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FDA, NIH, NIST

MEDICAL IMPLANT INFORMATION,
PERFORMANCE AND POLICIES

September 19-20, 2002
University of Maryland, Shady Grove
Gaithersburg, MD

FINAL REPORT

CO-CHAIRS:

Julia Weertman, Northwestern University
Y.C. Fung, University of California – San Diego

PURPOSE :

1) Consider the federal government's role in providing medical implant information for safer healthcare.

2) Evaluate the role for the federal government in extracting and disseminating information gained from explanted medical implants.

WORKSHOP DESCRIPTION:

The government agency-wide coordinating committee for Biomaterials and Medical Implant Science (BMIS) is holding a Workshop on medical implant retrieval on September 19 and 20, 2002 in Gaithersburg, MD. The Committee is chaired by Dr. John Watson, National Heart, Lung and Blood Institute, and is composed of a number of individuals at various NIH Institutes as well as representatives from NIST, NSF, FDA and other organizations. The goals of the Workshop are three-fold: 1) To define the role that the federal government can play in encouraging the use of explanted medical devices for research; 2) To design a possible structure for federal programs supporting gathering and dissemination of information derived from medical implant retrieval; and 3) To design a federal program to promote implant retrieval for use in research intended to promote safer health care. A few years ago (Jan. 2000) BMIS held a technology assessment conference entitled "Improving Medical Implant Performance Through Retrieval Information: Challenges and Opportunities". BMIS is now concerned with one of the recommendations that came out of the assessment conference which addresses patient education and information about implants and implant retrieval, which will be the focus of the Workshop in September.

BIOMATERIALS AND MEDICAL IMPLANT SCIENCE COORDINATING COMMITTEE:

The BMIS Coordinating Committee was formed by Dr. Harold Varmus, former NIH Director, in 1997 to serve as a trans-NIH technical committee which would coordinate agency research programs, and develop joint initiatives and workshops in the areas of biomaterials and medical implant science research. The committee also includes representatives from other federal agencies and public organizations which bring additional perspectives on biomaterials and medical implant research as well as the public good. The first BMIS symposium, Improving Medical Implant Performance Through Retrieval Information, was held in January 2000 and a report summarizing the recommendations of the meeting participants can be found at: http://odp.od.nih.gov/biomaterials/.

AGENDA:

Please send any comments or questions about this workshop to bmis@mail.nih.gov