🔎 Former FDA Investigator | Life Sciences Consulting | Quality & Compliance | MD+DI's Medtech Voice to Follow in 2024
Great reporting from Katie Hobbins on how #FDA is facing scrutiny over a huge increase in #meddevice recalls and in particular the Philips CPAP recall case. Katie writes that "congress is calling for a probe into how FDA tracks warnings about dangerous and recalled devices as well as how it takes actions against companies that put its customers at risk." What seems to be the reason for such an increase in recalls and adverse events⁉️ According to the article: "In 2022, nearly 900 medical devices were recalled by FDA, representing a 125% increase compared to 2012, which saw 399 recalls. "That number included 70 Class I recalls — FDA’s highest and most serious classification — becoming a 15-year high. "Medical device adverse event (AE) reports also increased by 505% from 2012 to 2022." https://lnkd.in/dZQwwZiZ ~~~ If you found this interesting, consider Reposting 🔄 and follow me Vincent F. Cafiso so you don't miss future content.
Michael Spiegler
10mo
Very intriguing Vincent F. Cafiso. Top of the order would be a better #maude and #FAERS tool to understand these incidents as per our discussion. The current databases and reporting don't seem sufficient to truly understand the background of these complex and time-consuming recalls.
The culprit is an industry and regulatory agency emphasis on managing risks through compliance rather than analyzing and managing risks based on good science and engineering principles. The first step is to rethink ICH Q9 from the standpoint of risks being more than just events that have a severity and likelihood of occurrence. Bad things happen because of bad system. The current methods pretty much ignore a risk's mechanism of action - its risk system.
Leader at Johner Institute | Passionate about patient safety | Expert in Clinical & Safety Regulatory Compliance | Personal Coach in Training
10moThe article on the FDA's increased scrutiny regarding medical device recalls, particularly following the Philips Respironics case, highlights a critical issue in healthcare. The significant rise in recalls and adverse events reports calls for urgent action and thorough review. Senators Durbin and Blumenthal's initiative for a GAO probe into FDA's oversight is a commendable step towards ensuring patient safety and accountability. This situation underscores the importance of stringent regulatory compliance and proactive risk management in the medical device sector.