I thought it would be good to get a blog post out before the big event starts in Louisville tomorrow. Packing? Heck, I get that nailed 15 minutes before I leave for the airport. The other thing I need to get done are the slides for my mini presentation at the Standards Update session. Longtime Healthpack sponsor and stalwart, Pat Nolan of DDL, was unavoidably detained this year and I was shanghied by our two illustrious co-chairs, Messer’s Spitzley and Larsen, to say a few words. Very few words. Mr. Spitzley felt that the complete history of the ASTM D 10 group, complete with footnotes, might be an appropriate topic. I believe I will stick to the labeling guidance that our IOPP MDTPC subcommittee is working on as well as a brief update of the Arthroplasty labeling standard that just passed in ASTM F04.

As I’ve written before in this space, current qualification and validation processes for pressure sensitive labeling of terminally sterilized device packages is like a gigantic cafeteria, where heaping plates of every standard or test that exists can be loaded on one’s gray, devoured, and turned into a testing procedure. The goal of this guidance is to offer a more streamlined and usable set of tests and processes to help quantify and satisfy the FDA’s ‘affixed and legible’ requirements in CFR 21, Subpart 820. If we are able to generate a useful guidance and it comes into accepted usage, it is possible that it may be crafted into a standard for testing in one of the ASTM committees. One step at a time however.

Once the label is affixed and legible on the package, we need to turn to the content of that label. Dr. Kent Lowry, in my stompin’ grounds of northern Wisconsin, and his committee have been working on a Standard Guide for Presentation of End User Labeling Information for Orthopedic Implants Used in Joint Arthropasty. After a few years and addressing the negative comments as they popped up, the standard was balloted and passed in F04 at the meeting in December of last year. It is scheduled to be published next month. The basic goal is to identify high priority labeling content and have it in a standard, easy to read format for end users in an OR environment. Like nutritional labeling of consumer food packages, the authors of this standard hope it provides a basis for standardization of labeling content for other implantable devices.

I know many attendees are awaiting Dr. O’s list of dives and micro brewed beer joint like last year’s seminal list for Albuquerque. Unfortunately this year I could not find a truthful and reliable source of information (as the criminal complaint and summons says) to provide such a document. A number of packaging professionals have sent me information gleaned from the internet but I require the personal touch of a friend, relative, or colleague that actually bellied up and plunked down some greenbacks in the establishment. I am confident however, that extensive research will be done, much like the work on the above guidances and standards, and that by Thursday a base of knowledge will have been developed that will guide future visits to the horse racing and baseball bat town on the Ohio River. I’m looking forward to seeing many of you tomorrow.