[Federal Register Volume 64, Number 239 (Tuesday, December 14, 1999)]
[Notices]
[Pages 69774-69775]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-32284]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


Technology Assessment Conference on Improving Medical Implant 
Performance Through Retrieval Information: Challenges and Opportunities

    Notice is hereby given of the NIH Technology Assessment Conference 
on ``Improving Medical Implant Performance Through Retrieval 
Information: Challenges and Opportunities,'' which will be held January 
10-12, 2000, in the Natcher Conference Center of the National 
Institutes of Health, 9000 Rockville Pike, Bethesda, Maryland 20892. 
The conference begins at 8:00 a.m. on January 10, at 8:00 a.m. on 
January 11, and at 9:00 a.m. on January 12.
    Various medical implant devices have been widely used since the 
1960s, and it is estimated that eight to ten percent of the American 
population currently has a permanent medical implant. Yet, there has 
not been any systematic effort developed in the United States for

[[Page 69775]]

implant retrieval analysis or data banking, even though medical implant 
retrieval research provides the only true long-term data on the host 
response to and the final condition of the implant. Thorough reporting 
on the performance of implants would allow physicians to evaluate 
devices, understand the clinical benefit and risks associated with 
medical implant treatment and prevention of disease, and advance the 
development of better devices and materials. This will ultimately 
benefit patients through superior implant technology.
    While most medical implants function very well, significant 
challenges remain associated especially with their intended long-term 
duration of use. The advance of medical implant science is hampered by 
a lack of study of implants retrieved after surgery or at autopsy. Much 
can be learned of clinical end points, implant performance, and design 
theory, and this information will again lead to superior medical 
implants that benefit U.S. patients.
    The objective of the conference is to assess the opportunities and 
challenges to developing a framework for independent research of 
explanted natural and synthetic implants, with the ultimate objective 
to provide benefits to patients through implant retrieval and analysis. 
For the purpose of this conference, implants are defined as having a 
minimum life span of three months; as penetrating living tissue; as 
having a physiologic interaction; and of being retrievable. This 
conference will bring together specialists in surgery, pathology, 
engineering, biomaterials, information systems, and other related 
disciplines, as well as representatives from the public, legal, 
ethical, and industrial communities.
    After 1\1/2\ days of presentations and audience discussion, an 
independent, non-Federal technology assessment panel will weigh the 
scientific evidence and write a draft statement that it will present to 
the audience on the third day. The technology assessment panel's 
statement will address the following key questions:
     What are the patient, health care provider, and societal 
expectations of the lifetime costs, risks, and benefits of medical 
implants?
     What can the role of information data systems be in 
educating the public, medical community, and policymakers about medical 
implants and retrieval?
     What are the legal, ethical, religious, cultural, public 
policy, and economic barriers to implant retrieval and reporting, and 
how can they be overcome?
     What information is necessary to evaluate and improve 
implant and material performance and device design?
     What future research and institutional support is 
necessary to ensure continuing advances in implantable devices?
    The primary sponsors of this conference are the National Heart, 
Lung, and Blood Institute (NHLBI) and the NIH Office of Medical 
Applications of Research (OMAR). Additional sponsors are the NIH 
Biomaterials and Medical Implant Science Coordinating Committee, which 
represents all of the NIH Institutes and Centers, the National 
Institute of Arthritis and Musculoskeletal and Skin Diseases; the 
National Institute of Dental and Craniofacial Research; the National 
Institute of Neurological Disorders and Stroke; the National Library of 
Medicine; and the National Institute of Standards and Technology. This 
is the 19th Technology Assessment Conference held by the NIH in the 23-
year history of the Consensus Development Program.
    Advance information on the conference program and conference 
registration materials may be obtained from Louise Harkavy, Prospect 
Associates, 10720 Columbia Pike, Suite 500, Silver Spring, Maryland 
20901-4437, (301) 592-3320, [email protected]. The consensus 
statement will be submitted for publication in professional journals 
and other publications. In addition, the statement will be available 
beginning January 12, 2000 from the NIH Consensus Program Information 
Center, P. O. Box 2577, Kensington, Maryland 20891, phone 1-888-644-
2667 and from the NIH Consensus Program site on the World Wide Web at 
http://consensus.nih.gov.

    Dated: December 7, 1999.
Ruth L. Kirschstein,
Deputy Director, NIH.
[FR Doc. 99-32284 Filed 12-13-99; 8:45 am]
BILLING CODE 4140-01-P