In an earlier post on this Blog I wrote an entry about the DeltaTrak WHO pre-qualified Vaccine Glycol Bottle Data Logger.
Based upon the market and use that this product is focused towards (i.e. Local, State and Distribution Center vaccine storage units) there has been a lot of interest and sales activity related to this product.
However, there seems to be a lot of confusion at the state public health department level, where products are recommended for use within the state run, or managed, facilities, related to what is a certified logger for use in this application.
The CDC is not a regulatory body, or organization, but in fact is a recommender of certain standards for usage, storage, transportation, etc, and provide general very descript guidelines related to the programs they themselves fund (through US Government funding) and manage - the VFC being one.
The CDC Storage and Handling Toolkit (CDC storage-handling-toolkit.pdf) is in fact an excellent and comprehensive manual describing their recommendations for such programs.
But they recently distributed a document defining certain levels of product testing that should be part of the final certification testing that any product supplier should perform prior to selling their products. These recommendations regarding what the state health authorities should look for prior to ordering a Vaccine Data logger and/or certified thermometer are left up to interpretation by state level administrators that are tending to use some of these recommendations as regulations.
So just for the record I would like to let our Blog readers that may be associated with these programs know that the DeltaTrak Vaccine Glycol Bottle Data logger is WHO Pre-Qualified, has a NIST Traceability certificate, all of the calibration of our equipment used for final certification of our loggers is calibrated by an A2LA ISO 17025 accredited lab' and we are an ISO 9001:2008 certified manufacturing and product supplier.
If any of the potential clients would like a unique ISO 17025 certificate we can supply this complete with unit serial number(s), test results, etc., but as this is an extra test step there is a charge for providing.