LTR Weekly Digest #5 - 23rd September, 2023
Catch up on this week's articles: world patient safety day challenge, medical device news update, post-market surveillance and a quick tip.
Dear colleagues, hello! 👋
This week, we focused on the theme of patient safety to mark the 2023 World Patient Safety Day, observed on September 17th. The World Health Organization (WHO) this year is encouraging us to help elevate the voice of patients so we can truly understand their perspectives on patient safety.
Want to help in this effort? Take the 2023 world patient safety day challenge for a chance to win a complimentary annual subscription (a $150 value) to the Let’s Talk Risk! newsletter. Note that the challenge closes on September 26th, 2023.
All of us have a strong desire to be patient-focused, yet we find ourselves stuck in a system that focuses mainly on compliance. This is one reason risk management proves to be a challenging exercise in practice. What if we made patient safety an explicit business goal? Would it inspire us to do things differently?
Check out the latest news about medical device innovations, warning letters and recalls here.
There is still time to register for live ISO 14971 training
Sign up today to save your spot in the next session of my Live ISO 14971 training starting early Oct 2023. Paid subscribers get 20% off list price.
Space is limited to only 15 attendees at one time. Pre-register here:
Last chance to register for this month’s webinar
A quick reminder to register for the September webinar where we will go deeper into 2 ways of estimating the probability of occurrence 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 “it is sufficient to analyze reasonably foreseeable misuse(s) only during the design and development phase of the lifecycle of a medical device” is FALSE.
Check out this week’s knowledge challenge question by scrolling down to the end.
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Here are the articles published this week
Premium content (with free preview)
Medical Device News Update - August 2023
Monthly roundup of FDA approvals, warning letters and recalls issued in August 2023 Each month, Let’s Talk Risk! (LTR) provides a comprehensive summary of new device approvals or clearances, warning letters, and Class I recall announcements issued by the FDA in the previous month.
Free content
2023 world patient safety day challenge
Dear colleagues, hello! 👋 This Sunday, September 17th, 2023, was the World Patient Safety Day. To mark this occasion, I would like to invite you to participate in this challenge so we can do our part in raising awareness of this important global issue.
Think of post-market surveillance as a value adding business process
Note: this article highlights key insights gained from a conversation with Per Maegaard as part of the Let’s Talk Risk! with Dr. Naveen Agarwal series on LinkedIn. Listen to the full recording of the discussion below. If you enjoyed this conversation, consider subscribing to
Quick Tip: Feeling stuck? Focus on patient safety, not compliance when managing risk
If you ask anyone in the medical device industry why they do risk management, you are likely to hear something like this: Yes, it’s good business sense. Not incorporating risk management can lead to exorbitant costs (and the obvious, patient safety issues) for a company in corrections and removals, not to mention the lawsuits if and when a device fails.