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 Risk Management Series Introduction – Beyond FMEA – Updated 10/30/2014

MEDIcept is presenting this paper as an introduction to an ongoing series of articles focused on the conduct of risk management in the medical device industry.

Medical Device Risk Management Series – Part 2: Prioritizing Risk Management Activities – Updated 10/30/2014

This second article in our series addresses a common risk analysis problem – prioritization.

In large medical device companies, the email invitation to a Failure Mode and Effect Analysis (FMEA) risk management session can strike fear (or at least dread) into the hearts of engineers and other members of the risk management team. One reason that they may not be eager to click “Accept” is that these sessions can quickly devolve into detailed investigations of issues of negligible severity or probability of occurrence that soak up the team’s time and energy – to the point that important issues may not receive the attention they deserve.

Small medical device companies, without a mature product line or risk management system, may have the opposite problem. There, the list of hazards being considered may be limited to those issues that are most obvious to the design team and may not provide a comprehensive assessment of device risks. Instead of an overly detailed analysis, these companies run the risk of not going deep enough.

This article provides an introduction to approaches that device companies have successfully implemented to focus their risk management activities and help to ensure the safety and efficacy of their products.

Risk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis – Updated 11/10/2014

In our previous article (Part 2: Prioritizing Risk Management Activities), we described an approach for identifying the design element(s) or process stages(s) to prioritize when conducting a comprehensive risk analysis. This prioritization helps to ensure that the team’s resources and energy are directed toward those areas that will have the greatest impact on device safety. This article focuses on the use of Fault Tree Analysis to ensure that you take a comprehensive view of hazards/failures before jumping into completing an FMEA.

Risk Management Series – Part 4: Transferring Risks from Fault Trees to FMEAs – Updated 11/10/2014

In our last article, Part 3: Using Fault Trees to Focus and Simplify Risk Analysis, we described the basic approach for conducting a Fault Tree Analysis (FTA) and the benefits of using FTA to conduct a comprehensive analysis of the causes of device failures and use errors. We also identified a few weaknesses of the FTA approach – i.e., its structure can be un-wieldy, and there is no efficient way to track the implementation of needed mitigations, or to document that you’ve verified that the mitigations are effective. These weaknesses happen to be two of the strengths of the FMEA risk analysis format. Therefore, this article describes an approach for transferring risk information from a completed FTA to an FMEA so that you will be able to take advantage of the strengths of both.

Risk Management Series – Part 5: Assessing Severity

Our previous articles have focused on the role of risk management in improving device safety, the importance of prioritizing risk management activities, the use of Fault Tree Analysis (FTA), and how to transfer FTA results into FMEAs. In this article, we will begin to explore specific topics related to the conduct of FMEAs by addressing the challenge of assessing the severity of harm.

Risk Management Series – Part 6: Estimating Probability of Occurrence

In our last article, Part 5: Assessing Severity, we addressed the importance of doing your “homework” before attempting to assess the severity of identified hazards/harms, clearly defining the use environment and user profile being considered, and distinguishing between harms that occur as a direct result of the hazard/hazardous situation and harms that will only occur as the result of a series of subsequent events. This article addresses the other major element of risk, the Probability of Occurrence of Harm.

Risk Management Series – Part 7: Determining Risk Acceptability – Part A

In our last two articles, RM 5 – Assessing Severity and RM 6 – Estimating Probability of Occurrence of Harm, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes the next step to address the question: Are we, as a company, willing to accept the risks associated with our device given the benefits that a patient is likely to receive? This article (Part A) provides a review of the standard approach. A second article (Part B), will provide our thoughts on the challenges.

Risk Management Series – Part 7: Determining Risk Acceptability – Part B

In our last two articles, RM 5 – Assessing Severity and RM 6 – Estimating Probability of Occurrence of Harm, we discussed approaches to develop values for these two elements of risk and the challenge of completing these assessments/estimates. This article takes the next step to address the question: Are we, as a company, willing to accept the risks associated with our device given the benefits that a patient is likely to receive? This first part of this article (Part A) provided a review of the standard approach. This article (Part B), provides our thoughts on the challenges of applying that approach.

Risk Management Series – Part 8: Risk Control

Our last article, Determining Risk Acceptability (RM7 – Parts A and B), described the standard approach (i.e., ISO 14971) for evaluating medical device risk and assessing the acceptability of those risks. We also identified some challenges that you will face when implementing the standard, and presented some approaches for overcoming those challenges. This article addresses Risk Control – i.e., what to do when you find you identify unacceptable risks.

Risk Management Series – Part 9: Risk Management Report

Our last article, Risk Control and Verification (RM8), described the standard approach (i.e., ISO 14971) for identifying appropriate risk controls – following the priorities: inherent safety by design, protective measures, and information for safety. It also, addressed the importance of verification and provided some guidance for determining the most appropriate approach for conducting your verifications. This article describes the Risk Management Report – i.e., summarizing the work that has been done, assessing the overall residual risks, and describing how risks will be managed going forward.

Clinical Evaluation Reports – Tying it All Together (Article 1 of 3)

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance.

As you work to update existing clinical evaluation reports, and create reports for devices that were previously exempted from the requirement, it’s important not to view these reports simply as a regulatory requirement – a report to be created, approved, filed and forgotten. The guidance is structured to help manufacturers bring important safety and performance together – providing a comprehensive evaluation of you devices, and confirming the alignment of key quality system elements. Maintaining these reports throughout the product lifecycle will support the continual improvement of your devices.

Clinical Evaluation Reports – Tying it All Together (Article 2 of 3)

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports (CERs) for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance. The last article gave a quick overview of CERs and the need for an internal Standard Operating Procedure. This article will discuss the elements of the CER.

Clinical Evaluation Reports – Tying it All Together (Article 3 of 3)

Our team at MEDIcept has worked with a variety of manufacturers to develop Clinical Evaluation Reports (CERs) for a wide range of devices and device classifications; with these articles, we will provide an overview of the steps for completing a CER and describe the benefits of bringing clinical and safety data, risk analyses, and product literature (e.g. labeling and manuals) together in one place to provide an objective, transparent evaluation of device safety and performance. The last two articles gave a quick overview of CERs, the need for an internal Standard Operating Procedure, and the basic elements of the CER. This article will discuss the final CER report.

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