Synopsis of Social media discussions
Discussions demonstrate strong agreement with the article's concerns, highlighting that many cardiovascular devices lacked proper clinical testing prior to approval, with phrases like 'little clinical evidence' and 'serious safety recalls.' The tone emphasizes urgency and policy impact, reflecting high interest and engagement among participants who refer to the limitations of device approval processes.
Agreement
Strong agreementThe majority of discussions agree that the article highlights a concerning lack of clinical evidence for recalled devices, emphasizing the risks involved.
Interest
High level of interestPosts show high interest, with many referencing the lack of clinical testing and calling for regulatory reforms, indicating strong engagement with the topic.
Engagement
Moderate level of engagementSeveral comments analyze the implications of the findings and cite specific studies or policy concerns, demonstrating meaningful engagement.
Impact
High level of impactThe discussions suggest the article could influence public awareness and regulatory practices, as users emphasize safety issues and potential policy changes.
Social Mentions
YouTube
2 Videos
3 Posts
13 Posts
Blogs
3 Articles
News
17 Articles
Metrics
Video Views
1,136
Total Likes
39
Extended Reach
192,479
Social Features
38
Timeline: Posts about article
Top Social Media Posts
Kushal Kadakia, MD
@AnnalsofIM @UCSFDOM @see_laudia @hmkyale @jsross119 @MaryamMooghali @US_FDA @ZekeEmanuel (9/9) Be sure to check out the full paper @AnnalsofIM
https://t.co/TyZh0Pudvp
CC: @harvardmed @YaleMed @Yale_CRRIT @UCSFDOM
view full post
AshuJadhav
Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis https://t.co/ZrI5omeERT https://t.co/IFyHc5Wm5F
view full post
Yale CRRIT
New Paper
view full post
Annals of Int Med
Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/o9zte2kxqI
view full post
Igino Contrafatto
Most Recalled Cardiovascular Devices Gained FDA Approval With Little to No Clinical Evidence.
https://t.co/8Oa92sMk5u
view full post
Posts referencing the article
New Insights on Cardiac Devices and Myocardial Infarction Paradigms
This week, John Mandrola MD reviews reader feedback on cardiac devices and discusses the new 'occlusion MI' paradigm transforming acute myocardial infarction diagnoses. Explore how advanced ECG methods and AI improve cardiac care and outcomes.
October 11, 2024
591 views
Analysis of Cardiovascular Device Recalls and Safety Concerns 2013-2022
Cardiovascular devices account for about one-third of all FDA Class I recalls from 2013 to 2022, highlighting significant safety risks. This analysis discusses design issues, reliance on surrogate endpoints, and limited postmarket surveillance for these devices.
September 20, 2024
545 views
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RT @Contrafatto: Most Recalled Cardiovascular Devices Gained FDA Approval With Little to No Clinical Evidence. https://t.co/8Oa92sMk5u
view full postSeptember 29, 2024
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Igino Contrafatto
@Contrafatto (Twitter)Most Recalled Cardiovascular Devices Gained FDA Approval With Little to No Clinical Evidence. https://t.co/8Oa92sMk5u
view full postSeptember 29, 2024
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Yale CRRIT
@Yale_CRRIT (Twitter)New Paper
view full postSeptember 27, 2024
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Isabella
@Ling_Sophla_ (Twitter)RT @AnnalsofIM: ICYMI: Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required…
view full postSeptember 20, 2024
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Annals of Int Med
@AnnalsofIM (Twitter)ICYMI: Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/PKisx7IqjV
view full postSeptember 20, 2024
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Annals of Int Med
@AnnalsofIM (Twitter)Most cardiovascular devices subject to Class I recalls did not undergo pre-auth clinical testing & were not required to undergo post-market surveillance studies: https://t.co/05c2uIcFMP @HarvardMed @YaleMed @UCSF https://t.co/o9zte2kxqI
view full postSeptember 17, 2024
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Kushal Kadakia, MD
@ktkadakia (Twitter)@AnnalsofIM @UCSFDOM @see_laudia @hmkyale @jsross119 @MaryamMooghali @US_FDA @ZekeEmanuel (9/9) Be sure to check out the full paper @AnnalsofIM https://t.co/TyZh0Pudvp CC: @harvardmed @YaleMed @Yale_CRRIT @UCSFDOM
view full postSeptember 17, 2024
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Tatyana Shamliyan
@ShamliyanTA (Twitter)recalled medical devices "often had little clinical evidence supporting their original authorization" Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis: Annals of Internal Medicine: Vol 0, No 0 https://t.co/ji1IFY1Zj3
view full postSeptember 17, 2024
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ong beng hooi
@ongbenghooi1 (Twitter)RT @AshuPJadhav: Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis https://t.co/ZrI5omeERT https:…
view full postSeptember 16, 2024
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AshuJadhav
@AshuPJadhav (Twitter)Class I Recalls of Cardiovascular Devices Between 2013 and 2022: A Cross-Sectional Analysis https://t.co/ZrI5omeERT https://t.co/IFyHc5Wm5F
view full postSeptember 16, 2024
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Sarah Melville
@sarahkmels (Twitter)@dr_benoy_n_shah @TCTMD_Caitlin @TCTMD relatedly, & I think related to a blog article that you wrote about device regulation too- (I think it was you, but I can't find it now...), this is a great study that was published today via @AnnalsofIM by @hmkyale et al: https://t.co/66uP2AxkTo $gated
view full postSeptember 16, 2024
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Robert West, PhD ✝️
@westr (Twitter)Most #cardiovascular devices with serious #safety recalls aren’t tested in patients https://t.co/bSO3sIpkCS via @statnews https://t.co/WFPS2Sxq2M
view full postSeptember 16, 2024
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Chris Hendel
@chrishendel (Twitter)Just out in @AnnalsofIM A study of CVD devices subject to Class I recalls from 2013 through 2022 found that most recalled devices did not undergo clinical testing prior to authorization & were not required to undergo postmarket surveillance studies. https://t.co/BeD2kRBeLx
view full postSeptember 16, 2024
Abstract Synopsis
- Cardiovascular devices account for about one-third of all Class I recalls by the FDA between 2013 and 2022, which are the most serious recalls indicating potential for severe health risks or death.
- During this period, 137 Class I recalls affected 157 different cardiovascular devices, mostly moderate-risk, with design issues being the leading cause.
- Most clinical studies supporting device approval relied on surrogate and composite endpoints, and many devices had multiple recalls; however, postmarket surveillance was limited, especially for 510(k) devices.
Antonio Giordano MD PhD/SHRO
@GiordanoHealth (Twitter)