Medical Device Recalls: Forms to Capture and Trace Data

In the last few weeks, we’ve heard three separate companies tell us about their problems with recalls of medical devices.  FDA regulations require that manufacturing companies archive test data for a certain period for each medical device serial number.

That’s an entirely prudent regulation, however some of the test data for some of the manufacturing and testing processes is done on paper.  When there’s a recall (such as this recent recall) the ability to quickly view that data is non-existent if the source is stuck in a file cabinet in Archives.

We, and those companies to whom we spoke, recognize that a paperless data entry form could alleviate this kind of quality/compliance issue, as well as providing real-time SPC feedback (which could help prevent some recall issues happening in the first place.  With 2003 medical device recalls costing, on average, $8 million per event in 2003, the business case for reducing product defects and quickly reporting on test data is clear and quantifiable.

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