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Videos

6/14/2017

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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2/8/2017

MDM West Tech Theater: New FDA Guidance on ISO 10993-1 and How it Affects You

In April of 2016, the FDA released their long-awaited guidance document on ISO 10993. This 65 page document provides insights and changes to how the FDA views biocompatibility. We will discuss the top 10 items in the document that will make the greatest impact; we will also discuss how this update impacts the newest draft of ISO 10993-1. Attendees will expect to learn:

  • The most current FDA trends regarding biocompatibility
  • How to add risk management into biocompatibility
  • How material/chemical characterization plays a role in biocompatibility
  • What’s on the horizon for change in biocompatibility
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12/7/2016

How the new FDA guidance ‘Use of International Standard ISO 10993-1' affects you and your medical device

In April of 2016, the FDA released their long-awaited guidance document on ISO 10993. This 65 page document provides insights and changes to how the FDA views biocompatibility. We will discuss the top 10 items in the document that will make the greatest impact; we will also discuss how this update impacts the newest draft of ISO 10993-1.

Attendees will expect to learn:

  • The most current FDA trends regarding biocompatibility
  • How to add risk management into biocompatibility
  • How material/chemical characterization plays a role in biocompatibility
  • What’s on the horizon for change in biocompatibility
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9/21/2016

Present and Future Changes to Packaging Industry Standards

Packaging standards continue to develop and evolve a decade after the most recent version of ISO 11607:2006 Packaging for Terminally Sterilized Medical Devices.  This presentation will provide an overview of the changes that are currently being discussed as well as working items that are under consideration that could affect the standards tomorrow. It will touch on the changes to the pharmaceutical packaging industry with regards to USP Guidance chapter <1207> PACKAGE INTEGRITY EVALUATION—STERILE PRODUCTS and Medical Device ASTM method work item developments and updates.
 
Presenter: Wendy Mach, Packaging Section Leader
 

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6/28/2016

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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