Healthpack 2012 in sunny Albuquerque, NM is in the books. The two winners in the informal brewpub and dive diners competition were both exceptional. The beer winner was a dead heat between the Elevated IPA and the Square Root of Elevated Bitter from La Cumbre. Both were not only exceptional ales but both were available pushed (regular CO2 tap) and hand drawn on cask. This of course, required four pints for proper evaluation, a mission I chose to accept gladly. The dive diner winner was the Frontier Restaurant, right across Central Ave from the University of New Mexico. The quick, cheap, homemade enchiladas and other southwest chow was flavorful and authentic. People allegeldy drive hours, all the way from Colorado, for their green chili. There was some whimpering about no beer at the Frontier but that situation was quickly rectified after dining. A good time was had by all in Albuquerque judging by all the bright eyes and smiling faces on Thursday morning.

In addition to beer and dining, some useful packaging trend and initiatives were discussed at Healthpack as well. I am biased since I chair the Labeling Subcommittee of IOPP’s Medical Device Technical Packaging Committee, but our group session was very well attended and we discussed some pertinent current labeling changes that are in the works. There is a major joint implant label standard that’s in ASTM balloting, E Labeling is a whisker away from approval in the EU, and UDI is aging like a fine vintage wine in the Office of Management and Budget after being sent there last July by the FDA. Actually on 20 March a bi-partisan sponsored bill was introduced in the Senate to require the FDA to issue a final rule on the UDI guidance by the end of the year. The other discussion the group had, one that seemed to pique everyone’s interest, was on creating a guidance document for testing pressure sensitive labels on terminally sterilized device packages.

The Labeling Committee did a poll two years ago to attempt to baseline what device companies were doing to qualify and validate their labeling systems. The result showed a bit of the ‘snowflake effect’. In other words, no two companies were alike. Reading the results reminded me of a dozen people walking through a cafeteria line. Everyone takes different items from the dozens being offered, based upon likes, dislikes, and past experience, and most people seem to be reasonably happy with their selections when they chowed down. Right now there are a pile of standards from anyone and everyone regarding labels. Companies seem to pick the ones they like and the ones that address issues they have had in the past, and then etch them in stone for future label testing. This makes changes very difficult and there is no commonly accepted standard on testing and confirming adhesion over time and print durability.

The FDA and other international agencies on the other hand, are fairly clear on what they want to see with device labeling. Good ol’ CFR 21, Part 820, Subchapter A, Part 11, Subpart K reads, “Labels shall be printed and applied so as to remain legible and affixed during the customary conditions of processing, storage, handling, distribution, and where appropriate, use”. In English that means they gotta stay stuck and you gotta be able to read ’em. For as long as the product is saleable.

In order to discuss how to go about creating this guidance we brought in the esteemed and estimable outgoing ASTM D 10 chairman, Pat Nolan, to describe the process of creating a guidance document. It would seem that choosing from the cafeteria of possible tests and protocols and then gathering them into one concise and cogent document is the process that needs to be followed. Since Healthpack, folks have sent me a pile of standards from ASTM, TAPPI, ISO, TLMI, and a few other alphabet organizations. The next step in this process is to get a group together that can evaluate and pull together a suitable, logical group of tests and standards that provides the most effective and simple path to assuring that labels are legible and affixed over time.

I would propose forming a working group to brainstorm this guidance. I have far more standards and tests than I think we need to come up with a workable product. I’d like to see a group of people that has real world experience with labeling issues as well as qualification and validation processes to help pull this thing together. At our Healthpack meeting, at least three people sitting at the table were dealing with the daunting task of explaining to their Reg Affairs people how they could assure FDA inspectors that a new label material would remain affixed and legible over time. I think the guy in the photo above had just left a meeting with some Reg Affairs folks on the topic. I pointed out at the meeting that if you work for a long established medical device company your label stock is almost certainly the equivalent of a nicely maintained 1988 Chrysler Cordoba. Sure, it has the fine Corinthian leather, the big V-8, and the spacious head and leg room, but it uses outdated technology, is inefficient, and costs a lot more to operate than a 2011 Chevy Monte Carlo. The key is explaining that to the regulatory folks and documenting how you can be certain that the Monte Carlo will outperform the Cordoba.

Call me, 612.706.3742. Email me, [email protected]. If you are interested I’ll send you the list of docs that I’ve collected with the help of IOPP MDPTC members (and Pat!) and we can begin what should be a rewarding and long overdue project. I’m looking for a few good women and men and the phone lines are now open.