Regulatory Open Forum

Hello, 

I am building a business case for upper management regarding the evolving regulatory landscape and the economic impacts of non-compliance for issues related to biocompatibility. Would appreciate some good examples to show either as recall or lawsuits!

Thanks

Hello, 

Sadly not so difficult to find some very recent examples:

https://journal.emwa.org/medical-devices-2017/french-breast-implants-the-medical-device-regulation-and-a-theoretical-case-study/article/3087/emwa-26-2-frumento-2.pdf

https://www.fda.gov/medical-devices/safety-communications/update-certain-philips-respironics-ventilators-bipap-machines-and-cpap-machines-recalled-due

BR, Michael

Yes, there have been many, large and small, with a variety of causes - lapses in process control, careless material selection, egregious disregard for safety, or unexpected problems detected through good surveillance.

https://www.fda.gov/medical-devices/medical-device-recalls/fresenius-medical-care-recalls-some-hemodialysis-machines-potential-exposure-toxic-compounds

https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-trilogy-evo-ventilators-potential-health-risks-pe-pur-foam

https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-recalls-certain-bipap-machines-plastic-issue-may-expose-patients-certain

https://www.fda.gov/medical-devices/medical-device-recalls/smiths-medical-recalls-normoflo-irrigation-fluid-warmers-and-warming-sets-due-possibility-harmful

https://www.fda.gov/medical-devices/letters-health-care-providers/evaluation-airborne-chemicals-neonatal-incubators-letter-health-care-providers

https://www.fda.gov/news-events/press-announcements/fda-takes-action-protect-patients-risk-certain-textured-breast-implants-requests-allergan

https://www.fda.gov/medical-devices/letters-health-care-providers/update-nuvasive-specialized-orthopedics-precice-devices-letter-health-care-providers

https://www.fda.gov/medical-devices/implants-and-prosthetics/metal-metal-hip-implants

https://healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/11440r-eng.php

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=194778

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=183873

https://ewi.org/many-medical-device-recalls-stem-from-predictable-material-issues/