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FDA Medical Device Approval Process Under Review Due to Recalls With Numbers of Implanted Devices

Posted Feb 15 2011 12:41am

On medical devices we are back to the sometimes controversial Fast track 510 (k) approval method to where the device can be similar to another device on the market and is intended for low and moderate risk situations.  Implants to me are not low or image moderate.  If you have read here enough and seen the poll on the right hand side then you are aware of the bar code scanning campaign I have had for about a year now.  This does not preclude the fact that the FDA needs a better system for approvals but at least when they happen patients can be notified faster and it even works for over the counter and prescription drugs, so we can kill many evils when recalls do occur. 

Here’s a sample of a past article.  I have written to the FDA, the DEA and some drug and device companies but nobody is interested in the consumer it appears. 

FDA Publishes Information on How to Identify Recalls – Why Not Scan That Stent With A Cell Phone and Make It Easy for the Public and Manufacturers To Keep Up, Notify And Automate Compliance

Tags for Use in Healthcare – Medical Stents, Medications - One Scan Away From Safety Information in Real Time

Devices also get tricky and complex when so many of them today also have software included, a chip that tells the device to do something and as having written software, that’s a tough subject and we heard all about that with the radiation errors and over doses created by the software.  How about all these blood pressure machines that were recalled?

Patients want the ability for over the counter products.  Again the FDA has no system and recalls are missed.  I don’t know what the real answer is here for access or speed, but one thing that looks like there’s room for improvement is the actual testing and not give all the fast track approval.  BD 

Pfizer Consumer Healthcare Recall of One Lot of ThermaCare HeatWraps Menstrual Product–Get A Better Recall System

The FDA is reviewing the current approval process of medical devices after thousands were linked to death or injury. Dr. Jon LaPook reports on the new study calling for stricter approval processes.

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