For medical uses, the only FDA-approved radio frequency identification (RFID) chip is the one made by VeriChip Corp, a division of Applied Digital Solutions (ADS). VeriChip Corp no longer manufacturers RFIDs, but according to recent reports, at least two other companies have plans to manufacture and market VeriChip’s innovation for medical purposes under the FDA approval granted in 2004. However, the FDA has been evaluating the effect of RFIDs on other medical devices -- an additional safety parameter that medical device manufacturers may need to evaluate if they seek FDA approval.
Radio frequency identification (RFID) chips use radio frequencies to transmit data wirelessly. The chips are approximately the size of grain of rice. They serve a variety of purposes including tracking items and people by retail establishments, hospitals, military personnel and government officials.
In a hospital setting, the RFID microchip is generally placed near a medical device, artificial implant or subcutaneously (beneath the skin) during surgical procedures. The data programmed into the RFID chip includes medical history and personal information, which can be used to identify unconscious people in an emergency situation. When a patient agrees to have the RFID chip implanted, they essentially make their personal data available to someone with a reader. This type of access raises concerns about privacy often associated with the digitalization of medical records; a potential “adverse health effect” cited by the FDA in 2004 as “compromised information security.”
In addition to privacy concerns, the FDA has been investigating the potential for the electromagnetic waves emitted by RFID chips to interfere with medical devices and instrumentation. Potential effects of RFIDs on medical devices include movement or failure of the device and incompatibility with MRIs. As a result, the FDA and California-based MET Labs have partnered together to evaluate safety concerns with RFIDs and medical devices. MET Labs conducts regulatory testing for RFID devices and much more in the US, Canada and Europe. The company recently announced the completion of its first susceptibility testing program with a medical device. In the first round of evaluations, MET Labs measured effects of different radio frequencies against the performance of a battery operated, vital signs monitoring device worn by a patient. Plans for testing other devices are on the table, and the company is open to inquiries from interested medical device manufacturers.
At least two companies are looking to manufacture and market the RFID technology for medical uses right now: PostiveID (PSID) and VeriTeQ. They are relying on the 2004 FDA-approval letter, which generically describes the VeriChip as an “implantable microchip with a radio frequency transponder system to be used for patient identification and health information.” PSID has partnered with Receptors LLC to target diabetes patients with a “Glucochip.” VeriTeQ reportedly plans to offer the RFID chip for identification of breast implants and artificial joint replacements. Whether or not these uses fall within the scope of the FDA’s 2004 approval letter is unclear.
Ultimately, susceptibility to RFIDs may become an FDA-required safety parameter for medical device manufacturers. This testing may also become an requirement for companies like PSID and VeriTeQ as the regulatory landscape evolves with new technologies.