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

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

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 – Article 7: Determining Risk Acceptability – Part A

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

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 6: Estimating Probability of Occurrence

MEDIcept presents this ongoing series of articles focused on the implementation and practical conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, to maintain compliance with risk management standards.

Our team at MEDIcept publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

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 5: Assessing Severity

MEDIcept presents this ongoing series of articles focused on the implementation and conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, maintain compliance with risk management standards. Our team at MEDIcept, publishes these articles to capture best practices, to explore the more challenging aspects of maintaining risk management systems over the long term, and to elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

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 4: Transferring Risks from Fault Trees to FMEAs

MEDIcept is presenting this ongoing series of articles focused on the conduct of risk management in the medical device industry to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, maintain compliance with risk management standards.

Our team at MEDIcept, plans to use these articles to capture best practices, explore the more challenging aspects of maintaining risk management systems over the long term, and elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know: 508-231-8842.

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 document that you’ve verified that the mitigations are effective. These weaknesses are 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.

Clinical Evaluation Reports 3 of 3

MEDIcept, an international medical device consulting firm is presenting this as an ongoing series of articles focused on Clinical Evaluation Reports in the medical device industry.

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.

If you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know. 508-231-8842.

Clinical Evaluation Reports 2 of 3

MEDIcept, an international medical device consulting firm is presenting this as an ongoing series of articles focused on Clinical Evaluation Reports in the medical device industry.

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.

If you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know. 508-231-8842.

Clinical Evaluation Reports 1 of 3

MEDIcept, an international medical device consulting firm is presenting this as an ongoing series of articles focused on Clinical Evaluation Reports in the medical device industry.

Recent changes to the Medical Device Directive (MDD) have led to a renewed focus on Clinical Evaluation Reports (CERs), and extend that requirement to all devices – regardless of classification.

Our team at MEDIcept has worked with a variety of manufacturers to develop 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.

If you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know. 508-231-8842.

Risk Management Series – Part 3: Using Fault Trees to Focus and Simplify Risk Analysis

MEDIcept is presenting this as an ongoing series of articles focused on the conduct of risk management in the medical device industry. The intent of the series is to provide practitioners with insight into how to apply risk management principles and tools to improve the performance and safety of their devices; and, as an added benefit, maintain compliance with risk management standards.

Our team at MEDIcept, plans to use these articles to capture best practices, explore the more challenging aspects of maintaining risk management systems over the long term, and elicit discussions among practitioners.

To this last point, if you have questions or comments on the issues discussed, or if you have recommendations for topics to consider in the future, please let us know. 508-231-8842.

Medical Device Risk Management Series – Part 2: Prioritizing Risk Management Activities

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.