MedTech Expert Explains Medical Device Reprocessing Validation | Pressure Tested

Hello. My name is Enrico Allegra. I’m the Director of Operations here at Test Labs. I’m an expert on reprocessing validation, and today I’ll be pressure tested.

So today, I’ll be answering some questions.

The first question today is, what is reprocessing validation?
Ideally, reprocessing validation will prove that your cleaning, disinfection validation have been safely demonstrated, and
they’re basically good to use. Ideally, what you want in your validation is that the end users can follow your instructions, and ultimately, they’ll feel safe to be able to use your devices again.

The main goal, again, will be to ultimately have a consistent way of reprocessing your device, which eliminates all contamination. And again, we want to make sure that the end user is happy that those instructions are being followed and they can be reused onto the next patient when handling your device.

Second question is, how long does it take?
So, the reprocessing validation, always going to say this a lot today, it depends, obviously. But ideally, we can say, look, it could take four to six weeks, we say, but it does depend a lot on your devices. So a lot of devices can be quite complex.

Cleaning can be quite tedious sometimes. So we’ll work with you to make sure that we create a plan that fits your purpose. Most of the time, we can try and streamline some of the testing to ensure we meet some of your deadline. But ideally, most of the time will depend on the complexities of the devices, how many devices are we handling. So that roughly should give an indication of how long it takes.

How many samples do I need?
This is probably one of the hot questions I always get asked by our sales team. How many samples do we need for our reprocessing? And I always reply with my usual, “It depends.” Well, how many test items do they have? Are they going for an FDA approval? Are they going for an MDR approval?

So it does depend, but there are some guidelines out there that we normally refer to. There’s really good standards, AAMI ST98, which we refer to, and normally gives an indication that you need three data points per device. So ideally, a minimum of five devices per test item, basically, will be what we require to the test. The more we get, the better, because that means we can do multiple tests at the same time, i.e., we can make the whole process smoother and quicker for you as well. So, I guess my final answer would be, give me as many as possible and that will solve the problem. So additionally, we do know the sample and manufacturing samples can be challenging for some manufacturers, so we’ll work with you to ensure that we give the best solution. So we’ll create a protocol and a plan that fits what you can give us. Therefore, we can work together on your current challenges.

So what’s the biggest risk in reusable device validation?
Look, ultimately, we always say it’s the complexity of some devices. So some manufacturer may not consider or take into consideration that some of the devices are very complex. So when we are performing some of the validation, some of the devices may pass, no problem, but because of the complexity, physical of some of the devices, some others may fail the validation. So we always say the actual structures and how many lumens, for example, or how many hinges your devices have may have an impact. So always consider that when you are creating a worst-case selection, when you’re creating your plan to do your reprocessing validation.

So, next question would be, what data do regulators question the most?
Again, a really good question, actually. I will always say different regulators may focus on different aspect of your reprocessing validation. If you are going for an FDA approval, if you’re going for an MDR approval, may have slightly different pushback, but ultimately, the data is what they’re always going to question you on. So, i.e., has your report been fully performed and validated by competent laboratories? Do the equipment that have been used in that process have been fully validated? And ultimately, have you got justification to say why have you chosen a certain approach on your reprocessing validation?

Remember, the report is only one part. You’re always going to have to have a second document to justify why you’ve chosen a certain path for your reprocessing validation. And if you show that to regulators, they’ll be very satisfied and be probably less question for you at the end of the day.

Next question is, what’s commonly missing in IFU for reprocessing?
It’s a tricky question. Sometimes it’s the opposite. There’s too much information rather than missing. But I would say two main points. Sometimes, manufacturers have too many options on their IFU. Therefore, it becomes a bit too vague. So you may say you can reprocess my test item with a manual cleaning, a disinfection, or an automated. And sometimes you have too many options, and those too many options can lead to confusion and ambiguity, especially for the end users. But at the same time, missing information such as washing, for example, temperatures or washing timing can be also problematic. Because again, the end user may get confused on how to use it, and ultimately, a regulator may push you back if they see an IFU which is too vague.

So I guess my main point would be that vague information is what can cause a problem. So make sure you have as many details as possible. At the same time, not too many details.

How do human factors affect reprocessing validation?
Imagine You’re an engineer, you’re probably amazing at your job, you love your medical device, but ultimately, there’s an end user who’s going to use it, and they’re going to find every single possible way of mishandling your test item. So make sure when you are validating or creating a reprocessing instruction, you do take into account what may happen in real life. And that could be from mishandling, from dropping, or from using different instruction, maybe even from what you’ve given them.

So your best option would be to validate what we call worst case scenarios. To make sure that real use and human factors that are affecting or may affect your devices are taken into considerations. So long procedures, for example, may have problems with the end users. So they might not follow them because they’re too long or they’re not very well explained, for example. And again, the end user may not following correctly and therefore mishandling your medical device. So make sure you take those into considerations when writing your instruction for use.

Next question. So this is more for the end users and it says, “What are hospitals struggling with most?”
Imagine hospitals are very complex environment. I think some of the main problems and regarding also the reprocessing validation the hospitals may have is trying to fit every single devices out there into what they already have validated in the sterile service department, for example, in the reprocessing department. So they do struggle sometimes with very odd or very specific IFU which they don’t quite fit into what they already validated.

And sometimes it becomes a struggle for them because they may really want to use your test item, but they now need to revalidate it on top.

So one recommendation from me would be to talk to this hospital sometimes and maybe trying to offer them some help and support in validating some extra procedures they might not have in place so that your interaction with them may be easier and maybe even help you selling a few more devices.

So next question we now have, “How do you validate real-world use cycles?”
So when we talk about real-world use cycles, obviously we’re trying to say, okay, what is the life cycle of your medical devices?

Where does it go? How does it move within a hospital environment? So it’s going from an operating theater, for example, for a surgical instrument, down to a reprocessing department where it’s going to get handled from a manual cleaning, for example. It’s going to go through some sink, some sonication, and then it’s going to go through, for example, an automated washer and eventually through an autoclave, for example. So taking all of these into considerations and making sure that when you’re replicating those processes and those stages are as close as possible to the real world will help you with getting real data.

And when I talk about real data, I mean significant data that you can use to understand, okay, what’s going to happen to my medical devices once this is actually in use.

What’s the impact of the real world to my devices?
So if you can take all of that into consideration, it’s going to give you some really good indication of what may happen, and you may even prevent certain problems along the line.

How early should reprocessing be considered?
Oh, I love this one. I would say as early as possible. Almost full stop. But the idea would be if you are designing a new, and if you’re in the early stage of device designing, I think trying to integrate reprocessing validation there and then. So trying to understand, okay, if my device had to be reprocessed, how do I, for example, create or remove certain complexities from my device design? From too many hinges or additional screws that might give you a problem along the line when they might get soiled and therefore they become very difficult to clean. So taking this consideration and how is it going to be reprocessed into your early stage and into your designing stages will help you a lot and especially will probably reduce some friction from regulators, from especially reduce cost along the line so you don’t have repeat testing. And obviously, it’s going to make the whole procedure also much smoother and quicker for you to validate because you’ve sort of already preempted some of the problems. So that would be my big recommendation.

Again, one more question would be, What is the most underestimated contamination risk?
I think this question, look, it’s a very interesting one and might almost change it slightly to what would be a big failure risk on the reprocessing validation. And to me, will be, again, complex design and ambiguous IFU and instruction for use. So your contamination may go anywhere in your devices. And very complex devices with too many hinges sometimes can pose a risk to failure. So we always recommend to create procedures and a study protocol to kind of match your device, first of all, has taken into consideration worst case conditions, and it’s sort of fit for purpose for your device. Do not overdo it at the end of the day. At the time, you can under or perform the bare minimal testing, so make sure it’s just fit for purpose for your device.

Next question is, How does material selection impact reprocessing?
So we probably all seen during COVID that everybody sort of quadrupled their amount of cleaning. And a lot of hospitals had to throw a lot of medical devices away. So a lot of them were literally melting, they were destroying because too much cleaning, too much reprocessing. There shouldn’t be such a thing as too much cleaning, too much reprocessing. It should just match your devices. But most of the time, it’s a compatibility issue.
So it’s your materials versus your Pre-processing instructions. So how compatible are they? So this should be taken into consideration when you’re selecting materials for your devices at the early stage of designing. If you know your materials in your device will have to be sterilised, you should choose materials that are compatible, for example, with steam sterilisation.

Or if you know you’re going to be manually clean and the certain specific wipes that you want to use because it just makes it easier, you should make sure that your devices and your components are compatible with that. So taking those into consideration at early stage, again, will probably save you a lot of troubles in the long run and a lot of repeat tests and a lot of going back to the drawing board to say, “Okay, what do we do now?” So yeah, big recommendation to make sure you take those into considerations.

So next question would be, what makes a reprocessing file regulator-ready?
Yes, big question as well. So obviously, look, ultimately what we say depends on if you’re going for an FDA approval from an MDR approval, but ultimately, you want to make sure that your file has answered a couple of pivotal questions. Remember, the important things about medical devices is to be able to answer some general safety performance requirement. I know this is very MDR-driven, but FDA also has a similar approach. So ultimately, have you considered all the risk associated with your device? Have you been able to answered and kind of justify why those risks have been accepted? And ultimately, have you validated your reuse and therefore any instruction that are associated with your devices?

If you can answer sort of those three question with your technical files, I’m pretty certain you will have a very easy life, or at least a much easier way of communicating with your regulator to ensure that your devices gets pushed through into the market.

So next question is, why is everybody talking about reprocessing validation all of a sudden?
Yes, a very good question, and it has definitely become a hot topic over the last few years. I do think COVID has had a lot to do with it. Obviously, there’s been a change in regulation, so we all know, especially in Europe, we’ve gone from an MDD sort of a directive into an MDR, so a regulation, and the new MDR has put a lot more pressure on manufacturers. But I do think that COVID has highlighted a lot of problem with the existing medical devices. Again, we often had a running joke here in the company that you could buy a shirt, like a £5 shirt, with a lot of instruction that tells you exactly how to wash it, how to reprocess it, et cetera. And then you have a CT scan, millions of pound, and then it says, “Use warm soapy water to clean it.” And that’s just not right.

So I do think that a combination of changes in regulations and the impact of a pandemic has highlighted that medical devices need a lot more firm and more
ad hoc instructions for their reprocessing. And I think that’s what is driving a lot of the regulators to push back and say, “Hang on a minute. You can’t just tell me your device will last for 10 years. Show me how it’s going to last for 10 years. Where is the data?” And therefore, manufacturer now are sort of, they can’t just rely a lot on hospitals, for example, doing all of this, and they need to do it themself. So I think that hopefully will answer that questions.

So the next question is, I state that my product will last 10 years. How do I validate it?
Well, ultimately, you need to almost get as close as possible to those 10 years. There’s always going to be a pushback from regulators if you state a number of years. A number of years can be vague, and by vague, I mean, imagine hospitals in Europe may use your device 10 times a day. A hospital somewhere else in the world, which could be China, for example, could use your devices 1,000 times a day. So ultimately, our recommendation is what is your real use and how is your device deployed into the hospital’s environment? And from that, you can extrapolate and say, “Look, my device is expected to be used X amount of days for X many years, and therefore, I’m going to try and validate it for X amount of uses.” My recommendation would be move away from number of years, but move closer to a number of uses. That will definitely help with the regulators to say, “Look, I now know X amount of uses would be absolutely fine with my devices. This is where I can now give you enough data because I’ve done a lot of reprocessing in a lab environment,” for example. You can back that up with your post-market surveillance and many other data that is available to you, and therefore, now you have a very robust dataset that will prove how long your devices can stay in the healthcare environment.

So the next question is, so my product has been in the hospital environment for years. They know they don’t break. Why do I need to validate it?
Yes, great question, and I tell you this. The MDR, with the new regulation, has almost tried to help some of those devices that have been in the market for a long time. They’re called legacy devices. Ideally, you know that your devices is safe, and you’ve got a lot of data from a lot of post-market surveillance that you’ve been performing. And at the same time, there’s a lot of manufacturers out there that have not got that data. So although you may have been in the market for a long time, it doesn’t necessarily means that you are fully safe. In fact, there’s been a lot of recalls over the years. There’s been a lot of issues, in particular, with reprocessing validation, which is one of the biggest risk of contamination in a hospital environment. So the justification of being in the market for a long time is not necessarily equals my device is safe to use. So I always say, make sure that you back it up with a full validation dataset from an authorised laboratories, which can help you with then moving forward and answering those questions from regulators. Ultimately, regulators are not going to accept, “I’ve been in the market for a long time.” They’re always going to accept… data and you need to back it up basically with that full data set.

Look, don’t worry, we’re here to help you. That’s the whole point of Test Labs.

The next question is, GSPR, what is it and why is it relevant to my medical devices?
So GSPR is General Safety and Performance Requirements. Ultimately, what it means is that your device can be used in a safe way, and however it’s used in the hospital environment doesn’t affect its ultimate goal, which, for example, is to improve obviously some patient’s life or whatever they may be.

So if you are a surgical instrument, for example, if I say a scalpel blade, the use of my device has to be safe, so I need to make sure I don’t cut myself with it. At the same time, if I reprocess the scalpel blade 100 times, it’s still sharp, for example, i.e., the performance requirement has not been impacted. So it’s pivotal almost to the point where MDR poses a lot of emphasis around the GSPR, where you have to prove that your general safety has been demonstrated and your performance requirement have not been impacted by clinical use, by reprocessing, and by anything that may, again, happen within the hospital environment or within healthcare settings. So GSPR ultimately is what you are demonstrating for your medical device to be safe and ready to use. And regulators will ask you that as part of your clinical validation report or clinical validation plan to say, “Okay, how have you proven or have you met your GSPR?”

So, one more question is, what global or local policies are driving reprocessing validation?
It didn’t seem to be the same in the past. It’s quite an interesting question. As much as we have regulations which incorporate different nations normally, or if you think about obviously the US is a very big state with FDA on top with some regulation to push manufacturer to perform the same, there’s a lot of local regulation that most of the time you need to follow. I do think, again, the biggest push over the last few years, and probably of the last decade, has been going back to reprocessing devices and, i.e., moving away from single use. The single use, what I would call a single use pandemic, has been affecting us for a long time. So in the ’90s, there was a massive push on single use items. There were a lot of concern about reprocessing. But we’ve moved a long way, and now we almost abuse that wave of single use, and now we sort of want to go back to reprocessing. And ideally, that will save, there’s a lot of data start pushing to save on carbon footprint if you able to reprocess items rather than single use. And one of the biggest policies that I can think of at the moment, we’re obviously in the United Kingdom, there’s a big push from the NHS. There’s almost a roadmap, in fact, called Design for Life, that are sort of pushing manufacturer to rethink their devices and moving away as much as possible from single use to reprocessing, to the point where there’s some deadline. By 2045, they’re trying to say, “Okay, how much can we cut back on single use? How much can we move back into reprocessing?” Which will eventually save money, cut cost within the NHS, for example, in the healthcare, and at the same time reduce the carbon footprint of a lot of these devices on the market.

Right, on to the next question, which is, what data do I get from a full reprocessing validation?
What is the full package, basically? So, ideally, reprocessing validation covers a few areas. So many aspect, which is, we know it’s cleaning validation, disinfecting validation, sterilisation should you need it, not all devices need sterilisation, and ultimately, its service life. So how long can my device be reprocessed, or how many times can it be reprocessed safely? A few more questions that you will need to answer is, is my device still biocompatible at the end of its service life? And do I have any residue, for example, accumulated over the course of its use within the healthcare systems? So when you perform a full validation, you will need and you will get all these answers from the various reports that you will get. So you’ll get a full clean validation report, a disinfection report, sterilisation, a reprocessing life cycle report, which will include, for example, some cytotoxicity, some biocomp at the end to prove that your device is still safe and hasn’t changed any of its adverse effect, for example, or the materials hasn’t decomposed or anything like that. So that would be, for me, the full package for reprocessing validation.

Okay. So we’ll go on to the next question. FDA and notified body, do they need the same data?
So we’re obviously talking about FDA, very known. Obviously, we’re in the US. Notified body, we are referring to Europe and, well, UK as well, so more MDR-driven. Look, ideally, it’s yes. Although they might have a slightly different approach, and may request you to perform testing according to slightly different regulation and standards. So FDA are very driven by ASTM standards and AAMI. Alongside, obviously, they do follow a lot of ISO standards.

And in Europe, we tend to base more on the ISO rather than ASTM. But a lot of these standards are very similar, and most of the requirements are pretty much the same. So I would say if you have answered all the big question about your devices in terms of safety and reusability, you will be able to basically go through both of them. So my final question is, yes, they need a slightly different approach, slightly different technical file, but the data behind is pretty much the same. So your reports will be the same. Your data that you need to support your devices will be the same for both. Right. I’m at the end of this.

I won’t deny it’s been a bit weird, first time being pressure tested, but thoroughly enjoyed. It is my topic, so feel a bit more relaxed probably talking about this than talking about something else.

Look, I thoroughly enjoyed this. Please feel free to reach out.
Again, we’re here to help, so more than happy to answer any of your questions, should you have more. And yeah, thank you very much.