February 2000 Bulletin

Panel urges formal implant retrieval plan

Patients who receive medical implants should be provided with a card containing information about their implant(s), including date of implantation, make, model, and serial number, said a technology assessment panel convened by the National Institutes of Health last month. The panel on medical implant retrieval and analysis also recommended the card should also serve as an implant "donor" consent form, analogous to an organ donor card, to simplify post-mortem retrieval.

Implant retrieval and analysis is of critical importance in the process of improving care of patients in need of implants, the panel said. However, the lack of a formal system for the process has impeded research in this area.

The panel recommended that the federal government begin planning to construct the regulatory protocols required by the new class of implants developed from tissue engineering.

The panel also recommended that the NIH and Food and Drug Administration sponsor a consensus development conference on the relationship between and possible adverse effects of litigation and medical innovation. The panel suggested the sharing of information on adverse experiences and encouraging professional societies to form groups such as the Orthopaedic Device Forum which represents the orthopaedic community, orthopaedic industry, NIH, FDA, ASTM and the public.

An aggressive educational program for teaching the importance of device retrieval and analysis also was recommended.

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