Fact -VS- Fiction? Read between the lines!

In so many instances we find ourselves listening to a Sales Representative tell us about their product.  This is FDA Approved, should be stated as"FDA Cleared".  But, was is it FDA Cleared for intended use.  For example, I talked to a physician yesterday using a product, an antimicrobial product for his wound care patients.  He stated that the sales person told him that is was an FDA Approved Antimicrobial for use in wounds.  So I pull out one of their brochures and asked him to get one of the products so we could read the label.  Their brochure reads: _ _ _ _ with germ killing preservatives, is not FDA cleared as an in-wound antimicrobial.  Ingredients, warnings and instructions for use are identified in adjacent label.  The physician said, I had no idea. 

So, it was not FDA cleared for the intended use, and has germ killing preservatives.  Another product sales representative stated their product killed xyz strains in 30 seconds, oh and it also kills Cdiff and Cdiff spores.  The physician thought that meant it killed the Cdiff in 30 seconds, also.  Not the case.  It did kill Cdiff, but it took up to 90 minutes in a study to do it.  Ninety minutes in an exudating wound? 

So, I guess the question is, is it the sales representatives fault for "mis-stating" the facts of the product and its uses, or is it the clinicians fault for not asking direct questions or proof of what the product is and it uses.  I think its a little of both.

This happens in all areas of health care from wound care products to medical devices.    We need to make sure for the clinicians, the patients, and the institutions that we are using products that are FDA Cleared and Clinically Evaluated for their intended use.  As sales goes, we need to sell products, but it shouldn't be at the cost of outcomes for the patient.  Choose the best product(s) that will be the best for the patient, the clinician, and fiscally responsible to the patient and the institution.