In September 2011 I received this question from a SPD Tech. in reference to an approved value for the amount of residual soil on surgical instruments by the FDA. My answer was that the US FDA had no approved value number. Although this may be true for hospitals and ASC’s, I was recently informed that there is an FDA approved value for residual proteinaceous soil on surgical instrumentation . This FDA standard is for third party Single Use Device reprocessors and it set at less than six point four micrograms of protein per square centimeter (<6.4µg protein/cm²).
Although I had heard this value before in reference to the cleaning of flexible endoscopes (Alfa et al. 2002) as the average soil marker for biopsy/suction channel of clean flexible endoscopes, I did not know that this value had been set as the FDA standard for SUD reprocessors.
This value is also the basis of cleaning verification tests for flexible endoscopes (eg. Healthmarks ChannelCheck™ ). Who knows, maybe one day this verification value will apply to all surgical instruments processed in Healthcare facilities and not just the SUD Reprocessors it applies to now?…only time can tell.