MARCH 2003
IoPP MEDICAL DEVICE PACKAGING COMMITTEE
SCOTTSDALE, AZ
03/27/03
On March 27, the IoPP Medical Device Packaging Committee met at the end of the first day of conferences presented by Healthpack in Scottsdale, AZ. The meeting was called to order by the co-chars of the committee, Curt Larsen of Dupont and John Spitzley of Medtronic. Welcoming remarks were made by the co-chairs and the antitrust statement was reviewed.
There were 41 meeting attendees and each person was allowed to introduce themselves along with the company or organization that they were representing. Because of the high level of interest in this meeting among Healthpack attendees, we allowed non-IoPP members to audit this event with the stipulation that they would not be allowed to comment or provide input to the activities discussed. They were strongly urged to join IoPP and our committee.
The mission and vision statements that Curt and I had previously developed were presented for any additional comments or observations. There were no major suggestions made, so these statements stand as written.
Stan Zelesnik of IoPP headquarters welcomed the attendees and gave us an update regarding upcoming improvements to the IoPP website.
The next order of business was updates provided by the task group chairs.
- Benchmark TG – Curt Larsen indicated that the benchmark study had been completed and the results shared with the participants. Some data was presented at the meeting in Chicago but the complete details belonged only to the participants. At this time, there will be no new efforts to complete a follow on benchmark study for at least a year. Benchmark study experts recommend this break.
- Defect Characterization TG – Chair Laura Bix of Michigan State University presented the work completed by her task group regarding research, which will determine the size of a defect, which would present danger to medical devices. The power point presentation that she made is available on the IoPP Medical Device Packaging Committee web site. (www.iopp.org) Please see this for details regarding this TG’s work. The major point of discussion following her presentation was around the topic of defect size. There was concern that the research would be dealing with defect sizes beyond the current capability of the medical device industry to measure them. Laura indicated that this was the type of input that she was looking for and encouraged members of the committee to contact her with suggestions.
- Data/Specification Sheet TG – Nick Fotis presented the results of a survey completed by his task group, which polled potential users about the format and content of a data/specification, which could be used in our industry. Nick’s power point presentation is also available on the committees IoPP web page. (www.iopp.org) The next goal for this TG is to draft a data/specification sheet format based on the inputs of the survey and present it to the general committee for comments and inputs.
- Labeling TG – Dave Olson of Web Label was introduced as the chair of the Labeling TG. Dave had no updates to provide as he had just recently volunteered to serve. He did say that he had secured the commitment of several committee members to serve on his TG. Two suggestions were made regarding potential work items for this TG. A) Develop an industry guideline which establishes the “real” requirements for medical device packaging labeling and B) Develop guidelines and suggestions for device manufactures to assist them in dealing with increasing multi-language requirements for package labeling.
Hal Miller of Johnson and Johnson, who serves as the committees 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. His report is
available on the committee’s IoPP web page. (www.iopp.org)
An open discussion followed covering the following topics:
- The committee co-chairs reiterated the need for involvement by the FDA in our work. A letter has been drafted and sent to Cathy Nutter of the FDA requesting that she join IoPP and participate on our committee. The letter details why we feel her membership is important and cites examples of the several work items we have undertaken, which need FDA, input. We also discussed the possibility that IoPP fund her membership in the event that budget constraints at the FDA prevent Cathy from joining. Stan Zeleznick (sp) of IoPP said that he would investigate. John and Curt will follow up with Cathy regarding the status of her membership in IoPP.
2. We discussed several possibilities for our next meeting site. Among them are: Pack Expo in Las Vegas in, MD&DI in
Minneapolis in October and somewhere in Washington DC to accommodate FDA participation. The co-chairs will investigate
each possibility further and update the committee.
3. An issue was raised regarding the balance of the Medical Device Packaging Committee membership. An informal survey of the
attendees at this meeting was conducted and it was discovered that there was considerably more representation from the
producer side of the industry than from the user segment. Other organizations attempt to remedy this imbalance by allowing
one vote per organization regardless of how many representatives are present from that organization. Since we have not had
any voting situations that have not been an issue for us at this point. We may have to consider such a remedy if the need
arises. Curt and John agreed to review the entire roster and categorize members by type of organization to see if the overall
membership is unbalanced. We will report those results in the future on the IoPP web site.
There were no other issues or concerns raised and the meeting was adjourned.
