MD&M West

New Approaches to Assessing Biocompatibility for Medical Devices

Audrey Turley

The regulatory environment for biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have typically been addressed with biocompatibility  testing on animals; however, alternate options are now available using literature research and chemical characterization tests when appropriate to reduce animal testing. Considerable progress is being made in the development and standardization of new in vitro test methods; particularly for cytotoxicity, sensitization and irritation, the basic tests performed for any medical device regardless of the device’s application. These alternative in vitro methods provide multiple benefits, including: less sample amount, less time required to perform the test, and reduced animal use.

Click here to view Research Scientist Audrey Turley’s presentation from MD&M West 2016.

What will be learned:
• Learn how to use a risk assessment approach for process and material changes
• Understand how to use material and chemical characterization to reduce animal testing
• Update on development of alternative in vitro testing methods for irritation and sensitization

 

MD&M West 2015: Celebrating 30 Years at the Forefront of Medtech Innovation

– Re-posted from PR Newswire –

SANTA MONICA, Calif., Jan. 12, 2015 /PRNewswire/ — In honor of the 30th anniversary edition of the Medical Design & Manufacturing (MD&M) West exhibition and conference, UBM Canon has announced a blockbuster line-up of content and special show features. As the nation’s largest medtech event, MD&M West 2015 will bring together thousands of global experts in the medical design field to celebrate the brand’s legacy of promoting innovation across the medical device manufacturing community. MD&M West will take place February 10-12, 2015 at the Anaheim Convention Center in Anaheim, CA. For more information and to register, please visit: mdmwest.mddionline.com.

The highlight of the anniversary celebration is the 30-year roundtable at the Center Stage, where veteran industry insiders will debate trends that will rock the medical device industry in 2015 and beyond. Speakers scheduled to attend include:

  • Stuart Herskovitz, President, Qosina
  • Tom Black, Vice President, B. Braun Medical
  • Jeffery Nelson, President and Chief Executive Officer, Nelson Laboratories
  • Brian Nash, Vice President Sales and Marketing, Nusil

Attendees will find a plethora of in-depth and entertaining content for this year’s event such as: a 3D printed drone, former NBA player turned medical device inventor, live product teardowns, guided Innovation Tours of the expo hall, and dedicated Speed Networking sessions right on the show floor. This year will also see the debut of the “Do You Science?” trivia game, where 5 grand prize winners will receive a free Microsoft Surface Tablet, courtesy of Nordson EFD.

In addition to the vast MD&M West exhibition, attendees will also have full access to the entire co-located Anaheim exhibition and conference. Co-located with 7 other advanced manufacturing events in Anaheim, MD&M West brings together thousands of top suppliers from across the nation onto one show floor. Attendees will be able to source the latest design innovations, participate in free networking events, and take advantage of free educational opportunities over three days. Nowhere else will you find the same level of content and resources across industry lines.

Read the complete press release online at www.prnewswire.comFor information about Nelson Laboratories’ MD&M West schedule visit www.nelsonlabs.com.

Healthcare Reprocessing of Medical Devices and Human Factors Debrief presented at MD&M West

The reusable medical device industry is facing challenges regarding device design considerations and usability. The demand for more complex devices has led to the introduction of devices that are difficult to reprocess. These design advances have impacted the sterile processing units in hospitals. Sterile processing department personnel who perform the reprocessing steps and the conditions they work in are referred to as human factor considerations.  Complex medical device designs and other enhancements that do not take these human factor considerations into account may make it difficult, or even impossible, for hospitals to clean, disinfect and sterilize these devices in an effective manner.

Presented by: Emily Mitzel

MD&M West

20140212-101806.jpgAre you visiting MD&M West? Stop by and visit with the Nelson Laboratories experts and find out what’s new in the industry. Nelson is exhibiting in booth 3228.

What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Materials Selection and ISO 10993 Biocompatibility Update

Thor Rollins, Biocompatibility Expert and Consultation MangerCytotoxicity-testing

Agenda:

Thor Rollins will present the latest information on standards affecting materials selection for medical device manufacturers at the 2014 MD&M West Conference. Thor is a Biocompatibility Expert and Consulting Manager at Nelson Laboratories in Salt Lake City, Utah. His presentation will include:

  • An overview of changes to last year’s FDA draft document, including rationale for the changes and how the draft may affect medical device manufacturers
  • Strategies and considerations for selecting materials for devices before development or early in the development cycle
  • What medical device manufacturers can do to proactively ensure materials are safe before the design stage
  • A summary of qualification processes required to ensure the safety of materials

Take Away:

  • Attendees will learn how to make smarter choices while selecting materials for medical devices, allowing them to save time and money later in the validation process
  • Attendees will gain a clearer understanding of the FDA’s intentions regarding implementation of ISO 10993, helping them be prepared before the FDA draft becomes an official guidance document

Details:

Thor will present for approximately one hour at the Nelson Laboratories classroom in 208AB on February 12, 2014 at 10:00 AM.

Register at www.canontradeshows.com/expo/west14/conference-nelson-rsvp.html

Nelson Laboratories website: www.nelsonlabs.com

What You’ll Learn at the MD&M West Nelson Laboratories Classroom on Packaging Test Methods for Validation of Sterile Barrier Materials

Wendy Mach, Section LeaderPackaging-burst-test

Agenda:

Wendy Mach will present various test methods for validating the sterility of medical device packaging at the 2014 MD&M West Conference. Wendy is a Section Leader at Nelson Laboratories in Salt Lake City, Utah. Her presentation will include:

  • How to determine the appropriate sample size
  • How to select and perform tests such as seal peel, burst testing, visual inspection, dye migration, bubble emission, microbial ranking, whole package microbial challenge, and ASTMF 2638
  • How to evaluate packaging test results for the product design file

Take Away:

  • Attendees will learn to select the best test method to validate their medical device packaging

Details:

Wendy will present for approximately one hour at the Nelson Laboratories classroom in 208AB on February 12, 2014 at 2:00 PM.

Register at www.canontradeshows.com/expo/west14/conference-nelson-rsvp.html

Nelson Laboratories website: www.nelsonlabs.com