FOR PATIENTS

1. Is this micro-transponder FDA approved for human use?

Yes, this device was US FDA cleared in 2004 for use in humans.

2. Can the micro-transponder be used as a GPS or tracking device?

No. This is a passive biomedical micro-transponder that only stores a UNIQUE 15-digit numeric sequence and only emits a signal when in the presence of the proprietary hand held reader.

3. What information is on the micro-transponder?

The only information on the micro-transponder is a 15-digit unique Electronic Serial Number (ESN). Information that correlates with that number includes; manufacturer name, serial number, lot number and date of manufacture, etc. The information is maintained in a password protected, secure database. This ESN will not mean anything to anyone, except the patient, the surgeon and the medical device manufacturer.

4. Should patients be concerned about their privacy with Q Inside Safety Technology?

No. There is no personal patient information stored on this device, only a unique 15-digit number that correlates to implant specific data (manufacturer, date of manufacture, serial number, lot number etc.). The databases that store any device or treatment data collected from our technologies are maintained by our clients in healthcare institutions and/or medical device manufacturers, all of which observe the strict guidelines published by HIPAA and follow the same information security protocols that are currently in place in the various hospitals, surgical centers and physician practices. VeriTeQ Corporation places the highest priority on patient privacy and confidentiality.

5. What is the life of the micro-transponder? Will it work forever?

The micro-transponder is good for as long as the medical device is implanted in the patient. There is no power and no batteries and therefore, never needs to be replaced.

6. What happens if the micro-transponder malfunctions? Is additional surgery required?

VeriTeQ has performed several clinical tests to ensure proper functionality of Q Inside Safety Technology, throughout the manufacturing process. In the event the health care provider cannot read the ESN they should refer to the Reader manual (see manual link) for operation instructions. In the unlikely event the micro-transponder ID is still is not found, there is no need to remove the implant.

7. Is it possible to feel the micro-transponder?

No. Q Inside Safety Technology does not alter the look, feel or recovery associated with surgical procedures to implant medical devices.

8. Are there any safety or biocompatibility concerns?

There are no issues with biocompatibility. Q Inside Safety Technology was FDA 510k cleared for human use in 2004 it is non-toxic and non-carcinogenic.

9. Is the micro-transponder MRI compatible?

Yes. It is safe to undergo MRI, Mammogram, X-ray and other diagnostic procedures while having Q Inside Safety Technology embedded in a medically implanted device.

Information for physician: There could be a potential to see artifact in an MRI due to the micro-transponder. If this occurs, order a different diagnostic test or different angle of the MRI. There is no artifact with the micro-transponder during mammogram as this is an x-ray based screening.

10. Is there a risk of developing cancerous tumors around the micro-transponder?

Q Inside Safety Technology is non-carcinogenic, non-toxic and non-antigenic. VeriTeQ's micro-transponder has been extensively studied in mice and rats and found not to cause cancer. Q Inside Safety Technology is held inside the implanted medical device and the micro-transponder never touches the tissue.

11. How many Implantations have there been with this device?

Q Inside Safety Technology has been successfully implanted in over 100,000,000 animals as well as subcutaneously in humans and has now been successfully implanted in over 1,500 breast augmentation patients.

12. Why would I consider choosing an implantable medical device with Q Inside Safety Technology? What are the benefits?

Through Q Inside Safety Technology, physicians and patients have access to SECURE, non-invasive verification of implant-specific data. Unlike product and warranty cards that are typically provided to a patient undergoing any type of procedure where they receive an implantable medical device, Q Inside Safety Technology can never be lost or misplaced. Q Inside Safety Technology can give patients increased peace of mind in the event of a safety issue or device recall, thereby helping to ensure safety and wellness

Medical Device Manufacturer Questions

1. As a manufacturer of medically implantable devices, why should I choose   to include Q Inside Safety Technology in my device?

1. VeriTeQ's Q Inside Safety Technology is the only FDA cleared Unique Device Identification (UDI) device on the market that can give an implantable medical device manufacturer and healthcare provider the ability to retrieve UDI information about an implantable medical device in vivo, on demand, at the point of care, from outside the body. Currently, VeriTeQ knows of no other companies that can offer this type of solution to the medical device community.
2. Q Inside Safety Technology Provides Manufacturers Brand Quality and Product Verification to patients and physicians and provides anti-counterfeiting protection.
3. Incorporating Q Inside Safety Technology into your medical devices could play an important role in inventory management, distribution and workflow management at the manufacturing level as well as at the physician and hospital level
4. As a medical device manufacturer, devices that include Q Inside Safety Technology keep you connected to your patients and surgeons/ customers and can provide post-surgical analytical data that is vital to your business.
5. Most medical device manufacturers include product or warranty cards with their medical devices for surgeons to give to their patients. However, most patients will either lose or misplace these paper based materials, surgeons and hospitals may or may not keep this data on a per patient basis and if so it may be very difficult and time consuming for a patient to gain access to their device data if and when needed. Q Inside Safety Technology can never be lost. In the event that a device recall or issuance of an adverse event report, device specific information can be accessed by a healthcare practitioner that has the VeriTeQ hand held reader which can be used to verify the device information of a medical device implanted in a patient.

2. What type of FDA clearance does VeriTeQ have?

In October 2004, VeriTeQ 's implantable RFID technology was cleared by the U.S. Food and Drug Administration (FDA) for medical use in the United States (as a Class II Medical Device). In fact, VeriTeQ's implantable micro-transponder, known as Q Inside Safety Technology, is considered a "predicate device" within the FDA, meaning other companies or manufacturers wishing to enter the industry will be measured against this device. VeriTeQ's radiation dosimetry technologies also have FDA clearance and CE marks.

3. What types of implantable medical devices can Q Inside Safety Technology be used with?

Q Inside Safety Technology, in its current form, can be embedded into breast implants, artificial hips, knees, shoulders, vascular ports, and traumatic fracture repair devices just to name a few. If you would like to explore how VeriTeQ can implement Q Inside Safety Technology into your device please contact us at sales@veriteqcorp.com or call our business development team at 561-846-7005.

4. How does Q Inside Safety Technology compare to other forms of UDI technology on the market?

While other forms of UDI technology such as bar coding systems, labeling systems, RFID systems, etching systems, etc., can be used to help medical device manufacturers (manufacturers of both implantable and non-implantable medical devices) and healthcare providers meet the FDA's UDI requirements, these technologies are typically used to identify medical devices from outside of the body. Once an implantable medical device is separated from its packaging and surgically implanted into a human, the UDI information on the packaging of the device may no longer be readable or easily accessible.

VeriTeQ's technology enables healthcare practitioners to retrieve UDI information about an implantable medical device, in vivo, on demand, at the point of care. VeriTeQ believes that it is the only company that can currently offer implantable medical device manufacturers and healthcare providers the ability to retrieve UDI information from an implantable medical device, in vivo, at the point of care