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July 31, 2007
Dear Colleague,
Welcome to the first edition of NAMSA's electronic UPDATE
Newsletter!
Over the years NAMSA has produced an informational, educational newsletter that was
mailed to our clients across the globe via "snail mail". We are proud to announce that this quarterly newsletter will now be an electronic version of
UPDATE emailed directly to you.
We're eager to share this electronic newsletter, so please feel free to forward
it to a friend or colleague by clicking here: forward to a friend. If you received this newsletter as a forward from a friend or colleague and would like to sign up to receive the next editions of UPDATE
newsletter, please click here: sign up. Our goal is to share relevant and cutting edge information
with our clients and colleagues within the medical device testing, pharmaceutical and healthcare manufacturing industries.
If you have any suggestions on what you'd like to hear from our knowledgeable
group of medical device experts and scientists in an upcoming issue of UPDATE newsletter, please email us at updatenewsletter@namsa.com. And, if you have any comments or concerns,
we appreciate your feedback. If you'd like to be removed from our mailing list, please click here: opt out.
Thank you and welcome to UPDATE Newsletter.
In this Edition (Click the headline to go directly to the
article):
The FDA has indicated that they would like to see results from both the C3a as
well as the SC5b-9 Complement Activation Assay.
Is Your Medical Device
Thrombogenic?
Developments in Medical Device Testing Seminar and Workshop Set For Brussels, Belgium; October 2 - 3,
2007
Sun Chemical
Exclusive Distributor for NAMSA Sterilization Indicating Inks
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The FDA has indicated that they would like to see results from both the
C3a as well as the SC5b-9 Complement Activation Assay.
ISO 10993-4 (2002) entitled “Biological evaluation of medical devices -- Part 4: Selection of tests for interactions with blood”
identifies complement activation testing as a recommended procedure for demonstrating one aspect of hemocompatibility for devices which contact
circulating blood.
The interaction of blood with a medical device or biomaterial may result in activation of complement and the production of complement cascade
protein products, specifically C5a, a powerful anaphylatoxin, and can result in the formation of the Terminal Complement Complex (TCC) by the
assembly of C5 through C9 proteins (see diagram to the right). The formation of TCC has the potential for harm and injury to the
patient. The assessment of the level of SC5b-9 (a soluble form of TCC) induced by contact of materials with normal human serum is
indicative of a material’s propensity to activate the complement terminal pathway. Generation of SC5b-9 is assessed by incubating test
articles with normal human serum and then measuring the amount of SC5b-9 produced in the serum.
The FDA requires complement activation testing to ensure that materials used in devices that come in contact with blood do not result in an
anaphylactic response in a patient. The primary reason why FDA is also recommending the inclusion of SC5b-9 testing is because C3a can be adsorbed
onto surfaces, especially if they are negatively charged, which could lead to the conclusion that the test material does not activate complement.
SC5b-9 has been shown to not adsorb onto surfaces.
NAMSA is pleased to offer SC5b 9 Complement Activation Assay testing. Please contact NAMSA Technical Sales and Service at 419.666.9455 for
additional information on the SC5b-9 Complement Activation Assay.
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Is Your Medical Device Thrombogenic?
The interaction of blood with a medical device or biomaterial may result in
coagulation of the blood and thrombus formation. To reduce the likelihood of a thrombogenic reaction with the blood-contacting
surface of a device, the device may be coated with an immobilized heparin as a means to render it thromboresistant. When medical
devices are coated with immobilized heparin, it is important to know the activity of the heparin that is bound to the surface.
This information is useful when characterizing the hemocompatibility of a surface material (reference ISO 10993). NAMSA is
pleased to announce that we are now offering an assay for the determination of heparin activity on heparin-coated medical devices.
The Heparin Activity Assay is a colorimetric method that was developed to quantitatively measure the biological activity of heparin
immobilized on a medical device surface.
The test method used is an ELISA assay performed by incubating test articles containing
immobilized heparin with specific biological factors that regulate the clotting process: thrombin, a clotting factor; antithrombin
III (ATT III), a clotting factor inhibitor; and a substrate. When coagulation occurs in the body, thrombin acts upon fibrinogen
(substrate) and cleaves it, forming a fibrin clot. Clotting is inhibited by the action of ATT III, which inactivates
thrombin. Heparin acts upon ATT III to enhance the rate of thrombin inactivation, thus acting as an anticoagulant.
In the Heparin Activity Assay, a substrate known as S-2238 is used in place of fibrinogen. When thrombin cleaves S-2238, a
yellow color is generated. Varying intensities of yellow color will be generated depending upon the amount of immobilized heparin
present in the sample being tested. Because heparin increases the inactivation of thrombin by ATT III, a lighter yellow color
correlates with a greater heparin activity. The heparin activity of test samples will be determined by spectrophotometrically
assaying a set of standards with known concentrations of heparin, followed by analysis of the heparin coated device.
Heparin + ATIII (excess) → [Heparin ● ATIII]
[Heparin ● ATIII] + Thrombin (excess) → [Heparin ● ATIII ● Thrombin] + Thrombin
Thrombin + S-2238 → Peptide + p-nitroaniline
p-nitroaniline is measured using a plate reader at 405 nm
There are many methods for application of heparin to the surface of a medical device or
biomaterial to render it thromboresistant. This Heparin Activity Assay is a means by which one can quantitatively measure the
amount of heparin present regardless of the method used to coat the device with the heparin.
Please contact NAMSA Technical Sales and Service at 419.666.9455 for additional information
on the Heparin Activity Assay.
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Developments in Medical Device Testing Seminar set for Brussels, Belgium - October 2-3,
2007
This seminar provides the most current information on preclinical testing required by regulatory bodies for market approval of medical
devices and component materials.
Anyone involved in the design, development, or manufacture of medical devices will benefit from attending this seminar and workshop.
NAMSA’s Medical Device Development Process and Testing Guide™ will be used to align test requirements with the phases of product
development and create a framework for managing the process.
The seminar concludes with a "hands on" workshop emphasizing the practical application of information presented over the course of the
seminar.
Participants will receive certificates of completion, reference materials, and the opportunity to interact with the
seminar presenters, all of whom are experts in medical device testing.
The following topics will be covered at this seminar:
Trends in Pre-Clinical Testing
Learn about the latest developments in Pre-clinical Testing and the International Standards
that impact regulatory requirements.
Materials Characterization and Risk Assessment – An in-depth look at the increasing role of Risk Assessment in
regulatory submissions. The publication of ISO 10993-18: Chemical Characterization of Materials, in 2005 combined with Risk Assessment is impacting
the way medical device manufactures design their test programs. Learn what is required and how to stay compliant.
Function and Performance Studies – These studies are critical to verify products perform according to their
intended function. Learn how data obtained in the R&D phase of development can be leveraged to minimize testing in later development phases to save
time and money.
Biocompatibility (in vivo and in vitro toxicology) – A streamlined approach to compliance with ISO 10993:
Biological Evaluation of Medical Devices, with special emphasis on recent changes and their implications to device manufacturers. Additionally,
requirements for submissions to the Japanese Ministry of Health Labor and Welfare will be discussed and compared to requirements for Europe and the
United States.
The Workshop provides an opportunity to apply the knowledge obtained throughout the day to create
a preclinical test program that is compliant with worldwide regulatory standards.
NAMSA
has conducted informative seminars benefiting the medical device industry for over 20 years. These seminars provide manufacturers
with the most current information on pre-clinical testing required by regulatory bodies for market approval of medical devices and
biomaterials. Concentrating on the practical application of regulatory requirements, seminar participants gain the knowledge to
design a testing program that can have a significant impact on the costs and time associated with regulatory compliance.
On occasion, medical device manufacturers may wish to present information on testing options to several people within their quality assurance
or engineering departments. In addition to public seminars, NAMSA Advisory Services provides on-site training seminars to device
manufacturers in key areas such as biocompatibility, material characterization, and packaging or sterilization considerations.
These on-site seminars can be customized specifically for your company to focus on critical topics that will strengthen the regulatory
knowledge level of management and fulfill internal training requirements. The following seminar topics represent a sampling of the
various areas of expertise offered by our consulting group:
- Understanding an ISO 13485 Quality Management System
- Sterilization of Medical Devices
- Biocompatibility and Compliance with ISO 10993
- Risk Management and Applications for Medical Devices
- Packaging Validation and Shelf Life Performance Studies
- Biocontamination Control in Medical
Manufacturing
NAMSA offers seminars throughout
the year at locations worldwide. If you are interested in obtaining further information
on an on-site seminar, please email info@namsa.com.
For more information or to register for the Developments in Medical Device Testing Seminar in
Brussels please click here: http://www.namsa.com/advisor/seminar_details.asp?id=16 or email Emily Mays, NAMSA Marketing Assistant at emays@namsa.com. Last year's seminar held in Zurich sold out. Reserve your space for Brussels
today.
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Sun Chemical Exclusive Distributor for NAMSA Sterilization Indicating
Inks
Applications in
Intelligent Chromatics (AiC), a division of Sun Chemical, the world’s largest producer of printing inks and organic pigments, and NAMSA have
announced a marketing agreement in which AiC will be the exclusive distributor of NAMSA’s Sterilization Indicating Inks.
With its global sales
network, Sun Chemical has developed tailored customer relationships to provide high quality products and services for a wide range of printing needs.
Under this agreement, AiC will offer NAMSA’s indicating inks, which are based on pigment technology that does not use heavy metals. These inks
are available for use in steam, ethylene oxide (EO), dry heat, hydrogen peroxide and steam formaldehyde sterilization processes. They are used
primarily for medical applications, and print as an area that changes color permanently when adequate sterilization treatment has been
applied.
For further
sterilization indicating ink product information, please call Jean-Do Turgis in France at +33 24013 42 40 or Gord Agar in North America at +1 416 970
8174.
NAMSA will continue to
offer our standard Class 1 Chemical Process Indicators (CPIs) and custom labels for radiation, EO, hydrogen peroxide, steam, dry heat and steam
formaldehyde.
Did you
know…
NAMSA can incorporate a
chemical indicator onto an existing label format or create a custom design with your company’s logo.
Custom Indicators
can:
-
Save labor by incorporating all secondary labeling into a single label. Applying a CI dot on to
an existing label? This is a labor intensive process. Simplify by incorporating all label requirements into one dynamic label.
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Add value by providing assurance that a product has been exposed to a given sterilization
process. Already using a CI? Include text on a label to provide additional guidance to the end users. Text could include lot number, expiration date,
instruction like Green is Exposed or Do Not Re-Process.
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Distinguish your product from
the competition by use of a vibrant indicator with an obvious color transition. Is an EO indicator which transitions from light yellow to dark yellow
really providing assurance of exposure or has the ink just darkened with age? NAMSA manufactures 20+ ink color
combinations.
Visit http://www.namsa.com/ or contact NAMSA Product’s Customer Service at 800-860-1888 or 419-662-4345 (outside the
US) to learn more about our CPIs and Custom Indicator products.
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