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Videos

April 19, 2018

The Future of Biocompatibility: Industry Trends and Hurdles

The regulatory environment for the biological safety evaluation of medical devices is changing rapidly. Biological safety evaluations following ISO 10993 have traditionally been addressed with biocompatibility testing on animals; however, alternate options are now available to reduce animal testing by using literature research and chemical characterization tests when appropriate. Additionally, there has been considerable progress in the development and standardization of new in vitro test methods. New testing is available for gas pathway devices. Chemistry testing, toxicological risk assessment, and other written evaluations addressing biocompatibility have received wide acceptance. These alternative in vitro methods provide multiple benefits, including: less sample amount, less time required to perform the test, and reduced animal use.
 

  • How can a risk-based approach be used to address biocompatibility
  • How can material and chemical characterization be used to reduce testing burden
  • Update on development of alternative in vitro testing methods for irritation and sensitization
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April 18, 2018

Extractable and Leachable Chemistry Testing: How to Prepare for the Future

Using extractables and leachables chemistry testing to support biocompatibility assessments and cleaning validations for medical devices is now widely accepted, but it remains a moving target as the approaches develop. A variety of chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance. New regulatory draft documents will aide manufacturers in the selection of the application, including the recently published standard ISO 18562 that addresses gas path devices. This presentation will provide a brief overview of the goals of chemical characterization, current approaches, and anticipated changes based on our involvement in industry committees. Attendees will leave informed about how and why we do chemistry testing for medical devices.
 

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February 7, 2018

Chemical Characterization: How to Prepare for the Future in This Time of Transition

Using chemical characterization to support biocompatibility assessments and cleaning validations for medical devices is now widely accepted, but it remains a moving target as the approaches develop. A variety of chemical characterization strategies are now available with differing degrees of scientific rigor and diverse regulatory body acceptance. New regulatory draft documents will aide manufacturers in the selection of the application, including the recently published standard ISO 18562 that addresses gas path devices. This presentation will provide a brief overview of the goals of chemical characterization, current approaches, and anticipated changes based on our involvement in industry committees. Attendees will leave informed about how and why we do chemistry testing for medical devices.

Speaker: Matt Jorgensen, PhD

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November 8, 2017

Satisfying ISO 18562 and FDA Biocompatibility Regulatory Requirements for Breathing Gas Pathways

In March of 2017, the new ISO 18562 standard series was released. This standard covers the general principles regarding biocompatibility assessment of medical device materials which comprise the gas pathway. This standard greatly increases the scrutiny for gas path devices and their required tests. This presentation will cover the required biological endpoints and the unique test methods to test these devices.

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June 14, 2017

Key Factors that Determine a Successful Reusable Medical Device Cleaning Validation

There are many considerations that need to be taken into account by medical device manufacturers when designing reprocessing validations, and it only takes one oversight to cause a failure mode. Alpa Patel, Senior Scientist at Nelson Laboratories and member of AAMI, ASTM, and AATB, will share her expertise in this presentation and discuss the key factors that determine a successful reusable medical device cleaning validation. Participants who attend the presentation will learn:

  • The key factors that determine a successful cleaning validation
  • The current thinking of FDA regarding cleaning validations
  • The main documents relevant to cleaning validations
  • The stages cleaning validations should be considered when designing a reusable medical device
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