Medical Device Packaging Tips, Learnings and Cautionary Tales. OMTEC 2015 Chicago Alison Tyler Technical Director Beacon Converters, Inc.

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2 Medical Device Packaging Tips, Learnings and Cautionary Tales OMTEC 2015 Chicago Alison Tyler Technical Director Beacon Converters, Inc. June 2015

3 Presentation Topics Why is Medical Packaging so Important? Packaging Guidance and Compliance Standards Major decision points for selecting materials and packaging design Review of Recent FDA Recalls

4 A Glimpse Inside Healthcare Environment (Where Medical Device Packaging is Used) 490,000 Americans have died in 5 year period due to medical errors. These were all categorized as preventable deaths Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health 2. System (Washington: National Academy Press 1999)

5 Survey of: 831 practicing physicians 1207 members of the public

6 Physicians 35% 291 Reported Medical Errors in their own care of family member care Public 42% 507 Reported Medical Errors in their own care of family member care

7 Neither physicians nor the public named medical errors as one of the largest problems in health care today. Malpractice Insurance 29% Cost of Healthcare 27% Insurance Companies and Health Plans 22% Cost of Healthcare 38% Cost of Prescription Drugs 31%

8 Medical Errors were reported as a minimal problem... Medical Errors 5% So how big a deal are they really? Medical Errors 6%

9 Medical Reality From a study was done regarding how many people DIED from preventable medical errors 490,000 Americans have died in this 5 year period due to medical errors. These were all categorized as preventable deaths 1. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health System (Washington: National Academy Press 1999)

10 So we were in Bad Shape in 1999 how are we today? Well, lets just say things aren t pretty Current data estimates that annually as many as. 440,000 Americans die every single year from preventable medical errors. This now ranks medical errors as the 3 rd leading cause of death in the United States.

11 Hospital Safety Score Source

12 Highland Park Hospital

13 Highland Park Hospital

14 Greater Boston Area

15 West Virginia

16 So What Does this Have to Do with Packaging? This is the same environment that packages will be opened in, one that is riddled with errors You aren t only going to sell your device in Boston. Your design must be easy to follow, must NOT contribute to any additional errors. You cannot depend on people working in this environment to police for package failures Lets get on to making great packages!

17 Guidance Standards Use Them! Packaging Guidance and Compliance Standards 1. AAMI/ISO Packaging for terminally sterilized medical devices Part 1- materials, sterile barrier systems and packaging systems Part 2- Validation requirements for forming, sealing and assembly processes 2. AAMI TIR 22- Guidance for ANSI/AMMI/ISO Parts 1 & 2 (Don t try to reinvent the wheel)

18 AAMI/ISO Standards Part 1 1. Protect the device from physical damage 2. Protect the device from undesirable environmental conditions 3. Allow device to be terminally sterilized 4. Allow that sterility to be maintained until the product is dispensed 5. Allow aseptic presentation

19 AAMI / ISO Standards TIR-22 (ISO 16775) Design Inputs Product Attributes Protection Requirements Storage, Distribution and Handling Requirements Manufacturing Requirements Sterilization Requirements Customer Requirements

20 Annex Information Regulatory references Test Method Validation Sterilization Considerations Design Inputs-Attributes & Requirements Investigating Failure Selection, Evaluation and Testing Generating a Validation Protocol Risk Analysis Tools AAMI Standards TIR-22 (ISO 16775)

21 5 Major Points; Packaging Performance What does your package need to do? 1 Protect your device from physical damage Puncture Abrasion Improper cushioning Glue flap Crushing Insufficient shielding Inside out / outside in puncture

22 Design Inputs Protection from Physical Damage Predict Damage Possibilities with good inputs Size, Profile Weight Center of Gravity Fragile or rugged Sharp edges or points Surface Characteristics Small component pieces Bend Sensitive

23 Multiple components of varying size and shape Heavy, bulky handle Fragile knob used to control the laser source Large fluid reservoir Bend-sensitive fiber optics and tubing Design Inputs Protection from Physical Damage PMP News webinar archive: Reduce, Recycle, Recover: Redefine your sterile barrier system in a flexible footprint

24 Design Inputs Protection from Physical Damage Orthopedic Drill and Pin Kit Multiple components Varied size/shape. Sharp edged Heavy (surgical steel). Materials include steel and molded polymer parts.

25 Damaging Environmental Conditions 2 Protect the device from undesirable environmental Microbes Moisture conditions What conditions could harm or degrade your device and packaging system? Ultra Violet Carbon Dioxide Temperature Extremes

26 Design Inputs Protection from Environment Water Vapor Oxygen Material (g-mil / 100 in 2 -day) (cc-mil / 100 in 2 -day) LDPE LLDPE HDPE Ionomer Cast PP OPP PET BON PVdC PCTFE AlOx PET MVTR: 100 F, 90% RH OTR: 73 F, 50%RH

27 Materials (0.001" caliper) Design Inputs Protection from Environment Typical Vapor Barrier Levels MVTR (g/100 sq.in/day) A60 AlOx PET PCTFE PVdC BON PET OPP Cast PP Ionomer HDPE LLDPE LDPE OTR MVTR OTR (cc/100 sq.in./day)

28 Layers of Protection What do your flexible packaging materials do PET Moisture Barrier Strength HDPE Oxygen Barrier PP UV Barrier Chemical Resistance LDPE Seal Strength

29 Protection from Environment Overwrap Bag for IV products Active drug substance will degrade in light. Fluid loss affects drug dosage. Must be autoclaved to sterilize. Product visibility is required.

30 Overwrap Bag for IV products Protection from Environment FDA UV Light Barrier protects active drug substance. AlOx Moisture/Oxygen Barrier prevents loss of fluid/drug effectiveness. Heat resistant layers are durable in high heat process temperatures of autoclaving. Bag is translucent for product visibility Bag designed for tear open application

31 Tissue / Collagen Like Products Protection from Environment A3460 A34 Polyester/LDPE/Aluminum Foil/Seal layer A60- AlOx Polyester/Seal layer Increase in products requiring very high barrier Sometimes liquid is part of product Low profile Moisture loss critical

32 5 Major Points; Packaging Performance What does your package need to do? Allow device to be terminally sterilized 3 Porous or impermeable? Compatibility with process steam, autoclave, VHP, EO, Gamma and electron beam Guidance for ANSI/AAMI/ISO Sterilization Considerations Compatibility of materials subject to sterilization

33 Sterilization Steam & Autoclave Steam Sterilization requires porous package Paper with good wet strength In some cases Tyvek can be used if temperature is less than about 121 C. HDPe, PP, PA are common film webs incorporated into high temperature moist applications Autoclave utilizes non-porous materials

34 Sterilization Ethylene Oxide Suitable for heat and humidity Porosity must be sufficient to: allow gases to penetrate or exhaust all layers reach the interior of the product minimize the stress on materials and seals (don t mask Tyvek ) How many layers will surround product? Primary and secondary packaging Double or triple bagged Kit building (all components must be considered) Be Careful with labels

35 Sterilization Radiation- Gamma & E-beam Radiation Materials must maintain their properties for desired shelf life protection Package need not be breathable Provide for outgassing Radiation can be damaging to packaging materials, paper and polypropylene in particular. Refer to TIR 17 or ask your supplier Flexible packaging uses thin caliper materials, more affected by sterilization dosages If re-sterilizing, re-package for safety and durability cumulative

36 Sterilization VHP- Plasma A hydrogen peroxide plasma is the primary sterilizing agent Non-cellulose porous packaging needed Process can be damaging to extrusion coated/laminated materials (adhesion to substrate is compromised) Typical package: PET/PE adhesive laminate sealed to Tyvek

37 5 Major Points; Packaging Performance What does your package need to do? 4 Allow that sterility be maintained until the product is dispensed Compromise of Sterility is event related Sterility is not time related A sterilized object will remain sterile until an event compromises its sterility

38 Sterilization Compromising Sterile Barrier Package seal failures Stressed in EO, improper seal strength specification Package material failures Abrasion, puncture, tear, material under/over engineered Package damaged in manufacturing Handling- manual or auto fills, damaged equipment Package damaged in distribution Pressure changes and non-porous packages, UV over exposure in storage

39 FDA Recalls Compromising Sterile Barrier Customed Inc., Surgical Convenience Packs Damaged Packaging On June 3rd, 2014 Customed, Inc. initiated a recall of sterile convenience surgical packs. The products have been found to have a potential defect due to adhesion. The defect could result in loss of product sterility and lead to infection. Reason for Recall: Surgical pack sterility may be compromised due to individual packs adhering to one another inside the shipping case. In some cases, the plastic packaging of one bag (along the printed words SNAP SMARTLY TO OPEN ) has adhered to the end seal of an adjacent pack. When the bags are separated, the plastic film can tear and compromise the sterility of the contents.

40 FDA Recalls Compromising Sterile Barrier Customed Inc., Surgical Convenience Packs Damaged Packaging How much product was included in the recall? ALL product manufactured from 1/9/2009-5/20/ ,146 units manufactured 3,562 manufacturing lots Products were distributed within the domestic (Puerto Rico Commonwealth, Florida State, New York State, US Virgin Islands); and international market (Geographical Area Central America- Costa Rica & Panama; and South America-Colombia).

41 FDA Recalls Compromising Sterile Barrier Class 2 Recall Medela Enteral Syringe, Acacia Piston Syringe March 11, ,959,187 units recalled The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.

42 FDA Recalls Packaging Process Controls Class 2 Recall Ringloc Acetabular Shell Limited Hole Finned 52mm Feb 17, 2015 Mallory Head 4 Finned Acetabular Shell 50mm (Lot ) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot ) following a mix up in packaging with the two FDA Determined Cause: PRODUCTION CONTROLS: Packaging Process Control

43 FDA Recalls Compromising Sterile Barrier Class 2 Recall Pulsiocath PiCCO ProAQT Monitoring Kit Feb 17, 2015 Internal testing and investigation of the packaging revealed cracks and holes in primary packaging FDA Determined Cause: PRODUCTION CONTROLS: Packaging

44 Class 2 Recall Four Lead TUR Irrigation Set FDA Recalls Compromising Sterile Barrier January 26, 2015 Manufacturer Reason for Recall Potential for failure of the pouch packaging seal at high altitudes. FDA Determined Cause: DESIGN: Packaging Design/Selection Quantity in Commerce 26,028 units Baxter Healthcare

45 Class 2 Recall cryoice cryoablation probe (CRYO2) FDA Recalls Compromising Sterile Barrier December 30, ,190 units Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek pouches. Affected product may have compromised sterility due to packaging defects. It was determined that some mishandling of the product during the packaging process could inadvertently damage the sterile barrier.. FDA Determined Cause: Packaging Process Controls

46 Class 2 Recall Trauma Large Screws FDA Recalls Compromising Sterile Barrier Manufacturer Reason for Recall: Firm is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.. FDA Determined Cause: Packaging Process Controls Zimmer

47 Shelf Life & Sterility Testing Sterile Barrier Maintain Sterility Until Point of Use / Expiry Some supplies and or devices have expiration dates and degrade over time Make sure you understand your product and packaging expiry and data to support it.

48 Shelf Life & Sterility Testing Sterile Barrier Test at worst case conditions within the validated window of manufacture Worst case configuration of device- most fitments, heaviest joint, most pieces Largest, smallest sterile barrier system size and/or seal area NOTE: Worst case is bad enough. Don t test for conditions that don t exist Do enough testing with enough units.

49 Accelerated Aging Different Objectives Accelerated Aging & Environmental Conditioning A protocol to determine the affects of time on a package/product. Humidity not part of the model Environmental Challenge Goal to determine sensitivities Can be extreme

50 Accelerated Aging and Environmental Conditioning Q~10~=2 Arrhenius equation = effect of increasing temperature on homogenous 1 st order reaction. Accelerated aging increase of 10 degrees Celsius doubles reaction rates. Don t get carried away!

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52 Clean Peel Material Considerations Tyvek is inherently clean peeling and low linting Coated Medical grade papers are designed to minimize particulate generation Clean peel minimizes the risk of introducing particulates into a clean environment.

53 5 Allow aseptic presentation Allows for sterile handling Peelable opening features allow for sterile presentation Outside of package is not sterile Aseptic Presentation how long will it remain sterile? Must peel easily but demonstrate a good seal

54 Packaging Design In Summary Package development is an involved task. Don t forget your packaging supplier.

55 5 Major Points; Packaging Performance What does your package need to do? Questions?

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