The FDA Rarely Forces Manufacturers to Recall Dangerous Medical Devices
a day ago
- #Medical Devices
- #FDA
- #Recalls
- The FDA rarely uses its authority to recall dangerous medical devices, with only four forced recalls since 1992.
- A GAO report highlights FDA's staffing shortages, impacting its ability to oversee recalls and protect patients.
- Philips Respironics recalled breathing machines in 2021 due to toxic foam, but only after years of complaints.
- The FDA received over 500 reports of deaths linked to Philips' devices since the recall.
- FDA's recall notification system is outdated, relying on faxes and lacking a modern data infrastructure.
- Staffing cuts under the Trump administration have worsened FDA's ability to manage recalls effectively.
- Philips agreed to pay over $1 billion to settle lawsuits but admitted no fault or liability.
- New legislation proposed by Senators Durbin and Schakowsky aims to improve FDA's recall processes and notifications.