Martell Winters

Martell Winters Recognized at AATB

By Alyessa D’Ewart, MPC

martellMartell Winters, senior scientist at Nelson Laboratories, received the Jeanne Mowe Distinguished Service Award by the American Association of Tissue Banks on Wednesday, September 21, 2016. Martell was chosen to receive this award due to his contributions to the tissue banking and transplantation industries. He is an active committee member of many working groups with AATB, and currently serves as the AATB liaison to the AAMI Radiation Working Group. Martell has also made great contributions to the radiation sterilization standards for human tissue-based products.

“I am honored to receive this award,” Martell said. “I have enjoyed working with the members of AATB, and look forward to continuing to contribute to the tissue industry.”

About the award from AATB’s website: “The Jeanne C. Mowe Distinguished Service Award recognizes an individual who has made a significant contribution in tissue banking or transplantation, whether in research, education, or laboratory improvement, or who has served the Association or the field of tissue banking. The individual should have demonstrated leadership qualities and a consistent willingness to lend his or her expertise to the Association and/or to his or her peers. The recipient shall be a member in good standing of the Association.”

Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

Thor Rollins, Martell Winters, and Matthew Jorgensen, PhD collaborated on a whitepaper that is available for download: Considerations for Sterilization and Biocompatibility of 3D-Printed Orthopedic Devices

This whitepaper is an in-depth look at the various biocompatibility and sterilization considerations surrounding 3D-printed orthopedic devices. 3D-printed orthopedic medical devices are gaining attention and popularity due to their potential for enhanced biocompatibility, customizability, and cost-effectiveness. As of late 2015, FDA had cleared more than 85 total 3D-printed medical devices, with more regulatory clearances on the horizon.

The whitepaper is available for download on the Qmed website http://directory.qmed.com/download-this-whitepaper-to-learn-about-the-file068515.html or click HERE.

Martell Winters Shares Expertise with University Students

martell_winters_3Martell Winters, consultant and senior scientist at Nelson Laboratories, is now instructing a course at Brigham Young University (BYU) entitled “Industrial Microbiology and Sterilization.” The course is limited to juniors, seniors, and graduate students and is focused on providing a thorough review of microbiology in the medical device industry. For years BYU has provided an excellent education in the department of microbiology and molecular biology. However, it was recognized that a good foundation in industrial microbiology and sterilization microbiology was missing.

Martell worked closely with Dr. Rich Robison (professor and Department Chair) and Hyrum Shumway (graduate student and TA) at BYU to develop a comprehensive curriculum to cover such topics as FDA regulatory requirements, validation concepts, terminal sterilization (including EO, radiation and steam), reusable medical devices, aseptic processing, water treatment, and biological evaluations/biocompatibility. Also incorporated into the course are several company tours to medical device manufacturers, Nelson Laboratories, a water treatment plant and a hospital central processing department. This is an exciting program as it will give students an opportunity to learn from industry experts as well as great preparation for those who want to enter into the medical device/pharmaceutical/sterilization industries.

Martell is an industry leader in microbiology and sterilization and has over 20 years of experience working with companies to improve their processes.  He is also an active committee member of many working groups for multiple regulatory bodies, and has been integral in the creation of multiple standards in place today. His expertise in these areas makes him well qualified to develop and teach this course.

ISO Meeting in Australia Updates International Standards for Medical Device Testing and Validation

Tissue testingBy Martell Winters, Senior Scientist, Nelson Laboratories

The International Organization for Standardization (ISO) hosted the Sterilization of Health Care Products Committee meeting (ISO Technical Committee 198) to update the worldwide standards used for testing and validating medical devices.

Australia was the site of this year’s meeting. I attended and served as a delegate from the United States to provide input to several documents. As part of the U.S. delegation, I contributed to discussions surrounding ISO 18362 for aseptic processing as well as ISO 11737-1 for microbiological methods.

ISO 18362 is a document detailing the minimum requirements for manufacturing cell-based health care products which are not terminally sterilized. Before attending the ISO meeting, my fellow U.S. delegates and I met to discuss and submit comments about the current document, and what we would like to see changed. We had mostly editorial comments rather than technical changes to the standard at this meeting.

This standard will help companies navigate the complexities of processing tissues and cells in a way that controls microbial contamination. Tissues and cells often cannot be sterilized by traditional means without affecting their functionality and thus are forced into an aseptic processing scenario.

This ISO 18362 document will go out for a Draft International Standard (DIS) vote. After approvals and edits, and a final vote, the new ISO standard will be implemented.

We also discussed the revision of the standard for testing and validating product bioburden—standard ISO 11737-1.  While we will likely not include any new requirements in this revision, we are adding more guidance to assist manufacturers in setting up tests and interpreting bioburden data.

For example, we are including better guidelines for determining the advantages and disadvantages to pooling multiple samples into one bioburden test when there is low contamination on a device, as opposed to using a different sample for every test.

The revision to the ISO 11737-1 standard is a result of questions we frequently receive from people unfamiliar with bioburden testing. The standard has addressed some of these questions previously but without much or any detail. A new draft of the standard should be sent out for a first review later in the year.

MD&M Texas

MDM_Seminar_Event_imageNelson Laboratories will be exhibiting at the MD&M Texas show, May 7-8, 2014, at the Fort Worth Convention Center in booth #523.

Presentation: Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels of Bioburden Excursions

During the two-day conference and showcase Martell Winters, Senior Scientist at Nelson Laboratories, will be presenting a Learning Lab on Thursday May 8th from 10:00- 11:45 am. He will be presenting Medical Device Sterilization: Selection of SAL, Evaluation of Bioburden Data, Alert and Action Levels and Bioburden Excursions to help manufacturers understand sterility assurance and bioburden data. Of interest to medical device manufacturers is the “absolute” necessity of a 10^-6 sterility assurance level (SAL), use of “less-than” values with bioburden data and properly establishing alert and action levels. These topics are applicable to all forms of sterilization (e.g. ethylene oxide, radiation, etc.) and all product types, but are of special interest to combination products, biologics and tissues.

Register now for this exclusive event.

If you can’t make the Learning Lab presentation, Mr. Winters will also present at the Tech Theater on Wednesday May 7th from 1:00-1:30 pm on “Updates to the Bioburden Standard ISO 11737-1; Significant Additional Guidance. P.S. What Happened to the Microbiologists?”. If you would like to meet one on one with Mr. Winters, he will be available in the Nelson booth for FREE consulting sessions, a $500 value. Availability will be determined on a first come, first served basis. If you would like to reserve a time for a consult in advance, please email mpizzi@nelsonlabs.com.

Below are topics that Mr. Winters will be available to discuss at MD&M Texas:

  • Radiation sterilization
  • Selection of SAL
  • Aseptic Processing
  • Evaluating of bioburden data
  • Bioburden alert and action levels
  • Environmental monitoring
  • Manufacturing microbiology

Don’t forget to stop by booth #523 to speak with Nelson representatives.

Location:
Fort Worth Convention Center
1201 Houston St.
Fort Worth, TX 76102
Booth #523

What You’ll Learn by Attending the MD&M West Nelson Laboratories Classroom on Radiation Sterilization Validation Overview

Martell Winters, Senior ScientistRadiation-sterilization

Martell Winters will present an overview on radiation sterilization at the 2014 MD&M West Conference. Martell is a Senior Scientist at Nelson Laboratories in Salt Lake City, Utah. His presentation will include:

  • Bioburden Testing: How it is performed and what constitutes a good bioburden count
  • Sterility Testing: How it is performed and how to avoid sterility test failures
  • Sterility Suitability Testing (also called B/F): How it is performed and how it relates to sterility testing
  • Radiation Validation: Review of applicable methods and standards
  • Case Studies: Review bioburden and sterility test data to understand approaches to a successful radiation sterilization validation

Take Away:

  • Attendees will learn how to evaluate bioburden data for establishing and monitoring radiation sterilization processes
  • Attendees will be educated as to how method suitability testing can help them receive the best sterility test results the first time around
  • Attendees will gain an understanding of what typically causes sterility test failures and how to avoid them

Details:

Martell will present for approximately one hour at the Nelson Labs classroom in 208AB on February 12, 2014 at 1:00 PM.

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

Nelson Laboratories website: www.nelsonlabs.com