It has been 3 years since the FDA began their investigation of tissue samples distributed through
an organization called BioMedical Tissue Services (BTS). This tissue organization was
allegedly selling tissue grafts to independent tissue banks without meeting certain FDA
requirements safeguarding patient safety. The news broke with this FDA announcement:
On October 26, 2005, FDA issued an information paper regarding its investigation of BTS.
The FDA expressed concern that BTS had supplied tissue from donors that had not been
subject to an adequate donor eligibility determination. The FDA and CDC recommended
that health care providers inform their patients of this potential risk and offer to provide
access to appropriate infectious disease testing. Donor eligibility is determined through
donor screening and donor testing. Donor screening involves reviewing all relevant medical
records, physically assessing the donor and questioning the donor’s next-of-kin to
determine whether risk factors for or clinical evidence of relevant communicable diseases
exist. Donor testing involves testing samples of the donor’s blood taken pre- or postmortem. Relevant communicable diseases for which the donor is tested are HIV-1 and 2,
hepatitis B virus, hepatitis C virus and syphilis. A donor is determined eligible to donate
tissues only if the results of donor screening and donor testing indicate freedom from
communicable diseases or communicable disease risks.
After a thorough investigation, the FDA determined that there was significant risk to the
recipients of these tissues. They issued the following instructions to healthcare providers:
On January 31, 2006, FDA issued an Order to Cease Manufacturing and to Retain Human
Cells, Tissues and Cellular and Tissue Based Products (HCT/Ps) to BTS and its Chief
Executive Officer and Executive Director of Operations. The order was issued after the
FDA's inspection of BTS uncovered serious violations of the regulations governing donor
screening and record keeping practices. Despite records maintaining otherwise, the firm
had inadequately screened donors for risk factors for, or clinical evidence of, relevant
communicable disease agents and diseases. In addition, the FDA found numerous
instances where death certificates maintained in BTS' files were at variance with the death
certificates the FDA obtained from the state where the death occurred, on important
information such as cause, place, and time of death, and the identity of the next of kin.
Therefore, the donor screening performed cannot be relied on to exclude donors with risk
factors for or clinical evidence of infectious disease. The FDA regulations require that,
before tissues are released for distribution, blood samples from each donor be provided to
the testing laboratory for donor testing. Each sample must be clearly linked to an individual
donor, and each tissue clearly linked to that donor. The FDA and the affected processors
now have additional information that calls into question the reliability of some of these donor
blood samples submitted for communicable disease testing from BTS tissue donors. In
some instances, blood samples did not come from the same donor as the linked tissues.
Therefore, the results of communicable disease tests obtained from the blood sample
may not correctly reflect the status of the donor.
The FDA and CDC strongly recommend that health care providers offer testing to their
patients or refer them to other health care providers who can provide such testing. While we
still believe the risks from these tissues are low because the tissues were routinely
processed using methods to help to reduce the risk of infectious disease, the actual
infectious risk is unknown. As mentioned previously, the relevant communicable diseases
for which tissue donors are required to be tested are: HIV-1 and 2, hepatitis B virus,
hepatitis C virus and syphilis, and health care providers should consider testing their
patients for these same disease agents.
Since these events occurred, hospitals have been challenged to efficiently track these tissues both
within their facilities as well as once they have been implanted in patients. It is critical for
hospitals to be able to respond quickly to FDA or tissue bank recalls. Patients must be informed
and have access to testing for communicable diseases they may have unwittingly been exposed
to such as HIV, Hepatitis and Creutzfeldt-Jakob disease.
In late 2005, The Joint Commission on Accreditation of Healthcare Organizations (Joint
Commission) also issued new standards (PC.17.10, PC.17.20, PC.17.30 and lab requirements
QC.5.300, QC.5.310, and QC.5.320) requiring hospitals that store or use tissue to maintain upto-date tracking records of all human tissue grafts, from receipt in the hospital to patient implant.
These standards were issued in response to several instances, following the FDA warnings,
where hospitals were not able to efficiently track the history of implanted materials.
Champion Medical Technologies created an internet based software program called
GraftTracker® to address this important need. The program provides a complete solution with
an advanced software service which gives hospitals the ability to automate the tracking of human
tissue grafts like bone, skin, cornea, cartilage - any stored tissue - from the point where the
hospital received the graft to implantation into a patient.
Peter Casady, Director of Marketing for Champion Medical Technologies, said, "GraftTracker®
was developed in order to aid hospitals in meeting the new Joint Commission guidelines, but its
primary benefit is for patients. The selling of human tissue grafts by funeral homes in 2005
without proper blood testing on donors, and in many cases without next of kin consent, raised a
lot of concern about patient safety as it relates to donated tissues. We believe GraftTracker®
plays an important role in solving a hospital's greatest challenge in efficiently handling recalls
with quick identification of patients who need to be notified."
GraftTracker® is an Internet-based software solution that allows hospital personnel to securely
enter information about each tissue graft they have in their facility. Transfers within hospital
departments or to other healthcare facilities can be reviewed and updated as they occur. A
permanent record of each tissue graft is maintained to provide hospital regulatory compliance
and improve patient safety.
"Since our implementation of GraftTracker® at our facility in November 2007, we have
discovered this is one of the best programs for capturing tissue implants and the recording of
vital information to meet all regulatory standards. Each screen is very user friendly and simple to
use,” reports Jerry Smith Surgical Services Coordinator at St. Agnes Medical Center in Fresno,
California.
Now hospitals can add a separate module that tracks non-tissue implants also. These implants
include prosthetic hips, knees and shoulders for orthopedic applications as well as pacemakers,
stents, and defibrillators for cardiovascular surgery.
GraftTracker® simplifies the entire process of tracking human tissue grafts, eliminating multiple
paper-based logbooks and minimizing human error. Patient confidentiality is ensured using stateof-the-art software encryption, providing the same level of security as online banks. Tracking
after implantation is simplified so that if there is ever an issue that requires a rapid response to a
tissue bank or FDA recall, the complete history of the tissue can be efficiently produced.
“GraftTracker® has made tissue tracking much more efficient. The program is concise, easy to
navigate and makes Quality Assurance checks a breeze. The company has been very receptive to
any changes to help us to meet all of our regulatory requirements,” states Joyce A. Watkins
Administrative Clinical Leader- Orthopaedic Spine at Rochester General Hospital in Rocheser,
New York.
Champion Medical Technologies is an applied information management company, with the
primary mission of developing inventory tracking solutions for hospitals. Utilizing state-of-theart, web-based software, Champion Medical Technologies offers multiple products for the
diverse needs of their customers.
The ability to effectively manage growing inventory of expensive medical products, whether
consigned or purchased, is a major challenge. Hospitals in particular need a tracking solution for
everything from human tissue grafts to titanium screws and plates.
With product names like GraftTracker and OrthoTracer; Champion has saved its hospital clients
millions of dollars in improving their ability to value outstanding inventory, provide an audit trail
for transfers, perform recalls as needed, and streamline patient implant records.