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IoPP Medical Device Packaging Committee
On Tuesday, Nov 5th, the first meeting of the IoPP Medical Device Packaging Committee was convened at McCormick place in
Dennis Young of Dennis Young and Associates presented information regarding a benchmark study that we recently conducted. He presented some limited data from the study such as the number of participants, the size of the participating organizations and at what point the package development process begins in the product cycle. Some discussion was held regarding what we are going to do with the benchmark study in the long term. For the 6 to 12 months, it is being distributed in it's entirety only among the participants. DuPont, the sponsor of the survey owns the data and may distribute the results through the media such as the Tyvek® Rx Newsletter or the IoPP publication. We also discussed the possibility of a follow-on study which would include more companies with more pertinent questions based on what we have learned from this effort. This will not happen for another 12 to 18 months. One of the possible outcomes would be the development of some guidelines for medical device packaging design and development based on the needs and level of sophistication established by this study and an additional expanded survey.
The next item of business was a review, discussion and finalization of the committee Vision and Mission Statements. The final versions will be put on the IoPP technical committee website.
A suggestion was made to add liaison activities between the various technical committees and trade groups that have an interest in medical device packaging information, standards and test methods. Such groups might be
Lastly, we discussed the formation of several task groups to deal with issues that were deemed to be important to medical device packaging. The proposed groups are:
1. A benchmark group that will manage the recently completed benchmark study and consider future expanded studies. This group will also address the feasibility of a guidance document based on information gained from that study. Curt Larsen volunteered to chair this group.
2. A research task group will investigate the feasibility of an industry funded
project to conduct research with a goal of characterizing and establishing sizes for sterile package defects which would cause the loss of sterility. If it proves to be feasibility, the technical committee would fund and manage the project.
Proposed chairperson - Laura Bix of Michigan State University School of Packaging (firstname.lastname@example.org). Jordan Montgomery of Medtronic volunteered to assist on this task group.
3. A data sheet task group will address the need for standardized data sheet or specification information for materials. This task group will research and recommend information that a packager needs when considering a material for use. Suggested Chairperson - Nick Fotis of Cardinal Healthcare (Nick.G.Fotis@cardinal.com).
4. A third task group will investigate the possibilities for sharing non competitive, non confidential data about commonly used materials in the medical device industry. An example made was that shelf life stability studies are continually being conducted on uncoated Tyvek®/polyethylene/polyester pouches. There could be a shared repository of data for a package such as this. It could help avoid costly and repetitive shelf life studies. There are many other materials which could be candidates for a project like this. The point was made that we should involve the FDA as much as possible before we undertake an activity such as this. It is important understand the content, format and amount of information needed that would address current international regulatory requirements. In addition, an individual from the FDA will be approached and encouraged to join IoPP and this committee. - Task group co chairs are John Spitzley and Curt Larsen.(until a permanent chair is named)
5. A task group that will address labeling for medical device packaging. Some issues for consideration are:
- Regulatory updates
- Bar code technologies
- Labeling software/validation
- Multi language issues
- Electronic media labeling
At this time, no specific activities have been defined. It will be up to the task group to define the scope for the activity and establish how they might deal with the issues noted above. Suggested chairperson (any volunteers ?)
In closing, the committee got off to a great start with over 45 attendees. The discussions were open and valuable with several good ideas from the participants.
Note that the majority of communication related to this technical committee will be done using the internet.
If you would like to become a member of this committee or any of the task groups, please contact John Spitzley (John.Spitzley@Medtronic.com) or Curt Larsen (Curtis.L.Larsen@usa.dupont.com). This committee exists to serve the members that have an interest in medical device packaging. It can only succeed if the members play an active role.
John Spitzley & Curt Larsen