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Talisman Limited develops medical self-interviewing systems that
improve quality and timeliness of patient information. The company
focuses on blood banking, having evolved its Quality Donor SystemTM
(QDS) via more than 300,000 competed donor interviews (12/2004) from
five organizations into a scientifically proven tool that reduces errors,
increases donor and staff satisfaction and saves staff time. QDS is
marketed and supported by Talisman Limited's sister company,
Talisman Medical Systems
(Talmed).
Our Mission
To design, develop and implement automated medical interviewing
and closely related systems in order to provide better information for improvement in
the quality of medical decisions and patient treatment.
History
Talisman
Limited was founded in 1982 by Paul
D. Cumming, Ph.D. Dr. Cumming is President of the company and
serves as Principal Investigator on the Small Business Innovation
Research grants awarded the company by the National Heart Lung and
Blood Institute (NHLBI), National Institutes of Health (NIH). The
original purpose of the company was to provide corporate means for
completing a NHLBI sponsored study of the Impact of Adenine on Blood
Banking at the time when Dr. Cumming was changing employment from
Science Applications International Corporation to the American National
Red Cross (ANRC). When Dr. Cumming left the ANRC in 1989, he transformed
Talisman Ltd. into a systems consulting firm engaged in support
work related to litigation, regulatory compliance, blood donor history screening, transmissible disease
testing, statistical consulting and database integration.
In the early 1990's, at the suggestion of Ronald Franzmeier of the Milwaukee blood center, Dr. Cumming started designing an automated blood and plasma donor screening system for the purpose of improving the quality of donor interviewing. The development of Talisman systems in this area evolved gradually, since implementations were delayed by the FDA Center for Biologics Evaluation & Research's (CBER) 1993 classification of blood software as a medical device.
In December 1997 Talisman secured FDA agreement that Talisman's
blood donor screening technology was not subject to medical device
regulations. At this point Talisman applied for and received a Small
Business Innovation Research (SBIR) Phase I grant from NHLBI which was
followed by a Phase II grant in 2000. (For more detail on results of
these research studies see Grants &
Research and Reference.) As part of the SBIR Phase II studies, in April
2000 Talisman entered into agreements with the Mississippi Valley Regional Blood
Center / Louis M. Katz,
MD (Davenport, IA) and the Center for Management
Systems, Inc. / Edward
L. Wallace, PhD (Naples. FL) to develop, install and research
a standardized version of QDS using Web browser technology. The resultant system, QDS Version 18,
was deployed
at MVRBC in Spring 2001. QDS V18 used the American Association
of Blood Banks (AABB) Uniform Donor History Questionnaire (UDHQ)
as updated to meet year 2002 CBER CJD/vCJD requirements. Initial
performance data on the Mississippi Valley installation was presented
at the AABB meetings in October 2001 and have been presented elsewhere
as detailed at Reference.
In 2003, FDA added requirements for questions regarding smallpox
vaccinations, SARS and West Nile Virus. Talisman updated QDS well
within the FDA time requirements, and consistently faster than blood
centers were able to update their own procedures. The WNV changes
were accomplished in less than a week from issuance of the FDA
guidance. During 2003, two more blood centers began to implement
QDS: West Tennessee Regional Blood Center (Jackson, TN) and
Lifeblood/Mid-South Blood Center (Memphis, TN). Late in 2003, CBER
advised Talisman that it must apply for a 510(k) premarket
clearance in order for blood centers to use interstate wide area
networks.
During 2004, Talisman developed an application for a 510(k)
clearance for QDS 2004, which clearance was granted by CBER/FDA in
October 2004. LifeShare Blood Centers (Shreveport, LA) and
Dartmouth-Hitchcock Medical Center (Lebanon, NH) began
implementation of QDS in 2004. QDS was updated to include the new
Uniform Donor History Questionnaire developed by AABB and approved
by CBER.
In early 2005, two blood centers (MVRBC and West TN RBC) upgraded to
the new UDHQ early in the year. Other centers plan to upgrade during
the summer.
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