The Necessity to Create a Standard for Medical Grade Media
With the potential for harm from an abundance of inferior media, TDK felt it was essential to become proactive. The medical industry could not afford to have its fate controlled or effected by manufacturers who cared very little for quality and good patient outcome. Thus, TDK took a bold step to ensure good media.
In Spring 1997, TDK traveled to the Food and Drug Administration and made a presentation on the merits of creating a standard for medical grade media. TDK explained CD-R technology in detail and described the inherent problems if attention to quality, engineering and testing is not made a high priority. The goal was to communicate that all media are not the same and that a company that applies a "medical" label to its media must be regulated or it will jeopardize the entire imaging chain.
As a result of that meeting, TDK submitted an application to the FDA for its Medical Grade CD-R media and has since received a 510K approval number. TDK, in fact, is the only manufacturer to receive a stand alone 510K for its CD-R Media. TDK has since developed and shipped a full line of multi-modality medical grade recording media - CD-R, DVD-R, DVD+R, DVD-RAM, Magneto Optical, Data Cartridges, S-VHS video tape. The medical industry has heartily embraced TDK's vision for its medical grade recording media.
(Source: Medical Grade Facts. TDK Medical Website. April 15, 2007. http://www.tdk.com/medical/support/necessity.html.)
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