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PUBLISHED ARTICLE

Testing in Flux: Changing Protocols for a Transformative Industry

Published In: Medical Product Outsourcing Online

As regulations and requirements around the world change, so too do the testing protocols for medical devices, sending OEMs to consult expert partners.


Testing methods and approaches continue to be shaped by regulatory changes. At the end of 2019, the Association for the Advancement of Medical Instrumentation (AAMI) completed a new Technical Information Report (TIR 76), Entitled “Sterilization of Health Care Products—Radiation—Substantiation of a Selected Sterilization Dose at a Specified Sterility Assurance Level: Method VDmaxSD-S.” “This document allows a company to optimize the sterilization dose so it corresponds exactly to its bioburden count, or the company can select a sterilization dose slightly or significantly higher, depending on the specific need of company and product,” said Martell Winters, director of scientific competency for Nelson Labs, a Salt Lake City, Utah-based provider of testing for medical devices.

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Martell Winters

Martell Winters

BS, RM/SM (NRCM), CISS-RAD
Scientific Competency Expert

Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.

Audrey Turley

Audrey Turley

BS, RM (NRCM), CBA (ASQ)
Biocompatibility Expert

Audrey Turley has 20 years of experience working in research, laboratory, and test design functions in the medical device industry. She is a biocompatibility expert having performed all the in vitro tests offered at Nelson Labs, which include cytotoxicity (MEM and agar overlay), hemolysis (PTT, PT, complement activation, blood circulation, ASTM, and NIH methods), and...

Matthew Jorgensen

Matthew Jorgensen

PhD
Chemistry and Materials Scientist

Dr. Jorgensen is an expert in chemistry and materials science. He has over a decade of experience designing, synthesizing, and analyzing complex materials. His analytical chemistry background includes research in organic chemistry synthesizing and analyzing a naturally occurring anti-cancer drug, computational treatment of photothermal spectroscopy, and professionally in a commercial lab. Most of his materials...

Thor Rollins

Thor Rollins

BS, RM (NRCM)
Toxicology and E&L Expert

Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs’ external seminars, webinars, and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has published many articles...

Helin Räägel

Helin Räägel, PhD, is a biocompatibility expert for Nelson Laboratories LLC.