FDA plans electronic medical device reports
The Food and Drug Administration is converting to an electronic system for medical device reporting. The FDA's proposed rule would require 57,000 makers and users of medical devices to report adverse events relating to medical devices. That would be a big change from the current and inefficient paper-based system.
But the cost would not be cheap. New electronic systems would cost the medical device industry between $58 million and $80 million, and would cost $9 million to maintain.
The FDA receives 100,000 reports of medical device errors a year, but the change is expected to eliminate costs of filing paper reports and transcription errors. This is a long overdue change, and it is certain to be a more efficient way to deal with device errors.
For more on the FDA's electronic plans:
- see this Federal Computer Week article
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