medical device packaging cautionary tales - · pdf file–radiation can be damaging to...

© 2012 Beacon Converters, Inc.

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

Beacon Converters, Inc. June 2015


• 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

Presentation Topics


• 490,000 Americans have died in 5 year period due to medical errors. These were all categorized as preventable deaths

1. 1. Kohn LT, Corrigan JM, Donaldson MS, eds. To Err Is Human: Building a Safer Health

2. System (Washington: National Academy Press 1999)

A Glimpse Inside Healthcare Environment (Where Medical Device Packaging is Used)


Survey of:

831 practicing physicians

1207 members of the public


291 Reported Medical Errors in their own care of family member care

35%

507 Reported Medical Errors in their own care of family member care

42%

Physicians

Public


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%


So how big a deal are they really?

Medical Errors were reported as a minimal problem...

Medical Errors 5%

Medical Errors 6%


Medical Reality • From 1994-1999 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)


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 3rd

leading cause of death in the United States.

Hospital Safety Score

Source www.hospitalsafetyscore.org

http://www.hospitalsafetyscore.org/

Highland Park Hospital


Greater Boston Area


West Virginia


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!


Packaging Guidance and Compliance Standards

1. AAMI/ISO- 11607 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-11607 Parts

1 & 2

Guidance Standards – Use Them!

(Don’t try to reinvent the wheel)


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

AAMI/ISO Standards 11607- Part 1


Design Inputs

• Product Attributes

• Protection Requirements

• Storage, Distribution and

Handling Requirements

• Manufacturing Requirements

• Sterilization Requirements

• Customer Requirements

AAMI / ISO Standards TIR-22 (ISO 16775)


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)


• Protect your device from physical damage

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

1

• Puncture

• Abrasion

• Improper cushioning

• Crushing

• Insufficient shielding

Glue flap

Inside out /

outside in

puncture


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



PMP News webinar archive:

Reduce, Recycle, Recover: Redefine your sterile barrier system in a

flexible footprint

• 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


• Multiple components

• Varied size/shape.

• Sharp edged

• Heavy (surgical steel).

• Materials include steel

and molded polymer

parts.

Orthopedic Drill

and Pin Kit



Protect the device from

undesirable environmental

conditions

Damaging Environmental Conditions

2

What conditions could

harm or degrade your

device and packaging

system?

Ultra

Violet

Moisture

Carbon

Dioxide

Temperature

Extremes

Microbes


Water Vapor Oxygen

Material (g-mil / 100 in2-day) (cc-mil / 100 in2-day)

LDPE 1.2 510

LLDPE 0.8 280

HDPE 0.4 170

Ionomer 1.7 500

Cast PP 0.7 240

OPP 0.4 120

PET 1.2 2.3

BON 10 1.7

PVdC 0.1 0.1

PCTFE

AlOx PET

0.015

0.1--0.005

9.8

0.2--0.006

MVTR: 100°F, 90% RH OTR: 73°F, 50%RH

Design Inputs Protection from Environment


024681012

0 100 200 300 400 500 600

LDPE

LLDPE

HDPE

Ionomer

Cast PP

OPP

PET

BON

PVdC

PCTFE

A60 AlOx PET

MVTR (g/100 sq.in/day)

OTR (cc/100 sq.in./day)

Mat

eri

als

(0.0

01

" ca

lipe

r)

Typical Vapor Barrier Levels

OTR

MVTR

Design Inputs Protection from Environment


PET HDPE

LDPE PP

Strength

Moisture Barrier

Oxygen Barrier

UV Barrier

Chemical Resistance

Seal Strength

Layers of Protection What do your flexible packaging materials do

• Active drug substance will

degrade in light.

• Fluid loss affects drug dosage.

• Must be autoclaved to sterilize.

• Product visibility is required.

Protection from Environment

Overwrap Bag for IV products

• 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

Overwrap Bag for IV products Protection from Environment

FDA

Tissue / Collagen Like Products Protection from Environment

• Increase in products requiring very high barrier

• Sometimes liquid is part of product

• Low profile

• Moisture loss critical

A3460

A34 –Polyester/LDPE/Aluminum Foil/Seal layer

A60- AlOx Polyester/Seal layer

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=OlKVZB4ohPQ06M&tbnid=oaWdkRMlX1hxSM:&ved=0CAUQjRw&url=http://stabilitybio.com/products_acd.php&ei=X_kTU6PnHcHF2QWl9oCICQ&bvm=bv.61965928,d.b2I&psig=AFQjCNGutNhMn-qfVS6fVrm9kiSJNq2IaA&ust=1393904250695490


• 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 11607 Sterilization

Considerations Compatibility of materials subject to sterilization


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


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


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


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


Allow that sterility be maintained until the product is dispensed


4

• Compromise of Sterility is event related

• Sterility is not time related

• A sterilized object will remain sterile until an

event compromises its sterility


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


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.



Customed Inc., Surgical Convenience Packs

Damaged Packaging

How much product was included in the recall?

ALL product manufactured from 1/9/2009- 5/20/2014

459,146 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).



Class 2 Recall

Medela Enteral Syringe, Acacia Piston Syringe

March 11, 2015

1,959,187 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.


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 364600)

and Ringloc + Acetabular Shell Limited Hole Finned 52 mm

(Lot 427840) following a mix up in packaging with the two

FDA Determined Cause:

PRODUCTION CONTROLS:

Packaging Process Control



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



Class 2 Recall

Four Lead TUR Irrigation Set

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



Class 2 Recall

cryoICE cryoablation probe (CRYO2)

December 30, 2014 19,190 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



Class 2 Recall Trauma Large Screws

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


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.


• 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.

Shelf Life & Sterility Testing Sterile Barrier


Different Objectives Accelerated Aging & Environmental

Conditioning

• Accelerated Aging

– 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


Accelerated Aging and

Environmental Conditioning

Q~10~=2

Arrhenius equation = effect of increasing

temperature on homogenous 1st order

reaction.

Accelerated aging – increase of 10

degrees Celsius doubles reaction rates.

Don’t get carried away!


• 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.

Clean Peel Material Considerations


– Allows for sterile handling

– Peelable opening features allow for sterile presentation

– Outside of package is not sterile

– Must peel easily but demonstrate a good seal

Aseptic Presentation how long will it remain sterile?

• Allow aseptic presentation 5


Package development is an involved task.

Don’t forget your packaging supplier.

Packaging Design In Summary



Questions?

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