Medical Device Link.

Originally Published PMPN December 2003

Medical Packaging Roundtable

John Spitzley (left), Medtronic’s fellow, packaging, and Curt Larsen (right), with DuPont Medical Packaging, discuss their revival of the medical device packaging committee.

For this year’s roundtable, PMP News editor Daphne Allen decided to scale things down a bit and focus on the feats of two medical packaging professionals. She catches up with John Spitzley, currently Medtronic’s fellow, packaging, and Curt Larsen, currently with DuPont Medical Packaging, on their revival of the medical device packaging committee of the Institute of Packaging Professionals.

The committee is busy on several fronts. Its task groups are busy characterizing sterile-package defects, developing standards for data specification sheets, and exploring myriad challenges in labeling, among other things. 

Why did you get the medical device packaging committee going again?

Spitzley: The committee fills a need between the two organized groups: the standards side of medical packaging, like AAMI and ISO, and the testing methodology side of it, ASTM. There needs to be a forum for people to talk about the technical issues and the problems they have. Solutions don’t always come from these other groups. And, in some cases, activities in this committee may result in activities or work items for the other groups. But there also needs to be a forum for discussion and actions that don’t necessarily result in new standards or regulations.

Larsen: This committee gives us a forum to disseminate a lot of information on industry developments. We are also trying to give members an area where they can share nonproprietary information about materials and equipment. Education is our underlying goal.

How are you reviving it?

Larsen: We’ve held the revival meeting at Pack Expo International 2002 in Chicago, one meeting at HealthPack in Scottsdale, AZ, and the last one during the ASTM meeting in Orlando, FL. ASTM was very receptive and more than happy to support us.

Spitzley: In addition to aligning ourselves with these events, we knew that we would have to develop activities and focus on topics that were of interest to the industry, or otherwise no one would pay attention. 

Larsen: Management support is also crucial. Medical device packagers don’t attend events on their own buck, so they have to have support from their companies. 

Spitzley: So we need to have activities that will have an impact on their business. We are developing a momentum that will make people want to get involved.

What are some of these activities?

Spitzley: Dr. Laura Bix, assistant professor at Michigan State University’s School of Packaging, is working on defect characterization in her task group. The driver behind her research is that, as an industry, we’ve always wanted to know what size of a package defect in your sterile barrier system would cause a loss of integrity. Some of us suspect that we are dealing with defect size ranges smaller than the ranges for which we are currently inspecting. We don’t know that for sure, but until we have data, we as an industry will continue to struggle with these small defects. The first task in Bix’s research is to make sure that the defects we are introducing in our test samples are of a known size. This is so we can compare the sensitivities of different test methodologies. They have run into some situations where the defects they are introducing are not always what everyone thought they were. They are struggling to come up with a method to introduce precisely the same defect from package to package so they can move forward.

Larsen: It’s what we’ve often found. It’s hard to make a failure. It’s hard to make a bad package. Especially when you are talking about these minute defects. 

Spitzley: It’s important to demonstrate that we consistently have a 0.002-in. hole in the packages we test, for instance, if we want to demonstrate that such a defect does not cause a loss of integrity. Bix is making a lot of progress; it just will take some time for the research. But at least there is some activity in this direction.

Isn’t this controversial? Isn’t there some debate as to whether such an answer is worth finding?

Spitzley: Some say that we may be dealing in sensitivity realms that are way beyond what we should be worried about. But until you prove that, it is just a lot of talk. The outcome of this research could have major implications. 

How is it going with standardizing data sheet specifications? 

Spitzley: Led by task group chair Nick Fotis of Cardinal Health, the group has made a lot of progress. They’ve had some discussion about how much data would suppliers want to include and what kind of data. For instance, would it be just a sampling of their production data or based on specific lot sizes with statistic sampling? 

Larsen: Exactly. Would the data be representative of a typical piece of material? What test methods would be used? What standard deviations would be allowed? What are the legal ramifications of specifications on such data sheets? It was interesting because a lot of suppliers are part of this task group, as well as medical device manufacturers. So they will just have to hash it out. But they actually are pretty far along, about 95%. 
We should have a format and a sample sheet ready for our next meeting. It is not rocket science, but it would have strength and performance characteristics—just information suppliers should normally have in their specifications. We don’t want to over- specify. If it is not critical to package performance, then don’t overspecify.

Spitzley: Some of it may also depend upon where in its life cycle the material is. An established material may have reams of data. But a new material may not have much. It will be a balancing act. We don’t want to make it tough for suppliers to introduce new materials. But there should be some minimum requirements.

What about suppliers that claim they can offer anything a medical device manufacturer needs, like, “We can make it as strong as you want?”

Spitzley: That’s what we are trying to clean up. That’s not good enough anymore. People need data. Honestly, some of us will take these data sheets and create our own specifications from them. Or attach them to a test report, and although you don’t really have the spec yet, at least you can identify what the material is and what its properties are.

Will the data sheet include information on formed materials?

Larsen: Suppliers don’t have any control over what happens in a customer’s facility. When it comes to Tyvek, the material is printed, coated, die-cut, etc. But whatever we at DuPont did as a material supplier could change after the converter handles it.

Where does the group go from here?

Larsen: I am not sure. It may be something we want to bring to the Sterilization Packaging Manufacturers Council. Maybe even coordinate it with AAMI or ISO requirements. Maybe even look at USP, since there may even be materials used for drug packaging included.

Spitzley: We talked about having it be an IoPP-endorsed format that suppliers can follow to give information to medical device manufacturers. Right now, data sheets are all over the map, ranging from a marketing sheet to a really extensive technical data sheet.

What has happened with the material and systems sharing task group, the group that would develop a means of sharing test results on commonly used packaging configurations?

Larsen: We don’t have any volunteers at this time, so we are sunsetting it. But we would be happy to pick this up again.

How is work in the labeling group going?

Larsen: Bar coding, regulations, validation of labeling and labeling systems, and the use of symbols and languages are all hot topics right now. The task group, led by chair Dave Olson of Web Graphics, serves as an informational resource, and we may call upon speakers in the future to present on these topics.

Is the industry anticipating bar coding every device?

Larsen: I think the handwriting is on the wall. But I don’t think that device manufacturers are limiting the implementation of bar coding. The fact is that healthcare institutions don’t have the wherewithal or even the interest in doing so. There is tremendous potential in bar codes, especially for inventory purposes to track use in the healthcare setting. 

Do you think that FDA’s interest in bar coding pharmaceuticals is driving interest on the device side?

Spitzley: The big buying consortiums, which are making bar coding a requirement for their customers, will be the ones to drive bar coding, not any regulation. 

How are your benchmarking activities going?

Larsen: Our work to benchmark current practices in medical device packaging, which began a while ago, is available in a report that is currently restricted to the study participants. However, we are talking about making it available to committee members. At our next meeting, we may bring in the consultant who helped us put it together, Dennis Young, to present the study results and statistics. The study gives medical device packagers a benchmark against which to measure their own organization. In some cases, it may give packaging professionals the necessary information to go to their management and get support to upgrade their operations. They could say, “Look, this is what most of the industry is doing, and we aren’t even close, so we need to upgrade.” 

Copyright ©2003 Pharmaceutical & Medical Packaging News