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.
Posted: October 3, 2016
By Matthew R. Jorgensen, PhD
Published: MD+DI online
Posted: November 22, 2016
Posted: June, 28 2016
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.
• 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