FDA Steps Up Medical Device Monitoring – It’s About Time
Could the entire mesh mesh have been averted much sooner before perhaps one million women were implanted with controversial transvaginal mesh?
Yes, if the U.S. tracked medical devices the way it’s done elsewhere.
The Food and Drug Administration (FDA) is finally taking a step in that direction.
The FDA has just announced a final rule for the Unique Device Identification System (UDI). This will allow a device to be tracked once it is approved to see how it fares in real-life conditions.
Here is how it will work. Each device will be assigned a number that identifies the version or model, production lot or batch, the date it was manufactured and if applicable, the expiration date. This will appear in the form of a barcode also known as AIDC or Automatic Identification and Data Capture.
The FDA had originally wanted to imprint each implantable device with this bar code, but in a concession to industry, it will appear on the label and packaging only. Better hope one does not become separated from the package. Some external devices that undergo repeated use will have the data marked directly on the device in the form of a readable barcode.
This is a reflection of the FDA’s “least burdensome” standard for the $100 billion-a-year medical device industry, which had an influence in crafting the UDI system.
And since this information is no good without a corresponding database, the FDA will create a Global Unique Device Identification Database (GUDID), which is searchable by the public. The device identification will be entered minus any specific patient information.
Head-In-the-Sand Approach Post Approval
Up until this time, the U.S. did not monitor medical devices after they were approved. Since the bulk of medical devices, as many as 3,000 of the 4,000 approved each year did not have to prove safety and efficacy, we’ve seen the real-life clinical trials in the unfortunate patients who’ve received defective devices.
This is particularly true in implantable hip and knee prosthesis, metal-on-metal hips, defibrillators, transvaginal mesh and stents, some of which were later recalled or have caused havoc in patients and likely should be recalled.
Since the U.S. is not watching such things, it did not notice, for example, that the DePuy hip implants were failing far short of their 15-year performance promises.
It took Australia, with its National Joint Replacement Registry, a post-approval monitoring program, to notice the higher than expected revision rates of metal-on-metal hips and initiate a recall far in advance of the U.S. saving many people from a lifetime of complications.
New, Improved System
When there is a problematic device, companies, doctors and patients will know sooner allowing any recall to be faster and more effective, says the FDA’s medical device director, Jeff Shuren, MD.
High-risk medical devices such as heart valves, hip prostheses and pacemakers will be introduced to the system first. Manufacturers will have one year to phase in the UDI on the label and packaging. Moderate risk or Class II devices will have three years and Class I, the least dangerous, will either be exempt or have five years to enter the information.
Mesh will be phased in under Class II. According to the FDA’s Morgan Liscinsky:
“Here is a link to the UDI information: http://www.fda.gov/
MedicalDevices/ DeviceRegulationandGuidance/ UniqueDeviceIdentification/ default.htm
“There is a chart that outlines the compliance dates for the UDI final rule. According to the chart, 3 years after publication of the final rule the labels and packages of class II medical devices must bear a UDI; dates on the labels of these devices must be formatted as required by § 801.18; class II stand-alone software must provide its UDI as required by § 801.50(b); and data for class II devices that are required to be labeled with a UDI must be submitted to the GUDID database.”
The plan is for this UDI system to go global since many U.S.-made devices are exported. Manufacturers also hope it cuts down on counterfeit medical devices.
Here is a fictitious medical device as an example of what the code will look like:
MDND, Sept 4, 2012, How to Follow Medical Devices
Fierce Medical Devices
FDA on UDI