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News Articles

ARTICLE

Posted: November 14, 2017

How to Select Sterile Barrier Systems for Reusable Medical Devices

By Jason Pope,  B.S., ASQ CQA
Published: Medical Design & Outsourcing
 

Sterile barrier systems are key components in medical device sterilization, so selecting the right barrier is essential. Reusable medical devices, prior to use in healthcare facilities, must undergo validation testing to demonstrate the effectiveness of the cleaning instructions and the microbiocidal instructions that will be provided to the healthcare facility. Often, the microbiocidal process that’s validated for a reusable medical device is a set of sterilization instructions.

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ARTICLE

Posted: August 9, 2017

Container Closure Integrity Testing Through Mass Extraction

By Andrew Manrique, B.S., CPLP (ISTA) 
Published: Packaging Digest

A package with a breach will not act as a sterile barrier, and the product contained within may reach the end user in a contaminated condition. Due to the high risk associated with a contaminated product, manufacturing companies spend significant time, money, and resources on creating and testing functional packaging. One of the most important integrity tests is container closure integrity (CCI).

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ARTICLE

Posted: June 22, 2017

Marketing Hospital Textiles in the EU Market

By Janelle Bentz, MS
Published: Nonwovens Report International (Issue 4)

Complications after surgical procedures are a major cause of death and disability worldwide. These complications are often caused by bacteria that are typically safe, but they lead to healthcare acquired infections (HAIs) when they breach the sterile field during operation. The sterile field is maintained in the surgical suite by the use of protective barriers, such as surgical drapes, gowns and clean air suits.

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ARTICLE

Posted: May 18, 2017

Is Your Biocompatibility Program on the Edge?

By Thor Rollins
Published: Medical Products Outsourcing Magazine

Regulatory changes in both Europe and the U.S. have created uncertainty among device makers.

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ARTICLE

Posted: April 3, 2017

Extractable/Leachable Chemistry Testing Strategies for Medical Devices

By Matthew R Jorgensen, Ph.D., and Thor Rollins, BS, Nelson Laboratories; Allison Komiyama, Ph.D., RAC, AcKnowledge RS
Published: Medical Device Outsourcing 

It has become more prevalent and acceptable to use the results of chemistry testing to assess the overall biocompatibility of medical devices. For many devices with prolonged or permanent patient contact, chemistry followed by toxicological assessment can provide a cost and time saving alternative to in vivo tests such as chronic, sub-chronic, genetic, and carcinogenicity testing. Manufacturers preparing to submit their device for approval by the U.S. Food and Drug Administration (FDA) rely on ISO 10993 standards and FDA guidance on the application of those standards in the planning of their chemistry testing. When it comes to the details of chemistry testing, however, the ISO standards are often vague. Furthermore, the recommendations regarding the appropriate level of testing rigor can vary within FDA. The following offers a brief overview of the framework provided by ISO 10993 guidance documents for extractable/leachable (E/L) testing, as well as three testing strategies that satisfy both ISO 10993 and FDA requirements.

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