In response to a recent blog post on ANTEC, veteran medical device design engineer Len Czuba sent the following email to PlasticsToday, which is published here with his permission. He is the president of his own product development firm, Czuba Enterprises, which is located in the greater Chicago area, and holds 15 U.S. patents for his work. Czuba has served twice as the chairman of the Medical Plastics Division of the Society of Plastics Engineers. Here he addresses his efforts to determine the safety of polycarbonate (PC) as a medical device engineering plastic.
I chaired a forum at the MDM shows in 2010, and as an unbiased medical device engineer, I wanted experts to help me form an opinion of whether we should be using PC or recommending its replacement.
This has been an issue much like the PVC and phthalate controversy over the years. Some scientists claim that BPA is bad and others point to studies showing that it is safe for use. My panel of experts included the spokesman from ACC, Steve Hentges, two suppliers of PC and two non-aligned toxicologists. Each gave fact-based information on the exposure of the population to BPA primarily from PC and from what I gathered, convinced me that there was absolutely no problem using PC in medical devices. As an aside, I also have been of the opinion that general use of PC is not a concern for health of the general population and recognize that BPA exposure comes from many things in our daily life including thermal printer paper.
In preparing for the sessions at the MDM conference, I did invite Dr. Frederick vomSaal from Missouri who at the time was the primary antagonist regarding use of PC and the effects of BPA. He made some excuse about not being able to participate and when I asked him for a recommendation for someone else to speak and represent his position, he gave me someone else that was not inclined to face the crowd.
I also invited the FDA to present but because they were in the midst of two studies trying to determine the safety of plastics and how people are exposed to BPA, they also declined my invitation.