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info at easymedicaldevice.com and I'm sure we can help you. Welcome to the Medical Device Made Easy podcast. I am Munir Al-Azouzi, a medical device expert specialized on quality and regulatory effects. My mission is to help you learn how to place a compliant medical device on the market. For that, I share with you my experience and the one of others on this podcast. Are you ready for your dose of regulation and standards today? So let the show begin!
Welcome to the Medical Device Made Easy podcast. Here is Munir Al-Azuzi from easymedicaldevice.com and today we'll help you to manage your alarm systems for your medical devices. This is maybe something that you think is easy to do but to... be honest, I had to do that with some customers and it's not so obvious. Even defining if an alarm is really an alarm or a signal or an alert, I mean, it's like a nightmare already. So this is something that is important for you to understand.
we will really try to help you to understand the full system and how it's working. And for that, I have with me Beate Keller from SMDC. So Beate, welcome to the Medical Device Made Easy podcast. Thank you for your invite.
I'm happy to be here again. Thanks for you to sharing all this information. And as I say, this topic is really important for people that have those kind of alarm system because the standard is a bit strict and you have some regulators that are also a bit strict. So we have really to...
put the right names where at the right places and make the right understanding. But maybe before to start, can you just make an introduction of yourself so that we have more understanding? You were already part of a previous podcast that you have done before. And now, yeah, you are coming back. another session here. Yeah, for sure. Thank you very much. So my name you already told is I'm the founder of SMDC, so Swiss Medical Device Consulting.
Before that, I was working in the engineering development of medical devices for, I don't know, much more than 10 years. And since many years, I'm also part of different working groups. working on the IEC 6601 standards family. And therefore, we thought that could be a good idea to have a look into one of these standards.
Exactly. And what is important to say, and we'll just talk about that, the 60601 is... a monster of a standard if i can say it's not when we say 6060 we think it's one standard no it's like a family of standards or a mega family of standards so it's why maybe it's important to start with that so can you maybe just explain quickly because as i said it's really mega thing so we should not take a lot of time on that what is the ic660601 yeah so the 6601-1 is this family of standards
which has these collateral standards, so horizontal standards, not only for one specific type of device, like EMC or usability alarm systems is one of them. Then we have the particulars, the vertical standards. One is for emergency care ventilators, one is for anesthesia machines, one's for pulse oximetry and so on. And the 6601-1 as the general standard, which is the main entry point for all of them. And here.
again for the scope it's for electrical medical medical equipment that are electric working electrically yep it's the 601 family is made for electrical systems not for once without electrical supply but if you have no specific device standard for your device maybe even for a non-electrical system it could be interesting to have a look at it. Exactly. Because sometimes when we try to make some tests, we don't know.
We have no standards for that. So then inspiring yourself from a standard or using a standard that is already existing can show some legitimacy for those testing that you are doing. But yeah, it's also a great idea. And don't invite the wheel again. Yeah, exactly. There is a fourth edition you told me about this standard that is coming, so maybe some news about this?
So this work started this year. So there was a large plenary meeting in the United States, I think it was, which was a kickoff meeting. And now we have a lot of working groups working on a different section of this standard and hopefully in some weeks months we get a first draft in the national mirror committees to comment. But until we have that published and available for the public will take some years. Okay. So everybody who is now just
Transition to 3.1 edition is not again tomorrow. It will take time until we get this fourth edition. Exactly. And what is important also to remember is that those standards are built by the industry, by people that are kind of voluntary to do that. It's not the authorities that are building those standards, it's really the industry that are meeting, discussing.
agreeing together and then putting that in a standard. But the authorities are not the ones that are imposing that or asking for that. So we have in Europe this harmonization where The standardization board is asked to write something, but yes, it's the industry writing the standards and not... Unearth the pulse of the MedTech world with MedTechConf.
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Exactly. Okay. So now let's try to focus on the alarm system. So as I said, alarm is a big word for a lot of things. So can you tell us more about... if every alarm that we have on our device are really needed to be tested through a standard. or if we have some alarms that have no need to be tested at all. I mean, is there some kind of rules in terms of what is an alarm, what is an alert, what is not an alarm at all? I mean, those kind of rules that are defined on the standard also.
I think that's the most important thing. What is an alarm? Yeah. I mean, there are a lot of informations, whether visual or audible, and they are not alarms. So if we have something that says, or a beep that says, okay, we started now the treatment. That's not an alarm. And if there is another beep coming up when the treatment is finished, this is also not an alarm. And if you go to the definition.
of an alarm condition in the 6601-1 it's in general then you can read there that it's always about a hazardous situation so an alarm is then when you want to inform the user or the patient, especially in home care, can also be the patient, about a hazardous situation where we need awareness or a response.
So if it's a normal situation and we hear some beeps and some sounds on some lights or whatever, nothing to test here. This is not an alarm. So no need to test, I suppose. Exactly. What you need to test is whether... The user can understand that, but this is not part of the alarm system norm, but it's a part of the usability studies you should do. So here we talked about audible.
and lights. Is there any other things than audible and light or it's only that? In principle, it's that. We also have the possibility for transferring it, so the distributed alarm systems, but in the end... it's visual or audio okay so now um maybe let's structure this discussion to first discuss about the one which is the lights, the visual alarms, and then we can go through the audible alarms. So can you maybe help us to understand more for people that have these visual alarms?
is what are the requirements and maybe what are the tricks or maybe the some tips for for that you can provide about how they can make the test or what what is really something that maybe some regulators are looking for when we are looking for those visual alarms The first thing is, can the user see it? You need to think about where is the user positioned?
And can he see this alarm light, the blinking, the LED, the light, whatever it is, from this position? And maybe if you have a treatment done with your device where the patient or... the user has to be moved or has to walk around then you need to ensure that also if he's walking one meter to the next that he still can see it because if he can't see it it does not make sense.
So there is a little combination between the use environment and the alarm signal itself. So can we see it? And then the next thing is, how does it look like? And we have. three different alarm priorities and for all the alarm priorities we have another visual indicator so for high priority alarm condition we need a red flashing light if it's medium it's a yellow flashing and low priority have a yellow or cyan non-flashing light and this colors and the flashing must be followed so
Those colors that you are describing, these colors are the ones that are on the standard. So if we follow the standards, these are the colors that we have to... I cannot use red for another... information than this kind of critical alarm and cyan also. I cannot use these colors for any other information than an alarm system in that case.
Well, the flashing, not. You can use a red non-flashing for any other warning. Okay. So if there is another warning where you need to inform the user, even if it's not an alarm. You can use the red, but you cannot use or should not use a red for telling the user everything's fine. Because for that we have a green light. Ready for use is a green light as it is defined. And as you said, we have all those colors. You said that we should visually see that.
Is there a rule also like I should be able to see that from... I remember we had some other things that said, oh, you have to see that from 30 centimeters with the light or whatever, with the right environment, whatever. So is there some rules also in terms of environment on how to... on the conditions to see that? So I think there are two different things we need to think about. The first thing is, we have the different distances, also a little bit depending on the type of device.
the standard and the other thing again is where is the user okay because if the user is two meters away from device then he need to see it from these two meters. If he's four meters away, he needs to see it from these four meters. So you need to consider both. Once the distance defined by the standard and Derek made this be different depending on your device, and then where is the user located. Just again, a precision. When you say user, if I am the patient that is on the bed,
put on the machine, I mean, on the machine, et cetera, and I'm not conscious, I'm not the user. I mean, in that case, it's more the nurse, I think, that is like the user for this kind of system. Yeah. I mean, in home care, the user, the patient may be the same. In hospital environment, it can be the nurse. And the default there is four meters in the standard. So in minimum, you should be able to. see it in a distance of four meters, the visual alarm signals. Okay, so this is also...
We talked about the standards, which is like, you have to see it from four meters. So can you tell us in that case, how should I test that? Should I just... put a person at four meters and say can you see it and then not down yes you see it so it's fine how is the protocol or process to to make this check here yeah so in in the end yes it is that you put a potential user or the test engineer in four meter distance and have a look whether he can see it. And just put the user again in.
the position where he usually will stand during the treatment or during the device is used and see where we can see it also from there. Because if he's on the other side of the device, It should also be seen from this side. Okay, so it's really usability testing. You have really to make it available from everywhere. You said the engineer also, so should I go for the real user or should I go just for the engineer that can just verify that yes, it's working?
So I think if you're verifying the distance, so can I see it from the four meters or can I see it from the one meter or whatever is required, there you can use the test engineer. But in the end, you will need a usability study also to see whether the user will see it detected and know what he needs to do. I think these are two different things the technical part and the part of the user. Okay, so this is mainly for
the alarm lights. So is there any other requirements for those alarm lights and colors? Is there any other things that are needed to be followed? So I think the next thing is I said there are different priorities. we need to ensure that you have the right priority. And alarm system standard in the dash one dash eight, there is a table, it's a matrix, a three to three matrix having on.
one side the harm potential harm in three levels and in your direction three levels of the delay how long does it take until this arm may occur And depending on this matrix, you need to use a high, medium, or low priority alarm. So if, for example, you have an alarm that says, hey, my patient is dying in the next... two or three seconds, then it's probably a high priority alarm. And if it's going to be uncomfortable in four hours, probably you should not use a high priority alarm.
a low priority or maybe even no alarm. What is the difference between a high and a low priority? Is it the blinking? Is it the light? Is it the power? What is the difference here? The color. Maybe the color. and the blinking so the high priority is red blinking medium yellow and blinking and the low priority is not blinking yellow or cyan So these are I suppose also things that users
should learn or it's maybe not obvious for them what is happening when they did that. So is there also a process where they should learn or it should really look obvious for them? I think it should be quite obvious that the red blinking is more important than the yellow or cyan not blinking ones. But yeah, in the end, you will have to show that in the usability study that he will be aware and know or can detect what to do.
Okay, yeah, just that they are not putting a fire system in place when there is nothing really, there is no really emergency here. Okay, so this is for the lights, the visual alarms. Now... What is the difference here with the audible alarm? So is there the same types of testing, high priority, low priority, et cetera? Is there the same time? It's not a color anymore, so it's a sound.
Is there specific types of sound? How is it working for this audible alarm? So there are defined beeps with defined lengths with the... repetition which is defined, the intervals are defined, the harmonics of the sound are defined. which is the basic is not really defined. So if you have a device from one manufacturer, it sounds a little bit different than from another, but the interval and the duration and so on, that's defined in the standard.
And you need to verify that in a room where you can record your audio signal and analyze it to show compliance with this table in the standard. which says how does this beeps need to look like and then again we have different beeps or or rhythms for high medium and low priority So the sound is something that is also a bit tricky because if you are like in an hospital, maybe in a noisy environment where everything is blinking, everything is ringing, everything is beeping, etc.
So what are the requirements in that case? Is there no testing to do because you have just to verify the beeps are OK? Or is there also a test in terms of the environment where this is in place? so there is a lot of a lot based on the risk management so you need to analyze that and ensure that the alarm is loud enough that you can hear it in the intended environment On the other side, in the last amendment of the standard, they included these icons.
Because what you said, one thing is we have the environment noise, like machines or the helicopter in the emergency care. But on your side, especially in the ICU ward, where we have a lot of devices it can be that we have different devices alarming so we can hear there is different alarms we can hear there is one maybe a high priority but which device is it now
Yeah. The idea of these icons is that in between of these beeps, you include an icon that shows or you have visual or audibly shows what kind of device it is.
if it's a ventilator you have the beep then you have a single inhale and exhale and then the beep again so it's beeping then and the beeping again so we can hear okay this high priority alarm we currently have is coming from a ventilator so you only have to check the ventilators and not all the devices and this may help it's currently voluntary to use it and yeah currently we're looking how this is in the in the field exactly okay um
Now, this is mainly when everything is going well. Now, let's say that I have in place my alarm system, I have the right colors, the right thing, etc. I don't know why it didn't work. So maybe the electronic system, there was a bug or there was an issue or whatever. Maybe the microcontroller was too busy and was not able to manage it.
everything, et cetera. So I mean, at the end, the alarm didn't work. So what is the situation in that case? What's happening? Because we have normally this standard that is testing alarms. So are we also testing that case where it's not working? You should also test that. But if you are in a situation where your alarm system cannot alarm, you need to have some redundancy so that you can alarm in another way.
but this alternative way must not re comply with the standard beeps so you can have another beep which is just implemented by electronics for example without any microcontroller. It sounds different, but it can alarm the user or make the user aware there is something. It sounds different, so go there and see what happens.
I suppose here you have also to manage this possibility of the alarm not working within your risk management file and define what kind of maybe... you should do to mitigate the risk do you do a testing also of overwhelming the system to verify that even when it's overwhelmed it can test or not the alarm etc so you do you have some
test also to do on the bench for this condition to to find a way to put this system at the in default and to see if it's really are reacting correctly or not? Yeah. So there mainly we have the single fault. So you should define in your risk management file which single fault conditions or which fault conditions should be tested during the 60601 testing.
And there you should describe in your risk management file, okay, we have this risk that the microcontroller is not working. Simulate that it's not working and see whether the alarm is still there. Maybe in another volume, maybe in another beep, but we still have an alarm. Hey, just a second. Do you need a EU, Swiss or UK representative? Then choose Easy Medical Device. We can represent you and also become your importer. Contact us at eo.easymedicaldevice.com
So this should be part of your risk management file, what and how to test it. Exactly. I mean, you cannot just say to a patient that maybe had a big deterioration of his health that, oh, sorry. We just had a bug on the system. It was not working. So it's not really good to say that on this type of devices. And in the end, if the device is crashing and you have a negative outcome in the patient, you...
We'll need to explain that also to the authorities and maybe recall your device so it can be expensive in this case. Exactly, yeah. I had another question about also the hospitals mainly. We have the room where there is the patient and we have this machine like the ventilator or whatever that is using or the the heart system to verify that you you are really hurt your heart is still beating or not um i suppose in that case visual or
sound is mainly for users that are in the room or close to the room of the patient. But you know that, for example, in the hospitals, you have maybe the nurses that are in one place.
and all the rooms are all over them so they cannot really have a view of all the rooms so we have those boards of alerts etc so is there also something to test on that to verify that the information coming from the room is also tested and verified and correct or is there a requirement also on the standard for that there is a complete section about that so these are the distributed alarm systems or distributed information systems so
We distribute the alarm and we don't consume it only in our own device, but we have an interface where we can send it to the nurses room or whatever. And there we have requirements for that. So like how can we detect or we need to detect when the connection is lost. We have our requirements for the confirmation. of such a receipt. So if the alarm is sent out to a distributed alarm system, this distributed alarm system should come back and say, yeah, I received it so that the.
ventilator or patient monitor whatever it is can know okay it is working and on the other side they know that something's happening there's a complete section about this topic I think it's also important for even the medical device manufacturers to, I suppose, have the way to send out this output.
to maybe a system, an external system. I don't know if there is a specific standard for communication between my device that is sending this alarm to maybe another device that is not done by another manufacturer, but there is this interdependency with the systems also that should be tested, I think. So it's a lot of... manufacturer specifics here. So there is not a standard which every device is implementing and you can transfer or distribute the alarms. So it's still
dependent on the implementation of the user. Maybe we once get a standard for that, that we have all devices using the same. What different devices are using is the nurse call. so you know this button you can press if you need a nurse if you're in the hospital and a lot of devices you can also connect to that system and this is standardized so they are all working the same way. But this is more or less a pure electronic open close of two wires. Okay.
But that's a simple thing that works and a lot of medical devices can also connect to this nurse call system. And then at least we have this red light in front of the room and in the nurse's room.
which says, okay, there is something in room 212. Exactly. Okay. So I think it covered really all what we wanted to say. Is there any... um maybe tips you want to give to those manufacturers that are having those alarm system that may be something that um authorities are really looking for or something that you should be careful of because
it's a low hanging fruit from some non-conformities during an audit yeah so saying that's also important to have a look at this everything with silencing alarms disabling alarms I mean, if I have an alarm and I'm there, I usually want to have a button or something where I can say, okay, I know it, I confirm it, and then I can do something without always having this noise.
And there are confirmation, mute, pause, and all these different status of an alarm or even a complete alarm system. And this is also something where manufacturers that have to look at it. to avoid that the alarm is too long off or it should not be and so on. So there is also some pitfalls to fall in.
exactly yeah i imagine that yeah during a stressful uh situation when we have to do something on the patient if we are hearing alarms everywhere etc it can be also more stressful so yeah having also this situation where we can shut that off and say please Let me work now. I know I understand that there is a situation. So yeah, it can be also something interesting or important for the user or the nurse to be comfortable then on her work also.
and and avoid that the user gets bored of the alarms i mean yeah true also if there is no more you are hearing and he goes the first time the second the third time the fourth time maybe Okay, it's again all this nonsense issue and the nurse is not there fast enough because the fourth package is really something. So also that's something we need to avoid.
too much alarming and in the end... Yeah, it's not working. Ignoring it. Yes. Great. So thank you, Beat. So can you maybe tell us more about how you can help the audience if they have really some need of support here?
So in one thing, it's interpreting the standard. I mean, I worked, I don't know how many years, more than 10 years with this standard. So there is a lot of experience and I know a lot of companies which are... also test laboratories we can get an accredited or cb scheme test report and then the implementation if we need or if someone needs
support in getting that implemented how to do it specify it i'm here to help so good so uh anyway i will put all your details on the show notes so the linkedin page and uh do you have a website also There is a website, SMBC. Okay, smdc.ch. I will put that also on the show notes. So, and then I will also put maybe the link to the standard, the standard for the alarm system so that people can get that also. And yeah, if there is any request, don't...
to contact beat as you see he's really knowledgeable on this uh on this standard and if you have really a project where you you need to make those testing so i think you you have the right person here in front of you uh so don't hesitate also to ask your questions on the youtube channel or on the page or also on LinkedIn. If you have the post on LinkedIn, you can just ask a question or just directly go to and don't hesitate to contact indirectly for that.
Okay, Beat, so it was really a pleasure to have you. Thanks again for all those knowledge about the alarm system. It's really important one. And I hope this will be helpful for every people that is listening. So thanks again, and I wish you a nice day. Thank you and thank you for the invite. No problem. Thank you. Bye. I'm