Gavin Stern What is the most significant challenge that you're seeing when it comes to developing effective sterilization and reprocessing instructions for use (IFUs)?

Steven Turtil The growing complexity of new devices is always a challenge. In addition to that, we also see new reprocessing technologies. Taking the two of them together, we sometimes see challenges from a regulatory perspective.

Damien Berg In talking to different manufacturers, they seem to have a good idea clinically about how an item is used, why it was designed, and the clinical application and use of it. The engineers do a great job of that, as do the scientists who work with clinicians. But there's less understanding of the sterilization process and time constraints. When they're developing these IFUs, taking that into consideration may come a little later in the game and it gets very costly for them to redesign or redevelop something that can actually be taken apart, cleaned properly, and sterilized with the new technologies that are evolving.

Loraine Durigan When IFUs are being developed, it's always in that initial stage and then when the IFU comes out, there's no follow up afterwards. There may be devices that initially would pass a standard, but later on, there may be a defect because the composition may change. That's a challenge that we see as an end user.

Janet Prust From a manufacturer standpoint, we're challenged with trying to identify a process that can be applied across the wide range of facilities where reusable medical devices are used. And, there's such a difference in the level of knowledge, resourcing, equipment that's available, and the policy regarding working with manufacturers. It's a challenge to develop an IFU that will work in an advanced sterile processing department that is well resourced and trained and then have that same IFU work in a small hospital with no full-time sterile processing staff. There's such a broad range. As Steve mentioned, devices continue to become more complex to deliver better healthcare outcomes. Trying to have all of those things come together with an effective but easy-to-follow IFU is a challenge.

There is guidance on usability testing, but there are many medical devices that don't require, from a manufacturer testing standpoint, any sort of in-process usability testing prior to launch of the product into the market. That's a key aspect to help improve the situation—testing the draft IFU with real users before it is finalized.

Loraine Durigan How to actually get back to the end user in a timely manner with updated information is also a challenge.

Ralph Basile I want to pick up on one point, which is new modalities of reprocessing, including new equipment, new chemistries, new sterilization technology, etc. That is definitely a challenge for device manufacturers to try to keep up with. Because something might come into the market that you're not even aware of and then all of a sudden you're getting asked, “Do you have an IFU for that?” or “Can you add that to your IFU?”

If you don't have validation data, you can't claim it and then you have an unhappy customer. You have to weigh the value of going out and validating for these new modalities. Are they going to survive in the market? Will they be widely adopted?

Janet Prust Prioritization and access are key from a manufacturing standpoint. Manufacturers have many active projects, so to go back and revalidate or do an assessment of some new technology may not immediately be at the top of the priority list. Especially if there isn't a significant problem and if the users of those devices aren't demanding it. Also, manufacturers don't necessarily have access to the new technology. It's often a real challenge to understand what it is and be able to do the assessment to determine if it would work with your product.

Ralph Basile That's a very good point. To add one other thing, even before COVID-19 it was getting very difficult (and now due to COVID-19 it is nearly impossible) to arrange on-site visits to healthcare facilities in order to help develop IFUs, products, and methods. It's important to partner with healthcare facilities to get feedback when developing a product, to get it in front of people who are actually going to do the reprocessing. I would love to see a portal of some kind that would help manufacturers do that, because I think it would help us do a better job writing IFUs.

Janet Prust Many hospitals or healthcare facilities refuse to allow manufacturers to come into the facility to do usability testing. Even when, for certain types of devices, it's become a regulatory and compliance requirement for the manufacturers. More and more facilities have just made it a policy to say “no,” to avoid a perceived conflict of interest.

Steven Turtil The FDA encourages users to utilize existing feedback mechanisms for voluntary reporting that will help improve patient safety. Voluntary reports about problematic IFUs may be submitted to MedWatch, which is FDA's Safety Information and Adverse Event Reporting Program. Additionally, MDRs (Medical Device Reporting) has been used to report labeling concerns. This is an opportunity that could be better used.

Gavin Stern What are the current efforts for standards and technical reports when it comes to sterilization IFUs? What progress has been made and what's still out there to be done?

Ralph Basile AAMI has a number of documents that are relevant. Damien and I are most closely involved with the technical information report AAMI TIR12, Designing, testing, and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers. That is a guidance document for ANSI/AAMI/ISO 17664:2017, Processing of health care products—Information to be provided by the medical device manufacturer for the processing of medical devices, which lays out requirements for manufacturers for their IFUs when it comes to device reprocessing. AAMI TIR12 is currently being updated—the whole effort with these documents is to increase the expectation of what a device manufacturer will provide the end user. We had tremendous input from device manufacturers, regulatory, and users. The guiding principle is to provide instructions that in fact the health-care facility can implement. This is a challenge, but from a standards standpoint, that's the number one priority.

“It's important to partner with healthcare facilities to get feedback when developing a product, to get it in front of people who are actually going to do the reprocessing.”

Ralph Basile, vice president at Healthmark

The other thing that we did within TIR12 was lay out four categories of protocols or processes that are used for cleaning with the idea that device manufacturers could validate to one or more of those processes and thus narrow the huge range of IFUs for cleaning that are out there.

Each of us as medical device manufacturers, we're in our own silo, we're trying to validate our product. And yet, down the road, another medical device manufacturer has a similar product is coming out with their own IFU. These products are may be so similar, though, that they could undergo the same processes. Working to help dwindle down the variety of variability of IFUs is one of our big efforts within TIR12.

Amanda Benedict I'm happy to provide some information about where we are with a few of the standards and TIRs related to this topic. AAMI TIR12 is bearing down on being finalized for publication, likely in the fall. On the ISO side, there are a few documents that get into information to be provided by the medical device manufacturer. Notably, there's the ISO 17664 series.

ISO 17664 was revised in 2017, and this covered information to be provided by the medical device manufacturer for the processing of medical devices. Then the working group under ISO technical committee (TC) 198 came out with a second part to the series, which covers information to be provided by the medical device manufacturer for processing medical devices, but specific to noncritical medical devices. That standard is finalized and ready to go to publication, but we're holding it to be released with a minor revision of ISO 17664 into ISO 17664-1. By the end of the calendar year, both of these documents should be ready to go to publication.

I did also want to mention that in ISO TC 210, there's a document under development that's also really close to publication, ISO 20417, Medical devices—Information to be supplied by the manufacturer, and it does get somewhat into processing. It tends to point to ISO 17664, but it does go a little bit in that direction as well.

“It's always a delicate balance between what the limit of detection is for some of these test methods, what constitutes “safe,” and what is attainable in a healthcare setting for what actually defines what is clean at any given point in time.”

Steven Turtil, biologist at the FDA CDRH.

Damien Berg The one unique thing about working with that group is that this was a very collaborative approach between end users, manufacturers, and regulatory folks. We're talking about a true manufacturers document, with the manufacturer's really sitting around the table and listening to the end users. The laboratory folks were there, too. Hopefully, this will be well received by the manufacturing industry when they're looking at developing IFUs in the future.

Steven Turtil I think that the upcoming AAMI TIR12 is quite an advancement over the previous version, with a lot of helpful information. What we would expect, and may possibly see in the future, is that some of the cleaning end points may become more refined with time just as the science and experience of doing cleaning validations and cleaning methods are enhanced with time. We would anticipate that for some devices, end points might become a little tighter, the bar might be raised—or the limits might be lowered—for what constitutes “clean” for certain devices.

It's always a delicate balance between what the limit of detection is for some of these test methods, what constitutes “safe,” and what is attainable in a healthcare setting for what actually defines what is clean at any given point in time. We anticipate that that will improve with time.

Janet Prust There's a lot of effort both internationally and in the U.S. in that area. For years, we've been asking “what is clean?” and “how clean is clean?” By tightening those end points and having consensus in a published, FDA-recognized standard, that will help manufacturers to identify the appropriate method, do the validation, and then assess the effectiveness of that validation.

Ralph Basile I wanted to add that AAMI ST98, Cleaning validation of health care products – Requirements for development and validation of a cleaning process for medical devices is also progressing, which I think is going to move the ball down the court. Janet was alluding to that and also the ISO 15883 series of documents for washer-disinfectors, including updates to ISO 15883-1 and ISO 15883-5. Part 5 is analogous to AAMI ST98 in that it will lay out requirements for doing validation of washer-disinfectors and demonstrating the cleaning efficacy of those machines. Again, that's all activity that AAMI members are actively involved with, and that will hopefully improve things when it comes to device reprocessing.

Steven Turtil It's worth noting that the FDA, as part of the standards recognition process, provides a pathway for proposing FDA recognition of any new standard, or any existing previously unrecognized standard. It's on FDA's website and available to everyone.

Gavin Stern What's the current state of regulations in this area?

Steven Turtil Our starting point is always the Federal Food, Drug, and Cosmetic Act. That dictates that a device must have labeling that bears adequate directions for use and the agency interprets that to mean that adequate reprocessing instructions be part of adequate directions for use for the devices. On top of that, we published a guidance document, which expands upon and provides a detailed explanation of that. Now we have FDA's Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling guidance document published in 2015. That guidance interfaces well with AAMI standards.

Developing effective instructions for use for processing medical devices is a challenge for a variety of reasons. For example, manufacturers have the difficult task of identifying a process that can be applied across a wide range of healthcare facilities, where levels of knowledge, resources, and equipment can vary greatly.

Developing effective instructions for use for processing medical devices is a challenge for a variety of reasons. For example, manufacturers have the difficult task of identifying a process that can be applied across a wide range of healthcare facilities, where levels of knowledge, resources, and equipment can vary greatly.

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Janet Prust We're seeing from the FDA increased recognition and the process for recognition of standards is changing, and—from a manufacturer standpoint—improving. There seems to be a clearer focus. As part of the development of standards, a goal is to have FDA recognize them. That helps manufacturers, as they're looking at and developing the validations and ultimately the reprocessing IFU.

Gavin Stern What are some of the challenges that hospital-based sterilization professionals are facing when it comes to navigating IFUs? What can manufacturers do to help?

Damien Berg Just as we stated before, the hospitals are such a challenge. I'm the chair for sterilization for the 16 hospitals in my healthcare system, and I have direct oversight over two of them. Just trying to get any two to do the same exact things when it comes to just simple policies and procedures and processes is a challenge at times, and to get all 16 on the same page on what product to use and how to use it and all this good stuff is an extreme challenge.

Having the vendors try to adjust to every hospital is a unique challenge that takes a lot of time and effort. Building those relationships is huge. In these COVID times, I leaned on my vendor friends to help me navigate some of the challenges with IFUs when we were having shortage of supplies. What else could I use? What subs could I use? If they didn't quite align with my policies, how did I handle those? We faced these challenges differently this year. Having a network, both inside and outside of your healthcare system and with vendors will really help us navigate these challenges because IFUs are just one piece of it.

“Having the vendors try to adjust to every hospital is a unique challenge that takes a lot of time and effort. Building those relationships is huge.”

Damien Berg, regional manager of sterile processing, UCHealth

One of the biggest challenges we have in IFUs, and we're addressing it with the new AAMI TIR12, is that the end users really honestly have focused on the sterilization. So, when we get an item in, the first the first things we think about are steam cycle, low temp cycle, etc. But that's far more than what an IFU is. The disassembling, the cleaning, as we've talked about earlier, is so important. So, I'm happy to see that people are looking more into the cleaning and the different aspects of the IFU other than just how to sterilize something. That is one of the challenges—getting people to read the entire IFU, which in our world, can be very complex. It's not easy reading sometimes, and it's not laid out the same way currently, and we're working on that. But I think that's the challenge, getting the end user to know that an IFU is more than just the sterilization parameters. There's so much more valuable information in there for us.

Loraine Durigan One of the things that I see at my facility is with different manufacturers that have different approaches to IFUs, it can either be too simple or it could be overly complicated. And there needs to be better standardization when it comes to that piece of it. I think we focused a lot on the sterile side of it, and I think it's fantastic and it is easy to read. But it is very convoluted when you have one manufacturer telling me how many different cycles I should have or what the time limit is for each wash cycle or the detergent I should be using that it's been validated for. That's just unrealistic in our environment.

Ralph Basile There is this tension between giving enough and stating too much. And some of it's regulatory. If it's part of your validation, it needs to be there. But there's plenty of gray area and I'll admit, as somebody who works on and reviews IFUs all the time, it's a challenge. Loraine and Damien were just sharing that even within their own health-care system, there's such diversity in understanding, capability, resources and practice. That adds to the challenge of authoring an IFU that is understandable and can be followed.

AAMI TIR55, Human factors engineering for processing medical devices, provides guidance on the application of human factors engineering principles to instructions provided by manufacturers for cleaning reusable medical devices. TIR55 is currently in the process of being reaffirmed.

Janet Prust It is important to understand that much of the focus for IFUs from the manufacturer comes from a regulatory compliance standpoint. Because if the product is not able to be cleared, the user wouldn't have access. We look at, what do we need in order to be able to get that product cleared or approved through the agency? A lot of the language is mandated with a standardized format without the flexibility to modify, to make it easier to understand.

There may be opportunities in standards development for modifying IFU standardized format, where manufacturers could also provide additional information to make it easier to understand. Maybe it's graphical instead of words.

The agency, users, and standards development processes should be able to address challenges and requirements for usability testing. For complex devices, the IFU should be tested by the people who would then be reprocessing that device. Comprehensive testing with a standardized rating would be helpful.

There are existing FDA usability compliance requirements of things to consider, no question, but then it's up to the manufacturer on how to accomplish that. Defining the key challenges for reprocessing could identify opportunities for a new standard or technical document in this area to help to address the overall challenge.

Steven Turtil I have noticed an increase in focus on human factors issues and labeling. We also have a relatively new guidance document on human factors: Applying Human Factors and Usability Engineering to Medical Devices. Perhaps this is an area where standards could fill in a bit more.

Janet Prust What exactly does “human factors” mean for reprocessing, for reusable medical devices? The interpretation for the individual manufacturer will vary widely depending on the manufacturer, what the device is, the resources applied, and the things we talked about earlier.

Gavin Stern How can sterile pressing professionals contribute to the development of more effective IFUs?

Damien Berg I've seen IFUs out there that had some interesting claims, such as using Dawn dish soap. They had valid label claims based off of what they did and what they submitted from way back when it was an older product. But working with the manufacturer, they kind of said that they didn't need to change it, but it might be beneficial for a formal FDA process to encourage the company to update their IFU. And sure enough, that's what we did. Now it's a modernized IFU, using all the correct language. That's kind of that good partnership, and it wasn't a threat. It was a more of a collaboration working with the manufacturer and the FDA.

Steven Turtil I think it's valuable to use our reporting systems and to give feedback to the companies. I'm also going to refer to FDA's 2015 reprocessing guidance document (section X. A.). That's where it stipulates that reprocessing instructions for some older, legally marketed, reusable devices may not be consistent with state-of-the-art science, and therefore those instructions may not ensure that the device is clean, disinfected, or sterile. That gives us the grounds to ask them to update their reprocessing instructions, if they're submitting a device to the FDA with IFUs based on a predicate device.

Damien Berg I think as far as the question is concerned; how can sterile processing professionals contribute? It's not just development, it's also the updating and the maintenance and all that fun stuff. It may include working with the manufacturers and the FDA in a conversation that needs to happen. I think there's good intent out there; we can just help them, particularly with older products.

Janet Prust There's power in numbers for the users. An individual facility working with the manufacturer, one manufacturer working with FDA are sort of one-offs, but I would encourage users to talk more about IFUs, present it at meetings, and publish on these challenges. It will increase the awareness and then activities can be initiated to help address that, such as new standards documents or changes within FDA or regulatory requirements. We know individual hospitals have these problems because we talk about it a lot in standards. The more users and sterile processing departments and professional organizations highlight it, make it a bigger deal, it'll get the attention that it deserves.

Ralph Basile It would be great if there was a vehicle, perhaps sponsored by one of the professional organizations, that was the portal to a device manufacturer to get feedback on their device and the ability to reprocess it from sterile processing professionals. As we were talking about earlier, it's becoming more and more difficult to be able to work directly with sterile processing professionals for a number of reasons. I think this portal or service would help device manufacturers in designing devices and in developing IFUs.

Steven Turtil I've had two experiences with family members going into the hospital for procedures and during the procedures you see technicians from the medical device companies entering the operating suite with the physician. They're seeing and they're getting immediate feedback about how the device is being used. It would be wonderful if there was a parallel to that between sterile processing or reprocessing facilities in hospitals with device manufacturers and the device designers. Can't get much more of an immediate feedback loop than that, direct information going both ways.

“a decade ago it was very easy for me to contact a healthcare facility and say, “We would like to have our designers and scientists come in and just observe what you're doing for a day or two.” Now, it's very difficult to do.”

Janet Prust, global standards director at 3M

Gavin Stern Are manufacturers doing enough to consider the input of sterile processing professionals during the initial phases of device design?

Janet Prust We spoke to this earlier, right? There is a desire and compliance requirements for manufacturers to gain user input. Are we doing enough? No. The challenge we have is, prioritization within a new product development or revalidation process. But the challenge is also related to facilities allowing us to come in for the assessment in an actual use environment. I could say a decade ago it was very easy for me to contact a healthcare facility and say, “We would like to have our designers and scientists come in and just observe what you're doing for a day or two.” Now, it's very difficult to do.

Even prior to COVID, more and more facilities have put in place policies that restrict access to users and the sites by manufacturers. The policies are put in place so that there's not a concern about a conflict of interest or a sales focus. This is one piece. The other part, and it doesn't apply quite so much to sterile processing, but it certainly does to the operating room is that there are requirements for certification and compliance by the vendor reps that come into facilities. That can be a cost concern for vendors in order to be able to get their reps qualified.

Most companies have multiple product lines and a lot of scientists, the cost can add up to become a cost and a resource issue. I like the idea that was mentioned earlier: we need a database for facilities that were willing to do usability testing. That would go a very long way in order to be able to allow manufacturers to have input from sterile processing professionals early in the process. Typically, through a product development process, it's ideal to do user testing multiple times. But again, you have to be realistic about what's really required to do that.

Damien Berg Even on our end, the end-user side, I've been contacted by many manufacturers to participate in advisory groups or different kinds of panels, and some of the healthcare systems are just flat saying, no, they don't want that. So, that's also a challenge that we face on our side. We would like to participate, but there are restrictions on our end as well. And there are legal and ethical compliances that we all have to follow in our healthcare facility. So, we're at that weird point of how do we help the manufacturers help us, and I think everybody wants to do the same thing, but bridging those gaps and making sure we're doing everything legal and right on all ends is a challenge.

Janet Prust I agree with that. Those advisory groups and advisory panels are very often the way that manufacturers can allow multiple of their developers to interface with users and ask specific questions. In my experience of organizing those, at least 30% of the facilities don't allow their employees to participate. That's a pretty significant percentage as a restriction on allowing users to participate and provide input.

Ralph Basile I'd like to end on a positive note. There is a whole lot more emphasis by device manufacturers early on in the design stage to consider reprocessing the device in a way that didn't exist in the past. More has got to be done. But I've seen a sea change in the last decade. It was like something that was not even thought of before. And now I see more and more device manufacturers making reprocessing a key consideration in the design of a device. It is something that's in consideration right from the start or early on. That's an encouraging sign that things can and will improve in the future.

Roundtable Participants

Gavin Stern, MPH, MS, is editor in chief at AAMI.

Gavin Stern, MPH, MS, is editor in chief at AAMI.

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Amanda Benedict is vice president of standards at AAMI.

Amanda Benedict is vice president of standards at AAMI.

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Ralph Basile is vice president at Healthmark.

Ralph Basile is vice president at Healthmark.

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DamienBerg is regional manager of sterile processing at UCHealth.

DamienBerg is regional manager of sterile processing at UCHealth.

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Loraine Durigan is central sterile manager at AdventHealth Altamonte Springs.

Loraine Durigan is central sterile manager at AdventHealth Altamonte Springs.

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Janet Prust is global standards director at 3M.

Janet Prust is global standards director at 3M.

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Steven Turtil is a biologist at the FDA CDRH.

Steven Turtil is a biologist at the FDA CDRH.

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