, what is the point of getting complaints or post market surveillance or anything else if you're going to act on it now?
Even if. Because remember, I don't want to overgeneralize here. I'm not suggesting that every complaint should be investigated to the same degree. As a matter of fact, I'm adamantly against that.
I think that we need to take sort of a triage approach. Kind of like when you go to the emergency room, a person that, that is having a heart attack is going to get treated first, I hope, as opposed to a person that has a splinter in their finger. You should take the same logic here.
So even if you have a complaint, let's say it's a cosmetic defect, let's say that it's like a little scratch on the hous of the outside of the device that somebody tells you about your device.
Okay, fine, you note that, but there's no action really necessary because it's purely aesthetic. It's not going to affect the safety, efficacy, performance, function of the device and so on.
So, we should not assume that we have to handle all complaints equally. I don't think that makes any sense. But nonetheless, complaints of device failures were not investigated. That's inexcusable.
Complaints were not reviewed and evaluated to determine if an investigation was necessary or lacked rationale for not conducting an investigation. That's very similar to the one that I just said.
What's the point of getting this information if you're not going to at least think about it or investigate it a little bit? And maybe your Conclusion is that no investigation, no further investigation is necessary.
And here's one or two reasons why the last two examples and then feel free to chime in with questions or maybe your own examples.
Complaints that were deemed reportable that were not promptly investigated.
Now, again, I don't want to get into the weeds of complaint handling because there are different requirements depending on the type of complaint, depending on the severity. Sometimes companies have to look into this within a few days, sometimes within a month, sometimes longer. But. But nonetheless, you need to investigate these things, let me just say, in a timely fashion, and don't just wait until you have multiple complaints. Trending is an important thing to keep in mind as well, because you might have one complaint today and another of the same complaints tomorrow and three more of the same complaints the day after that when you start to see an escalation.
This is something where you got to get off your, you know what, and you need to stop, you know, whatever else you're doing and say, hey, what the heck is going on here?
Yeah, especially if this can have a significant impact on the safety and efficacy of the device. And regrettably, Etienne and I see examples where Even in the Class 3PMA universe, that doesn't always happen. Things slip through the cracks.
And finally, the complaint records did not contain required information. In other words,
they were missing information.
But. But more often I see it as the complaints did not contain adequate information. And we could have an entire discussion of what constitutes, you know, what is adequate, how much detail that you need, and so on. But at the very least, you need to make sure that you have the required information.
You need to make sure that your name and your date is on the paper, so to speak. So those are some of the most common reasons why companies got in trouble from the. Under the category of complaint handling. Does that make sense?
Etienne Nichols: It does. The thing that stood out to me as shocking is a company would deem it reportable but not investigate it.
They have convicted themselves in that situation, if you know what I mean.
Mike Drues: I wish I had a rationable explanation, and I suppose there might be some circumstance that might be justifiable to do that. But in the 30 years that I've been playing this game, now, I can't offer you off the top of my head, think of one.
Etienne Nichols: And as you go through those, I think of, I still think about the root cause. And this may be me just jumping to an assumption here. So, which is why I try to always be, you know, surround myself with people smarter.
Why I wanted the love conversations with you the what? What could promote somebody or incentivize somebody to maybe be in charge of that complaint handling and get something in and not necessarily investigate it appropriately, whether it's.
They don't know.
Again, going to the root cause analysis, but maybe even upstream of that, I think about management responsibility and producing a culture of we want to hear about problems. You know, we want to know these things, we want to investigate those things. I wonder if sometimes that is part of the problem.
Mike Drues: Well, it's a good question. I would say two things. First of all, going back to what I said a moment ago, the root cause of many, if not most problems, in my opinion, the true root cause is what's up here, or perhaps in some cases, what's not up here. And let me be a little more specific.
What I mean by that, and this is another recurring theme that I've talked about over these many years of podcasts, and that is so many people, they're focusing on following the regulation, ticking the boxes, not trying to understand what is the intent of this regulation, what is it that we're trying to accomplish? Why is it important here? I have discussions with my customers all the time because I want them to understand not just what the regulation says.
I mean, anybody that's graduated elementary school that knows how to read, they can read the regulation. But more importantly, why is the regulation there?
What is it intended to do? As a matter of fact, I just created a new slide for some of my presentations. The other day, I came up with another of my regulatory litmus tests. All right, if it makes sense, meaning the regulation. If the regulation makes sense, then we shouldn't need it.
Because quite frankly, we should all know that we should do it anyway.
And if the regulation doesn't make sense, then we shouldn't have it.
If it makes sense, we shouldn't need it. If it doesn't make sense, we shouldn't have it. I don't know any. And maybe in my old age I'm getting a little naive or something, but, I mean, does that make sense to you?
Etienne Nichols: So, it's interesting. There will always be that upper 50% or upper 10%. Maybe it's a 9010 thing, I don't know. But how many people are listening to things like this who don't want to be better, you know, or who are researching and looking at these statistics who don't want to be better?
The ones who are making perhaps, you know, committing the most problems, they may be the ones who aren't really interested in perfecting their practices, but it's a good point. That's really interesting.
So, yeah, yeah, let's talking about CAPA, design control, complaint handling.
You've talked about this, these, you've looked at this almost on a yearly basis, I think, for a few years now.
What do you see as far as trending? What do you see as new here? Anything?
Mike Drues: Yeah, great. Great question. And I'm glad you brought up that word I mentioned a moment ago in terms of trending, because when it comes to, for example, complaint handling but other things, trending is very important.
As a matter of fact, it's a regulatory requirement in a lot of the sections of the QSR, and yet we don't seem to do that for the kinds of things that we're talking about today.
And specifically, what I mean by that is the short answer to question of what we're Is anything that we're talking about today new?
The short answer, regrettably, Etienne, is absolutely not. Absolutely not. In fact, the top three reasons that we talked about, the top three most common reasons for getting 483s, CAPAs, design controls and complaints, they were the same top three reasons for the last 13 years.
The same top three reasons, design controls, CAPAs and complaints for the last 13 years. And over that same period of time, they always added up to approximately a third, plus or minus a couple percent maybe, but approximately a third of all 43s.
And looking even a little bit longer period of time, the same pattern holds for the last 16 of the past 17 years.
So, these are not new things within the design controls and the design validation and design change.
These are, you know, for years have been among the most commonly cited reasons, you know, problems cited in 43s.
I hate to say it, but we are the poster children for Einstein's definition of insanity. Doing the same thing over and over and over and expecting a different result, following the letter of the law over and over and over without trying to understand the spirit of the law, what I call the regulatory logic, and expecting a different result.
You know, it's interesting. You've probably heard of the adage, practice makes perfect.
Well, that's actually not true.
Practice does not make perfect. Perfect practice makes perfect.
We have gotten very good as an industry because we've been practicing this for a long time of making the same mistakes over and over and over. We've gotten very good at that. So, practice does not make perfect. Perfect practice makes perfect.
Again, maybe I'm naive or maybe I'm being too harsh. As I said at the beginning, and I mean this sincerely, my intention is not to simply bash or play the blame game, but to try to use these as specific lessons to be learned. I hope through, you know, our discussions, not just today, but all of our podcast discussions, we're trying to do that.
Etienne Nichols: Absolutely. And when I look at this, you can look at it as the glass half empty, the glass half full, or as the engineer looks at it and asks the question, well, which way is it trending?
And if I'm a med tech company looking at this, I look at this and say, okay, well, Dao, I can compare myself and start doing my audits and comparing how is my company doing on these different things like this.
Don't be like the college student who relies on the incompetence of their peers.
Try to be in the top echelon and really work towards perfection in these areas.
Mike Drues: Absolutely. So maybe we should wrap this up with some final thoughts and some, some takeaways for our audience.
Etienne Nichols: Yeah, very quickly, I would.
What did we miss? And, and you know, I do, I would like to hit just real quickly. When FDA finds these problems during the inspection, it's not the kiss of death. I don't know if we want to go there necessarily, but do you want to talk about that at all? I know we're almost out of time.
Mike Drues: Well, a little bit. I mean, so when FDA finds these problems, depending on the severity of the problem, they have a few choices. One is to issue what's called a 483 observation.
And those legally, you're not responsible for responding to, although most companies do.
And in fact, the average number of citations in a particular 43 observation is about three and a half right now for the last calendar year.
So roughly about three or four observations are typically in a 483. A little more severe than a 483 would be an actual warning letter. And a warning letter is something that the manufacturer is required to respond to.
And then finally, the ultimate penalty, if you will, would be a consent degree.
And that would be, you know, if the company is really doing, you know, things that are not good or that they shouldn't be doing and so on.
So those are sort of at a, at a high level. The, the options we can, you know, in maybe a different discussion, if you want, we can go into those details more.
But, but, but anyway, those are the options that FDA had.
Etienne Nichols: That's, that's a great, great synopsis or a summary of that. I, you know, one of the things that stood out to me, just kind of going back to high level again, looking at all of the top reasons in these different categories, whether it's design controls.
CAPA complaint.
One of the things that I consistently saw is a lack of or inadequate procedures. And I just want to highlight one little thing about this, because sometimes, like you said, we want to write a procedure to check a box sometimes.
But really that procedure should be to ensure a consistent, reproducible quality product. And so, these things should be written in this way so that they could do that.
Mike Drues: But to be fair, we, as I've said before, we got to be careful about over generalizing.
So not having a procedure, a lack of a procedure, that's obviously a problem.
But most of the time it's not having an adequate procedure because now you get into the whole gray, very fuzzy area of what constitutes an adequate procedure. One of my friends who used to do GMP training and would teach people how to write an sop, a standing up standard operating procedure.
He liked to use the example of imagine you wanted to write an SOP for scrambling eggs, right? We know how to scramble eggs for breakfast.
One way to do it is you could write it in one line, you know, cook some eggs in a pan. End of discussion.
Another way you can do it is go on, you know, for hundreds of thousands or thousands of pages, you can specify the genomic makeup of the chicken, that where the egg comes from, you can talk about what direction that you stir the eggs and at what RPMs and how much turbulence and shear and so on.
So, it's this whole nature of what constitutes an adequate description that I find to be very interesting. And that again is a topic of a different discussion.
Etienne Nichols: That's a great point.
Let's go ahead and talk about today's takeaways. I know we're close to being out of time. CAPA design controls complaints. The top three 483s. It's nothing new.
One of the things that I took away was don't be a C student. As a medical device company, that is. There are better things to aspire to. But what are some of the takeaways you would advise our listeners today?
Mike Drues: Yeah, if you, if you had to have surgery, would you want it to be done by a C rated surgeon?
Etienne Nichols: No.
Mike Drues: Although speaking from somebody who used to teach medical school, that's a, that's a scary thought.
You know what they call the person that graduate graduates last in their class in medical school?
Etienne Nichols: A doctor.
Mike Drues: A doctor. But the same can be said for engineers and attorneys and, dare I say it, regulatory professions. So anyway, more seriously, to wrap things up, so I Think we talked about a lot of good stuff today in terms of audits.
One thing that companies should be aware of we've had through Covid. There's been fewer audits and certainly fewer on-site inspections than there has been in the past. But now that's all coming back to normal.
So don't feel that well, if you haven't heard from the FDA for the last couple of years that that's going to likely continue because they are now catching up.
But more importantly, in terms of the substance, remember a couple of the key things that we talked about.
First of all, in terms of CAPA. First of all, why is the emphasis on the CA as opposed to the pa? Maybe we should call this a PACA as opposed to a CAPA.
Think about what you talked about earlier, root cause. And try to ask yourself what is the real reason why this regulation is in place to try to avoid problems like a failure to verify that the device has been washed properly before we stick it into a patient.
I mean, I'm sorry, but is there any better word to describe that than boneheaded? You know, I just don't, I just don't get it.
And oh shoot, there was one other thing.
Oh yeah, probably the, the most significant is recommendation is use this, use these things that we're talking about today as lessons to be learned.
And what I mean by that is take the statistics and we can, as part of the podcast again, we can provide the sources but take these things and apply them in your own company.
In other words, ask them. Could ask yourself and your team, could these problems or similar problems happen to us? In other words, where is it written that you have to wait for a problem to be reported to you? That's corrective action, preventative action.
But the whole philosophy of reversing that prevention and then correction is to take a look at other people's mistakes and say, is it possible for something the same or something similar to happen to us?
If it's not possible, then terrific. But if it is possible, then the next step is, okay, what kinds of measures can we do to try to minimize the chance of that happening to me? Those are all attributes of a true medical device professional, not somebody who's just simply ticking boxes on a form.
But maybe that's just me and I'm naive or smoking my socks and this couldn't possibly happen.
Etienne Nichols: It makes me think of something my dad used to tell me. An intelligent man learns from his mistakes. A wise man learns from others mistakes. And I like that. Yeah, thank you so much.
Mike Drues: Your father was a smart guy.
Etienne Nichols: He was. He was. I need to call him.
Thank you so much, Mike. This has been fantastic.
I'll do it. I'll definitely do it. Thank you so much for being on the podcast. Looking forward to future discussions and yeah, we'll let you guys get back to it.
Mike Drues: It. Thank you, everybody. Bye bye.
Etienne Nichols: Thanks for tuning in to the Global Medical Device Podcast. If you found value in today's conversation, please take a moment to rate, review and subscribe on your favorite podcast platform. If you've got thoughts or questions, we'd love to hear from you. Email us at podcast@greenlight.guru.
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About the Global Medical Device Podcast:
The Global Medical Device Podcast powered by Greenlight Guru is 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.
