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LTR 162: Using HHE for Risk-Based Decisions · Let's Talk Risk! Podcast

• 0:00
  SPEAKER_00: Hi, everyone, and welcome to Let's Talk Risk!.
• 0:02
  SPEAKER_00: I'm your host, Naveen Agarwal.
• 0:04
  SPEAKER_00: Here we explore how leaders in medtech navigate uncertainty,
• 0:07
  SPEAKER_00: make better risk-based decisions,
• 0:09
  SPEAKER_00: and build safe and effective products to support sustainable growth.
• 0:13
  SPEAKER_00: Today, I'm super excited to welcome my guest, Keri Flecknow.
• 0:16
  SPEAKER_00: She is the Senior Manager of Global Quality at Geringa.
• 0:20
  SPEAKER_00: Responsible for their corporate-wide health hazard evaluation or HHE process.
• 0:25
  SPEAKER_00: Now, before we get started, I just want to share with you a couple of quick disclaimers.
• 0:30
  SPEAKER_00: Nothing that we say today should be treated as regulatory advice.
• 0:34
  SPEAKER_00: And everything that we are going to talk about are our own personal
• 0:37
  SPEAKER_00: and professional opinions do not reflect the opinions of our organizations.
• 0:41
  SPEAKER_00: With that, I want to welcome all of you today.
• 0:43
  SPEAKER_00: Guys, health hazard evaluation, HHE,
• 0:46
  SPEAKER_00: if you're not doing it,
• 0:47
  SPEAKER_00: if you're not aware of it,
• 0:48
  SPEAKER_00: Know that it is a wonderful decision-making tool to facilitate
• 0:52
  SPEAKER_00: and document your risk-based decisions.
• 0:54
  SPEAKER_00: And we know with QMSR, this is going to be a big issue, right?
• 0:57
  SPEAKER_00: So Keri is an expert in HHE.
• 0:59
  SPEAKER_00: She just gave a talk at a conference in Boston last month on this topic.
• 1:04
  SPEAKER_00: She has a lot of experience and I'm so excited to talk about HHE with Keri.
• 1:07
  SPEAKER_00: Sure, no problem.
• 1:24
  SPEAKER_01: So, an HHE stands for Health Hazard Evaluation,
• 1:28
  SPEAKER_01: and in the medical device industry,
• 1:30
  SPEAKER_01: it's a structured risk-based assessment,
• 1:33
  SPEAKER_01: and it's performed when there is a known or potential product issue in the market.
• 1:38
  SPEAKER_01: And its purpose is to really determine whether that issue
• 1:43
  SPEAKER_01: that you've identified is Yeah, that is a fantastic summary.
• 1:46
  SPEAKER_01: So it's a very...
• 2:09
  SPEAKER_00: Yeah.
• 2:20
  SPEAKER_00: A documented entity for the issues you have handled and made decisions
• 2:24
  SPEAKER_00: about would be pretty useful, right?
• 2:26
  SPEAKER_01: Absolutely.
• 2:26
  SPEAKER_01: And QMSR compliance is not going to be determined by whether you have these procedures.
• 2:32
  SPEAKER_01: It's going to be determined by
• 2:33
  SPEAKER_01: whether you can prove risk-based decisions were made consistently and intentionally
• 2:38
  SPEAKER_01: across the entire QMS.
• 2:39
  SPEAKER_01: And for many years,
• 2:41
  SPEAKER_01: I understand that CAPA was one of the most common
• 2:43
  SPEAKER_01: and heavily scrutinized FDA inspection findings.
• 2:46
  SPEAKER_01: Because it was a dedicated subsystem within the QCID inspection model.
• 2:50
  SPEAKER_01: But with the transition to QMSR,
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  SPEAKER_01: we're seeing the FDA place much greater emphasis on risk management as
• 2:56
  SPEAKER_01: an enterprise-wide discipline.
• 2:59
  SPEAKER_01: And so that's to say you need to be able to prove that risk-based decisions were made.
• 3:04
  SPEAKER_01: And that includes those within HHE.
• 3:23
  SPEAKER_01: So on the FDA website, you can find information and guidance related to HHE.
• 3:29
  SPEAKER_01: But there's a nuance here.
• 3:31
  SPEAKER_01: HHE is, for the FDA, it's a tool that the FDA uses to classify a voluntary recall by a firm.
• 3:39
  SPEAKER_01: And so the tool that's posted is the FDA's tool to do just that.
• 3:44
  SPEAKER_01: And if you look,
• 3:45
  SPEAKER_01: they actually post a Word document that is their template
• 3:49
  SPEAKER_01: for doing such classification of a recall.
• 3:52
  SPEAKER_01: And if you look at that Word document,
• 3:54
  SPEAKER_01: there's a section in there For the firm's conclusion about health risk,
• 3:59
  SPEAKER_01: and they explicitly say attach a copy of the firm's HHE or HHA.
• 4:05
  SPEAKER_01: And it's important to note here, Naveen, you may have picked it up, HHE, HHA.
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  SPEAKER_01: There is no statutory requirement to perform an HHE, call it an HHE.
• 4:17
  SPEAKER_01: Or do it in any specific way as we as the industry have come to know.
• 4:21
  SPEAKER_01: You must demonstrate that you've made a risk-based conclusion about health risk.
• 4:26
  SPEAKER_01: HHE is the way that we as a firm accomplish that and you can use the FDA's guidance
• 4:33
  SPEAKER_01: about what they're looking at to tailor your HHE form to your firm's specific needs.
• 4:39
  SPEAKER_00: Yeah, so Kerry, honestly, my head is already spinning.
• 4:42
  SPEAKER_00: There are so many terms, HHE, HHA, HRA I've heard.
• 4:47
  SPEAKER_00: The bottom line is this.
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  SPEAKER_00: There is no mandatory requirement or terminology that you have to use.
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  SPEAKER_00: These are terms commonly used in the industry.
• 4:55
  SPEAKER_00: It doesn't matter what you call it.
• 4:56
  SPEAKER_00: But make sure that it is a very structured, documented process for making risk-based decisions.
• 5:01
  SPEAKER_00: I think that is the message we want to give people, correct?
• 5:03
  SPEAKER_01: Absolutely.
• 5:04
  SPEAKER_01: And when we think about how do organizations approach risk in a structured, risk-based way?
• 5:12
  SPEAKER_01: Well, guess what?
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  SPEAKER_01: There's a standard for that, and it's the ISO 1497B1 standard.
• 5:17
  SPEAKER_01: And so what I find as a best practice is if you're unsure of where to start,
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  SPEAKER_01: take a look at that form on the FDA's website of what they're looking for.
• 5:27
  SPEAKER_01: But also consider ISO 14971 as the framework for your HHE process
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  SPEAKER_01: because ultimately you as a manufacturer want to be able to say with confidence,
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  SPEAKER_01: we performed a risk-based evaluation and we made a risk-based decision.
• 5:43
  SPEAKER_01: And to do that, it's really important to use a framework that's rooted in defensible rigor.
• 5:47
  SPEAKER_00: That's right.
• 5:48
  SPEAKER_00: That's right.
• 5:49
  SPEAKER_00: Guys, if you're just joining, let me welcome all of you.
• 5:52
  SPEAKER_00: My guest today is Kerry Flecknoe,
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  SPEAKER_00: and we are talking about the health hazard evaluation or the HHE process.
• 5:58
  SPEAKER_00: So Kerry, you bring up a good point about 14971.
• 6:01
  SPEAKER_00: Most people in our industry now, I think, are familiar with that.
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  SPEAKER_00: They have a structured risk management process conforming to ISO 14971.
• 6:08
  SPEAKER_00: I want to spend a little bit of time Talking about how this HHE process might fit
• 6:14
  SPEAKER_00: into the overall risk management process, can you share some thoughts on that?
• 6:17
  SPEAKER_01: Sure.
• 6:18
  SPEAKER_01: So obviously we know that ISO 14971 defines the risk management process across
• 6:23
  SPEAKER_01: the product lifecycle.
• 6:24
  SPEAKER_01: HHE, if you think about it,
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  SPEAKER_01: is just a very specific post-market application of those same principles, right?
• 6:31
  SPEAKER_01: At a very high level,
• 6:32
  SPEAKER_01: identify the hazard and estimate risk,
• 6:34
  SPEAKER_01: evaluate acceptability and control if needed, right?
• 6:37
  SPEAKER_01: And so if you think about what are the elements of the standards You can map those
• 6:43
  SPEAKER_01: to these are the core elements that I think should be in my HHE process.
• 6:47
  SPEAKER_01: What is the problem description that maps to like what are identifying the hazards?
• 6:52
  SPEAKER_01: Then identify the hazardous situations that are born out of those hazards in
• 6:56
  SPEAKER_01: the sequence of events, right?
• 6:57
  SPEAKER_01: That's part of the standard.
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  SPEAKER_01: Characterizing those harms, estimating the risk, evaluating the risk.
• 7:03
  SPEAKER_01: And then the standard talks about risk control options.
• 7:06
  SPEAKER_01: And that's where we make decisions on action.
• 7:08
  SPEAKER_01: Decisions on action of what to do with product in the market when we have
• 7:12
  SPEAKER_01: a quality issue is in itself a risk control measure.
• 7:16
  SPEAKER_01: And of course,
• 7:17
  SPEAKER_01: we have to think about risks that could arise from that risk control measure itself,
• 7:21
  SPEAKER_01: right?
• 7:22
  SPEAKER_01: We have to think about Does the risk control measure introduce any product shortages?
• 7:26
  SPEAKER_01: Are there alternative therapies if we're considering a removal retrieval?
• 7:30
  SPEAKER_01: We need to make sure any recall strategy is aligned with patient safety and public health.
• 7:35
  SPEAKER_00: I think you made such an important point,
• 7:37
  SPEAKER_00: I want to spend a little bit of time on that,
• 7:39
  SPEAKER_00: is this whole notion of the action we take in the marketplace itself being
• 7:43
  SPEAKER_00: a risk control measure, but it's balanced against the benefits of the intended use.
• 7:48
  SPEAKER_00: And you mentioned the shortage point, and that's a COVID time, we have lived through that.
• 7:52
  SPEAKER_00: There were many shortages during the COVID time.
• 7:55
  SPEAKER_00: And yeah, someone on paper could say, why didn't you remove this product?
• 7:58
  SPEAKER_00: But there is a maybe responsible way of using that potentially troublesome product
• 8:03
  SPEAKER_00: with some more care and more instructions.
• 8:06
  SPEAKER_00: So I don't want people to think that the outcome of HHE is always necessarily
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  SPEAKER_00: a correction or removal.
• 8:11
  SPEAKER_00: It could be a combination.
• 8:12
  SPEAKER_00: Thank you.
• 8:13
  SPEAKER_00: Thank you.
• 8:32
  SPEAKER_01: So this is where additional benefit risk analyses are appropriate to make sure
• 8:36
  SPEAKER_01: that any strategy is for the best
• 8:38
  SPEAKER_00: interest of patient safety.
• 8:40
  SPEAKER_00: Wonderful.
• 8:41
  SPEAKER_00: Okay, let's dig into a little more detail here about the practice of doing this.
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  SPEAKER_00: In your experience,
• 8:47
  SPEAKER_00: where have you felt people struggle the most when they have to do this analysis?
• 8:51
  SPEAKER_00: And I'll give you a classic case, and we don't have to go into details of that.
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  SPEAKER_00: If you have unknown adverse events reported from the field,
• 8:57
  SPEAKER_00: I feel like that analysis is a little bit Less difficult than
• 9:01
  SPEAKER_00: a potentially internal non-conformance that could have an implication.
• 9:05
  SPEAKER_00: Let's take these two scenarios apart.
• 9:07
  SPEAKER_00: And I would like to start with the internal non-conformance first as a signal to
• 9:11
  SPEAKER_00: the HHE process or a trigger to the HHE process.
• 9:14
  SPEAKER_00: Where have you seen people struggle?
• 9:15
  SPEAKER_01: So I have seen people struggle.
• 9:18
  SPEAKER_01: And this, I think, builds into the larger issue of P1 and probability.
• 9:24
  SPEAKER_01: And like,
• 9:24
  SPEAKER_01: what is the likelihood that we will see this manifest in the field
• 9:28
  SPEAKER_01: and have some downstream effects on it?
• 9:30
  SPEAKER_01: And I'll see you next time.
• 9:54
  SPEAKER_01: But the standard does not provide much guidance on how to work with those terms, right?
• 9:59
  SPEAKER_01: We certainly know that in assigning P1,
• 10:02
  SPEAKER_01: we want to make sure we have individuals in our organization familiar with design,
• 10:06
  SPEAKER_01: construction, use,
• 10:07
  SPEAKER_01: servicing,
• 10:08
  SPEAKER_01: an adequate understanding of the use environment, all of this for the device.
• 10:11
  SPEAKER_01: But then we need to make sure we're focusing on the best quality data that we have available.
• 10:16
  SPEAKER_01: And that may not always be complaints.
• 10:18
  SPEAKER_01: We may not get signals from the field.
• 10:20
  SPEAKER_01: So we have to look at other post-production data that we have.
• 10:24
  SPEAKER_01: Maybe we have service records for stuff that's in the field, but maybe we don't.
• 10:28
  SPEAKER_01: And we found this through internal testing,
• 10:30
  SPEAKER_01: bench testing, production, inspection, scrap, non-performance.
• 10:33
  SPEAKER_01: We need to take into consideration what can we do with products that's
• 10:37
  SPEAKER_01: in our control to get a better picture,
• 10:41
  SPEAKER_01: a high quality sort of good understanding of what's happening.
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  SPEAKER_01: And maybe that means we take lots of devices that still remain in our control
• 10:49
  SPEAKER_01: and we look at them.
• 10:50
  SPEAKER_01: Yeah.
• 11:12
  SPEAKER_01: Similarly, consider underreporting.
• 11:15
  SPEAKER_01: What happens when a defect that's usually just an inconvenience and,
• 11:19
  SPEAKER_01: you know,
• 11:19
  SPEAKER_01: somebody doesn't want to go through the complaint process,
• 11:22
  SPEAKER_01: but it does have a potential to create a severe harm in certain situations.
• 11:26
  SPEAKER_01: And so when we don't have a reasonable, well,
• 11:29
  SPEAKER_01: first of all,
• 11:30
  SPEAKER_01: you can get a reasonable understanding of the data usually
• 11:33
  SPEAKER_01: through further bench testing and internal testing.
• 11:36
  SPEAKER_01: But there are times, Naveen,
• 11:38
  SPEAKER_01: when you don't have any data to go by, when, when,
• 11:42
  SPEAKER_01: There's an absence of a reasonable understanding of the relative quality of
• 11:46
  SPEAKER_01: the data available when there's insufficient information.
• 11:49
  SPEAKER_01: And that's when conservative estimates of the probability of occurrence can be used
• 11:54
  SPEAKER_01: to give some indication of risk.
• 11:56
  SPEAKER_01: And this is where I think we get into the weeds, but we struggle.
• 12:00
  SPEAKER_01: This is where statistical analysis comes in.
• 12:02
  SPEAKER_01: Now, I'd love to give my opinion on this.
• 12:04
  SPEAKER_01: I'm not an expert in statistics by any means.
• 12:07
  SPEAKER_01: There are some very,
• 12:08
  SPEAKER_01: very simple statistical models out there that can be good estimates
• 12:12
  SPEAKER_01: when data is poor,
• 12:13
  SPEAKER_01: when we don't have signals from the field,
• 12:15
  SPEAKER_01: when we don't have internal test data because maybe we don't have anything in-house
• 12:19
  SPEAKER_01: to test and we can't get that data.
• 12:21
  SPEAKER_01: But we know that just because something hasn't happened doesn't mean that it cannot
• 12:25
  SPEAKER_01: or will not, right?
• 12:27
  SPEAKER_00: That's right.
• 12:30
  SPEAKER_01: Yeah.
• 12:52
  SPEAKER_01: Yeah, yeah.
• 12:54
  SPEAKER_00: So what I'm hearing you say, Kerry, is that yes, it is challenging.
• 12:57
  SPEAKER_00: Yes, we may not have information.
• 12:59
  SPEAKER_00: We may have to do some statistical analysis and modeling and have some estimates.
• 13:03
  SPEAKER_00: But at the end of the day, we have to make a judgment.
• 13:06
  SPEAKER_00: And that judgment involves probably looking at the situation
• 13:10
  SPEAKER_00: from different perspectives, have a cross-functional review.
• 13:13
  SPEAKER_00: And even the standard tells us that when the probability cannot be estimated,
• 13:18
  SPEAKER_00: With confidence, make the judgment based on potential severity alone.
• 13:21
  SPEAKER_00: So we have guidance that we can use.
• 13:23
  SPEAKER_00: I think that the point here is let's not get hung up on what we don't have.
• 13:27
  SPEAKER_00: Let's figure out what we know to the best of our ability and make a judgment call
• 13:32
  SPEAKER_00: whether it poses an unacceptable risk to the patient or not.
• 13:36
  SPEAKER_00: So we get into...
• 13:37
  SPEAKER_00: A little bit more detailed discussion, but guys, again, welcome to all of you.
• 13:40
  SPEAKER_00: I would love for you to participate.
• 13:42
  SPEAKER_00: Please share your thoughts, questions, comments, opinions in the chat.
• 13:46
  SPEAKER_00: What do you think about the HHE process?
• 13:48
  SPEAKER_00: Are you familiar with it?
• 13:49
  SPEAKER_00: What challenges you have come across and what best practices you can share with
• 13:53
  SPEAKER_00: the rest of our community?
• 13:55
  SPEAKER_00: Please be open.
• 13:55
  SPEAKER_00: This is a very open sharing platform and I will bring your questions and comments
• 14:00
  SPEAKER_00: to our discussion, live discussion with Kerry to the extent possible.
• 14:04
  SPEAKER_00: So I invite you to participate.
• 14:06
  SPEAKER_00: Okay, Carrie, so let's keep going.
• 14:08
  SPEAKER_00: I think that another thing I had in mind for you is in terms of just the mechanics
• 14:13
  SPEAKER_00: of like, how does it work in practice?
• 14:15
  SPEAKER_00: Let's say you have a signal or a trigger.
• 14:17
  SPEAKER_00: Let's take the scenario of a field event,
• 14:20
  SPEAKER_00: like a complaint comes in,
• 14:21
  SPEAKER_00: medical safety people say, yeah, it's reportable, it's serious enough.
• 14:24
  SPEAKER_00: Now you have the ball in motion.
• 14:26
  SPEAKER_00: Tell us how it unrolls, like what happens?
• 14:28
  SPEAKER_00: What kind of meetings take place?
• 14:30
  SPEAKER_00: Who gets involved?
• 14:30
  SPEAKER_00: What gets challenging for decisions?
• 14:32
  SPEAKER_01: I think Really, the mechanics should be up to the individual legal manufacturer entity.
• 14:38
  SPEAKER_01: I don't think it's wise for Me and corporate
• 14:42
  SPEAKER_01: to prescribe how you involve your stakeholders,
• 14:45
  SPEAKER_01: but the best practice is to involve those cross-functional stakeholders early
• 14:50
  SPEAKER_01: and often.
• 14:51
  SPEAKER_01: So we should at minimum make sure that quality,
• 14:54
  SPEAKER_01: medical,
• 14:54
  SPEAKER_01: regulatory,
• 14:55
  SPEAKER_01: if you have legal as a resource,
• 14:58
  SPEAKER_01: the top management,
• 14:58
  SPEAKER_01: these individuals should be at minimum informed of the issue that you have met,
• 15:03
  SPEAKER_01: the threshold of whatever your triggering event is,
• 15:07
  SPEAKER_01: and you will be initiating an HHE.
• 15:09
  SPEAKER_01: I think it's great to have that Working Document in a Shared Repository.
• 15:14
  SPEAKER_01: So those individuals can look,
• 15:16
  SPEAKER_01: can see, can do a sniff test of, I think we're going in the wrong direction.
• 15:19
  SPEAKER_01: I think we need to document this.
• 15:21
  SPEAKER_01: This is an important detail to include and make sure everybody has line of sight
• 15:25
  SPEAKER_01: to what's going on.
• 15:27
  SPEAKER_01: And then we have once really it's the quality R&D,
• 15:31
  SPEAKER_01: those groups that are going to be responsible for defining what is The issue here,
• 15:37
  SPEAKER_01: are there any risk mitigations?
• 15:39
  SPEAKER_01: Are there any design factors that may mitigate risk?
• 15:43
  SPEAKER_01: And then we hand it over to medical.
• 15:45
  SPEAKER_01: And it's very important that medical is independent player,
• 15:49
  SPEAKER_01: doer in this,
• 15:50
  SPEAKER_01: and they are free to use their medical judgment to perform the medical assessment.
• 15:56
  SPEAKER_01: But what's important here is that we are Always linking back to our risk management file.
• 16:02
  SPEAKER_01: So medical,
• 16:03
  SPEAKER_01: although they are independent and making their independent medical judgments based
• 16:08
  SPEAKER_01: on their experience,
• 16:09
  SPEAKER_01: we still want to make sure that the RMF is consulted and there's a connection to
• 16:14
  SPEAKER_01: the risk file so that we are ensuring consistency between severity ratings, right?
• 16:20
  SPEAKER_01: Employing a systematic way of characterizing severity levels or probability levels.
• 16:24
  SPEAKER_01: All of that is contained in your RMS in your risk management plan, really.
• 16:29
  SPEAKER_01: So the connection to the risk file throughout the life cycle is important.
• 16:34
  SPEAKER_01: And then once the assessment from medical is made,
• 16:37
  SPEAKER_01: we're comparing it back to what the firm has decided is acceptable risk and
• 16:43
  SPEAKER_01: the risk acceptability criteria for that particular product.
• 16:47
  SPEAKER_01: So these should be product specific, right?
• 16:49
  SPEAKER_01: And then we want to do another look back to the RMS because remember,
• 16:53
  SPEAKER_01: the original risk analysis is performed under assumptions.
• 16:56
  SPEAKER_01: Intensive use, foreseeable misuse, expected failures.
• 16:59
  SPEAKER_01: But HHE's provide real post-market evidence about how your device is truly behaving
• 17:04
  SPEAKER_01: in the field.
• 17:05
  SPEAKER_01: Actual incidents may reveal Failure mode is not previously identified.
• 17:10
  SPEAKER_01: User interactions and environmental conditions can differ from our assumptions.
• 17:14
  SPEAKER_01: So updating the RMF at the end of the HHE process makes sure that
• 17:20
  SPEAKER_01: the RMF is not just a one-time activity during development,
• 17:24
  SPEAKER_01: but that our post-market data is feeding back into our risk management files.
• 17:28
  SPEAKER_01: Controls are reassessed based on post-market performance.
• 17:30
  SPEAKER_01: Benefit risk decisions are documented.
• 17:32
  SPEAKER_01: And this keeps the RMF in sync with actual device performance.
• 17:37
  SPEAKER_00: Yeah, Kerry, what a wonderful map you have created for us.
• 17:41
  SPEAKER_00: I want to make sure that I emphasize a couple of key points for our audience today.
• 17:45
  SPEAKER_00: What you are telling us is that, hey, it is a cross-functional
• 17:52
  SPEAKER_00: And on this one, Kerry,
• 17:59
  SPEAKER_00: I will share with you without naming names,
• 18:02
  SPEAKER_00: FDA has cited warning letters where they found that the severity table
• 18:06
  SPEAKER_00: and descriptions in the HHE procedure were different from the severity and So guys,
• 18:13
  SPEAKER_00: make sure that you have alignment, consistency across the board.
• 18:16
  SPEAKER_00: And your last point is even more important.
• 18:18
  SPEAKER_00: Make sure that your risk management file is updated after the HSE analysis as needed.
• 18:24
  SPEAKER_00: Because if it is static, Guess what?
• 18:26
  SPEAKER_00: Next time you will not have the appropriate severity and probability numbers.
• 18:30
  SPEAKER_00: So I think this is an excellent point that you have made, Keri.
• 18:34
  SPEAKER_00: But again, guys, welcome.
• 18:35
  SPEAKER_00: Please continue to share your thoughts and questions and comments once again.
• 18:39
  SPEAKER_00: So Keri, building on this.
• 18:42
  SPEAKER_00: Now, final point I have is how do people even start to learn about this?
• 18:46
  SPEAKER_00: Big companies, I'm sure they have established procedures.
• 18:49
  SPEAKER_00: But if you are a small company and you don't have a lot of resources,
• 18:52
  SPEAKER_00: you're one quality person maybe working somewhere and And trying
• 18:56
  SPEAKER_00: to make this happen,
• 18:57
  SPEAKER_00: what would be your advice to small to mid-sized companies to put a process together
• 19:02
  SPEAKER_00: which is lean and simple and helps with the decision making?
• 19:05
  SPEAKER_01: My advice would be if you have product on the market,
• 19:08
  SPEAKER_01: having a process and a template for making these risk-based decisions
• 19:16
  SPEAKER_01: to demonstrate, hey, we didn't dismiss issues.
• 19:18
  SPEAKER_01: We looked at them objectively, systematically, made risk-based decisions.
• 19:22
  SPEAKER_01: You'll want a process.
• 19:23
  SPEAKER_01: We call it HHE,
• 19:24
  SPEAKER_01: but to your point earlier,
• 19:25
  SPEAKER_01: Naveen, your organization can call it what it wants, HRA, HHA.
• 19:31
  SPEAKER_01: But ultimately, HHA,
• 19:32
  SPEAKER_01: You as a organization needs to use your own judgment about what,
• 19:37
  SPEAKER_01: for you, would be sufficient to trigger an HHE.
• 19:41
  SPEAKER_01: Typically,
• 19:42
  SPEAKER_01: this is triggers like events that are either unanticipated,
• 19:45
  SPEAKER_01: events that are more serious than anticipated,
• 19:48
  SPEAKER_01: occurring at a higher frequency than anticipated,
• 19:50
  SPEAKER_01: information from internal testing suggesting
• 19:52
  SPEAKER_01: an unexpected problem affecting distributed product,
• 19:55
  SPEAKER_01: regulatory noncompliances, when you recognize there's a regulatory need.
• 20:00
  SPEAKER_01: So listing those triggers out,
• 20:02
  SPEAKER_01: being very clear about what they are,
• 20:04
  SPEAKER_01: having a process for ensuring you are escalating issues
• 20:07
  SPEAKER_01: that meet those triggers appropriately and timely,
• 20:10
  SPEAKER_01: and then ensuring that you have the cross-functional team in place to be able
• 20:14
  SPEAKER_01: to do this.
• 20:16
  SPEAKER_01: And then lastly, baking your decision into the end of that process.
• 20:21
  SPEAKER_01: For me, including a clear documented decision at the end of your HHE for or
• 20:26
  SPEAKER_01: against field action is critical.
• 20:29
  SPEAKER_01: It's the evidence trail that your organization didn't make an arbitrary
• 20:33
  SPEAKER_01: or reactionary decision, but you followed a structured risk-based process.
• 20:37
  SPEAKER_01: And when regulators review all of this,
• 20:39
  SPEAKER_01: they want to see how your decision was reached, not just how.
• 20:43
  SPEAKER_01: Yeah.
• 21:02
  SPEAKER_00: So just to clarify your point that,
• 21:04
  SPEAKER_00: hey, deciding not to take field action with a good rationale is perfectly fine.
• 21:09
  SPEAKER_00: You don't have to take field action, right?
• 21:11
  SPEAKER_00: So Kerry, we have a question here, which I think is an excellent question.
• 21:15
  SPEAKER_00: Who exactly does this evaluation evaluate?
• 21:16
  SPEAKER_00: Yes, it is a great question.
• 21:18
  SPEAKER_00: And so typically the legal manufacturer should be responsible.
• 21:36
  SPEAKER_01: But if you are a distributor,
• 21:38
  SPEAKER_01: you may come to recognize that that legal manufacturer is not willing or able
• 21:43
  SPEAKER_01: to take the steps that are necessary.
• 21:45
  SPEAKER_01: I think it's a good practice to have something in your HHE that says
• 21:49
  SPEAKER_01: when your firm is acting as a distributor,
• 21:52
  SPEAKER_01: you can still employ this process,
• 21:54
  SPEAKER_01: even not as the legal manufacturer,
• 21:56
  SPEAKER_01: if the legal manufacturer is unwilling or unable to perform the risk analysis
• 22:03
  SPEAKER_01: and take those
• 22:03
  SPEAKER_00: So that's an interesting point you make.
• 22:05
  SPEAKER_00: And actually, I concur with you.
• 22:08
  SPEAKER_00: It's not always a legal or a regulatory consideration,
• 22:12
  SPEAKER_00: but also business risk consideration from a distributor point of view,
• 22:16
  SPEAKER_00: that if a defective product continues to remain in the field,
• 22:19
  SPEAKER_00: they may be held liable, even though they are not the legal manufacturer.
• 22:22
  SPEAKER_00: So we are not going to go into the legal minutiae here.
• 22:24
  SPEAKER_00: But the point here is that even if you are just a legal distributor,
• 22:27
  SPEAKER_00: you have to be sensitive that the product you are shipping in
• 22:31
  SPEAKER_00: the market You absolutely are.
• 22:36
  SPEAKER_01: And I think that's the good point.
• 22:42
  SPEAKER_01: When your company is acting as a distributor of third-party products,
• 22:46
  SPEAKER_01: perhaps the defect is actually related to your firm's activities,
• 22:49
  SPEAKER_01: storage or handling.
• 22:52
  SPEAKER_01: Maybe there's marketing claims for compatibility with that third-party product item
• 22:57
  SPEAKER_01: that include combined use with one of your products.
• 23:00
  SPEAKER_01: Or perhaps, in fact, that legal manufacturer is not willing or able to carry out a recall.
• 23:05
  SPEAKER_01: And you can and should apply the HHE process.
• 23:09
  SPEAKER_01: Because all of these decisions should be made in the interest of patient safety
• 23:13
  SPEAKER_01: and public health.
• 23:14
  SPEAKER_00: You know,
• 23:14
  SPEAKER_00: now that you tell me, Keri,
• 23:16
  SPEAKER_00: I do remember seeing several warning letters and even,
• 23:20
  SPEAKER_00: no, not necessarily warning letters, but safety advisory notices from the FDA.
• 23:25
  SPEAKER_00: That involved these convenience kits or combination kits that are assembled
• 23:29
  SPEAKER_00: and distributed by distributors.
• 23:31
  SPEAKER_00: So I think the discussion is very relevant.
• 23:33
  SPEAKER_00: If your company is playing that role,
• 23:35
  SPEAKER_00: be aware that this might be a tool you can use
• 23:37
  SPEAKER_00: to document your risk-based decisions.
• 23:39
  SPEAKER_00: So Kerry, I think we have such a great conversation already.
• 23:42
  SPEAKER_00: We are coming to a close,
• 23:44
  SPEAKER_00: but there's one question I always ask from someone who has so much experience.
• 23:48
  SPEAKER_00: What advice would you give?
• 23:50
  SPEAKER_00: From a career development point of view
• 23:52
  SPEAKER_00: to early stage quality regulatory engineering professionals
• 23:56
  SPEAKER_00: who are entering this field from a risk management point of view,
• 23:59
  SPEAKER_00: what should they be learning about?
• 24:01
  SPEAKER_00: How they should be practicing it, even though it may not be in their job description.
• 24:05
  SPEAKER_00: So how can they use this type of a knowledge to advance their careers?
• 24:09
  SPEAKER_01: Yeah, that's a great question, Naveen.
• 24:11
  SPEAKER_01: I think challenging yourself to step outside of what your expertise or role is,
• 24:19
  SPEAKER_01: it is,
• 24:20
  SPEAKER_01: Within the QMS,
• 24:21
  SPEAKER_01: the quality organization is really key because these processes do not operate
• 24:27
  SPEAKER_01: in silos, right?
• 24:28
  SPEAKER_01: The HHE process is the very first step of And then, even before the HHE process.
• 24:52
  SPEAKER_01: The quality hole, the non-conformance, all of those, all these processes work together.
• 24:58
  SPEAKER_01: And so just exposing yourself and being thirsty for knowledge
• 25:02
  SPEAKER_01: in those other areas is, it will really help your perspective.
• 25:05
  SPEAKER_00: Wonderful.
• 25:06
  SPEAKER_00: So that will broaden your perspective and actually help you to play
• 25:09
  SPEAKER_00: a more leadership role in your current assignment.
• 25:12
  SPEAKER_00: Kerry, wonderful conversation.
• 25:13
  SPEAKER_00: I'm going to give you a couple of minutes to just process your thoughts
• 25:16
  SPEAKER_00: and share some key takeaway points in the end.
• 25:19
  SPEAKER_00: During this time, guys, I want to share with you a couple of announcements.
• 25:23
  SPEAKER_00: Very exciting to announce that our next session will actually be with
• 25:27
  SPEAKER_00: a legal professional who works with the FDA very, very closely and Let's Talk Risk!
• 25:48
  SPEAKER_00: The second announcement is about the LTR Risk Coach.
• 25:52
  SPEAKER_00: Today we talked about HHE process that involves a lot of judgment, right?
• 25:55
  SPEAKER_00: Data may not be available, situation may be complex, very urgent.
• 25:59
  SPEAKER_00: How do you learn to make these judgments?
• 26:01
  SPEAKER_00: How do you challenge your assumptions?
• 26:03
  SPEAKER_00: How do you explore options?
• 26:04
  SPEAKER_00: This is where the LTR Risk Coach can help you,
• 26:07
  SPEAKER_00: which is an AI-based tool I have developed utilizing
• 26:10
  SPEAKER_00: the underlying chat GPT platform, but it works only on my knowledge sources.
• 26:15
  SPEAKER_00: It's a kind of a closed loop system It doesn't go out to the internet to respond
• 26:19
  SPEAKER_00: to your questions.
• 26:20
  SPEAKER_00: And it doesn't give you just no answers.
• 26:21
  SPEAKER_00: It's actually a coach.
• 26:22
  SPEAKER_00: It helps you to navigate the decision-making process.
• 26:26
  SPEAKER_00: It's available to people on a limited launch basis.
• 26:28
  SPEAKER_00: So if you are interested, please reach out to me and I will share that information with you.
• 26:32
  SPEAKER_00: Carrie, with that, the floor is yours.
• 26:34
  SPEAKER_00: Please share two or three key takeaways with us.
• 26:37
  SPEAKER_01: First takeaway, the risk landscape is evolving.
• 26:40
  SPEAKER_01: You need to be able to prove that risk-based decisions are made
• 26:43
  SPEAKER_01: across your entire QMS, including HHE.
• 26:46
  SPEAKER_01: Using ISO 14971 as the framework for that process can enable you to do just that.
• 26:52
  SPEAKER_01: Build your decision into that process.
• 26:54
  SPEAKER_01: Ensure clear linkage to your RMF throughout that process.
• 26:58
  SPEAKER_01: And ultimately,
• 27:00
  SPEAKER_01: when done well,
• 27:01
  SPEAKER_01: HHE's evolved from that procedural requirement to the strategic tool
• 27:07
  SPEAKER_01: that really reflects your organization.
• 27:10
  SPEAKER_00: Wonderful.
• 27:10
  SPEAKER_00: These are great points to take away.
• 27:13
  SPEAKER_00: Keri, thank you so much for giving us your time.
• 27:16
  SPEAKER_00: Your perspective today.
• 27:17
  SPEAKER_00: Guys, thank you for showing up.
• 27:19
  SPEAKER_00: I appreciate your support, your involvement, engagement.
• 27:21
  SPEAKER_00: This is your show.
• 27:22
  SPEAKER_00: Please reach out to me anytime if you have any feedback or if you want
• 27:26
  SPEAKER_00: to participate,
• 27:26
  SPEAKER_00: if you want to come to the show as a guest speaker,
• 27:29
  SPEAKER_00: trust me, no preparation required.
• 27:30
  SPEAKER_00: It's not a webinar or a lecture.
• 27:32
  SPEAKER_00: It is just a very simple conversation.
• 27:34
  SPEAKER_00: So raise your hand, be a part of the community and share your perspective.
• 27:38
  SPEAKER_00: With that, thank you, everybody.
• 27:39
  SPEAKER_00: Have a good weekend.
• 27:40
  SPEAKER_00: We will see you soon.