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Archive for ISO 14971:2019 (Risk Management)

ISO 14971 3rd Edition Available for Purchase

The new ISO 14971 3rd edition was released for sale by ANSI / AAMI on December 16, 2019, and as a member of AAMI, the cost is $133.

Risk management process 2019 1024x773 ISO 14971 3rd Edition Available for Purchase

2019 Risk Management Process – 3rd edition

In October of 2018, I wrote a blog on the draft version of ISO 14971 3rd edition of the risk management standard for medical devices. That article explained the differences between the different versions of the ISO 14971 standard (i.e., 2000, 2007, 2009, and 2012). I also explained what changed between ISO 14971:2007 and ISO/DIS 14971:2018–the 2018 draft of the standard that was released this week.

The changes proposed in the draft included subtle changes to the names of the processes and a minor adjustment to the numbering of the clauses. Many of the annexes were also moved to ISO/TR 24971 guidance–which has not yet been released. The draft did not, however, result in a change in the overall process of risk management.

All of the changes that were discussed in my 2018 review were maintained in the final 2019 version that was released, but the ISO/TR 24971 guidance was not released at the same time as the committee had hoped for.

There are not any surprises in the 3rd edition (i.e., 2019 version). Therefore, I plan to wait until the ISO/TR 24971 guidance is released and then prepare a new blog specific to the guidance. If you are interested in training on the ISO 14971:2019 standard, the training I recorded on October 19, 2019, provides an excellent overview of these changes and highlights some of the challenges that you will encounter when trying to harmonize your risk management procedure between the ISO 14971:2019 standard and Regulation (EU) 2017/745.

If you want to know when the new guidance is released, please subscribe to my blog, and you will receive an update as soon as I can purchase the new guidance. Once the new guidance is released, I will also be providing a new risk management training bundle for $499 that includes the following:

This is a lot of information to absorb. Therefore, I recommend purchasing the October 2019 webinar and your copy of the ISO 14971:2019 standard from AAMI. Anyone that has already purchased either the webinar or the procedure will receive an email offering them a discount on this new bundle that credits them for their previous purchase. If you have purchased both, you will receive credits for both purchases. Just think you can watch the video and read the new version of the standard while you are working out at the gym in January. Learn and burn!

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What is a pFMEA? (i.e., process Failure Mode and Effect Analysis)

This article explains what a pFMEA is (i.e. Process Failure Modes and Effects Analysis) and how to use them as part of your risk management process.

RPN Scoring Table What is a pFMEA? (i.e., process Failure Mode and Effect Analysis)

I recently had someone ask for help understanding the Process Failure Mode and Effect Analysis (pFMEA) a little better. I can’t blame them, because I was lost the first time I tried to fill out a form for one. It can be confusing and overwhelming if you have never created one before.

First things first, what is a pFMEA

FMEA= Failure Modes and Effects Analysis

A lower-case letter will come before the FMEA, and that denotes the ‘what’, of what the failure is that is being analyzed. A pFMEA will often be examining process failures where a dFMEA might evaluate design failures. (dFMEA’s can be confusing as well, Robert Packard created training on how to document risk management activities without using one in his Death of the dFMEA Webinar)

Some systems capitalize all the letters. Some capitalize none. That is not what is important as long as it is consistent throughout your system. Everyone should be able to easily understand that whatever variation of pfmea is used; it means “process failure modes and effects analysis.” 

What does a pFMEA do?

A pFMEA will break down your manufacturing process into its individual steps and methodically examine them for potential risks or failures. For companies that utilize our Turn-Key Quality Management System, FRM-025 process Failure Modes, and Effects Analysis can be used as a template.

For this example, we will look at receiving inspection of injection-molded casing parts for a medical device. This receiving inspection includes a manual inspection of 10 randomly selected parts out of each delivery of 100 using an optical overlay.

Process Step

This area, as the section title suggests, is the process step. When looking at the process as a whole, the pFMEA will break it down into each and every step included in that process. This area is simply that individual step that is going to be examined.

The Process Step or item function depending on what your form uses for this scenario, is going to be part of the random sampling for manual inspection of the received parts using an optical overlay. Our example is going to be the backlighting element of the optical overlay display. The backlighting element will illuminate the inspected part against the template to verify that the part is within specific dimension criteria.

Potential Failure Modes

A failure mode is a way in which that process step might fail. Since it is failure modeS, it needs to be considered that there may be more than one way for the process step to fail. Do not be fooled that because this box on the form has been filled in that the pFMEA will be complete. A thorough examination of all of the possible failures should be investigated.

Our example in this process requires the backlighting element to illuminate a visual template over the parts. The light not illuminating properly is a potential failure mode of this process.

Potential Effects of Failure

the potential effects of the failure is a look into what the ramifications would be if that failure for that process step actually happened.

In our scenario, one of the potential effects of the lighting not functioning properly is that parts outside of the designated sizing acceptance criteria may be accepted rather than rejected as non-conforming parts.

S (Severity)

The next area is the first area that requires an estimated grading of the failure. That is ‘Severity’ which is abbreviated as S. There is a scale provided in the rating section of FRM-025 that outlines the numbering system that Medical Device Academy uses.

Below is a snippet of the rating scale used, this is included with the purchase of the SYS-010 Risk Management Procedure.

Severity (S)
Severity of the effect Scale Definition
Business Risk 0 No potential harm to patient or user
Superficial 2 Little potential for harm to patient or user

In this case, our example is using molded plastic pieces of the outside casing of a medical device. Pieces that are too large or too small will not fit when making the final assembly of the device. These plastic pieces do not happen to be patient contacting, and do not affect the function of the device.

The evaluation of this failure is determined to have no potential effect on patient safety or increase any potential for risk of harm, therefore the severity is assigned as a ‘business risk’ meaning that it bears no risk for the user or the patient. This makes the Severity Score 0.

Causes of Failure

This column is exactly that. What might cause this identified failure to happen? In our example might be the light bulbs in the overlay machine may slowly burn out over time with use. This burnout causes potential failure.

If the bulb is expected to only have a lifetime of 100 hours, then the more hours the bulb is used, the dimmer the light may become. A slowly dimming light decreases the sharpness of the overlay template and our parts that are supposed to have a + or – size criteria of 10% now have a fuzzy template that in reality changes the overlay to show closer to + or – 13%. Now parts that are too small or too large may be accepted.

O (Occurrence/Probability)

This grading criterion is also found in the Rating section of FRM-025. This is how often the failure is expected to occur. How often will the lighting element of our optical overlay fail to function in the appropriate manner for this cause?

Hopefully not very often. In fact, regularly scheduled maintenance and calibration of the overlay machine could prevent this from ever happening in the best-case scenario. Our evaluations determine that the probability of this happening is low. However, since we cannot be certain it will never happen the potential for this risk exists and makes the Occurrence score a 4.

Current Process Controls

What is currently being done to control this risk? Our example uses regularly scheduled maintenance and calibration to prevent bulb burnout affecting the overlay.

D (Detectability)

Our current process is based on routine maintenance and visual inspection. This means that the bulb burnout is something that is visually inspected for and visual inspections for detectability on the rating scale are graded as 8. This chart is found in the Rating Section of FRM-025.

RPN (Risk Priority Number)

This is a number that is found by multiplying the Severity, by the Probability, by the Detectability. In our example, the numbers RPN is  0X4X8=32 for an RPN of 32 which is considered LOW.

pFMEA math

Below is a short video explaining the math behind calculating the Risk Priority Number

https://www.youtube.com/watch?v=OWfyHyx-zhI&feature=youtu.be

Recommended Actions

What if anything can be done to improve this process? In our example, a recommended action may be to transfer from visual only inspections to verification of light output by the meter. This makes the Detectability of the failure measurable by meter or gage which is a detectability score of 4.

This changes the RPN now to 0X4X4=16

The pFMEA shouldn’t be a solo thing

If it can be avoided this type of analysis should be done by a multidisciplinary team. Sometimes in smaller companies, people end up having to wear more than one hat. There are many entrepreneurs that have to function as the CEO/CFO/Design Engineer/RA/QA manager.

Ideally, a team approach should be used if feasible. Have the management level staff who have ownership of the processes participating in this analysis. They should know the process more intimately than anyone else in the company and should have more insight into the possible failure modes of the processes as they have likely seen them first hand. They are also the type of employee who would know the types of recommended actions to control the risk of those failures as well.

The pFMEA should also be a living document

As new failure modes are discovered they should be added to your pFMEA. A new failure mode might be discovered through a CAPA because the process had an actual failure that was not originally analyzed. Take an instance like that as an opportunity for improvement and to update your pFMEA as part of a living breathing risk management system. Also, use this as a time to re-brainstorm potentially similar failure modes that may not have been considered previously so that they can be controlled before they happen.

If you took the time to watch the video above it is also mentioned that in some instances the very first FMEA must be based on estimates because there is no data. Managers and engineers may be forced to estimate the probability of occurrence. If that is the case the FMEA should be updated in the future to adjust the (O) score to reflect what is occurring in actuality based on real data and not the theoretical data that was used for the initial estimate.

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ISO 14971 Risk Management Updates in ISO/DIS 14971:2018

This article describes updates being made to the ISO 14971 Standard in the new draft version released for comment in July 2018.

There are two versions of ISO 14971 that are currently available. The first is the international version: ISO 14971:2007. The second is the European normative version: EN ISO 14971:2012. There is also a new draft being created by the TC210 committee for release in 2019.

Explanation of the different versions of the ISO 14971 standard

In 2000, the first edition of ISO 14971 was released as the international standard for risk management of medical devices. In 2007, the second edition of ISO 14971 was released. When new international standards are released, a European normative version is also released. The “European Norm” or EN version is intended to identify any gaps between the international standard and the requirements of the applicable European directives (i.e., the MDD, AIMD, and the IVDD). These gaps historically were included in the ZA annex at the end of the EN version. However, in 2009 this annex was split into three annexes (i.e., ZA, ZB, and ZC) to address each of the three directives separately. In reality, the 2009 annex only differed concerning the directive referenced. In 2012, a new EN version was released. This new standard included seven deviations, which were controversial. These deviations were intended to identify contradictions between the directives and the international standard, but the interpretations were not agreed with by companies or most of the Notified Bodies. Ultimately, the seven deviations were required to be addressed in the risk management files for any medical device that was CE Marked.

What changed between ISO 14971:2007 and ISO/DIS 14971:2018?

The TC210 working group assigned to update the ISO 14971 standard (JWG1) was tasked with improving guidance for the implementation of ISO 14971. Still, the committee was also tasked with making these improvements without changing the risk management process. Also, the committee was asked to move the informative annexes at the end of ISO 14971 from the standard to the guidance document ISO/TR 24971. Therefore, in July, the committee released a draft for comment and voting. Draft versions are identified with the prefix “ISO/DIS.” The ISO/DIS 14971 standard released in July has only three annexes: A) Rationale for the requirements, B) Risk management process for medical devices, and C) Fundamental risk concepts (formerly Annex E). The other seven annexes were moved to the draft of ISO/TR 24971. The reason stated for moving these Annexes to the guidance document was to make future revisions to the guidance easier to implement because it is a guidance rather than a standard. However, there were also some objectionable recommendations in the informative annexes that were the subject of deviation #3—ALARP from Annex D.8 vs. “As far as possible,” in the first indent of section 2 of Annex I in the MDD.

Although the committee was tasked to make improvements in the implementation of ISO 14971 without changing the process, the new draft has subtle changes in the process. Most of these changes can be identified quickly by reviewing the updated risk management flow chart provided in Figure 1. The updated flow chart now has two places where risks are evaluated. The first place is identical to the original Figure 1, but now the associated section is clarified to be specific to evaluating individual risks. The second place in the flow chart is new and specific to the evaluation of overall residual risks. The draft standard also states that different acceptability criteria and methods of evaluation may be used for each evaluation phase in the process. There have also been subtle changes to the names of process phases:

  • Section 7.4 is now “Benefit/Risk” analysis instead of “Risk/Benefit” analysis—although the draft flow chart does not reflect this.
  • Section 9 is now “Risk Management Review” instead of “Risk Management Report”
  • Section 10 is now “Production and post-production activities” instead of “Production and post-production information”

There is also more detail in the diagram under the phases for 1) risk analysis, 2) risk control, and 3) production and post-production activities.

Three new definitions are introduced in the draft standard: 3.2, benefit; 3.15, reasonably foreseeable misuse; and 3.28, state of the art. The section for identification of hazards, Clause 5.4, was reworded and expanded to consider the reasonably foreseeable sequences or combinations of events that can result in a hazardous situation. The draft standard now states that your risk management plan must also include a method to evaluate the overall residual risk and the criteria for the acceptability of the overall residual risk. In the section for risk estimation, Clause 5.5, the draft standard states that if the probability of the occurrence of harm cannot be estimated, the possible consequences shall be listed for use in the risk evaluation and risk control. The risk control option analysis priorities in section 7.1 are updated to match the new MDR, Regulation (EU) 2017/745, nearly exactly. In section 9, risk management reports were changed to risk management review, and the Clause now requires determining when to conduct subsequent reviews and when to update reports. This emphasizes the requirement to continuously update risk management documentation with input from production and post-production information. This mirrors the emphasis on continually updating post-market clinical follow-up in Regulation (EU) 2017/745, Annex XIV, Part B, Section 5, and continuously updating clinical evaluations in Regulation (EU) 2017/745, Annex XIV, Part A, Section 1.

Will ISO 14971 2019 eliminate the deviations ISO 14971 Risk Management Updates in ISO/DIS 14971:2018

Will ISO 14971:2019 address the 7 Deviations in EN ISO 14971:2012?

The new MDR, Regulation (EU) 2017/745, revised and clarified the wording of the essential requirements in the MDD. The MDR attempts to explain the requirements for risk management files of CE Marked products, but the MDR remains different from the requirements of ISO 14971. Unfortunately, because the ISO/DIS 14971 was not intended to change the risk management process of ISO 14971:2007, there will continue to be “deviations” between the MDR and standard.

Some people have tried to use ISO/TR 24971, the risk management guidance, as the official interpretation of how the risk management standard. However, the guidance is also a product of the TC210 committee, and it does not meet all requirements of the MDD or the MDR.

The new draft does, however, include changes that address some of the deviations in EN ISO 14971:2012. Below, each of the seven variations is listed, and hyperlinks are provided to other articles on each deviation.

  1. Negligible Risks – The word “negligible” was only in one location in the body of the standard as a note referring to Annex D.8. In the draft, Annex D was removed and relocated to ISO/TR 24971, and the note was eliminated from Clause 3.4—now Clause 4.4 in the draft. The draft should fully resolve this deviation.
  2. Risk Acceptability – Clause 7 was renumbered to Clause 8 in the draft. Still, the title of this Clause was also changed from “Evaluation of overall residual risk acceptability” to “Evaluation of overall residual risk.” However, if you read the Clause it still refers to determining the acceptability of risks. In note 2 of Annex ZA of the draft, it states that determining acceptable risk must comply with Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11, and 12 of the Directive. The draft should fully resolve this deviation.
  3. ALARP vs. “As far as possible” – The European Commission believes that the concept of “ALARP” implies economic considerations, and some companies have used economics as a reason for not implementing certain risk controls. ALARP was eliminated from the notes in the risk management plan clause and by moving Annex D.8 to ISO/TR 24971 and adding note 1 in Annex ZA. The draft should fully resolve this deviation.
  4. Benefit/Risk Analysis – The contradiction in requirements between the International Standard and the MDD, as it relates to determining when a benefit/risk analysis must be conducted, has not been updated. The draft does not resolve this deviation. Companies that CE Mark products will need to perform a benefit/risk analysis for all residual risks and all individual risks—despite the wording of the standard.
  5. Risk Control – The contradiction in requirements between the International Standard and the MDD, as it relates to determining when risk controls must be implemented. The International Standard gives companies the option to avoid the implementation of risk controls if the risk is acceptable. At the same time, the MDD requires that risk controls be implemented for all risks unless the risk controls create additional risks that increase risks, or the risk controls do not reduce risks further. The draft does not resolve this deviation. Companies that CE Mark products will need to implement risk controls for all individual risks—despite the wording of the standard.
  6. Risk Control Options – The intent of Clause 6.2 in ISO 14971:2007 was likely to be the same as the MDD. However, the European Commission identified the missing word “construction” as being significant. Therefore, to prevent any misunderstandings, the TC210 committee copied the wording of Regulation (EU) 2017/745. The draft should fully resolve this deviation.
  7. IFU Validation – Again, to prevent any misunderstandings, the TC210 committee copied the wording of Regulation (EU) 2017/745. However, the examples of information for safety (i.e., warnings, precautions, and contraindications) were not included. Hopefully, the final version of the 3rd edition will consist of these examples. Clause 8, evaluation of overall residual risk, was also reworded to state, “the manufacturer shall decide which residual risks to disclose and what information is necessary to include in the accompanying documentation to disclose those residual risks.” The draft should fully resolve this deviation.

Recommendations for your Risk Management Process?

The most important consideration when establishing a risk management process for medical devices is whether you plan to CE Mark products. If you intend to CE Mark products, then you should write a procedure that is compliant with the current requirements of the MDD and future requirements of Regulation (EU) 2017/745. Therefore, the seven deviations should be addressed. Also, you need to maintain compliance with the current version of the standard.

I recommend creating a process based upon the newly updated process diagram in the latest draft. The process should begin with a risk management plan. For your plan, you may want to create a template and maintain it as a controlled document. It could also be part of your design and development plan template, but the plan should include each of the following risk management activities:

  1. Hazard identification
  2. Risk estimation
  3. Risk evaluation
  4. Risk control option analysis
  5. Risk control verification of effectiveness
  6. Benefit/Risk analysis
  7. Evaluation of overall residual risk
  8. Risk management review
  9. Production and post-production activities

Your procedure should also be integrated with other processes, such as 1) design control, 2) post-marketing surveillance, and 3) clinical evaluation. Your procedure must indicate the priority for the implementation of risk control options. The best strategy for ensuring risk control priorities are compliant is to copy the wording of the new EU Regulations verbatim. Your process should include performing benefit/risk analysis. You should also define your process for risk management review. Your review process should specify when subsequent reviews will be done, and when your risk management report will be updated. Finally, you should identify a post-market surveillance plan for each device or device family, and use that post-market surveillance data as feedback in the risk management process.

The one element that appears to be weakly addressed in the body of the standard is the requirement for traceability of each hazard to the other aspects of the risk management process. Although traceability is mentioned in Clause 3.5 of the 2nd edition, and Clause 4.5 of the draft 3rd edition of ISO 14971, that is the only place is mentioned in the body of the standard. Traceability is mentioned several more times in Annex A, but the focus seems to be on the risk management file. Companies need more guidance on how to achieve this traceability. The appropriate place for this guidance is probably in ISO/TR 24971. Still, in order to maintain this documentation, a software database will likely be critical to maintaining traceability as changes are made during design iterations and after commercialization. This type of software tool is also needed to expedite the review of risk management documentation during a complaint investigation.

Which Risk Analysis Tool should you use?

In Annex G of ISO 14971:2007 and the EN 2012 version, there are five different risk analysis tools described. The word “described” is emphasized because informative annexes are not “recommended.” The committee that created the 2nd edition of ISO 14971 wanted to provide several suggestions for possible risk analysis tools to consider. However, each tool has strengths and weaknesses. Additionally, the widespread use of the failure-mode-and-effects analysis (FMEA) tool in the automotive and aerospace industries has spread to the medical device industry, and companies seem to believe that regulators prefer the FMEA tool. This is not true. Companies should be trained in all of these tools, and training should consist of more than just reading Annex G, and the tools should be used where they are most beneficial. My recommendations are below:

  1. Preliminary Hazard Analysis (PHA) – This process is critical during the development of design inputs. It is also the most underutilized analysis tool. I have not seen a single example of this tool written in a procedure by any medical device company. I believe this process should be continuously updated as part of training new design team members and should be both product and project-specific.
  2. Fault-tree Analysis (FTA) – This process is a top-down approach to risk analysis. It is heavily utilized by transportation engineers when intersections are designed, and accidents are investigated. This tool depicts risk analysis pictorial as a tree of fault modes representing each possible root cause for failure. At each level of the tree, fault mode combinations are described with logical operators (i.e., AND, OR). The information displays the frequency of each fault mode quantitatively. Therefore, when you are investigating a complaint, the tree can be used to help identify possible fault modes that may have been the root cause of device failure. You may also be interested in the standard specific to Fault tree analysis (FTA): IEC 61025:2006.
  3. Failure Mode and Effects Analysis (FMEA) – This process is a bottom-up approach to risk analysis. The automotive and aerospace industries heavily utilize it. This tool systematically lists all failure modes in groups organized by component. Risks are estimated based upon the severity of effect, probability of occurrence, and detectability. Over time, the FMEA process split into three tools: 1) process FMEA (pFMEA), 2) design FMEA (dFMEA), and 3) use FMEA (uFMEA). The first is ideal for analyzing and reducing risks associated with the manufacturing of devices. In particular, the detectability factor can be linked closely with process validation. The second evolved from the realization that the detection of a risk after the device is in the user’s hands does not reduce risk. A risk reduction only occurs if detectability is proactive. Therefore, this was stated in Annex G.4, and companies began to eliminate detectability and continued to use FMEA as their primary tool. Due to the widespread familiarity with the FMEA tool, usability FMEAs became popular for documenting risks associated with the use of a device. Unfortunately, the only real advantages of a dFMEA and uFMEA are familiarity with the tool. You may also be interested in the standard specific to FMEA: IEC 60812:2018.
  4. Hazard and Operability Study (HAZOP) – In addition to the risks of using devices, there are also risks associated with the production of devices. Processes related to coating, cleaning, and sterilization are all processes that typically involve hazardous chemicals. The chemical and pharmaceutical industries use HAZAP as a tool to analyze these process risks and prevent injuries. You may also be interested in the standard specific to HAZOP: IEC 61882:2016.
  5. Hazard Analysis and Critical Control Point (HACCP) – This process is primarily used by the food industry to prevent the spread of contaminated food supplies. Even though medical device manufacturers do not typically use it, it should be considered as a tool for managing the supply chain for devices. This model is useful when manufacturing is outsourced, or secondary processing is conducted at second and third-party suppliers. Since many FDA inspectors started in the food industry as inspectors, this is also a method that is supported by the FDA as a risk control process for outsourced processes.

How to document your risks?

For simple devices, risk management documentation is a burdensome task. For complex devices, a spreadsheet could include hundreds of lines or more than even one thousand individual lines. Also, the requirement for traceability requires additional columns in a table. Therefore, it becomes nearly impossible for you to include all the required information on a page that is 11 inches wide. If you expand your page to 17 inches wide, the size of your font will need to be very small. If you make a change, your spreadsheet can be challenging to update quickly. You could purchase a 43” widescreen TV for your monitor, or you can use dual monitors for your display, but changes remain challenging to implement without a mistake.

You need to stop relying upon spreadsheets. Use a database, and don’t use Microsoft Access. Purchase a database that is designed to document design controls and risk management traceability. If your company has software expertise, develop your software tool to do this. You should also design standardized templates for exporting your reports. By doing this, it will only take minutes to create an updated report when you make design changes. If you describe the risk management activities as notes in your software, the description of these activities can also be automatically converted into summary pages for each report summarizing that risk management activity. You can even prompt the user to answer questions in the software to populate a templated document. For example, you can prompt users to input subsequent updates of your risk management reviews, and that can be automatically converted into a summary paragraph. This reporting capability is especially helpful when responding to FDA review questions asking for cybersecurity risks.

Additional Training Resources for ISO 14971

The risk management training webinar was being completely rewritten to address changes proposed in the new draft of ISO 14971 (i.e., ISO/DIS 14971) released in July 2018 and European requirements for compliance with Regulation (EU) 2017/745. The webinar was live on October 19, 2018, but it was recorded for anyone unable to participate in the live session.

SYS-010, Medical Device Academy’s Risk Management Procedure, is compliant with EN ISO 14971:2012. The procedure includes templates for documentation of design risk management and process risk management. However, we are rewriting the procedure for compliance with ISO/DIS 14971:2018 and Regulation (EU) 2017/745. The new version of the procedure will be available on or before October 26, 2018. The procedure is temporarily available at a discounted pre-order price, but the cost will increase to $299 once the new version is available.

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Risk Management Requirements – 510k vs DHF

This article compares the risk management requirements for a 510k submission with the risk management requirements for your design history file (DHF).

Design Controls and Risk Management Risk Management Requirements   510k vs DHF

Risk Management Requirements and Design Control Requirements

Last week I presented a free webinar on how to combine risk management with design controls when planning to submit a 510k. Many questions were asking what the design control and risk management requirements are for a 510k.

What are the Design Control Requirements in a 510k?

There is no specific part of the regulations stating what the 510k design control requirements are. However, some aspects of the DHF are required as 510k design control documentation, but not necessarily in the exact form as maintained in the DHF. For example, Design Inputs and Design Outputs are presented as applicable recognized standards and design specifications, while others will remain precisely the same (i.e., verification and validation test reports).

What are the Risk Management Requirements in a 510k?

For 510k submissions, the only risk management requirements are the inclusion of risk documentation for devices containing software of at least moderate level risk. There are some exceptions to this as well, though, based on a few special control guidance documents—especially when the submission type is an abbreviated 510k. This is article identifies which of the DHF and RMF elements are 510k design control requirements and 510k risk management requirements.

510k Design Control Requirements

Design Controls are identified in 21 CFR 820.30. Every manufacturer of any class II or class III devices and certain Class I devices (class I devices with software, tracheobronchial suction catheters, surgeon gloves, protective restraints, radionuclide applicators, radionuclide teletherapy devices) need to control design per this regulation. The requirement for a Design History File is item j) and states:

“Each manufacturer shall establish and maintain a DHF for each type of device. The DHF shall contain or reference the records necessary to demonstrate that the design was developed following the approved design plan and the requirements of this part.”

The “requirements of this part” refer to the other bullets in 21 CFR 820.30 which can be summarized as:

a) Establish and maintain procedures to control the design of a device.

b) Design and Development Planning – Each manufacturer shall establish a plan that describes the design and development activities, and defines responsibilities for implementation.

c) Design Inputs – Manufacturers need to ensure design requirements relating to a device are appropriate and address the intended use of the device.

d) Design Outputs – Design outputs need to be documented in terms that allow an adequate evaluation of conformance to design input requirements. Design outputs that are essential for the proper functioning of the device should be identified.

e) Design Review – Formal documented reviews of design results should be planned and conducted at appropriate stages of device development.

f) Design Verification – Design verification confirms that the design output meets the design input requirements.

g) Design Validation – Design validation shall be performed under defined operating conditions on initial production units or their equivalents. It shall ensure that devices conform to defined user needs and meet the intended use of the device.

h) Design Transfer – Design transfer documentation shall ensure that the device design is correctly translated into production specifications.

i) Design Changes – changes should be identified, documented, validated/verified, reviewed, and approved before their implementation.

The Design History File is intended to be a repository of the records required to demonstrate compliance with your design plan and design control procedures. While companies are required to create and maintain this documentation according to the FDA regulation, not all of the documentation will be reviewed as part of the 510k. The following table compares the elements that comprise a DHF with the 510k design control requirements.

DHF Element 510k Design Control Requirements
Design Plan Not Required
User Needs Not Required
Design Inputs

Cover Sheet (Section 1) and

Declaration of Conformity (Section 9)

Some design inputs will appear in the form of standards in FDA Form 3514 (Cover Sheet) and the Declaration of Conformity FDA Form 3654 (Standards Data Report)

Design Outputs

Device Description (Section 11)

The Device Description lists the specifications of the device, and your Design Outputs document will help populate the Device Description. This can include drawings, pictures, or written specifications that describe your device.

Labeling

Proposed Labeling (Section 13)

The labeling is usually considered part of the Design Outputs within the DHF and is included specifically in the labeling section of the 510(k) submission. This includes both the Instructions for Use and any Package Labeling.

Verification and Validation Protocols

Not Required

You do not have to include the protocols, but the reviewer may ask to see them if they have any questions when reviewing the reports.

Verification and Validation Reports

Sterilization (Section 14)

Biocompatibility (Section 15)

Software (Section 16)

Electrical Safety and EMC (Section 17)

Bench Performance Testing (Section 18)

Animal Performance Testing (Section 19)

Clinical Performance Testing (Section 20)

Of course, not all of these sections will be applicable to every device. Still, you should include all relevant validation test reports within your submission in the appropriate part of the 510k. Typically, each of these sections will have a cover sheet that outlines the reports that are included within the section, and then you can just include the report from the DHF in its entirety behind the cover sheet in that section.

Process Validation Only required for sterilization validation typically, but there are exceptions for novel materials and coatings
Work Instructions Not Required for 510k
Design Review Meeting Minutes Not Required for 510k
Design Trace Matrix Only required for software
Risk Management File Sometimes – See Risk Management File Table Below
Post-Market Surveillance Plan Not Required, but a few exceptions for high-risk devices
Clinical Data Summary Required only if used to demonstrate safety and efficacy
Regulatory Approval It Will result from 510k Clearance, so nothing to be included in 510k submission.

510k Risk Management Requirements

Regarding the FDA regulations for risk management, there is a requirement under the Design Validation section of 21 CFR 820.30 that states:

“Design validation shall include software validation and risk analysis, where appropriate.”

For FDA compliance and CE Marking, both recognize ISO 14971 as the standard for risk management. FDA recognizes ISO 14971:2007 whereas EN ISO 14971:2012 is the European National version for CE Marking. Rob Packard wrote an article describing the contents of the risk management file as well as the specific differences in the requirements between the FDA and CE Marking with regard to ISO 14971.

For your 510k submission, the FDA only requires risk management documentation to be included if the product contains software, and the risk is at least a level of “moderate concern”. There are some other cases when risk management is required by special controls guidance documents, but even when it is required, you only have to submit your risk analysis. The table below describes the risk management requirements in greater detail.

RMF Element 510k Risk Management Requirement
Risk Management Plan Not Required
Hazard Identification

510ks with Software Only (Section 16)

Hazard Identification is only required for devices that have a software component. It is not required for most other devices.

Risk Assessment

510(k)s with Software (Section 16)

Certain Special Controls Guidance

The Risk Assessment is only required to be included in your device contains software, or if a special controls guidance document specifically requires a risk assessment. It is not required for other 510ks.

Risk Control Option Analysis Software and Certain Special Controls Guidance
Risk Control Verification and Validation

Sterilization (Section 14)

Biocompatibility (Section 15)

Software (Section 16)

Electrical Safety and EMC (Section 17)

Bench Performance Testing (Section 18)

Animal Performance Testing (Section 19)

Clinical Performance Testing (Section 20)

This will not be any additional or special documentation specific to Risk Management and was already included in the DHF breakdown above. Still, the verification and validation also relate to risk management in ensuring that the risks have been adequately mitigated.

Risk-Benefit Analysis

Not Required for 510(k)

Risk-Benefit analyses are only required for De Novo applications, Humanitarian Device Exemptions, and PMAs.

Informing Users and Patients of Risks

Labeling (Section 13)

Part of the risk management will appear in the Labeling section of the 510k as warnings, contraindications, and precautions within the Instructions for Use and Package Labeling.

Risk Management Report Not Required

Special Controls Guidance Documents with Risk Management Requirements

Your first step in preparing your 510k submission is to search the FDA Guidance Document Database to determine if there is an applicable guidance document for your device. You can read another blog we wrote to explain Special Controls Guidance documents, and how to determine if one applies to your device. The following list provides examples of Class II Special Controls Guidance documents that require risk analysis to be included within the 510k:

When there are 510k risk management requirements, the special controls guidance document will typically state, “We recommend that the summary report contain:

An identification of the Risk Analysis method(s) used to assess the risk profile in general as well as the specific device’s design and the results of this analysis. (Refer to Section 6 for the risks to health generally associated with the use of this device that FDA has identified.)

Discussion of the device characteristics that address the risks identified in this class II special controls guidance document, as well as any additional risks identified in your risk analysis.”

The special controls guidance will also identify risks to health that have been identified for products of that type, which you should be sure to include in your risk analysis as appropriate.

More Information on Design Control and Risk Management Requirements

Hopefully, you are now able to determine which elements of your DHF are 510k design control requirements and which elements of your RMF are 510k risk management requirements. If you would like more information about how to implement design controls and risk management within your product development process, please consider registering for one of our training webinars:

If you need any further information or specific assistance with your 510k submission, please feel free to send me an email at mary@fdaecopy.com or schedule a call with our principal consultant, Rob Packard. He can answer any of your medical device regulatory questions.


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Checking adverse event history for your device and competitors

The article explains checking adverse event data for medical devices as part of design and development, risk management, and post-market surveillance.

TPLC Database Checking adverse event history for your device and competitors

When should you be checking adverse event history?

There are three times when you should be checking adverse event history:

  1. when you are planning a new or improved medical device, and you want to know how current devices on the market malfunction (design and development planning),
  2. when you are identifying hazards associated with a medical device as part of your risk management process, and
  3. when you are gathering post-market surveillance data about your device and competitor devices.

Where should you be checking adverse event history?

Most countries have some kind of database for gathering adverse event data for medical devices, but most of these databases are not open to the public. The most common question I am asked is, “How do you access the Eudamed database?” for reporting of adverse events in Europe. Unfortunately, you can’t access Eudamed. The Eudamed database is only available to competent authorities at this time. The primary publicly accessible database for adverse event reporting is the US FDA MAUDE database. The MAUDE database is also integrated with other FDA databases for 510k submissions and recalls. This combined database is called the Total Product Life Cycle database.

Are there other public databases for checking adverse event history?

Yes. The Therapeutic Good Administration (TGA) in Australia makes adverse event data publicly available. The TGA also has a national registry for implanted orthopedic devices that publishes an annual report. Other countries also have public registries.

When will checking adverse event data for Europe be possible?

The Eudamed database for Europe was created in 1999 by the German organization DIMDI. In 2000 the responsibility for the database was taken over by the European Commission. The latest update is that manufacturers will be responsible for updating the Eudamed database in the future as part of the new European Regulations. This requirement will be implemented during the next years. The database will also become accessible to the public.

When you collect post-market surveillance data, which data should you collect?

Searching for post-market surveillance data should be performed on a risk-based frequency. If you have a brand new device, a high-risk device, or a device that is implanted, post-market surveillance data should be reviewed frequently–either monthly or quarterly. The new European guidance document for clinical evaluation reports (MEDDEV 2.7/1 rev 4) requires that clinical evaluation reports be updated at least annually for these devices. It is also important that you collect post-market surveillance data for both your device and competitor products. Therefore, you should be reviewing all the publicly available adverse event databases. You should also be reviewing your complaint data, and you should be searching for journal articles that may include adverse event data–possibly associated with a clinical study.

Available Resources

If you want to learn more about post-market surveillance data collection, please visit our webinar page. There is also a procedure for Post-Market Surveillance (SYS-019).

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Risk Management Traceability for CE Marking Technical Files

This article explains how to use risk management traceability for CE Marking in order to cross-reference hazards, risks, and risk controls throughout your technical file. This approach will more efficiently integrate risk management tools into your Design History File (DHF), post-market surveillance documentation, and clinical evaluation reports (CERs).

The table below provides a simple template for the nomenclature of risk management elements that you need to cross-reference and provides risk management traceability throughout your technical documentation.

Screenshot 2015 11 05 at 7.29.21 AM Risk Management Traceability for CE Marking Technical Files

The table does not include a cross-reference code for verification and validation reports because there could and typically are multiple risk controls that are validated and verified for each risk. Many times they are applied across multiple product lines. Therefore, it is more efficient to simply reference the controlled document number for the verification report that is applicable to that risk control.

Basic Concept of Risk Management Traceability

The concept of risk traceability is more than being able to identify the verification and validation study that was performed to verify the effectiveness of risk controls in your FMEA because it is in the same row of your table. The best practice is to number your hazards, risks, and risk controls so that you can cross-reference more easily throughout all your technical documentation [i.e., design requirements matrix, risk management file, clinical evaluation report, post-market surveillance plan / reports and post-market clinical follow-up (PMCF) report].

Design Requirements Traceability Matrix (DRTM)

The design requirements traceability matrix (DRTM) is a combination of two documents that have been used for the past two decades by medical device manufacturers: 1) the design requirements matrix or IOVV (i.e., inputs, outputs, verification, and validation), and 2) the risk traceability matrix. The second document is less commonly used, but an example of one is provided in Figure 3 of the GHTF risk management guidance document SG3 N15R8.

The risk management summary table that is presented in Figure 3 of the guidance also provides cross-references to specific tests, and each test has an identification number for traceability. This approach is also used frequently in risk control plans–an excellent tool for production process controls and planning product realization before process validation.

Risk Management Traceability to Post-Market Surveillance

I recommend that companies create a post-market surveillance plan for devices or device families during the design transfer process. This is NOT the post-market surveillance procedure. Your procedure should indicate the process you use for post-market surveillance. Still, your plan should be process-specific and identify specific risks that you intend to gather post-production data for. The post-market surveillance plan should provide traceability back to each risk in your risk management file (e.g., R1, R2, R3). You should include a post-market clinical follow-up (PMCF) protocol and report that also cross-reference to these risks and associated risk controls–or provide a justification for not conducting a PMCF study. In 2016, the new European Medical Device Regulations (EMDR) will require that both the protocol and the report be included in your post-market surveillance plan as a required section (see Annex II of the proposed regulations) of the technical file or design dossier. Finally, I recommend that you revise and update your risk management plan for post-production data collection at the time of design transfer. When you make this revision, I recommend moving the risk management plan from the design plan to your post-market surveillance plan as an integral part of the plan (i.e., one of the primary sections of the plan).

Risk Management Traceability for Your Clinical Evaluation Report (CER) 

In your clinical evaluation report (CER), if you simply said that “the clinical data reviewed addresses all of the residual risks identified in the risk management summary report,” you are not specific enough. Your clinical evaluation report (CER) should explain how the clinical study data you reviewed addresses each of the risks that you identified in your risk analysis. Personally, I like to have subsections in the discussion section of the clinical evaluation report (CER) for each of the risks identified in the risk management file. I also do this when I write my post-market surveillance plan. When I do this, I include a cross-reference to the applicable hazard in my design requirements matrix, risk analysis, and hazard identification summary report (e.g., “HZ1”, “HZ1” and “HZ3”).

Risk Management Traceability to Warnings & Precautions

ISO 14971:2007 indicates that disclosing residual risks to users of your device is risk control. In Annex ZA, deviation 7 of EN ISO 14971:2012, it indicates that you cannot claim to reduce the risks of your product by disclosing these residual risks–even though these are considered risk controls. You should still validate the effectiveness of the instructions for use, technique guide, and training through simulated use studies before product release. However, you cannot claim a quantitative risk reduction in your risk analysis as per deviation 7. Of course, there can be a reduction in overall risks when you train users, but you can’t claim it, and the prevalence of “use errors” demonstrates the limited effectiveness of IFUs and training.

Additional Risk Management References

I have published 14 previous blogs, specifically on the topic of risk management over the past couple of years. Please click here if you are looking for more information related to risk management. You can expect many more blogs on this topic during the next six months because I will be presenting four presentations in Brussels at an international medical device conference scheduled for June 13-17, 2016.

Procedures & Templates for Risk Management

If you are looking for a procedure (SOP) and associated form for risk management, please click here.

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Risk Management File Compliance for 510k and CE Marking

This article compares risk management file FDA requirements for CE Marking and 510k submission requirements.

Risk Management File Risk Management File Compliance for 510k and CE Marking

The FDA only requires documentation of risk management in a 510k submission if the product contains software, and the risk is at least a “moderate concern.” Even then, the 510k submission-only requires submission of a design risk analysis. Knee implants do not require submission of risk analysis, even though manufacturers are required to perform risk analysis in accordance with ISO 14971, because knee implants do not contain software. Therefore, it is not uncommon for a product that is already 510k cleared to receive audit nonconformities related to the risk management documentation during a technical file review by a Notified Body.

The FDA recognizes ISO 14971:2007 as the standard for risk management of medical devices. CE Marking also requires compliance with ISO 14971, but specifically the European national version of the standard (i.e., EN ISO 14971:2012). The most common technical file deficiencies related to risk management during a CE Marking application include the following:

  1. compliance with ISO 14971:2007 instead of EN ISO 14971:2012
  2. reduction of risks as low as reasonably practicable (ALARP) instead of reducing risks as far as possible (AFAP)
  3. reducing risks by notifying users and patients of residual risks in the IFU
  4. only addressing unacceptable risks with risk controls instead of all risks–including negligible risks

Each of these deficiencies is also explained in Annex ZA, ZB, and ZC of EN ISO 14971:2012.

7 Deviations

Notified Body auditors are supposed to be reviewing your risk management process and sampling your risk management files to verify that you conform with the requirements for risk management as defined in EN ISO 14971:2012 and the applicable European directive. Most manufacturers with CE Certificates have updated their procedures for compliance with the European National version, but the updates are not always complete or done correctly. Therefore, auditors need to be systematic in their review for compliance. I recommend creating a three-column table in your audit notes for each of the seven deviations. The first column would state the requirement from the applicable annex of EN ISO 14971:2012. The second column is used to document wherein the risk management procedure, each of the seven requirements, is addressed. Suppose you can’t find it quickly during your review–as the person you are auditing to find it for you. The third column is used to document which risk management file you sampled, and wherein the risk management file, the auditor was able to find compliance with one of the deviations. If the auditor can’t find an example of compliance in the procedure or the risk management file, then there is a minor nonconformity that needs to be corrected and recurrence needs to be prevented.

Note: Remember that auditing is about verifying compliance–not scouring 100% of the records for nonconformity.

Procedure Review

The first step in responding to correcting deficiencies in your risk management process is to update your procedure. The following basic elements need to be included in the procedure:

  • risk management plan
  • hazard identification
  • risk analysis
  • risk control option analysis
  • verification of risk control effectiveness
  • risk/benefit analysis
  • risk management report

Many of the procedures I review focus on the risk analysis process, and the most common tool for risk analysis is a failure mode and effects analysis. This is an excellent tool for process risk analysis, but it is only one of many possible tools, and it is not ideally suited for design risk analysis. In addition, your procedure is not adequate as a risk management plan. You need risk management plans that are product-specific or specific to a product family. Your risk management plan must also change and adapt as products progress from the design and development process to post-market surveillance. Finally, many of the procedures only require a risk/benefit analysis to be performed when risks are not acceptable, while the European MDD requires that all CE Marked products include a risk/benefit analysis for each risk identified in the risk analysis and the overall risk of the product or product family.

Risk Management Plans

Risk management is required throughout product realization, but the activities are quite different during the pre-market and post-market phases. Therefore, I recommend including a risk management plan as part of the design and development plan to address pre-market needs for risk management. Once a product development project reaches the design transfer phase, then a post-market risk management plan needs to be written. I incorporate this plan into the post-market surveillance plan for the product or product family. This approach ensures that the risk analysis will be linked directly with post-market surveillance after the product is released.

Hazard Identification

Many companies do create a specific document that identifies all the hazards associated with a product. This is an important step that should occur early in the design and development process before design inputs are finalized. During the development process, these hazards may need to be updated as materials and production processes are developed. Some companies may choose to identify hazards at a different time or in a different way. Still, the proposed European Medical Device Regulations (EMDR) requires that the dangers are recognized as one of the essential requirements. The ISO 14971:2007 standard suggests that design teams should identify as many hazards as possible, estimate the risks, and then implement risk controls for any unacceptable risks. The EN ISO 14971:2012 standard requires that risk controls be implemented for hazards–regardless of acceptability. For this reason, I recommend companies restrict their identification of hazards to the most likely product malfunctions and hazards of high severity. This list should include any hazards already identified in the FDA’s MAUDE database.

Risk / Benefit Analysis & Risk Traceability Matrix

To perform a risk/benefit analysis, you have to know the likelihood of potential hazards resulting in harm and the clinical benefits of a product. Unfortunately, reduced cost cannot be used to justify the acceptability of a device. Risk/benefit analysis must be performed for each risk and the overall residual risks. Therefore, it is important to identify the clinical benefits that outweigh each of the risks. I recommend using a risk traceability matrix in order to document each risk/benefit analysis. This can be a separate risk management document, or it can be incorporated into a design requirements matrix. It is also important to identify any warnings, precautions, or contraindications that should be documented in the information provided to patients and users when risks cannot be eliminated. This may be the last column of your risk traceability matrix.

Risk Management Report

The risk management report should be a summary technical document (i.e., STED). The STED should reference the procedure that was used and indicate all the risk management activities that were performed specifically to the product or product family defined in the scope of the risk management report. The dates of activities, changes made, and cross-references to any controlled documents should be included in the risk management report. I recommend maintaining the risk management report as a controlled document and revising the document to reference additional risk management activities when they occur. The bulk of details should be contained in the referenced risk management documents within the report.

Procedures & Templates

If you are looking for a procedure (SOP) for risk management, please click here.

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Using Instructions for Use and Labeling as Risk Controls in ISO 14971

Residual Risks Using Instructions for Use and Labeling as Risk Controls in ISO 14971This article reviews the requirements for Instructions for Use and labeling as risk controls in the risk management standard for medical devices: ISO 14971. Specifically, the impact of the seventh deviation identified in the European national version of the ISO 14971 Standard (http://bit.ly/ISO14971-2012changes) is reviewed. 

Labeling, instructions, and warnings are required for medical devices. Unfortunately, the information provided by manufacturers is not effective at preventing hazardous situations and foreseeable misuse–especially if the user throws the paper leaflet in the garbage 10 seconds after the box is opened. Since the information provided to the user and patients is not effective in preventing harm, the European Commission indicated that this information should not be attributed to risk reduction. 

The European Commission is not suggesting that your company should stop providing directions or warning users of residual risks. This deviation intends to identify incorrect risk estimation procedures. For example, if you are using Failure Mode And Effects Analysis (FMEA), (see Annex G.4 of the risk management standard) to estimate risk for a new product, you should not be listing labeling and IFUs as primary risk control. Clause 6.2 of the ISO 14971 Standard correctly identifies “information for safety” provided by the manufacturer as risk controls. Still, the effectiveness of these risk controls is so poor that you should not estimate that the implementation of labeling and IFUs reduces risks.

In Clause 2.15 of the ISO 14971 Standard, residual risk is defined as “risk remaining after risk control measures have been taken.” However, I prefer the following definition, which incorporates the concept of clinical evidence, design validation, and post-market surveillance:

“Residual risks are risks that remain: 1) after implementation of risk controls, 2) when products are used for new indications for use, 3) when products are used for wider user and patient populations, 4) when products are misused, and 5) when products are used for periods of time longer than the duration of pre-market clinical studies.”

The second essential requirement (ER2) states that users shall be informed of residual risks, but the conclusion that “information about residual risks cannot be a risk control” is incorrect. The most important wording in the deviation is ¨the information given to the users does not reduce the (residual) risk any further.¨ Failure to reduce risks any further is due to the lack of effectiveness of risk controls. Validation of risk control effectiveness should be performed during design validation, but validation will be limited to a small group of users and patients.

Risk Management Report & Post-Market Surveillance Plan

In your risk management report, risk control options analysis should be summarized. Instead of evaluating risk acceptability before implementing risk controls, risk controls should be implemented, and any residual risks should be identified. A risk/benefit analysis must be performed for each residual risk and the overall residual risks. If the conclusion is that the benefits of the device outweigh the residual risks, then the device can be commercially released.

At the time of the final design review and commercial release, a Post-Market Surveillance (PMS) plan should be developed that includes an updated risk management plan. The updated risk management plan should specifically address how to estimate residual risks and verify the effectiveness of information provided to users and patients. Verification of risk control effectiveness should be part of the design verification and validation activities, but verification of effectiveness should also be part of on-going PMS.

To facilitate future updates of your risk management report, you may want to organize risk controls into the following categories (in this order):

  1. Design elements (highly effective)
  2. Materials of construction (highly effective)
  3. Methods of manufacture (highly/moderately effective)
  4. Protective measures & alarms (moderately effective)
  5. Information provided to users & patients (least effective)

Each of the above risk controls will need to be addressed by your PMS plan.

This is the 7th and final blog in our Risk Management series. A Risk Management whitepaper will be released in January.

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Risk Control Options for Medical Devices: Deviation #6

This blog discusses risk control options for medical devices; the 6th deviation identified in the European National version of the Risk Management Standard.%name Risk Control Options for Medical Devices: Deviation #6

Design is not the same as design and construction. This is the interpretation of the European Commission. The sixth of the seven deviations identified in the European National (EN) version of the Risk Management Standard (i.e., EN ISO 14971:2012; http://bit.ly/ISO14971-2012changes), states that “inherent safety by design” is not precise enough. Section 2 of the Essential Requirements (i.e., Annex I of the MDD) states that the first risk control option must be selection of design and construction that eliminates or reduces risk as far as possible, while the international (ISO) risk management standard (i.e., ISO 14971:2007) only states that inherent safety by design is required.

The difference between the requirements of the ISO and the EN standard are not just semantics. If you read part II of the Essential Requirements (ERs; i.e., ER 7-13), there are many examples of how the construction of devices should be considered. The following are three examples:

  • ER 7.5 – leaking from the device
  • ER 8.2 – tissues of animal origin
  • ER 9.2 -aging of materials

Therefore, in order to comply the the intent of the Directive, you must consider far more than just the design of the device.  Construction is interpreted as both the risks associated with the materials to fabricate a device and the methods of manufacture. In the proposed EU regulations, the European Commission seeks to clarify the requirements for implementation of risk controls, but the draft legislation still seems vague.

Implementing Risk Control Options for Medical Devices

The following wording for implementation of risk control options in the new proposed second Essential Requirement is below:

“The manufacturer shall apply the following principles in the priority order listed:

a. identify known or foreseeable hazards and estimate the associated risks arising from the intended use and foreseeable misuse;

b. eliminate risks as far as possible through inherently safe design and manufacture

c. reduce as far as possible the remaining risks by taking adequate protection measures, including alarms; and

d. provide training to users and/or inform users of any residual risks.”

In this proposed wording, the word “construction” was replaced by the word “manufacture.” However, in other parts of the new proposed Essential Requirements (http://bit.ly/NewERCGap) the materials of fabrication are specifically addressed, as well. For example:

  • ER 7.1d) was added as a new requirement…”d) the choice of materials used, reflecting, where appropriate, matters such as hardness, wear and fatigue strength.”
  • ER 7.6 was added as a new requirement to address risks associated with the size and properties of particles—especially nanomaterials.

The new proposed Essential Requirements also include numerous examples of how the manufacturing processes must ensure proper safety. Essential Requirement 10 specifically references new Commission Regulation (EU) No 722/2012 (http://bit.ly/AnimalTissueReg)–specific to devices manufactured using animal tissues or cells of animal origin.

Even though the proposed regulations are more detailed with regard to application of risk management, they do not specify if it is required to implement risk control options for both materials and methods of manufacture simultaneously, or if the manufacturer may choose between the two. The phrase “taking account of the generally acknowledged state of the art” is used in the second Essential Requirement, but “state of the art” is a moving target, and the European Commission may find existing Standards to be deficient.

For reducing the risk of infection, the Commission does not require that companies implement aseptic processing, antimicrobial materials and terminal sterilization. One of the three is sufficient. This is why we have ISO Standards for sterilization validation, and we define “sterile” as a sterility assurance level of 10-6.

If the Commission maintained the language of the ISO 14971:2007 Standard, “as low as reasonably practicable,” then manufacturers could select risk control options based upon acceptability of risk. However, the EN version of the risk management standard creates significant challenges for implementation, and we are forced to evaluate the risk control measures we implement against those used by other manufacturers during the process of risk option analysis.

If you are interested in ISO 14971 training, we are conducting a risk management training webinar on October 19, 2018.

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Risk Control Selection – Deviation #5 in ISO 14971

The author reviews ISO 14971 Deviation #5, which is specific to selecting risk control options and protective measures for CE Marking medical devices.

%name Risk Control Selection   Deviation #5 in ISO 14971If your company is CE Marking medical devices, you are required to satisfy the Essential Requirements for Safety and Performance as defined in the three European Directives: the MDD, the AIMD, and the IVDD. Throughout these Essential Requirements, there is a requirement to reduce risks “as far as possible” (AFAP) by implementing risk controls. At one time, the expectation was for companies to implement state of the art concerning risk controls, and “state of the art” was interpreted as the latest version of the harmonized ISO Standards. However, lawyers dominating the European Commission appear to disagree with the status quo.

Therefore, in 2012, the European National (EN) version of the Medical Device Risk Management Standard was revised. There is no change to the content of Clauses 1 through 9. Instead, the European Commission identified seven content deviations between the ISO 14971 Standard and the EU Directives. These deviations are identified and explained in Annexes ZA, ZB, and ZC. This blog is the fifth installment of Medical Device Academy’s seven-part blog series on this topic. The goal of the series is to identify solutions for meeting the Essential Requirements by suggesting changes to the current best practices of implementing a risk management process for medical device design.

Discretion as to the Risk Control Options/Measures

Essential Requirements 1 and 2 require that risk control options are implemented for all risks before determining the acceptability of residual risks. The 2nd Essential requirement also requires manufacturers to implement all risk control options—unless the risk controls do not further reduce risk.iso14971 deviation 5 Risk Control Selection   Deviation #5 in ISO 14971

Clause 6.2 of the 14971 Standard suggests that you only need to use “one or more” of the risk control options, and Clause 6.4 indicates that further risk control measures are not required if the risk is acceptable. There is an apparent contradiction between the intent of the Standard and the Directives.

If risk acceptability has no impact upon whether you will implement risk controls, there is no need for performing a preliminary risk evaluation. Therefore, I have three recommendations for changes to your current risk management process:

  1. Ignore Clause 5 of the 2007/2009 version of ISO 14971
  2. Eliminate the second step of risk assessment from your flow chart for risk management (see Figure 1 from the 14971 Standard)
  3. Define risk management policies upon clinical benefits, rather than absolute risks

Instead of performing a preliminary risk evaluation (Clause 6.5), risk/benefit analysis should be moved to Clause 7, where the evaluation of overall residual risk acceptability is required. By making this change, risk controls will be implemented, regardless of risk acceptability, and acceptability of risks will be dependent upon the risk/benefit analysis alone.

Impact of this Deviation

Implementing changes to your risk management process to address this deviation has great potential to impact the design of devices—not just the risk management documentation. Design teams will no longer be able to stop the design process with an initial design that has an “acceptable risk.” Instead, design teams will be forced to implement additional risk controls and protective measures for device designs that already have a low risk of harm for specific failure modes.

The requirement to implement additional risk controls will increase the cost of devices that may have been relatively safe without the risk controls. For example, if a device is not intended to be implanted, but it is a potential foreseeable misuse. Your company may have used the instructions for use to communicate the residual risk associated with misuse of the device. However, now your company will have to implement design controls (e.g., –a selection of materials suitable for implantation) to eliminate the risks associated with misuse and protective measures (e.g., – radio-opaque thread) to help retrieve product that was implanted in an “off-label” usage.

If you are interested in risk management training, Medical Device Academy offers a risk management training webinar.

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