LTR Weekly Digest #3 - 9th September, 2023
Catch up on this week's articles: a case study about using post-market data to evaluate changes in risk level, focusing on the customer not compliance, and a summary of 5 recent LTR conversations.
Dear colleagues, hello! 👋
Do you use the P1, P2 approach to estimate the probability of harm (POH) in your risk analysis process?
If so, check out this week’s case study about how you could utilize complaints and adverse events data to estimate P1, P2 and POH for different risks of harm and evaluate if they still continue to meet your risk acceptability criteria.
Catch up on recent Let’s Talk Risk! conversations you may have missed in this summary article.
Finally, a quick tip to periodically review your procedures, work instructions, forms and templates to make sure they make sense from a practical point of view and encourage continuous improvement, rather than serve as a tool for compliance.
Monthly Webinar
As part of our monthly live webinar series, this month I will review two different approaches for numerically estimating the probability of harm (POH).
If you are a paid subscriber, you will receive an email with a link to register for this month’s webinar on Sep 26, 2023 at 11:00 AM EST. You don’t need to pay extra.
If not, you can still attend this webinar with a one time payment of only $25. Click the link below to make a payment and secure your spot. Once you complete the payment, you will receive the registration link by email.
Ask a risk management question
Now you can ask a risk management question for quick answer and practical tips!
Weekly knowledge challenge
I hope you enjoyed the knowledge challenge question last week. Here is the correct answer:
The statement “a device malfunction will always lead to patient harm” is FALSE.
Check out this week’s knowledge challenge question by scrolling down to the end.
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Thank you for your support and I hope you enjoy reading these latest articles!
Here are the articles published this week
Premium content (with free preview)
Case study: Using post-market data to evaluate changes in risk level
What if we could develop a method to directly estimate a probability of occurrence of harm (POH) associated with device malfunctions using actual post-market data? This could not only help us monitor changes in the risk level for an existing device, but it could also provide a set of baseline data to use in the development of the next generation of devices.
Free content
Quick Tip: Focus on the customer not compliance in your procedures
Are we too focused on regulatory compliance in the medical device industry? Yes, it is absolutely critical to be fully compliant with applicable regulatory requirements. But that is not the main goal of your Quality Management System (QMS)! Did you know that one of the most common findings in audits is
Insights from 5 recent Let's Talk Risk! conversations: July-Aug 2023
Note: Each week, we talk to risk practitioners and thought leaders in a live LinkedIn audio event. These are very casual and informal conversations about practical challenges and best practices for risk management of medical devices. Key highlights are published each week on Saturdays.