Planning your MD&M East 2016 schedule? Make sure you leave room for Nelson Laboratories, Inc. We are proud to announce that we will be exhibiting in booth #1838 at the MD&M East 2016 in New York, NY June 14-16, 2016.
We will be presenting a half-day seminar session and in the Tech Theater.
Seminar: Tuesday, June 14, 2016, 1:00- 4:30 PM
Title: Sterilization Validation and Biocompatibility for Medtech Companies
Dan Floyd, Ethylene Oxide and Radiation Sterilization Validations Overview for Medical Devices
High level overview of radiation and EO validation procedures
Tricks and tips on how to complete a successful sterilization validation
Thor Rollins, Biocompatibility: Understand the basic testing requirements of ISO10993 an how to choose the correct methods for your product.
This presentation is designed to help you understand what the basic testing requirements
How to categorize your products according to the ISO 10993 table
How to interpret the results cytotoxicity, sensitization, and irritation
What to do if you fail a test
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.
Everything necessary to collect and send a sample from a reprocessed endoscope for testing to determine the presence or absence of objectionable microorganisms will be provided in the kit offered by Healthmark. The sample will be sent by the healthcare facility to Nelson Labs for independent testing of the sample for the presence of any microorganisms. If present, the organisms will be identified and quantified.
The Endoscope Sampling Kit is intended to be used as a proficiency assessment for healthcare practices and not as a safety assessment for the reprocessed scope (not a “fitness for use” test). This surveillance assessment is important to help the clinical user determine if their scope is safe for use, requires additional reprocessing, requires additional testing or should be quarantined. The kit and related tests are intended as another help to assess the adequacy of healthcare facility scope reprocessing.