The intersection of complaint handling, risk management and postmarket surveillance in the medical device industry

The Integration of Complaint Handling and Risk Management

By Roberta Goode, Julie Cabezas
8 Comments
The intersection of complaint handling, risk management and postmarket surveillance in the medical device industry

A review of the important aspects of risk management and post-market surveillance processes, and how to resolve common concerns.

In another first for warning letters, complaint handling supplanted CAPA as the violation found most in letters.1 Medical device manufacturers often struggle to keep up with complaint investigations and MDRs, but that’s not even their biggest challenge. The biggest challenge is establishing and maintaining a feedback loop from post-market surveillance to risk management, so that decisions about risk controls and future designs can be informed by actual market performance.

This article reviews the most important aspects of integrating the risk management and post-market surveillance processes, and review options in resolving some of the most common concerns. Part two of the article will discuss these aspects from clinical and engineering perspectives.

One of this article’s authors, Roberta Goode, will be speaking at MedTech Intelligence’s Integrated Complaints Management Conference, September 17-18, 2015. Register hereComplaint handling is a means of monitoring product performance in the field, post-commercialization or limited product release. It’s a critical step in monitoring, analyzing and evaluating risk in the clinical setting. In the development of a device, risks of similar and predicate products are documented as the basis for the estimation of risks associated with the new device, along with the use of clinical literature and expertise. In many cases, and especially for breakthrough or novel products, many risks are not known or are only vaguely known. In fact, all risk management is actually risk estimation. Actual severity and occurrences are unknown and can only be estimated by a cross-functional team of engineering and clinical experts. It is not until both a device and a procedure have been well-understood in clinical use that risk estimations can be considered reliable.

It is therefore imperative that medical device manufacturers have robust processes for monitoring complaints in the field and reviewing their risk estimations consistently, in order to:

  • Identify new or previously unforeseeable hazards, hazardous situations and harms
  • Determine whether risks are being maintained within acceptable levels
  • Monitor the state-of-the-art to determine if risk has been reduced as low as possible

To do this in a compliant way, let’s start with the regulations that require risk management and complaint handling activities.

Complaint Handling Regulations

The requirements for complaint handling are fairly straightforward. In the United States, FDA’s 21 CFR 820 Subpart M, Records, addresses complaint files. 21 CFR 803 covers Medical Device Reporting. Outside of the United States, the European Commission’s MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System, as well as ISO 13485 Section 8.1.2, provide comparable requirements.

Risk Management Regulations

In contrast, the requirements for risk management are difficult to find, and when located, they are challenging to interpret and implement.

In the United States, FDA’s 21 CFR 820, The Quality System Regulation (QSR), makes mention of risk analysis in Subpart C, Design Controls. This is currently the extent to which the FDA attempts to enforce risk management officially. However, we have witnessed several 483 observations for lack of adequate risk management in which FDA inspectors cited this element of the QSR as support.

More recent efforts by FDA to provide regulations for risk management include the guidance on human factors and quality by design.2,3  However, FDA lacks a complete guidance on the use of specific risk management tools for device manufacturers.

Outside the United States, ISO 14971:2007 is the international risk management standard.4,5  In order to meet the applicable Medical Device Directive, medical device manufacturers must conform to both ISO 14971:2007 and EN ISO 14971:2012.6 The release of EN ISO 14971:2012 to include Annexes ZA, ZB and ZC for clarification of the inherent alignment between risk management and the Medical Device Directive is critical to the proper application of risk management and complaint handling in medical devices, since it mandates the reduction of all risks as far as possible, considering state of the art and known stakeholder concerns. To conform to EN ISO 14971:2012, updates to existing product documentation may be necessary based on new guidance provided to industry through a Consensus Paper for Interpretation and Application of Annexes Z in EN ISO 14971:2012 version 1.1.7

Six Stages of the Risk Management Process, Complaint handling
Figure 1. The Six Stages of the Risk Management Process. Permission to use figure granted by ANSI.*

The Content Deviations contained in EN ISO 14971:2012 upend many long-standing practices in our industry. For example, no longer can device manufacturers count on instructions for use to reduce risk. That labeling must still exist, but it can no longer be used to mitigate risk in the FMEA. Furthermore, the concept of reducing risk as low as reasonably practicable (ALARP), which includes economic considerations, was replaced with a requirement to reduce risk as far as possible (AFAP), and the complexity of risk assessment and reduction becomes more complicated than ever. Beyond the technical challenges involved with risk assessment, there are the potential disparities between the benchtop product performance and clinical performance. It’s one thing to assesses expected risks in the product design phase, but reality in a clinical setting can be quite another. Therefore, it makes sense that post-market information must be fed back into the design of products. For that reason, the ISO 14971 standards reference the essential feedback loop from post-market information into risk management, as shown in Figure 1. The purpose of this feedback loop is to take the information from the complaint handling process and use it to review and revise the risk analysis in order to determine whether the benefit of the device continues to outweigh the risk, which requires addressing the three challenges previously mentioned:

  • Identify new or previously unforeseeable hazards, hazardous situations and harms
  • Determine whether risks are being maintained within acceptable levels
  • Monitor the ever-changing state-of-the-art to determine if risk has been reduced as low as possible

Identify New or Previously Unforeseeable Hazards, Hazardous Situations and Harms

The core challenge in the identification of new hazards, hazardous situations and harms is garnering the right information and enough information from the end user in their complaint submission. The receipt of accurate information is critical in determining the true root cause(s) of the failure and making accurate risk-based decisions. Complete and accurate information can be difficult to obtain, for several reasons:

  • Clinicians must report their perception of the apparent failure mode, which may or may not always align with engineering theory or terminology
  • Complex reporting requirements can lead to the deliberate avoidance of complaint submission or a reduction in the provision of useful information
  • Insufficient detail as it pertains to the hazardous situation that occurred is often provided, due to it being unknown or potentially legally implicating
  • Insufficient detail as to the specific harms (if any) incurred by the patient is often provided, due to the terminology used having been too general

There are many options for minimizing lost information or missing information from your complaints reporting, which include:

  • Simplifying your complaint forms as much as possible, and requiring only the mandatory fields, so as to reduce the burden to provide unnecessary information
  • Asking clear and relevant questions in your complaints forms so as to target the right information and to improve the probability of receiving accurate information
  • Collaborating with your sales team to follow-up on missing complaint data, which is a form of good customer service and provides the opportunity for in-servicing
  • Providing options for clinician training, in order to consistently improve their level of knowledge of the device and any terminology that may be helpful in properly assessing the complaint data

Determine Whether Risks Are Being Maintained Within Acceptable Levels

In order to carefully assess device performance, manufacturers need to be able to perform several tasks well during complaint analysis, including:

  • Achieving specificity about the patient population, intended use, and the clinical procedure being performed,
  • Understanding details about the use scenario that occurred, including the user, the environment, and any ancillary devices or product interactions, to determine whether use-related failure modes may have contributed to the failure or whether there are usability issues with the device
  • Ensuring consistent severity ratings for similar outcomes are available within the organization in the form of a severities listing
  • Capturing the hazards and hazardous situations consistently, allowing for differentiation between “as reported” and “as analyzed” hazards

Once the organization has obtained these four critical pieces of information (patient, use scenario, severity, and hazard/hazardous situation), then the engineering team has the ability to produce educated feedback about the device’s performance and its associated risk, based on the information provided, as well as the investigation of the returned goods.

The first step in determining whether risk levels have increased or exceeded acceptable limits is to understand how the hazard and/or device failure mode occurred by using the hazardous situation and use scenario as context for the evaluation. Some questions to consider:

  • Was the device used inside or outside of its intended use?
  • Were the instructions for use properly followed in whole or in part?
  • Was the hazard new or previously unforeseeable?
  • Was the hazardous situation unique or commonplace?
  • Was the use scenario unique or commonplace?
  • Were all fluids, energies, devices, and tools that interacted with the device accounted for in the risk analysis?

These questions are used to determine the bounds of the investigation. Analysis of the product can then provide clues as to whether the failure was design-related, use-related or material-related.

In order to determine whether the severity should be increased: Based on the investigation, the hazard, its specific hazardous situation, and subsequent harm should be compared against the risk analysis to determine whether:

  • The harm that occurred was previously identified
  • The harm was more severe than previously anticipated (e.g., localized bleeding vs. severe bleeding)

In order to determine whether the occurrence should be increased: Based on the investigation, the manufacturer often makes a quantitative assessment based on the number of times a situation occurred relative to the overall opportunities for occurrence. However, it has been our experience that FDA is less interested in a quantitative evaluation of frequency of occurrence than in general, systemic trends towards increasing or decreasing frequency of occurrence.  Qualitative assessments of risk may be more appropriate than quantitative assessments, as quantitative assessments are subject to minimization error due to multiplying serial fractions.

Monitoring State-of-the-Art to Determine if Risk Has Been Reduced as Far as Possible

Complaint Handling is a great way of monitoring. State of the art, which is defined in ISO 14971 to mean what is currently and generally accepted as good practice. It is somewhat subjective and determined by the combination of several different factors:

  • The intended use and the indications for use for a specific procedure
  • The specific technology being used
  • Medical practice at the time of design (use and reasonably foreseeable misuse)
  • Known stakeholder concerns, as seen through complaints

Since EN ISO 14971:2012 now requires the reduction of risk as far as possible, considering state of the art, it is important to be monitoring complaints for a change in state of the art. For example, during the review of complaint data, manufacturers may see an increase in complaints of a certain nature, not because the device has failed to function as intended, but because of clinicians’ changing:

  • Perception of risk
  • Tolerance of risk
  • Preference for an alternative device or therapy, which they feel is safer

This analysis is subjective. However, it is critical that manufacturers consider all these factors, since it is the responsibility of the manufacturer, per EN ISO 14971:2012 content deviations, to reduce the risk as far as possible, considering state-of-the-art and known stakeholder concerns.

If the manufacturer were to see an increasing trend of complaints due to their product becoming less favorable in the market place, due to increasing safety concerns, they would have the obligation to implement a market correction and/or design changes to further reduce the risk to as low as possible.

Part II of this article, “Considerations When Using Postmarket Data in Risk Management“, reviews how to incorporate complaint handling and risk management into the postmarket surveillance.

References

  1. Schmitt, S.M., (March 14, 2013). Record Number of Warning Letters Issued in 2012; Complaint Handling Troubles Significant. The Silver Sheet, Article #09130313001.
  2. Food and Drug Administration. (June 22, 2011). Draft Guidance for Industry and Food and Drug Administration Staff – Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
  3. Nasr, M.M. (February 28, 2007). “Quality by Design (QbD) – A Modern System Approach to Pharmaceutical Development and Manufacturing – FDA Perspective”. FDA Quality Initiatives Workshop. North Bethesda, MD.
  4. International Organization of Standardization. (March 1, 2007). ISO 14971:2007 Medical devices – Application of risk management to medical devices.
  5. International Organization of Standardization. (July 31, 2012). EN ISO 14971:2012 Medical devices – Application of risk management to medical devices.
  6. European Commission. Council Directive 93/42/EEC of 14 June 1993 concerning medical devices.
  7. European Association for Medical devices of Notified Bodies. (October 13, 2014). Consensus Paper for the Interpretation and Application of Annexes Z in EN ISO 14971:2012. Version 1.1.

*Figure 1 credit: This excerpt is adapted from ISO 14971:2007, Figure 1 on page 6, with the permission of ANSI on behalf of ISO. (c) ISO 2015 – All rights reserved.

About The Author

About The Author

Julie Cabezas, Goode Compliance International
Julie Cabezas
Quality Engineering Project Manager

Julie Cabezas is a graduate of the University of Miami with a Bachelor’s Degree in Biomedical Engineering. She has worked as a quality engineer in manufacturing, transferred a manufacturing facility to Heredia, Costa Rica, and built a nationwide medical education & clinical training program for the start-up robotics company MAKO Surgical Corp, which included the design of a new training center and surgeon education courses for partial knee and total hip arthroplasty. After MAKO’s acquisition in early 2014, she joined forces with Goode Compliance International to design cutting edge risk management compliance strategies.

Comments

  1. Dr. D

    Thank You! A well-written article that places an emphaisis on risk management and the importance of assessing risk as part of the complaint management process. Nicely done. Be Well, Dr. D

  2. Dan O'Leary

    This article contains Many factual errors. In the spirit of clarification and improvement, I would like to point out a few of them. Unfortunately, I did not get to the end of the article before reaching the limits.

    “Outside of the United States, the European Commission’s MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System, as well as ISO 13485 Section 8.2.1.2, provide comparable requirements.”
    ISO 13485:2003 does not have a section 8.2.1.2.

    “Outside the United States, ISO 14971:2007 is the international risk management standard.”
    ISO 14971:2007 is an international standard both inside the US and outside. In fact, it is an International standard for all countries.

    “In order to meet the applicable Medical Device Directive, medical device manufacturers must conform to both ISO 14971:2007 and EN ISO 14971:2012.”
    The premise of EN ISO 14971:2012 is that meeting ISO 14971:2007 is not adequate because the EU directives are more restrictive.

    “The release of EN ISO 14971:2012 to include Annexes ZA, ZB and ZC for clarification of the inherent alignment between risk management and the Medical Device Directive …”
    There are three annexes, one for each of the EU directives. The manufacturer selects the annex based on the directive that applies to the device.

    “EN ISO 14971:2012 is critical to the proper application of risk management and complaint handling in medical devices”
    EN ISO 14971:2012 does not address complaint handling specifically. This is the role of MEDDEV 2.12-1 (see the trend analysis section) and EN ISO 13485:2012.

    “EN ISO 14971:2012 … mandates the reduction of all risks as far as possible, considering state of the art and known stakeholder concerns.”
    This statement appears to confuse the policy for determining criteria for risk acceptability with a restriction of ALARP methods to technical means only.

    “Updates to existing product documentation may be necessary based on new guidance provided to industry through a Consensus Paper for Interpretation and Application of Annexes Z in EN ISO 14971:2012 version 1.1.”
    This document is not relevant, since it is the opinion of one group. The best approach follows the directives and avoids all of the opinion documents.

    “The Content Deviations contained in EN ISO 14971:2012 upend many long-standing practices in our industry.”
    The content deviations assert that the product directives are more restrictive than the international standard. The position is that every device manufacturer understands this and, in order to legally apply the CE Mark, has followed the directives not the International Standard.

    “For example, no longer can device manufacturers count on instructions for use to reduce risk. That labeling must still exist, but it can no longer be used to mitigate risk in the FMEA.”
    This is a common misunderstanding of the MDD content deviation #7, which deals with disclosure of residual risk. Since residual risk is the risk after risk control, disclosure could not possibly reduce risk.

    Since all risk control measures are applied cumulatively in MDD content deviation #3 it strains logic to state, “one must apply information as a risk control option, but information for safety is not a risk control option.”

    The standard does not mitigate risk, but reduces it. The word mitigate does not appear in standard.

    An FMEA (FMECA) does not satisfy ISO 14971:2007. It requires hazard analysis in both normal and fault conditions. An FMEA, since it deals with failure modes, does not address hazards, hazardous situations, or harms in normal conditions.

    “Furthermore, the concept of reducing risk as low as reasonably practicable (ALARP), which includes economic considerations, was replaced with a requirement to reduce risk as far as possible (AFAP), and the complexity of risk assessment and reduction becomes more complicated than ever.”
    This statement is a misunderstanding. The content deviation, in part c) says that manufacturers my not apply economic considerations when applying ALARP. This means only technical considerations. The criterion has not changed. The risk must be acceptable when evaluated by the criteria in the risk management plan and, if not, demonstrates the benefit outweighs the risk.

  3. David Amor

    This was a great article that highlights some key aspects of risk management that companies often fail to consider – especially post-market integration back into the risk management file. Thanks for establishing this as a critical element and reminding companies that risk management doesn’t end when the product gets to market.

    Unfortunately, I feel like I need to weigh in on Mr. O’Leary’s comments below, as I do not agree with several of his statement. Many of his points were based on interpretation – and as such, he should qualify them with such a disclaimer before refuting your points. Some of his points may have value but I believe others represent a mischaracterization for prospective readers- enough so that I would like to interject. Out of professional responsibility I believe I need to chime in. Points of contention and clarification below (note: several of my points are professional and anecdotal opinion and denoted as such):

    COMMENT: “Outside of the United States, the European Commission’s MEDDEV 2.12-1 Guidelines on a Medical Devices Vigilance System, as well as ISO 13485 Section 8.2.1.2, provide comparable requirements.” ISO 13485:2003 does not have a section 8.2.1.2.”

    RESPONSE: The author never mentions a section 8.2.1.2, that I can see. However, and furthermore, ISO DIS2 13485:2015 does have a Section 8.2.1.2 related to complaints. As the author didn’t clarify which standard was being referenced, this is a possibility. Please review.

    COMMENT: “Outside the United States, ISO 14971:2007 is the international risk management standard.”
    ISO 14971:2007 is an international standard both inside the US and outside. In fact, it is an International standard for all countries.

    RESPONSE: This is incorrect. ISO 14971 is an international standard. The FDA has recognized ISO 14971 as a Consensus Recognized standard (it is also part of the MDSAP program) but indicating that it is a standard for the US – through origin and intent – is incorrect.

    COMMENT: “EN ISO 14971:2012 is critical to the proper application of risk management and complaint handling in medical devices”
    EN ISO 14971:2012 does not address complaint handling specifically. This is the role of MEDDEV 2.12-1 (see the trend analysis section) and EN ISO 13485:2012.

    RESPONSE: I believe the author is inferring that complaints trending and analysis falls under post-production monitoring which is in fact an explicit requirement in 14971. This is a fairly common and accepted extrapolation. If a company is following 14971 for risk management, the author’s statement is valid as all post-market risk data should be fed back into the risk management file.

    COMMENT: “EN ISO 14971:2012 … mandates the reduction of all risks as far as possible, considering state of the art and known stakeholder concerns.”
    This statement appears to confuse the policy for determining criteria for risk acceptability with a restriction of ALARP methods to technical means only

    RESPONSE: I believe you should review the ‘Monitoring the state of the art’ paragraph. The author clearly mentions other means and considerations including medical practice.

    COMMENT: “Updates to existing product documentation may be necessary based on new guidance provided to industry through a Consensus Paper for Interpretation and Application of Annexes Z in EN ISO 14971:2012 version 1.1.”
    This document is not relevant, since it is the opinion of one group. The best approach follows the directives and avoids all of the opinion documents.

    RESPONSE: This is a dangerous statement and should not be followed. Application of position statements – especially groups such as GHTF, IMDRF and NBRG (now called Team NB)- which are all key policy driver organizations, is a critical part of compliance. Team NM stakeholders are in fact notified body members. Companies who do not review white papers and recommendations from these groups are at a significant disadvantage to their peers who are cognizant of the latest and greatest industry recommendations.

    COMMENT: “For example, no longer can device manufacturers count on instructions for use to reduce risk. That labeling must still exist, but it can no longer be used to mitigate risk in the FMEA.”
    This is a common misunderstanding of the MDD content deviation #7, which deals with disclosure of residual risk. Since residual risk is the risk after risk control, disclosure could not possibly reduce risk.

    RESPONSE: Please note the MDD does not have content deviations.

    COMMENT: Since all risk control measures are applied cumulatively in MDD content deviation #3 it strains logic to state, “one must apply information as a risk control option, but information for safety is not a risk control option.”

    The standard does not mitigate risk, but reduces it. The word mitigate does not appear in standard.

    RESPONSE: Please note that a risk mitigation indeed may lower risk. ‘Mitigation’ is commonly accepted vernacular used across many notified bodies. Inherent to its definition is the action of reducing the severity or dimension of something – including risk. Please reference as an example a BSI white paper written by a technical director (http://medicaldevices.bsigroup.com/LocalFiles/en-US/Roadshow%20Resources%202014/Risk_Management_Impact_Annex_Z.pdf)

    COMMENT: An FMEA (FMECA) does not satisfy ISO 14971:2007. It requires hazard analysis in both normal and fault conditions. An FMEA, since it deals with failure modes, does not address hazards, hazardous situations, or harms in normal conditions.

    RESPONSE: Although you are correct, technically, that FMEAs in itself do not provide hazard analysis (if applying per IEC 60812), many companies use single fault risk assessments in order to extrapolate this information as a starting point. A failure mode can be characterized as a hazard or hazardous situation – depending on how the company decides to define this. Furthermore, terminology like ‘harm’ may be considered as ‘clinical harm’ or ‘clinical effect’ if sufficiently defined in SOPs/ WI/etc. There is plenty of anecdotal evidence of FMEAs being implemented successfully in companies. While I agree with the assessment that an FMEA cannot represent the full scope of RM per 14971 on a standalone basis, it can certainly be leveraged effectively in conjunction with other risk analysis and evaluation tools. Lastly, the author does use hazard/ failure mode in several instances within the document, supporting my comment.

  4. Theresa M

    Great article! Ms. Goode and Ms. Cabezas make a confusing and complicated topic easier to understand for us ‘non-quality’ people. Based on the negative comments of one reviewer, it’s obvious that this topic is thought provoking and continues to be interpreted differently across industry, which of course makes the implementation of a risk management process even more challenging. Keep the articles and commentary coming!

  5. Brian Keogh

    Excellent article! Thanks for the honest and open insight into what is considered a difficult subject that can lead to confusion and ultimately to potential patient safety and compliance risks. I appreciate the discussion regarding an organizations approach to ensure it has effective monitoring in place to gain insight into changes in state of the art. Very enlightening and something that I see as a gap as medical procedures, processes and technology change rapidly. The risk based approach to complaint management is critical and the timely and accurate feedback into the overall quality system is crucial to ensure both patient safety and compliance.

  6. Brett Nowlin

    I think the article does a wonderful job at underscoring the importance of linking your Post-Market processes with Risk Management. Without the connection, you clearly only have half a system and will struggle to show compliance with any regulatory body, you’ll also be short-changing your companies ability to quickly read and react to potential issues in the field. For all the effort we put into FMEA’s, Hazard Analysis, FTA’s or any other risk analysis tools during development, we need to remember that the effort does not stop once the submission/clearance is gained and the product is out the door.

    As far as the nuances of the EN ISO 14971:2012 version, there’s been a lot of confusion throughout industry on how to interpret the deviations from the MDD. I know that I’ve relied heavily on interpretation papers published by reputable organizations like IMDRF/GHTF as David stated above. When you combine your own interpretation of a standard with applicable white papers and well-written publications like this, you can do nothing but increase your chances at implementing systems that can be compliant while still being flexible. I think the points that were made here by the authors have done exactly what should have been intended, they’ve created dialogue and commentary on a critical piece of our industry. Different people at different companies will have varying opinions over exactly how to implement systems or argue the specificity of language within regulatory requirements. Usually, the truth lies somewhere in the middle, and we’re all responsible for our own systems and ensuring they not only show compliance but drive action that is value added. I personally think the article provided a clear and concise, process for “connecting the dots” in order to get more value out of a requirement that must be complied with if you’re going to play in the med device space.

  7. Dan O'Leary

    I commented on this article and read with interest the comments, in response, from David Amor. I would like to respond to a few, in a cooperative spirit. Responding to all would, in my opinion, not add a lot of value.

    I said that ISO 14971:2007 is an international standard, but the objection says, “This is incorrect. ISO 14971 is an international standard.” I fail to see why Mr. Amor does not want to include the revision of the international standard. He goes on to say, “The FDA has recognized ISO 14971 as a Consensus Recognized standard … but indicating that it is a standard for the US – through origin and intent – is incorrect.” I’m not clear what the point is here. FDA has recognized both the international standard, ISO 14971:2007, and the US standard, ANSI/AAMI/ISO 14971:2007. It is important to realize that other regulatory regions have their own version. For example, the Canadian standard is CAN/CSA-ISO 14971-07 and the EU standard is EN ISO 14971:2012. In some cases, the national or regional standards align with the international standard, e.g., US and Canada, and in some cases there are differences, e.g., EU.

    Mr. Amor says, correctly, “Please note the MDD does not have content deviations.” However, EN ISO 14971:2012 has two versions for content deviation #7. One is for the MDD and the other is for the IVDD. My statement, as written is correct.

    I said, “The standard does not mitigate risk, but reduces it. The word mitigate does not appear in standard.” The response state, “Please note that a risk mitigation indeed may lower risk. ‘Mitigation’ is commonly accepted vernacular used across many notified bodies.”

    The implication is that mitigation and reduction are synonyms and that, because some make the error, all of us must make the error. Mitigation means reducing the effect of the harm once it has happens, while risk reduction means reducing the probability or severity of the harm. Confusing these terms is a major mistake. For example, hopefully extreme, loss of a limb could be mitigated by a prosthetic. However, preventing the loss of the limb is risk reduction. Please don’t confuse the two!

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