Frequently Asked Questions
When was VeriTeQ formed?
VeriTeQ as a corporate entity was formed in 2011; however the Company and its leadership have a long legacy in the RFID and healthcare information technology industries. VeriTeQ's technologies have been utilized in multiple applications since 1993.
Is VeriTeQ publicly traded?
VeriTeQ is a private company at this time.
What is VeriTeQ's stance on privacy?
VeriTeQ places the highest priority on patient privacy and confidentiality. Our RFID technologies are passive in nature and inaccessible without the proper equipment, which is only available to doctors, hospitals, and manufacturers of implantable medical devices. 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 oncology practices that use our technologies.
What is VeriTeQ's value proposition? Why would I as a manufacturer of implantable medical devices put the VeriTeQ UDI in my medical devices?
There are several answers to this question. First and foremost is because the VeriTeQ UDI is the only UDI 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, there are no other companies that can offer this type of solution to the medical device community.
Secondly, most 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. The VeriTeQ UDI can provide peace of mind to medical device manufacturers, hospital surgeons and patients, as the UDI is actually implanted in a medical device and can never be lost. In the event that a device recall or issuance of an adverse event report, the VeriTeQ UDI can be accessed by a healthcare practitioner that has the VeriTeQ hand held scanner which can be used to confirm or deny the device information of a medical device implanted in a patient.
Finally, the technology used in the VeriTeQ UDI has a long legacy, is safe and reliable, and has regulatory authority approval.
What type of RFID do VeriTeQ's technologies utilize?
VeriTeQ's technologies use a passive form of RFID, which in generic terms means that our technologies are always "off" yet always available, and cannot be activated until they receive a signal from our proprietary hand held scanners.
What is the VeriTeQ UDI?
VeriTeQ's Unique Device Identifier (UDI) is the world's first implantable, passive RFID technology cleared for use by the FDA. VeriTeQ believes its UDI is the only technology on the market that currently enables manufacturers of implantable medical devices to fulfill the Direct Marking and Automatic Identification and Data Capture (AIDC) - on demand - requirements of the FDA Rule.
What is the FDA's requirement for Unique Device Identifier's (UDI's) for implantable medical devices?
In July 2012, the FDA released a Proposed Rule for a Unique Device Identification (UDI) System (FDA Proposed Rule under Docket No. FDA-2011-N-0090 RIN 0910-AG31). The Objectives of the FDA Proposed Rule and the benefits that a UDI System would provide are:
- Allow more accurate reporting, reviewing and analyzing of adverse event reports so that problem devices can be identified and corrected more quickly.
- Reduce medical errors by enabling healthcare professionals and others to more rapidly and precisely identify a device and obtain important information concerning the characteristics of the device.
- Provide a consistent way to enter information about devices in electronic health records and clinical information systems.
- Provide a standardized identifier that will allow manufacturers, distributors and healthcare facilities to more effectively manage medical device recalls.
- Provide a foundation for a global, secure distribution chain, helping to address counterfeiting and diversion and prepare for medical emergencies.
- The FDA Proposed Rule at Â§ 801.50(a)(1) includes a direct marking requirement which would exist for implantable medical devices because these devices present unique risks that would be better controlled through such a direct marking (versus simple labeling on the outside of the medical device packaging).
- The FDA Proposed Rule at Â§ 801.50(c)(1)(ii) requires the form of the UDI providing the direct marking to include Automatic Identification and Data Capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand.
To read more about the Proposed Rule click here.
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 microchip 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.
Do VeriTeQ's implantable UDI and radiation dosimeters contain any personal or patient information?
No. VeriTeQ's UDI only contains a unique 16-digit number. This unique number can only be accessed by our proprietary handhel scanner. The 16-digit number is then transferred to a secure, password-protected database and used to access implantable medical device information such as serial number, lot number, batch number, manufacturer name, etc. VeriTeQ's radiation dosimeters are only used to measure the exact dose of radiation delivered to a patient at skin level or inside a tumor or tumor area. There is no patient identification information on or in these technologies.
How does the VeriTeQ UDI 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 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 of the device is no longer readable or accessible.
Are there any health risks to having the VeriTeQ UDI inserted into an implantable medical device or in a human body?
No. VeriTeQ's implantable RFID technology has been tested and cleared by the FDA. It is MRI compatible and safe.
What types of implantable medical devices can the VeriTeQ UDI be used with?
The VeriTeQ UDI, in its current form, can be embedded into vascular ports, breast implants, artificial hips, knees, shoulders, pacemakers, and traumatic fracture repair devices.
If I have the VeriTeQ UDI inside my implantable medical device can I be "tracked" in any way?
No. VeriTeQ 's UDI is not a GPS and does not support any long-range or wireless communications. It is a passive RFID microchip containing only a unique 16-digit identifier and, for security reasons, can only be read by VeriTeQ's proprietary handheld scanner which must be used in close proximety to the implantable medical device.
Unique Device Identification (UDI)
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Informatics & Data Analytics
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