The past few decades have witnessed huge growth in the field of industrial sterilization for the production of medical devices. Despite this growth, the narrow nature of the field has led to a dearth of published research by experts. To help fill this void, the Association for the Advancement of Medical Instrumentation (AAMI) has published "Industrial Sterilization: Research from the Field" to promote the further development of industrial sterilization science.
“Through its efforts and research, industrial medical device sterilization has become more sophisticated, and an applied science in its own right,” wrote Joseph Lewelling, AAMI’s vice president of standards development, in a column in the publication.
Written by a group of sterilization experts, the 100-page publication is divided into four areas: industrial ethylene oxide sterilization, microbiological methods, steam sterilization, and quality management system and sterility assurance. It is intended as an aid for design and process engineers, operations managers and technicians, corporate quality assurance and regulatory compliance personnel, and others involved in sterilization processes.
The publication includes a paper titled “Basic Concepts in Process Validation” by Donna Swenson, clinical operations manager of the SPD at Mount Sinai Hospital, Synergy Health, PLC, in Chicago. Swenson discusses a number of important topics in her paper, including the difference between validation and verification, two terms that she has seen used interchangeably.
Also included in the publication is a paper titled “Assessment of Bioburden on Samples of Human and Animal Tissues: Part 3—Implications of Results of Bioburden Method Validation Studies on Underlying Premises in ISO 11737-1.” Authors Gregg Mosley, founder and former president of Biotest Laboratories, and John Kowalski, PhD, senior advisor with STERIS Isomedix Services, discuss the validation of bioburden testing described in an earlier paper. Their conclusions lead them to ask broader questions about bioburden test method validations and potential unreliability.
“Using a combination of the inoculated product and repetitive treatment approaches to bioburden method development and validation gives the best opportunity to obtain an accurate bioburden estimate during routine testing,” they conclude.
The publication is available as a PDF for download by clicking HERE. The price is $60 for members and $100 for nonmembers. The print edition will be available soon.