Tracking and surveillance of patients with medical devices and implants.
The United States Congress and FDA recently proposed modifications to the regulation for the tracking of certain medical devices and implants that will place significant demands on the manufacturers and importers of those products.  The regulation, which comes into effect in August this year, will require the industry to carry out not only tracking of those devices or implants to the end user, but also continued observation of the device user or implant recipient throughout the life of the patient or the device.  In this article, the author outlines FDA requirements and advises how best to meet those demands.  The important elements for setting up a patient-tracking programme are discussed; these include the use of a Patient Registry as a basis for tracking and the importance of confidentiality throughout the tracking process.
Morgan
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Health Devices Research Institute, Redwood City, California 94065.
D003219:Confidentiality; D004869:Equipment Safety; D004864:Equipment and Supplies / Q000592:standards*; D006801:Humans; D007883:Legislation, Medical; D011159:Population Surveillance; D011358:Product Surveillance, Postmarketing; D019736:Prostheses and Implants / Q000592:standards*; D012042:Registries; D014481:United States; D014486:United States Food and Drug Administration