Webinar 2: two ways to estimate the probability of harm

In this month's webinar, we discuss 2 ways you can use the post-market surveillance data to estimate the probability of harm, and how it can help you evaluate changes in the risk level.

Dear colleagues, hello! 👋

We continue our monthly live webinar series this month with a focus on estimating risk and a practical way to monitor changes in the risk level during the post-market phase.

Here is an excerpt from this webinar - paid subscribers, please scroll down to access the full recording.

Our discussion focused on two different commonly used methods of numerically estimating the probability of occurrence of harm (PoH). We used a case study to illustrate how post-market data could be used to calculate the PoH using the P1, P2, method.

Here are some of the questions from the audience we discussed during the webinar:

1. How would you define probability categories for a new device with little clinical information on frequency?

2. How to build a probability scale for different types of medical devices?

3. How to analyze complaints data using standardized codes to estimate the probability of harm?

4. Is there a certain sequence for severity and probability we should use when analyzing a hazardous situation? For example, first assess the severity of harm for a hazardous situation, then calculate the probability?

5. Why do you recommend using a logarithmic scale for probability categories?

6. Let us say one of the harms in our list is the harm of bleeding from a cut. It can have a low severity or high severity. How should we calculate the probability for these two different situations?

Watch the full recording with audience Q&A below.