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Posted: May 17, 2016

Nelson Laboratories and Healthmark have Joined Forces to Offer a Surveillance Tool for Testing of Duoendoscopes

SALT LAKE CITY, UT AND FRASER, MI – May 17, 2016 – Nelson Laboratories and Healthmark Industries today announced the introduction of an Endoscope Sampling Kit for the random testing of duodenoscopes in compliance with CDC guidelines. Endoscope manufacturers, regulatory bodies and healthcare facilities are increasingly concerned about the spread of communicable diseases, including clinically relevant microorganisms, on reprocessed medical devices. Healthmark Industries and Nelson Laboratories have joined forces to create an endoscope sampling kit for the purpose of monitoring and reporting objective results from clinical scopes.

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Posted: October 3, 2016

Top 3 Questions About Extractable/Leachable Testing

By Matthew R. Jorgensen, PhD
Published: MD+DI online

Extractable/leachable chemistry testing can save, time, money, and animal life for certain classes of devices. Over the past decade, regulatory bodies have shifted their evaluation of biocompatibility from a strict linear approach to a less linear approach that includes in vitro tests and assessment using chemistry. Chemistry has the advantage of providing detailed information on the identity and amount of substances that can leave devices, while traditional biocompatibility tests are pass or fail. The challenge with chemistry can be that a deeper understanding of device materials and the science of extractable/leachable testing is required to correctly interpret results. Fortunately, for those companies without expertise in using chemistry to fulfill regulatory requirements, help is available through consulting services. The following are three frequently asked questions when consulting on these matters.

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Posted: November 22, 2016

IMRP Roundup

The 40th International Meeting on Radiation Processing (iia) was held two weeks ago in Vancouver, Canada. Nelson Laboratories’ Senior Scientists Martell Winters and Wendy Wangsgard, PhD attended. Winters was the Program Chair and also led a preconference day workshop on dose audit failures. Wangsgard chaired the Healthcare Strand session on radiation microbiology. The discussion covered microbiology […]

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Posted: June, 28 2016

How to Use Biocompatibility to Evaluate Changes in a Medical Device

Medical devices often go through many changes throughout their normal product lifecycles. Whenever a device goes through one of these changes, it should also undergo a review to determine the impact the change had on the biological safety of the device. While many changes have little impact and can be justified based on the minimal risk, other changes (or a compilation of changes) could pose a serious biological safety impact and require a revalidation. This presentation will cover the questions manufacturers need to ask to determine what impact changes may bring to their devices and the testing that should be performed to measure the impact of these changes.

Bullet Points:

• How to use chemical characterization to evaluate a change
• Questions to ask to determine the biological impact of a change
• What if I am changing or adding a colorant?
• What testing do I need to repeat to demonstrate a change is safe?
• Determining the possible impact of changing to 3D printing

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