Researchers at the University of Pittsburgh have
developed Ortho-tag, a system designed to identify orthopedic implants and
their surrounding environment in the body through use of a wireless tag and
touch probe. The Ortho-tag, which integrates radiofrequency identification
technology developed at the University of Pittsburgh, uses human tissue instead
of air as a conduit for radio waves.
Ortho-tag is bringing smart tag
technology to the specialty of orthopedics. This technology will enable
orthopedic surgeons and health care providers to obtain important information
regarding the identification of implanted hip, knee, spine and other implanted
medical devices in patients and, with the incorporated Ortho-tag biosensors,
obtain information about the tissue environment in which the device is
implanted, Lee Berger, MD, orthopedic surgeon and inventor of the tagged
implant, told Orthopedics Today.
The Ortho-tag and its patented touch probe system have
been developed and tested in the laboratory at the University of Pittsburgh
School of Bioengineering RFID Center of Excellence under the direction of
Marlin H. Mickle, PhD, MSEE. Berger, Mickle and the University of Pittsburgh
RFID Center for Excellence have combined their intellectual property and
together developed the Ortho-tag System for implanted medical devices.
Ortho-tag, Inc. was incorporated in April and now has optioned the rights to
Attached, not built in
Ortho-tag is affixed to an orthopedic implant prior to
packaging and sterilization or intraoperatively at the time of surgery by the
surgeon. The attached Ortho-tag is scanned via near field transcutaneous
technology with a patented touch probe to obtain real time information about
the implant and associated biosensors. Ortho-tag is applying for FDA approval
of the system, Berger said.
Ortho-tags are attached not built-in
to medical implants. This enables the tag to be applied and universally easily
accepted by all orthopedic manufacturers without any change in design or
manufacture of their products, Berger said. I envision that
orthopedic surgeons will offer patients the optional choice of having their
implant provided with the Ortho-tag system.
Berger said that patients want to know more about
medical devices that are implanted in their bodies and want the security of
knowing that there may be a way of possibly detecting infection or other
problem in a non-invasive way.
Ortho-tag is working to create integrated
biosensors that can act as an early warning system of a change in the tissue
environment around an implant and this may be beneficial to health care
providers to improve patient diagnosis and treatment, he said.
Orthopedic surgeons would upload information about the
patient, implant and procedure performed to the Ortho-tag interoperatively or
postoperatively. Once implanted, biosensors interacting with the Ortho-tag
would gauge the environment around the implant, such as the chemical balance
and temperature of surrounding tissue, and the presence of harmful organisms.
The information would then be read by a handheld probe and displayed on a
computer using software for secure data collection. The interactive data
system, Berger said, includes the Ortho-tag Total Hip and Knee Registry, which
has programmed templates for the surgeon to complete by using the Ortho-tag
Touch Probe scanner to enter the implant and patient information into the
registry postoperatively and during follow-up visits.
The Ortho-tag implant information and registry
information is programmed directly into the Ortho-tag so it is always with the
patient, and this will ensure better and more accurate data collection,
validation and improve outcome studies at a lower cost than anticipated for a
paper- or computer-based national total joint registry, he said.
Berger said that patient confidentiality is protected by
the touch probe, which is more secure than wireless RFID readers because it
must physically touch the patients skin in the vicinity of the implanted
orthopedic prosthesis for transcorporal transmission of the signal to send and
receive information to the Ortho-tag and biosensors. This eliminates the
possibility of hacking into the information programmed into the
Ortho-tag, he said.
The patients themselves decide whether or not they
want to be touched by the touch probe as that is the only way to obtain
information from the Ortho-tag on the implant, he said.
Once data is collected, it is protected by a
password-encrypted security system as commonly used in electrical medical
records as per Health Insurance Portability and Accountability Act
Berger said the next step is to work with orthopedic
surgeons and manufacturers to bring the Ortho-tag system to the orthopedic
community. For patients with existing orthopedic implants, the Ortho-tag card
to provide patients and surgeons interactive access to the Ortho-tag registry
system will be available by the end of the year.
We will work with orthopedic surgeons and
hospitals in offering this technology to their patients in FDA-approved
clinical studies, he said. We will also work closely with the FDA
to obtain approval of Ortho-tag products.
He said that he believes that the Ortho-tag will not
significantly add to the price of the implant and may ultimately save
manufacturers time and money. The technology could also be useful in the case
of a recall as defective implants are typically recalled by serial number.
This technology will help to create a new type of
information highway for implanted medical devices that will enable major
advancements in health care, Berger said. by Kristine Houck,
- Lee Berger, MD, can be reached at Orthopaedic Associates, 15-01
Broadway, Suite 20, Fair Lawn, NJ 07410; 201-794-6008; email:
- Disclosure: Berger is chairman of Ortho-Tag Inc.