Tuesday, May 22, and Friday, May 23
10:30 a.m. CT
IoPP MEDICAL DEVICE PACKAGING TECHNICAL COMMITTEE
There were 30 meeting attendees and each person was allowed to introduce themselves along with the company or organization that they were representing. As we did at our previous meeting in
The next order of business was updates provided by the task group chairs.
1. Benchmark TG – Curt Larsen, the task group chair, indicated that it might be appropriate to publish the complete results of the survey and make them available to MDPTC members via our web site. Prior to this being done, a formal presentation is being planned for our next meeting; We will inform the members when the survey results are available on the website.
2. Defect Characterization TG – Chair Laura Bix of
3. Data/Specification Sheet TG – Chair Nick Fotis provided an update for the Data/Specification TG. They have made good progress in establishing the look and format for the data sheet. They continue to have concerns within the group regarding two issues: A) There was a lot of discussion on this topic relative to the proper use of data sheets in the process of identifying candidate materials, whether sample size was valuable or would lead to misunderstanding and the value of data sheets if actual data, mean and standard deviation were not provided. B) Whether data used to generate information for the data sheets would be available for inspection. Detail regarding the format for the data sheet are available in the presentation given by Nick and is available on the MDPTC website.
4. Labeling TG – The MDPTC co-chairs made a presentation on behalf of the Labeling TG Chair, Dave Olson, who was not able to attend the meeting. The presentation was an overview of some of the issues facing the medical device packaging community, namely bar coding and bar code standards, regulatory trends in labeling, labeling validation, labeling hardware and software validation, symbols and multi-language labeling issues. After the presentation, the general committee discussed what they would like to see from this TG in the future. The general opinion was that they could be a valuable information resource by presenting more detailed presentations and updates on the topics covered in their overview. Arranging for outside experts to present at future MDPTC meetings could enhance these presentations.
5. Hal Miller of Johnson and Johnson, who serves as the committee liaison to other groups such as
6. Material and Systems Data Sharing TG - The committee discussed the open leadership position for the Material and Systems Data Sharing TG. The co-chairs asked the attendees if there were any volunteers or if there was any interest in continuing this effort. After some discussion, there was general agreement that most of the entities involved (suppliers and
An open discussion followed covering the following topics:
After the open discussion concluded, the meeting was adjourned.
Curt Larsen / John Spitzley
IoPP Medical Device Packaging Technical Committee