Medical Device Reporting: The Do's and Don'ts

May 2, 2024 ░░░░░░

GMDP_365

In this episode, Lisa Van Ryn, a seasoned expert from Greenlight Guru, shares her extensive knowledge on the FDA’s Medical Device Reporting (MDR).

We unpack the nuances of when and how to report incidents, the definition of serious injuries, and the importance of effective complaint management systems. Lisa provides practical advice on setting up robust reporting processes and explains how manufacturers can avoid common pitfalls.

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Key Timestamps

[01:20] Introduction of Lisa Van Ryn and discussion on FDA's Medical Device Reporting
[05:45] Lisa's transition from the restaurant industry to medical devices
[10:30] What triggers a medical device report to the FDA?
[15:25] Role-play on handling complaints and determining reportability
[25:00] Detailed explanation of the decision tree for reporting
[35:15] Differentiating between device malfunctions and serious injuries
[40:10] Real-life examples and clarifying complex reporting scenarios
[50:30] The repercussions of late reporting and the importance of timing
[55:20] Wrapping up and resources for deeper understanding

Key Takeaways

Understanding MDR: The importance of being thoroughly familiar with Medical Device Reporting guidelines to ensure proper reporting and compliance.
Setting Up Processes: Tips on setting up an effective complaint handling system to manage and report incidents correctly.
Common Pitfalls: Common issues manufacturers face and how to avoid them by implementing efficient and compliant processes.

Memorable quotes:

"Every complaint needs to be evaluated to determine if it is reportable under 21 CFRR Part 803." - Lisa Van Ryn
"Having a beginner’s mindset but the heart of a teacher is essential in the medical device industry." - Etienne Nichols
"If you’re not considering the feedback as important, whether it’s reportable or not, you are missing valuable data." - Lisa Van Ryn

Feedback:

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This episode is brought to you by Greenlight Guru, a quality management system and electronic data capture software designed specifically for medical device companies. Streamline your processes and stay compliant with Greenlight Guru.

Transcript

Lisa Van Ryn: When does that clock start?

And what the regulation says is when you become aware.

And what does that mean? Who becomes aware? Right. And it's basically the simplest way to describe it. Is anybody that works for your company that is aware, that is the date that the clock starts.

Etienne Nichols: Hey, everyone. Welcome back to the Global Medical Device Podcast. My name is Etienne Nichols. I'm the host for today's episode. Today we get to talk about a wonderful topic of MDR.

Not Europe's MDR, but the medical device reporting for the FDA. Every medical device company in the US is likely going to be faced with some form of this at some point in their existence.

I would assume so. With us today is to talk about. This is Lisa Van Ryn, a medical device guru here at Greenlight Guru. Lisa, how are you doing today?

Lisa Van Ryn: I'm great. How are you doing?

Etienne Nichols: Doing well. Why don't we start by talking a little bit about your background, because it's the first time you've been on the podcast, and we typically like to do a meet the guru.

So, people are aware and kind of get to know some of the gurus here at Greenlight Guru. So, tell us a little bit about your journey and your origin story and how you got to Greenlight Guru.

Lisa Van Ryn: Oh, thank you.

Etienne Nichols: Yeah.

Lisa Van Ryn: So, my origin story, I probably didn't start out in the medical device industry like most people did. I came here out of the restaurant industry as a restaurant manager, where I had to deal with quality inspections in terms of ServSafe® certification for food safety.

And I came over and I started working for a contract manufacturer many years ago, and it was a great experience, a lot of opportunity to learn. And basically, my entire career has been a development of someone saying, we need somebody to do everything X, Y and Z.

And I would just say, I'm pretty sure I can do that.

Etienne Nichols: Figure it outer.

Lisa Van Ryn: Yeah. Yeah. And a lot of cases it was a case of me being thrown into a frying pan and just figuring it out, learning from, from a lot of great mentors in the quality realm, in the manufacturing engineering realms.

And I have just really made it a point to step up and take on the next new challenge, which eventually has brought me from being a just a office assistant all the way through being quality manager, quality engineer over the last 16 plus years.

I work for OEM contract manufacturers, implantable devices, cardiology devices, and just have had a lot of fun being a quality nerd and which some people may appreciate, others may not. So much like, I don't want to deal with any of this quality stuff.

Etienne Nichols: I'm sure if they're listening to the global medical device podcast on quality and regulatory topics, they're okay with it, of course, for sure.

Lisa Van Ryn: But all of that has brought me here with my experience to be a medical device guru here at Greenlight to help our customers learn how to use the software to implement, to go through going from a paper or another eQMS over to GG and just helping them along their journey with even things fundamentally in terms of industry knowledge, experience, best practices, state of the art type of activities.

Etienne Nichols: So, yeah, I wrote something once where I talked about what is a medical device guru? Because a lot of people asked us that question, and I basically said that we look for people who have a beginner's mindset but the heart of a teacher.

And because you are constantly learning, but you're also constantly teaching, and so it's just constantly looking forward and looking back. And so, no, it's always fun to see who winds up in those roles and get to talk to those people.

Usually when I have a meet the guru episode, I like to lead up to the conversation by asking, what do you consider yourself really good at? Or what are you a specialist at?

And I know you had the similar response that a lot of gurus have, like, well, I don't know if I'm a specialist at anything, but you spent a lot of years doing a lot of different things. And so, one of the things sounds like we landed on was medical device reporting. So, I wonder, how would you like to start down that, that road or topic?

Lisa Van Ryn: Well, everybody needs to consider and deal with medical device reporting, and if you think that you don't, I would definitely start re reviewing the guidance documents and the FDA regulation in typical in fashion, when it comes to complaints, the definition for complaints, what that means, and the things you need to really take into account and consider, and really, when it comes to complaints, what it is. What is that definition coming from? The definition section of part 820.3 is that a complaint is any written, electronic, or oral communication that alleges a deficiency related to, and this is a big one.

Think about every single thing on this list is the identity, the quality, the durability, reliability, the safety, effectiveness, or performance of your device after you've released it for distribution. So, once it is out on the market, so you really need to break down that definition and keep those things in mind when you're considering, first of all, is this a complaint?

And now, in terms of things, particularly with EU MDR, complaints are much bigger than that. Now we're talking feedback these days where it's like, even if the customer doesn't like the color of your device, yeah, you probably want to document that because it technically is a complaint, but also positive feedback is good to document as well.

But one of the things when it comes to the FDA regulation is that every complaint needs to be evaluated to determine if it is reportable under part 803 of the medical device reporting chapter.

What I really think is important to consider is, in doing that evaluation, are you asking yourselves the right questions to determine if you need to report that complaint as a medical device adverse event or device malfunction?

Etienne Nichols: So, with the medical device reporting, it's essentially, you're taking a complaint and you're trying to determine how you're going to handle this. If it's severe enough, maybe we need to tell the FDA just at a high level.

So that being said, maybe we can back up a little bit and think, okay, what are the different ways in which I might receive a complaint? Can we talk about that? First the inputs and then what we need to do as an organization?

Lisa Van Ryn: Oh, sure, sure. Absolutely.

I have had experience receiving complaint inputs from the facility directly in terms of the physician hospital, a technician working in the or maybe reporting those complaints. In some cases, they may report them directly to a resource at the manufacturer's location.

In a lot of my experience that we have had sales representatives out in the field at cases collecting that information. And in other cases, maybe it's device that goes directly to the patient with its own IFUs.

The patient just uses it. Maybe there are technical difficulties or the device breaks, and the patient says, hey, can I get a replacement? That's where another resource of input could come in from.

But you can theoretically receive input for your customer feedback and complaints process from any source that says something about your device, like any written, electronic, or oral communication. And we used to talk back in the old days, like, if you're at happy hour and one of your customers is there and says something to you, technically you're being made aware of an issue.

So, I would, I would take any input source. Even employees can identify issues with, with devices and report complaints as well.

Etienne Nichols: Okay, so let's, let's just kind of play through a scenario, if that's okay, we'll do a little role play. So, if, if a physician calls calls the facility on the phone and they say, I've got.

I've got an issue with this scalpel that I just used. This is bent or something when it came out of the. The box. What is the work of the organization going to do?

Lisa Van Ryn: You're going to need to document it.

The requirements of part 820 require you to keep records of all of your complaints, customer feedback information, so you would have a procedure or process to document. If you have Greenlight Guru, of course you're going to document that in our customer feedback workspace and capture as much information as you can about the complaint.

Who is reporting it? What's the facility? Do you have a name of a person that you can contact? You might need to follow up and ask additional questions. In my experience, the follow up process has been hit or miss because in a lot of cases, particularly with physicians, it's not something that they can build time for. So, getting responses from physicians sometimes is a challenge, and sometimes you can reach out to a tech that might have been working in the or even the facility itself.

But response on follow up is often challenging. But take whatever detail you can get, particularly about the details surrounding the event, what exactly occurred, maybe even try to follow the steps in the process.

In some of my experience, some facilities are even willing to share, like procedure notes or real, actual documented details of the case, which always can be very helpful in determining that.

And in a lot of cases, you may be questioning, is this serious injury directly tied to our device? If it's questionable, oftentimes the physician may say, absolutely not. This patient had a lot of pre-existing conditions, and your device did not impact this. You know, so all of those things should be reviewed, documented.

You know, you definitely want the date the event occurred, where. Where it occurred, and, and who was participating in the event. If you can get that device back, get it back, because then you have a whole another process of doing analysis on the device to see maybe there was a malfunction, maybe there was a user error. Any of these things should be documented as part of the record for that complaint.

Etienne Nichols: And so maybe I skipped ahead a little bit too far. Let's just assume maybe you have been dropped into a startup who is just now building out some of their documentation for their complaint management system.

How are you going to set that up? And what are some of the things that maybe you see companies not do well and some pitfalls that they can into?

Lisa Van Ryn: Yeah, definitely. You need a procedure. You need a way to collect the data, a process for documenting what information is valuable and relevant I'm sorry, what was the second part of you?

Etienne Nichols: Yeah, the second part is, like, issues that people get into. I was actually just bringing up my ISO 1345. I just did some lead auditor training, and I have it on my desk and.

Which I'm super pumped to have a hard copy back with me. I don't know. I lost my last one, but just the feedback.

Lisa Van Ryn: How?

Etienne Nichols: Just some issues that you see, or could potentially see companies getting into when they are building out that part of the organization, because now just give some experience or an example.

From my experience, I can remember going to a quality engineer's office or a desk. He had a cubicle, and he had stacks and stacks and stacks of paperwork, and he was struggling to get through all of the different complaints he.

He managed. I don't know. I don't know how many product lines he was in charge of, but he handled all of the complaints that came through there. And I don't know.

I don't actually know what the interface he worked with. I don't know all the detail he. He recorded. I'm assuming everything that you talked about, but there's got to be a better way.

And are there. Are there issues that you see? Yeah. Companies typically mess this up, but it would be so much easier if they did this instead.

Lisa Van Ryn: Oh. In terms of efficiencies.

Etienne Nichols: Efficiencies. Getting it right, you know, it's long. Playing the long game. Yeah.

Lisa Van Ryn: Yeah. I mean, I think I haven't had a lot of issues. Like, I've really had the privilege of working for a lot of companies that are good at documentation in terms of what are the important things we need to consider.

Had some great mentors, particularly when it came to complaint complaints and MDRs. And some of my experience, I can say that there have been teams I've worked with in the past that maybe have been overly liberal, if that's the right direction. I want to say that in terms of, oh, maybe our product is perfect. I don't even really need a complaints process or that customer doesn't know what they're talking about. That's not even how it's supposed to work.

Taking for granted the value in assessing this information, not just for the purposes of regulatory reporting. I guess one of the biggest things, I would think is that if you're not taking the data and putting it into the feedback cycle, to look deeply at trends in reporting, to consider what improvements you might need to make with your device or even with your labeling an IFU, because if you're having user errors, maybe there's something wrong with your instructions, something, you know, putting that into the cycle as part of post market surveillance for follow up and improvements.

That, that is where I think a lot of companies don't invest where they should, but also more so if you're taking for granted the feedback that's coming in and not considering it as important, whether it's reportable or not, there is valuable data in the information that comes in.

Etienne Nichols: So, if I am a company that I have some complaints coming in, I'm looking at those, the trends. That makes a lot of sense. And I really, I think that's good advice. Obviously, you want to be doing some trend analysis. How do you determine, okay, this. This one, it's gotten to the point, or maybe we have enough little ones.

I don't know which direction. Are those two different options that we need to do an official medical device report to the FDA?

Lisa Van Ryn: Oh, that's a, that's a one case at a time review that you need to do.

Etienne Nichols: Okay.

Lisa Van Ryn: So there, there are specific questions that I recommend you consider, and one of the, one of the best tools that you can do, that you can create is what is called, like, a decision tree.

So more or less a flow chart. How do I know if this one specifically is reportable?

So, first of all, part of the regulation says that any event that you have become aware of that reasonably suggests that the device may have caused or contributed to a death or serious injury, that's really the first place that you start.

So, if there's a reasonable suggestion that it could be contributing in that way, then you really need to dig in deeper.

And so, it's either death or serious injury or device malfunction. Those are the two kind of key questions that you want to ask. And so, when I'm building a decision tree, the first thing I say is, did a death or serious injury occur?

And death is pretty simple to answer. That's a yes or no question. Right. But serious injury is a little bit more vague.

My question, but that's okay, because serious injury is defined by the FDA. So, when you ask that question, you say, okay, what do they consider to be a serious injury? So, I even would pull that definition into the decision tree so that the person that's evaluating the information can say, is this a serious injury?

And what a serious injury is, it could be considered life threatening. It could result in a permanent impairment to a body function or permanent damage to a body structure.

And then the third one, and this is the one that's most complex, is that it necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to the body structure. So permanent means irreversible to the. To the structure, including trivial impairment or damage.

So, if that first question is a yes, then a medical device report will be required for sure. But the type of report that you want to do, we don't know quite yet. So that would be the first step in your decision tree.

Etienne Nichols: Okay. I don't want to slow us down on the first step, necessarily, but I do have a clarifying question that I'm curious about. Necessitates medical or surgical intervention to preclude permanent impairment of a body function.

Do you have an example of that that you might not? And I don't mean to put you on the spot, or maybe I do mean to put you on the spot, but do you have an example of that that you might not?

At first glance, this doesn't seem like it was that way, but this actually turned out to be one that fell into this category.

Lisa Van Ryn: Yeah. So, this is where things become a little bit nuanced. So, if there is information in your instructions for use on how to perform a device explant, maybe a device explant is. Is kind of an expected potential issue, but it isn't necessarily a permanent damage or injury to the structure. But if they performed the explant and also needed to apply medication, maybe to prevent infection, something along those lines, or maybe they needed to use a catheter to resolve the issue that was occurred for the device, that might be an example. Any time where the physician does something that's not expected or not included as part of the instructions for use or the typical surgical procedure for that device, speaking in terms of surgery, which is where I have had my most experience, that is something that would necessitate medical or surgical intervention, something.

Etienne Nichols: I'm just going to put that back in my own words for the simpler minds, I guess. So, I've got a surgical procedure that this medical device is involved in. Steps one through ten and step four, five.

Are my, my, my devices involved in those.

But for whatever reason, because of something to do with my medical device, they had to insert a step four b and five b. And so now they've told me, hey, there was an issue with this surgery because this.

And we had to come in and change the way we typically would do this. So that's the complaint. And you're like, okay, this is going to. Likely going to be an MDR.

Lisa Van Ryn: Yeah.

Etienne Nichols: Yeah.

Lisa Van Ryn: And I mean, even if.

Even if the device itself did not necessarily cause, but the surgical procedure, something about the procedure, it could have easily been a physician user area. Maybe they put the device in the wrong place or, you know, the instruments they use, the scalpel they use to, to perform that first incision.

Maybe they made a slip of the hand or something along those lines that's still related to your device because there's a procedure involved and should be documented even if it is a user error.

Etienne Nichols: And they, if they reasonably point the finger at you, the manufacturer, and say, hey, yes, I know this is user error, but I didn't know I was putting it upside down and I should have known.

There should have been clearly marked that that's okay. That makes sense.

Another similar question might be, and you said your, your, your experience is more around surgery, so feel free to punt this one if we need to. But let's say software, software is one of those where it feels very, the industry tends to want to say, well, I'm not really device, I'm not really interacting with the patient sometimes. I'm not, not trying to be too generic there, but what if you have, and I'm going to go, not even software that's involved in surgery or something like that, because of course, that can be a little bit more clear cut. What about software that has to do with psychological things or is monitoring somebody or something along those lines?

Any thought or input that you might have or creativity that you can help us figure that one out?

Lisa Van Ryn: Oh, wow.

And particularly when it comes to behavioral health, that is, that is a realm I haven't ever even considered.

That's okay, because, I mean, that's difficult to pinpoint. So, I wouldn't want to speak on that as sort of an expert, especially when it comes to like an application on your phone that might be like a mindfulness thing that's helped, supposed to help you with depression or anxiety that I,

it would be difficult to measure in terms of what's reportable there. But that, that would be maybe a conversation for another guru on another podcast, for sure.

Etienne Nichols: So, one other thing you had said, too was the three areas, death, it's clear cut, is binary. The other one, serious injury. And we kind of talked about the definition of that.

But you also mentioned device malfunction. Yeah. So, does that mean device malfunction regardless of the impact or what are some thoughts there?

Lisa Van Ryn: No, not regardless of the impact. So, after you ask that first question. So, let's say there is no serious injury, there is no death. The answer to that first question is no, you still need to ask the malfunction question, so did the device malfunction?

And again, we're going back to the 803.3 CFR definitions of what is a device malfunction. Okay. And that is a failure of a device to meet its performance specifications or otherwise perform as intended.

Performance specification includes all claims made in the labeling, and the intended performance of the device refers to the intended use for which the device is labeled. So, what was approved by the FDA in your PMA submission for intended use and performance?

So, is that question, did it malfunction?

If it's no, then you don't have to report. But if it's yes, and in some cases, you don't know yet, maybe you don't know at all if it malfunctioned. Okay. Because you don't get the device back. You have no idea if somebody dropped it on the floor before they used it.

So that unknown question leaves you hanging a little bit. But there's a follow up question.

So, is the malfunction likely to cause or contribute to a death or serious injury? So, we're going back to the first question, is if the malfunction is likely to cause or contribute to death or serious injury if it were to recur.

So, if the malfunction happened again, could it, is it possible? Is it low? And if the answer is yes, then you do need to do a medical device report.

Etienne Nichols: Okay. I'm just thinking of, like, an example of something like that. I remember, let's just say maybe there's a device that holds a bone in place or an arm in place while I had distal radius surgery. I had a plate put in my distal radius when I. During college because I just shouldn't have been doing some of the things I was doing. Anyway, my arm broke. They went to put surgery on. They went to put a plate in.

And so, this is me being just completely creative. Who knows if this could ever happen. But let's say he slips. He. He or something's holding my arm while he's drilling on it.

But that thing, that holding my arm isn't screwed down very tight and it starts to slip, and my arm could fall off, but the nurse catches it, so nothing bad happens.

Maybe the nurse catches whatever fixation device should have been in place, or, you know, but. But it. But it malfunctioned. That sounds like a potential for this. This area. Is that.

Lisa Van Ryn: Yeah. Yeah, because there's a. Even if maybe, you didn't have an injury, but that type of malfunction could be an injury, then, yes, I would consider that reportable?

Etienne Nichols: Okay, so we talked about step one, and I slowed you down a lot. What's, what are some of the step twos and the next steps? Maybe we need to run through some of those.

Lisa Van Ryn: So, there is another level of question. So those first two, death or serious injury and device malfunction. Just determine if you need to report.

The third question suggests, oh, say that I have to correct myself on one thing because I missed a statement.

So, if the malfunction was likely to cause or contribute to the death or serious injury, than it is reportable. Did I already say that?

Etienne Nichols: I think so, but I always appreciate a clarification. Go ahead.

Lisa Van Ryn: Okay, so then, so you need to report. But there's two different kinds. There's a five-day report, which is five business slash working days.

Etienne Nichols: Okay.

Lisa Van Ryn: And there is a 30-day report, which is 30 calendar days. And you can follow all this through with the guidance for reporting, for medical device manufacturers to kind of hash out the details of the reporting part of it.

Etienne Nichols: And we'll put that in the show notes, just those of you listening, we'll put that link to the FDA guidance. Go ahead.

Lisa Van Ryn: Perfect. So, if the event necessitated a remedial action to prevent an unreasonable risk of substantial harm to public health, then it's a five-day report.

If not, then it is a 30-day report. So that last question determines which type and what a remedial action is. Could be something other than routine device maintenance that is necessary to prevent that risk of harm to the public.

Etienne Nichols: Okay. And so, walk me through that a little bit more. Maybe I need to break that down. If we believe that it was dropped and this would never happen unless you drop it on the floor, that sounds to me like, okay, that's, that may not need remedial action.

We need to look into that. Maybe we need to change some of the packaging, some of the stability or the robustness of the device. But really, this is a one-off situation. But we are not really sure. And it sounds like something bad happened and we have no idea. And the next surgery is next week, and the same thing could happen.

We don't have any idea that they're going to be using is the exact same device. That sounds like it could be the former or the first category.

Lisa Van Ryn: Correct? Correct. So, kind of a single one. What it says in the 803.3 definition for remedial action is that an action taken to correct just a single device is not considered the remedial action.

But if there is any reason to think that devices currently on the market could cause death, serious injury, then that would be the remedial action, which in most cases would be some type of field action, whether it be a recall, that kind of activity would be an example of remedial action that would necessitate that five day report.

So, you can really get the word out and prevent risk of injury or death.

Etienne Nichols: So, it's kind of the difference between a broken design and a broken device.

Lisa Van Ryn: Right. That's a good. That's a good way to think of it.

Etienne Nichols: Okay, cool. Okay. That. That helps a lot in thinking how the timeframe. Five days versus 30-days.

Lisa Van Ryn: Yes.

Etienne Nichols: What are some of the differences? Yeah, go ahead. Go ahead. Yeah.

Lisa Van Ryn: I have one follow up caveat, because this has always been kind of a question of, when does that clock start?

And what the regulation says is when you become aware. And what does that mean? Who becomes aware? Right. And it's basically the simplest way to describe it is anybody that works for your company that is aware, that is the date that the clock starts.

And a lot of times, people might be confused. Maybe you are a complaint handling specialist, and you receive the information from Joe Schmidt, who's out in the field, and you think, okay, this is when I became aware.

But you actually have to count when Joe becomes aware, because if Joe finds out three weeks ago and he's like, oh, I forgot. I. I forgot to tell Lisa that I had this adverse event, and he's reporting it on the 29th day.

I still have one day to get that report done. According to the FDA, it would be considered late if I get it in past the 30 days, regardless of how long Joe sat on the information.

Etienne Nichols: Okay, so it's kind of like the organization is the body, and I'll just. I'm going to torture this metaphor. So, you're going to tell me when to stop. But let's say I, as Etienne Nichols, in my entire body, I am the organization. I put my hand on a hot stove, and it takes my hand a little bit longer to travel to my brain to say, hey, you're burning your hand.

Maybe it takes me an hour versus the half a second that it should take. The time that I'm burning my hand is from the time I put my hand on the stove.

Okay. This terrible analogy. I feel like it might be from.

Lisa Van Ryn: The time you turn your. No, it's from the time you. You put your hand on the stove. I don't know. That's. Maybe it is.

Etienne Nichols: But I guess I'm just picturing, I guess, the organization being. There are lots of people on the periphery, maybe people in the field, maybe people who interact with the customers, even salespeople and so forth, when they receive that information, the organization has received the information. And so that's the way the FDA looks at that.

Lisa Van Ryn: Yeah. Yeah.

Etienne Nichols: Okay.

Lisa Van Ryn: Okay.

I tend to be very conservative on this as well. So, if they sent me an email, I typically will go from the date that they sent the email. But I always, always, always made a good practice to try to get those reports done as soon as possible, as soon as I had enough information.

Now, if you are, have your complaint still open? Maybe you are expecting to get that device back. You still want to get your report in at the 30-day mark, because there is an option in the reporting process to do a follow up. And that is what is required is that if you receive new information after you've submitted your first report, you need to do a follow up again within 30 days for that typical 30-day report.

Etienne Nichols: Okay. And then at some point, I'd love to get into the nuances of actually submitting that report or getting set up on the e submitter. Maybe we don't want to do that necessarily today, but I would like to, I would like to ask what are, what are some of the things that happen after you submit? Is there interaction with the FDA? Do they, what, what do they do with that information?

When you have a follow up, what do they do with that? What's your input?

Lisa Van Ryn: So, they will capture the data that you send. If there's any issues with the report, they might shoot an email back to you and say, hey, there's information missing, or. This was not quite clear.

I have had very few occasions where I had interaction with the FDA in any way after I submitted the report. But the data is published publicly in the Mod database on the FDA's website, and it also is used as part of the total product lifecycle database, the TPLC database, because when you put in your report, you also put in your device code with the FDA.

So, in the TPLC database, it will have a listing of types of harms and hazards that occurred with relation to your device. And also, you can look up competitors’ data as well. But you are able to go into the FDA's website and review the published information when you have those reports.

Etienne Nichols: Okay, that makes sense. So, it does become public knowledge if they see something like this and competitors doing, having similar issues or whatever that may be, do they ever do more of a proactive or.

That's not really the right word, like push, pull communication. I mean, when I think of pull information, that's just, we're going to put information you need to come get it, versus the FDA saying, okay, there are things going on in the field right now.

Manufacturer A, manufacturer B, manufacturer C. And so, we need to let all of the clinicians out there know that this product may have a similar, or maybe it's just this manufacturer.

Does that ever any thoughts about that?

Lisa Van Ryn: I have not had experience with them taking action that I needed to manage or mitigate in any way, but there is always that opportunity for them to find something that might trigger an inspection or additional scrutiny.

But I could definitely see that if you saw a similar type of device and all people making that type of device were having the same issue, and it was a serious public health, that the FDA would probably trigger some sort of notification.

Etienne Nichols: Issue a safety alert.

Lisa Van Ryn: Yeah, issue a safety alert or even require a mandatory recall or additional investigation. So, I'm sure that if something was alerting them in terms of a trend, that they would dig deeper and ask for more data or follow up.

Etienne Nichols: Yeah. Okay. Well, I look forward to maybe completing this conversation a little bit in the future as far as setting that e submitter up and so forth. But I think we're on a good start.

If I'm a company that needs to, to work on this, what are the things I need to be thinking about? Any other pieces of advice that you have for someone who, who's in the role that you used to occupy?

Lisa Van Ryn: Yeah, I think going through definitely the FDA regulation on complaints, part 803 on complaints, and the guidance document that we're going to share as well. And then if you're getting started with this process and you expect to be receiving feedback anytime soon, that could potentially be something that needs to report. I would get a jump on preparing the process, not just in terms of the procedure, but the, there is a web interface e-submitter application that you need to go through a procedure with, with the FDA to download this application and get that configured onto your desktop for each user individually, that's going to be doing any submissions, whether they be electronic submissions for regulatory updates or for this type of thing, because the, the reg team probably uses this for submitting PMA supplements and whatnot. But also, there is a gateway portal.

So, you go through this e submitter application to create the report, and then you zip it up into a package, and then you need this portal to upload it to the FDA's site.

So, getting all of that set up in advance, maybe even weeks in advance, is highly recommended because the process to do it is a little bit complicated and fraught with a lot of troubleshooting.

So, if you're not very tech savvy, it's going to be a bit of a struggle. But I would definitely love to cover that part of the process on a future conversation, for sure.

Etienne Nichols: Well, that especially sounds important if you're, if you get one of those first categories where you, you need to report in five days. You don't want to be spending that five days getting set up with the FDA.

Lisa Van Ryn: No, no. And there might be some workarounds in the guidance documents, like if you are struggling here and they do have support to help you with it. But, but it is definitely a bit of a process, takes some time.

Etienne Nichols: We'll see if maybe we can add a link to that guidance as well, or some recommendations to help people out there, too, until that next episode does come out. So.

Lisa Van Ryn: Sounds great.

Etienne Nichols: Very cool. Thank you so much, Lisa. Where can people find you? Is it okay if they reach out to you and ask questions, if they have more?

Lisa Van Ryn: Of course. Of course. If you are a GG customer and you have assistance, you can find me or any of our gurus on this from 09:00 to 05:00 eastern. If you have industry related questions or questions about the GG app, we also have open office hours for our customers where you can go on online, have a face-to-face conversation with other customers and our gurus on any of our workspaces related to the use of the software.

Otherwise, you can reach out to me on LinkedIn, too, and connect and follow me there.

Etienne Nichols: Okay, sounds good. Thank you so much, Lisa. I really appreciate you sharing your experiences and look forward to future conversations. Everybody who's been listening, you've been listening to the global medical device podcast.

We'll see you all next time. Take care.

Lisa Van Ryn: Thank you.

Etienne Nichols: Thank you so much for listening. If you enjoyed this episode, can I ask a special favor from you? Can you leave us a review on iTunes? I know most of us have never done that before, but if you're listening on the phone, look at the iTunes app. Scroll down to the bottom where it says leave a review. It's actually really easy. Same thing with computer. Look for that. Leave a review button. This helps others find us and it lets us know how we're doing. Also, I'd personally love to hear from you on LinkedIn. Reach out to me. I read and respond to every message because hearing your feedback is the only way I'm going to get better. Thanks again for listening and we'll see you next time.

Lisa Van Ryn: When does that clock start?

And what the regulation says is when you become aware.

And what does that mean? Who becomes aware? Right. And it's basically the simplest way to describe it. Is anybody that works for your company that is aware, that is the date that the clock starts.

Not Europe's MDR, but the medical device reporting for the FDA. Every medical device company in the US is likely going to be faced with some form of this at some point in their existence.

I would assume so. With us today is to talk about. This is Lisa Van Ryn, a medical device guru here at Greenlight Guru. Lisa, how are you doing today?

Lisa Van Ryn: I'm great. How are you doing?

Etienne Nichols: Doing well. Why don't we start by talking a little bit about your background, because it's the first time you've been on the podcast, and we typically like to do a meet the guru.

So, people are aware and kind of get to know some of the gurus here at Greenlight Guru. So, tell us a little bit about your journey and your origin story and how you got to Greenlight Guru.

Lisa Van Ryn: Oh, thank you.

Etienne Nichols: Yeah.

And I would just say, I'm pretty sure I can do that.

Etienne Nichols: Figure it outer.

Etienne Nichols: I'm sure if they're listening to the global medical device podcast on quality and regulatory topics, they're okay with it, of course, for sure.

Usually when I have a meet the guru episode, I like to lead up to the conversation by asking, what do you consider yourself really good at? Or what are you a specialist at?

But one of the things when it comes to the FDA regulation is that every complaint needs to be evaluated to determine if it is reportable under part 803 of the medical device reporting chapter.

So that being said, maybe we can back up a little bit and think, okay, what are the different ways in which I might receive a complaint? Can we talk about that?

First the inputs and then what we need to do as an organization?

Lisa Van Ryn: Oh, sure, sure. Absolutely.

The patient just uses it. Maybe there are technical difficulties or the device breaks, and the patient says, hey, can I get a replacement? That's where another resource of input could come in from.

So, I would, I would take any input source. Even employees can identify issues with, with devices and report complaints as well.

I've got an issue with this scalpel that I just used. This is bent or something when it came out of the. The box.

What is the work of the organization going to do?

Lisa Van Ryn: You're going to need to document it.

In some of my experience, some facilities are even willing to share, like procedure notes or real, actual documented details of the case, which always can be very helpful in determining that.

How are you going to set that up? And what are some of the things that maybe you see companies not do well and some pitfalls that they can into?

Etienne Nichols: Yeah, the second part is, like, issues that people get into. I was actually just bringing up my ISO 1345. I just did some lead auditor training, and I have it on my desk and.

Which I'm super pumped to have a hard copy back with me. I don't know. I lost my last one, but just the feedback.

Lisa Van Ryn: How?

He managed. I don't know. I don't know how many product lines he was in charge of, but he handled all of the complaints that came through there. And I don't know.

I don't actually know what the interface he worked with. I don't know all the detail he. He recorded. I'm assuming everything that you talked about, but there's got to be a better way.

And are there. Are there issues that you see? Yeah. Companies typically mess this up, but it would be so much easier if they did this instead.

Lisa Van Ryn: Oh. In terms of efficiencies.

Etienne Nichols: Efficiencies. Getting it right, you know, it's long. Playing the long game. Yeah.

I don't know which direction. Are those two different options that we need to do an official medical device report to the FDA?

Lisa Van Ryn: Oh, that's a, that's a one case at a time review that you need to do.

Etienne Nichols: Okay.

So more or less a flow chart. How do I know if this one specifically is reportable?

So, if there's a reasonable suggestion that it could be contributing in that way, then you really need to dig in deeper.

And death is pretty simple to answer. That's a yes or no question. Right. But serious injury is a little bit more vague.

And what a serious injury is, it could be considered life threatening.It could result in a permanent impairment to a body function or permanent damage to a body structure.