Frequently Asked Questions
Is VeriTeQ publicly traded?
VeriTeQ trades as VTEQ on the OTC Market.
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 VeriTeQ's Q Inside Safety Technology (Q.I.S.T.) in my medical devices?
There are several answers to this question. First and foremost is because VeriTeQ's Q.I.S.T. is the only FDA cleared 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, VeriTeQ knows of 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. VeriTeQ's Q.I.S.T. 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, VeriTeQ's Q.I.S.T. can be accessed by a healthcare practitioner that has the VeriTeQ hand held reader which can be used to confirm or deny the device information of a medical device implanted in a patient.
Finally, the technology used in Q.I.S.T. 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 readers.
What is the VeriTeQ UDI?
VeriTeQ's Unique Device Identifier (UDI) is its Q Inside Safety Technology (Q.I.S.T.).
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). Then on September 20, 2013, the FDA released a Final Rule for a Unique Device Identification (UDI) System (Food and Drug Administration 21 CFR Parts 16, 801, 803, 806, 810, 814, 820, 821, 822, and 830, FDA Final Rule under Docket No. FDA-2011-N-0090 RIN 0910-AG31). The Objectives of the FDA Final 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.
- (a) In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.
- (b) UDI for direct marking. The UDI provided through a direct marking on a device may be:
- (1) Identical to the UDI that appears on the label of the device, or
- (2) A different UDI used to distinguish the unpackaged device from any device package containing the device.
- (c) Form of a UDI when provided as a direct marking. When a device must bear a UDI as a direct marking, the UDI may be provided through either or both of the following:
- (1) Easily readable plain-text;
- (2) Automatic identification and data capture (AIDC) technology, or any alternative technology, that will provide the UDI of the device on demand.
- (d) Exceptions. The requirement of paragraph (a) of this section shall not apply to any device that meets any of the following criteria:
- (1) Any type of direct marking would interfere with the safety or effectiveness of the device;
- (2) The device cannot be directly marked because it is not technologically feasible;
- (3) The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use.
- (4) The device has been previously marked under paragraph (a) of this section.
- (e) Exception to be noted in design history file. A labeler that decides to make use of an exception under paragraph (d of this section) must document the basis of that decision in the design history file required by § 820.30(j) of this chapter.
To read more about the FDA's Final 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 Q.I.S.T. 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 handheld reader. 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 Q.I.S.T. 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.
Are there any health risks to having Q.I.S.T. 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 Q.I.S.T. be used with?
Q.I.S.T., in its current form, can be embedded into vascular ports, breast implants, artificial hips, knees, shoulders, and traumatic fracture repair devices.
If I have Q.I.S.T. inside my implantable medical device can I be "tracked" in any way?
No. VeriTeQ 's Q.I.S.T. 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 reader which must be used in close proximety to the implantable medical device.
Unique Device Identification (UDI)
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