Feb 09, 2023
On February 2, The Capitol Forum hosted a conference call to discuss problems in the FDA’s review process with Madris Kinard, founder and CEO of the company Device Events. The full transcript, which has been modified slightly for accuracy, can be found below.
MIKE WILLIAMS: Good morning, everyone. Thank you for joining The Capitol Forum’s Conference Call on the FDA’s Approval Process for Medical Devices and Problems Within that Program. I’m Mike Williams, Senior Correspondent at The Capitol Forum. And I’m joined today by Madris Kinard, the former Adverse Event Subject Matter Expert for devices and unique device identification at the FDA, and the Founder and CEO of Device Events, which analyzes millions of complex medical device reports and recalls that have been filed with the FDA.
A quick note before we get underway. The first 20 minutes or so of the call will be an interview with Madris, and then we’ll move into a Q&A format where we will entertain questions from the audience. If you do have questions for us, please email them to firstname.lastname@example.org. That’s email@example.com. And Capitol is spelled with an “O”.
So Madris, I want to thank you very much for taking the time to speak with us this morning.
MADRIS KINARD: I’m happy to be here. Thank you for inviting me.
MIKE WILLIAMS: And to start, I wanted to start with a broad overview of the FDA’s approval process for medical devices, and particularly the program known as the 510(k) program, which not a lot of people know about, but is a pretty major program. So could you give us an overview of what is the 510(k) program at the FDA?
MADRIS KINARD: Oh, certainly. Certainly. So, it generally is thought that most devices go under, you know, have clinical trials similar to drugs and go through this pre-market approval. But that’s not necessarily the case with devices. About 95 percent of devices go through a program called 510(k). And they’re actually not considered approved devices. They’re considered cleared devices. And what that program does is it only checks for substantial equivalence of a device to a predicate. So if you want to submit an application to the FDA for a 510(k), you don’t have to show safety or effectiveness. You have to show that your device is substantially equivalent to a device already on the market.
MIKE WILLIAMS: And what’s the sort of threshold for substantial equivalence? Because obviously, if you’re bringing a new device to the market, you want to have some new feature, some new improvement. How does the FDA categorize substantially equivalent?
MADRIS KINARD: So that’s a good question. I think that when the program began, it was intended to be kind of a one off. It wasn’t supposed to be used all that often. So if you think of something like a hip implant and they slightly change the curve of the implant, that’s the type of change that they were thinking would be coming in on these 510(k) applications.
But what’s happened over the years is now this loophole essentially is being used for 95 percent of the applications that come to the FDA. And so when that application comes to the FDA, in fact, the FDA doesn’t even look at adverse events of the predicate device. They only look at whether it’s substantially equivalent. Does it do the same thing that the other device did? And if so, then it gets cleared and it goes to market without any clinical trials or safety data.
MIKE WILLIAMS: So you’re saying that even if the predicate device, the device that the manufacturer is saying has substantial equivalence to, had underlying problems that have been identified before, that’s not taken into review by the FDA? Basically, they’re saying this is substantially similar to a potentially problematic device that you’ve already cleared. So it can go to market.
MADRIS KINARD: Yes, yes. And so sometimes it’s not necessarily that predicate that had the issues, but the one before that. So you have essentially what’s called this daisy chain. So you have like a whole row of these devices that this one was considered substantially equivalent to the last one, and that one was to the one before that. And so you can have devices that have been recalled used as predicates.
And the other thing is that when the FDA started the Devices Division, anything that had already been on the market was grandfathered in. So you can have a device and mesh is a good example where mesh was already being used prior to the Device Division being created. And so the devices that are coming out now, the mesh—and I think more with hernia mesh. I think with transvaginal mesh, they actually found some issues and changed the class of that device. But hernia mesh is considered substantially equivalent to hernia mesh that was used pre-amendment, which was grandfathered in. So there were no tests done on that.
MIKE WILLIAMS: And this daisy chain, do you get a 510(k) that shows substantial equivalency to the predicate device? Or a 510(k) to something that was already 510(k) to a project hip device? Does it go always go back to the source?
MADRIS KINARD: Essentially, this chain keeps going. So you can have multiple predicates in a single chain. But they just choose one device to say that they are substantially equivalent to that.
MIKE WILLIAMS: So do you ever, looking at 510(k) approvals, see almost like an evolution? Or it almost sounds like a game of telephone where if each underlying device is changed just a little bit, you could get to a new device that potentially shows little actual equivalency to the already marketed device. Are there any examples of that you’ve seen where you sort of just scratch your head at how was this was cleared given that it’s now evolved so far beyond what was initially approved?
MADRIS KINARD: There are. So my understanding and I did work in postmarket surveillance. I kind of looked at what happened after these clearances. But my understanding is that robotic surgical devices were considered substantially equivalent to a manual surgical device. And so that’s one that always kind of has surprised me more than others, that those are on the market without any clinical trials being done. So that’s kind of the big one for me.
MIKE WILLIAMS: Wait. So you’re telling me that robotic surgical devices like that- are you referring to that da Vinci machine that has become popular?
MADRIS KINARD: Yeah, that’s one example, definitely. That’s a 510(k).
MIKE WILLIAMS: So those have entered the market with a 510(k) and they were found to be substantially equivalent to- I can’t even think of what would come before that. What were they comparing it to and showing equivalence to?
MADRIS KINARD: Something similar to a scalpel.
MIKE WILLIAMS: Okay. Well, that’s a little bit further of a leap than I thought you were going to bring up.
MADRIS KINARD: That’s my understanding. So, yes. Yes, that’s one that’s been of concern for some time.
MIKE WILLIAMS: And what is the FDA’s actual review process when this comes in? Because what actual review is the FDA doing on, say, that robotic surgical device?
MADRIS KINARD: Well, so they’re reviewing whatever the manufacturer gives them. So the surgical manuals, the training manuals, the instructions for use and, if they have any, training materials for that. Like I said, I didn’t work in pre-market. So I don’t want to assume I know everything that was in those files. But that’s my understanding is that they’re looking solely at whether this device functions just like another device that’s already on the market.
MIKE WILLIAMS: Well, then switching gears a little bit to look at the postmarket performance of some of these devices. We noted in the invitation to this conference call that there are recently two studies that showed significant increases in recalls for devices that had gone through the 510(k) process. But to start out, could you explain a little bit how the FDA maybe collects data on problems with devices that are on the market?
MADRIS KINARD: Certainly. So the FDA requires or mandates that manufacturers report adverse events to the FDA. So if a physician or a patient or even the medical device rep finds an issue with a device, they take that to the company and then the manufacturer is mandated to report it to the FDA within 30 days. And so those adverse events which come into the FDA are the basis primarily. Two-thirds of recalls begin as an adverse event report. And so that database of adverse events is really the primary source of these complaints and deaths, injuries, malfunctions. There are other sources of data, but none of them come close to being used as much as that adverse event report data.
And another group is mandated to report too. Hospitals are also mandated to report, but they don’t have oversight. So the FDA can’t really mandate it. It’s more of a, this is what you should do. But there’s really nothing they can do if the hospitals aren’t reporting.
MIKE WILLIAMS: And how do those adverse events factor into the FDA’s regulatory process with devices? Because, correct me if I’m wrong, but aren’t most recalls actually voluntary on the part of the manufacturer?
MADRIS KINARD: They are. So the recalls, the FDA really pushes the manufacturer to put together all the materials when a safety signal is found. So a signal is a pattern of adverse event reports or it can be just one death. It can be information from their medical device reps. But the recalls are considered voluntary. And the only piece of it that the FDA truly comes in and says this is how you’re going to do it is whether it’s a class one recall, meaning pay attention to this, this is serious or whether it’s a class two or three. And so the FDA does assign the risk class, but the recall itself is still considered voluntary.
And that is used. When a device rep is in the hospital, they can say, oh, we’re doing this because of an abundance of caution. This is voluntary. We decided to do this. The FDA isn’t making us do this. And so that causes problems because then there are misunderstandings, of course, on the hospital’s part. So a voluntary recall makes it sound like the FDA isn’t necessarily telling them they have to do it. I think if the FDA were to mandate recalls, there would be a lot more attention to them and that the health care providers using them would be a lot more careful.
MIKE WILLIAMS: That’s a really interesting point. I mean, when people think of recall, that means this thing should be taken off the market immediately. Are there instances you can think of where companies have leaned hard into the voluntary nature of those recalls, and hospitals and doctors have continued using devices that really should have been off the market?
MADRIS KINARD: Yes, there are quite a few instances of that. One of the devices that I’ve seen a lot of reports coming in for, but yet the recall was three years ago, were the Alaris infusion pumps. And so infusion pumps are, there’s one used pretty much on every single patient in a hospital setting to provide the fluids that the patient needs. And there was a recall on these devices. But yet, with COVID, the hospitals didn’t want to have a shortage of them because they have to have one for every patient. And so the recall kind of went in slow motion. So when they could get to it. Could they spare that infusion pump? I mean, obviously, if it didn’t work at all, it couldn’t be used. But sometimes there was an alarm error or they weren’t sure if it was working correctly and they had to continue to use them.
So since COVID, the bulk of the crisis is deemed over, they’ve been able to increase the number of devices to meet the need. We don’t have the PPE shortages like we used to have. So now these pumps are being reported to the FDA and we just received in the last year 400,000 adverse event reports for these pumps. And so it’s very obvious that they had to continue to use them. And so that call was made on the part of the hospital and potentially, I don’t know what Alaris, how their involvement was in negotiating when to do those recalls.
Sometimes a recall is just a software update also. So it doesn’t always mean that a device is being taken out of a patient. Sometimes it’s just a repair to a device or a notice that a battery is going to run out sooner than what you thought. And so if that’s an implanted device, that can be an important note to the doctor and to the patient that they’ll need to take care of something sooner than they intended to.
MIKE WILLIAMS: And I want to stay on this point on implanted devices. Because earlier before the call, we were discussing what’s known as the exit strategy for medical devices. And you had told me that the FDA does not review sort of exit strategies for implantable devices. Could you tell the audience a little bit more about that?
MADRIS KINARD: Certainly. So there are devices that are implanted in the body and there’s essentially no thought to what do you do if something goes wrong with the device? So something like a spinal cord stimulator or a vagal nerve stimulator in which leads are placed in the neck and then there’s a unit placed inside the body, if that device doesn’t work, it typically isn’t removed. They just turn it off. And because sometimes it can’t safely be removed. And so when patients go in to get these devices, they’re not thinking, well, what happens if it doesn’t work? They may hear, oh, well, you might experience a side effect. So doctors typically will tell you the side effects. But are the companies being transparent about, well, what happens if this doesn’t work for me? Well, they turn it off. And so that’s the problem.
With the Essure contraceptive device, it was a coil. It was intended to be permanent. And so there was no way that doctors knew to remove it for the first ten years it was on the market. Because you can’t just pull on it. It breaks and fragments in the body. And so essentially, there was no exit strategy and the physician didn’t know what to do if the patient wasn’t doing well. And that, of course, now we see the outcome of that is that the patients have to get a hysterectomy. And there have now been over 50,000 hysterectomies to remove Essure devices. And that was a device that actually never was recalled. It was a market withdrawal. They said it was due to business reasons, sales reasons. So we do have a lot of these instances where the device has to be left in place or it’s major surgery if the device has to be removed.
MIKE WILLIAMS: You’re telling me that there were 50,000 hysterectomies done pretty much solely to remove this device because there had been from the manufacturer no “exit strategy” for removing these devices if something went wrong? 50,000 hysterectomies?
MADRIS KINARD: Yes. So they have to remove the organs. Because if they tried to remove the device, it just breaks into pieces. So they have to take the whole organ out. So yes, it’s major surgery and it’s certainly not something that the patients were expecting. But in the last few years, we’re really seeing what happens after a device can’t be removed. It’s major surgery.
MIKE WILLIAMS: This kind of seems like a simple fix that the FDA – obviously, not a very simple fix. But couldn’t the FDA just require companies to have exit strategies for their implantable devices? Is the FDA working on this? And if not, why isn’t the FDA working on this?
MADRIS KINARD: I’m not sure if they’re working on it on the whole. There may be some devices where they’re learning from what happened and they’re asking companies what happens if you have to remove it? But for the most part, I mean, if you go in and get a hip, I don’t think that the thought is, you know, sometimes hips have to be replaced every so often, ten years. I don’t think thought is really given to what that entails. How big a surgery is that? Because if someone who’s 50 years old gets a hip, that means they likely have to replace it one or two more times in their lifetime. And things like breast implants, which women are getting younger and younger, the life of a breast implant is really only about ten years. And so this is major surgery that the patients have to get every ten years. And sometimes it’s out of pocket. Depending on if it was for cosmetic reasons, a lot of times the women have to pay for the replacement and/or removal of the device.
MIKE WILLIAMS: I want to backtrack a little bit back to adverse events, because that’s what your company Device Events deals a lot with. So could you give us a little background into what Device Events does with the FDA’s MAUDE database and the analysis you’re able to perform?
MADRIS KINARD: Certainly. So after leaving the FDA, I decided to start Device Events because there was no easy way to dig through the adverse events that the FDA receives. They have what’s called the MAUDE database. And you can search, but when you search for an event, you can only see 500 at a time. And now that we know there are 15.5 million adverse event reports, having to view each one, one at a time, it’s really almost impossible. If you have researchers that are working for months, it might be doable. But for the most part, if you want to know something about a device, you should be able to type it in like it’s a Google search and just say, oh, these are my side effects and this is the device, and see how many other people have these issues. Or a physician could say, wow is this just me? Or is this happening to other physicians using this device? And they can just type it in and it will return 20,000 reports, 5,000 reports, that are similar to the problems that they’re seeing.
And so essentially the purpose was to make these problems easier to find so that hospitals could make decisions for supply chain purposes. Physicians at a hospital can say, well, we’re having some issues with this device. Is it just us? What other device might we want to use instead? And so that’s one of the ways that Device Events is used. And we’ve pulled in adverse event reports, as well as recalls and summary reports, which are spreadsheet reports, that there were about 5.8 million of. So we have three different sources of data to search.
MIKE WILLIAMS: And from that, are you able to, are there any emerging trends that adverse events has been able to identify in MAUDE data, either from specific devices or types of devices or industries? Is there anything that you’re seeing in recent data?
MADRIS KINARD: Oh, certainly. So one of the ways that we can look for trends in devices is sometimes there will be a recall on a device, but they’ve only recalled one model. And I can look to see if the other models have the same reported problems. And often they do. And so a company will recall one model at a time because they can only handle that recall, but yet others have the same problems.
We also look for patterns of issues. Sometimes a signal would be considered to be 100 malfunctions of a device. Or it could be two deaths. And so you can just at physician reports. You can look through biomedical engineer reports and identify potential issues with devices sometimes ahead of the FDA. Because they are reviewing just a vast number of reports. They’re now getting over 11,000 reports per day. And so waiting for them to act and recommend recalls or send out a notice, sometimes we can get ahead of that and find these patterns of problems.
So with textured breast implants, that’s one where we’ve really found a huge number of issues. And this was before the recall. With Essure, we found that there were large problems with nickel, reactions to nickel. And with Duodenoscopes, there was an outbreak of some contamination, some bacteria that was antibiotic resistant. And we were able to identify that that’s showing up in other types of scopes as well.
So there’s a lot that you can do. Even just doing a search on like the term positive for, it will bring up all the devices where they’ve found microorganisms that perhaps shouldn’t have been in that device. And sometimes a company will say, well, we’re not sure if it’s really a problem yet. So we’re going to report this under an abundance of caution. They’ll use that term. And I was curious how many times abundance of caution appeared in the narrative of reports. And last night I just searched on the term and I found 21,000 reports where that phrase came in. And it was primarily for different types of scopes and for defibrillators. So those would definitely be ones that I would want to look at and think, okay, is there a problem? Is there a recall coming with these? Is there something going wrong that perhaps we can find this out even ahead of the FDA?
MIKE WILLIAMS: That’s really interesting. So you can sort of see the ripples before they become a wave, essentially.
MADRIS KINARD: Yes. Not everything, but we can catch quite a bit.
MIKE WILLIAMS: Okay, I have one more question before I turn it over to some of the questions we’ve gotten from the audience. But in the adverse events that you have been receiving and analyzing, have you found an association between products that have received 510(k) clearance obviously, that’s now essentially 95 percent of all products but 510(k) clearance and an increase in either recalls or adverse events?
MADRIS KINARD: Yes, definitely. So the number of adverse events just from 2021 to 2022 increased by over a million. So the FDA used to, when I left, they were getting 60,000 reports per month. It’s now over 200,000. And the 510(k) approvals have been happening faster and faster because you’ll hear the word innovation used a lot. People do want devices to be available more quickly and so the devices are getting pushed to market. The FDA just said they’re hiring 144 new scientists just for the Device Division to review these applications to get devices out faster. But there are ramifications to that. Because if they’re speeding these through a clearance process, you’re then going to see there’s a lot more devices on the market. But you’re also going to see more adverse events. And an increase of one million in a year is very, very substantial. It’s like an exponential change from past years.
MIKE WILLIAMS: Wow. And speaking of speed, if a company has recalled the device, could you talk a little bit about the timing of devices that come to the market that are essentially substantially equivalent to what was just recalled by a manufacturer? How fast can manufacturers take something off the market and then put it right back on so they don’t lose market share because of a recall?
MADRIS KINARD: Yeah. So that’s one of the concerns I’ve had is that I’ll often see a problem with the device and I’ll see that there’s a recall. And then the following day, there will be a new version of the device that has been cleared. And so my thought is that the FDA is allowing the companies to dictate the timeline, potentially because they don’t want a shortage. So there was an Olympus scope that was recalled and there was a fix for it the next day.
So the question is, is the FDA allowing them to hold off on the recall because there’s a new device or a fix coming? But in that amount of time, how many people are using that device that perhaps shouldn’t have been? And really the FDA shouldn’t be concerned about whether a company is losing a market share. If there is an alternative on the market, there’s no reason to hold a recall until there’s a replacement.
If there’s going to be a shortage, for instance, with CPAP, if Philips is making the majority of these devices, do you want to completely pull them off from the market knowing that there aren’t enough out there to meet the need and that patients could die because of that? But now after over a year of the CPAP information, you have another company, the ResMed, which has now amped up its production and said that they can meet the need. So they can replace these devices. But companies just don’t want to give up their customers and their market share. And so that’s a really big problem going on right now that I think the FDA needs to crack down on when it’s possible.
MIKE WILLIAMS: Okay. Well, that takes us to our first audience question, which is, does the FDA have no mandatory recall ability?
MADRIS KINARD: So the FDA can do a mandatory recall. But there was an instance and I don’t know which product it was – I think it was about 20 years ago, maybe 30 now, where the FDA was sued because the device that they did a mandatory recall on was needed for other things. And so the FDA is very reluctant to do a mandatory recall. So pretty much they make everything voluntary. But if the voluntary recall isn’t being handled the way they like, they will come back in and ask for additional things to be done. But no, I mean, there have been maybe four or five mandatory recalls in history for devices. I remember one of them was the powdered gloves. And that’s simply because there were so many manufacturers of those that they just had to get them all off the market right away and not wait for each manufacturer to do that.
MIKE WILLIAMS: What was the issue with the powdered gloves?
MADRIS KINARD: So it was actually not the latex, but the powder itself was causing anaphylaxis in some patients. And so the powder was being left behind in the abdominal cavity and the patient with allergic to the powder.
MIKE WILLIAMS: Got it.
MADRIS KINARD: It was very serious.
MIKE WILLIAMS: Yeah. Okay, so our next question from the audience is for a device like the da Vinci machine, what would the FDA process normally be versus the 510(k) process, both for cost and timing?
MADRIS KINARD: So the PMA process or Premarket Approval, can take several years. And so that is one of the reasons that companies try to do the abbreviated version. It involves clinical trials, more stringent review. They have to show safety and effectiveness of the device. And so it can take 2 to 3 years for a device to come to market. Sometimes even longer if they have any issues that the FDA requires them to address before they’ll approve the device.
MIKE WILLIAMS: So essentially for the company trying to market—
MADRIS KINARD: Oh, and the money, the money as well. So it’s over $100,000 to do a pre-market approval and it can be up to a million, I believe. And for a 510(k), it’s tens of thousands of dollars. So it’s a much cheaper option.
MIKE WILLIAMS: Got it. And our next question is you mentioned new hiring at the FDA. Is this primarily a staffing issue? Is there a lack of manpower to actually do more thorough reviews?
MADRIS KINARD: So, yes, there is. The number of applications that they’re getting for clearance, essentially, the companies are paying for more reviewers so that their applications can be reviewed faster and get the devices to market faster. And so that’s going to continue as long as the number of devices that need to go to market increases. And so, yes, that’s a huge number of staff.
When I worked at the FDA the year I was hired, they hired 80 new people. So it’s up to 144 per year now, perhaps, or at least just for this next year. And those people are only doing premarket reviews. That doesn’t include the people that read these adverse events. So when you see an increase of a million reports in one year, that doesn’t mean that funding or those people that are hired are not reviewing adverse events. So I fear that we’re going to see it take longer. Right now, it takes about two months to two years to identify a signal and do a recall. But I suspect that that’s going to increase exponentially until Congress sets aside more money for FDA reviewers or analysts for post-market.
MIKE WILLIAMS: I have a follow-up on that. What’s driving this huge- I mean, you make it almost sound like a flood of new devices. Is there anything driving that?
MADRIS KINARD: Innovation. There are a lot of new devices that are, you want a mobile device to be able to read your heartbeat. There’s a lot of new innovation. And so it’s a fair word to use. There are a lot of new products that are coming to the market. And it’s just a matter of whether every product is innovative. And it doesn’t mean that it’s safe and effective. And if they aren’t checking for safety and effectiveness of the device, is the FDA really doing its job when they clear a device rather than going through that PMA approval?
MIKE WILLIAMS: Got it. And our last question from the audience, again, deals with PMA approval. What are the benefits to a company going through a premarket review?
MADRIS KINARD: So a PMA approval for the most part, it’s more expensive. They do have a protection, however, under the law. There was a case that went to the Supreme Court, Regal v Medtronic in 2008. And it’s a device that’s gone through premarket approval and they’ve done clinical trials. Essentially, that’s considered like the gold standard. If there are problems with that device that they didn’t know about, that company cannot be sued for harm that it’s inflicted on patients.
And so the FDA doesn’t think in terms of, oh, well, if we approve this device as class three, they are protected. That’s not something that’s in the FDA’s realm. But what’s happened is devices that have gone through that process now, the patients essentially have no recourse if that device harms them. Unless they can prove fraud, which is very difficult to prove. So it’s kind of an unintended consequence of a Supreme Court decision that perhaps wasn’t—they weren’t thinking about the ramifications on the whole industry. They were just ruling on one case.
MIKE WILLIAMS: So essentially what you’re saying is, it kind of places some liability out of the hands of the manufacturer because through of pre-market approval, it’s the FDA doing the review. So it kind of makes it almost the FDA’s responsibility. Is that essentially what you’re saying?
MADRIS KINARD: That’s my understanding. Yes, that’s what I’ve seen. And so a class three device, when something goes wrong, patients are kind of left out, that there’s nothing that they can do unless they can prove the fraud, of course. And that’s, like I said, very difficult to do.
MIKE WILLIAMS: And we actually just got a couple more questions related to Device Events. One question is what are the thresholds or what should people be looking for in MAUDE data to get a sense of whether a device may be recalled?
MADRIS KINARD: You know, the FDA’s MAUDE database search doesn’t necessarily allow you to search this way. But one of the things I look for is an uptick in physician reports and an uptick in attorney reports. And those two things typically indicate to me that something bigger is going on. Or if there’s like a percent change over the previous year. So I’ll take a look every month and see, okay, well, what devices are coming in this month? And is there anything that’s surprising me? Is there anything I didn’t expect to see? And so that’s essentially how I look for signals and how they come to my attention.
MIKE WILLIAMS: I didn’t realize that. I look at the MAUDE database every now and then, and that 500 limit is very annoying. But I didn’t realize, can you filter by attorney reports?
MADRIS KINARD: You can’t using the MAUDE database. So when I built Device Events, I was building it – it was actually a system I wanted to build for the FDA. A lot of the things in it were features that the analysts told me that they really wanted, but the software they had just couldn’t handle it. And so when I built Device Events, I added some capabilities to, I mean, it was built to identify signals to help you find a way to identify what’s going wrong and get to those answers faster. But yes, the MAUDE database search—the data is very good in MAUDE, but it’s very hard to get to. And so that’s where Device Events comes in.
MIKE WILLIAMS: Yeah. Well, that’s a good advertisement for Device Events, I’ve got to say, because I can definitely tell you—
MADRIS KINARD: Oh, that’s—
MIKE WILLIAMS: The MAUDE data is very hard to sift through.
MADRIS KINARD: It is.
MIKE WILLIAMS: Okay, we have another question. This question is, does it matter who the end user is? Essentially, they’re saying, will the FDA scrutinize things more if it’s for home use without physician supervision?
MADRIS KINARD: Wow. I wish they would. I think that every type of device is going to have a different user group. So a lot of times patient reports, I don’t know that they get the same attention they should by the FDA. But when you’re looking at a device, I mean, look at the CPAP machine. Physicians weren’t reporting those. It was those customers because they were the ones using the device. And so I do think there needs to be a change with home health devices so that there’s a different mechanism to reach those users when something goes wrong with the device or if there’s a recall.
There was one recently that Amazon informed a patient about a recall and they hadn’t heard anything from the FDA or the manufacturer. It was actually Amazon that alerted them. And so I think we need to look at these distribution channels. And the FDA shouldn’t necessarily have a one size fits all. It should be based on how is this product distributed? That’s how you should communicate. You need to get to the right people and to see Amazon get ahead of that. It was refreshing, but also a little alarming that that was the only way people knew.
MIKE WILLIAMS: Yeah, that’s a bit of an indictment of the FDA.
MADRIS KINARD: It is. It is, unfortunately.
MIKE WILLIAMS: Yeah, I didn’t realize that. So with the big Philips CPAP recall, these were patients submitting reports to MAUDE. So the layperson on the street doesn’t know what MAUDE is. So that’s a pretty high threshold for a patient to know they have a problem, seek out MAUDE and go through this obtuse process of submitting a report to MAUDE.
MADRIS KINARD: Well, it is and it isn’t. So what CPAP did though was when you get a machine, it had a number that you call if you have a problem with the device. And so Philips was collecting complaints and they were not converting those. So when Philips gets the complaint from the consumer or the patient calls in, they are supposed to then submit an MDR to the FDA. And they failed on that process and they were cited for it in their inspection. So CPAP is one of those where I actually couldn’t have found a signal because the company wasn’t reporting them and because most consumers don’t know to report directly, that they can report directly to the FDA. And so this is one where it took everybody by surprise, including me. And typically, I see things a little bit before others.
Even physician reports, most of those go through the manufacturer and not directly to the FDA. So you’ve always got this stopping point. You’ve got this gatekeeper that says, okay, is this reportable to the FDA? Or did the patient just not know how to turn it on? Is it a battery failure or a use of the device failure? And so this is a really good example of where these inspections that the FDA does, they need to be in person. They need to be more frequent. And things like this can be faster.
MIKE WILLIAMS: I didn’t realize that. So these reports flow through the manufacturer first a lot of the time? That’s a massive conflict of interest. I mean, that’s a manufacturer—
MADRIS KINARD: Yes, it’s self-reporting. Self-reporting, yes. And they didn’t submit the reports. And so now we see this influx. And to me, I’m not sure if these are the complaints that they got over the years that the FDA is now making them submit. Or are these new? Because maybe these are different patients who, oh, I used this device and I noticed this problem and didn’t think to report it. Or I thought I did something wrong. So you have a lot of questions now when it comes to this particular recall as to are these new reports or are these people that reported to Philips and the reports just never made it to the FDA previously?
MIKE WILLIAMS: Got it. Okay. Well, Madris, I’m not showing any more questions from the audience. So I think that’s a good place for us to wrap up the call. I’ve got to tell you, this has been equal parts fascinating and alarming when it comes to knowing what review is actually going into the medical devices that people are using to stay alive and are implanting in their bodies. So I want to thank you very much for taking the time to walk us through these issues.
MADRIS KINARD: Well, thank you so much for having me. I appreciate it.
MIKE WILLIAMS: Okay. And I want to thank the audience for the great questions that they asked during the call. And this concludes The Capitol Forum’s Conference Call on the FDA’s review process and 510(k)s and Device Events. So thank you very much. And I hope everybody has a great rest of your day.