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IEC 60601 is a challenge for companies that are developing electronic medical devices. It’s wise to have a guide to help you understand and work through the process, and today we have a guest who will give you the guidance you need.
What makes the 60601 process different from the other regulatory compliance processes.
Some of the details on the differences between creating a device for the ER vs. for home use and for use in other types of facilities.
Tips on preparing for success when creating a timeline for getting through the 60601 process, as well as some of the steps involved.
Differences between different types of safety labs and the criteria that’s vital to understand to help you make the right choice.
What to do early in the process of product design and development to be sure you’re on the right track long before you get to the production phase.
Why it’s vital to keep the 60601 standard in mind, not only when it comes to meeting the standards, but also when it comes to patient safety.
Leo Eisner, founder and principal consultant of Eisner Safety Consultants, knows IEC 60601 inside and out.
Leo has a great background in compliance, quality systems, and more. For nearly two decades, he has been heavily involved in the standards committees and has been working as a consultant.
Eisner Safety Consultants helps clients get through the product safety and regulatory processes. Today he shares some great insights on the 60601 approval process.
Quotes from Leo:
“Give yourself a buffer. There will be bumps in the road... guaranteed.”
“Some labs know medical very well, and there are a lot that don’t.”
“Start early.... Testing can take six to 12 weeks.”
Announcer: Welcome to The Global Medical Device Podcast, where today's brightest minds in the medical device industry go to get their most useful and actionable insider knowledge, direct from some of the world's leading medical device experts and companies.
Jon Speer: IEC 60601 will continue to be a challenge for medical device companies who are developing electronic medical devices. You need a guide through this process; luckily for you, we found one. This is Jon Speer and listen to this episode of The Global Medical Device Podcast, where my guest is Leo Eisner of Eisner Safety Consultants. Yes, Leo knows IEC 60601 inside and out, so much so, that I've dubbed him 'The 60601 Guy'.
Jon Speer: Hello, and welcome to The Global Medical Device Podcast, this is your host and founder, and VP of Quality and Regulatory at greenlight.guru, Jon Speer. And today I have 'The 60601 Guy' on the podcast today. Yes, that's right, we have Leo Eisner. Leo is the Principal Consultant, and owner, and CEO, and all those wonderful things that go along with being the head of Eisner Safety Consultants. Leo, welcome to the Global... Welcome back to The Global Medical Device Podcast.
Leo Eisner: Thanks, Jon.
Jon Speer: So remind everyone of who you are, tell us a little bit about Eisner Safety Consultants, and then we're going to have a little bit of a conversation about IEC 60601 and some of the finer points and details, that sound okay with you?
Leo Eisner: Sounds great. So I'm going to start backwards, I'm going to start with Eisner Safety Consultants first. We try to help our clients, from small clients all the way up to Fortune 500 companies, get through the product safety and regulatory and quality system processes, which can be complicated at times. So that's what we do, and we have a great set of experts to help out. I'm the 60601 Guy, as Jon said. I've been doing 60601 for... What is it? About 25 years, roughly, I think.
Jon Speer: Yeah.
Leo Eisner: 19... When was it? 96?
Jon Speer: I don't know, you're making me do math.
Leo Eisner: So it's been a while.
Jon Speer: You're making me do the math.
Leo Eisner: Yeah, I need to do some math. I guess it's 20 years. Yeah, 20 years, not 25. My background... Out of college I started at Underwriters Labs, got lots of experience, but never did medical. Then I decided to go to a competitor, TUV Product Service, which is well-known for medical. And I got amazing training in the two years I was there. And a couple of years after that, I was at Karl Storz Imaging, doing all the product safety, managing all the compliance work, technical file work, the engineering quality system, etcetera, etcetera. And it was quite a full job. But a couple of years later, I finally decided to go out and start consulting, so that's been almost 19 years ago. And I've been consulting, primarily, in 60601, 'cause that's my expertise. And I'm heavily involved in the Standards Committee's work, so I'm really on top of what's going on, what's being developed and what's... Where the interpretations are too.
Jon Speer: Yeah. Sure. Absolutely. And having gone through a device that needed to go through the 60601 testing, or actually several in the past, every single time it's like, "Man." I remember the first time anyway, it was like... I don't know that I knew Leo at the time, and after you and I met and spoke, and you shared some tidbits and knowledge about 60601, and I'm like, "Alright, it's clear that if I have any questions or comments about how and what to do, from a 60601 perspective, I'm coming to Leo from now on." And... But, I guess, on that topic, talk to me a little bit... Share with me and our audience a little bit about what's the difference between getting approval to a standard like 60601 versus a 510(k) or a CE marking, and things of that nature, what is... How... Explain a little bit of the relationship of all of these things together.
Leo Eisner: Sure. So 60601 is one part of putting a technical file together for the MDD, or design dossier, or putting a 510(k) together, but it's not just electrical safety, it's more than electrical safety, that's what everyone thinks of 60601. The first thing that comes to mind is, "Oh, it's an electrical standard, so it's electrical safety," but it covers mechanical safety. There's tons of labeling involved in the standard, more than most people would think, there's risk management involved now, in third edition, which I'll talk about during the webinar a little more, and there's... It's a heavy-duty standard, it's about, front-to-back, 400-500 pages long, so there's a lot of detail. And one of the problems with 60601 that drives everyone nuts, including me sometimes, is it jumps around, it doesn't have all the requirements in one spot, it says something, then says, "Go see somewhere else," and so that takes some extra effort to understand that well.
Jon Speer: Yeah. Yeah. And do you have all that standard memorized? [chuckle]
Leo Eisner: No, not totally, but I do know a lot about it. [chuckle]
Jon Speer: Probably it's fair to say that if I had an electromechanical device of any kind, I can come to you and you could, once you understand a little bit more about my product and its indications for use, and the type of settings that the product would be used in, you would be able to provide a lot of guidance and direction for me as to what parts and pieces of a 60601 I need to worry about and why. I'm guessing that's probably a fair statement, right?
Leo Eisner: Yeah, that definitely is. So one thing that I should add to the comment for before was, the 60601 series of standards, and the collaterals, and all the particulars, which I'll explain again more in the webinar, in a really good slide that shows sort of visually what that means, there's more than electrical, mechanical safety, there's the usability standards, there's alarm standards, there's the EMC standard, which I have a couple of experts in my group that know EMC really well.
Jon Speer: Very cool.
Leo Eisner: They've designed labs and stuff, so they're great go-to people. And then there's home use, if your product's home use, which means anything outside of a clinical environment. So outside of the hospital, the doctor's office, the clinic, the Surgery Center, that would be a home use device, even though that wouldn't always be in the home.
Jon Speer: Right, right. Absolutely, and you hit on a few things that I think are very important and something that's... Seems to be hitting a lot of medical device companies these days, as kind of... We'll say new, although some of these things aren't really new, but usability, that's important. Home use, 'cause I think there are a lot of technologies, wearables and other technologies, that are looking to get into the home. I think that's a big challenge that a lot of companies are trying to tackle is, trying to keep patients or consumers of healthcare devices and products in a home environment, but there's obviously a lot of challenges that one has to deal with if you're... There's a lot more... It's a lot less controlled environment, electrically speaking, than if you're in a hospital setting, right?
Leo Eisner: Most definitely. Home use, like you said, the environment of the home, if you're looking specifically at a home, some have air conditioning, some don't. Many homes around the world don't have grounds, which is a big issue that it was a three-year fight in the development of standard, that unless you're permanently installing with professional electrician, you can't use the ground or rely on the ground. So a lot of products that were designed for the clinical environment that have a ground, now have to pull a ground out, and that's going to affect their AC at a minimum. So it's a huge redesign, I've dealt with several companies on that specific issue, and that's taken them six months to get over sometimes, to deal with...
Jon Speer: Yeah, yeah. The other thing that tripped me up a while back on a device that I was part of is the ambulatory environment, that's also potentially a problematic area because of just being in the field and things of that nature. Also similar sorts of issues, I would imagine, right?
Leo Eisner: Yes, and that's the fairly newly released 60601-1-12 standard. That's for emergency medical services environment, and the scope is very specific about that environment, and it's even more harsh than the home use environment.
Jon Speer: We had a device that, every time we were doing the... We were doing through some pre-screen testing at EMC, and... Oh my God, and ESD. So there's a few areas that seem to be challenging, from a device perspective, and I'm sure there's a lot of parts and pieces in it, and I'm sure you have a lot of advice. Talk to us a little bit about what those steps are in this process. I've got a device, I want to get it to market, it's an electronic device, I'm going to have to go through this testing at some point in time, but there's a lot of things that I can do to prepare myself for success when it comes to the formal testing, a lot of things I can do to prepare myself for my regulatory submissions and so on. So talk to us a little bit about what those steps might look like, and how I can do things the right way to streamline my timeline and my efficiency, and not have to go back to the drawing board over and over again, 'cause there's... You and I can both share a lot of stories, I'm sure, where we didn't do it the right way, and... Or know of people that didn't do it the right way, rather, and that's painful. Talk to us a little bit about that preferred process, best case scenario.
Leo Eisner: Talking about painful, I had one client that went to the wrong test lab.
Jon Speer: Oh, yeah?
Leo Eisner: And the test lab just didn't do a good job, to put it nicely. They went to Notified Body, and they had like, I don't know, 5 or 10 page report just on the 60601 aspect that I had to help him recover from it. It took him about six months to get there, 'cause they had a lot of redesign to do, 'cause they didn't think things through, and that's critical, knowing...
Jon Speer: Yeah, that's step one
Leo Eisner: Knowing what test lab... Yeah. So there's a lot of steps involved, 15 or 16, so I'm not going to touch on them all, because we just don't have the time today. So I'll talk about a couple of them. The first thing after you know all the steps, because you can't do it before, is put a project plan together. Who's doing what, what resources are you using, how much money, what are your expected times, including testing time, pre-testing time, etcetera? Put that in a plan, give yourself some buffer, 'cause there's going to be bumps in the road. Even if you have a perfect project, the lab's going to give you some questions, guaranteed. I've never come through a project without the lab asking questions and sort of stopping the clock of the test time. So that's really important, to give yourself at least a two to four-week buffer on testing, if you can, sometimes that's not possible. You need to know upfront, once you get into the project, what standards apply, 'cause if you pick the wrong standards, and you go to the test lab, and they say, "No, you need to test these others," you're not going to be ready for it. That's pretty important. Once you know the standards that apply, I always... How I determine that is, I look at the scope and the definitions that are in the scope, and that pretty much tells me, does this apply or not to my product?
Leo Eisner: Sometimes you have to go searching on the web, through the IEC and ISO websites, to figure out what are the the applicable standards. Next, I try to classify my product, especially to the 60601 standard. There's very specific clauses that apply, usually clause six. And there's a couple of other elements like, is the device portable? Is it transportable? Is it mobile? Is it permanently installed? Those definitions are critical, because it affects your test lab, what tests are you going to have to do.
Leo Eisner: So the next step I do is usually put an isolation diagram together. I do that as early in the project as possible, if not even before the project, because without that, if I design it, the product, and I don't match the isolation diagram, I'm going to have to re-design my product or I'm going to have to redo my isolation diagram, and sometimes you can't. Sometimes there's certain things that are locked in, like your power supply is usually pretty locked in by the time you start a project. Usually, a lot of people who use power supplies, auto switchers, that's usually pretty good as long as they meet 60601, if you need that, sometimes you don't. It depends on where your part of the product is versus the patient. That gets pretty important.
Jon Speer: And Leo, while you're going through this, you mentioned that there are 15 steps in this process, and I just want to remind our listeners that you're doing a full webinar on all 15 steps to get approval to IEC 60601, so we'll make sure that, in the text that follows or accompanies this podcast, that there's a link to access that webinar and sign up for that webinar. So you're just hitting the highlights for us today, you're giving us a teaser, so I just want to make sure the audience is aware of that.
Leo Eisner: Great, thanks for the reminder, too. So I mentioned sort of early on that picking the right test lab's really important. So that's one of the steps is, determining what are your requirements for a test lab? Do you need a local lab? Do you need one that can turn something around quick, and you don't care where it is? Most people, for EMC, do local. I've rarely done EMC testing away from where the client is, but safety testing clients sometimes will ship it to other locations, so you need to, obviously, obtain one or more quotes, figure out what the pluses and minuses, which... That's one thing I do, I help my clients understand what are the strengths and weaknesses of the labs, which they don't always know coming in, which is really important, I think.
Jon Speer: Yeah, I'm sure. Can we pause there for a moment? I have a couple of thoughts about that that I wanted to kind of tease out and ask you a bit about, is that okay?
Leo Eisner: Sure.
Jon Speer: Yeah.
Leo Eisner: Yeah, of course.
Jon Speer: So like labs, so explain the difference between... And I get these confused sometimes myself, but there's NRTLs, and then there's just regular safety testing labs, and then I might do some work like pre-screening and things like that. Can you talk about some of the different types of labs and help us understand some of the criteria that we need to understand so that we can choose wisely?
Leo Eisner: That's a really good point. So NRTL stands for Nationally Recognized Test Lab. It's specifically for the US, and it's administered through OSHA. So I guess over 30 years ago, METLAB sued the US government, saying, "You can't have, in the National Fire Protection Agency code, the Electrical Code, NEC, NFPA 70," which is the National Electrical Code, "UL Listed." It used to say Only UL Listed, now it says something like, Listed and Approved, or... They made it more generic. So METLAB said, "UL can't be the only lab in the US that's okay for that."
Leo Eisner: So METLAB won that suit, and now there are NRTLs. NRTLs are basically test labs that have been approved through OSHA's auditing of the labs, that they meet certain criteria for test labs, they have the right equipment, they have the right knowledge for doing testing under certain standards. So in the US, for the 60601 series of standards, what NRTLs are allowed to do is either third edition with amendment one, or the UL 60601-1, which is the second edition equivalent, it's the US National deviations, but they're not allowed to do third edition testing. So that's one really important point if you use NRTL. If you use NRTL, you're in pretty good shape going to the FDA, typically. FDA looks for a lab that is at least accredited to 17025, which is the ISO standard for auditing labs, so you don't have to use NRTL to go to FDA.
Jon Speer: NRTL, NFTL, just to make sure we're all speaking the same language.
Leo Eisner: Yes, I'm sorry. [laughter]
Jon Speer: It's okay. No, it's okay. It's good, it's good, it's easy to understand. Just want to make sure we're all speaking the same language, that's all.
Leo Eisner: So that's Nationally Recognized Test Lab, or NRTL.
Jon Speer: Or NRTL. [laughter]
Leo Eisner: Yeah, or NRTL. That's what I've grown up saying for however many years it's been around. So NRTL, or a lab that's been accredited through 17025 in one way or another, which, there's several accreditation methods outside of the NRTL, are acceptable. In the US, the NRTL's probably the easiest way to go. We got UL, CSA, METLAB, Intertek, SGS, TUV, most of them are NRTL, even Nemko, which is a smaller lab, but they're a good lab in San Diego area as well. What was the other part of the question? There was one other part.
Jon Speer: Yeah, the other part of the question, I mean, I go to the NRTL when I want that testing that I need to have to support my submission, that NRTL is going to be an important component, but I might be using other types of labs before I get to that final certification testing. I might be doing some pre-screening, or I might be doing some preliminary work. And so how and when should I choose those types of labs and how do they work with the NRTLs?
Leo Eisner: So pre-screening typically means EMC pre-screening from what I've seen over the years. And that's a good thing, because if you have a box without a ground especially, you're going to have more of a challenge than with the ground, because the ground provides some EMC protection for your unit so it doesn't radiate noise out as much. So pre-screening for EMC is a good thing to do. NRTLs typically are not doing EMC testing, they're doing safety testing. So an EMC lab is also fine, doing pre-screening you might be able to use that same EMC lab for your full testing. The one thing I warn most of my clients is that EMC labs, some know medical really well, and there are a lot that don't.
Jon Speer: Yeah, right.
Leo Eisner: And knowing that going in, can be a real eye opener, and asking the right questions can help you save a lot of money and time. 'Cause it's easily $5,000 to $10,000 for EMC testing for 60601, and that's third edition of 60601-1-2B and C standard, where fourth edition probably is more expensive, because there's more involved testing. The fourth edition for FDA now is due, I think it's December 31 of either the end of 2017 or 2018. They moved the date to line with Europe, and I need to look up that date. I don't remember that off the top of my head.
Jon Speer: Well, I'm sure you'll have that dialed in for the webinar, but that kind of raises yet... I mean, there's all these twists and turns, and I know we're not going to cover every single twist and turn, but you know...
Leo Eisner: You think? [chuckle]
Jon Speer: A couple years ago, we're like, "Oh, well, China is still accepting the second edition, but everywhere else in the world is third edition," and now we're at the stage where, "Well, third edition, and soon it's going to be fourth edition." So it really kind of leads really another... It really emphasizes that point of planning is important, but it's also another point that this is why companies and people like you exist. This is why Eisner Safety Consultants is around is because you can help provide guidance and direction and help navigate or at least help with the planning process, if I'm not mistaken, right?
Leo Eisner: Oh, definitely, I can help from nuts and bolts, all the way through doing the whole project. Depends on what the client needs. And I try to work with them to get what they need, 'cause sometimes they have some of the knowledge and other times they're going, "What 60601 mean exactly?" [chuckle] Starting from, "I have no idea what that number is."
Jon Speer: Yeah, well, and I'm sure that you have dealt with this many times. I worked on a project a few years ago, came in kind of mid-late in the efforts, and I asked somebody the question, like, "Hey, have you done any work on 60601?" And they looked at me like I had monkeys flying out my rear, you know. But it was confusing for them 'cause they didn't even know what it was, and they were planning on submitting a 510K within just a very short period of time, and that ended up kind of a challenging exercise, because we had "a final design of a device" and we were just beginning the IEC efforts. And actually the IEC efforts, at that time for that project, ended up being the gating item to hold up our 510K submission, and we had issues, we had challenges. We had to deal with some, couple of EMC issues, and then we had to deal with some ESP issues, and we got to the point where we were spraying the inside of a plastic enclosure with conductive paint, and then we were wrapping the boards in kapton tape, and we had all kinds of issues on this thing. And I was like, "Wow, this was really painful," and, "Wow, it would have been great had we known, the company had known about this sooner and started dealing with that sooner and actually implemented some of those steps earlier in the design process." So talk to us a little bit about that. What can I do early? When should I start? When should I contact somebody like you to help provide some guidance and direction?
Leo Eisner: So what tends to happen is people call me too late. In reality, as early as when you're starting to design or think about your product development, you should start thinking about planning, as early as alpha and beta design, not a month or three months before production, 'cause you're just not going to get there in time if you have issues, and unless you know the standard well, you're going to run into issues. Almost guaranteed. I won't say always, but I'd say most of the projects I've seen, there's always issues. I've had many clients where it's taken months and months to get them to redesign the product to even get close to meeting the standard, and then going into testing. And testing can take 6 to 12 weeks easily, just for the basic 60601 standard, depending on the product, and then whatever additional standards apply.
Leo Eisner: Another really critical step, especially with third edition, and amendment one of third edition, is the essential performance of the device. What are the clinical functions that, if the product falls outside of those functions in range or stack, that becomes essential performance? Because the failure of that clinical function is critical to the device. You need to know that because that affects your test plan. So knowing that impacts the test plan. The other thing is, there's this risk management file thing that is a royal pain in the paperwork backside, is a nice way to put it. I've recommended to clients, if they're going in for the first time doing it, it's going to take one person about a month of their time to put this risk management file paperwork together, and that's after you do your ISO 14971 risk management process in general, because you're going to feed back into the risk management process, the 14971 process. But the compliance statements in the standards say, "In at least 100 instances, compliance is verified by reviewing the risk management file against this mechanical hazard issue or this electrical shock issue or this labeling issue or whatever other issue there is." So you have to have that done before you really do your test plan. Both the essential performance and risk-management file really should be at least well-defined, if not finalized, before you do your test plan.
Jon Speer: Yeah, absolutely, absolutely. And that's one of the things that we talk a lot about at greenlight.guru when we talk to med device companies, is how important risk management is to everything that you're doing these days. I mean, you mentioned ISO 14971.
Leo Eisner: Hugely.
Jon Speer: Obviously, for those that have listened to other podcasts and webinars and read our content, obviously you're probably aware that ISO 13485 has been revised to the 2016 version, and that standard too is also putting a much heavier emphasis on risk management, and...
Leo Eisner: And many other standards too.
Jon Speer: Of course.
Leo Eisner: The bio-compatibility too.
Jon Speer: Yeah, 10993. Obviously 60601. I believe, 62366. I'm rattling off a lot of numbers, folks. Don't worry about memorizing what all these are. You can search them, but all of these things are the chance. 60601, 62366, 10993, these are all standards that you should be... There's others, but those are all standards that you should be familiar with if you're developing a medical device, because there's a good chance that they impact you in some way, shape, or form. And guess what? They all point to risk as a key foundational component.
Leo Eisner: Yeah.
Jon Speer: Well, Leo, I know you've done a lot of work, a lot of homework, frankly, that I don't have to do because you've already done it. And you've got reports and documentation, and you're very active in the standards community, but you've got this annual standards trends report. Talk to us a little bit about that. I know that's something that you're going to go into more detail also on the webinar, and I believe that's something we're setting up to provide to listeners and participants at that webinar too, but talk a little bit about what that is, and why I would want that type of information.
Leo Eisner: So I had a great example come up today. I got an email from someone that's read some of my blog posts and articles, and asked me a question about third edition and FDA. And I looked at their website and I realized they are a medical device robot. And that's a standard that hasn't been developed. Well, it's not published yet, but it's one that's in process, along with some technical report, which is a guidance document on degrees of autonomy.
Leo Eisner: And so that company, I told them, "Hey, you should look into this product," 'cause what I'm doing is giving advance warning of what standards are getting developed, what are getting published or recently published, all in the 60601 series, but also in the supporting standards like 62366, the usability; 62304, software life-cycle process; TR 60601-4-3, that's the interpretation guidance for 60601, which I'm on that committee. I'm on a bunch of 60601 committees, a convener of a standard, so I'm very involved. And I was in Frankfurt a couple weeks ago, for two weeks, for all the standards that... Right now, we're having annual meetings, we may go to once every year and a half; we're debating that right now.
Leo Eisner: So, I'm involved in TC 62, SC 62A and D, which are all... Some of the committees that are involved in the particular standards, the collateral standards, the general standards. Amendment two is already in process and should be published in 2019. If you want to find out more on what's going on with that, that's part of what I'm doing in these reports. Last year I wrote two reports, one for medical-electrical equipment and systems, so more general, and then one for home use, because it's an exploding market, and I had a specific client for that. And both of those reports were about 50 pages each. Lots of detail what's going on in the committees, not just what's public information.
Jon Speer: Yeah, that's good.
Leo Eisner: So if you want to be able to strategically design your product and know what's going on by the time the standard's published, you need some reconnaissance. Do you want to spend the time and money to sit in those committee meetings and pay all the travel expenses, pay all the National Committee fees, which for big companies is ridiculous. It could be hundreds of thousands of dollars. I'm already on those committees.
Jon Speer: My answer to that question, Leo, is no. I want to call you, because you've already done all the homework, and you can be my guide through this 60601 jungle that I have to deal with. And let's... Don't miss the topic. I mean, 60601, of course there's a lot of things that are involved, but let's make sure everyone understands how important that is, because this is about electrical safety. So pretty a big deal when it comes to patient care, and I think sometimes we might lose sight of those things. We might hear, "Oh, I got to do this. I got to go by the standard because the FDA is requiring that I do that." But really, it's more than that. It's making sure that your product is safe, and I think that's a thing that we need to make sure everybody listening to this today and who are dealing with medical device product development realize that all of these things, standards and so on, have evolved over time to ensure that your product is safe. I think that's a really key point.
Leo Eisner: Yeah, and one good example would be that software has become a very big deal. And all these stories in the last couple of weeks about hackers and medical devices has become even a bigger deal. That's part of the safety of the product, and that's some of the standards that are being developed or have been developed. So if your product is networked to a network, there are standards for that. There are standards for software. Cybersecurity is being discussed very at length at this point, so that's sort of bubbling up. I don't think there's anything written within our series of standards yet, but definitely very serious discussion about it, because it's become such an issue that it can affect patient safety. And there was an article today in the New York Times about cybersecurity and safety, and not about medical products, but about how there could be a mass hack of hundreds of thousands of homes all at once.
Jon Speer: That's crazy. That's really crazy.
Leo Eisner: And home use products being in the home for medical device, is going to be impacted by that, potentially. And there's a paper releasing the details, which I was little leery of, because why do you want to release the details? So the hackers can do this? That bothered me a little bit.
Jon Speer: It bothers me a bit, too. But conversely, I've talked with companies from time to time, and they're like, "Oh, that home use standard is a lot more rigorous. And it's going to mean more time, it's going to be more expensive, it's going to mean more testing. I just want to do the standard in-hospital environment-type testing," but they know full well that there's a very good chance the product is going to be used in the homes. So folks, I can't emphasize...
Leo Eisner: Risk management.
Jon Speer: Yeah, exactly.
Leo Eisner: FDA's going to look at your risk management, and... Oh, actually, under the new medical device regulation, you have to look back at all your vigilance and incident reports for the past year and report back. I forget the organization they're calling it, under the MDR, that says, "I've reconsidered all this, put that into my risk management system, updated it, updated my technical file, design dossier," whatever they're going to call the document, and boom, you're going to get hit by it anyway. So you might as well do it upfront and be smart about it. And the home use market's exploding.
Jon Speer: Yeah, it is.
Leo Eisner: That's why I'm focusing on the home use market as one of my areas, and I'm involved in quite a few committees on home use for medical devices as well, 'cause I see that as just a huge market that is exploding.
Jon Speer: I do too. I do too. And Leo, I know we can go on and on, but I am curious. You mentioned attending the event in Frankfurt a couple weeks ago on the 60601 Standards Committee. And I'm curious, what was one of the biggest topics of discussion that the committee had that those of us in the med device community should be aware of?
Leo Eisner: Well, the first thing is probably amendment to the third edition. It has started in earnest now. We had a vote on, I think it was 500-some odd items. No, I guess it was about 200 items, and we whittled it down to about 150-ish items, I think, that are going to get worked on in the next two and a half, three years. That amendment two is going to get published. That also is going to affect all the particular standards and most of the collateral standards.
Jon Speer: Wow.
Leo Eisner: So it's going to be a huge impact, because every time there's a rev to a standard, it impacts manufacturers. And every country adopts those standards at a different pace. As you mentioned, China was still on second edition, I believe, which I need to double check. I think they're still on second edition, going into third edition. The other big thing which you brought up briefly in our call is fourth edition of 60601-1 is on the books, to be done by 2024, which sounds like a long time away, and some people are going to retire by then. But there's a lot of other people that are going to be hugely impacted by it.
Jon Speer: Yes.
Leo Eisner: 'Cause it's going to be a redesign of the standard. They're talking about writing a design spec and maybe making it a database standard, which scares the bejeebees out of me.
Jon Speer: Yeah.
Leo Eisner: 'Cause that would mean they would put all the particulars and all the collaterals together as one database.
Jon Speer: Wow.
Leo Eisner: That's going to be really expensive for manufacturers, and I'm against that. Because the cost of standards are ridiculous as it is, and there are sources that are, some a little cheaper than others, but it's a huge expense for manufacturers.
Jon Speer: It sure is. It sure is. Well, Leo, I appreciate you sharing a little bit of insight today with our audience at the Global Medical Device Podcast. I want to remind our listeners again that Leo is providing a webinar here soon on the topic of 15 steps to get approval to IEC 60601-1, 3rd Edition, plus amendment one. So be sure to check that out again. There will be a text accompanying this podcast to give you the link and the information for how to participate in that event. I want you to realize that... Obviously, hopefully you picked up today that this can be a challenging area to navigate and fortunately for you, fortunately for me, we have a guy like Leo Eisner, the 60601 guy, at Eisner Safety Consultants, who has already done all the legwork and the homework, and he's involved in all of these committees. So when in doubt, when you have questions, pick up the phone, get a hold of Leo at Eisner Safety Consultants. Look him up on the Internet. I know he's at Twitter at Eisner Safety, and that's E-I-S-N-E-R. Leo, how else can people get a hold of you?
Leo Eisner: My website, eisnersafety.com, or they can give me a holler at 503-244-6151, or shoot me an email at email@example.com.
Jon Speer: Yeah.
Leo Eisner: Leo at E-I-S-N-E-R-S-A-F-E-T-Y dot com.
Jon Speer: I encourage you to do it, I mean, the phone call, the conversation is likely going to save you a lot of time, effort, energy, a lot of headaches. Leo knows his stuff. Check out Eisner Safety Consultants. And again, Leo, thank you for giving us a few insights today and...
Leo Eisner: And thank you, Jon.
Jon Speer: Yeah, we look forward to your webinar here soon. So, ladies and gentlemen, as you know, greenlight.guru is all about providing you with guidance and direction and helpful tips and pointers as you continue your journey of designing, developing, and manufacturing medical devices. We always want to hear from you. If anything that we're doing is applicable to you, share that with your friends and colleagues. If there's something you want us to tackle and talk about, just drop me a note, and we'll be happy to cover that on blog posts and podcasts and webinars. Again, this is Jon Speer, the Founder and VP of Quality & Regulatory, at greenlight.guru, and you have been listening to the Global Medical Device Podcast.
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Nick Tippmann is the Chief Marketing Officer for Greenlight Guru, a MedTech Lifecycle Excellence Platform (MLE) that provides an industry-specific solution to help medical technology innovators around the world use quality as an accelerator to move beyond baseline compliance and achieve True Quality. Tippmann is...