Jamm's Q Inside ID Technology is a first-of-its-kind implantable RFID technology cleared for use by the FDA in 2004 as a Class II medical device. This micro-transponder is approved for subcutaneous use in humans or as part of an implanted medical device (subject to device efficacy testing). It is especially important for medical device manufacturers interested in identifying their products during manufacturing, supply chain, and distribution, and more importantly, to help physicians identify medical devices from within the body after they are implanted.
Implementation of Jamm's Q Inside ID system can help provide peace of mind to patients, device manufacturers, healthcare providers, risk managers and regulatory authorities.
Jamm's Q Inside ID Technology can be used within implantable medical devices such as breast implants, vascular ports, artificial joints and dental implants, among others. Including Q Inside ID Technology within implantable medical devices helps ensure rapid and accurate access to device data (i.e. device manufacturer, serial number, lot number, batch number, etc.), which may be potentially lifesaving in the event of a product recall or when an adverse event report is issued by the FDA. Q Inside ID Technology also validates a device manufacturer's brand quality and verification.
The FDA published its Final Rule for Unique Device Identification in September 2013, which incorporates a Global Unique Device Identification Database (GUDID) maintained by the FDA. One of the main principles of the FDA's GUDID is to ensure the safe use of medical devices and to allow for a more efficient corrective action should a medical device recall be necessary. Q Inside ID Technology can safely and effectively identify medical devices within the body using a proprietary external reader in a matter of seconds, and could therefore be useful in the GUDID database.
All implantable medical device manufacturers include a product identification or warranty card in their packaging that is supposed to be given to a patient after surgery. Patients often lose or misplace their product and/or warranty cards. Jamm's Q Inside ID Technology can never be lost as it is implanted in the medical device and can be accessed with Jamm's proprietary hand-held reader, on demand, at the point of care.