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March 2007

 

 

Minutes

Medical Device Packaging Technical Committee

HealthPack 2007- New Orleans, LA

Crown Plaza Hotel

March 8th (Thursday), 2007

5:00 PM

I.         Call to order – Curt Larsen and John Spitzley
II.                   IoPP Confidentiality Statement
III.                  Approval of last meeting minutes
IV.               Reports – Comm. Secy., Membership Secy. & Webmaster – Eric Carlson
1.      Secretary
                                                              i.      Raw notes to be prepared in 1 week
                                                            ii.      Email notification – Carlson asked for a show of hands for email notification for posting of the notes; email will be sent to members. 
2.      Membership has remained somewhat constant in the last 6 months.
                                                              i.      No current member outreach – we would welcome recommendations for a member outreach strategy
3.      Website is our communication vehicle and historical repository
                                                              i.      Hal Miller – Is there a plan to periodically purge the website of old information
1.      Carlson – Good question - no plan at the present but as many standards need to be updated every 5 years, this would be a good cut-off point for our web information to be reviewed. Some will stay, obsolete information could then be purged.
4.       
V.                 Report on MDPTC new officers job performance– Spitzley / Larsen
1.      Our TC is only as good as the members’ participation. We must develop our officers into active, participating self starting leaders. As title is not good enough, we need to see activities and actions w/o depending on the committee chairs for direction on every issue.
2.      We need more ideas and work items from the membership to keep the MDPTC vibrant.
VI.               Update on MSU Package Integrity Project and Fund Raising Effort – Hal Miller / Karen Polkinghorne
1.      There will be a presentation tomorrow on the MSU project by Dr. Bix and Dr. Severin
2.      Cathy Nutter from FDA CDRH recently retired – we have lost the only informed expert in the FDA.
3.      There are a number of tests with known sensitivities – to get more information for the industry, we’ll need improved test methods. This is an area where the membership can contribute with ideas/in-house methods that can become work items within the committee and ultimately, ASTM work items.   
4.      This effort still needs money – please consider giving to this project – as FDA goes through changes, there is some risk that tests and methods will be reevaluated with new eyes which can potentially have the effect of “turning back the clock” to requirements which are not based on science and data.
VII.              Education Task Group Report – Jennifer Neid
1.      What do people need and want to know?
2.      Between the meetings more information is needed
3.      “Ask the Expert” page
                                                              i.      Not yet live, but will be soon
                                                            ii.      Carlson is working with Chris Barry at IoPP national on this
4.      Experts needed from the group
                                                              i.      Add the TG member emails to the front page
                                                            ii.      Miller – if you would like to sign up to be an expert … is there a simple button to click on the website
1.      Not at this time – the search for experts has not begun
                                                          iii.      Miller – how will the questions be handled
1.      Questions will be sent to a pop3 email account (gmail) that each of the committee members will have access to. Each member will have a rotating responsibility to monitor the account. The member will assign expert to answer the questions and the response will be sent back and the question and answer may or may not be posted online
                                                           iv.      Limit liability – website and ‘expert’ are to be held non-liable
1.      Format is yet to be designed – won’t know the need for the experts or the traffic until we launch
2.      Liability – a limited liability statement will need to be on the “Ask the Expert” page and on every email that is sent
                                                             v.      Probably an FAQ eventually – Larsen
                                                           vi.      Spitzley – limit the exposure of time requirments to the ‘experts’
VIII.            Label Task Group Report – Dave Olson
1.      e-Labeling: there has been progress – in Europe especially
                                                              i.      The website will show the new directive – update is not much different than last year
                                                            ii.      EU expected to pass on the first reading – likely in April
                                                          iii.      Asia likes CD vs. web based e-Labeling method
                                                           iv.      Japan prefers the EU model
                                                             v.      Countries can individually dictate how the IFU is to be provided
                                                           vi.      Consult your notified bodies
2.      Guidance document
                                                              i.      Rough outline available on the website
                                                            ii.      This TG is working with ASTM
                                                          iii.      Performance criteria matrix under review
                                                           iv.      Reviewing option for each performance criteria
                                                             v.      Based on performance criteria vs. simply test results
3.      Unique Identification of medical devices
                                                              i.      Linear barcode systems are in use
                                                            ii.      www.fda.gov/cdrh/ocd/udi
                                                          iii.      A standard currently exists for drugs
                                                           iv.      ID is driven by supply chain rather than regulatory bodies
1.      Gunderson – Is anyone doing RFID – how are you going about imparting the numeric coding to the tag
2.      Bix – there is online info MSU – difficult on combination products, temp tracking, etc. Rob Clarke is RFID
3.      Olson – most hospitals have a hard time working with linear barcode
4.      Gunderson – 64k amount of information – there is a lot of information in 64k – more than just a few characters
5.      Olson – 2D – most of the customers are only using 25% of the capacity of 2D barcodes
6.      Spitzley – Medtronic has been involved to some degree, but not sure about the current status
7.      Daphne Allen – drug industry is only a little ahead of the device industry – they are only getting barcodes onto the blisters
a.      GS1 HUG group are looking for device companies to get involved
b.      “The GS1 global Healthcare User Group (HUG; www.gs1.org/hug) is a voluntary group of specialists who have come together to develop automatic identification standards specific to the needs of the healthcare industry.”[1]
8.      Olson – e-labeling – there is a real estate issue for the 24 languages – difficult to implement on small packages
9.      Miller – FDA comment period is over, then there will be a ruling in a few months – regulatory arena players – HIBCC – had been trying to be an advocate in this area – any of the regulatory groups will need to be involved with and many companies represented here have some representation
10.Olson – the advocates are the big hospitals
11.Allen – is there something that could be put in a G10?
a.      Olson – this is being discussed
IX.               Tech. Committee of the Year Award – Glenn Petrie
1.      Larsen – Petrie was to be here – he was appointed to the job of gathering all the information and applying for this award
                                                              i.      Chemical has won last 5 years  
                                                            ii.      We’re very likely to win. All we need is to enter
X.                 Old Business –
1.      Elections – Larsen – we’re getting serious about voting ourselves out of office – in the next year will want to get a selection committee – more information coming
XI.               New Business
1.      Next Meeting – PackExpo West /  October 16th 2007 / Las Vegas, NV
2.      Neid suggests MDM Minneapolis
                                                              i.      That will be under consideration
                                                            ii.      Poll to the members
                                                          iii.      Larsen and Spitzley likely to make a command decision. At this point, Minneapolis is the likely winner. We haven’t had a MDPTC meeting there and the proximity of hundreds if MDM’s make it a good choice.
3.      Miller – distribution testing survey – interesting questions arise from this – ASTM, ISTA, compliance standards that say you must do distribution testing – guidance missing for distribution testing for med devices.
                                                              i.      What happens when you send products out in pallet loads, overseas, - should we consider a guidance document
                                                            ii.      Spitzley – storage and conditioning
                                                          iii.      Not a lot of guidance currently – when do you look at environmental factors
                                                           iv.      The new TIR doesn’t provide this guidance
                                                             v.      Should a new task group be formed?
                                                           vi.      Nolan – what standards should we use – what is approved by FDA – ASTM and ISTA; deciding which to use is a big question
1.      Standards provide some guidance; guidance document to describe all the hazards in the environment would be very difficult;
2.      Committee ASTM D21 this is the venue where the experts should provide another document – write a new standard, improve 4169;
3.      Tomorrow I will talk about a standard update that is being worked on; similar to ISTA 3A; if IoPP wants to provide a liaison committee to develop ideas or a white paper guidance document – ASTM needs experts to bring that information forward.
4.      Spitzley – this committee can help bridge the gap between ASTM and ISTA; people here want to get information from all sides
a.      If people look at the results of the survey – it shows that a lot that the respondents know about distribution testing
b.      Benchmark study will need to be redone in the next year or so – will need some money to make it happen
5.      Nolan – we would support a TG from this committee
a.      ASTM and ISTA has some established structure – easier to get some more forward motion;
b.      ASTM is accused of moving slowly; if we could get the experts at this level – then the consensus process will move more quickly
6.      Larsen - If this task group did nothing other than inform the committee about the activities of ASTM and ISTA it would be good
7.      Troutman volunteers as TG chair to investigate
8.      Spitzley / Troutman – need an objective and work with Carlson to get email to the membership to get volunteers based on a charter for a specific goal
9.      Karen Greene – synergies with cold chain management – biotech – cold chain is their issue -
10.Troutman – include the ASTM distribution group
11.Troutman will look to see if this can be sustained; timeline – level of interest – please contact me with interest to be involved and who wants leadership – speak to Randy today – high level structure
XII.              Adjourn – Co chairs – 536pm
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