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31 May 2011



A notion on "A more ethical and efficient practice is to chemically characterize materials and compare them to materials in existing clinical use before performing animal tests.":

To my experience, Asian regulators can hardly be convinced by scientific rationales based on characterization data, in contrast to European or US regulators. In Asia you are most likely still required to do your (animal) testing according to "The Matrix".

Jack Douglas, PhD

Thank you for this succinct historical account. Obviously safety is a primary concern for our industry, yet I wonder if this is one area of excessiveness. As you describe, regulatory requirements have meandered ("evolved"?) over the years. A great deal of company resources have been invested, often for the same material over and over. Thousands of animals have been, and continue to be sacrificed. Apparently there have been no efforts to consolidate and leverage from the collective experience as the FDA believes each case is too unique (eg, "process residues"). Even now the FDA is stepping up the requirements for bio testing even for products that have been around for many years (eg, cardiac catheters). Often the risk of a disease, or a therapy far outweighs the risk a nanogram of a purported toxic substance presents, yet the government persists in what appears to be insane paranoia (or is it just CYA?). Can the authors cite examples of widespread device toxicity that warrants all of this concern (other than well known examples such as latex)? Do you envision a way to establish a database of material testing and research experience that could mitigate this need, and perhaps update the often poor quality of MSDS reports?

Dan McLain

Jack has asked a two-part question. With respect to "wide-spread" (a subjective term) device toxicity my answer is no, I cannot cite an example, but that would seem to support the FDA safeguards (translation=testing) that is the topic of discussion. However, there have still been "incidents" of device toxicity that have harmed and killed (I won't open old wounds by reminding these device manufacturers of the events). If you would like to speak off-line we can discuss those. With respect to a database of material testing that would be a wise decision for any company, regardless of size. When decentralized there is generally poor communication and testing redundancies will occur. Centralizing the control or management of testing should allow the different business units to know what exists. FDA did start their own material database under Stan Brown but I don't know whether that project has continued.

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