Medical Device Packaging Introspective Survey Results

Transcription

1 Medical Device Packaging Introspective Survey Results Russell Darley Medical Applications, Sealed Air Corporation Kathryn Thompson Clemson University, BS Packaging Science student

2 Agenda Acknowledgements Purpose Demographics and Background Information Technical Questions and Results Next Steps

3 News: Jennifer s have babies!! Emery Foreman Born: 02/07/2014 Weight: 5 lbs, 5 oz

4 News: Jennifer s have babies!! Dorthy Benolken Born: 02/11/2014 Weight: 9 lbs, 6 oz

5 Acknowledgements Content Contributors Tara Ford, Amcor Jennifer Foreman, Sealed Air Mackenzie Lussier, Clemson University IoPP MDPTC Content Review Distribution Poll Everywhere technology HealthPack Distribution Presentation Forum PMP News Online article with survey link

6 Purpose & Goals Benchmark industry practices for package testing Improve design, development, or testing Identify educational opportunities IoPP webinars HealthPack presentation topics MDPTC education sub-committee

7 Survey Information Survey Software Communication IoPP s & Linked In PMP News article Duration: Oct 2013 Feb 2014

8 Survey Information Survey Details 43 questions 4 sections Demographics Package Distribution Process & Product Validations Material Validations sample size = 133 respondents (88 complete responses) LinkedIn: medical packaging + packaging and containers = 517 profiles (25%) packaging + medical devices = 1000 profiles (13%)

9 Disclaimer educational purposes only company representation not regulated light use of statistical analysis

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11 Instructions: Use cell phone Text answers to Florida Answer question by: Multiple Choice: Enter number that correlates to answer choice (ex ) Open Ended: Enter code followed by a space then your free response

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14 Demographics and Background Information

15 What is your education level? n = 133

16 If you have a college degree, what field did you study? (check all that apply) Question #3 Other 19 Marketing 14 Business 25 Polymer Science 1 Other Engineering 25 Chemical Engineering 3 Chemistry 3 Mechanical Engineering 15 Packaging

17 How long have you been working on medical packaging? n = 133

18 What best describes your company? n = 133

19 What best describes your job title? Packaging Engineer = 40% Pkg Eng + Directors / Managers = 76% 42% of Director / Managers = Packaging Engineer Degree n = 133

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21 What size best describes your company? n = 133

22 If you have dedicated pkg resources, what part of the organization do they report to? No 13% Yes 87% n = 133

23 Technical Packaging Questions and Results Results: Total population Company Size Company Type Reference: ISO & TIR 22

24 Are you currently responsible for developing or carrying out packaging validations? No 26% Yes 74% 40% of non-degreed packaging engineers answered yes Validations are learned on the job n = 133 Reference: ISO : Section 5.0 TIR (process), 12.0 (design), Annex G

25 What standard do you follow (or use as a guidance) when setting up your ship testing procedures? n = 125 Reference: ISO : Section 6.2 TIR 22 Section 5.5, 6.3.2, Annex D.4

26 If an ASTM standard is used, describe the cycle and level. (open question) 2% 2% 4% 4% DC 13 = 92% 39% 49% DC 13 DC 13 Level I DC 13 Level II DC 12 Custom Other DC 13 = Air + motor freight; single pkg up to 100 lbs n = 92 DC 12 = Air + motor freight; single pkg over 100 lbs

27 If an ISTA standard is used, describe the schedule. (open question) 9% 8% 8% 1A 3% 5% 2A 3A 2B 3% 3% ISTA 3A ISTA 2A 39% 2C 7D 1G NA Other n = 47 22% Procedure 2A: Packaged-Products weighing 150 lb or Less Procedure 3A: Parcel Delivery System 150 lb or Less (standard, small, flat or elongated)

28 Size of Company vs. Shipping Standard n = 118

29 How do you determine your ship testing criteria? (select all that apply) n = 150 Risk based approach

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31 What does worst case mean to you/your company with regards to the packaging process? (open question) Total Population (n = 87): Risk = 23% Sealing Parameters = 38% Sealing Parameters: MDM s = 48% Suppliers = 6% Reference: TIR , Annex K.4

32 What does worst case mean to you/your company with regards to the packaging process? (open question) 10 yrs or less experience (n = 37): Risk = 30% Sealing Parameters = 35% + 10 yrs of experience (n = 50): Risk = 25% Sealing Parameters = 40% Reference: TIR , Annex K.4

33 Does your company have a procedure for process validation and verification? n = 101 Reference: ISO : Section 5.0 TIR

34 Size of Company vs. Procedure for Process Validation and Verification n = 101

35 Does your company have a policy for revalidation of your packaging equipment? n = 101 Reference: ISO : Section 5.7 TIR

36 Size of Company vs. Policy for Revalidation n = 101

37 If yes, how does your company determine the point of revalidation of packaging equipment? n = 88 Reference: ISO : Section 5.7 TIR

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39 Does your company require the validation of test methods? n = 100 Reference: ISO : Section 4.4 TIR 22 Annex B

40 What types of packaging / product compatibility testing do you consider? (open question) n = 73 Reference: TIR 22 Annex E

41 Are you able to adopt supplier aging data rather than performing your own independent study? n = 90

42 Size of Company vs. Use of Supplier Aging Data n = 88

43 How does your company perform accelerated aging studies? n = 88

44 Summary Risk based approached Understanding of own processes No gaps in technical knowledge No gaps with Smaller companies

45 Next Steps HP presentation will include 2 presentations 43 questions (total population results) HP 2014 version Raw Data submitted to MDPTC Education Sub-committee EU AORN (2015) Nurses Survey at HP 2016

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47 Thank You! Questions?