FDA Releases Video on Counterfeit Detection Device 3
The FDA has released more information about their new counterfeit drug detection device, Counterfeit Detection Device 3 (CD-3). In this newly-released video, Nico Ranieri, the FDA research biologist who developed this new technology talks about how important such innovations are to patient safety.
In
2005, it first occurred to Nicolas Ranieri to try to use the type of
ultra-violet light devices deployed in crime scene investigations in a
hand-held counterfeit drug detection device.
Up to that point, drug testing equipment was both delicate, expensive, and
also required highly-trained scientists to
perform the tests for fakes. Says
Ranieri, “We wanted to find counterfeits, and we wanted to find them as fast as
possible,” reports the FDA.
The FDA has released more information about their new counterfeit drug detection device, Counterfeit Detection Device 3 (CD-3). In this newly-released video, Nico Ranieri, the FDA research biologist who developed this new technology talks about how important such innovations are to patient safety.
In
2005, it first occurred to Nicolas Ranieri to try to use the type of
ultra-violet light devices deployed in crime scene investigations in a
hand-held counterfeit drug detection device.
Up to that point, drug testing equipment was both delicate, expensive, and
also required highly-trained scientists to
perform the tests for fakes. Says
Ranieri, “We wanted to find counterfeits, and we wanted to find them as fast as
possible,” reports the FDA.
Ranieri
started building the mobile testing tool at home after work, where he created a
basic test version. Then with the help
of Mark Witkowski of the FCC, he built a prototype handheld testing device.
The
current model of the device, CD-3, was unveiled September 10, 2012, reports
CNN. According to the FDA, CD-3 makes
drug and package differences obvious, even to laymen. Its ease of use and small size makes it an
ideal testing tool for remote locations throughout the globe.
When
Margaret Hamburg spoke at the Partnership for Safe Medicines Interchange in
2012, she described the CD-3 as a low-cost and effective counterfeit
drug-testing tool that was already in use in 50 FDA field laboratories.
The
FDA reports it is working in partnership with the Presidential Malaria
Initiative, and the US Agency for International Development (USAID) to
introduce the use of the CD-3 device globally.
The first place outside of US jurisdiction it will be deployed is Ghana,
where The Centers for Disease Control and Prevention and the National
Institutes of Health will provide technical training on its use. Samples from hospitals, clinics, and
pharmacies will be tested with the CD-3.
Products that are discovered to be fake will be subjected to further
chemical testing in a quality control laboratory.
Describing
the FDA’s mandate for developing the CD3, Leigh Verbois, Acting Assistant
Commissioner for Compliance Policy said “Developing innovative approaches to
address public health needs is critical.
And that’s what we did here.”