Labeling Task Group Update

1. Labeling Task Group Update Healthpack’09 Memphis, TN

2. Topic overview • E Labeling (lack of) progress in the EU • The new (14 Jan 2009) ISO 28219:2009, Packaging -- Labeling and direct product marking with linear bar code and two-dimensional symbols • EN 980 Symbols for use in the labeling of medical devices and EN1041-Information supplied by the manufacturer of medical devices; updates in 2008 • Survey results: Preliminary work on a guidance doc for the pressure sensitive labeling of terminally sterilized medical devices.

3. The looong proposed E labeling directive……. • “In the light of technical progress in information technology and medical devices, a process should be provided to allow information supplied by the manufacturer to be available by other means”. • Amendment to Article 11…..the following paragraph is added: “14. The Commission may, in accordance with the procedure referred to in Article 7(2), adopt measures allowing instructions for use to be provided by other means.”

4. Pretty much nothing has happened since last years update... • Updated MDD no longer expressly prohibits E Labeling. • Proposed MDD acceptance may occur sometime this century. • Asia – Move toward E Labeling, CD ROM widely accepted. Japan modeling requirements after EU; Hong Kong has accepted E Labeling • Eucomed and Global Harmonization task force have come up with guidelines for safe and effective labeling

5. Key points – E Labeling • Countries can still individually dictate how they will accept IFU’s; with the acceptance of Bulgaria and Romania there are now 23 recognized European languages. • Consult with your notified body to see if your product is eligible for E labeling in a specific country. • Pay close attention to rev control, access, proof of delivery, language requirements, security, etc. • CD’s with product has generally been acceptable with notified bodies. • Research specifics for your device in each regulated region you are going to distribute in and be aware of ‘nuances’.

6. ISO 28219:2009, Packaging - Labeling and direct product marking with linear bar code and two-dimensional symbols • Pertains to labels with barcodes only • is intended to “include, but it is not limited to, multiple industries” including healthcare manufacturers. • Defines minimum requirements for identifying items. • Provides guidelines for item marking with machine-readable symbols. • Covers both label and direct marking of items. • Includes testing procedures for label adhesive characteristics and mark durability. • Provides guidance for the formatting on the label of data presented in linear bar code, two-dimensional symbol or human readable form

7. EN 980 – Symbols for Use in the Labeling of Medical Devices • Revised in 2008 – symbols “deemed suitable without need for further explanation”. • Expanded from 12 to 29 symbols; 10 new EN 980 symbols and 7 from ISO 15223 • Manufactures can still create their own symbols as long as they are described in the IFU

8. EN 1041-Information Supplied by the Manufacturer of Medical Devices • First change in 10 years, although not much has really changed • Annex A is the useful part, similar to the EN 980 symbol library. • Does clarify that full postal addresses are not needed, just enough so the physical location of the manufacturer is apparent; PO box is no good. • Annex B discusses alternate labeling and e-labeling.

9. PS Labeling Guidance doc….The Survey-- • The Labeling Task Group put together a 10 question survey on Label Testing Methods & Practices. • Summary to follow………….

10. Q1- The design of the label *stock* is formally evaluated for acceptable performance through the supply chain and printing system. Examples include evaluation of face cuts/back cuts, perforation pattern's), suitability of face sheet to accept thermal transfer printing, colorfastness, etc. • 80% - yes • 20% - no • Comments: • We evaluate our label as part of our packaging transit qualification testing. • Originally completed, have not changed in years to require evaluation.

11. Q2-The evaluation of label *stock* performance (ex.: adhesion) is described in some manner within a formal Test protocol. • Yes, specific criteria and pre-defined acceptance – 80% • No, not specifically noted or tested – 20%

12. Q3 -The performance of label *copy* (ex.: smudge resistance) is predetermined in a formal Protocol • 60% - yes • 40% - no

13. Q4- I test for specific performance or attributes based on prior field experience or known risk areas in my design. • 60% - yes • 40% - no • Comments to “in general, what have you learned ‘the hard way’?” • 1.adhesion to specific substrates and temperature and humidity conditioning equal or above that tested for the final product • 2. ink rub test is an objective method to compare ink adhesion.   • 3.Readability of barcodes after smudge test  • 4.Be careful with DOE work to ensure product labels will remain legible in shelf life testing.  • 5.Tamper evident seals falling off.   • 6."Kiss-cut" vs. "Perf-cut" on label sets. For certain applications the kiss-cut allowed labels to peel up or peel completely off the package prior to point of use. This type of background is very relevant and valuable when evaluating new label set stocks.   • 7.Ribbon performance verses cost and maintenance

14. Q5 -As you formulate your test protocol, what Methods do you use/reference for conditioning of adhesive label samples? • ASTM D4169, Distribution simulation – 85.7% • ISTA Distribution simulation practices – 28.6% • ASTM F1980, Accelerated aging - 92.9% • TAPPI methods – 7.1% • UV exposure or other "fading" method – 0%

15. Q6-If you employ Accelerated Aging, do you control for humidity? Do you specify "Freeze/Thaw" cycle's) in your Protocol? • 1.No  • 2.Yes. 6 day conditioning. 2 days @ 95 degrees/95%RH , 2 days @ 135 degrees/25%RH, 2 days at -30 degrees. 3.RH is controlled.   • 4.No Humidity. We do specify environmental conditioning that includes Freeze/Thaw as part of our test protocols.  • 5.Typically, humidity is held at less than 20% in our AA protocols.  • 6.We use ambient for humidity  • 7.Yes. • *continued next slide*

16. Accelerated aging continuation.... • 8.Yes, but only based on Product requirements. AM  • 9.yes.  • 10.There is a "freeze/thaw" conditioning step used fro time zero testing. Humidity is controlled at <20% which is the default humidity used by the testing facility and relevant standards.  • 11.no and no  • 12.No, unless substrates are paper... then Yes.  • 13.We monitor humidity level; typically less than 20% is good; 11% is ideal We do not use Freeze/Thaw cycles  • 14.No freeze thaw. Humidity controlled at high temperature and 'non-condensing' humidity used at low temperature 

17. Q7-For what milestone's) do you specify the evaluation of the Label Samples • Pre-sterilization - 46.7% • After a defined period of time - 46.7% • Post-sterilization - 73.3% • Post-distribution - 86.7% • After several pre-defined conditioning events • -13.3% • At more than one conditioning milestone • -26.7%

18. Q8 - Describe the general sample size criteria for critical features. • Varies by feature or aspect - 33.3% • 100% inspection or testing - 13.3% • Sample size determined by statistical method-66.7% • Fixed sample size (ex. n=30) - 33.3% • Comment: each lot of printed labels is inspected as a unit. The lot is spot-checked for smudges, accuracy of content, and general legibility. 100% of printed lots are inspected.

19. Q9 - each lot of printed labels is inspected as a unit. The lot is spot-checked for smudges, accuracy of content, and general legibility. 100% of printed lots are inspected. • ASTM D3330, Peel adhesion of PS material - 20.0% • ASTM D5264, Sutherland abrasion and smudge resistance test - 20.0% • ASTM F1319, Crockmeter abrasion and smudge resistance test 0.0% • ASTM F2252, Ink adhesion tape test - 6.7% • (CEN/CENELEC) EN45502-, General Requirements for marking - 6.7%1 • Visual inspection (legibility) - 93.3% • Internal corporate standard - 20.0%3 • "Simple" performance such as corner flagging - 26.7%

20. Q10-Do you require delamination/fracture/tearing of the label face sheet as part of your adhesion evaluation? • Yes – 13.3% • No - 60% • Other (comments) • depends on the application/purpose of the label • We inspect for corner peeling and label tearing.  • no, it is a part of the peel test failure modes • Simple tear testing is employed.

21. Thank you • This information will be posted on the IOPP Medical Device Technical Committee’s Labeling Task Group link. • http://www.iopp.org/i4a/pages/index.cfm?pageid=363 • Please direct comments and questions to Dave Olson, 612.706.3742 dolson@advancedweb.com

22. Labeling Task Group Members • Dave Olson, Advanced Web - Chair • Mark Andersen, BSCI • Ryan Cannon, American Medical Systems • Jan Gates, Abbot Vascular Cardiac Therapy • Gerry Gunderson, Quality Tech Services • Laurie Jordan, Smith Nephew • Susan Ritter, Tyco Healthcare/Valleylab • Judy Salzer, Medtronic CRDM • Dan Schaefer, Zimmer Spine