Medical Device & Diagnostic Industry

Article Summary

A medical product might pass through rigorous testing in-house, but if it can’t survive the transportation process, the efforts made to get it to market are in vain. A process called vibration testing can help avoid this problem, but a lot of people don’t understand its significance, according to a recent survey.

More than half of the 200 medical device packaging professionals who responded to a quiz conducted by DDL Inc. (Eden Prairie, MN) didn’t know that vibration testing is important. Only 46% of those surveyed said they knew the test was imperative.

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Minneapolis, MN September 25, 2008 — www.testedandproven.com DDL, leader in medical device package and product testing announced that, via findings from their September Validation for Extended Shelf Life Quizzler, nearly 100 percent of the medical device packaging engineers who responded understand the importance of medical device package validation testing for extended shelf life.

“We are pleased to have learned that the packaging engineers who participated in our September Quizzler are aware of the requirements for validating the extended shelf life of medical device packaging,” Patrick Nolan, COO of DDL, stated.

The government requires that all sterile medical device products claiming a shelf life or expiration date must have data to support the claim and their packaging must also withstand the same shelf life capability.

“Without proper evidence to support a claimed shelf life capability the product could be recalled by a regulatory body which could significantly delay product introduction to the market,” Nolan said.

Before validating a medical device for extended shelf life, several questions must be answered;
1.What types of packages are we validating?
2.What type of expiration date do we want?
3.Which strength and integrity methods do we use?
4.What are the glass-transition, melt, and heat-distortion temperatures of the package and device?

“All sterile medical device products and their packaging must have data to validate their shelf life,” Nolan said. “The expiration date can range anywhere from 1-5 years with 3 years being the most common.”

Testing for package integrity and sterility is vital to ensuring that there was no loss in package integrity due to the aging study. Generally speaking, ASTM standard F88 is used for strength testing and F1929 is used for integrity testing. Dye leak testing is commonly done on thermoform trays and bubble leak testing is performed on pouches.

To gain more insight into the importance of extended shelf life validation for medical device packaging, please visit http://www.testedandproven.com/shelf_life.html.

About The DDL Packaging Quizzler
DDL’s Packaging Quizzler is a semi-monthly online challenge which poses real world packaging questions Medical Device Packaging Professionals encounter on a daily basis.

One randomly-selected winner who correctly answers The Packaging Quizzler will be awarded a prize, such as an iPod.

To participate in the next Quizzler, please visit “The Packaging Quizzler” at http://www.testedandproven.com/lp/quizzler4/.

About DDL
DDL offers expert package, product and material testing services, including shock testing, vibration testing, tensile testing, leak testing and validation services. DDL also recently implemented a package design, development and prototyping department. DDL maintains full service testing labs in Minnesota, Southern California and New Jersey. (www.testedandproven.com)

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C Category

C749 - Standard Test Method for Tensile Stress-Strain of Carbon and Graphite has been revised to C749-08

F Category

F1306 - Standard Test Method for Slow Rate Penetration Resistance of Flexible Barrier Films and Laminates has been reapproved, available as F1306-90(2008)

Work Order Category

WK21138 - Standard Test Method for Rubber Property—Plasticity and Recovery (Parallel Plate Method) is a work item revision to existing standard D926-04

WK21139 - Standard Test Method for Determination of Green Strength of Raw Rubber or Unvulcanized Compounds is a work item revision to existing standard D6746-08

WK21149 - Standard Test Method for Elongation of Narrow Elastic Fabrics (Static-Load Testing) is a work item revision to existing standard D5278-98(2004)

WK21150 - Standard Test Method for Tearing Strength of Fabrics by Falling-Pendulum Type (Elmendorf) Apparatus is a work item revision to existing standard D1424-07a

WK21154 - Standard Test Method for Breaking Strength and Elongation of Textile Fabrics (Grab Test) is a work item revision to existing standard D5034-08

WK21164 - Test Method for Determining the Effects of Bending a Membrane Switch or Assembly

WK21168 - Standard Test Method for Elongation of Narrow Elastic Fabrics (Static-Load Testing) is a work item revision to existing standard D5278-98(2004)

WK21170 - Standard Test Method for Determining the Effect of Random Frequency Vibration on a Membrane Switch or Membrane Switch Assembly is a work item revision to existing standard F2187-02

WK21171 - Standard Test Method for Determining the Effect of Variable Frequency Vibration on a Membrane Switch or Membrane Switch Assembly is a work item revision to existing standard F2188-0

This week, an iPod preloaded with DDL’s webinar series “How Will ISO 11607 Revisions Affect Packaging Professionals?” could be yours if you correctly answer the question below.

This week’s question is:
What testing is used to assure medical device packages endure shipping & distribution?
a. Fatigue Testing
b. Stability Testing
c. Compression Testing
d. Distribution Simulation

Accept the challenge of The Packaging Quizzler!

Minneapolis, MN September 11, 2008 — www.testedandproven.com — DDL, the leading product and package testing services firm specializing in medical device package testing, made a startling discovery in its August “Accelerated Aging and Environmental Conditioning Test Quizzler.”

Of the group of medical device professionals that responded to DDL’s Quizzler campaign, 17 percent indicated they are bundling accelerated aging and environmental conditioning tests together. The result is that their medical device packaging may not meet the requirements set forth by ISO 11607, because these tests should be considered separate inputs to package performance.

“If accelerated aging and environmental conditioning tests are conducted together, the product’s packaging integrity may be compromised,” stated Patrick Nolan COO of DDL. “The risks associated with bundling testing and the loss of package integrity can be infection caused by bacteria and pathogens entering the package.”

“We ensure each custom medical device we develop that requires compliance to ISO 11607 is subjected to accelerated aging and environmental conditioning tests separately,” said Tim Tipple, Product Engineer of Metrix Company and winner of the accelerated aging and environmental conditioning test Quizzler question. “These two testing methodologies are designed for completely different situations.”

Accelerated aging tests for shelf life survivability of a package, while environmental conditioning tests ensure the package is capable of surviving extremes in environmental conditions.

Take for instance a catheter’s packaging that has been modified and needs to be reintroduced into the medical marketplace. Before it is sent to market, it requires the assurance that the new packaging can be stored for an extended period without any decrease in performance that may affect the safety and efficacy of the catheter.

“Medical device professionals understand the importance in the integrity of a product and the need for products to be tested to ensure safety,” stated Nolan. “What they may be overlooking is the need for the packaging to be held to that same standard of integrity. This is why conducting accelerated aging and environmental conditioning tests separately is essential in the effectiveness of medical device packaging.”

To gain more insight in the importance of the need for accelerated aging and environmental conditioning testing, please visit www.testedandproven.com/aging/index.html.

Minneapolis, MN August 12, 2008 — DDL, the leading product and package testing services firm specializing in medical device package testing, recently discovered through the company’s July “Vibration Testing Quizzler” that only 46 percent of Medical Device Packaging Professionals truly understand that vibration testing can prevent defective products or packaging from going to market.

In his winning Vibration Testing Quizzler response, David Anderson VP of Research & Development at GT Urological stated, “When there is the slightest chance that any of our medical products will be exposed to a transportation, operation or storage environment, it is vital that we implement vibration testing before going to market.”

The vibration testing quizzler question below received answers from nearly 200 medical device packaging professionals.

Question: Package and product testing should always be expanded to include vibration testing when there is a chance of exposure to what environments?

Answer:                Percent Responded:
Transportation                    50
Operation and Storage        4
All of the Above                    46

“Essentially, vibration testing is something products and packaging should be subjected to when there is a chance of its exposure in transportation, operation or storage,” states Patrick Nolan COO of DDL.

To gain more insight into understanding the importance in executing vibration testing and the critical need for continuing education in medical device packaging guidelines please visit http://www.testedandproven.com/vibration_testing.html

About The DDL Packaging Quizzler:
The DDL’s Packaging Quizzler is a semi monthly online challenge which poses real world packaging questions which Medical Device Packaging Professionals encounter on a daily basis.

One winner who answers The Packaging Quizzler correctly and is selected at random will be awarded a significant prize, such as an IPod.

To participate in the next Quizzler please click “The Packaging Quizzler”.

D Category

D3786 - Standard Test Method for Bursting Strength of Textile Fabrics—Diaphragm Bursting Strength Tester Method has been revised to D3786-08a

D999 - Standard Test Methods for Vibration Testing of Shipping Containers has been revised to D999-08

A custom iPod, preloaded with DDL’s webinar series “How Will ISO 11607 Revisions
Affect Packaging Professionals?” could be yours this week if you are up to the challenge
of the Packaging Quizzler!

This week’s question is:
What questions must be answered before a medical device package is validated for
extended shelf life?
a. What is the overall package configuration?
b. What type of expiration date do we want?
c. Which strength and integrity methods should be utilized?
d. All of the above – and more!

Accept the challenge of The Packaging Quizzler!

D Category

D2256 - Standard Test Method for Tensile Properties of Yarns by the Single-Strand Method has been reapproved, available as D2256-02(2008)

D2594 - Standard Test Method for Stretch Properties of Knitted Fabrics Having Low Power has been reapproved (with editorial change), available as D2594-04(2008)e1

D737 - Standard Test Method for Air Permeability of Textile Fabrics has been reapproved (with editorial change), available as D737-04(2008)e1

Work Order Category

WK20962 - Standard Test Method for Determining the Actuation Force and Contact Force of a Membrane Switch is a work item revision to existing standard F1597-02

WK20963 - Standard Test Method for Determining the Actuation Force and Contact Force of a Membrane Switch is a work item for the withdrawal and replacement of the existing standard F1597-02

WK20964 - Standard Test Method for Determining Travel of a Membrane Switch is a work item for the withdrawal and replacement of the existing standard F1682-02

WK20965 - Standard Test Method for Determining the Sensitivity (Teasing) of a Tactile Membrane Switch is a work item for the withdrawal and replacement of the existing standard F1997-07

WK20968 - Standard Test Method for Determining the Contact Bounce Time of a Membrane Switch is a work item revision to existing standard F1661-96(2002)

WK20969 - Standard Test Method for Measuring the Force-Displacement of a Membrane Switch is a work item revision to existing standard F2592-07a

D Category:

D5607 - Standard Test Method for Performing Laboratory Direct Shear Strength Tests of Rock Specimens Under Constant Normal Force has been revised to D5607-08

Work Order Category:

WK20922 - Standard Test Method for High Speed Puncture Properties of Plastic Films Using Load and Displacement Sensors is a work item revision to existing standard D7192-05