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OCTOBER 2003

 

MEETING MINUTES

IoPP MEDICAL DEVICE PACKAGING TECHNICAL COMMITTEE

Tampa, Florida

22 October 2003

 

 

On October 22nd, 2003, the IoPP Medical Device Packaging Technical Committee (MDPTC) met after the ASTMF02.60 Medical Packaging Subcommittee sessions. The meeting was called to order by the co-chairs of the committee, Curt Larsen of Dupont and John Spitzley of Medtronic. Welcoming remarks were made by the co-chairs. The attendees were referred to the MDPTC web pages for information regarding the IoPP anti trust statement and the committees’ mission and vision statement.

 

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 Arizona, we allowed individuals who were not IoPP members to attend and observe this meeting. They were not allowed to comment or vote on any issues discussed.

 

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 MichiganStateUniversityprovided an update her TG’s work to characterize defects. They have run into a problem regarding the consistency in the small holes that they are burning into the PETG trays with laser technology. Under intense magnification, the pinholes measurements are not consistent with the anticipated dimensions indicated by the vendor. Most of the inconsistency is along the wall thickness of the tray material rather than in the actual hole diameter on the tray surfaces. Detailed photos are provided in the presentation that Laura made at the meeting and are available on the MDPTC website. (www.iopp.org) The task group will continue to investigate methods, which will provide consistent defect dimensions both along the wall thickness and at the surface. They will not begin testing until this issue has been resolved.

 

    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 ASTM, AAMI and ISO presented an update regarding the recent activities of these organizations relating to medical device packaging. This report is also available on the committee’s IoPP web page.

 

      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 MDM’s) are not willing to share this data at this time. Based on this input, this activity will be terminated.

 

          An open discussion followed covering the following topics:

  • 1.The co-chairs led off the open discussion session with a question to the attendees – Are you satisfied with the general direction that the MDCTP is heading and are you happy with the results to date. We received a generally favorable response. One suggestion for improvement was to consider expanding the meeting time to a full day rather than the 1-2 hours we are doing now. We could still align ourselves with other organizational meetings such as ASTM, HealthPack, MDMregional shows and IoPP meetings but consider taking a full or half day immediately before or after these options. The co-chairs will discuss this further with other MDPTC members.
  • 2.Our next meeting is tentatively scheduled to be at the Healthpack conference, March 18th and 19th, in Palm Beach Gardens, Florida. We will be providing more details soon; HealthPack 2004 details may be found at http://www.healthpack.net/

After the open discussion concluded, the meeting was adjourned.

 

Curt Larsen / John Spitzley

Co-chairs

IoPP Medical Device Packaging Technical Committee

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