FDA: How to Follow Medical Devices?

Jane Akre
September 4, 2012

Public Invited to FDA meeting on Postmarket Surveillance

Barcode, Wiki, author, Maly LOLek

September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime.

If there is an auto recall the owner is notified and an auto dealership can easily identify a vehicle that might fall under a recall.

But if you have a medical device permanently implanted – there is no VIN number and no way to track the device - sort of out of sight, out of mind. Until it breaks, or is defective, or misfires, or causes more harm than it was used to treat.

Sounds a bit backwards doesn’t it?

The U.S. Food and Drug Administration will hold a Public Meeting “Strengthening the National Medical Device Postmarket Surveillance System” on September 10, 2012 at the Greenbelt Marriott in Greenbelt, Maryland but will also be available by Webcast.

If you want to attend you must register online by September 10, or if you want to watch the Webcast, registration to do so will close by the end of business on Wednesday, September 5. See more here.

This is of issue because so many devices have been found to be defective after they are implanted, largely due to the absence of oversight by the FDA pre-market.

The majority of medical devices are approved through an FDA process (510(k) ) that bypasses medical scrutiny and instead allows a manufacturer to site a similar device already sold as a "predicate" device.

Least Burdensome Approach

We believe we should consider the least burdensome approach in all areas of medical device regulation.”

In this case, the FDA is addressing manufacturers, not the public, who might benefit from the "least burdensome" medical device.

The FDA says it is notified of a problem with a medical device by a reviewer in the Office of Device Evaluation, or a scientist or the Office of Surveillance and Biometrics. However, some FDA whistleblowers have come forward to say their employer, the FDA, forced them to approve drugs and devices when they came forward and identified potential problems.

Tracking System Proposed, Not Implemented

The FDA has proposed each medical device have a unique code to allow for tracking.

Five years ago Congress mandated tracking codes that resemble bar codes found in grocery products. They would be affixed to the riskiest implant like pacemakers or mesh. Bed pans would not require a code. The code would also be on the packaging and would cost industry a projected $500 million to implement over a ten-year framework.

The tracking codes would be known as Unique Device Identifiers (UDI) and that code would be entered on a public online database. Not only could doctors and hospitals pull a faulty device from the market faster, but patients would be able to receive information about their defective device.

A UDI would also prevent counterfeit or stolen devices from the market.

As it stands now, a doctor or company must report a problem with a device, leaving it unclear whether the issue effects an entire lot or just that device.

“The UDI is really the lynchpin for modern post-market surveillance for medical devices,” Jeffrey Shuren, head of the FDA’s devices center told reporters in July.

Australia’s post surveillance monitoring was the first to identify problems with the now recalled DePuy metal-on-metal artificial hip.

The FDA can order Postmarket Surveillance under Section 522 (here) of the Federal Food, Drug and Cosmetic Act meaning that the manufacturer will be required to come up with a plan to monitor adverse event reports among users of its medical device that is implanted in the body for more than one year or is a life sustaining or life supporting device used outside of a facility.

Learn More:

Reuters on UDI


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